DarshanTalks Podcast: Recent Episodes
Darshan Kulkarni
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical trials, and personalized patient care. As AI-driven technologies become more integrated into these processes, the allure of acquiring AI-powered companies grows stronger. However, the complexities that come with AI introduce significant risks, especially when it comes to mergers and acquisitions (M&A). Life sciences attorneys must move beyond just understanding AI technology—they need to be deeply familiar with the regulatory, ethical, and legal intricacies that AI introduces in these transactions.
At the heart of successful M&A due diligence involving AI companies lies a deep dive into regulatory compliance. Life sciences is one of the most heavily regulated industries globally, and AI technologies operating within this space must comply with laws such as FDA guidelines, GDPR for data privacy, and HIPAA for patient data protection. Failing to evaluate the target company’s compliance with these regulations can lead to severe penalties and jeopardize the entire deal. Attorneys must ensure that AI systems are compliant to avoid unexpected liabilities post-acquisition.
Another critical area is intellectual property (IP). AI-driven companies typically possess valuable assets, such as proprietary algorithms and data models, but ownership of these assets is not always clear-cut. Life sciences attorneys need to thoroughly review the IP portfolio to ensure full ownership and absence of any disputes or pending litigation. Overlooking these issues can result in future challenges, potentially devaluing the acquisition. Partnering with experienced IP counsel during the due diligence process is crucial to securing a clean and clear transfer of assets.
Data integrity and security are also paramount in AI-driven life sciences companies. AI is only as good as the data it is trained on, and flawed or biased data can lead to catastrophic outcomes, especially in critical areas like patient care. Attorneys must assess the quality, source, and security of the data, ensuring that robust security measures are in place to protect sensitive patient information. This is non-negotiable in a sector where data breaches or flawed AI outcomes can lead to massive financial and reputational damage.
Lastly, ethical considerations must be part of the M&A conversation. AI systems in life sciences raise issues of transparency, accountability, and bias, and attorneys must evaluate whether the target company adheres to ethical standards. This includes ensuring human oversight over AI decisions and preventing biased outcomes that could lead to discriminatory practices. Failing to address these ethical considerations could harm the acquiring company’s reputation and market standing in a sector where trust is paramount.
In conclusion, while AI holds immense potential in life sciences, the risks associated with acquiring AI-driven companies cannot be ignored. Thorough due diligence—covering regulatory compliance, intellectual property, data integrity, and ethical considerations—is essential to a successful M&A transaction. The Kulkarni Law Firm, with its deep understanding of both AI technology and the life sciences regulatory landscape, is uniquely positioned to guide companies through these complex processes, ensuring that all risks are identified and managed effectively. For those seeking expert legal advice on AI-driven M&A, the Kulkarni Law Firm is your trusted partner. Reach out to us today to safeguard your business objectives and ensure a smooth and compliant acquisition.
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Healthcare and life sciences are on the brink of transformative change, fueled by a combination of technological innovation, ideological shifts, and evolving regulations. Visionaries like Elon Musk, Vivek Ramaswamy, and RFK Jr. are advocating for decentralization in healthcare, pushing for more personal control over patient data. While decentralization promises to reduce federal oversight, potentially lowering compliance costs and streamlining operations, it also raises serious concerns about the security and privacy of health data. Weakened federal regulations like HIPAA could lead to increased risks of data breaches and misuse, and state laws may not be enough to fill the gaps.
Elon Musk’s innovations, such as integrating Neuralink with blockchain technology, could pave the way for patient-owned data systems, allowing individuals to control and even monetize their health information. However, this could create a divide between tech-savvy individuals who benefit from these systems and others who remain vulnerable due to a lack of access or understanding. RFK Jr.’s approach to decentralization could shift more power to states and private entities, resulting in a patchwork of privacy standards. While this could encourage innovation, it could also complicate compliance, increase disparities, and challenge the interoperability of health data across states.
The move towards decentralization and innovation comes with significant risks. Who will ensure AI systems process patient data securely, without bias, and in compliance with regulations? How will healthcare and pharmaceutical companies maintain accountability in a less-regulated environment? The balance between fostering innovation and protecting patient rights is critical. Companies in this sector must stay ahead of these changes with strategic legal guidance to ensure compliance and safeguard patient interests in this rapidly evolving landscape.
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In this episode, we're diving into the intersection of technology and healthcare, specifically the role of Artificial Intelligence (AI) in clinical trials. As a Food and Drug lawyer, Darshan has seen firsthand how AI is revolutionizing drug development and testing. The FDA is closely monitoring this shift, recognizing the potential of AI to enhance patient outcomes, improve trial efficiency, and reduce costs.
However, it’s not all smooth sailing. AI can help identify the right patients for specific treatments, but it’s crucial to address potential biases in AI algorithms, which could affect diversity in clinical trials. AI can also streamline trial processes, but the “black box” nature of how decisions are made raises concerns about transparency and fairness. Cost reduction is often touted, yet we’re still waiting to see if AI will truly lower expenses in the long run.
Data privacy and security are also big considerations. With AI relying on massive data sets, how can we ensure patient privacy is protected? And who truly owns the data? Algorithmic bias is another serious concern—especially when it comes to underrepresented patient populations.
The FDA is working on issuing guidance for AI in clinical trials, but we’re still in the early stages. They are encouraging collaboration between industry, academia, and other stakeholders to develop best practices. Plus, the FDA is investing in research to better understand both the benefits and risks of AI in healthcare.
In the end, AI’s potential is enormous, but we need to be careful about how it’s implemented. What do you think are the biggest challenges when using AI in clinical trials? Drop your thoughts in the comments!
And if you’re a drug or medical device company looking to leverage AI, reach out to us at Kulkarni Law Firm for legal guidance through the complex regulatory landscape. Visit our website for more info.
Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance in the pharmaceutical industry.
Key topics include:
- What is Ad Promo?
- Chevron decision's influence on FDA/FTC
- Should administrative agencies cite letters?
- Can the FDA establish rules after someone challenges them?
- Uncertainty of Compliance White Space
- Is regulatory medical advice now just seen as a risk?
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Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.
In one notable case, PIs were prosecuted due to inadequate training and oversight of research staff. Study coordinators, often without relevant research experience and from low-wage backgrounds, were left to manage studies without proper guidance. This lack of training led to errors and potential fraud, highlighting a crucial gap in compliance.
Ensuring that all research staff are properly trained is essential for the integrity of clinical trials. If you need help developing a robust clinical research program, reach out to me.
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Neuralink recently received the FDA's Breakthrough Device label for its neural implant aimed at restoring vision to the blind by interfacing with the brain. While this sounds like a monumental achievement, it's important to understand that the Breakthrough Device program merely expedites the review process for promising innovations without guaranteeing approval or effectiveness. Essentially, this label serves more as a marketing badge than a concrete breakthrough at this stage. While there's hope for the technology's potential, it's crucial to remain skeptical and not let flashy terms cloud judgment. Real-world results are still a significant distance away.
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DOJ filed criminal charges against 193 defendants, including 76 medical professionals for telemedicine violation. This alarming crackdown reveals the vulnerabilities within telemedicine, as illegal kickbacks and brief consultations have led to significant fraud, particularly in Medicare claims.
Among the troubling cases highlighted, one psychiatrist was accused of billing for telehealth visits lasting only 10 to 30 seconds, falsely classified as legitimate patient consultations. The DOJ’s focus on these practices serves as a critical reminder that telehealth providers must adhere to stringent federal and state regulations to avoid legal repercussions, including criminal charges and loss of medical licenses.
Healthcare practitioners are urged to ensure their telehealth practices are not only clinically sound but also compliant with legal standards. For those in the telehealth space, seeking legal guidance is paramount to safeguarding their practices and upholding patient care standards. The Kulkarni Law Firm is available to assist healthcare professionals in navigating these challenges and avoiding potential fraud schemes.
As the telemedicine landscape evolves, it's vital to consider whether the convenience of remote consultations outweighs the increased scrutiny and risks associated with them. Join the conversation by sharing your thoughts on the future of telehealth in the comments below.
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In this episode, Heather McFalls discusses the pros and cons of in-house versus outsourced advertising compliance roles, along with tips for new regulatory professionals to embed themselves and add value. They also explore how the shift from FDA to FTC oversight may impact Ad Promo training and mentorship.
We discuss,
1. Role as a Director of Advertising & Promotion.
2. Is this job typically done in-house, or is it often outsourced?
3. What are the biggest advantages and disadvantages of using in-house staff for ad promo?
4. What are the pros and cons of using outside contractors for ad promo?
5. How does one get embedded as a contractor or as a full-time employee?
6. What advice do you have for new regulatory professionals to become more embedded and add value?
7. Is the shift from FDA to FTC letters affecting ad promo training?
8. Opportunity of mentorship for newer reviewers
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Nature and Vox highlight the severe consequences of research fraud and its widespread impact on sectors like marketing, clinical research, medical affairs, regulatory compliance, and legal practices. Fraud can manifest in various ways, such as fabricating data or manipulating results, and its effects are far-reaching.
The Nature article stresses that fraudulent research erodes public trust in science and endangers patient safety, especially in the pharmaceutical and medical device industries, where fraud can lead to legal issues, financial losses, and reputational damage. For marketers and medical affairs teams, relying on invalid clinical data can result in severe regulatory penalties and brand damage.
Clinical researchers and physicians face additional risks, as relying on faulty research for treatment decisions could harm patients, leading to legal liabilities. Regulatory professionals and life sciences attorneys must stay vigilant in identifying red flags in research to advise clients on avoiding compliance pitfalls.
At Kulkarni Law Firm, we focus on FDA regulatory compliance, clinical research, and pharmaceutical advertising law. Reach out to us today to ensure your work remains compliant and beyond reproach.
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Influencers are NOT KOLs. We discuss using key opinion leaders (KOLs) and influencers in pharmaceutical and medical device marketing.
Key Takeaways:
- Influencers vs. KOLs: Influencers have large social media followings and can engage younger demographics, while KOLs are respected experts whose endorsements are based on scientific evidence.
- Benefits and Risks: Influencers can create relatable content but risk non-compliance, while KOLs offer credibility but may deliver more conservative messages.
Best Practices:
- Align with influencers and KOLs who match your target audience.
- Ensure understanding of regulatory requirements.
- Conduct thorough vetting and provide training.
- Establish clear contracts and monitor content for compliance.
For Life Sciences Attorneys:
It's vital to review contracts, monitor content, and collaborate with marketing teams to protect company interests.
For more insights, subscribe to our podcast and reach out to the Kulkarni Law Firm for guidance on navigating influencer campaigns while minimizing legal risks.
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In this episode, we’re diving into a crucial topic: the role of artificial intelligence in clinical research and the evolving landscape of data privacy laws that will impact every step of the process.
In this episode, we’ll be unpacking insights from Dr. ElZarrad, the FDA’s Deputy Director for the Office of Medical Policy, on how AI is shaping clinical trial design and research. We’ll also explore how AI can speed up trials, enhance patient recruitment, and even predict outcomes with greater accuracy. But with these advancements comes a significant responsibility, especially when it comes to patient data privacy. We'll talk about how laws like HIPAA, GDPR, CCPA, and others play a crucial role in safeguarding sensitive patient data at every step of AI development.
If you're as passionate about the future of clinical research as we are, hit **like, subscribe, and share—it really helps grow the channel!
Now, let’s start from the beginning: Why is AI such a game-changer in clinical research? Well, it enables researchers to analyze vast datasets quickly, allowing for more tailored, personalized therapies. It’s a breakthrough for precision medicine and personalized healthcare, and if we get this right, it could transform the entire industry.
Dr. Dr. ElZarrad from the FDA highlights how AI can identify eligible patients more effectively and analyze real-time data, speeding up clinical trials significantly. AI also supports the rise of decentralized trials, where patients can participate remotely, making trials more accessible and diverse. This shift will be crucial, especially given the recent clinical trials guidance and the growing role of telemedicine.
Of course, with this technological power comes the critical need for transparency and patient consent. AI relies heavily on sensitive data like medical histories, genetic information, and treatment responses. We’ll also dive into the different layers of privacy laws—from data collection to tracking and communication regulations—and discuss why ensuring compliance at every stage is essential for maintaining trust and avoiding major legal pitfalls.
Stay tuned as we break down these complexities and offer practical tips for staying compliant in this ever-evolving space.
Eli Lilly's changed its opinion on Off-Label uses! Eli Lilly, a company that makes a diabetes drug, is now urging people not to use it for weight loss, a common off-label use, despite not raising concerns about off-label uses in the past. Off-label use, where a drug is used for something other than its original purpose, is a normal part of healthcare, and the FDA acknowledges this practice. However, Lilly's sudden stance seems driven by a shortage of the drug, which they want to prioritize for diabetes patients. This shift appears more about supply management than safety. It's crucial that companies and regulatory bodies maintain consistent messaging to avoid confusion and ensure patient care remains a priority.
Let's continue advocating for what's best for patients.
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In this episode, Isaac Rodriguez- Chavez and I discuss the impact of DCTs on sponsor relationships, CROs, and industry dynamics with the FDA.
We discuss,
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How will DCTs impact sponsor relationships with CROs?
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How do small CROs and sponsors adapt to emerging trends?
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How do new trends impact industry relationships with the FDA?
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Does DCT allows the FDA to advise sponsors?
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What is the role of technology in DCTs?
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How do DCTs reduce the cost of bringing drugs to the market?
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What are the risks and advantages of DCTs?
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What are the initial risks of DCTs?
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Does the FDA even have jurisdiction over patient privacy?
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In this episode, we discuss the importance of integrating insurance considerations into the due diligence process during M&A transactions with Kenneth White.
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We'll briefly discuss when a pharmacist might choose not to dispense medication, even with a valid doctor's order.
In a recent case, a doctor sued the Iowa Board of Pharmacy and the Iowa Board of Medicine when a pharmacy refused to fill a prescription for Ivermectin, a livestock drug sometimes used to treat parasites in people and allegedly COVID-19. This incident highlights a dilemma in the pharmacy world, especially post-pandemic. While pharmacists ensure the safety and appropriateness of medication, the debate around drugs like Ivermectin has spotlighted their autonomy and clinical judgment. Many states require pharmacists to act independently, determining the appropriateness of therapy in conjunction with doctors. This independent role can impact reimbursement, licensing, and job descriptions.
Switching gears, we also discuss pharmacists refusing to dispense birth control due to personal beliefs. A USA Today story exposed a scenario where a pharmacist refused to fill a birth control prescription, citing faith as the reason. Such actions raise questions about the extent to which pharmacists can exercise independent medical judgment.
Governmental authorities, like the Department of Health and Human Services, argue against pharmacists withholding medications based on personal beliefs, stating it creates barriers to essential healthcare. However, courts often decide these cases on a state-by-state basis.
As pharmacists, you're trusted to make decisions prioritizing patient care. These instances stress the traditional framework, urging a discussion on balancing professional discretion with medical guidelines. The ongoing cases and complex conversations invite deeper exploration into the ethics, laws, and evolving roles of pharmacists.
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Today we're delving into the evolving role of artificial intelligence (AI) in drug development and clinical trial design. We’ll explore the key concerns raised by the FDA and insights from Dr. ElZarrad on integrating AI into clinical research.
AI has the potential to transform clinical trials by enhancing efficiency, accuracy, and outcomes. However, several challenges must be addressed to ensure its effective and ethical use. The FDA has highlighted six primary concerns:
- Bias: Variability in data quality and representativeness can introduce bias, affecting the reliability of AI-driven results.
- Data Quality and Relevance: AI models may be ineffective if they rely on irrelevant or incomplete data.
- Fitness of AI Models: The applicability and robustness of AI models in diverse clinical scenarios are crucial.
- Transparency: The complexity of AI methods can lead to challenges in interpreting and trusting AI-driven decisions.
- Uncertainty: Difficulties in interpreting AI models can create uncertainty in clinical trial decision-making.
- Performance Degradation: AI models may experience performance issues or data drift over time.
To address these concerns, it’s vital to use diverse, high-quality data for training AI models, implement rigorous validation processes, enhance transparency through interoperable algorithms, and continuously monitor model performance.Understanding and tackling these challenges will help harness AI's potential to improve clinical research.
Stay tuned for more discussions on the latest developments in drug and medical device law from the Kulkarni Law Firm.
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Patient Advocates play a crucial role in the pharmaceutical industry, especially in clinical research. They serve as the voice of patients, ensuring their needs and concerns are addressed throughout the drug development process. Here's a simple breakdown of their contributions and when their involvement might not be ideal.
Why Are Patient Advocates Important?
1. Improving Clinical Trial Design: Patient Advocates provide valuable insights into patient experiences and needs. Their feedback helps researchers design more patient-friendly clinical trials, leading to higher participation rates and more reliable results.
2. Bridging the Gap: They help bridge the communication gap between pharmaceutical companies and patients. By ensuring clear and understandable communication, they aid in better recruitment and retention of patients in clinical trials.
3. Ensuring Transparency: Advocates promote transparency and trust by fully informing patients about the trials, including the risks and benefits. This transparency builds trust and encourages more patients to participate.
When Might Patient Advocates Not Be the Best Choice?
1. Overcomplicating Simple Studies: In straightforward clinical trials, involving Patient Advocates can add unnecessary complexity. For very clear protocols, this additional layer might slow down the process without adding significant value.
2. Misalignment of Goals: Sometimes, the goals of Patient Advocates and pharmaceutical companies may not align perfectly. If Advocates push for changes that conflict with the scientific or regulatory goals of the study, it can create conflicts and delay research.
3. Limited Expertise in Specialized Areas: In highly technical or specialized areas, Patient Advocates may lack the necessary expertise to contribute meaningfully. For example, in rare disease states or cutting-edge technologies, the required insights may be highly technical and specific, beyond the scope of patient advocate knowledge.
While Patient Advocates are invaluable in many aspects of clinical research, their involvement should be carefully considered based on the study's complexity and specific needs. Proper alignment and clear communication between all parties can help maximize the benefits of involving Patient Advocates.
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In this episode, we discuss key risks a life sciences company should consider during an acquisition with Kenneth White. We also explore the role of insurers in managing these risks.
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Pharmacists often use a process of elimination to decipher doctors' handwritten prescriptions. Pharmacists rely on clues like drug names and doses, this method isn’t foolproof. If the handwriting is unclear, identifying the correct medication can be challenging, leading to potential errors. The shift to electronic prescribing has improved accuracy and reduced confusion. For more insights on this topic, check out my video linked below.
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We explore how AI is transforming content generation in the pharmaceutical industry, particularly in marketing, sales, and medical engagements. While AI presents groundbreaking opportunities, it also raises critical challenges, notably concerning data ownership and compliance.
A significant issue is the lack of clarity around ownership of input and output data, illustrated by legal disputes like The New York Times suing OpenAI. For pharma companies, the stakes are high due to stringent FDA regulations. Missteps in AI-generated promotional materials can lead to hefty fines and reputational damage.
We discuss the importance of rigorous internal reviews (PRC and MLR) for sales and marketing teams to ensure compliance and accuracy. Medical Affairs must also prioritize precision in AI-generated content to avoid misinformation that could harm patients.
AI holds immense potential, but navigating issues of data ownership, regulatory compliance, and accuracy is essential for pharma companies. Join us for more discussions on AI in pharma, and feel free to reach out with topics you'd like us to cover!
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In this episode, we are joined by Istvan Fekete to have a discussion over tech transfer offices, IP, and more. The video explains what tech transfer offices are, their significance in the research ecosystem, and why they might be the best place to negotiate equity stakes in intellectual property (IP) created by investigators, especially when funded by charitable organisations. We discuss the pros and cons of sponsors seeking a return on investment (ROI). Additionally, the video delves into the interest of physicians in the outputs, offering a comprehensive overview of how to navigate these complex relationships and interests effectively.
Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there’s the chemical name, which is a technical identifier describing the drug’s molecular structure—these names are often long and complex, like “acetylsalicylic acid,” and are more for scientific use. Next, there’s the generic name, which is what most people are familiar with, such as “penicillin” or “aspirin.” These names are standardized and easier to remember. Finally, there’s the brand name, which is where the complexity often comes into play.
While pharmaceutical companies aim to create brand names that are simple and easy to remember, there are several critical factors they must consider. The FDA mandates that brand names be unique and not easily confused with other existing drug names. This is crucial because a mix-up at the prescribing stage could lead to serious health risks if a patient receives the wrong medication. To prevent this, companies must ensure their drug names don’t look or sound too similar to any others on the market.
In addition to FDA requirements, there are also intellectual property concerns. A drug’s trademark must be unique, which means it can’t infringe on existing trademarks. Balancing these various interests often results in drug names that are more complex than they might otherwise be. Some companies even go so far as to purchase a pre-approved drug name, sometimes paying millions of dollars, to avoid delays in bringing their drug to market. Every day a drug isn’t on the market can result in significant financial losses, making it worthwhile to invest in a unique, approved name.
In summary, the complexity of drug names is the result of a careful balancing act between FDA guidelines, intellectual property laws, and marketing considerations. The goal is to create a name that is distinctive, memorable, and safe to use in the healthcare setting. Darshan’s insight into this process sheds light on the intricate considerations behind something as seemingly simple as a drug’s name.
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In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency reviews. The discussion will also cover the potential benefits of involving third-party to ensure the accuracy and integrity of the review process.
Points Discussed:
•What are the biggest mistakes made in Congruency Reviews?
•What would a CAPA consist of?
•Do institutions want to allocate funds for additional quality checks?
•Do contracts need IRB congruency checks?
•Who should do a Congruency Review?
•What errors occur in congruency reviews besides human error?
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Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance.
Overview of the Innovasis Settlement:
Innovasis Inc. recently settled a $12 million case for alleged kickback schemes to doctors. This highlights the importance of promotional compliance.
Allegations Against Innovasis:
From Jan. 1, 2014, to Dec. 31, 2022, Innovasis allegedly provided improper remuneration to surgeons, inducing them to use their products. These remunerations included consulting fees, IP acquisition fees, travel, and lavish events.
Implications for Compliance Practices:
Regulatory bodies like the FDA and DOJ are closely monitoring promotional practices. Companies must ensure both effectiveness and compliance in their marketing strategies.
Key Strategies for Compliance:
Transparency and documentation are vital in all interactions with healthcare professionals. Training and education are essential to understand boundaries, and internal audits help identify and rectify compliance issues early.
Conclusion:
Compliance safeguards reputation and builds trust. For assistance with compliance strategy, contact the Kulkarni Law Firm.
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Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an FDA regulatory lawyer.
Darshan explains that FDA-approved treatments for hair loss include minoxidil and finasteride. Minoxidil, originally a blood pressure medication, can lower blood pressure and has other side effects. Finasteride, used for benign prostatic hypertrophy, is also FDA-approved for hair loss but has limitations and potential side effects.
He also discusses other treatment ideas. Oral proteins are ineffective because they are broken down in the digestive system and cannot be absorbed properly. Topical proteins are similarly ineffective because their large molecules cannot penetrate the skin.
Darshan mentions stem cell treatments but notes that the evidence for their effectiveness is still limited. Despite their potential, no stem cell therapies for hair loss have been approved by the FDA, suggesting the data isn’t sufficient yet.
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Today's discussion revolves around the legal clauses found in clinical trials, with a focus on
Article 8, the Publication Rights Clause.
The following points are discussed:
- Unrestricted Rights: The clause prov
- ides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the integrity and proper use of the data.
- No Sponsor Review: There's no requirement for the Sponsor to review or approve publications, which can lead to issues with data accuracy, intellectual property rights, and compliance with regulatory standards.
- Intellectual Property Issues: The clause includes 'intellectual property' in the publication rights, which can lead to loss of proprietary information and patents for the Sponsor.
- Patient Data Exposure: Allowing publication of patient data without restrictions can breach confidentiality agreements and violate privacy laws.
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We discuss the seven ways pharmacy investigations can begin:
1. Data Analysis: Agencies like the DEA and DOJ monitor prescription data for unusual patterns, such as excessive dispensing of certain drugs.
2. Tips: Anonymous reports from the public or industry insiders alert authorities to suspicious activities.
3. Whistleblowers: Individuals within organizations can confidentially report wrongdoing, potentially leading to legal action under the False Claims Act.
4. Patient Complaints: Concerned patients can file complaints with state boards overseeing pharmacies.
5. Insurance Investigations: Agencies like the Texas Department of Insurance audit pharmacies to ensure billing practices are legitimate.
6. Billing Audits: Contractors such as Racs Maxs UPIC identify billing errors or questionable practices, triggering investigations.
7. Strike Forces: Government agencies collaborate across programs like Medicare and Medicaid to combat fraud through coordinated efforts.
In essence, pharmacy investigations start with someone noticing suspicious behavior. For legal advice regarding your pharmacy, contact me at 302-252-6959.
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We dive into the critical issue of racial bias in AI, highlighted by a recent Yale study focusing on ChatGPT. This has significant implications for clinical research sponsors, sites, and principal investigators. We also explore the FDA's perspective on AI in clinical trials, presented by Dr. Elzarrad.
Overview of the Yale Study:
The Yale study found that ChatGPT demonstrates racial bias in its responses, raising concerns about the use of AI in clinical research. Biased AI tools can lead to skewed data and misrepresentation of minority populations in clinical trials.
Implications for Clinical Research Sponsors:
Sponsors must ensure AI tools are free from biases through thorough testing and validation. Collaboration with AI developers to refine algorithms and use diverse data sets is crucial for maintaining the integrity and fairness of clinical trials.
Implications for Clinical Sites:
Clinical sites are pivotal in implementing AI tools. Regular audits to detect and mitigate biases, along with training staff to recognize and address AI bias, ensure equitable and ethical treatment of all trial participants.
Implications for Principal Investigators:
Principal investigators must oversee the ethical conduct of trials. The discovery of bias in AI tools like ChatGPT underscores the need for transparent AI practices and the development of unbiased AI protocols.
FDA's Perspective on AI in Clinical Trials:
Dr. Elzarrad from the FDA emphasized AI's potential to revolutionize clinical trials by improving efficiency, accuracy, and patient outcomes. However, rigorous testing for biases and ethical considerations is essential, aligning with the Yale study's findings.
Role of Regulatory Bodies:
Regulatory bodies must establish comprehensive guidelines for AI use in clinical research, including mandatory bias testing and documentation. Collaboration between regulators, sponsors, and AI developers is essential for ethical AI use in clinical trials.
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Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail.
In a landmark case, the Department of Justice sentenced Richard Hall, a 53-year-old pharmacy owner from Fort Worth, to several years in prison. The charges? Hall paid illegal kickbacks to patient recruiters and physicians, leading to unnecessary prescriptions and defrauding federal healthcare programs. Court documents and trial evidence revealed that Hall, along with others, created and marketed expensive compounded medications. These medications, meant to be custom-tailored to individual patient needs, became the focal point of the fraud. Hall paid marketers to recruit doctors to write prescriptions for these costly compounded medications, offering "investment opportunities" that allowed the doctors to profit from the pharmacy operations. Furthermore, Hall engaged in a conspiracy to launder the unlawful proceeds of this scheme.
The Anti-Kickback Statute is explicit – financial incentives should never influence healthcare decisions. Yet, Hall crossed this line, resulting in severe legal consequences. This case was not just about kickbacks; it also involved money laundering to conceal the origins of the illicit funds. Such actions undermine the integrity of the healthcare system and highlight the critical need for strict compliance with legal and ethical standards.
This scandal emphasizes the importance of ensuring that: Every prescription dispensed is medically necessary and appropriately documented. As pharmacists and pharmacy marketers, it is our duty to prioritize patient care and uphold the highest ethical standards. The ramifications of failing to do so can be devastating, both legally and professionally.
So, what steps can you take to avoid similar pitfalls? First, steer clear of any financial incentives that could be construed as kickbacks. Second, ensure that every prescription is justified by medical necessity. Third, closely monitor financial transactions to ensure they comply with all legal requirements.
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Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs).
PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-world setting. PMCs, while not legally mandated, are additional studies agreed upon by the drug developer, providing valuable insights.
Both PMRs and PMCs are essential for ensuring the safety and efficacy of medications.
For clinical research sites, adhering to these protocols can be challenging but offers opportunities to showcase expertise and attract more research partnerships.
For Sponsors: Sponsors must manage the costs and potential delays, but the insights gained can strengthen product value and regulatory trust.
For CROs: CROs need to stay compliant and adapt to these requirements to secure lucrative collaborations.
Join us as we explore the latest FDA report and its implications for everyone in the clinical research arena. Don't miss out on understanding how these regulations shape the future of medical treatments and industry collaborations!
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Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an FDA perspective, a drug is defined by its claims and indications. Some supplements make drug-like claims and can interact with medications. Common examples include grapefruit juice and vitamin K, which often interact with drugs. Dietary supplements, like any food or drug, can cause interactions. Have you experienced a drug interaction from using a supplement? Tune in to the DarshanTalks podcast to learn more.
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In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expectations of this privacy-conscious generation. This begins with three key measures:
1. Consent Management: Clear communication about data usage is essential, aligning with regulations like CCPA and GDPR. Seeking user consent without relying on cookies is crucial.
2. Context-Based Information: Emphasize direct data collection from customers, in line with FTC guidelines. Implement opt-in provisions across all touchpoints to ensure explicit consent.
3. Robust Data Protection Practices: Ensure collected data meets regulatory standards, including FTC, GDPR, and CCPA requirements. Adhering to these standards is vital for maintaining trust and compliance.
By implementing these measures, manufacturers can navigate the evolving privacy landscape while building trust with consumers.
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Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapidly growing startup specializing in AI-driven solutions for regulatory content creation. Edye discussed her journey from freelance consultancy to joining Weave, highlighting the unique challenges and opportunities this transition presented.
We discuss:
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Edye shares her journey of joining Weave
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Leading the charge in hiring new talent
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Dealing with competitors like Veeva
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Building a culture of innovation at Weave
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Managing Non-competition concerns
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In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure patient needs are met conveniently. However, there are three major concerns:
1. Ignoring Pharma Laws: Telehealth companies might not adhere to pharma marketing laws and could act as agents for pharma due to developed relationships. This has drawn scrutiny from Congress, FDA, and FTC, raising concerns about potential non-compliance.
2. Inappropriate Product Sales: There are significant concerns about how telehealth and marketing companies are identifying patients. Inappropriate sales to patients who don't need the products have led to Department of Justice inquiries.
3. Signing Unnecessary prescriptions: Some telehealth companies use doctors to sign off on prescriptions for patients who may not need them, often influenced by kickbacks. This practice is highly problematic and may deter pharma companies from associations unless proper controls are in place.
For assistance with advertising compliance, reach out to us!
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Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by a recent case in Biloxi. Mary Mahoney's Old French House Restaurant and its co-owner, Anthony Charles Savanovich, recently pled guilty to conspiracy and misbranding seafood. Over six years, they sold over 29 tons of fish fraudulently labeled as local premium species, when in fact, it was imported and frozen from Africa, India, and South America.
This case underscores the serious consequences of misrepresentation. Savanovich's guilty plea to a felony reflects the FDA's stance that such actions mislead consumers and pose health risks. For your restaurant or food marketing practice, any form of misbranding can lead to fines, recalls, and even criminal charges.
How can you protect your business? Ensure all promotional materials, from labels to advertisements, are truthful and compliant with food regulations. At the Kulkarni Law Firm, we specialize in FDA compliance, offering services such as promotional material review, compliance training, and legal guidance. Don't wait for legal issues to arise—take proactive steps to ensure compliance today.
Thank you for tuning in to this episode produced by DarshanTalks and powered by the Kulkarni Law Firm.
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We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce these drugs due to low profitability. Factors include factory shutdowns for quality issues, a complex global supply chain, and older generic drugs being unprofitable to produce. Government pressure on prices further reduces profit margins, disincentivizing investment in production quality. Consequently, manufacturers prioritize newer, more expensive drugs, leading to treatment delays and stress for patients.
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In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates for patient-centric practices, and underscores the roles of telehealth and AI in research, promoting transparency and ethical standards in clinical research operations.
- What are the key challenges faced by clinical trial sites?
- How can we ensure that sites have a platform to voice their concerns?
- What is Save our sites?
- Why SCOPE and ACRP may not be suitable platforms for sites?
- How can we address the economics of running a conference when we do need people to buy those slots?
- What is the incentive for individual sites to speak up?
- The Decentralized Clinical Trials Controversy and Citizen Petitions
- The role of Telehealth in Clinical Research
- Does a DCT eliminate the need for localized PIs?
- The Future of AI in Clinical Research
Check out Daniel Fox's websites:
CRPN- crpn.crpaynet.com
Save Our Sites- www.saveoursites.com
White paper- https://lnkd.in/ek9_NNT7
YouTube: @CRPNCentral
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In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disruptions in menstrual cycles, violent episodes, or even deaths were not reported. While some cases were eventually identified, others went unnoticed, highlighting the importance of vigilant compliance. Sites should be aware that regulatory bodies like the FDA and DOJ closely monitor for such violations.
Need assistance with your trial compliance? Reach out to Darshan at Darshan@kulkarnilawfirm.com.
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In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their health. They play a crucial role in various aspects:
Firstly, patient advocates are instrumental in representing the patient voice in clinical trials. By advocating for patient-centric endpoints and highlighting symptoms that matter most to patients, they help ensure that trials are not only rigorous but also relevant to real patient needs.
Secondly, these advocates support the development and adoption of innovative drugs. They identify gaps in treatment options and advocate for the development of drugs that address unmet medical needs. By collaborating with pharmaceutical companies and healthcare providers, they advocate for the adoption of these drugs to improve patient outcomes.
Thirdly, patient advocates work tirelessly to ensure access to medications. They advocate for policies and practices that remove barriers to medication access, such as affordability and availability issues. By engaging with policymakers, healthcare providers, and the public, they strive to make sure that every patient can obtain the medications they need without undue hardship.
Moreover, patient advocates play a crucial role in healthcare decision-making processes. They participate in meetings with drug companies, hospitals, regulatory bodies, and government agencies to ensure that patient perspectives are considered in policy-making and healthcare delivery.
For those interested in becoming patient advocates, we discussed practical steps such as educating oneself on healthcare systems, clinical trials, and specific health issues, joining patient advocacy groups, attending conferences and workshops, volunteering, and sharing personal experiences to raise awareness.
In conclusion, patient advocates are instrumental in shaping a healthcare system that truly serves patients' needs. Their advocacy ensures that healthcare decisions are informed by patient experiences and priorities, ultimately leading to more effective, patient-centered care.
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Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over investigational products, ensuring they are only administered under direct supervision. Clinical research organizations also conduct routine audits to verify drug accountability. However, instances of improper disposal or false certifications have been identified, highlighting the importance of vigilance in maintaining accurate drug records.
Compliance with drug accountability regulations is essential, as both the FDA and the Department of Justice oversee this area closely.
For assistance with clinical trial compliance, reach out to us!
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We discuss how to address drug shortages. First things first, it's important to stay calm. Just because there's a shortage doesn't mean you'll lose access to your medication entirely. Here are some action steps you can take:
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Schedule an appointment with your doctor to discuss alternative medications that might be effective for you. It's crucial to also talk about potential side effects and weigh the options together.
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Pharmacies can be a great resource. They may have information on when your medication might be restocked or suggest similar drugs in the meantime.
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Explore online FDA resources that track drug shortages. This way, you can stay updated on the situation.
Remember, communication is key. Talk with your doctor about any concerns and work together to find the best course of action. Stay informed and proactive in managing your healthcare.
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We discuss the risks associated with using AI in your pharma marketing plans:
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Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patients, is paramount.
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Bias: Questions arise regarding the sources of information, control over data, and addressing privacy concerns to prevent biases and comply with regulatory standards set by organizations like the FDA and FTC.
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Lacks Transparency: AI decisions must be transparent and understandable. Stakeholders need clarity on how decisions are made, and there should be traceability to ensure accountability and build trust in AI-driven processes.
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Intellectual Property Concerns: There are significant legal concerns surrounding intellectual property rights when using data to develop AI models. Lawsuits from entities like The New York Times or Google underscore the importance of protecting proprietary information and ensuring compliance with intellectual property laws.
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Consumer Protection: Implementing AI in marketing plans raises consumer protection issues. It's crucial to consider how AI-driven decisions may impact consumers and ensure that practices align with ethical standards and regulatory requirements to safeguard consumer interests.
By addressing these risks proactively, businesses can navigate the complexities of AI in marketing while minimizing potential pitfalls and ensuring compliance with legal and ethical standards.
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In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse:
- Verify the prescriber's identity.
- Know the prescriber's DEA number.
- Know your patient thoroughly.
- Verify prescription dates for validity; ensure prescriptions are current.
- Communicate directly with prescribers if any concerns arise.
- Request identification when necessary.
- Act decisively if fraud is suspected—never dispense suspicious prescriptions and report incidents promptly.
- Recognize and report misuse patterns to appropriate authorities for swift action and prevention.
Tune in to DarshanTalks for more insights on healthcare compliance and safety.
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In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance of compliance in avoiding legal pitfalls. Plus, learn valuable insights on the role of legal and compliance in navigating the complexities of ad promo. Don't miss out on this enlightening discussion!
Points discussed:
1. How has the concept of regulatory evolved?
2. Is legal essential in MLR?
3. How do we define the roles of legal, compliance, and regulatory?
4. How does a company's history and risk tolerance affect PRC committee interactions?
5. How much flexibility should be given to regulatory consultants?
6. How to manage pushback within PRC team dynamics?
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Today, we discuss four legal pathways to acquire unapproved drugs.
First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph.
Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval.
Third, the FDA's new policy allows for state-imported drugs, provided certain protocols are adhered to.
Lastly, individuals can legally import drugs for personal use from abroad within specified limits.
For further insights, consult with legal and medical professionals.
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We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use:
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Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging.
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Establish Policies and Procedures: Clearly defined policies and procedures are necessary to understand and adhere to compliance standards. They provide guidelines for ensuring ethical and legal AI usage.
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Implement Training Programs: Training programs are essential for ensuring compliance with policies and procedures. They educate employees on AI usage protocols and help align their actions with organizational goals.
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Conduct Continuous Quality and Audit Checks: Regular quality and audit checks are vital for ensuring adherence to policies, achieving goals, and maintaining ethical AI usage. Continuous monitoring helps identify and address any deviations from established guidelines.
For assistance in aligning your marketing plan with AI use and ensuring compliance, feel free to reach out to us.
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In this short, we explore four key reasons to get involved in clinical research.
First, it offers potential access to cutting-edge therapies, though it's important to note you might only receive the standard of care.
Second, participation ensures closer monitoring by healthcare professionals.
Third, it provides an opportunity to contribute to medical progress, benefiting others with similar conditions.
Lastly, while financial compensation is a factor, it's controversial as it may impact informed consent.
Tune in to hear more about these considerations and their implications.
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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee .
Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services.
What are medspas?
Different kinds of medspas
How medspas are structured
Qualifications for running a medspa
Services offered by medspas
Can non-physicians run a medspa?
Setting up a Management Service Organization (MSO)
How can pharmacists get involved?
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Darshan explains why you shouldn’t Trust Celebrities When Choosing Your Drugs!
Hidden Agendas: They're paid to promote, not give unbiased advice.
Not Medical Experts: Trust your doctor's knowledge, not a celebrity's opinion.
Oversimplified Info: 30-second ads can't tell the whole story.
Not Personalized: Your doctor can give you the right advice for your needs.
Ditch the Hype, Talk to Your Doctor!
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Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk.
Here are 5 tips for pharmacy owners and managers to prepare for potential temporary closures:
- Cross-Train Staff: Train front-end staff on basic pharmacy procedures (depending on state regulations) so they can assist with paperwork like taking in prescriptions and completing end-of-day tasks.
- Stock Up on Prescriptions: Anticipate closures by keeping a surplus of routine
- prescriptions filled. This ensures patients don't miss important doses.
- Notify Patients & Physicians: Develop a call list to efficiently notify patients and local doctors of a potential closure. This gives them time to make alternative medication arrangements.
- Post Signage & Update Messages: Prepare clear signage indicating closure dates and times. Update voicemail messages to explain the situation.
- Offer Prescription Transfers: Contact nearby pharmacies to see if they can take prescription transfers during a closure. This allows patients seamless access to their medications.
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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee.
Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services.
Points discussed:
- What are medspas?
- Different kinds of medspas
- How medspas are structured
- Qualifications for running a medspa
- Services offered by medspas
- Can non-physicians run a medspa?
- Setting up a Management Service Organization (MSO)
- How can pharmacists get involved?
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We dive deep into 5 uses of Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might not have heard of:
Liver Support: Early research suggests Ozempic could benefit liver health, but more studies are needed.
Weight Loss Weapon: Ozempic has a weight-loss version, offering a powerful tool many don't know exists.
Addiction Fighter: Ozempic might hold promise in combating alcohol and substance abuse (this one might surprise you!).
Heart Health Hero: Studies show Ozempic could help reduce the risk of heart problems.
Cancer Prevention & Treatment: Emerging evidence suggests Ozempic's potential role in preventing and treating certain cancers.
Alzheimer's Hope: Early research hints at Ozempic's possible use in managing Alzheimer's disease, although further investigation is crucial.
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In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content generation, they must navigate murky waters to ensure compliance with existing regulations and respect for intellectual property rights.
Controlling AI output presents another challenge. Unlike human creators, AI can produce content that may not align with intended guidelines or quality standards. For pharma, where precision and compliance are paramount, this unpredictability poses risks. It's crucial for companies to implement robust review processes, involving both legal and regulatory teams, to mitigate potential errors and ensure content accuracy.
Moreover, the issue of ownership looms large. Both legal and regulatory bodies have expressed concerns about the ownership of AI-generated content. The US Patent and Trademark Office requires human oversight to verify accuracy and compliance with existing rules. Similarly, the US Copyright Office has stringent criteria for copyright protection, requiring human authorship. This raises questions about how much human intervention is necessary before AI-generated content can be considered owned or copyrighted.
In conclusion, while AI offers immense potential for innovation in content creation, pharma companies must navigate a complex legal and ethical landscape. By staying informed, implementing robust review processes, and seeking legal guidance, companies can harness the power of AI while ensuring compliance and ethical use. For tailored advice on integrating AI into your content strategy, reach out to us at the Kulkarni Law Firm.
Stay tuned for more insights on navigating the evolving landscape of AI in pharma.
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In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That means a drug company spends between $420,000 and $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What kind of return would you expect on that investment? That's why drugs are so expensive.
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Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law.
In this podcast series, we'll dive deep into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and ethical considerations to the latest FDA guidance, we'll cover it all. Whether you're a legal professional, an industry insider, or simply curious about the future of AI in healthcare, this series will provide the insights and expert analyses you need to stay ahead of the curve. Let's get started!
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Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also provide remuneration, such as free meals, to attendees. Between 2017 and 2020, drug and device companies reportedly paid nearly $2 billion to HCPs for services related to speaker programs. It's important to note that some iterations of these events are referred to as drug dinners.
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We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.
We discuss the following:
- What does off-label mean from a reimbursement standpoint?
- Lessons from the US v. Eli Lilly 2009 case
- How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau
- How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid?
- How are compounded drugs reimbursed?
- Could a company be held accountable for off-label use of a drug due to
- compounded products?
- Are weight loss drugs exempted from reimbursement?
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Buying a Drug or Device Company? 6 Compliance Must-Knows
Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:
The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it!
The DOJ demands strong compliance programs with thorough risk assessments, effective training, and clear reporting channels.
Companies can now claw back bonuses from employees who break compliance rules.
Accurate risk assessments, comprehensive training, and clear misconduct reporting are key for HHS compliance.
Disclosing payments to doctors and hospitals is crucial too, with details readily available online.
Don't forget about mandatory clinical trial disclosures on ClinicalTrials.gov. Skipping this can lead to hefty fines and hinder future research.
Need Help Navigating M&A Due Diligence? We can help!
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We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them.
It's important to communicate with your doctor, who can provide the latest information and discuss alternative treatment options tailored to your needs.
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Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address
concerns with a knowledgeable medical professional. For minors, parental involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts before the research begins and continues until the study concludes or the subject withdraws.
Need assistance with your clinical trial compliance program? Email us at darshan@kulkarnilawfirm.com
In this podcast, we discuss the following:
1. Recent updates from the courts in class action lawsuits.
2. Difference between equity and law.
3. Demerging or diverging equity and law.
4. Dictionaries used by courts to interpret contracts.
5. Update on Johnson and Johnson baby powder case (Suing plaintiff’s witnesses for defamation and false advertising)
6. Experts need to be cautious to avoid false advertising allegations against them.
7. Update on Maybelline 24-hour make-up case. (24-hour sunscreen)
Rebecca Tushnet is our guest. She is a Harvard Law School professor specializing in copyright, trademark, and advertising law.
Let’s get into it.
Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the body's natural functions. This fundamental principle underscores how drugs interact with our biology.
We discuss the five common reasons behind the failure of mergers, acquisitions and licensing deals in the life sciences industry.
Inadequate understanding of capability, where focusing solely on financials without comprehending the target company's regulatory and compliance processes leads to failure.
The side project dilemma, illustrated by Philip Morris' venture into pharmaceuticals, emphasizing the importance of aligning with core business objectives.
Clash of perspectives, exemplified by cultural and business differences between BioGene and Novartis, highlighting the necessity of alignment in strategic vision.
Low margins on generic drugs, as seen in Teva's acquisition of Actavis, revealing the
challenge of profitability in this sector.
Overpaying, stressing the significance of thorough due diligence to avoid paying more than a company's actual value.
For assistance with M&A due diligence, contact us at 302-252-6959.
In this short, Darshan sheds light on the relationship between doctors and pharmaceutical companies. He explains how pharmaceutical companies often pay doctors to ensure they understand their drugs and promote their products.
However, patients can now access information on what doctors are being paid by pharmaceutical companies through the CMS website, as mandated by the Sunshine Act Law. This transparency allows patients to make informed decisions about their healthcare.
We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include
- Hefty fines, revoked licenses, and even legal charges, potentially ruining your business.
- Additionally, non-compliance can result in reputational damage, eroding public trust and deterring potential partners.
- Moreover, loss of distribution rights could leave you unable to serve customers in entire states.
To avoid this nightmare scenario, ensure registration with state boards of Pharmacy. For
assistance, contact us at Darshan@kulkarnilawfirm.com
Have you ever wondered why your prescription takes what feels like an eternity to fill at the pharmacy? Darshan will shed some light on the process.
When you drop off your prescription, the pharmacist isn't just mindlessly grabbing bottles from shelves. They're meticulously reviewing your medication to ensure it's the right fit for your condition, checking for potential interactions with other drugs or even your diet, and making sure it's covered by your insurance.
This detailed process, while aided by computer systems, often requires a human touch and can take some time. And remember, you're not the only one waiting for their medication – there's a queue of patients with prescriptions to fill.
So next time you're twiddling your thumbs in the pharmacy waiting area, remember that your pharmacist is doing their best to ensure your health and safety.
We cover three steps for preventing food recalls:
Identify all potential hazards.
Focus on known and foreseeable risks.
Develop preventive controls for specific hazards.
Ensure every bite is safe! Need help? Call Darshan at 302.252.6959.
In this video, Darshan distinguishes between dietary supplements and drugs. The
primary difference lies in the claims they can make. Dietary supplements are treated as foods and can only make limited claims, such as improving health or well-being. In contrast, drugs undergo rigorous FDA approvals and trials to make claims of curing, treating, preventing, or mitigating diseases. While there may not be much difference chemically, the key distinction is in the level of proof required for their claims. Darshan highlights that drugs may have once been dietary supplements but must meet higher evidentiary standards.
Here are 5 clinical trial record retention problems.
1. Fabricating Data and Documentation,
2. Forging the Principal Investigator's signatures,
3. Data Manipulation,
4. Misappropriating Samples and
5. Forging Subject Dairies
Join us as we delve into the complexities of record retention and data integrity in clinical trials. Learn why compliance is key for FDA approval and how we can help. Call us at 302-252-6959 for expert assistance with your clinical trial compliance program.
Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from small animals to extensive human trials. The drug company, whether partnering with a university or a private investor, foots the bill for each phase of testing, ensuring safety and efficacy before reaching the market. The investment covers meticulous testing procedures, safeguarding against potential risks and ensuring the drug's viability on a large scale.
McKinsey’s vision for Medical Affairs in 2030 envisions profound integration of digital tools, analytical innovation, evidence generation, and leadership transformation. However, this vision faces a critical challenge as recent lawsuit losses against the FDA have shifted the landscape. Previously, Medical Affairs held the exclusive right to share off-label information, but FDA losses prompted guidelines allowing sales reps, under supervision, to share such information.
This regulatory change provides a more cost-effective approach for companies, challenging the traditional role of Medical Affairs representatives. Artificial intelligence is also emerging to supplement or replace certain functions of Medical Affairs in a compliant manner. The evolving landscape necessitates Medical Affairs to swiftly redefine its role with a strategic vision to avoid becoming sales-centric, potentially jeopardizing its educational and patient-centric functions.
Without a clear vision, Medical Affairs risks devolving into sales roles, hindering its potential impact on patient outcomes. The legal and regulatory reality demands a careful alignment of Medical Affairs activities with compliance.
For further insights and compliance discussions in Medical Affairs, contact at 302-252-6959. Stay tuned for more updates!
In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for collecting diversity data in clinical trials, following guidelines from the FDA.
The guidance emphasizes that one size does not fit all when it comes to race and ethnicity, encouraging detailed categories to embrace the global diversity of participants.
Darshan advises starting by asking about identity, specifically Hispanic and Latino, before delving into race, respecting the complexity of ethnicity and allowing participants to self-identify.
He emphasizes the importance of trusting participants to share their own stories, asserting that self-reported data on race and ethnicity is not only more accurate but also honors individual identity, contributing to a more nuanced and enriched dataset.
We explore the chemical similarities and key differences between brand-name and generic drugs. Learn about:
Equivalence in active ingredients, as approved by the FDA.
Exceptions: Narrow Therapeutic Index drugs and inactive ingredients.
When to consult a doctor before switching brands.
Listen to find out if you can save money without sacrificing quality!
In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibility for ensuring congruency between the budget, contract, informed consent form (ICF), and coverage analysis. Istvan mentions that a lack of congruency affects both parties and, therefore, both sides should actively participate in the vetting process. While pharmaceutical companies are responsible for ensuring budget and contract congruency, research sites should also conduct thorough reviews to align coverage analysis, budget, and contract. In Istvan’s view, it's not an either-or scenario; both sides play a crucial role in maintaining congruency throughout the clinical trial process.
Today, we analyze a fictional drug advertisement, identifying and highlighting the nine key unethical and non-compliant elements.
- Misleading Information: The claim "The End of High Blood Pressure" suggests that the drug can completely cure high blood pressure, which is likely exaggerated and misleading.
2- Absolute Efficacy Claims: Stating "Proven to work in 100% of patients" is an absolute claim that is unrealistic and unsubstantiated, making it misleading.
3- Ignoring Risks and Side Effects: The risks and side effects are not prominently displayed, which fails to provide a balanced view of the drug’s benefits and risks. Additionally, the color and font is difficult to read.
4- Small Print for Important Information: Essential information in tiny, unreadable font is a common tactic to downplay risks and is generally inappropriate.
5- Adverse Event Reporting- Should include a statement saying "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088."
6- Lack of Supporting Data: Claims made in the advertisement are not likely unsupported by scientific data, which is misleading and non-compliant.
7- Efficacy Claims: Claims like "The End of High Blood Pressure is unrealistic, as is "Proven to work in100% of patients without any side effects"
8- No Mention of Generic Name: Not including the generic name of the drug can be considered a violation of advertising standards.
9- Omission of Necessary Lifestyle Changes: Failing to mention that the drug should be used in conjunction with lifestyle changes and possibly other medications provides an incomplete picture of the treatment process.
Did we miss anything? Let us know in the comments.
The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications.
We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal.
Firstly, leveraging the public comment period,
Participating in Part 15 hearings provide direct avenues to voice concerns and influence final regulations,
Additionally, joining industry associations allows for collective lobbying efforts on behalf of developers,
Exploring legal challenges, though potentially premature without final action, remains an option,
Raising public awareness through media campaigns is suggested, emphasizing the benefits of LDTs and drawbacks of proposed regulations.
Collaboration with healthcare providers to gather real-world evidence and testimonials strengthens the developers' case.
Lastly, engaging in congressional lobbying harnesses legislative power to potentially alter or block the FDA's proposals.
Despite the FDA's focus on patient safety, developers are presented with a multi-pronged approach to effectively challenge and shape the outcome of the regulatory process.
eBay found itself as an unexpected marketplace for pill-making equipment, resulting in the company paying a hefty $59 million for facilitating the sale of such equipment. In our video, Darshan delves into this crackdown, shedding light on the hidden underbelly of online retail. The incident highlights the ease with which tools for potentially illegal drug manufacturing can evade e-commerce oversight. He emphasizes the importance of consulting with consumer safety and regulatory lawyers before engaging in the sale of materials that could be easily diverted in the digital age. The podcast serves as a cautionary tale, urging awareness and proactive measures in the ever-evolving landscape of online commerce.
In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries of neurotechnology.
In our latest short, we discuss key considerations for those venturing into such groundbreaking work.
We emphasize the importance of having a clear investigational plan that outlines study design, methodologies, endpoints, and analysis strategies.
Additionally, we also highlight the significance of obtaining adequate informed consent to address potential health risks
The need for meticulous record-keeping for regulatory compliance, including maintaining detailed delegation logs and up-to-date resumes.
These measures are crucial for navigating the complexities of both technological advancements and regulatory policies in this innovative field.
In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First Circuit ruled against Facteau, emphasizing the distinction from the Caronia case. Unlike Coronia, where the focus was on broader free speech and off-label promotion issues, the US v. Facteau case centered on the roles and actions of individuals involved. Notably, Facteau's direct executive involvement in promoting off-label uses, coupled with evidence of intent to circumvent FDA regulations, set this case apart. This ruling highlights the nuanced considerations surrounding off-label marketing and underscores the importance of individual actions and intent in legal outcomes.
We discuss biotech fraud and the pivotal role of a comprehensive legal strategy, especially one that integrates FDA regulatory lawyers. A biotech CEO's admission to securities fraud, misleading investors about a crucial test, underscores the need for stringent legal oversight.
At the Kulkarni Law Firm:
We’re on the lookout for major red flags,
We ensure press releases not only comply with SEC regulations but also meet FDA requirements.
Evaluating the scientific accuracy of information,
Analyzing clinical data,
Understanding regulatory pathways, and
Ensuring public disclosures are truthful.
An effective legal strategy, integrated with FDA regulatory lawyers, collaborates with communication teams, works closely with the R&D department to grasp the science behind claims, and liaises with compliance teams to cover all regulatory bases. By integrating FDA regulatory lawyers into the communication process, companies can prevent missteps, rigorously vetting public statements for accuracy, legality, and scientific validity. This proactive approach significantly reduces the risk of misleading investors and the public, addressing concerns related to fraud and compliance.
For expert guidance on navigating the complex intersection of securities, FDA regulations, and legal compliance, look no further. Call us at 302-252-6959.
In December 2023, two US senators raised concerns, urging the government to scrutinize the FDA's oversight of medical device recalls, notably amidst the ongoing Phillips Respironics recall.
Join us today as we delve into the world of medical device recalls. Facing a recall is every manufacturer's nightmare, but handling it right is paramount. It safeguards patients, preserves reputations, and sidesteps legal nightmares.
Educate Yourself: The first step? Knowledge is power. Familiarize yourself with FDA guidance – understanding what you can, should, and must do. Develop policies consistent with this guidance to fortify your approach.
Transparency Is Key: Building trust is pivotal. Be upfront with the FDA when necessary. Clear, concise communication lays the foundation for swift and effective action.
Meticulous Planning: Plan with precision. Consider logistics and support. Identify affected devices, create a comprehensive notification strategy, and establish clear instructions for replacement or return. A well-thought-out plan is your best defense.
Legal Support Matters: Recalls happen, but with the right legal partner, you can minimize the impact. The Kulkarni Law Firm is here to help you navigate recalls with reassurance, ensuring the protection of your patients and your business.
Trust the Kulkarni Law Firm to guide you through the maze of medical device recalls, ensuring minimal scars and maximum protection. The path to a well-managed recall starts here.
In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determining designations based on National and Local Coverage Determinations. This forms the foundation for what is billed to the study sponsor and insurance. Any discrepancies at this stage can lead to downstream errors.
Following the coverage analysis, it becomes imperative to align the calendar with the protocol's schedule of events and the designated elements from the coverage analysis. Once the calendar is established, the focus shifts to the budget negotiation phase. Multiple touchpoints during budget negotiations necessitate periodic checks to confirm alignment with the calendar and coverage analysis designations.
On the contractual side, congruency revolves around matching the contract and budget provisions. This involves verifying that payment terms and the final budget in the contract align with the negotiated terms. Another critical aspect is ensuring congruency between the informed consent and the contract, specifically focusing on subject injury language. Standardized language for subject injury in both the informed consent and contract streamlines the congruency process. Deviations from these standards trigger communication between those handling the informed consent and contract to ensure alignment. This meticulous congruency review safeguards against discrepancies and ensures a seamless process in clinical research.
We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more than just single business deals; they are a testament to the increasing interest in fueling healthcare innovation and services.
As this trend gains momentum, thorough due diligence becomes crucial in navigating the complexities of these acquisitions. The Kulkarni Law Firm, specializing in Life Sciences law, plays a pivotal role in providing comprehensive support for regulatory compliance, contract reviews, and risk assessments. Daron emphasizes that these investments go beyond financial gains, contributing to the redefinition of the healthcare investment landscape.
The Kulkarni Law Firm keeps a watchful eye on the latest updates from the Department of Justice (DOJ), Office of Inspector General (OIG), and the Food and Drug Administration (FDA), ensuring that clients are well-informed and compliant.
In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points:
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Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such as those in academic conferences or scholarly articles, falling within FDA safe harbors.
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Consistent with label guidance from the FDA: Sharing information aligning with the appropriate use of a drug or device, even if not explicitly mentioned, is legally acceptable.
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FDAMA 114: The guidance emphasizes sharing health economic information, including off-label data, with specific entities.
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SIUU guidance: It introduces a nuanced framework for discussing information implying off-label use, necessitating companies' awareness of its implications.
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Education and non-company representatives: Engaging in discussions independent of pharmaceutical companies, provide crucial avenues for off-label information sharing, avoiding FDA scrutiny.
Darshan discussed crucial updates to the Department of Justice's (DOJ) corporate enforcement policies, particularly impacting FDA-regulated industries like pharmaceuticals and medical devices. The DOJ's focus on mergers and acquisitions (M&A) emphasizes the importance of compliance professionals throughout the entire process.
Key Highlights:
1. Corporate Enforcement Policies Update: The DOJ has introduced significant changes to its corporate enforcement policies, impacting companies engaged in M&A transactions. Compliance professionals are now essential stakeholders at the due diligence table.
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Antitrust Division's Impact on Pharma: Recent cases involving pharmaceutical companies Teva and Glenmark showcased the DOJ's shift in approach. Divestiture of a core product was required, marking the first instance of such a demand in a corporate criminal resolution.
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Compliance Program and Compensation: The new pilot program mandates companies to incorporate compliance-promoting criteria into their compensation systems. The DOJ urges companies to address this now, emphasizing the need for proactive compliance policies.
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Voluntary Self-Disclosure Policy: The DOJ announced a voluntary self-disclosure policy, creating a safe harbor for companies that promptly report wrongdoing. The policy encourages self-reporting, offering a presumption of declination for qualifying companies.
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Qualification for Safe Harbor: Companies must disclose misconduct within six months of acquisition, with one year to fully remediate. These deadlines may be extended based on case specifics. The Safe Harbor applies only to criminal conduct in bona fide M&A transactions.
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DOJ Principles: The DOJ aims to hold wrongdoers accountable, incentivize compliance, and deter repeat offenses. The new policy offers a presumption of declination for companies self-disclosing, cooperating, and remediating.
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Impact on Pharma and Device Companies: FDA-regulated industries, particularly pharmaceutical and device manufacturers, may benefit from the clear safe harbor. Voluntary self-disclosure, under the new policy, could become more common in the life sciences sector.
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Considerations and Conclusion: Companies must carefully evaluate when self-disclosure is appropriate, with minor regulatory violations potentially better handled directly with the FDA. Compliance teams play a vital role, and ongoing developments at the intersection of compliance and FDA regulation will be closely monitored.
In this podcast, we discuss the legal and regulatory factors for securing approval for your digital speaker program. Key points include
prioritizing audience privacy,
adhering to FTC disclosure regulations,
explicit audience definition,
distinguishing between educational and promotional content, and
navigating health versus product claims.
Link to the detailed podcast: https://www.youtube.com/watch?v=MH6UEY_I-kI
FDA Issues Crucial Guidance on Prescription Drug Software!
Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations:
1. software functions,
2. end-user output, and
3. regulatory guidelines.
Notably, the FDA emphasizes distinguishing between functions relying on direct device data transfer and those that don't. The document also outlines the significance of characterizing software output, such as symptom data and alerts. Lastly, regulatory guidelines stress that functions not directly transferring device information should be omitted from product information unless essential for safe use, with details to be determined on a case-by-case basis. Tune in for expert insights into this pivotal FDA update!
Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed!
In the clinical trial agreement activation pathway, the journey involves several critical steps. It begins with the signing of the Confidentiality Disclosure Agreement (CDA), followed by the study team's review of the protocol and feasibility goals. Once the study gets the green light, the congruency review phase becomes crucial. This phase kicks off with a Medicare coverage analysis to determine what falls under research billing and sponsor billing versus insurance billing.
The Medicare coverage analysis further involves creating a detailed calendar and schedule of events in the clinical trial management system. Budget negotiations come into play, and once finalized, the financial console aligns with the clinical trial management system calendar. Simultaneously, contract and informed consent negotiations occur, often involving multiple groups within the institution and various vendors.
Despite the complexity, there's a notable gap in the industry – the lack of comprehensive congruency review. This gap is observed both on the site side and the pharmaceutical side. Many times, discrepancies arise when regulatory discussions conflict with legal interpretations, and there's no final congruency review to ensure alignment between the Medicare coverage analysis, calendar, budget, contract, and informed consent form. Bridging this gap becomes pivotal to ensure a seamless and error-free process.
Accelerate your digital speaker program review with these 5 game-changing strategies:
Policy Creation & Training
Pre-reviews
AI-based Reviews
Modular Reviews
Applying Quality Learnings Across the Program
Dive deeper into each strategy on our podcast!
Watch the full podcast- https://www.youtube.com/watch?v=Ud8jn4c3cCM
Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies entering the clinical trial recruitment space, advising careful assessment of their experience and disease state knowledge. He also suggests that while this trend is emerging, its ultimate impact remains uncertain. Additionally, he concludes by encouraging those in need of assistance with training, policy development, or gap analyses to contact Darshan Kulkarni at darshan@kulkarnilawfirm.com
We discuss five key legal and regulatory considerations for a digital sales force:
Starting with updates to the Physician Payment Sunshine Act, emphasizing the need for training, robust internal controls, and monitoring.
It also touches on guidance for interactions with healthcare professionals, emphasizing transparency and ethical practices.
The SIUU guidance is discussed, emphasizing accurate and fair presentation of scientific information.
The updated CMS guidance recommends comprehensive compliance programs, promoting a culture of compliance and
Lastly, the DOJ pilot program for clawbacks in employment agreements is outlined, urging employers to review agreements, establish clear policies, and conduct due diligence.
Addressing these considerations ensures digital sales forces contribute to an ethical and responsible healthcare industry, requiring companies to stay updated and provide ongoing training.
We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising.
the paramount importance of transparency in promotional efforts,
the pitfalls associated with broad generalizations, and
the need for readiness in the face of scrutiny from both the FDA and the FTC.
Providing a valuable intersection of pharmacy, law, and marketing, our short offers a comprehensive guide for navigating the complex landscape of comparative claims in the healthcare industry.
In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board (IRB) goals with the essence of a clinical study becomes pivotal. If the trial's outcome is already known, it may be labeled a seeding trial, raising ethical and FDA-related red flags. Conversely, administering a drug with uncertain effectiveness to a hopeful patient brings its own set of ethical and legal challenges.
This evolving landscape demands careful consideration and resolution of ethical and legal issues associated with integrating clinical research and care.
Stay tuned as discussions on this innovative approach continue to unfold.
In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of computer science, statistics, and engineering, employs algorithms to perform tasks like learning, decision-making, and prediction. Within the context of drug development, we unravel three significant applications of AI. First, it aids in scanning medical literature for pertinent findings; second, it predicts individual responses to treatments and assesses side effect risks; and third, it enables the creation of digital twins for intervention modeling.
Join us as we navigate the potential of conversational agents and chatbots equipped with AI, serving as invaluable tools in clinical trial inquiries and adverse event reporting. Yet, the integration of AI comes with its own set of risks. As regulatory bodies like the FDA shift toward a risk-based analysis approach, it is crucial for stakeholders—whether practitioners, sites, sponsors, or research organizations—to remain vigilant and comprehend the evolving regulatory landscape. In this episode, we shed light on the impact and risks associated with AI in drug development, offering insights into navigating this transformative era.
The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The ad suggested Bravecto's greater effectiveness, disputed by NexGard. NAD sided with NexGard, emphasizing the need for clear and conspicuous disclosures in comparative advertising.
In a separate case, Google's ads for YouTube TV claimed a $600 cost savings over cable, leading to a dispute with a cable provider. NAD supported the cable provider, stressing the importance of clear definitions for comparable services to prevent consumer misinterpretation.
These cases underscore the FTC's focus on addressing ambiguous and misleading comparative claims, particularly in drug product advertising—a realm already subject to FDA caution.
In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed:
- Privacy Compliance:
- Consider where audience data will be stored and ensure compliance with privacy laws (TCPA, CCPA, GDPR, etc.).
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Prioritize secure handling of sensitive information and always obtain audience consent.
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Transparency and Disclosure:
- Adhere to FTC requirements for transparency and disclosure.
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Communicate upfront about sponsorships, product claims, and any financial relationships impacting the content.
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Controlled Audience Targeting:
- Tailor the digital presentation to specific individuals or groups.
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Adjust tone, scientific detail, and compliance messages based on the target audience (e.g., clinicians, P&T committees).
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Distinguishing Marketing from Education:
- Clearly differentiate between marketing and educational content.
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Ensure that educational materials genuinely inform without serving solely as a sales pitch to benefit from legal protections.
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Product or Health Claim Evaluation:
- Scrutinize the presentation topic to determine if it constitutes a product claim or a disease awareness advertisement.
- Adhere to FDA requirements for product claims, ensuring substantial evidence, while disease awareness ads follow a lower scientific evidence standard.
For assistance with digital engagement or marketing programs, contact Darshan Kulkarni at darshan@kulkarnilawfirm.com
he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facility registrations, creation of safety substantiation information, and implementation of adverse event reporting. Daron breaks down key definitions, clarifies information submission processes, and discusses public accessibility.
Tune in to stay informed about the crucial expectations, including adverse event reporting, recordkeeping, and safety substantiation, to ensure compliance with the evolving regulatory landscape.
In this podcast episode, we'll uncover five strategies to expedite the digital promotion review process. Starting with
1. Policy creation and training emphasizes aligning policies across platforms, incorporating key stakeholders' expectations, and ensuring consistency with relevant agreements and guidelines.
2. Pre-review meetings with marketing teams help establish a shared perspective, streamlining the process.
3. AI-based tools offer preliminary data analysis, although current applications are somewhat basic.
4. Modular approvals involve reviewing individual components before the final review, aiming to accelerate the overall process.
5. Lastly, applying quality learnings from past programs aids in avoiding mistakes and optimizing the promotional review process.
Tune in for more insights and tips!
Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.
The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of these features.
Design-related recalls take center stage in the FDA's recommendations. The agency discourages choosing a predicate device that has been subject to a design-related recall. If a submitter opts for such a device, they must explicitly address how they've mitigated the safety concerns that led to the recall.
Transparency and documentation constitute the third crucial consideration. The FDA stresses the need for a detailed 510(k) summary that provides a comprehensive understanding of the basis for determining substantial equivalence.
The guidance encourages the inclusion of a narrative explanation in the 510(k) summary. This narrative should elucidate the process behind selecting the predicate device, offering transparency and insight into the decision-making process.
Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional collaboration, and foster a more integrated organizational culture. Key goals include
strengthening IT infrastructure,
modernizing enterprise services, and
optimizing the IT services portfolio for stable, resilient, and adaptive solutions aligned with mission needs.
The FDA emphasizes the importance of sharing data to drive efficiency, excellence, and public health innovation. Additionally, the strategy involves adopting artificial intelligence and staying proactive in identifying opportunities and risks related to emerging technologies.
In a significant update on September 19th, Samuel Levine, Director of the #FTC's Bureau of Consumer Protection, outlined the agency's key priorities at the National Advertising Division's annual conference. Levine emphasized a three-pillar enforcement agenda.
The first pillar targets practices causing substantial consumer harm,
While the second aims not only to cease violative conduct but also alter incentives to deter future misconduct and
The third pillar introduces tools beyond case-by-case enforcement, emphasizing corrective and preventative actions (CAPA).
Levine's increased focus on substantive concerns and his expressed concern about "dark patterns" highlight a proactive stance in FTC enforcement.
This week, a data breach was disclosed by 23andMe, affecting 6.9 million users and compromising their genetic data information.
The incident raises significant concerns about data privacy and security. It's important to note that while some perceive this as a violation of HIPAA, it typically doesn't apply to direct-to-consumer genetic testing services like 23andMe, as they don't involve covered entities such as physicians. This leaves a gap in privacy protection, and alternative legal frameworks, such as those enforced by the Federal Trade Commission, may come into play. However, actions against direct-to-consumer genetic testing companies by the FTC have been rare. The breach highlights the need for increased awareness and potentially new laws and regulations to safeguard sensitive genetic data in the rapidly evolving digital landscape.
Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally not. Key considerations include the complexities of handling publication rights, the impact of tax-exempt municipal bonds on project restrictions, ensuring equal patient treatment, the reality of universities generating revenue from intellectual property, the distinct goals of principal investigators versus institutions, and the necessity of a comprehensive congruence review among documents related to clinical trial agreements.
Points discussed:
- What are the 6 big areas that large academic medical institutions tend to think about that sponsors or smaller hospitals/private institutions may not be thinking about in the context of clinical trial negotiations? - 2:29- 4:55
- Are tax-exempt municipal bonds a factor in clinical trial negotiations? 4:58- 12:03
- What is the impact of the Bayh-Dole Act on publication rights? 12: 04- 13:40
- Why do we not discuss confidentiality as much as we talk about publication rights?- 13:41- 21:26
- Should sponsors have the right to be present during an FDA audit in a large medical center?- 21:27- 24:19
- Should sponsors have a right to review and change a proposed audit in the case of a larger academic medical center? Check out our latest podcast episode to find out. 24:20- 26:20
- 6 different types of clinical trial transparency. - 26:21- 29:30
Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship.
In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast delves into seven hierarchical layers that dictate how organizations should approach compliance. These layers include:
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The Constitution (First Amendment): Highlighting the clash between First Amendment rights like free speech and FDA regulations. Emphasizes the importance of truthful and non-misleading information.
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Laws Made by Congress: Discussing how laws such as the Food, Drugs, and Cosmetics Act set the rules but can be ambiguous, potentially leading to regulatory challenges.
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Regulatory Agency Interpretation: Exploring how FDA, FTC, and OIG interpretations through regulations, guidances, and enforcement actions add another layer of compliance focus for Pharma companies.
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CIA Settlements: Examining Integrity Agreements or CIA settlements as legal precedents that set industry wide regulatory expectations for Pharma companies.
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Industry Codes: Discussing voluntary codes like Pharma or AdvaMed codes, which, while not legally binding, may influence industry standards.
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Internal Policies: Highlighting the importance of company-set policies for day-to-day operations, which are more conservative than the law but serve as prudent forms of engagement.
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Personal Risk Tolerance: Acknowledging that individual risk tolerance varies, and while policies guide the process, they won't eliminate personal risk tolerance.
The podcast emphasizes the need for companies to navigate these layers carefully and stay informed and compliant. It concludes with an invitation to seek assistance in creating digital health engagement programs by contacting the speaker via email at darshan@kulkarnilawfirm.com
Website: http://www.darshantalks.com
Law Firm: http://www.kulkarnilawfirm.com
Twitter: https://twitter.com/darshantalks
LinkedIn: https://www.linkedin.com/in/darshanku...
Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relat
Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including:
- Pressure from insurers to lower prices,
- Rising costs of manufacturing and distribution,
- Inflation,
- Supply chain disruptions and
- Increased competition from other generic companies
Pharmacies are fighting back against these challenges by:
- Bypassing wholesalers and negotiating directly with manufacturers,
- Offering discounts and coupons to patients and
- Partnering with other organizations to negotiate lower prices
Recently, Celia Sandhya Daniels was announced to be one of the top 20 LGBTQ leaders in Bio Pharma by Endpoints News.
In this episode, We're venturing into the captivating world of Diversity, Equity, and Inclusion (DEI) in the realm of pharmaceuticals and healthcare. Get ready for a journey that will unravel the mysteries and intricacies of DEI!
We’re joined by Celia Sunday Daniels, a seasoned professional with 25 years of experience in the pharmaceutical and healthcare industry.
We discuss:
Why is DEI crucial, especially in a world where companies could face scrutiny for advocating DEI? (3:07- 9:13)
How can we reconcile the goals of DEI with privacy concerns? (10:20- 18:32)
Does the FDA prioritize certain intersections more than others in its risk-based approach to DEI? (18:44- 24:33)
The case study on academic research center misconduct highlights the urgency to address and prevent such issues in the field. Instances of research misconduct, as exemplified by the Miami case, have drawn the attention of regulatory agencies like the Department of Justice, emphasizing the need for stringent oversight and ethical conduct. Examining the fictional case of Padre Pio Hospital in Philadelphia reveals the complexities and challenges involved in managing research misconduct, requiring strict adherence to FDA and IRB guidelines, staff training, and internal auditing.
To effectively address the situation, a comprehensive compliance program, self-disclosure, and corrective actions as per the FDA, OIG, and DOJ guidelines must be implemented, underscoring the importance of ethical conduct, timely reporting, and ongoing staff training in research centers.
Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations. In his discussion, Darshan Kulkarni highlights the FTC's recommendations for AI:
FTC expects that AI will foster fair, open and competitive markets,
FTC intends to use its tools to challenge unfair and deceptive practices involving claims based on AI including the use of AI to discriminate the and
FTC intends to promulgate market-wide rules to address harms from AI this includes fake reviews impersonators and other issues.
Jessica Thompson discusses how project management can be a game-changer in clinical research. We talk about how poor project management can lead to delays, cost overruns, and regulatory violations, and that lawyers can play a role in ensuring that clinical research projects are managed effectively. Thompson emphasized the need for early planning and communication between all stakeholders involved in a clinical research project.
Points discussed:
Do clinical research project management tools differ from those used in other industries?- 1:58- 4:25
What does the term 'critical path' mean?- 4:25- 6:34
How to companies respond to the concept of critical path?- 6:53- 8:46
How is Association of Clinical Research Professionals (ACRP) connected to Association of Clinical Research Project Managers (ACRPM)?- 9:54- 12:01
How should sponsors involve project managers in their projects?- 12:04- 18:47
Is a project manager different from a manager?- 19:07- 21:00
How do Kaizen and Lean Six Sigma fir into clinical research project management?- 21:02- 22:47
What is the significance of the Iron Triangle in clinical research project management?- 22:49- 28:08
What is the advantage of being a part of ACRPM?- 28:34- 30:48
Sign up for our newsletter- https://darshantalks.com/
Virginia Tech recently received a $50 million gift from the Red Gates Foundation for Health Sciences research expansion. In light of recent news about research fraud prosecuted by the Department of Justice, it is crucial for the Fralin Biomedical Research Institute to implement robust research integrity policies.
Here are five key steps that the institute can take to address research fraud:
1. develop and implement a clear research integrity policy,
2. establish written procedures,
3. provide comprehensive training on research integrity,
4. form a research integrity committee, and
5. encourage the reporting of suspected misconduct.
We discuss the 7 things to do before closing your pharmacy:
- Return your DEA registration,
- Notify the Board of Pharmacy,
- Dispose of controlled substances appropriately,
- Inventory your pharmacy and create a clear inventory list,
- Keep all documentation, especially for controlled substances, for at least 2 years,
- Know where your records are stored, as the DEA may request them later and
- Contact the Board to let them know that you will be transferring documentation and any drugs and/or devices.
The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process.
Key steps include:
1) Develop a risk-based framework- 0:39- 1:03
2) Get pre-market clearance or approval- 1:04- 1:37
3) Quality control and quality assurance- 1:38- 2:04
4) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:21
5) Ensuring data security and patient privacy- 2:22- 2:43
6) Conducting post-market surveillance- 2:44- 3:03
7) Staying proactive in meeting new compliance requirements- 3:04- 3:20
For expert guidance on FDA approval and regulatory clearance, contact Darshan Kulkarni at 302-252-6959.
On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data.
We highlight the significance of pharmacists recognizing red flags indicating potential fraud, including patients unknowingly or involuntarily enrolled in clinical trials.
Beyond the broader impact on public trust, pharmacists could face specific repercussions, such as disciplinary actions from the State Board of Pharmacy. Moreover, clinic owners could be barred from participating in research activities.
Implementing robust internal controls and collaborating with law enforcement to identify and report suspected fraud are essential steps for pharmacists and clinic owners to safeguard themselves from legal ramifications.
In this episode, guest Dave Bulger delves into the intricate role of AI, questioning whether it functions as a creator, a copycat, or perhaps both. Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave underscores that while LLMs can generate text, they lack true understanding. The conversation explores the challenges of scraping data for accuracy and ponders the future of AI, emphasizing the value of content creators and the necessity for expert verification in an AI-augmented world.
We discussed the following:
Introduction to the discussion- 1:09- 2:21
Are the tools we are using AI or LLMs? 2:23- 6:14
Can these tools replace people? 6:15- 9:45
Can you provide two descriptive comparisons that are relevant to the current state of generative AI? 9:46- 11:46
What is the current state of generative AI? 11:47- 13:05
Is there value to having different large language models? 14:26- 18:02
Why is it difficult to train these models on language using Reddit and other websites? 18:03- 19:51
What are your thoughts on content is king when we know that it's unsustainable? 19:52- 21:23
Who owns the results provided by these models? 21:41- 24:32
Should government agencies regulate AI? 24:33- 25:41
The FDA has taken action by sending warning letters to eight companies that have been marketing unapproved eye products, potentially violating federal laws and risking consumer health.
These companies include Boiron Inc, CVS Health, Dr. Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan USA or Similasan AG, TRP Company Inc., and Walgreens Boots Alliance Inc.
These companies are now under increased scrutiny and may face legal consequences if they fail to comply with FDA regulations. They must either seek FDA approval for their products or remove them from the market to avoid further repercussions.
Additionally, they need to establish appropriate marketing compliance programs to ensure accurate product labeling.
FDA is suggesting the use of one-pagers to provide essential drug information to patients. Past attempts faced challenges, such as one-size-fits-all content and patient trust issues.
Darshan emphasizes that while the FDA's proposal is a step in the right direction, it must ensure that these one-pagers are comprehensive, accurate, and transparent. Patients often rely on healthcare providers and trusted sources like WebMD for drug information. This short explores the potential benefits and concerns surrounding this FDA initiative, stressing the need for precise and reliable drug information.
In this episode, we’ll discuss how to speed up your marketing approval process with these must know concept review tips. We will talk to Heather McFalls, Director of AD Promo at Organon. In this interview we will address the following questions:
1. How often do people do concept reviews?
2. Is it useful to have an attorney at the concept review stage?
3. Is the role of PRC advisory or quality-focused?
4. Who owns the PRC process?
5. Should the PRC process be sequential or parallel?
6. Has AI been disruptive in the concept review process?
We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading promotion, as many unapproved applications lack scientific support. It's worth noting that the FBI oversees biohacking, despite its primary purpose not being generalized research.
AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave underscores that while LLMs can generate text, they lack true understanding. The conversation explores the challenges of scraping data for accuracy and ponders the future of AI, emphasizing the value of content creators and the necessity for expert verification in an AI-augmented world. We discussed the following:
- Are the tools we are using AI or LLMs?
- Can these tools replace people?
- Can you provide two descriptive comparisons that are relevant to the current state of generative AI?
- What does generative AI represent right now?
- Is there value to having different large language models?
- Why is it difficult to train these models?
- Who owns the results provided by these models?
We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading promotion, as many unapproved applications lack scientific support. It's worth noting that the FBI oversees biohacking, despite its primary purpose not being generalized research.
Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clinical trials. Specifically, Tatsene failed to test on the appropriate number of subjects, thus compromising the integrity and reliability of the trial data. How to Avoid this Fate: To sidestep such consequences, individuals and organizations must strictly adhere to FDA guidelines, which include rigorous clinical trial protocols like proper sample sizes for testing. Failing to do so could result in severe penalties, including debarment. Impact: This action sets a precedent that has significant implications for clinical researchers and Contract Research Organizations (CROs). Not only does it tarnish reputations but it also raises questions about data integrity, potentially delaying drug approvals and harming patients in the long run.
The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He discusses the CTP's evolution in the past decade and shares insights from his recent article published in the New England Journal of Medicine. We discussed the following:
- When was Micah a part of CTP? - 0:58 - 1:27
- What was the vision behind CTP's creation? - 1:35 - 4:48
- What caused CTP to be created? / The background of how CTP was established – 5:07 – 12: 33
- What was the reasoning behind the tobacco industry's move to be regulated by the FDA? – 12:35 – 17:16
- What challenges did the FDA and CTP encounter when they first started regulating cigarettes, and how does the situation compare in 2023? – 17:17 – 25:19
- Can the FDA shut down the entire tobacco industry? – 25:20 – 27: 30
- How can the FDA, with its authority over tobacco product regulation, improve public health? – 27:31– 29:33
- Micah talks about his article: 29:33 – 34:50
- What should the FDA focus on while regulating tobacco products/cigarettes? – 34:57 – 40:08
Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA examines various aspects like manufacturing, clinical research, pharmacovigilance, advertising, and distribution. FTC now addresses advertising and antitrust concerns. DOJ concentrates on corporate compliance. Is your organization well-prepared for these assessments? Get in touch with us for more information.
In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for identifying and addressing any roadblocks or gaps in the preclinical program before the actual filing. By doing so, potential delays or complications during the clinical trial phase can be mitigated. The discussion also includes insights into optimizing dosing strategies in oncology phase two studies, prioritizing patient experience, and finding tolerable doses that allow for extended drug administration. The conversation touches on cultural differences in FDA approval approaches across regions and the collaborative nature of successful FDA meetings. Overall, the episode emphasizes the importance of preparation, data-driven justifications, and effective collaboration to advance drug development and ensure safe treatments for patients. Points discussed: FDA meetings and Pre-IND significance: 1:30- 3:48 Optimizing oncology dosing strategy: 3:49- 8:32 Navigating maximum tolerated dose across cultures: 8:33- 13: 56 Key Indicators to address: 13:57- 15:38 Collaborative FDA meetings: 15:39- 21:59 FDA meeting composition: 22:00- 25:16 Learning from virtual FDA meetings: 25:17- 27:42 Strategic planning for FDA meetings: 27:43- 28:42 #FDAMeetings #FDA #FDAInsights #DrugDevelopment #PatientCentric #FDAapproval #FDAteam patientexperiences #medicalinnovation #patientsafety #clinicaltrials #clinicalresearch #darshantalks #kulkarnilawfirm #dt #klf #recentrecap
Isaac Rodriguez-Chavez discusses the role and the significance of the Decentralized Clinical Trials guidance.
We discuss the following:
- What are decentralized clinical trials? - 2:05- 4:25
- What factors led to the rise of decentralized trials? – 4:26- 10:58
- What is the role of decentralized clinical trials?- 10:59- 14:36
- What is the process of FDA to develop a guidance?- 14:42- 17:48
innovativeapproaches #healthcarerevolution #industryinnovation #hybridapproaches #remotetrials #diversityintrials #patientcentrictrials #inclusiveresearch #clinicaltrials #clinicalresearch #patientempowerment #kulkarnilawfirm #klf #darshantalks #dt #recentrecap
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Disclaimers: This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship
Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include:
- Industry-Sponsored Trials,
- Phase Four and Post-Market Studies,
- Registry Studies,
- Federally Funded Studies,
- Drug and Device Studies,
- Consortium Studies,
- Investigator-Initiated Studies:
We discuss the potential risks of seeding trials, and the need for both sponsors and sites to be vigilant about potential fraud and compliance issues.
Discussions include practical advice for both sponsors and sites, encouraging proactive feasibility assessments and streamlined concurrent negotiations.
The conversation underscores the multifaceted nature of clinical trial agreements, underscoring their pivotal role in advancing medical research while ensuring ethical practices and efficient collaborations. Join our discussion between Darshan Kulkarni and Istvan Fekete.
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clinicaltrialagreements #researchcontracts #ResearchAgreements #compliancematters #medicalbreakthroughs #trialagreementtips #advancingmedicine #regulatoryguidelines #clinicaltrialethics #darshantalks #dt #kulkarnilawfirm #klf
Website: https://www.darshantalks.com/
Law Firm: https://kulkarnilawfirm.com/
Twitter: https://twitter.com/darshantalks
Tune in to the @Darshantalks podcast on this Tuesday to hear host @Darshankulkarni and guest @Catina O'Leary discuss Healthcare Literacy.
A discussion on a variety of issues involved in marketing including the use of prequalification of people for targeted advertising, the loss of cookies for prequalification,. directed advertising and much more.
Join me for a conversation with attorney Donna Tobin about state and federal requirements around cheese labeling.
A discussion with FCC Chairman Ajit Pai on the role of the FCC in expanding healthcare access via Telemedicine, the impact on privacy, cybersecurity and net neutrality.
A discussion with CRO CEO John Reites. Our discussion will explore decentralized clinical trials, the missing secret ingredient in clinical research, global studies and more, development of advisory boards, the methodology to choose an initial board, how to work with patient advocates and influencer communities and briefly discuss virtual visits.
Both of us attended the virtual summit. What did we discover, what did we miss and what we think it means.
Discussion with guest Matthew Nichols about the transparency and consent framework and the impact of tailored advertising for non-marketing purposes. The discussion included talking about the potential federal privacy bill, the ad supported internet and the impact of the ad supported internet on healthcare engagement and advertising. Discussion includes the role and controls by content creators, appropriate governance, the use of an appropriate code of conduct and much more.
A discussion with health and clinical trial entrepreneur Zedrick Buhay on starting a clinical trial site, choosing studies and therapeutic areas, balancing other similar health initiatives and maintaining and managing sponsor expectations
Discussions will range from sourcing technology to help a company find unicorns from data scientists to pharma doctorates to specialty nurses. We hope to also discuss sentiment analysis on emails, surveys and performance reviews to proactively give clues to trends and patterns.
A discussion on Project Management/Clinical Monitoring/Clinical Operations including on Clinical Development Training, recruitment and retention with focus on specialized populations.
A brief discussion on the history of antibiotics from history maven Douglas Bucklin PhD.
An interview with author Hedley Rees about changing the drug development process from a "patent focused" approach to instead leverage current technologies and past successes. The discussion gets into the use of #organonachip, #tissueengineering, #biohacking and more.
A brief discussion with Dr. Robert Pugliese about health innovation, changes expected and how it ties into the future of health.
A discussion with Senior Privacy Consultant Avishai Ostrin about privacy and trust. The conversation explores the difference between data lawyers and data consultants. We also discuss the connection between data ownership and data intellectual property, and if there is a real difference in EU and US views on privacy - is privacy a human right or a property right? We also briefly delve into data and its implication on clinical research. Another question we explore is whether there is a difference between whats app and ancestry.com and 23 and me?
A discssion on promotional compliance, the role of podcasting in marketing compliance, addressing patient needs, addressing loss of trust between patients, did marketing play a role in the rise of trust in pharma, how should medical affairs engage as compliance loosens its grip? This discussion will get into discussions about podcast interview compliance, virtual poster presentation compliance, influencer training and compliance, and the bad Ad program.
Fascinating conversation with Dr. Alison Bateman-House, Research Assistant Professor of Medical Ethics, about the need for #bioethics in the #medical field. Discussions ranged from #patientadvocacy groups, #fundings for such groups, issues of #trust associated with such funding, #conflictofinterest and much more.
We had a conversation with Vivian Juter Frankel, CEO of #PharmaSalon, about the importance of practical #compoundingpharmacy education. We will discuss disruptive events, the importance of intimate conversations at conferences, what is an unconference, the importance of learning from others, representation in the context of #diversityandinclusion, and whether we will transition back to live events in the near future.
I spoke with Erin Fox, Senior Director at University of Utah Health, about the future direction of the #pharmaceutical industry and the changing role of #pharmacists. We will discuss everything from #drugshortages to on-shoring, #cybersecurity to Civica Rx and much much more.
Join me as I speak with Kate Woods, JD, MPH Chief Compliance Officer at Schweiger Dermatology Group about the basic tenets of #healthcare #leadership. We discuss how to build a team including the basic tenets of #people #process #culture while also briefly discussing #diversityandinclusion and building a #trustedworkforce.
Join me as I talk with Matthew Nichols from Network Advertising Initiative (NAI) the reasons people join the group, how traditional advertising routes like TV are making a comeback in data personalization, about the ownership and sharing of data, the working with the FTC in cases of non compliance and #digital #advertising as a whole as it may impact the life sciences.
Join me as I talk with Head of Patient Engagement Emma Sutcliffe about the importance of #patient #advocacy within the #lifesciences. We discuss the differences between #patientengagement, #patientcentricity, #patientsupport and #patientadvocacy, discuss Trishna Bharadia, the role of agencies in brokering relationships, the appropriate residence of patient engagement in #medicalaffairs, #sales, #marketing, #regulatoryaffairs, post approval support, #transparency and technology.
Join me for a conversation with #digitalhealth leader Melinda Decker about how digital health products have been increasingly #commercialized. Our conversations ranged from the differences in commercialization models between direct to consumer therapeutics versus prescription only models, data collection considerations, #dataprivacy #socialdeterminantsofhealth, #patientcentricity and discussions on #trust.
A conversation with General Counsel Matthew Fisher at Carium about the importance of patient #privacy. We explore #telehealth , #telemedicine , #dataownership, #datasecurity and its impact on #clinicaltrials and #clinicaltrialresearch
A conversation with intellectual property lawyer Donna Tobin about #cannabis-related #trademark issues including state registrations, Martha Stewart's cannabis plan, pending legalization issues and their impact on trademarking and much much more.
Darshan Hey everyone, my name is Darshan Kulkarni and I'm your host for the Darshan talks podcast. As some of you know, I'm an attorney, I'm a pharmacist, and advise companies with FDA regulated products. So if you work or have an interest in FDA regulated companies or their products, this is a podcast for you. If you are working in an FDA regulated, regulated company or are interested in the products associated with it, you're probably dealing with with something that has had medical writers fingers all over it. And if the fingers have been all over it is because they've probably been through a lot of school. And to get there, they may have been THROUGH THROUGH THROUGH Danny's guidance. So you should care about today's podcast because our guest is someone who has spent a lot of time educating students. I believe it's over 22 years of distance learning 16 years of online teaching. But we'll talk about that more. Please leave a comment and subscribe. If you find this interesting. We'd love to have you listened to the next podcast. But Danny himself is currently the Director of biomedical writing programs. He's the professor of biomedical writing. He has a PhD in biology and has a decade at Wyatt where he worked on 14 MBAs. He redesigned he's now at the University of the sciences, where he redesigned the curriculum for the biomedical writing program significantly contributed to the creation of a graduate program in regulatory sciences and created or revised 12 courses. He's been the instructor for 10 regularly occurring courses and seven Special Topics courses, many of which have been taught multiple times. He's the author, co author of 14 manuscripts, two book chapters and numerous clinical reports. He's been on nine professionals, society, society meeting program committees, Danny, what did I miss? Dan Actually, it's now for book chapters because we have a second edition and significantly revised those two. So they really aren't the same thing anymore, since quite a bit happened between version one and version two. I have other manuscripts in the hopper. We'll see what happens. But that's part of Of course, being a professor. It's not just publish or perish. It's published because that's what we're supposed to do. Darshan Yeah. Ladies and gentlemen, our guest for the day, then Ben now, then you can thank you for coming on. I appreciate it. Dan Thanks for having me. Darshan It's so so let's, let's ask some basic questions. Right. Why did you decide to go from being in Wyatt working on NDA to being a professor? Well, Dan actually, I worked at y for a decade. I moved on from there. I was at Santa Fe, cinta labo for a bit over a year and then decided to go freelance. Darshan Okay. Dan So I freelanced. We kind of set an industry record before I left freelancing. I was hired in at the beginning of October, and we submitted an NDA in the middle of December. Darshan Wow. Then two months, right? Dan Yeah, two and a half months, and that product ultimately went to market, Darshan which was a dino, excuse me, which product was it? Dan Um, it was called ventes. It was it was a treatment for advanced prostate cancer used history colon, which was an off patent drug that was originally used to treat precocious puberty, but they wrapped it up in a the material that was so as a combo product, it was wrapped up in a tube made out of material from gas permeable contact lenses and was then implanted under the skin. So it was good for a year in creating in treating metastatic prostate cancer. Darshan Okay, so so your your biology knowledge is not skin deep, if you will, a PhD Dan II Yeah, I'm actually just of interest anybody. My in terms of history and pedigree. My dissertation adviser Charles Turner himself had been a graduate student of Sir Hans Krebs, as in the Krebs cycle. Wow. And I met that guy a couple of times. Darshan That's kind of cool. I remember Matt trying to memorize the Krebs cycle.
Darshan Hey everyone, welcome to the Darshan talks Podcast. I am your host Darshan Kulkarni. As some of you know, I'm an attorney, I'm a pharmacist, I advise companies with FDA regulated products. So if you work for or have an interest in an FDA regulated company or its products, this is the podcast for you. Today's guest is the president of witzel innovations, Inc, she refers to it as wi because she's cool and I'm not and has a background in clinical development. So if you are in regulatory, if you're in clinical, if you're in statistics, you might be someone who, who's working with medical writers and you'd care about this because someone like Robin or Robin herself, might be working on your next NDA. If you if you think this is interesting to you, please like leave a comment, subscribe. Um, one of the things I do want to also point out is today's guest, which is Robin has, has a extensive background in clinical development. So she's not just a medical writer, not the just associate with it, but she has a wide range of experiences. And you can actually reach her where can Where can they reach you again, Robin, Robin so they can reach out to me on LinkedIn or email me at Robin dot witsel at Mattel innovations calm. I recognize it's like the world's longest email address. And I apologize. Darshan Very cool. And ladies and gentlemen, our guest for today, Robin Woodall. So thank you for coming on Robin. Robin Hey, starsan Thanks for inviting me, of course. Darshan So um, Robin talked to me a little bit about just some oil with the we had a conversation right before we started. And actually, before we started should probably introduce what innovations actually is. It is a full service medical scientific writing company focused on pharmaceutical, biotech and device clients, your employees write regulatory documents from the preclinical stage, all the way through the clinical stages, including your ind protocols, IBS, clinical study reports, narratives, etc, etc, etc. You also go into manuscript writing, slide and abstract, abstract presentations, sales, AIDS, and module compilations, and also performed literature reviews, you write and edit continuing medical education, and book chapters for accredited institutions and firms. So that seemed like a mouthful. Robin It is well, and we acquired electronic regulatory publishing company back in 2019. So now we can push through the electronic submission gateway for the FDA with electronic regulatory submissions. Okay, so you very exciting soup to Darshan literally the nuts. Robin I guess. So. Darshan Apparently, I did discover recently that soup to nuts is not a thing most normal because Robin it kind of has like a, I don't know, I would go with end to end. Darshan Way better than soup to nuts. Right. So let's focus on the basics. Rob, you obviously have a background in clinical development. When you started with Wi Fi, why did you start wi with with your background? That was slightly different, if you will? Robin Sure. So my background was clinical development. And my my last job before I started WI, I was an assistant director of preclinical and clinical programs at a startup. And because it was a startup, and I was literally like the 20 somethings employee, like I would just come into work. And pretty much everything would be my job, like, oh, who's gonna write that protocol that we, you know, who's gonna work on that master manuscripts still you so and then I worked on one compound from ind through NDA. And I've written plenty of work on plenty of imds throughout that period, as well. So after that experience, after my second daughter was born, I thought, okay, I'll just hang out a shingle, I'll consult. And right away I had a ton of work and with this small startup company here in the Research Triangle Park, where I'm located, and they discovered that they really needed help with the writing piece like that was their big gap.
Darshan Hey everyone, welcome to another episode of Darshan talks. My name is Darshan Kulkarni. As you all know, the goal of this podcast has always been to talk about the life sciences to talk about things that impact the life sciences. And one of the things that keep popping up is the idea of privacy, the evolving and emerging role of privacy and the discussions around it, and how that impacts the life sciences. And if you're in clinical research, if you are in marketing, if you are in PR, if you have if you are a medical device that has patient data, every single one of you are probably impacted by the discussion around privacy. Along the way, I, I follow a lot of really interesting people on LinkedIn. And one of the most interesting people I follow is an Amish shy Austrian. And Avishai is the head of privacy at axon. He is both a qualified privacy solicitor in England and Wales and also in Israel with a strong background in corporate commercial law. And, and what we're discussing is really how this all comes together and have a shot. Before I jump into some questions. Is there anything I missed? Would you like to answer any questions? clarify something I said or didn't mention? No, I think that was, first of all, thank you very much Darshan, for having me having me on the podcast, the chat always, always great to chat to friends all around the world. And that's what's amazing about this, this time that we're in now is that it's so easy just to hop on virtual chat and just Avishai have a conversation. So I love it. Darshan You never he never quite got this chance before. I'm gonna try. Let me ask you, oh, let's put some things out of the way. Because as lawyers, we kind of have to worry about this. This isn't legal advice. So if you're interested, I need legal advice. I wish I Why should they contact you? Avishai LinkedIn is a great place to find me. I'm very, very active there. So just drop me a line. And we'll we'll get the conversation started from there. Darshan Perfect. Um, so let's start with a couple of different questions. So we had a very brief conversation, as you know, started before the, this this starting the interview, and you talk to me about how you were born in Harrisburg. And, and yet here you are a solicitor in in Wales and the UK and and well, in England, Wales, and also in Israel. How does that all come together? Why Why did you come Bring these pieces together from a global perspective? And Yet, You're both not only an expert in, in privacy, but also corporate and commercial. So how do you bring that all together? Avishai Yeah, so a bit of a you highlighted a bit of my split personality there. But yeah, born in the US grew up in Israel, trained as a corporate and commercial lawyer went to law school here in Israel, trained as a corporate and commercial lawyer worked at one of the big firms and like every good young corporate lawyer, I did really everything I did, you know, high tech mergers and acquisitions, bit of antitrust even which was fascinating, and really fell in love with the area with privacy and data protection, and how basically how technology and the law, interact and sometimes clash with each other. And realize I wanted to develop my to have a career in this fascinating field, looked around at the Israeli privacy regulations and realized they weren't really the gold standard of privacy around the world. And they were talking about this new emerging regulation called GDPR. your listeners may be familiar with it, which is the privacy regulation that applies in the EU, that was supposed to be this new gold standard of privacy. And I said, great, you know, let's let's do that. And so I found the, you know, I knew of a UK firm that was actually based here in Israel. So I applied to work there and got my English qualification got my privacy knowledge up to date, and I really founded the privacy practice at esterson, which I had today. So that's, that's my journey.
Darshan Hey everyone, we have as you guys know, my podcast really deals with life sciences and pharmacy, and things that impact the engagement between the two, and things that impact just the care of patients. This specific podcast I thought was really interesting because I think groups like ascp come out and actually connect with a unique set of patients, patients who, whose needs are often not being met. So if you are in the pharmacy in this pharmacy, if you are a pharmacist or pharmacy, you want to be talking to someone like Chad, because you might want to find out Well, can I learn from lessons that that ascp has, if you're in the pharmaceutical industry, you may want to talk to Chad because these are pharmacists were frontline workers who are actually learning from patients and they need education. They need to know what your drugs are doing, what your devices are doing. So that's why I thought today's podcast makes sense. My name is Darshan Kulkarni, this is Darshan talks, and we have Chad Morris. So Chad, welcome. Chad Happy to be here. A little bit about yourself and escp. Sure. Well, first of all, thanks for having me on. Just from the audience perspective, I think the first time we met was a, a live stage podcasts. We were on stage in front of a group being recorded for a podcast and we had met I think, at lunch like 20 minutes before, and it's still one of the I had the best time. You know, obviously your personality lends to that. But just thanks for thanks for inviting me. Your show is fun. That's going to be a lot of fun today, you'll be good. Yeah. So um, yeah, to your point. asep is a is a unique organization. In pharmacy, we represent pharmacists, and pharmacies that take care of people in older adults setting. So traditionally, that's been skilled nursing facilities, assisted living facilities. Some states have intermediate care facilities, our pharmacists take care of a lot of individuals that live in group home setting, so developmentally disabled individual, so generally patients with complex medical needs. And it started, you know, 50 years ago, probably because a corner drugstore pharmacist said, How can I better serve these nursing homes that are popping up in the community? And ultimately, what what happened was the pharmacist figured out that there's a lot of things that those kinds of buildings need from efficiencies, like, how do you package medications and nurses can pass them better to how do you manage patients clinically when they start to accumulate medications. So the last 50 years has been this sort of growth and experience in how to take care of older adults that are complex from a medication standpoint. And now we sit at this intersection of sort of the Golden Age of pharmaceutical companies where we've got a lot of options to treat patients. So you've got a lot of demand for medications, and a lot of use of medications. Plus, you've got a population that over the age of 65 is growing faster than any other segment of our population. And even within that the over 85 population is growing the fastest within that over 65 population. So you've got older adults, they're living longer, they're healthier, primarily because of medications, but they're also dealing with the fact that they're they have to take a lot of those medications. So how do we do that safely? And how do we do that with an eye on the fact that they're a very different person than a younger, healthier population? So our pharmacists do that. You'll see them again, in nursing homes, assisted living facilities, and in the community. A lot of them are being embedded in in physicians, clinics and doctor's offices that take care of generally older adults. So let's start with the basics. Because when I talk to pharmacists, the big question I get asked is, how do I stop being a retail pharmacist? How do I stop licking, sticking, counting pouring? Generally speaking, if the big box retailers, I'm not knocking them.
Darshan Hey, everyone. So we, as you guys know, on this podcast, we land up talking a lot about the life sciences. And we talk about things that impact on life sciences, including clinical trials. today's podcast is going to be talking about what is what are clinical trials, like, from the perspective of a site, who is doing oncology? It's a multi multi location site, if you will. And we have with us, Kathleen ritardo. Kathy, I believe I know you're a pharmacist, but is it PharmD or is it RPh? Kathleen RPh. Darshan Okay. So we have Kathleen with us and Kathleen is unusually a pharmacist, which I know for me at least that for something when I was going to pharmacy school, I always wanted to ask to talk to people who've done the goi ng down that pathway of being a pharmacist and clinical research. I've never found one. And the ones that I did find really ended up being more people who mix up the drugs as opposed to people who actually administer the site. So a Kathleen is what I think of as a unicorn. So welcome, thank you. And this is my name is Darshan Kulkarni, this is Darshan talks. This is Kathleen Hurtado. Happy to introduce yourself, please. Kathleen So thank you, Darshan. Really nice to be here with you today. So you kind of already did it. My name is Kathleen Hurtado, and I am the VP of research administration for Cancer Treatment Centers of America. And I've had a very, you know, blessed career very varied career, but started started out as a oncology pharmacist at MD Anderson, my first job out of pharmacy school. So, and I've had lots of different things all the way around and kind of ended up serendipitously here. So Darshan I'm not gonna let you go that or that easily. Okay, go from pharmacy school to run your clinical research site. Because, personally, like I said, You're the unicorn. How did you even think, did you think you'd land up here? Kathleen Oh, no, never. I love being a pharmacist and thought that's what you know, I would, I would, you know, do for the rest of my life, but it was just very serendipitous. So I am working at MD Anderson, we, I was worked in pediatrics, and we had a lot of, you know, sales reps come and call on us. And so one of them was we I got to be, you know, friends with her. And she kept saying, Oh, you should come into sales, you should come to sales. And I was like, no way. So I'm, I'm really pretty much an introvert by nature. And so it was something I could just never see myself doing. And so at the time, they were starting, that company was starting in oncology, Salesforce. And so they were looking for people that knew oncology, oncology, pharmacist, psychology nurses, because they knew that to go out to doctors, you had to be able to speak the science speak to the science. So I thought, Well, you know what, I'm going to go interview because what's the worst possible thing that can happen? The worst possible thing that can happen is I go, I tried to do it. I don't like it. I go back to being a pharmacist. You know, I knew I could I love that. I could always go back and do that. And as it turns out, I was actually good at it. Yeah, I wish I would never ever, ever have expected. And I think I was I started out as a surprise, I started out carrying the bag. So yeah, in fact, I had a five state territory. So I had Minnesota, Iowa, Wisconsin, North and South Dakota and the Upper Peninsula of Michigan. And so yeah, and so for somebody who had never driven in snow in their entire life, it was kind of a rude awakening. And I used to scare my district manager half to death. Because I was a little bit crazy, it was like, as a company car, let's, you know, spin it and see what happens. So but, um, but it was great, because it got me out of my comfort zone. So what I learned from that was that, you know, sometimes you have to, you know, you take a risk and do something different. And I always encourage people to, you know, try try something new, like, you know,
Your voice helps to define your personality, mood, and health. In this episode, speech-language pathologist Jessica Schwartz explains what can impact your voice (and how you can take care of it!).
Join me as I talk with Jordan Fischer, CIPP-E, CIPP-US, CIPM about the role of #privacy in the #lifesciences. Discussions included the EU privacy shield, US Surveillance laws and why they matter for data privacy, the #Brexit Adequacy decisions, and #biometricdata privacy laws - and how all of these affect #clinicaltrials, clinical trial #transparency and life science #marketing.
Sales and marketing representatives in the life science industry must comply with state and federal regulations. What are these regulations and how should you navigate them? Join Darshan Kulkarni as he talks with Marc Banjak, General Counsel at Dova Pharmaceuticals, about sales compliance in the life sciences. We’ll also discuss some problems that arise with patient ambassadors.
Pharmaceutical companies have spent billions of dollars in an effort to create COVID-19 vaccines and drugs. Should the federal government force these companies to offer their products for free? Join Darshan Kulkarni as he talks with guest Doug Bucklin about the basics of vaccines. Plus, we’ll discuss the new possibilities offered by mRNA vaccines.
Marketing and medical affairs are often perceived as being separate. What happens when drug companies market their own products? Join Darshan Kulkarni as he talks with guest Dr. Stephen Towers about the intersection between marketing and medical affairs. We’ll also discuss how medical affairs can inform marketing efforts.
Blockchain technology has become an increasingly common tool for life science organizations. How is this technology being used by life science companies? Join Darshan Kulkarni as he talks with guest Jim Nasr about the use of distributed ledger technologies such as blockchain during COVID-19. Plus, we'll discuss how blockchain technology encourages trust.
Publications are a central part of medical affairs. What is publication planning, and what are some common mistakes associated with it? Join Darshan Kulkarni as he talks with Head of Medical Affairs and Operations Elisabeth Fine about the major functions involved in publication planning. Plus, we’ll discuss the importance of creating a story for your publication.
How should you name your drug? Join Darshan Kulkarni as he talks with trademark lawyer Donna Tobin about the importance of performing a trademark search when naming your drug. Plus, we’ll discuss the advantages of performing a knockout search.
Decentralized studies are becoming increasingly common as a result of COVID-19. Will this trend continue? Join Darshan Kulkarni as he talks with guests Kelly Willenberg and Geoffrey Schick about the challenges presented by decentralized studies, and why this new way of conducting studies might not be ideal. Plus, we’ll discuss what the future clinical trial patient may look like.
Decentralized clinical trials are becoming increasingly common as a result of COVID-19. Will this trend continue? Join Darshan Kulkarni as he talks with clinical research expert Dan Sfera about the future of clinical trials, and whether decentralized studies will continue to grow in popularity. Plus, we’ll discuss the function of patient organizations.
Blockchain technology has become an increasingly tool for life science organizations. How is this technology being implemented, and what value does it offer? Join Darshan Kulkarni as he talks with guest Jim Nasr about the function of blockchain, and how distributed ledger technologies such as blockchain are making an impact on healthcare. Plus, we’ll discuss the importance of technological trust.
Britney Spears was recently in the news due to her conservatorship ruling. How does this scenario help explain decision-making capacity? In today’s episode, Darshan Kulkarni talks with Professor of Philosophy Peter Koch about the applications of decision-making capacity in healthcare. Plus, we’ll discuss the basic tenets of bioethics.
Space health encompasses many different technologies. What applications does space health have on Earth? Join Darshan Kulkarni as he speaks with physician and investor Falgun Chokshi about the innovations of space health, and what impact these discoveries have on healthcare. Plus, we’ll talk about the potential for space health to improve the development of pharmaceuticals.
Rather than target physicians, marketing companies are beginning to reach out to patients. What does this shift in focus mean for the healthcare industry? Join Darshan as he talks with guests Omar Khateeb and Keith Piper about new marketing efforts to reach patients, and what this entails. We’ll also talk about the changing role of the patient.
Balancing clinical trial transparency with privacy can be difficult. How can you make patient-level data available while still protecting patient privacy? Join Darshan as he talks with transparency expert Nirpal Virdee about the tension between transparency and privacy. We’ll also talk about the role of CCI and CBI.
Creating a business for the first time can be overwhelming. Which agreements should you have in place before starting your company? Join Darshan Kulkarni and guest Major Hoffman as they discuss the top five agreements you should create when starting a new business. Plus, we’ll talk about where to find templates for agreements and how to use them.
Creating a transparency plan for your company can be a difficult undertaking. What are five steps to take when creating a transparency program for the first time? Join Darshan Kulkarni as he talks with guest Major Hoffman about the basics of setting up a transparency plan. Plus, we’ll discuss how to avoid potential pitfalls.
Technology is occupying a more central role in different industries. Is technology the solution to most problems companies face? Join Darshan Kulkarni as he talks with technology expert Jim Nasr about the changing role of technology, and the potential problems it may cause. Plus, we’ll discuss the dangers posed by ransomware.
Creating a mail-order pharmacy can be a difficult undertaking. What are some considerations to keep in mind? In today’s episode, Darshan talks with regulatory lawyer Mujadala Abdul-Majid about the basics of setting up a mail-order pharmacy. Plus, we’ll discuss the importance of ensuring products are safe and efficacious.
The COVID-19 pandemic has rapidly transformed the clinical trials landscape. What is happening to data as clinical trials become increasingly decentralized? Join Darshan Kulkarni as he talks with guests Craig Lipset, Artem Andrianov and Moe Alsumidaie about the new role of data in clinical trials. Plus, we’ll discuss the advantages of risk based monitoring.
For people living in areas with underdeveloped infrastructure, it is often difficult to access jobs. How can businesses attract people from impoverished areas for employment? Join Darshan Kulkarni as he talks with Ride to Work President and CEO Tim Styer about how to make jobs more accessible for people living in economically depressed areas. We’ll also talk about how for-profit companies can give back to disadvantaged communities.
Due to Brexit, the distribution of the COVID-19 vaccine has been affected. Has Brexit slowed Britain’s COVID vaccine program? Join Darshan Kulkarni as he talks with transparency expert Nirpal Virdee about the impact of Brexit on vaccine distribution in Britain. We’ll also talk about the approval process for the vaccine.
Living with diabetes can be difficult but is always a balancing act between nutrition and medication. In this today's episode, Darshan interviews Michael Castagna, CEO of MannKind Corporation. They discuss the evolution of diabetes treatment and how the prescription use of inhaled insulin can significantly improve quality of life.
Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. I had actually promised not to show my face when I was talking to Tia a few seconds ago, but I seem to have forgotten all about that. I have a very special guest. I have Tia. You guys met her, I want to say a couple of weeks ago. We had her on the podcast and it was a hit, and we're welcoming her back. Tia is entrepreneur extraordinaire. Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com. Darshan: She's going to tell you all about herself, but what I do like to point out is, she's breaking boundaries. She is leading the way for black and brown entrepreneurs in Philadelphia, and in the East Coast, really, for advancement in the life sciences. So, Tia, tell us more about yourself before we jump into the conversation today. Tia: First, thank you for having me, Darshan. Founder and CEO of LucasPye BIO, as well as HelaPlex. LucasPye BIO is a medicine manufacturing company. HelaPlex is the first life science co-working space with a built-in accelerator. So, I have 20 years in the biotech industry, myself. Working my way up literally from, I guess you say the benchtop, and rolling patients into clinical trials as a intern, to, senior manager was my last title as far as being an employee in big pharma. Then, now I have my own two companies as a, I guess you call it C-suite executive. So, [inaudible 00:01:41]... Keep going? Darshan: Keep going. I mean, I love hearing about you, because I [crosstalk 00:01:44]. Tia: Keep going? I am a HBCU graduate of Howard University. I got my bachelor's in biology from there. Later on, I went back and got my master's in entertainment business from Full Sail University. I actually have a chronic condition myself. I thank about two-and-a-half years off, and during that time, I ended up following my friends to LA. They're all in music and film, so I got into the music area as far social media marketing and all that stuff when it was super, super hot, and at the beginning of Twitter's hype and all that stuff at that time. Then, when I was cleared by the doctor, I went back to biotech. In that time, I got my second master's in regulatory science from University of Southern California. Regulatory science is the study of taking food, medical devices, and drugs, of course, from benchtop, or research, or another country, for food perspective, and bringing it into the commercial market, whether it's in the US or any other country around the world. So, that's a bit of background around me. I love science. I've been science nerd since day one. I got [inaudible 00:02:47] nerd out on biotech feature, bioconference, a few years ago. Darshan: Oh, I love it [crosstalk 00:02:54]. Tia: Happy to be here, and glad to speak with you today, Darshan. Darshan: Thank you again, Tia. So, Tia, we're actually going to have... We're both in Philadelphia, and we've been dealing with some riots and some protests in the last few days. We're going to tangentially get into that, but I want to use this opportunity to actually have a discussion about how to... Actually, you phrased it better than me. Say it again about what our discussion's going to be, because I was like, "Yes, that is exactly what I want to talk about." Tia: Got you. So, our topic of discussion today is to, as entrepreneurs, or any other business, how to attract people of color for employment. More specifically, how to retain them, and more specifically than that, how do you retain and attract African-American men into these respective roles, and how do you go out and search for them? So, this is right on time for me as well, because I'm actually having this discussion with my staff. Darshan: So, talk to me, was this discussion raised to you by your staff, or did you do it yourself? Tia: I did it myself. We had a outside contractor come to us,
A site management organization (SMO) provides services to the investigator at a clinical site. How does this business model reflect a franchise model? Join Darshan Kulkarni as he talks with clinical trial expert Dan Sfera about the stigma associated with SMOs and how the SMO business model really works. We’ll also discuss some common pitfalls related to SMOs.
The FDA has already granted several emergency approvals to COVID-19 vaccines, and the UK is just beginning its first round of vaccinations. Is approval of these new vaccines premature? Join Darshan Kulkarni as he talks with guest Maria Chester about how the COVID vaccines may perform as they’re being deployed. Plus, we’ll discuss the importance of durability in vaccines.
For entrepreneurs in the startup business, it’s often difficult to navigate the new business terms they come across. For instance, what’s the difference between an accelerator and an incubator? Join Darshan Kulkarni as he talks with guests Kate Merton and Julia Huettner-Pumar about the different roles of accelerators and incubators, and which might be best suited for your startup. Plus, we’ll discuss how an accelerator might help your startup expand.
Although companies often need to develop clinical trial transparency programs to meet regulations, it can be unclear where to start. How should you create a compliant transparency program? Join Darshan Kulkarni as he talks with guest Major Hoffman about the different components of transparency programs and the dangers of not complying with regulations. Plus, we’ll discuss how transparency programs may affect any privacy programs being developed.
For entrepreneurs, finding good health insurance coverage can be difficult. What are your options for getting the best care? Join Darshan Kulkarni as he talks with national managed care practice leader Kenneth White about finding an effective health plan as an entrepreneur. Plus, we’ll discuss the difference between going to the federal exchange versus a state exchange.
Creating an effective clinical trial transparency program can be difficult. What should your company consider before developing a transparency strategy? Join Darshan Kulkarni as he talks about how to successfully create a transparency strategy that complies with state and federal regulations. Plus, we’ll discuss why understanding your competitors is so important.
Clinical studies have become increasingly virtual because of COVID-19. How has this affected the way the FDA inspects clinical trials? Join Darshan Kulkarni as he talks with former FDA auditor Patrick Stone about his experience investigating sites and sponsors. Plus, we’ll discuss why virtual monitoring may be more cost-effective than other options.
Clinical study transparency programs are necessary for companies looking to disclose data and fully comply with state and federal regulations. Why else should your company create a transparency program? Join Darshan Kulkarni as he talks with guest Major Hoffman about six factors to consider before developing your transparency program. Plus, we’ll discuss why lay summaries are such valuable tools when communicating with patients.
It can be difficult to set up a clinical research site for the first time. What are some of the most common issues? In today’s episode, Darshan Kulkarni joins clinical research expert Kelly Willenberg to talk about setting up a compliant clinical research site. Plus, we’ll talk about the importance of adhering to Good Clinical Practice (GCP).
Many ethical concerns are raised after patients die in clinical trials. Once a patient dies, what happens to their consent? Join Darshan Kulkarni as he talks with professor of philosophy Peter Koch about the rights patients have after death. Plus, we’ll discuss the principles of “do no harm,” and how this applies to patients who have passed away.
It’s important to know the right time to file a trademark. How early should you file? Join Darshan Kulkarni as he talks with trademark lawyer Donna Tobin about the application process when filing for a trademark. Plus, we’ll discuss the key differences between trademarks, patents and copyrights.
As digital health evolves, many people have become concerned about the potential limitations HIPAA places on technological advancements. Is HIPAA relevant for all digital health services? Join Darshan Kulkarni as he speaks with privacy attorney Shannon Hartsfield about the applications of HIPAA in the digital health world. We’ll also talk about a few situations in which HIPAA does not apply.
Due to Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has had to develop its own procedures separate from the European Medicines Agency (EMA). What new guidance has the MHRA released? Join Darshan Kulkarni as he talks with transparency expert Nirpal Virdee about the MHRA’s impact on transparency in clinical trials. We’ll also talk about how the European Medicines Agency (EMA) is dealing with the aftermath of Brexit.
How can bioscience companies foster diversity within their industry? Join Darshan Kulkarni as he talks with entrepreneur Tia Lyles-Williams about the value of diversity within the life sciences. Plus, we’ll talk about the barriers to diversity in the life science industry, and how these barriers make it difficult for people of color and those within the LGBT community to break into the field.
Life science company Verily has recently launched a new health insurance venture. How might this affect the healthcare industry? In today’s episode, Darshan Kulkarni talks with healthcare lawyer and practice leader Kenneth White about the implications of Verily’s reinsurance platform. Plus, we’ll discuss the meaning of stop loss and provider excess loss.
There is growing pressure being placed on pharmaceutical companies to make their clinical trials more transparent. Despite this pressure, there remain privacy concerns about publicizing clinical research data. How can companies successfully balance privacy requirements with transparency? Join Darshan Kulkarni as he talks about the growing need for transparency in clinical research, and how to develop transparent clinical trials.
Figuring out how to conduct a coverage analysis can be difficult. Is it necessary for your company? Join Darshan Kulkarni as he talks with research healthcare compliance consultant Kelly Willenberg about what coverage analysis entails in clinical trials. We’ll talk about the importance of coverage analysis and how to avoid common pitfalls.
Virtual reality has been rapidly developing in recent years. What does this mean for bioethics? Join Darshan Kulkarni as he talks about recent developments in the field of virtual reality, and how these new technologies raise important bioethical questions. Plus, we’ll discuss some of the applications virtual and augmented reality have in the life sciences.
What is the FDA’s stance on cannabis, and how has it evolved? Join Darshan Kulkarni as he discusses recent FDA guidance on cannabis, and the differences between hemp and marijuana under federal law. Plus, we’ll talk about the basics of the Controlled Substances Act and how federal regulation of cannabis products differs.
What are 503B compounding pharmacies, and how are they evolving? In today's episode, Darshan Kulkarni talks with pharmacist Syed Saleem about the basics of 503Bs, and the future of the compounding pharmacy industry. Plus, why it’s useful to maintain pharmacy licenses across different states.
The F.I.R.E. movement is geared toward helping people retire early and achieve financial independence. How much of your income should you be saving to achieve financial independence early on? Join Darshan Kulkarni as he talks about the basics of the F.I.R.E. movement, and how to start saving for early retirement. We’ll also talk about the importance of understanding your own net worth.
The E.U.-U.S. Privacy Shield agreement has recently been declared invalid. What does this mean for businesses that transfer data between the E.U. and the U.S.? Join Darshan Kulkarni as he talks about how to ensure that your business is not exposed to risk. Plus, we’ll discuss the basics of GDPR, and how this regulation impacts companies in the European Union.
Will COVID-19 make the practice of virtual monitoring more commonplace in healthcare? Join Darshan Kulkarni as he talks with former FDA auditor Patrick Stone about how auditing is becoming virtual. Plus, we’ll discuss whether the FDA might end up going virtual as the pandemic continues.
How can we ensure access to healthcare for Americans living in rural areas? Join Darshan Kulkarni as he talks with telemedicine expert and lawyer Anjali Dooley about new opportunities arising in telehealth. We’ll talk about the importance of telehealth services in rural areas in the Midwest, and how telehealth is changing the way we view healthcare.
How has COVID-19 affected the way clinical trial sites conduct their training programs? Join Darshan Kulkarni as he talks with Director of Business Development Justin Goodarz about the changes happening in the clinical research industry in response to the pandemic. Plus, why sites are turning to online training programs.
What tools should you use when starting a pharmaceutical company? Join former pharmacist Darshan Kulkarni as he talks about a few online tools that startup pharmaceutical companies may find useful. Plus, how to use tools such as Trello to track the progress of your projects.
COVID-19 has caused a sizable increase in insurance losses among businesses. What does this mean for your business, and is it possible to offset these financial losses? In today's episode, Darshan Kulkarni talks with Kenneth White, healthcare lawyer and healthcare practice leader, about dealing with insurance losses in the wake of the COVID-19 pandemic.
What tools should you use when starting a pharmaceutical company? Join former pharmacist Darshan Kulkarni as he talks about five online tools that startup pharmaceutical companies may find useful. Plus, how to use tools such as Trello to track the progress of your projects.
Are you thinking about going in-house as an attorney? Join Darshan Kulkarni as he talks with healthcare lawyer Kenneth White about the process of going in-house, and why transitioning to an in-house position may be worth considering. Plus, how working in-house may give you more predictable hours.
Darshan: Here are the top five movies every pharma practitioner should watch right now. So as we all know, what's happening right now is we've got the COVID crisis going on. You've got the entire world that's shut down and here are five movies that almost capture what a Aaron Tobias or Mike Rowe might look like. The first movie is a movie called Contagion, and it's a Steven Soderbergh's movie. And it's known for the terrifying death Gwyneth Paltrow early in the movie and it's front loaded with dread. So if you're not into some level horror, this may not be the right movie for you. The second movie, and I actually happened to have just watched this over the weekend, is a movie called Outbreak. And that's the one that Dustin Hoffman, I believe it was Cuba Gooding Jr as well. And it's set in a fictional California town that's quarantine and becomes ground zero for Ebola like outbreak in the U.S. It's about using the CDC and military medical researchers and how they actually deal with this type of patient. And again, you've got some drama associated with the U.S. government trying to bomb the city or something, but that's your second movie. So you have Contagion and you have Outbreak. The third one is a movie I haven't seen. It's called Cassandra Crossing and it starts Sophia Loren and Martin Sheen and Ava Gardner and Burt Lancaster. And it's about a European train that's attacked by Swedish terrorists. Well, you don't really see that so much, but it's effective with deadly pathogen and it's also speeding towards an unstable bridge, but no one on the board is being allowed off. So it seems like a mix of Outbreak mixed with Speed with a Keanu Reeves movie. So, that's kind of interesting. That was number three. Number four is World War Z. And that is a Brad Pitt movie that features the largest mass of sprinting zombies ever put on screen. Pitt plays a UN investigator who agrees to make his way through an infected landscape to find the source of the outbreak and hopefully a cure before everyone falls to the epidemic. This is one of the things that I actually don't know enough about. I'd love to hear from someone who understands why patient zero matters so much. I understand that they would have the original genome, but wouldn't that have changed. So if you know the answer, please leave a comment. I'd love to hear more from you. If not, just hit the like button. I'd love to hear from you anyways, and know that you appreciate the content being put out. And the last movie, so we had Contagion, we have Outbreak, we have Cassandra Crossing and we had World War Z. Last one is one of my favorites, which is I am Legend with Will Smith. And it talks about a hollowed out Manhattan. He's fighting vampiric monsters and essentially it uses this measles vaccines that was intended to cure cancer, but instead of kills 90% of humanity and the opportunities that come out of that. So if you're in the mood for monster slash pandemic type movies, these were the five movies you should be watching. Contagion, Outbreak, Cassandra Crossing, World War Z and I am Legend. I can't wait to hear from you. Stay tuned. If you disagree, if you think I forgot a movie, please leave a comment for me. Narrator: This is the Darshan Talks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter at Darshan Talks or the show's website at darshantalks.com.
What should you do after getting a PharmD degree? In this episode, Darshan talks about the most useful degrees pharmacists can get after recieving their doctorate in pharmacy, and how these degrees can translate into new careers in the life sciences.
When is off-label marketing permitted, and when does it become a problem? Join FDA regulatory attorney Darshan Kulkarni as he talks about the legal uses of off-label marketing, and the consequences of going against FDA regulations. We'll also discuss the FDA's response to the pandemic in this episode.
Before launching a life science business, make sure that you are fully prepared. Join FDA regulatory attorney Darshan Kulkarni as he discusses the 5 most important points to consider before starting a business in the life sciences.
It can be difficult to bring drugs to market successfully. What can you do to ensure this process runs smoothly? Join Darshan Kulkarni as he discusses the steps required to bring a drug to market. Plus, the dangers of violating FDA regulations and making misleading claims about your product.
Want to learn more about artists who are inspired by the pharmaceutical industry? Join Darshan Kulkarni as he discusses the artists whose work he follows. These individuals create pieces which raise awareness about ongoing health crises among the general public, and open up commentary on issues such as the opiod epidemic going on in the United States.
Marketing events can be very valuable opportunities to network with peers in your industry. How should you make the most of these events? Join Darshan Kulkarni as he talks with research healthcare compliance consultant Kelly Willenberg about the value of networking. Plus, how networking events have adapted in the face of COVID-19.
Want to learn more about artists whose works are inspired by their mental health conditions? Join Darshan Kulkarni as he discusses the artists whose work he follows. These individuals focus on raising awareness among the public about mental health conditions, and create pieces that serve to destigmatize those who experience mental health disorders.
Setting up a clinical trial site can be a difficult process. How can you create a successful trial site? Join Darshan Kulkarni as he talks with clinical research site adviser Deena Bernstein about how to set up a site while remaining compliant.
Want to stay informed about updates on COVID-19 from qualified academics? Join Darshan Kulkarni as he discusses who he follows on social media for news about the disease. From deans of global health to professors of medicine, these individuals can give you a better understanding of how the pandemic is unfolding.
COVID-19 has reshaped our daily lives, but how has it affected healthcare? Join Darshan Kulkarni as he talks with health IT expert Emmanual Fombu about the major changes happening in healthcare due to the pandemic. We'll talk about how the pandemic has resulted in an increase in demand for telehealth services and virtual clinical trials, and how long this trend might last.
Want to stay informed about news on COVID-19 from leaders in the LBGTQ community? Join Darshan Kulkarni as he discusses the LGBTQ leaders he follows on social media to find out how the US government is handling the pandemic. These individuals will keep you updated on the policies and regulations being put in place to stop the spread of the disease.
Due to COVID-19, laboratory workers are either being overworked or are being furloughed. Why has the pandemic affected laboratories in this way? Join Darshan Kulkarni as he talks with attorneys Stephanie Noblit and Dale Cooke about the impact of the pandemic on lab testing. We'll also discuss some of the primary issues with promotional compliance.
Would you like to stay informed about news on COVID-19 from leading doctors from the south east asian diaspora? Join Darshan Kulkarni as he discusses who he follows on social media to stay up-to-date about the disease. From physicians and radiologists to infectious disease doctors, these individuals can give you a better insight into how the pandemic is progressing.
In the wake of COVID-19, health care workers are on the front lines of the crisis--navigating keeping patients safe, while also keeping themselves healthy. As the pandemic progresses, health care workers become exposed to more risks. Darshan talks with Paul B., a clinician who has worked in multiple hospital departments, about how the disease is affecting essential workers. We'll also ask him about what precautions patients are taking to protect themselves.
Want to stay informed about updates on COVID-19 from qualified health care professionals? Join Darshan Kulkarni as he discusses who he follows on social media for news about the disease. From data scientists to clinical investigators, these individuals can give you a better understanding of how the pandemic is unfolding.
As the pandemic unfolds, clinical research continues to progress. How has the field of clinical research changed as a result of the crisis? Join Darshan Kulkarni as he talks with the CEO of Affinity Bio Partners Christina DiArcangelo about how patients have been impacted by the disease, and whether clinical research has been stalled. We'll also talk about how the clinical research space has had to adapt in the face of the global pandemic.
Want to stay informed about news on COVID-19 from current government officials? Join Darshan Kulkarni as he discusses who he follows on social media to find out how the US government is handling the pandemic. These government officials will keep you updated on the policies and regulations being put in place to stop the disease from spreading.
How has COVID-19 had an impact on patient centricity? Join Darshan Kulkarni and the mother of patient advocacy in research, Deborah Collyar, as they talk about the lessons that the pandemic has taught them in terms of patient centricity. We'll also discuss the importance of terms such as self-isolation and physical distancing.
As COVID-19 spreads across the country, it becomes important to recognize the workers on the frontlines fighting this disease. How are essential workers limiting their exposure to COVID-19? In today's episode, Darshan Kulkarni talks with guest Timothy Youkhana about how workers are dealing with the risk factors of the pandemic, and what role telepharmacy plays in reaching patients.
Indian privacy law has many nuances that health technology companies should stay informed about. How does GDPR relate to HIPAA? What new regulations could change the way you do business? What if they criminalize your current actions? Join regulatory attorneyDarshan Kulkarni as he discusses how privacy laws apply to health technology companies.
Although many companies are aware of privacy laws such as GDPR and HIPAA, not many are informed about CCPA. The passage of CCPA in California would mean that companies would have to comply with privacy laws on the same level as the GDPR. Are you subject to this law? In today's episode, regulatory professional Darshan Kulkarni discusses the legal nuances of the CCPA, and the implications of the law for HealthTech companies.
Many pharmaceutical, medical device and HealthTech companies find privacy laws such as GDPR to be problematic. Often, clinical research organizations (CROs) advise their clients to avoid Europe to escape being subject to GDPR. Is the GDPR going to change how you conduct business? Join Darshan Kulkarni as he discusses the nuances of this privacy law, and how the law differs from the requirements in the United States.
It can be difficult to successfully navigate privacy laws such as HIPAA and remain compliant. Are you truly subject to HIPAA, or do you just believe that you are? Join regulatory attorney Darshan Kulkarni as he discusses a few of the most common misconceptions around HIPAA. We'll also talk about how to determine whether you are subject to HIPAA as a HealthTech company.
As more states pass cannabis supportive laws, companies often need to reevaluate how they approach cannabis use. Are your employees using cannabis? Regulatory attorney Darshan Kulkarni discusses the legality of cannabis use at both the state and federal levels. We'll also talk about how companies should engage with their employees who use cannabis, and the legal implications of this practice.
Are pharmaceutical companies allowed to provide financial assistance for travel, lodging and other expenses to certain patients? Join FDA regulatory attorney Darshan Kulkarni as he discusses why the Office of Inspector General (OIG) decided in favor of financially helping patients, and what the implications of this decision may be.
Transparency, or the practice of disclosing clinical trial data, is highly important in clinical research. What happens when companies decide to not publish all of their clinical trial results, and fall out of compliance with the FDAA? FDA regulatory attorney Darshan Kulkarni discusses the dangers of not being transparent, and the consequences facing companies who withheld their results.
In the wake of COVID-19, many companies have had to reshape how they conduct business. What is the role of the general counsel during this time? How should general counsel officers determine the ways in which COVID-19 may impact their businesses? Join attorney Darshan Kulkarni as he talks about some of the primary issues facing the general counsel during this crisis. Plus, the importance of considering contractual impact.
What are the four branches of patient centricity, and how can they apply to your company? In this episode, Darshan Kulkarni explains how companies can foster patient centricity through privacy, transparency, innovation and access. Plus, how the FDA created their own program for clinical trial transparency.
Often, clinical trial results do not end up being disclosed. How can companies address this lack of transparency in clinical research? Darshan Kulkarni investigates the four ways in which health care companies can improve data transparency while still protecting patient privacy.
Patient centricity has become a major focal point for companies in 2019. What are four ways life science companies can incorporate patient centricity? Join Darshan Kulkarni as he discusses how health care companies can implement more patient-centric practices while still protecting patient privacy.
Promotional Review Committees (PRCs) serve an important role for pharmaceutical companies wanting to stay compliant. How can PRCs help ensure compliance for promotional materials? In this episode, Darshan talks about how companies should handle LESE summaries in the context of clinical trials. Plus, whether your company might be subject to clinical trial transparency laws.
Promotional Review Committees (PRCs) serve an important role for pharmaceutical companies. How can PRCs help ensure compliance for promotional materials? Join Darshan Kulkarni as he talks about how your company should review its promotional materials. Plus, the dangers of making fraudulent claims in advertising.
As awareness of the General Data Protection Regulation (GDPR) increases, companies are scrambling to protect customers' personal data. What might this mean for life science companies in the United States? Darshan discusses the implications of the recent law and other major legal issues facing life science companies in 2019.
As pharmacy continues to grow, what changes can we expect to see in 2020? How will privacy laws and telepharmacy affect life science companies? And how will the FDA respond to cannabis supportive laws? We investigate these questions and more with former pharmacist Darshan Kulkarni.
The consequences of committing pharmacy fraud are often costly. How can pharmaceutical companies navigate various state and federal laws and remain compliant? Former pharmacist Darshan Kulkarni discusses the six major trends in 2019 surrounding pharmacy fraud.
How will Pharmacogenomics look in 2020? Is your company sufficiently prepared? Join FDA regulatory attorney Darshan Kulkarni as he discusses how pharmacogenomics may change in 2020, and whether your clinical trials may be affected.
How might patient centricity progress in 2020, and what does this mean for your company? In this episode, Darshan Kulkarni talks about the different factors affecting clinical trial transparency, and the four branches of patient centricity. We'll also discuss the importance of privacy laws including GDPR and CCPA.
Pharmacy has undergone a series of changes in 2019. What might this mean for the future of pharmacy? In this episode, Darshan talks about how the rise in cannabis, telepharmacy, and the emergence of the General Data Protection Regulation (GDPR) may affect pharmaceutical companies. Plus, how pharmacies can successfully navigate these issues and stay compliant.
Pharmacogenomics is the study of how a person's genes affect how he or she responds to medication. Pharmacogenomic testing, however, remains medically necessary in very few cases. How has the increased use of genetic testing led the federal government into launching over 300 investigations for alleged fraud? In this episode, Darshan discusses some benefits and pitfalls of genetic testing.
In today's episode, I sat with Trishna Bharadia to discuss solutions to issues around informed consent.
In today's episode, I sat with Trishna Bharadia to discuss operational engagement with patient advocates.
Francesca Rothseid, Esq. and I sit down to discuss pharmacists and how best to engage with patients in the context of better communciations.
Part 3 of my discussion with Dale Cook, MA, JD on OffLabel Promotion: Off-Label Promotion Is Going Away
Part 2 of my discussion with Dale Cook, MA, JD on OffLabel Promotion: Off-Label Promotion Is Not Going Away
Part 1 of my discussion with Dale Cook, MA, JD on OffLabel Promotion: Is Off-Label Promotion Going Away?
Within healthcare, there is a tendency to treat patients in a dehumanizing way that does not consider them as individuals. How should patient advocates address this problem? On this episode, Darshan talks about the language used to discuss patients. We'll look at how the patient is treated in healthcare, and how to change the way we consider patients.
Patient advocacy may still be in its early stages, but it has the potential to change the role of the patient in healthcare. What is patient advocacy, and how might it change the way we view patients? In today's episode, Darshan Kulkarni talks with Deborah Collyar, the Matriarch of Research Advocacy, about the main components of patient advocacy.
Health literacy has a positive impact on clinical trial participation, and plays an important role in the life sciences. Can health literacy improve transparency? Join Darshan Kulkarni as he discusses the steps your company can take to promote health literacy among its patients. We'll also look at how to structure clinical trials so that they're easier for patients to navigate.
The healthcare system can be hard for patients to navigate, especially for those who lack health literacy skills. Health literacy is the ability to understand basic health information and services. How can companies improve health literacy among their patients? Join Darshan Kulkarni as he talks about the disconnect between healthcare providers and insurance companies. Plus, two ways to increase health literacy.
New drug companies can enter the financial market successfully by focusing on their relationships with PBMs.
In today's episode, I sit down with Mark to unpack how pharmaceutical companies can use risk management programs to lower drug costs
Patients offer different perspectives about the healthcare industry pharmaceutical companies. How do patient insights differ, and should companies take note?
The 3 different types of patient advocates offer unique insights about health literacy and patient engagement to pharmaceutical companies.
Patient centricity may still be in its early stages, but it has the potential to change the role of the patient in healthcare.
Pharmacogenomics is the study of genes and how they impact drug response in certain individuals. This information allows physicians to customize treatment plans for their patients by taking into account a patient’s genetic unique background. How have these emerging technologies changed the structure of drug development? In today's episode, Darshan Kulkarni discusses the implications of pharmacogenomics for the drug approval process, and how it may impact FDA regulatory law.
Pharmacogenomics makes drugs safer through genetic and DNA testing. Who should pay for genomic testing as they become more common?
Pharmacogenomics is the study of how a person's genes affect how he or she responds to medication. As the field expands, it may have a significant impact on the future of drug development. Darshan discusses how pharmacogenomic testing may lead to changes in FDA regulatory guidelines. Also, how pharmaceutical companies are beginning to rethink the drug development process.
What is the actual value of pharmacogenomics, and how will genetic testing lead to lower healthcare costs?
Dietary ingredients are required to be registered with the FDA, but the process of registration can be complicated. What should companies keep in mind?
Pharmacogenomics promises to make drugs safer through genetic and DNA testing. What are the challenges facing this field in a clinical setting?
Who is not being accounted for in the field of pharmacogenomics? Pharmacogenomics is the study of how a person's genes affect how he or she responds to medication. Often, the data being collected during genetic testing represents a racial bias. On this episode, Darshan talks about the social issues of pharmacogenomics, and why certain minority groups are left out of pharmacogenomic testing.
Biohacking is described as citizen or do-it-yourself biology. This can mean individuals changing their bodies using technology, taking dietary supplements, or increasing their amount of exercise. However, some have taken it to the next level and are incorporating technology or cellular modification based approaches to health. Join Darshan as he discusses why biohacking is not heavily regulated by the FDA, and what the major risks are for the individuals who take part in it.
Dietary supplements and ingredients are required to be registered with the FDA, but the process of registration can be complicated. What should companies keep in mind?
Dietary ingredients are required to be registered with the FDA, but the process of registration can be complicated. What should companies keep in mind?
Cosmetic products are often advertised with claims that can be misleading or exaggerated.
Clinical research and medical treatment are often confused for one another, leading drug companies and healthcare professionals to risk falling out of compliance.
Drug manufacturers developing OTC drugs have a lot of important decisions to make. One of these decisions is determining which regulatory pathway works best for their product.
Drug manufacturers developing OTC drugs have a lot of important decisions to make. One of these decisions is determining which regulatory pathway works best for their product. In this episode, Darshan discusses how the OTC monograph process takes place, and when drugs are considered safe and effective.
The FDA issued warning letters to several CBD companies for selling unapproved products with unsubstantiated medical claims.
Many have been assigned blame for the nation’s prescription opioid epidemic--including clinicians, patients, and pharmaceutical distributors. This has shifted attention away from policymaker attempts to address the crisis.
Setting up effective, compliant investigational drug pharmacies means reviewing FDA requirements and applicable state boards of pharmacy. Depending on the regulatory body reviewing the pharmacy, different parameters may need to be met. In this episode, Darshan discusses how to develop a process that will ensure the accuracy and precision of drug products, and meet FDA requirements.
A grey area within bioethics presents some very challenging questions as it becomes increasingly harder to distinguish what is moral and immoral in the realm of science. Join Darshan Kulkarni as he talks about the importance of bioethics, and some of the problems that arise.
Not all products have to meet the U.S. Federal Drug Administration’s (FDA) approval: certain biologics and dietary supplements do not require it, and there are alternative pathways for OTC drugs and other products to skip the process.
Drugmakers have become increasingly entangled in kickback and bribery schemes, and as a consequence, face millions in settlement to the U.S. government.
Opioid drugmakers Insys Therapeutics and Mallinckrodt Pharmaceuticals face millions of dollars in settlement as a consequence of allegedly bribing doctors to prescribe their drugs.
US Food and Drug Administration (FDA) cracks down on false claims--issuing warning letters to companies for marketing supplements as valid treatment options for Alzheimer’s disease.
The US Food and Drug Administration (FDA) issued a warning letter to stem cell clinics about releasing unproven treatments which posed high health risks to patients.
Companies must develop a plan to ensure that they are in compliance with FDA regulations during inspections. How should they accomplish this goal? Join FDA regulatory attorney Darshan Kulkarni as he discusses how to put together a war room in advance of an FDA inspection.
How should your company prepare for FDA inspections? In this episode, FDA regulatory attorney Darshan Kulkarni discusses the steps companies should take to respond to an FDA inspection, and ensure compliance. Plus, what actions the FDA has jurisdiction to take against companies that do not comply with regulations.
How can you ensure readiness and compliance for FDA inspections? Join FDA regulatory attorney Darshan Kulkarni as he talks about how to prepare for FDA inspections, and what actions the FDA has jurisdiction to take against companies that do not comply with regulations.
It is necessary for companies to prepare before an FDA inspection to ensure that they are in compliance. How should you develop a plan before an inspection? What are some of the benefits of forming a war room? FDA regulatory attorney Darshan addresses the key points you should keep in mind when preparing for an inspection.
Bioethicists tend to refer to the four Belmont Principles when determining what is ethical, but what happens when it is not so clear?
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Tobacco companies are using social media platforms like Instagram and Twitter to promote e-cigs and other vape products to children as young as 13.
Bioethics is the study of ethics arising from the field of medical and biological research. Bioethicists tend to refer to the four Belmont Principles when determining what is ethical, but what happens when it is not so clear? Join Darshan Kulkarni as he talks about the main components of bioethics, and the ethical grey areas of the field.
The US Food and Drug Administration (FDA) has announced new marketing restrictions on vaping products. How might these new guidances affect how you promote your products? In today's episode, FDA regulatory attorney Darshan Kulkarni discusses the main points of these restrictions, and how vaping companies can effectively comply.
The genetic testing company 23andMe has sold its customers' data to GlaxoSmithKline for $500 million. Is this ethically justified? Darshan Kulkarni discusses some of the moral quandries behind selling genetic data, and whether customers are being informed.
The FDA recently went after VIVUS, a pharmaceutical company, for making false health claims about its product. Inappropriate drug promotions can pose serious issues for pharmaceutical companies that go beyond superficial penalties--companies can face multibillion dollar fines as a consequence of making false claims about their products.
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Once patients are enrolled in your clinical trial, how do you get them to stay? We will examine the factors that determine if patients will remain enrolled in your clinical trial.
Education during non-study visits
Creating a network of support for patients can extend beyond the study-related visits. In fact, the routine primary care visit is a good opportunity to expose patients to the possibility of a clinical trial in a no-pressure environment. It can be a space to provide some background information and let the patient decide to follow up (or not) regarding participation.
Remind participants of the big picture
In most cases, people do not decide to participate in a clinical trial for the money, but rather for the opportunity to help health research. Study participants might have been excited about contributing to health research when they enrolled, but after all the visits and time invested in the study, they lose sight of their impact. Remind patients why their choice to participate in the study is impactful. Spread positive awareness of clinical trials in your office, share good news about patients benefiting from health research. Participants will appreciate knowing the positive impact that their actions are having on patients.
Convenience to the patient
Some clinical trials require extensive in-person visits and travel, which can make patients question their commitment to participating in the study. If there are aspects of the study that could be done from the patient’s home, consider arranging for that. A nurse could visit the patient at home to draw blood take a measurement. Additionally, appointment reminders and flexible hours to work with differing schedules will help participants make and keep appointments.
Fear of the unknown
Patients are told what will happen in the course of the study, but it is not reasonable to expect them to remember every detail discussed during the informed consent process. Instead, it would be great to give patients a handout or takeaway folder that contains all the information presented in a format that those outside the medical professions can understand. Researchers should always make the informed consent form accessible to patients, so they can refer back to it throughout the course of the study.
Engage with patient communities
Patient Leaders
Some people with illnesses find other people with similar conditions to lean on for support and guidance. If you are enrolling a patient population in a clinical trial, you may consider reaching out to a patient group to interview the leaders. It may also help to organize a focus group with the group leaders to find out more about patient priorities and expectations. It may surprise some health care professionals that there are patient leaders since these leaders are not usually considered among the key opinion leaders in medicine. The patient leaders are trusted by patients and have intimate knowledge of the patient experience.
Contemporary Participants
Past and current participants can play a significant role in easing the concerns of recruited participants by talking them through what their individual experiences. Side effects that sound scary on paper might not be that important to patients, whereas a test that seems routine to the medical professional was frightening for patients.
Unblinding Concerns
It is also important to proactively address concerns around unblinding. The concern that patient groups could unblind patients from their course of treatment is valid, but there are ways to ensure the blind is maintained. Arguably the greater risk is to create a vacuum in which patients cannot communicate as patients will almost definitely find a way to communicate. Those unexpected interactions would not be monitored to ensure the blinds are maintained.
Participant support
Relationships
Studies should look at key relationships in the participants’ lives to understand is their suppor...
In this follow-up to our recent discussion on clinical trial enrollment, we will discuss how an emphasis on patient centricity will help clinical trial researchers overcome a few challenges when trying to enroll in research subjects.
Enrollment is the lifeblood of a clinical trial and is yet one of the most problematic issues. This blog explores the reasons why your patients may not enrolling and how they can be addressed.
Patient centricity is already affecting the way pharmacists interact with patients and poses unique challenges and opportunities for pharmacists. In this Podcast, Darshan and Major discuss Patient Centricity.
PillPack was acquired by Amazon for almost a billion dollars. In this Gavel and Pestle podcast episode, we discuss what that means for pharmacists.
Amazon has made moves recently to get into the pharmacy space. In this podcast, we discuss 3 ways pharmacists can compete with the Amazon Pharmacy of the future.
The Pharmacist was the most trusted profession until that trust was tarnished by fraudulent practices. In this podcast, we discuss those practices.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy.