Computational ADME Tox AnaLYsis for Safer Therapeutics (CATALYST) Innovative Solutions Opening   3

Background
The Advanced Research Projects Agency for Health (ARPA-H) is initiating the DRAFT Innovative Solutions Opening (ARPA-H-SOL-24-114) for the Computational ADME Tox Analysis for Safer Therapeutics (CATALYST) Program. This program aims to enhance drug development processes by creating a robust repository of biomedical data and developing AI/ML applications to improve therapeutic safety and efficacy. The goal is to foster innovative solutions that can lead to safer therapeutics through advanced computational methods.

Work Details
The work under this contract involves multiple Technical Areas (TAs):

1. **TA1 - Data Repository Development**:
- Create a high-quality repository integrating diverse biomedical data types, including physicochemical properties, genomic and proteomic data, metabolic pathways, immunological data, and physiological data.
- Implement automated data ingestion, quality enhancement, AI-guided exploration, anomaly detection, standardization, cleaning, normalization, ontology integration, and quality assurance.
- Monthly technical and financial status reports are required.

2. **TA2 - Living Systems Tools for Model Development**:
- Develop innovative in vitro and ex vivo models to enhance data collection and analysis.
- Focus on human-relevant models and comparator animal models to improve predictive power.
- Collaborate closely with TA1 and TA3 to ensure alignment with scientific objectives.

3. **TA3 - In Silico Human Physiology Models**:
- Improve mechanistic models for better representation of human physiology.
- Collaborate with TA1 and TA2 to standardize input data formats and enhance predictability through novel tools.

4. **Product Sponsor Role**:
- Engage in advisory roles during Phase I and test tools in real-world scenarios during Phase II.
- Validate platforms against preclinical and clinical study results while ensuring compliance with regulatory standards.

Period of Performance
The overall CATALYST program spans 54 months, divided into two phases: Phase I lasting 36 months focused on developing predictive in silico platforms and Phase II lasting 18 months aimed at regulatory application processes.