Talking the Cure by Hogan Lovells

In this episode, Andreas von Falck will tell us that he actually wanted to work for an NGO, but then followed his father’s path and became one of the most successful patent attorneys in Germany. Andreas will tell us how he came to his Life Sciences mandates, which case influenced him the most, and what he considers to be the three most important points that the next generation should consider in o...

In this episode, Dr. Victor Stephani, Chief Of Staff at the German digital health high flyer HelloBetter, and Arne Thiermann, a life sciences partner in the Hamburg office and very familiar with the regulations of digital health applications, discuss the exciting yet rocky road bringing a digital health application into reimbursement by German social security. Victor took us behind the scenes to s...

In the first episodes of Season 3, Jonathan S. Kahan, partner and passionate lawyer in the Medical Device and Technology Regulatory practice, took the time to talk to our host, Julius Bülow, about his work as a lawyer, how he built his practice from the ground up and what talents he discovered along the way, what continues to excite him about his work, and we find out that he was already portrayin...

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...

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 litigato...

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 Due to the fast developments of the situation, a few comments are already outdated, but this didn't take away any of the essences of the conversation.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

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 t...

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...

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 c...

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...

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 g...

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

In this episode, Randy J. Prebula, Susan D. Tiedy-Stevenson, and Erkang Ai, Ph. D. are talking about the “world” of what is considered to be in in-vitro diagnostics, the current SARS-CoV-2 situation, and the various IVD’s that are being granted Emergency Use Authorization by the FDA.

Jon Wasserman, a new partner at Hogan Lovells and former Bristol Myers Squibb vice president, is going to talk about his past, the state of the industry, his decision to make the move to Hogan Lovells, and a potential dinner with two British gentlemen and Abraham Lincoln.

On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), aimed at shoring up domestic manufacture of "essential medicines", "medical countermeasures", and "critical inputs" (API and other raw materials), and decreasing dependency on non-domestic sources. Philip Katz leads a discussion with Joy Sturm, Mike Heyl, Kelly Ann Shaw, and David Horowi...

In this episode, Arne Thiermann and Dr. Julian Braun, director of legal at Heartbeat Labs, discuss the opportunities and risks for international companies planning to enter the German market in the digital health sector, especially with regard to reimbursement and the impact of regulatory changes in Germany.

In this episode, May Lyn Yuen and Hein Van den Bos discuss the balance of innovation in drug development, the competitive aspects and affordability of medicines in Europe, and the changes in the regulatory environment at the EU level as well as the EU Member State level.

In our latest episode, you will get to know members of our Science Unit Dr. Marion Palmer and Dr. Rachel Gribben, who talk about their experience working in this unit for over 20 years, as well as their latest work on COVID-19 related matters. We also discuss how they are providing pro bono work and what they do to relax.

In this episode, our partners Brooke Bumpers and William Ferreira talk about the growth of the telehealth industry during the COVID-19 pandemic and the opportunities and challenges for companies and providers in the United States and internationally. We also discuss how providers and patients are reacting to the increased use of telehealth.

In the second part of our two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals and Biotechnology Regulatory Practice, we discuss team management, diversity and we also get to learn about Phil, when he shuts down his blackberry. We had a lot to cover in our conversation with Phil, so if you haven't checked out yet, listen to the first part of our conversation.

In the first episode of our two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals and Biotechnology Regulatory Practice, we discuss developments in the pharmaceuticals and biotechnology industry, the global practice of law in this space, and we also get to learn about Phil and his career journey. We had a lot to cover in our conversation with Phil, so stay tuned for more i...

In this episode, our partners Jörg Schickert and Nikolas Zirngibl talk with Jörn Bungartz, an adviser in the digital health sector, about opportunities and barriers for venture capital in the life sciences and health care industry in Germany. You can find additional thought leadership and information regarding venture capital in the life sciences and health care industry on HL Engage. If you are i...

In this episode, Elisabethann Wright, Jane Summerfield, and Hein Van den Bos talk about developments in Belgium, the UK, and the Netherlands and how the Covid-19 pandemic impacts clinical trials and the authorization process of the local authorities.