Notice ID: ARPA-H-SOL-24-114
Related Notice: ARPA-H-SN-24-114
The Advanced Research Projects Agency for Health (ARPA-H) is posting this DRAFT Innovative Solutions Opening (ARPA-H-SOL-24-114) for the Computational ADME Tox AnaLYsis for Safer Therapeutics (CATALYST) Program in order to help potential proposers prepare for Proposer’s Day and plan for solution summary submission.
The finalized ISO will be posted at a later date.
CATALYST will revolutionize current preclinical and clinical study practices with the following deliverables:
- AI/ML-enabled in silico human physiology modeling platforms for ADME-Tox simulation, that replace IND-enabling preclinical animal studies. The platforms will be adaptable to create fit-for use in silico models of various major organ systems in the human body.
- Living system tools that generate new human data, and fill human data gaps, for the development of in silico platforms for ADME-Tox simulation.
- Independently verified in silico platforms using existing or new human clinical data and comparable validated assays.
- Demonstrated predictive capabilities of the in-silico platforms through regulatory qualification of these platforms, and proof-of-concept FIH approvals based on data generated by these platforms.
Success in CATALYST will yield adopted methodologies that have been applied to IND-enabling studies, enhanced predictability of human outcomes in clinical trials, and a path towards digital clinical trials, more predictive Phase 0 studies, and drug candidates that have been evaluated in backgrounds that represent the population diversity of the United States. Technologies and methods developed in CATALYST will also create new market opportunities for “Digital CROs” to support more predictive regulatory science interaction that will enable easier clinical entry of drugs with smaller markets or that target underserved diseases and populations …
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