Safety Evaluation and Toxicology Studies and Related Services for Drug Development
Closed Solicitation Posted
This opportunity was awarded. See its 5 award notices in the notice history.
- Solicitation number
- 75N95023R00029
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health (NIH), specifically the Therapeutic Development Branch within the Division of Preclinical Innovation at the National Center for Advancing Translational Sciences (NCATS), is seeking contractor support for Safety Evaluation and Toxicology Studies and Related Services for Drug Development. The primary objective is to conduct comprehensive safety assessments and toxicology studies to support the preclinical development of small molecule and biologic therapeutics and diagnostics, including preparation of regulatory filings. Contractors will be required to perform both in vitro and in vivo safety studies for regulatory submissions to the FDA, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs), as well as exploratory studies to support therapeutic target evaluation, lead optimization, and compound selection. The work encompasses chemical entities, biological products such as monoclonal antibodies, enzymes, and gene vectors, and supports the establishment of first-in-human starting doses, dose-limiting toxicities, and safety/pharmacodynamic biomarkers. The initial Request for Proposals was posted on May 26, 2023, with a proposal deadline of July 24, 2023, at 3:00 PM local time, as extended by Amendment Number 02 issued on June 26, 2023. Amendment Number 01, released on June 20, 2023, distributed questions and answers relevant to the solicitation.
This solicitation was issued without a set-aside designation and falls under NAICS code 541715 (Research and Development in the Physical, Engineering, and Life Sciences) and PSC code AN11 (Health R&D Services; Health Care Services; Basic Research). The solicitation documents do not specify an anticipated award value, budget ceiling, or contract timeline in the available materials. No incumbent contractor information or previous award values are indicated in the opportunity notice. Offerors selected for award will be required to submit subcontracting plans through the specified SBCX link provided in Amendment Number 02. The performance location and specific contract duration terms would be detailed in the complete RFP documents (RFP Number 75N95023R00029), which were amended on June 26, 2023, and are available for review through the government files associated with this solicitation.
Notice text
3 versions
Update #3 · Latest ·
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.
Update #2 ·
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.
Update #1 ·
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.
Files
Notice history
| Notice | Type | Posted |
|---|---|---|
| Safety Evaluation and Toxicology Studies and Related Services for Drug Development | Award Notice | |
| Safety Evaluation and Toxicology Studies and Related Services for Drug Development | Award Notice | |
| Safety Evaluation and Toxicology Studies and Related Services for Drug Development | Award Notice | |
| This notice | Solicitation | |
| Safety Evaluation and Toxicology Studies and Related Services for Drug Development | Pre-Solicitation |
5 of 7 notices listed here. See the rest on GovTribe.
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