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

3. 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

4. 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

5. 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

6. Communication Cont
Other
Regulations
Guidance

7. Current Regulatory Text: “A summary of the pharmacological and
21 C.F.R. § (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.”

8. 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)

9. 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

10. 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

11. Pharmaceutical Policy Program Director
Elizabeth Baker, Esq.
Pharmaceutical Policy Program Director