4:15 PM (PT)
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HHS secretary mandates NIH and FDA federal agencies to implement immediately the FDA Modernization Act which aims to establish a new roadmap to reduce animal testing in preclinical safety studies. Such recent legislative changes endorsed by Congress, and combined with some public sentiment support, encourage the use of alternative testing methods, or so-called New Approach Methodologies (NAMs), which encompass AI/ML computer modeling, organoids, and human organ-on-a-chip technologies. Although pharma and biotech companies are increasingly exploring and adopting NAMs in drug development, including for clinical studies, their readiness and widespread adoption are still evolving. To overcome these challenges, the panel of experts will discuss how to build a national framework leveraging current investment in NAMs with domains of expertise and infrastructure from academic and clinical institutions, and their industry partners, to ramp up technological scale-up access and quality manufactur ...Breakout Session 24BC
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With federal agencies commitments being uncertain and wavering, many researchers as well as emerging drug and device developers are struggling to find funding or to continue projects. At the same time, academia is struggling as federal funding is also being scaled back. States such as Maryland and Massachusetts are attempting to help bridge the gap by working with industry, investors, and academia to keep innovation going. This session will explore how academic institutions are attempting to not only do drug discoveries but also become clinical research sites. As the industry adapts to the new landscape, is collaboration between state, academia, and the industry the most viable way forward?Breakout Session 30ABC
1:45 PM (PT)
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The April 2025 Food and Drug Administration Roadmap to Reducing Animal Testing in Preclinical Safety Studies is a signature effort to shift the prevailing drug development paradigm. Aiming to reduce costs, time, and ethical burdens associated with animal studies and thereby streamline drug development pathways, the FDA Roadmap outlines a stepwise approach to reduce and replace animals via human-centered new approach methodologies (NAMs). It began with a three-year effort to explore existing data availability, develop an open-access data repository, encourage sponsors to submit NAMs data, and reduce the length of toxicology testing for mAbs. Many experts believe this paradigm shift is possible with the right investment, incentives, and clear guidance. Session attendees will hear updates from government panelists on progress and early successes, and discuss the kind of guidance, regulation, funding, and other incentives industry can expect. Panelists will discuss how academia and other c ...Breakout Session 32AB
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The biopharmaceutical industry needs sources for more, and better prepared talent, and there is building enthusiasm for skills-based hiring. Over the past few years, the Registered Apprenticeship (RA) model of workforce development has been successfully deployed in a variety of life science related career pathways, predominantly for biomanufacturing technicians. However, misinformation, outdated assumptions, and lack of a nationally consistent model have hampered large-scale adoption of RAs by this industry. Efforts are currently underway to establish National Registered Apprenticeship Standards, starting with those for biomanufacturing technicians, which can be shared across the country to streamline development of new programs. These national standards will allow customization to meet local employers’ needs while ensuring site-to-site consistency regardless of location. By offering a 360º perspective this session will inform biopharma professionals on workforce development efforts in ...Breakout Session 26AB
10:15 AM (PT)
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The path from academic discovery to patient impact has never been more complex. Federal funding shifts, market turbulence, and evolving expectations for commercialization are challenging traditional models of university tech transfer. Yet these pressures are also driving fresh approaches to how institutions partner, de-risk early science, and connect with industry and investors. This session convenes leading translational and academic innovation experts to share how top universities are reimagining models of partnership and entrepreneurship to ensure innovation thrives despite uncertainty. Panelists from MIT, Penn, Yale, and Brown will explore strategies for aligning institutional incentives, strengthening university–industry collaboration, and building regionally connected ecosystems that move discoveries from lab to market faster.Breakout Session 29AB
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