Safety Evaluation and Toxicology Studies and Related Services for Drug Development

The purpose of RFP Amendment Number 02 is to extend the proposal deadine to 03:00 PM local time on July 24, 2023; and to share the following SBCX link through which offerors are required to submit their subcontracting plans:
https://osdbu.hhs.gov/subcontracting/b08bd2d7-6f7c-4317-af71-8e2302ba62b3

The purpose of RFP Amendment Number 01 is to distribute RFP questions and answers.

The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), conducts translational research on human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, TDB hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, TDB seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development.

The scope of this requirement is providing safety assessment of therapeutics and diagnostics. These assessments play a pivotal role in determining and evaluating therapeutic targets; selecting and optimizing therapeutic lead candidates; and establishing first in human starting doses, dose limiting toxicities, safety/pharmacodynamic biomarkers and therapeutic indexes.

The objective is to conduct toxicology studies to support the preclinical development of therapeutics and diagnostics including the submission of regulatory filings. Contractors will be required to perform in vitro and in vivo safety studies for small and large molecules to support the submission of regulatory filings to the US Food and Drug Administration (FDA) or other regulatory bodies, such as Investigational New Drug (IND) applications, New Drug Applications (NDA) and Biologics License Applications (BLA). In addition, in vitro tests and in vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis. Therapeutic modalities may include new and repurposed chemical entities and biological products (e.g., monoclonal antibodies, enzymes, gene vectors, etc.).

Offerors' questions regarding this RFP must be emailed by 03:00 PM EDT, June 9, 2023, to the Contract Specialist at mark.mcnally@nih.gov. Qestions and answers shall be published on SAM.gov to this Notice ID as an RFP amendment.