Talking the Cure by Hogan Lovells

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 information, and provide key recommendations for companies to safeguard their most critical assets against theft and unauthorized disclosure. You can find additional thought leadership and information regarding digital health on Engage. If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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 roadmap's timeline and policy direction. You can find additional thought leadership and information regarding digital health on ⁠⁠⁠⁠HL Engage⁠⁠⁠⁠. If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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 software in life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior. 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 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 life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior. 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 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 software in life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior. 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, 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 who would like to pursue a career in this field. 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, 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 themselves and the same sense of quality.

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 successful.

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 the challenges of out-licensing. They highlight the complexities and potential risks in dealing with IRA.

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 the challenges and unknowns​ іt presents​ tо sponsors, including what constitutes adequate diversity, potential data collection hurdles, and highlight upcoming FDA public workshops and guidances. If you are interested in more information all around Hogan Lovells Life Sciences and Health Care, follow us on LinkedIn and Twitter.

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 questions about the regulations and potential liability issues around AI in the MedTech industry.

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 and retention efforts as well as how to get involved with MedTech Color and take action in their day-to-day business to help advance the representation of persons of color in the medical device industry.

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.

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.