FDA Tox Working Group Which goals of the FDA Roadmap are most important to FDA stakeholders? Integration of predictive technologies Replacing animal tests

Training Should FDA partner with its stakeholders for these training courses and how might this be achieved? Absolutely, let’s partner! Are there relevant courses that you can recommend? ASCCT webinars Institute for In Vitro Sciences CE courses on predictive tox at scientific conferences Private companies

Communication How can FDA better communicate with stakeholders to encourage discussion on the use of qualified new toxicology methods early in the regulatory process? Policy statement/Guidance Maintain running list of qualified methods

Communication Cont How can new toxicology methods and approaches be integrated into FDA’s review of regulated products? Review scientific merits of all applications and provide substantive feedback What information do stakeholders need from FDA to qualify alternative methods for a specific COU? Conduit for data sharing of submitted data

Communication Cont Other Regulations Guidance

Current Regulatory Text: “A summary of the pharmacological and 21 C.F.R. § 312.23(a)(5)(ii) Current Regulatory Text: “A summary of the pharmacological and toxicological effects of the drug in animals, and, to the extent known, in humans.” Proposed Regulatory Text: “A summary of the pharmacological and toxicological effects of the drug in nonclinical approaches, and, to the extent known, in humans.”

Collaborations What partnerships could be useful to FDA to advance the roadmap? Nonclinical Innovation and Patient Safety Initiative (NIPSI) American Society for Cellular and Computational Toxicology (ASCCT) Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)

Research How can FDA encourage and support research in areas of importance to its mission? Microphysiological Systems IQ Consortium National Center for Advancing Translational Sciences (NCATS) Tissue Chip Collaboration

Oversight How can FDA ensure transparency in its progress? Create avenue for communication with leadership if agency unresponsive to requests to help with implementation Required reports to Chief Scientist made public

Pharmaceutical Policy Program Director Elizabeth Baker, Esq. Pharmaceutical Policy Program Director ebaker@pcrm.org