Talking the Cure by Hogan Lovells Cadwalader

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, 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.

In the third part of our clinical trial diversity series, Deborah Cho, Stephanie Agu, and Ashley Grey dissect FDA's new draft guidance on Diversity Action Plans for clinical trials, released on June 28, 2024. Discover what this pivotal document means for clinical trial design and conduct, and its implications for drug and biologic sponsors. Tune in for an insightful discussion on the future of clinical trials and FDA recommendations to ensure diverse 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.

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 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.

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.