1:45 PM (PT)
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Real world data (RWD) are increasingly relied upon to inform drug policy decisions at both the state and federal levels. For example, state Prescription Drug Affordability Boards (PDABs) are using all-payer claims databases (APCDs) to support decisions on drug affordability. Further, CMS is leveraging Medicare claims to select eligible drugs and set the maximum fair price (MFP) for drugs in the Medicare Drug Price Negotiation Program (MDPNP). A potential overreliance on claims-based data for these decisions highlights concerns such as unequal data access amongst stakeholders, data infrastructure gaps, and the need to utilize more patient-centric data. This panel will illustrate the current state of how RWD is being used in state and federal drug pricing decisions, discuss the limitations of current data, and examine opportunities and actionable solutions to address these and other challenges. Attendees will gain a better understanding of the way RWD can inform policy decision-making an ...Breakout Session 26AB
3:00 PM (PT)
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As technology evolves and AI requires more data, the question largely becomes how much do we need versus how much do we want and subsequently, what are the harmful consequences. The combination of web traffic data and voting records can easily manipulate societies. Adding patient data, whether it be from clinical trials or from a patient’s stored ChatGPT history, creates cybersecurity risks for societies that are unparallel. As we see geopolitical tensions rise and cybersecurity attacks increase, what is the industry’s responsibility to protect patient data? Attendees will hear from industry thought leaders as they explore these topics, questions, and more.Breakout Session 29AB
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Biomarker legislation is reshaping insurance and diagnostics policy across many US states, with more than 20 currently mandating coverage for biomarker testing under certain conditions. However, translating law into consistent practice remains complex. This session will bring together leaders from patient advocacy, diagnostics, legal policy, and industry coalitions to share real-world insights into implementation. Panelists will explore how states, payers, and laboratories are interpreting coverage mandates, navigating evidence requirements, appeals, and prior authorization, and uncovering practical challenges in aligning policy with operational reality. Attendees will gain a clear view of both the opportunities and potential pitfalls in biomarker legislation, leaving with actionable strategies for how stakeholders can collaborate to help ensure laws achieve their intended goal - improving patient access to precision testing in a sustainable, equitable, and affordable way.Breakout Session 26AB
1:45 PM (PT)
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Recent changes in FDA’s leadership and approach have caused some concern among industry leaders and patients about the stability, predictability, and reliability of our regulatory framework. While our existing framework is dependable, there have been concerns with it being slow and unwilling to embrace emerging regulatory science. The change in leadership’s perspective and approach, however, offers a unique opportunity to reform FDA and modernize our current regulatory paradigm. Concepts such as shifting to dynamic, real-time data exchange from current practice of static, paper-based reviews; de-risking by offering actionable feedback earlier in development and empowering patients by embracing transparency are all ideas that industry and patients can support. Speakers will examine how industry can seize the current moment as an opportunity to build a modern FDA that is patient-centric, technologically enabled, and scientifically sound.Breakout Session 23BC
1:45 PM (PT)
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Although artificial intelligence (AI) has existed for decades, recent advances in computational power, data availability, and machine learning models have significantly accelerated its development and expanded its practical applications. Nowhere is this rapid evolution more apparent than in the field of healthcare, where AI is transforming how we understand, diagnose, and treat medical conditions. Today, AI systems play an increasingly vital role in accelerating the discovery of new therapeutics and medical devices, streamlining clinical workflows, and enhancing the accuracy and timeliness of diagnoses and treatment recommendations. Panelists will discuss their contributions to the global regulatory AI framework, share insights from the regional AI evaluations, and explore the broader implications for global health governance. The session will also examine cross-cutting themes such as emerging regulatory trends, critical legislative gaps, and opportunities to harmonize policy approache ...Breakout Session 30DE
4:15 PM (PT)
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Venture capital funding specifically for women’s health biotech and pharmaceuticals has undergone a significant transformation since 2023. While the broader "Women's Health" category is often dominated by "Femtech" (apps, digital platforms, and medical devices), the women’s health biopharma sub-sector is seeing results and advancing assets into the clinic. Join this session to hear about exciting developments in women’s health therapeutics, new partnership models and challenges developers face when researching some of the toughest challenges in women’s health.Breakout Session 26AB
9:00 AM (PT)
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The biopharmaceutical industry faces persistent misinformation campaigns targeting patent practices, with myths about patent thickets, evergreening, and excessive patent filings driving misguided policy proposals. This session presents evidence-based analysis directly contradicting these narratives using USPTO data, empirical research, and economic studies. Panelists will examine how organizations propagate flawed methodologies that inflate patent counts by including abandoned applications and non-Orange Book patents, creating misleading impressions of the patent landscape. Distinguished experts from industry, law firms, and global jurisdictions will demonstrate how robust patent protection enables both innovation incentives and timely generic competition, while debunking claims that follow-on innovations represent trivial evergreening. Attendees will gain crucial insights into defending evidence-based patent policy against activist narratives threatening the innovation ecosystem that ...Breakout Session 29C
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