IQ MPS Leaders to Share Industry Progress on Advancing In Vitro NAMs Toward Regulatory Acceptance at the Investigative & Preclinical Toxicology Summit

As New Approach Methodologies (NAMs) and microphysiological systems (MPS) continue to gain momentum across drug development, the imperative facing industry scientists is increasingly clear: translating scientific innovation into regulatory confidence.

This challenge will be addressed at the Investigative & Preclinical Toxicology Summit, taking place May 12–14 in Boston, where senior members of the IQ MPS Affiliate will convene to share how coordinated, cross‑industry collaboration is actively advancing the regulatory acceptance of in vitro NAMs.

The IQ MPS Affiliate, an established industry consortium focused on accelerating the qualification and implementation of MPS technologies, will be prominently represented across keynote presentations, workshops, and panel discussions, offering attendees direct insight from scientists to drive these initiatives forward.

Anna Kopec (Pfizer), former Chair of the IQ MPS Affiliate, will present “IQ MPS Affiliate and Industry Collaboration: Accelerating Adoption of in vitro NAMs.” Her presentation will outline how structured collaboration across pharmaceutical companies is progressing the qualification, credibility, and implementation of MPS platforms within preclinical toxicology.

The program will also feature a hands‑on, discussion‑driven workshop led by Colin Choi (Biogen), focused on navigating global regulatory expectations for preclinical toxicology packages incorporating NAMs, in vitro systems, and AI‑enabled approaches. Through real‑world case studies, participants will explore practical strategies for positioning innovative datasets in support of Investigational New Drug submissions across multiple regions.

In addition, Anna Kopec (Pfizer) and Colin Choi (Biogen) will be joined by May Freag (Takeda) for a cross‑industry panel discussion alongside a regulatory representative from VICT3R. This session will examine current regulatory and pharmaceutical expectations for NAM adoption, the role of IQ MPS Affiliate collaborations in advancing both simple and complex in vitro platforms, and the evolving contribution of virtual control groups and data‑driven approaches in toxicology decision‑making.

Collectively, these sessions provide a focused opportunity to hear directly from scientists actively shaping IQ MPS initiatives and influencing how NAM‑derived data are evaluated by global regulators.

With four weeks remaining until the summit and limited seats available, interest from across the biopharmaceutical toxicology community continues to build. The event is supported by VivoSim Labs, HUB Organoids and Insilica, with limited additional partnership opportunities still available.

The full agenda is available to download at: https://ter.li/2g4gtsjw

The Final early bird discount ends this week on Friday, April 17.

Register now to save up to $400: https://ter.li/3ckw9800

To inquire about group registration and preferred rates, interested attendees may contact Erica Kamweti at erica.kamweti@hansonwade.com