Partnerships for Biodefense (R01)

RFA-AI-13-013

Posted Date	February 26, 2013
Open Date (Earliest Submission Date)	May 2, 2013
Letter of Intent Due Date(s)	June 2, 2013
Application Due Date(s)	July 2, 2013, by 5:00 PM local time of applicant organization.

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by bioterrorism and emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for certain pathogens and toxins.

With this FOA, the NIAID invites research applications for projects focused on preclinical development of lead candidate therapeutics, vaccines, or medical diagnostics that address NIAID Category A, B, or C priority pathogens and toxins (agents) (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx). This FOA also invites research applications for projects focused on preclinical development of candidate technologies (including adjuvants) that would improve vaccine effectiveness and/or simplify vaccine delivery to patient populations during a natural outbreak of an infectious disease or following the intentional release of an infectious agent. For the purpose of this FOA, “lead candidate” is defined as a candidate product or technology for which proof-of-concept data have been obtained and “preclinical development” is defined as all activities beyond lead candidate identification (therapeutics or vaccines) or assay/platform/prototype development (diagnostics or vaccine technologies). Examples of supported research areas may include: lead optimization; efficacy testing, safety evaluation; stability testing; manufacturing; adaptation of products or platform technologies to biodefense applications; development of broad spectrum platforms and/or production technologies; optimization of products or technologies; process development; scale-up; production of quantities sufficient for preclinical regulatory requirements; and diagnostic validation. Priority will be given to projects that address the greatest clinical need.

Industrial Participation

All applications submitted to this FOA by academic organizations must demonstrate substantive investment and participation in the project by at least one industry participant. For the purpose of this FOA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies (or non-profit agencies) with demonstrated experience in candidate product development. “Substantive investment" is defined as a commitment of one or more resources including, but not limited to: product development support/guidance, personnel, in kind contributions of materials and/or reagents (i.e. chemical libraries, innovative biotechnology platforms, scale up of Good Manufacturing Process (cGMP) chemical synthesis or production, etc.), provision of animal or other laboratory models for evaluation, subcontracts, data management resources, regulatory support, or alterations/renovations of facilities or provision of equipment to address biohazard concerns.  Support for industrial partner activities may be included in the project budget. The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the project may be affiliated with either an academic organization or industry. Applications submitted by industrial institutions do not require an additional industrial partner.