MODIFICATION
A -- Safety Evaluation and Toxicology Studies and Related Services for Drug Development
- Notice Date
- 5/26/2023 2:35:19 PM
- Notice Type
- Solicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023R00029
- Response Due
- 7/10/2023 12:00:00 PM
- Archive Date
- 07/25/2023
- Point of Contact
- Mark McNally, Contract Specialist, Phone: 3018275869, Khurram Shaikh, Contracting Officer, Phone: 3014436677
- E-Mail Address
-
mark.mcnally@nih.gov, kj.shaikh@nih.gov
(mark.mcnally@nih.gov, kj.shaikh@nih.gov)
- Description
- 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. �
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/2c5c055d587140d0919b76165c214a09/view)
- Record
- SN06695842-F 20230528/230526230105 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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