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. 

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.

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.

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.

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.

In this episode, host Phil Katz sits down with Deborah Cho, a legal expert in biologics and biosimilars, 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.

In this episode of the third part of the clinical trial diversity series, Ashley Gray, Deborah Chow 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.

In this episode 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.