Alternative Methodologies in Pharmaceutical Development Workshop
Pharmaceutics, Artificial Intelligence and Neuroscience workshop
Starts in 11 days
About
New approach methodologies can support drug safety and efficacy evaluation while improving the mechanistic understanding of human disease and therapeutic response. This workshop addresses two barriers to their wider use: awareness of available applications and confidence that their results are biologically relevant, reproducible and translatable. Pharmaceutical developers, regulators and biomedical researchers will discuss validation, standardisation and integration of NAM-based evidence into research and development. Sessions consider human-based models, organoids, tissue microenvironments, organ-on-chip systems and computational approaches, alongside regulatory and industry implementation challenges. In-person attendees can explore National Medical Phantom Library demonstrations during breaks.
The workshop takes place on 20–21 October 2026, starting at 10:00 EDT (America/New_York) on each day. Both in-person participation and a live webcast are available; in-person attendance is encouraged for fuller discussion. In-person registration closes at 17:00 EDT on 13 October. Webinar registration remains available through the end of the workshop and supplies individual connection details. Participants are responsible for their own meals and refreshments.
Guest speakers
- Anthony Letai, National Cancer Institute
- Amber Daniel, General Dynamics Information Technology, contractor supporting NIH ORIVA
- Anna Curle, Mass General Brigham and Harvard Medical School
- Chris Sheth, Aclairo
- Haleh Saber, FDA, Division of Hematology Oncology Toxicology
- Helena Hogberg-Durdock, NIH ORIVA, Division of the National Interagency Center for the Evaluation of Alternative Test Methods
- Imein Bousnina, Genentech
- Jason Meyer, Indiana University School of Medicine
- Jeffrey Siegel, FDA CDER, Office of Drug Evaluation Sciences
- Joseph Wu, Stanford University School of Medicine
- Margaret Ochocinska, NIH Office of the Director
- Michael Shen, Columbia University
- Rahul Thakar, NIH/NHLBI
- Randy Daughters, Emulate, Inc.
- Rong Xu, Case Western Reserve University
- Sonja Beken, Belgian Federal Agency for Medicines and Health Products
- Thomas Hartung, Johns Hopkins University
- Warren Casey, NIH ORIVA
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