NFRP Outreach and Invitation for Response

The Congressionally Directed Medical Research Program (CDMRP) Neurofibromatosis Research Program (NFRP) and the US Army Medical Research Acquisition Activity (USAMRAA) are exploring the possibility of pursuing a Research-based Other Transactions Agreement (rOTA) to support a major goal/product-driven team of exceptional institutions and investigators that will accelerate the clinical translation of basic NF research and ultimately decrease the impact of the disease. The objectives of the resulting rOTA shall be to conceive, design, develop, and conduct collaborative Phase I and II clinical evaluations of promising therapeutic agents for the management or treatment of NF1, NF2, and schwannomatosis. • The Government is seeking feedback regarding the proposed approach and capabilities. • The Government anticipates an arrangement with a single Operations Center and a minimum of five Clinical Trial Sites. • The participants will be jointly responsible for prioritizing, proposing, conducting, and analyzing Phase I and Phase II clinical trials focused on therapeutic interventions for NF1, NF2, and schwannomatosis. • The Government is open to discussions regarding teaming arrangements or consortiums. • Cost sharing is required, with Government funds not to exceed the total amount provided by other parties to the maximum extent practicable. • Any resulting proposal request may include a requirement to partner with a for-profit company. • Milestone-based payments are anticipated. • Technical/data rights will be negotiated as needed. • Demonstrated access to patient populations is required.