Talking the Cure by Hogan Lovells: Recent Episodes

Hogan Lovells

Hogan Lovells is always thinking about how to conquer and foresee the most significant industry issues facing our clients. If you’ve been following us for the past two years, you’ve heard first-hand from our lawyers around the world on significant developments in the Life Sciences & Health Care sector and why they are so passionate about the industry. In season 3, we’ll unpack new and exciting industry trends and bring you more outside perspectives to keep you ahead of the curve.

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FDA’s recent splash of 100+ enforcement letters objecting to drug advertising looks like a trend, not a blip. And although the UK and EU prohibit DTC ads for Rx drugs, there are new efforts creating risk for pharma companies, even if they’re not the main focus. In this episode of Talking the Cure, host Phil Katz is joined by Heidi Gertner, Sally Gu, and Bonella Ramsay to unpack what’s happening and what it means pharma companies should be thinking about, and steps they should be taking now to mitigate current – and future – risks.

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In this episode of Talking the Cure, Hogan Lovells partners Phil Katz, Alice Valder Curren, and Jane Summerfield discuss the evolving landscape of pharmaceutical pricing, particularly legislative and administrative changes in the United States and their implications in Europe. The discussion includes the Inflation Reduction Act (IRA) in the U.S., Most Favored Nations (MFN) pricing policies, and the impact of tariffs on drug prices and supply chains.

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In this episode of Talking the Cure, Hogan Lovells partners Phil Katz, Melissa Bianchi, and Jodi Scott explore how artificial intelligence is transforming the pharmaceutical, biotech, and medical device industries. From AI-driven clinical trials and diagnostic tools to regulatory challenges and global compliance complexities, the discussion dives deep into both the promise and the pitfalls of integrating AI in health care. Tune in to hear how industry leaders are navigating this fast-evolving space – and what companies need to know to stay ahead.

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Starting with tariffs and Executive Orders, there are myriad incentives – some would say imperatives – for pharma and biotech companies to increase and expand manufacturing in the US. But this is a classic “easier said than done” situation, for a number of reasons. Sally Gu and Chris Middendorf, drug manufacturing and quality experts and leading members of the Hogan Lovells Pharma/Biotech Regulatory Compliance and Enforcement Practice, join Phil Katz to dive into one particular set of issues – those related to the technical, logistical and other practical considerations of manufacturing these products. Drawing on their years of experience advising and advocating for product sponsors, manufacturers, and others on how to efficiently and compliantly manufacture or source drug and biotechnology products, Sally and Chris tackle the challenges in adding or changing manufacturing sites. They bring an integrated and strategic approach, and discuss how companies can (and should) do the same.

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In this episode of Talking the Cure, Phil Katz talks with Cybil Roehrenbeck, Josh Gelula, and Kelly Zhang about the announced and seemingly ever-changing plans for tariffs on imported goods – and pharmaceutical products in particular – may effect the industry, as well as the availability and cost of drugs. The discussion unpacks the law, the politics, and policy to offer suggestions on steps businesses can be taking to deal with the impacts.

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In this episode, host Phil Katz sits down with Deborah Cho, to discuss the evolving landscape of biosimilarity and interchangeability. They dive into the FDA's changing approach, highlighting the shift towards treating biosimilars and interchangeable biosimilars as a single category. Deborah explains how advancements in technology and experience have reduced the need for additional studies, and why the FDA is pushing for a statutory change to streamline approvals.

The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.

You can find additional thought leadership and information regarding digital health on Engage.

If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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In this episode of the third part of the clinical trial diversity series, Ashley Grey, Deborah Cho and Stephanie Agu dissect the FDA's new draft guidance on the Clinical Trial Diversity Action Plan, released on June 28, 2024. Discover how this pivotal document influences clinical trial design and conduct, thoroughly exploring its implications for drug and biologic sponsors. Tune in for an insightful discussion on the future of clinical trials and the strategies to ensure diverse and effective participant inclusion.

You can find additional thought leadership and information regarding digital health on Engage.

If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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In this episode of "Pharma: The Last Word," Phil Katz and Hein van den Bos discuss early access programs in the EU, exploring the various types of programs, their practical implications, and the regulatory challenges. They delve into compassionate use programs, named patient supply, and the nuances of implementing these programs across different EU countries. The conversation also touches on the benefits and risks of early access, including potential ethical and reputational concerns.

The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.

You can find additional thought leadership and information regarding digital health on Engage.

If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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In this episode of "Pharma - The last word," host Phil Katz, discusses regulatory and legal trends in the pharma and biotech industries with Komal Karnik Nigam. They delve into the FDA's evolving approach to data packages required for drug approval, highlighting the increased flexibility in accepting alternative forms of evidence. Komal explains how FDA's guidance has shifted from demanding large, multicenter trials to considering confirmatory evidence such as natural history studies, mechanistic data, and data from other products in the same class. The episode emphasizes the importance of strategic planning and early consideration of data presentation in regulatory interactions.

The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.

You can find additional thought leadership and information regarding digital health on Engage.

If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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Welcome to the inaugural episode of "Pharma: The last word," a podcast hosted by Partner Phil Katz from Hogan Lovells. This series aims to dive into the intricate world of pharmaceuticals and biotech regulatory and legal landscapes, exploring new innovations, trends, and their practical impacts. Join Phil and his first guest, Lynn Mehler, co-head of the Life Sciences and Health Care industry sector, and Lead of the Pharmaceuticals and Biotech Regulatory Practice, as they discuss the unique insights and deep expertise their team brings to the table, the largest of its kind outside the FDA. They will share the inner workings of their practice, how they stay ahead of industry trends, and their passion for the field.

Each episode will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.

You can find additional thought leadership and information regarding digital health on Engage.

If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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In this episode of Talking the Cure Hogan Lovells Life Sciences and Health Care Podcast Ruud van der Velden and Chantal Van Dam highlight the importance of protecting intellectual property and trade secrets in the life sciences and health care industry. They discuss the legal framework for trade secrets in the EU, the increasing focus of cybercriminals on valuable company data beyond personal information, and provide key recommendations for companies to safeguard their most critical assets against theft and unauthorized disclosure.

You can find additional thought leadership and information regarding digital health on Engage.

If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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In this episode Jane Summerfield and Owen Robinson discuss UK medical device regulation, focusing on the regulatory roadmap published by the MHRA, its implications for businesses, and the process for legislation development. They highlight the delay in core regulation target dates, the importance of stakeholder consultations, and the potential impacts of the upcoming general election on the roadmap's timeline and policy direction.You can find additional thought leadership and information regarding digital health on ⁠⁠⁠⁠HL Engage⁠⁠⁠⁠.If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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In the second part of the episode, ⁠⁠Arne Thiermann⁠⁠ is leading the conversation with ⁠⁠Richard Backhaus⁠⁠, and ⁠⁠Lars Cornels⁠⁠ discussing the integration and implications of digital health, artificial intelligence, and legal considerations in the medical device industry. They explore how traditional companies like ⁠⁠Drägerwerk AG & Co. KGaA⁠⁠ adapt to digital innovation, the role of AI and software in life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior.

You can find additional thought leadership and information regarding digital health on ⁠⁠⁠HL Engage⁠⁠⁠.

If you are interested in more information all around Life Sciences and Health Care, follow us on ⁠⁠⁠LinkedIn⁠⁠⁠ and ⁠⁠⁠Twitter⁠⁠⁠.

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In this first part of the episode, Arne Thiermann is leading the conversation with Richard Backhaus, and Lars Cornels discussing the integration and implications of digital health, artificial intelligence, and legal considerations in the medical device industry. They explore how traditional companies like Drägerwerk AG & Co. KGaA adapt to digital innovation, the role of AI and software in life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior.

You can find additional thought leadership and information regarding digital health on ⁠HL Engage⁠.

If you are interested in more information all around Life Sciences and Health Care, follow us on ⁠LinkedIn⁠ and ⁠Twitter⁠.

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In this episode, Robert F. Church⁠ takes the time to look back on his career with us. We talk about what ultimately led him to become a lawyer, how he ended up at Hogan Lovells, and how he became the institution in clinical trials. Of course, we also talk about what it means to manage such a heavy workload, how he takes time to switch off, and what he would like to pass on to aspiring colleagues who would like to pursue a career in this field.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Alice Valder Curran sits down with us to talk about her impressive career, why she ultimately chose Hogan Lovells as her employer, and what it takes to be successful in this area of the industry, even in times when you can only work part-time. Alice gives us a behind-the-scenes look at how to create your own niche and surround yourself with people who have the same standards for themselves and the same sense of quality.

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In this episode, Randy Prebular sits down with us and we talk about his impressive professional career, how he actually wanted to be a pediatrician at the beginning of his career, and how he then went from being a research scientist to a partner in a major law firm. We hear many exciting anecdotes, Randy gives us a behind-the-scenes look and tips on how young lawyers can make their careers more successful.

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In this podcast episode, Alice Curran and Cullen Taylor discuss the implications of the Inflation Reduction Act (IRA) on the life sciences and healthcare sector. They explore how IRA can impact drug pricing, development, collaboration, and partnerships. The episode covers assessing IRA’s impact, economic provisions in agreements, launch strategies, backup compounds, fixed-dose combinations, and the challenges of out-licensing. They highlight the complexities and potential risks in dealing with IRA.

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In this episode​ оf 'Talking the Cure,'​ we dive into the latest developments​ іn clinical trials diversity, driven​ by the Food and Drug Omnibus Reform Act (FDORA). Join Stephanie Agu, Akosua Tuffuor and Deborah Cho​ as​ we explore FDORA's key provisions related to diversity action plans.We'll briefly summarize the history​ оf FDA's efforts​ іn this area, discuss the impact​ оf FDORA, examine the challenges and unknowns​ іt presents​ tо sponsors, including what constitutes adequate diversity, potential data collection hurdles, and highlight upcoming FDA public workshops and guidances.If you are interested in more information all around Hogan Lovells Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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Arne Thiermann and Nicole Saurin talk about the current state and development of artificial intelligence in the medical device industry. How will AI medical devices be classified by the AIA Proposal? What is the relationship between the AIA Proposal and the MDR? What laws apply to the liability of medical AI products? Who is liable if the AI application makes a wrong decision? And a lot more questions about the regulations and potential liability issues around AI in the MedTech industry.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Beth L. Roberts (Partner, Washington, D.C.) is talking to Kwame Ulmer (Founder and Executive Director) about MedTech Color, its mission, programs, and resources they provide. In addition, they're discussing which hot topics in diversity and inclusion should medical devices, pharma, and other healthcare companies should be aware of, best practices regarding diversity recruitment and retention efforts as well as how to get involved with MedTech Color and take action in their day-to-day business to help advance the representation of persons of color in the medical device industry.

Learn more about MedTech Color MedTech Color | Diversifying the Med Tech Industry

Learn more about our pitch competition MedTech Color | Pitch Competition

If you are interested in more information all around Hogan Lovells Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Ina Brock invites us to her home and tells us that she actually wanted to become a journalist, but chance brought her to law. And the result of this decision is an impressive career, which we review together, Ina gives us insights into her daily work and how she sees the future of the Life Sciences & Healthcare Industry.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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“Enhancing clinical trial diversity is a moral and scientific imperative.”

Robert F. Church, Sarah Thompson Schick, Stephanie Agu, and Akosua Tuffuor, J.D. discuss recent developments in FDA’s and industry’s approaches towards clinical trials and ensuring meaningful trial participation from members of historically underrepresented populations. 

You can find more insights on diversity in clinical trials in our Life Sciences & Health Care Horizons Brochure 2022 here: https://bit.ly/3bh0b8G

Learn more about our clinical trials capabilities on our website here: https://www.hoganlovells.com/en/aof/clinical-trials

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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What to expect if you want to repurpose existing UK real estate, in particular, offices/retail to laboratory space? Graham Cutts will give an overview of potential building reconfigurations, occupier profiles, and the current industry hot topic for building owners: who bears the risk of a power outage and potential data breach?

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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What’s on the horizons for orthopedic devices? In this episode, Michael Kasser and Jemin Jay Dedania talk about their journey in the field of orthopedic devices, why orthopedics is still a little like the wild west of the FDA, how new technologies will reshape the conduct of clinical trials, and the do’s and don’ts, when working with the FDA.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Andreas von Falck will tell us that he actually wanted to work for an NGO, but then followed his father's path and became one of the most successful patent litigators in Germany. Andreas will tell us how he came to his Life Sciences mandates, which case influenced him the most, and what he considers to be the three most important points that the next generation should consider in order to leave their footprint in a large law firm.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Dr. Victor Stephani, Chief Of Staff at the German digital health high flyer HelloBetter, and Arne Thiermann, a life sciences partner in the Hamburg office and very familiar with the regulations of digital health applications, discuss the exciting yet rocky road bringing a digital health application into reimbursement by German social security. Victor took us behind the scenes to share how HelloBetter had four successful fast track processes at BfArM and his tips for anyone planning to follow.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In the first episodes of Season 3, Jonathan S. Kahan, partner and passionate lawyer in the Medical Device and Technology Regulatory practice, took the time to talk to our host, Julius Bülow, about his work as a lawyer, how he built his practice from the ground up and what talents he discovered along the way, what continues to excite him about his work, and we find out that he was already portraying the digitization of health care two decades ago.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, I talk with Dr. Tina Welter-Birk and Komal Karnik Nigam about the Early Access Programs (EAPs), known as Expanded Access Programs in Germany, and the United States, which allow pre-approval access to medicines for certain patients. While the name of EAPs varies by country, there are two main types of early access programs in Europe; Compassionate Use Programs (CUPs) and Named-Patient Programs (NPPs). Both of these differ in certain ways to typical Expanded Access Programs in the US and with this podcast, we're trying to shed some light on whats to consider entering these programs. Overall an interesting overview of the Early Access Programs (EAPs), which you should listen to if you're interested in this field.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Christian Di Mauro, who is heading the Italian litigation and arbitration practice talk about his 17 years of experience working with the Life Sciences and Health Care industry and being involved in products including pharmaceuticals, vaccines, medical devices. He is also discussing the interesting role he is in, including his ability to advise Italian and French law as a litigator, his biggest matter, how he approaches his job, and what he does for his work-life balance.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Thierry Meillat, Stefan Martin, Eckard Schwarz, and Zachary Siegel talked about the various return to work policies, testing at work sites, mask mandates, and vaccinations. Due to the fast developments of the situation, a few comments are already outdated, but this didn't take away any of the essences of the conversation.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Lowell M. Zeta, who just rejoined the firm after serving as Senior Counselor to the Commissioner at FDA, is going to talk to Philip Katz about his work on cross-cutting and high-priority initiatives promoting innovation and addressing public health issues, including the COVID-19 pandemic response and the decision to make the move back to Hogan Lovells.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, I talk with Michael Druckman, Jane Kalinina and Bert Lao about the impact of Covid-19 on cell, tissue, and gene therapy products. We touch base on the enforcement discretion for tissue products and those transitioning under explicit enforcement and approval to satisfy good manufacturing practices under the FDA. In addition, we focus on orphan drug sameness and individualized therapies issues. Overall an interesting overview on the cell, tissue, and gene therapy products and its market developments.

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, I talk with Suzanne Levy Friedman and Michael Penners about how both U.S. and Germany have seen a lot of legal/regulatory activity around advertising and promotion of COVID-19 test kits. Suzanne and Michael are giving an overview of efforts/authority with respect to regulating advertising and promotion of medical devices/products in the two jurisdictions, especially one area where this comes up frequently with clients is the increasing trend of promoting devices on social media. It was interesting to hear about these two jurisdictions and how both markets are regulated. 

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, I talk with David Horowitz about his work around bringing hand sanitizers onto the market in the US. Understanding FDA’s expectations for the guidance that opened up hand sanitizer manufacturing, including denaturants; impurities; pharmaceutical grade vs. food or industrial grade ingredients. And his pre-covid-19 regulatory over the counter drug work, overall a super interesting conversation about David's career.

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, I talk with Fabien Roy and Jonas Albert about the current "surge" of Digital Health Innovations in Europe, receiving the CE-Marking, getting reimbursed for their product, and what that means for Start-Ups as well as established companies. Obviously, we touched on the ongoing Covid-19 pandemic, due to the fast developments, a few things are unfortunately already outdated, but that doesn't take away anything from this conversation and I hope you'll enjoy this as much as I did.

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Jodi Scott, a partner at Hogan Lovells in Denver, is going to talk about her time spent as an in-house FDA counsel with the world's largest medical device manufacturer, the state of the industry, her decision to make the move to Hogan Lovells, and her overall career.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, I talk with Jeff Jay and Tina Welter-Birk about their involvement in the life sciences and health care associate committee. This position was created about 18 months ago to give associates more insight into the developments coming out of the leadership team. In addition, Tina and Jeff talk about their experiences with the role, their work in the life sciences and health care industry group, and how they are pursuing their career at Hogan Lovells.

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Jason Lohr and Imogen Ireland, are going to explore some interesting questions to do with whether or not patent law is set up to deal with innovations developed by AI. In the second half of the podcast, they’ll do a practical assessment of the potential legal issues stemming from the way in which AI is being used today.

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Randy J. Prebula, Susan D. Tiedy-Stevenson, and Erkang Ai, Ph.D. are talking about the “world” of what is considered to be in in vitro diagnostics, the current SARS-CoV-2 situation and the various IVDs that are being granted Emergency Use Authorization by the FDA.

You can find additional thought leadership and information regarding COVID-19 on HL Engage.

If you are interested in more information about Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Jon Wasserman, a new partner at Hogan Lovells and former Bristol Myers Squibb vice president, is going to talk about his past, the state of the industry, his decision to make the move to Hogan Lovells, and a potential dinner with two British gentlemen and Abraham Lincoln.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), aimed at shoring up domestic manufacture of "essential medicines", "medical countermeasures", and "critical inputs" (API and other raw materials), and decreasing dependency on non-domestic sources.

Philip Katz leads a discussion with Joy Sturm, Mike Heyl, Kelly Ann Shaw, and David Horowitz about what they're seeing, what they expect, and what actions companies are – or should be – taking or considering.

You can find additional thought leadership and information on recent industry developments on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Arne Thiermann and Dr. Julian Braun, director of legal at Heartbeat Labs, discuss the opportunities and risks for international companies planning to enter the German market in the digital health sector, especially with regard to reimbursement and the impact of regulatory changes in Germany.

You can find additional thought leadership and information regarding digital health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, May Lyn Yuen and Hein Van den Bos discuss the balance of innovation in drug development, the competitive aspects and affordability of medicines in Europe, and the changes in the regulatory environment at the EU level as well as the EU Member State level.

You can find additional thought leadership and information regarding innovation in drug development on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In our latest episode, you will get to know members of our Science Unit Dr. Marion Palmer and Dr. Rachel Gribben, who talk about their experience working in this unit for over 20 years, as well as their latest work on COVID-19 related matters. We also discuss how they are providing pro bono work and what they do to relax.

As mentioned in the podcast, here is the link to support the crowdfunding campaign to fund the COVID-19 airways procedures box, which was created by Dr. Palmer and Mr. Declan Costello FRSC.

You can find additional thought leadership on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, our partners Brooke Bumpers and William Ferreira talk about the growth of the telehealth industry during the COVID-19 pandemic and the opportunities and challenges for companies and providers in the United States and internationally. We also discuss how providers and patients are reacting to the increased use of telehealth.

As mentioned in the podcast, we just launched a new publication titled "What's on the horizon for virtual health?". In this report, members of our Global Digital Health team explore the opportunities and potential legal hurdles for companies involved in telehealth and remote monitoring – addressing both the regulatory exceptions that exist now, and the risks that will endure.

You can find additional thought leadership and information regarding Digital Health on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In the second part of our two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals and Biotechnology Regulatory Practice, we discuss team management, diversity and we also get to learn about Phil, when he shuts down his blackberry. We had a lot to cover in our conversation with Phil, so if you haven't checked out yet, listen to the first part of our conversation.

You can find additional thought leadership and information regarding Pharmaceuticals and Biotechnology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In the first episode of our two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals and Biotechnology Regulatory Practice, we discuss developments in the pharmaceuticals and biotechnology industry, the global practice of law in this space, and we also get to learn about Phil and his career journey. We had a lot to cover in our conversation with Phil, so stay tuned for more industry insights in part two of our interview!

You can find additional thought leadership and information regarding Pharmaceuticals and Biotechnology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, our partners Jörg Schickert and Nikolas Zirngibl talk with Jörn Bungartz, an adviser in the digital health sector, about opportunities and barriers for venture capital in the life sciences and health care industry in Germany.

You can find additional thought leadership and information regarding venture capital in the life sciences and health care industry on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Elisabethann Wright, Jane Summerfield, and Hein Van den Bos talk about developments in Belgium, the UK, and the Netherlands and how the Covid-19 pandemic impacts clinical trials and the authorization process of the local authorities.

For all updates around COVID-19, visit our COVID-19 hub.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Charlotte Damiano and Fabien Roy talk about reimbursement issues, early access and the collection of clinical data in France. In the end they both address general developments of the medical device regulation.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Phil Katz and Jim Johnson continue their conversation about the impact of COVID-19 on FDA’s drug inspection program and the steps companies should take now and in preparation for when the pandemic is coming to an end.

For all updates around COVID-19, visit our COVID-19 hub.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Phil Katz, David Horowitz, and Jim Johnson explore the impact on industry and FDA of the agency’s decision to halt foreign inspections and take other steps that reduce international activities. They anticipate further steps by the agency and talk about how companies can strategically address the implications, which create obstacles but also opportunities.

For all updates around COVID-19, visit our COVID-19 hub.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Michael S. Heyl and Jonathan S. Kahan explore questions around FDA’s Emergency Use Authorization authorities, how it has been used historically, and how it may be used for the coronavirus. They highlight very recent FDA actions and project how these authorities could be applied to address supply chain issues, in addition to the development of new technologies/devices to aid in the diagnosis and treatment of the virus.

Please contact us with any questions regarding this series or if there is a specific topic you would like us to talk about.

For all updates around COVID-19, visit our COVID-19 hub.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Arne Thiermann and Mike Druckman explore questions around the supply chain in the life sciences and health care industry. They highlight the reality and the expectation when it comes down to the draft of a contract in this kind of situations.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Jörg Schickert, one of the leading life sciences and health care lawyers for regulatory and commercial issues in Europe, is going to talk about his work, his views on the industry, and why he wouldn't change anything if he had the chance to start his journey all over again.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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In this episode, Elisabethann Wright and Robert F. Church from our Global Regulatory practice explore questions around the use of digital tools in clinical trials and how they are regulated by international authorities. They highlight the confusion around clinical trials within the European GDPR framework.

You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.

If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.