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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.

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 order to leave their footprint in a large law firm.

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 share how HelloBetter had six successful fast track processes at BfArM and his tips for anyone planning to follow.

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 portraying the digitization of health care two decades ago.

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.

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.

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.

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, 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.