Talking the Cure by Hogan Lovells

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...

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 th...

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 inte...

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 Regula...

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 busi...

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 w...

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 c...

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 a...

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 cons...

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 s...

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 info...

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 roadma...

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...

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 lif...

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 w...

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 t...

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 su...

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 th...

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 th...

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 quest...

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 an...

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.

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.

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?

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.