Talking the Cure by Hogan Lovells

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 ...

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 ...

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 Pra...

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 t...

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 statutor...

In the third part of our clinical trial diversity series, Deborah Cho, Stephanie Agu, and Ashley Grey dissect FDA's new draft guidance on Diversity Action Plans for clinical trials, released on June 28, 2024.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 recommendation...

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 ...

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...

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...

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 recommenda...

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 ...

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 o...

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...