Opportunity
Simpler Grants.gov #W81XWH-21-NFRP-OUTREACH
Research-based OTA for Accelerating Neurofibromatosis Clinical Trials
Buyer
U.S. Army Medical Research Acquisition Activity
Posted
June 18, 2020
Identifier
W81XWH-21-NFRP-OUTREACH
NAICS
541715, 541714
This opportunity from the US Army Medical Research Acquisition Activity (USAMRAA) seeks feedback on a research-based Other Transactions Agreement (rOTA) to accelerate clinical trials for neurofibromatosis (NF1, NF2, and schwannomatosis). - Government Buyer: - Department of the Army - US Army Medical Research Acquisition Activity (USAMRAA) - Program Focus: - Congressionally Directed Medical Research Program (CDMRP) Neurofibromatosis Research Program (NFRP) - Support for a major goal/product-driven team to advance clinical translation of basic research - Structure: - Single Operations Center - At least five Clinical Trial Sites with a history of collaborative research - Products/Services Requested: - Collaborative Phase I and II clinical trials of promising therapeutic agents for neurofibromatosis - Operations and management of clinical trial sites - Unique/Notable Requirements: - Cost sharing - Potential partnership with a for-profit company - Milestone-based payments - Negotiation of technical/data rights - Demonstrated access to patient populations - No specific OEMs or vendors are mentioned, as this is a research-focused initiative.
Description
The Congressionally Directed Medical Research Program (CDMRP) Neurofibromatosis Research Program (NFRP) and the US Army Medical Research Acquisition Activity (USAMRAA) are exploring a Research-based Other Transactions Agreement (rOTA) to support a team of institutions and investigators aimed at accelerating clinical translation of basic NF research. The goal is to conduct collaborative Phase I and II clinical evaluations of therapeutic agents for NF1, NF2, and schwannomatosis. The Government anticipates an arrangement with a single Operations Center and at least five Clinical Trial Sites with a history of collaborative research. Cost sharing is required, and the program may include partnering with a for-profit company. The Government is currently requesting feedback and this notice is for information and planning purposes only.