FY13 Solicitation of Applications to the Bridging Interventional Development Gaps (BrIDGs) Program


Notice Number: NOT-RM-13-003

Key Dates

Release Date: December 5, 2012

Issued by

National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)

Purpose

The Bridging Interventional Development Gaps program (BrIDGs) makes available, on a competitive basis, certain critical resources needed for the development of new therapeutic agents. This is not a grant program. Instead, successful applicants receive access to NIH contractors who conduct preclinical studies at no cost to the investigator. In general, synthesis, formulation, pharmacokinetic and toxicology resources are available to support investigator-held Investigational New Drug (IND) applications to the U.S. Food and Drug Administration.

Access to these contracts is based upon a peer-reviewed application process. The number of awards made will depend on the number of applications received, their scientific merit, and the availability of NIH funds. Contract costs are supported by the NIH Common Fund and collaborating NIH Institutes and Centers. BrIDGs is administered by the Division of Preclinical Innovation within the National Center for Advancing Translational Sciences.

Applications are accepted once per year. The next submission deadline for applications to the BrIDGs program will occur on February 1, 2013. Final decisions are expected to be made by September 2013.

Program Scope

Potential therapies for any disease or disorder may be submitted to BrIDGs. All proposed therapeutic agents should have demonstrated pharmacological activity in an appropriate in vivo disease model before applying.

Applications are accepted for the development of the following therapeutic agents:

  • Small molecules
  • Peptides
  • Oligonucleotides
  • Gene vectors
  • Recombinant proteins
  • Monoclonal antibodies

Available services include:

  • Synthesis
  • Scale-up production
  • Development of analytical methods
  • Development of suitable formulations
  • Pharmacokinetic/ADME studies including bioanalytical method development
  • Range-finding initial toxicology
  • IND-directed toxicology
  • Manufacture of clinical trial supplies
  • Product development planning and advice in IND preparation

The following organizations are eligible to apply:

  • Domestic Academic and Non-profit institutions
  • SBIR-eligible small businesses
  • Eligible Agencies of the Federal Government (including NIH intramural)
  • Non-domestic (non-U.S.)Academic and Non-profit institutions
How to Apply

Applications may be submitted electronically through the proposalCENTRAL application system between December 1, 2012 and February 1, 2013. Details on the application content and format can be found in the "how to apply" section of the BrIDGs website.

Inquiries

Please direct all inquiries to:

Tony Jackson
Program Analyst
National Center for Advancing Translational Sciences
6701 Democracy Blvd, Room 929
Bethesda, MD 20817
Phone: 301-594-4660
Email: bridgs@mail.nih.gov
Web: www.ncats.nih.gov/bridgs.html