Talking the Cure by Hogan Lovells
Hogan Lovells is always thinking about how to conquer and foresee the most significant industry issues facing our clients. If you’ve been following us for the past two years, you’ve heard first-hand from our lawyers around the world on significant developments in the Life Sciences & Health Care sector and why they are so passionate about the industry. In season 3, we’ll unpack new and exciting industry trends and bring you more outside perspectives to keep you ahead of the curve.
Episodes
Episodes
Thursday Dec 16, 2021
Talking the Cure: Discussing Early Access Programs (EAPs) in the US and Germany
Thursday Dec 16, 2021
Thursday Dec 16, 2021
In this episode, I talk with Dr. Tina Welter-Birk and Komal Karnik Nigam about the Early Access Programs (EAPs), known as Expanded Access Programs in the US, in Germany, and the United States, which allow pre-approval access to medicines for certain patients. While the name of EAPs varies by country, there are two main types of early access programs in Europe; Compassionate Use Programs (CUPs) and Named-Patient Programs (NPPs). Both of these differ in certain ways to typical Expanded Access Programs in the US and with this podcast, we‘re trying to shed some light on whats to consider entering these programs. Overall an interesting overview of the Early Access Programs (EAPs), which you should listen to if you‘re interested in this field.
Wednesday Dec 01, 2021
Talking The Cure: Exploring the industry with Christian Di Mauro
Wednesday Dec 01, 2021
Wednesday Dec 01, 2021
In this episode, Christian Di Mauro, who is heading the Italian litigation and arbitration practice talk about his 17 years of experience working with the Life Sciences and Health Care industry and being involved in products including pharmaceuticals, vaccines, medical devices. He is also discussing the interesting role he is in, including his ability to advise Italian and French law as a litigator, his biggest matter, how he approaches his job, and what he does for his work-life balance.
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.
Tuesday Jul 06, 2021
Tuesday Jul 06, 2021
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.
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.
Tuesday Jun 15, 2021
Talking The Cure: Exploring the industry with Lowell Zeta
Tuesday Jun 15, 2021
Tuesday Jun 15, 2021
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.
Thursday May 06, 2021
Thursday May 06, 2021
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.
Thursday Apr 15, 2021
Talking The Cure: Discussing advertising and promotion of COVID-19 test kits
Thursday Apr 15, 2021
Thursday Apr 15, 2021
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.
Monday Mar 08, 2021
Talking The Cure: Discussing hand sanitizers and their way to the market
Monday Mar 08, 2021
Monday Mar 08, 2021
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.
Tuesday Feb 16, 2021
Tuesday Feb 16, 2021
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.
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