Talking the Cure by Hogan Lovells Cadwalader

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.
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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?