BioTech IQ: Recent Episodes
Ammon Rivera
Increase your IQ and understanding of the Biotech industry by listening to interviews with key business leaders who have built successful companies and departments. We discuss everything from the science, clinical operations, clinical development, safety/PV and more! We address how each function plays an important role in the drug approval process. We also discuss the people that make up these departments. Get ready to hear about cutting edge development and the people who make it happen!
On this episode of BioTech IQ, Ammon interviews Paul Lammers the CEO of Triumvira about developing autologus cell therapies using their T-Cell Antigen Coupler Platform (TAC). During this insightful discussion Paul talks about how he started in the industry, running a biotech company in today's environment, and what sets Triumvira's T-Cell therapy apart from the rest! Don't miss it!
Show support for show https://www.buymeacoffee.com/biotechiq
Check out the books recommended by Paul:
CEO Excellence - https://amzn.to/3OGjI3G
The Emperor of All Maladies - https://amzn.to/3IDyZ1l
The Physician Syndicate: Angel Investing | Venture Capital | Startups | Personal Finance
The Physician Syndicate Podcast: A podcast for physicians to jump into the startup world.
Listen on: Apple Podcasts Spotify
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Bryan Kobel decided to pursue a career in biotech after seeing its massive opportunities to change the world. He sits down with Ammon Rivera to share how he translated his background as an investment banker into his role as the CEO of TC BioPharm, a company that develops cancer therapy. He opens up about finding his purpose in this space that allows him to save lives and molds him into a compassionate leader. Bryan also talks about their allogenic Gamma Delta T Cell therapy platform, which involves injecting isolated Gamma Delta T Cells to treat cancer-stricken patients. He explains how they are continuously evolving this method to make it cost-effective and easily accessible to underserved and economically disadvantaged individuals.
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In this episode of BioTech IQ Ammon shares some real stats on the state of the hiring market in Biotech/pharma. We discuss what both job seekers and hiring managers can do to increase their success when searching/hiring. Bringing innovative treatments that make a difference in the life of people is the goal but the business side of drug development is as complex as the science sometimes. Don't miss it!
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Cary Claiborne Sr. is the CEO of Adial Pharmaceuticals and member of the board. He also sits on the board for Nuerosense Therapeutics and CytRx. Cary holds an MBA from Villanova University. In this episode Cary shares how his interest in finance at an early age led him to become the CFO of a small biotech that led him to where he is today.
Books that Cary referenced:
Holy Bible - https://amzn.to/3Y6um4W
Control Your Destiny or Someone Else Will - https://amzn.to/3ITDuWc
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On this episode of BioTech IQ Ammon interviews Farahnaz Forozan, PhD, MB who is a 20 year veteran in the industry. She discussed how she immigrated from Iran to the United States, became a Phd, was the Head of Translational Development with BMS, to running her own consulting practice. She has taken all this experience and is driving innovation within biotech.
Don't miss it! It's about Innovation.
www.forozanoncogenconsulting.com
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Throughout many of the discussions on BioTech IQ it is clear that a combination of therapies is likely the answer to treating cancers and other diseases. This is a point well made by the guests on this episode of the show. CEO Jack Hoppin, PhD and Chief Scientific Officer, John Babich PhD are Co-Founders of Ratio Therapeutics. Both bring a successful background in biotech and not only discuss what their organization is doing but lessons they have learned as entrepreneurs in treatment development.
Don't miss it!
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Science will only get you so far in biotech. No matter how ingenious your products are, you will never succeed as a company if you don’t have all the pieces if business development in place. And there is no greater piece than the people piece. As the Chief People Officer of Biomea Fusion, Naomi Cretcher knows that company culture is what is going to make or break her company’s success. Despite everything that went on with COVID and with a recession looming, Naomi is confident that investing on their talent pool with pay off in terms of company success. She joins Ammon Rivera in this episode to tell us what it takes exactly to build an excellent company culture in a biotech company and why the act of building one will give any business its biggest ROI. Tune in!
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Ammon shares an update what has changed and why no new episodes have been release for the last couple of months. And discussing some interesting facts about the biotech industry and where it's headed from a hiring perspective.
Atlas 2022 Year in Review
https://youtu.be/LONM9ekseJ4
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In this epsisode of BioTech IQ Ammon interviews the Chief Growth Officer of M2GEN Todd Johnson, MD. M2GEN partners with 18 of the nation’s leading cancer centers, through the Oncology Research Information Exchange Network® (ORIEN), to deliver oncology informatics-based solutions to accelerate therapy discovery, development and delivery of precision medicine. M2GEN is one of the only companies to ensure that patient data has been granted through consent.
M2GEN utilizes the IRB-approved protocol, Total Cancer Care®, that allows for enhanced patient engagement through the ability to re-contact patients and facilitates linkages across disparate sources of data, creating a research ecosystem which can significantly benefit patients and improve patient care.
Dan Sfera's interview with Ammon https://youtu.be/86MtcfBnUmg
There isn’t a cure for cancer yet, but if everyone can come together, we may find that cure sooner rather than later. One biotech company that is trying to solve cancer is Qualigen Therapeutics. With their oncology therapeutics pipeline, they could be onto something with their leading asset QN-302.
Join Ammon Rivera as he talks to the Chief Medical Officer of Qualigen Therapeutics, Tariq Arshad, MD, about where they are right now in their therapeutics pipeline. Learn why cancer is the greatest injustice and how Tariq is fighting to stop it. Find out more about their research in Qualigen Therapeutics when it comes to killing these cancer cells. Let's all come together and stop cancer.
In this episode of BioTech IQ, Ammon Rivera continues his exploration of Qualigen Therapeutics by interviewing the founder and CEO of the company Michael Porier. Michael discusses how Qualigen was started and the motivation behind the therapeutics pipeline. There are incredible developments underway for the company, and the turn of the market is hopefully on its way as well. Listen in on their discussion about the growth of Qualigen and what investors can look forward to as they continually develop drugs with a goal of turning cancer into a manageable disease instead of life-threatening one. Hear all about it and more of the company’s significant moves in the market by tuning in to this episode.
Qualigen Therapeutics is a biotechnology company that develops novel therapeutic products to treat adult and pediatric patients with rare cancers. A leading name in the industry, they have decided to build a therapeutics pipeline within the last few years. In this first episode of a three-part series featuring top executives of Qualigen Therapeutics, Ammon interviews Amy Broidrick, the firm's President and Chief Strategy Officer. She shares what she brings to the table in the company's transition from a preclinical stage company to a brand new business venture. She also talks about her deep love for market research, her career's pivotal and most fulfilling moments, and how she deals with negativity.
AI has gone so far as to potentially change drug development, and these developments have the potential to make a difference in people’s lives. On this episode of BioTech IQ, Ammon interviews Noam Solomon, the CEO of Immunai. Immunai is developing an AI platform that leverages big data, single cell multiomics, and machine learning to bridge the gap between casual immunology and translational disease biology. Their platform is mapping the human immune system at an unprecedented level of granularity, allowing them to identify the right targets to go after. In this interview, Noam shares his knowledge on reprogramming the immune system for better diagnosis and treatment. He shares his amazing team and how they make patient’s lives easier and meaningful. Tune in to learn more about immunotherapies!
Social anxiety disorder is the third most common mental health disorder. Over 23 million Americans alone are affected by it. This disorder can continue to grow into depression and drug abuse, so it's very important to catch it early so it can be stopped.
But how can it be stopped? Shawn Singh, the CEO and Director of VistaGen Therapeutics, and his team are creating a nasal spray to help people with social anxiety disorder. Just like an inhaler for asthma, this nasal spray can do for social anxiety. Join Ammon Rivera as he talks to Shawn Singh about the PH94B nasal spray. Find out how it works and how far along they are in the process. If they get approved, VistaGen has the opportunity to be the first FDA-approved acute treatment for adults with social anxiety disorder. Discover how VistaGen is going beyond the current standard of care for anxiety, depression, and CNS disorders.
Companies in the biotech space are making contributions to help find a cure for cancer. Today’s guest is no exception. In today’s episode, Ammon Rivera sits down with Daniel Teper, Co-Founder and CEO of Cytovia Therapeutics, to talk about the unique technology they’re using to develop a treatment for cancer. Daniel discusses how they’ve developed three types of iPSC-Derived Natural Killer Cells and are now targeting unmet needs in treating hepatocellular carcinoma (HCC). There is a lot of disruptive innovation coming from the biotech industry. Daniel also discusses how the field is dealing with worsening market conditions amidst recent news of a special purpose acquisition with Isleworth Healthcare Corporation. There’s much to learn from this episode, both in medicine and economics.
On this episode of BioTech IQ Ammon talks with Co-Founder and CEO of Anima Biotech, Yochi Slonim. Yochi is a serial entrepreneur with experience building multiple successful companies before starting Co-Founding Anima. Anima Biotech is developing mRNA Lighting, a novel platform for the discovery of selective small molecule mRNA drugs and their mechanisms of action. Automated high scale phenotypic screening combining live biology with AI mRNA image analysis for the discovery of small molecule mRNA drugs and their mechanisms of action.
https://www.animabiotech.com/
Catch the latest on BioTech IQ
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Cell cycle biology is key to understanding cancer. You have to hit the cancer cells early before they become smart and adapt. There is a stage in the cell cycle called mitosis. This is where, if done right, can cause cancer cells to suicide. This is where the biotech company, Cyclacel comes in with all their research into the cell cycle of cancer. Join Ammon Rivera as he talks to Spiro Rombotis about some of Cyclacel's cell cycle therapies. Spiro is the CEO of Cyclacel. His mission is to use cell cycle biology to treat cancer and other serious diseases. Ammon and Spiro go over the use of Cyclin-dependent Kinase and its role in the cell cycle. Spiro also talks about Cyclacel's pipeline and drug candidates. They also go through discussion strategy, the drug approval process, and what it means to fail fast.
Have you ever thought about having replacement parts for your body? It sounds like science fiction, but it’s now as real as the eyes you’re using to read this, thanks to cell-based therapy. Brian Culley is one of the leaders in this field. He is the CEO of Lineage Cell Therapeutics, a company developing treatments for multiple indications based on their proprietary cell-based therapy platform. Leveraging in-house manufacturing, they are attacking multiple indications from ophthalmology to immuno-oncology. In this episode, Brian joins Ammon Rivera to explain what their strategy is, where they are currently in the development process, and where they’re going from there.
The biotech industry has been bombarded with disruptions in recent years, from a global pandemic to rising global tensions. How are they dealing with the supply chain issues and how else has it impacted the industry? In this episode, Ammon Rivera sits down with two-peat guest, Guillermo Morales, PhD, CEO of Innoventyx. Guillermo makes us privy to the issues brought on by COVID-19 and the geopolitical tensions such as the Russia-Ukraine conflict. He also discusses intellectual property in greater depth and why it’s important to act fast when patenting your product. Moving from Latin America to the United States, Guillermo also shares his experience learning and re-learning the science in both languages and how it impacts communication. Don’t miss out on their enlightening conversation by tuning in!
In this episode of BioTech IQ host Ammon Rivera talks about the current state of the market with respect to recruiting. He also shares a real and recent experience highlighting the challenges of compensation and it role in landing the right individual for the job.
https://thebiotechiqpodcast.com/
https://www.linkedin.com/in/ammonr/
On this episode of BioTech IQ, Ammon Rivera interviews Robert Foster Pharm D, PhD, CEO of Hepion Pharmaceuticals. Robert brings 30 years of experience to this discussion and shares with us details of his background that led him to where he is today. We also discuss Hepion Pharmacetuicals current clinical trials to development treatments targeting chronic liver diseases including NASH, cancer, and chronic hepatitis virus infection. A quarter of the people in the US have fatty livers and of those, about a fifth will likely develop NASH. It’s a big problem that affects a lot of people. The company’s lead drug candidate, Rencofilstat, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Tune in to learn more about their pharmaceutical development process and other possibilities with the drug in terms of treatment.
Some of the main problems with sequencing in identifying mutations are its cost and the time it takes. Fortunately, with the rapid growth of technology, revolutionary products that simplify processes are being made. One of those is from DiaCarta, a diagnostics company using translational genomics and molecular precision technology to develop ways of detecting disease. In this episode of BioTech IQ, Ammon Rivera interviews its CEO, Adam Zhang. Their patented technology reduces the "background noise" in testing, allowing for the detection of the "bad actor." Join in to learn the processes behind their work, what this means to the future of testing and treating diseases, and where the company is headed. Don't miss out!
In this episode of BioTech IQ Ammon interviews professional coach Jeff Harmon. Jeff specializes in working with life science companies by helping them develop their unique company cultures that drives success at all levels.
TNF is a protein that contributes to inflammation. Anti-TNFs can be used to stabilize this and stop the inflammation. It's used for diseases like arthritis and psoriasis. Discover how clinical trials are done so these medicines and anti-TNFs can be utilized. Join Ammon Rivera as he talks to M.D., Ph.D. and CEO of 180 Life Sciences, Jim Woody about anti-TNFs and the trial process behind them. Jim's goal is to address one of the biggest drivers of disease – inflammation. Learn more about Jim's career as a venture capitalist. Find out why trials need to be uniform and randomized. And, discover what it takes to run a biotech company today.
This episode of BioTech IQ features James Mackay, PhD, Founder and CEO of Aristea Therapeutics. Aristea Therapeutics is a clinical-stage immunology focused drug development company developing novel therapies to treat serious inflammatory diseases. In particular, their lead asset is addressing palmoplantar pustulosis (PPP), a rare, chronic inflammatory skin condition with no approved therapy in the United States that affects about 100,000 people.
Don't miss this episode as we discuss James' background and the strategy of Aristea's approach to their current asset.
https://aristeatx.com/
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This episode on BioTech IQ is actually a recording of two separate interviews. In the first half of the show I interview Pete Mariani who is the CFO of Axogen, Inc. Pete has strong experience in public markets experience including successful raises of equity, debt and strategic financing; driving strong, consistent investor communication and strategies; and establishing solid SEC reporting structures.
The second guest is Robert w. Mays, Ph.D, Co-Founder and Vice President of Regenerative Medicine and Neuroscience programs at Athersys, Inc. Dr. Mays has more than 25 years of experience in technology development, drug discovery and translational stem cell experience.
https://thebiotechiqpodcast.com/
On this episode of BioTech IQ Ammon interviews Maria Maccechini is an accomplished scientist, successful biotech executive, and angel investor. She is the CEO of Annovis Bio, Attacking Alzheimer's Disease and Neurodegeneration by Improving AXONAL TRANSPORT , this enhances the FLOW of Information Along the Information Highway of Nerve Cells.
https://www.annovisbio.com/
https://thebiotechiqpodcast.com/
James Joyce is the CEO, Chairman of the board, and a co-founder at Sigyn Therapeutics. Did you know that multiple healthcare agencies report "community acquired pneumonia" as the number cause of infectious disease death? And this indication leads to about 50% of sepsis cases? On this episode of BioTech IQ we discuss Sigyn Therapeutics blood purification device can calm the storm and change that.
https://www.sigyntherapeutics.com/
https://thebiotechiqpodcast.com/
https://www.linkedin.com/in/ammonr/
Did you you know that 70% of costs related to patient care are spent on chronic conditions? In this episode of BioTech IQ we talk with Founder and CEO of Biotricty on how their technology is changing the landscape for patient care in the cardiovascular space.
https://thebiotechiqpodcast.com/
https://www.linkedin.com/in/ammonr/
https://www.biotricity.com/
Live interview with Dr. Waqaas Al-Siddiq, DBA, CEO of Biotricity and Omar Manejwala, M.D. Chief Medical Officer at Dario Health. We have a discussion on what is digital health, the problems it's solving, and the major opportunity it is for patients, physicians, and investor alike.
https://thebiotechiqpodcast.com/
https://youtu.be/ZQP2Nra7BgY
https://www.biotricity.com/
https://www.dariohealth.com/
digitalhealth #biotechiq #biotechiqlife
An interview with John Glasspool, CEO of Anthos Therapeutics. Did you know that VTE is the 2nd leading cause of death in cancer patients after the cancer itself? Did you know that many patients choose not to us the current standard of care to blood clotting due to excessive bleeding? Anthos Therapeutics is addressing this major unmet medical need in thromboembolic events with their lead candidate abelacimab. Abelacimab is an investigational monoclonal antibody that achieves profound suppression of the novel antithrombotic target Factor XI.
https://anthostherapeutics.com/
https://thebiotechiqpodcast.com/
This episode of BioTech IQ features Kleanthis Xanthopoulos, Ph.D. He is the co-founder, chairman of the board, and CEO of Shoreline Biosciences. As part of our "What's Ahead in Biotech: #2022" series Kleanthis talks about the power of induced pluripotent stem cells (iPSC) derived NK cells, and macrophage immunotherapies. What is the future of immunotherapies? Listen and find out!
https://shorelinebio.com/
https://thebiotechiqpodcast.com/
Tom shares with us some of his journey and how that led him to co-found Biomea Fusion. We discuss some of the science behind irreversible drugs and covalent bonding. Using their fusion system there is greater potential for high selectivity, deep inactivation of target, and a greater therapeutic window.
https://biomeafusion.com/
https://thebiotechiqpodcast.com/podcast/
CliniStart launched to provide innovative tech-enabled solutions focused on global investigator contracts, budgets, and payments. And they did all of this just as the COVID-19 pandemic was hitting. This gave them an opportunity to shift and adapt. In this episode we address the challenges causing friction at during clinical trial start-up and what it takes to launch a start-up company.
https://clinistart.com/
On this episode we have Brenda Sousa, previously the Chief Human Resources Officer with Constellation Pharmaceuticals. Brenda shares with us part of her backstory and entry into the world of Biotech. We discuss people, culture, the function of HR, and how the industry requires a unique yet similar approach. Ammon also shares past experiences with Brenda and gets her take on them.
BiotechIQ #Biotech #Drugdevelopment #Recruiting #Staffing
In this episode of BioTech IQ Ammon interviews Stewart Hallet the COO of SFJ Pharmaceuticals, a specialty pharmaceutical company with a unique business model. The discussion touches on a number of things in clinical operations including working with CROs, leadership, and resourcing.
BioTechIQ #ClinicalOperations #DrugDevelopment #Podcasts
Co-founders Shawn Carbonell and Brent Witgen discuss the progress of the 1st cohort (BRZN1) as they are well into the Brazen Bio program. We also get the chance to interview one of the founders currently in the program. We discuss what he is working on and what his experience has been in the program. Do you have a project that needs acceleration? Then don't hesitate, go to brazen.bio and get your application in for the next cohort.
Kathleen shares fantastic insights on understanding behavioral psychology and how it applies to successful clinical trials. We had a great conversation that touched on increasing diversity in trials to understanding our own behavior and how we can potentially understand patients better. This can be applied in a way to close the gap between intention and action. Kathleen co-authored a Book called "Why We Resist: The Surprising Truths about Behavior Change: A Guidebook for Healthcare Communicators, Advocates and Change Agents" You can check it out at the link below. PSA: I have no sponsorships or financial agreements to promote the book. I figured since I read it and talked about it on the show people might want to check it out.
https://www.amazon.com/Why-Resist-Surprising-Healthcare-Communicators/dp/057854766X
Seth Lederman is the CEO of Tonix Pharmaceuticals and a physician scientist with a two decades of research experience. Prior to becoming an entrepreneur, he was an Associate Professor at Columbia University. Dr. Lederman’s groundbreaking research led to the discovery of the CD-40 ligand and its role in T cell helper function. Currently, Dr. Lederman oversees Tonix Pharmaceuticals and its diverse programs that are aimed to develop therapeutics for chronic CNS and immunologic conditions, that include indications like fibromyalgia, Covid-19 and Long Covid, amongst others. Dr. Lederman earned an AB from Princeton University in Chemistry and an MD from Columbia University's College of Physicians and Surgeons. Dr. Lederman trained in internal medicine and rheumatology at Columbia's Presbyterian Hospital.
https://www.tonixpharma.com/
Doug Looker is the VP of Operations with Validus Cellular Therapeutics. Validus is using cellular therapy to target infections by fighting the biology of antimicrobial resistance by activating the biology of the mammalian immune system. Doug walks us the through the process of establishing the CMC process that will drive success at every stage of the clinical trial process. And we have a brief discussion on animals being used in trials.
During the recording and editing of this episode Doug was the VP of Preclinical Development and Manufacturing at Amicrobe, Inc. Therefore the intro does not reflect his currrent position.
https://validustherapeutics.com/
Mike is the CEO of IDEA Pharma and author of the Pharmaceutical Innovation Index. He just launched a new company, Protodigm, that’s mission is to act as a pharma/biotech skunkworks that can test and troubleshoot drug development and avoid failure by determining the best possible development paths. Here’s the release.
He is an expert on all things drug development and has positioned 8 of the 15 biggest drug launches of the last 5 years. Mike is a contributor to Fortune, STAT, and Endpoints and also hosts his own podcast. https://podcast.ideapharma.com/
Mike also refers to Protodigm as a next generation CRO.
Grant is the Chief Business Officer with Bolt BioTherapeutics. Bolt Bio recently went public in February this year and announced a partnership with Genmab. Grant talks business development strategy and helping to navigate Bolt through their recent milestones.
Bolt Bio focuses on the development of ISACs – immune-stimulating antibody conjugates – which are anti-cancer drugs comprised of two main parts: a tumor targeting antibody attached to an immune system stimulant. This stimulant activates both the innate and adaptive arms of the immune system, potentially turning a “cold” tumor environment into a “hot” one. Their lead therapeutic candidate, BDC-1001, targets HER2+ tumors and is currently in Phase 1/2 trials.
https://www.boltbio.com/
https://www.globenewswire.com/news-release/2021/06/02/2240329/0/en/Genmab-and-Bolt-Biotherapeutics-Announce-Oncology-Research-and-Development-Collaboration.html
The founders of Brazen Bio discuss how their program is helping potential biotech founders prove their concepts and launch their company. Be Brazen!
Shawn Carbonell, MD, PhD quit his neurosurgery residency to found his first biotech startup a decade ago. He had invented and developed a first-in-class cancer drug which is currently in phase 1 clinical trial.
Brent Witgen, PhD had been in big pharma for the past decade, with direct involvement in over a dozen drug and device regulatory filings across multiple areas of human disease. He has built high-performing biotech teams in the US, EU, and Asia.
Together they have recently launched Brazen Bio to help biotech founders advance human health. Brazen Bio is building a turnkey incubator program with state-of-the-art laboratory access, including specialized equipment, technical support, expert advisors and accommodation. Based in LA they are planning to run the first cohort of founders through the program this year.
https://wefunder.com/brazenbio/
https://www.linkedin.com/company/brazenbio/
https://www.brazen.bio
Mike discusses the advancements that OnQuality Pharmaceuticals is making toward to the treatment of toxicities caused by cancer treatments. Mike also shares with us the challenges and importance of strong leadership in our evolving workforce.
https://twitter.com/onquality_rx
https://www.linkedin.com/company/onquality-pharmaceuticals-ltd/
https://www.onqualityrx.com/
Dr. Ekuta helps to educate us on the function of regulatory affairs by sharing an acronym he calls RCI. Regulatory Requirements, Compliance, and Interaction. He shares how regulatory affairs professionals can had value to companies at all stages of the process, pre-clinical to post-market. Dr. Ekuta is currently the VP of Global Regulatory Affairs with Alexion Pharmaceuticals and is an accomplished RA and pharmacovigilance executive. Learn some of his secrets to regulatory strategy.
Let's talk a little bit of tax and financial strategy! On this episode we have guests Derick Van Ness, a tax/financial strategist and owner of Big Life Financial and Justin Maxwell, President of Small Business Incentive Consultants. They discuss in further detail section 41 of the IRS tax code which cover R&D tax credits.
Dr. Leire discusses some of his background and the amazing things that GenFlow Biosciences are doing to develop gene therapies that slow or reverse aging in humans an dogs.
Dr. Du shares how he was chosen to study medicine in China and how he immigrated to the United States for a research fellowship. He subsequently went into industry and drug safety. We discuss some of the details and nuances of the medical case review side of drug safety.
Dr. Tucker shares insight from his career on leadership to team building. He also discusses some of the the great things Mirum is doing to fight rare liver diseases in children.
Patti started in the Rare Disease space back when it wasn't as well known. Her career led her to founding Engage Health a company that is helping to solve some of the unique challenges faced with patient recruitment in Rare Disease.
Dr. Baxter practiced pediatric emergency medicine which led her to discover a common challenge people face; fear of needles and needle pain. She went on to develop a medical device called Buzzy. This has now evolved into another device called VibraCool that can be used to help people deal with pain. An interesting fact, Dr. Baxter was a guest season 5, episode 8 of Shark Tank. She actually turned the sharks down. And has continued find success in growing Pain Care Labs. Her device is also used in many clinical trials by multiple well pharmaceutical companies. Listen to hear the whole story!
https://shop.paincarelabs.com/
Dr. Chonzi started his career in pharma/biotech as a drug safety physician learning both pre and post-market PV. Since then he has gained a large amount of experience helping companies develop their PV/drug safety function in the pre NDA and the NDA submital stages of the clinical trial process. In this episode of BioTech IQ he shares detailed insight into pharmacovigilance in the pre-market phases the clinical trial process.
Dr. Oliveira discusses some of her background and uses her wealth of knowledge in drug development to discuss the development of a phase III clinical trial.
Quantgene has combined precision genomics, machine learning, and a new perspective to detect cancers at early stages. By doing this they have brought one of the biggest needle movers to the market for beating cancer, catching it at an early enough stages for treatments to be effective. Jo discusses some of the science, approach, and system his company is taking to advance a new model for early cancer detection. Join us for the full episode!
James Kirwin has worked for some of the most well-known and successful large pharma organizations and successful start-up biotech firms. He has been on the front lines and cutting-edge of clinical operations strategy and has been directly part of multiple treatments on market today. Join us for a discussion on the other critical half of drug development: Clinical Operations.
Michelle has as a long and successful history leading compliance, quality assurance, and regulatory affairs. She discusses the difference between QA and Regulatory Affairs and how they affect both clinical trials and commercialization. Michelle also shares part of the story about her father who suffered from CADASIL syndrome, a rare disease that has no treatment, and how that inspired her throughout her career to make key decisions in her life. She has worked for well both well-known generics companies such as Mylan and big pharma companies such as AstraZeneca and Sanofi. Join for the journey and to learn a few things on along the way!
Aleisha shares how she became an expert consultant in helping clients with GCP Auditing, building functioning QA operations, and getting them inspection ready. All critical functions to not only manufacturing but running successful clinical trials as well.
Dr. Kivilghn is a senior Pharmaceutical and biotech executive with a rare blend of science and business acumen. Dr. Kivlighn discusses what drove him into the industry, controversial challenge trials, and how having a science background contributed to successfully commercializing multiple drugs. Some of those drugs include Losartan (Cozaar®), a market-leading antihypertensive drug becoming a $3.5B franchise (Merck & Co.) and RotaTeq®, a required vaccine for children in the US, resulting in an $800M franchise (Merck & Co.)Very interesting insights shared!
Dr. Linke shares his wealth of global drug development knowledge by discussing clinical trials and interacting with US, European, Chinese, and other regulatory agencies! Dr. Linke also shares his career progression and what drove some of the decisions he made that led to his current role. Being the Chief Medical Officer located in Germany with the company headquartered in California, you can bet he gets his share of travel and late nights.
A trained Oncologist and physician scientist Dr. Nichols discusses what she has seen from working as an academic in research on the front lines as a principal investigator to transitioning into pharma and now in the non-profit setting.
Doniel Jackson, MD is a 24+ year Drug Safety and PV veteran in the pharmaceutical industry. Dr. Jackson and I discuss aspects of Drug Safety and Pharmacovigilance and how it is a critical part to successful submission, registration, and post-marketing.
Dr. Kalsi shares some insight on the difference between vaccine clinical trials vs. rare disease vs. oncology. While practicing medicine, experiences working as a principal investigator drove Dr. Kalsi to pursue a medical degree in pharmaceutical medicine and join the industry. Over 20 years later Dr. Kalsi shares some of what he's learned.
Through an interesting turn of events Biosortia discovered they had access to large amounts of Aquatic Microbiome. With a broad range of capabilities they are able to extrapolate this into drug discovery. Ross believes that Biosortias ability to mine microbiome on such a large scale will change drug discovery in the coming years.
When Dana's brother-in-law was diagnosed with pancreatic cancer she helped her family discover the power of access to clinical trials. That led her founding Lazarex Cancer Foundation, a non-profit organization that helps people find clinical trials and deal with the costs associated. Dana has literally worked to induce change on how the FDA views reimbursements to patients from pharma companies and her foundation is doing some amazing things to further diversity. Listen for the whole story!
Dr. Morales discusses how COVID-19 affects the clinical trial supply chain, IP Strategy, and transitioning from pre-clinical to clinical.
On August 14, 2020, Identifyd Life Sciences launches, Biotech IQ hosted by Ammon Rivera. A podcast that interviews those at the cutting edge and front lines of drug development. Ammon interviews people from all aspects of biotech and pharma!