AAPS PharmSci 360 Spotlights AI and Adaptive Approaches to Drug Development
Key Points
- FNIH president Julie Louise Gerberding opened AAPS PharmSci 360 2026 with a plenary on AI, adaptive clinical trials, and novel alternative methods for drug development.
- Sessions explore nonanimal safety testing approaches, including AI, organ-on-a-chip, and neural organoids, following the FDA's 2025 move to phase out certain animal testing requirements.
- The October 25-28 New Orleans meeting also covers complex generics, excipient quality, research integrity, and credibility in peer-reviewed science.
Julie Louise Gerberding, MD, MPH, president and CEO of the Foundation for the National Institutes of Health (FNIH), delivered the opening plenary at AAPS PharmSci 360 2026, focusing on how emerging technologies and new research approaches could reshape pharmaceutical development. Gerberding brings experience across public health and the pharmaceutical industry to the discussion. She served as director of the U.S. Centers for Disease Control and Prevention from 2002 to 2009 and has held executive positions at Merck. The meeting, organized by the American Association of Pharmaceutical Scientists (AAPS), runs October 25-28 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.
Gerberding’s October 25 presentation, titled ‘Adaptive Intelligence: Accelerating Biomedical Innovation,’ will explore the potential of artificial intelligence (AI), adaptive clinical trials and novel alternative methods to improve the efficiency and safety of translating scientific discoveries into medicines. The session comes amid growing interest in rethinking traditional drug development processes, which can involve lengthy timelines and sequential stages of research, testing and clinical evaluation. Parag Kolhe, PhD, chair of the AAPS 2026 PharmSci 360 Scientific Programming Committee, said the challenge extends beyond speeding up individual tasks. A more integrated approach to development could allow activities to proceed in parallel, potentially reducing timelines while maintaining scientific rigor and product quality.
The plenary’s focus on novel alternative methods reflects broader changes in how drug developers and regulators are evaluating nonanimal approaches to safety testing. In April 2025, the U.S. Food and Drug Administration announced plans to phase out certain animal testing requirements for monoclonal antibodies and other drugs, encouraging the development and use of new approach methodologies. These include computational toxicity models, cell-based assays and organoid systems that may provide additional insight into drug safety and biological responses.
Other sessions at PharmSci 360 will examine how these technologies could be incorporated into pharmaceutical research. On October 28, Thomas Hartung, MD, PhD, of the Johns Hopkins Bloomberg School of Public Health, will lead a track focused on emerging testing approaches, including AI applications, organ-on-a-chip platforms and neural organoids. The conference will also cover pharmaceutical standards, complex products and research integrity. An AAPS-U.S. Pharmacopeia workshop scheduled for October 26-28 will address complex generics, excipient quality, inhalation standards and emerging requirements for novel excipients.
Brian Nosek, PhD, of the Center for Open Science, will lead a six-session track on credibility in peer-reviewed research. Topics include identifying problematic publications, checking citations and considering the ethical use of AI in scientific work. David Berry, MD, PhD, managing partner at Averin Capital, is scheduled to deliver the closing plenary on October 28.
Ahead of the meeting, AAPS named Patrick J. Sinko, PhD, RPh, a former association president, as its chief science officer. Sinko will guide the organization’s scientific strategy, oversee programming across in-person and digital platforms, and direct its peer-reviewed journals. He will continue in his academic role as distinguished professor and Parke-Davis Endowed Chair in Pharmaceutics at the Rutgers Ernest Mario School of Pharmacy. For more information, visit www.aaps.org.
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