Talking the Cure by Hogan Lovells Cadwalader

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 Due to the fast developments of the situation, a few comments are already outdated, but this didn't take away any of the essences of the conversation.

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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.

In this episode, I talk with Michael Druckman, Jane Kalinina and Bert Lao about the 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.

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.

In this episode, Elisabethann Wright, a partner at Hogan Lovells in Brussels. She is among a handful of lawyers specialized in EU law and regulation of pharmaceuticals and medical devices who have consistently drawn praise from market sources for her knowledge of the legislation, technical competence, and commercial acumen. We talk about her highlights in her career and why she is not just a member of the bar in Belgium, but also England/Wales and in addition to the Republic of Ireland.

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.

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.

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.

In this episode, I talk with Jeff Jay and Tina Welter 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.

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, we’ll do a practical assessment of the potential legal issues stemming from the way in which AI is being used today