Lorenzo Refolo & M-D Kerns National Institute on Aging Small Business Awards to Advance Research on Alzheimer’s Disease and Alzheimer’s –Related Dementias Lorenzo Refolo & M-D Kerns National Institute on Aging

The NIA SBA Program aims to support the discovery, development and commercialization of new therapies, novel devices, analytical tools, health care programs and practices that will improve prevention and treatment, as well as caregiving for patients with AD/ADRD.

Broadly speaking the NIA SBA Program will support research that address the following topics: Prevention Diagnosis Treatment Care Analytical Tools  

Application Types Phase I- feasibility and proof-of-concept Phase II-continue R&D initiated in Phase I - funding is based on results achieved in Phase I + scientific and technical merit and commercial potential of the project proposed in Phase II Fast Track- 1 application for Phase I and Phase II that is submitted and reviewed together Phase IIB Competing Renewal- for projects that require additional funding beyond the original Phase II award. These applications require competitive peer review. Direct to Phase II- for Phase II R&D for projects that have demonstrated the scientific and technical merit, feasibility and proof of concept

Currently Active SBIR & STTR Funding Opportunities PA-16-032/Parent SBIR [R43/R44] Application Types Allowed -new Phase I, new Fast Track, Phase II renewal, Phase IIB-competing renewal Application Due Dates -Sept 5, Jan 5, April 5 3. Expiration Date -April 6, 2017 4. Award Budget -statutory guidelines -$150K (Phase 1), $1.0M (Phase II) -for specific topics and with appropriate justification ->$225K (Phase I) , >$1.5M (Phase II) ***Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines

PAR-14-088 Direct Phase II SBIR [R44] Application Types Allowed - new Direct Phase II 2. Application Due Dates - Sept 5, Jan 5, April 5 3. Expiration Date - January 8, 2017 4. Award Budget - statutory guidelines :$1.0M - for specific topics and with appropriate justification $2.0M/ 3yrs

PA-16-303/ Parent STTR[R41/R42] Application Types Allowed - new Phase I, new Fast Track, Phase II renewal, Phase IIB-competing renewal Application Due Dates - Sept 5, Jan 5, April 5 3. Expiration Date - April 6, 2017 4. Award Budget - statutory guidelines -$150K (Phase 1), $1.0M (Phase II) - for specific topics and with appropriate justification ->$225K (Phase I) , >$1.5M (Phase II) ***Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines

Coming Soon Advancing Research on Alzheimer's Disease and Alzheimer's-related Dementias (ADRD) (R43/R44) - $15M set aside for 2017 Advancing Research on Alzheimer's Disease and Alzheimer's-related Dementias (ADRD) (R41/R42) - $5M set aside for 2017

NIA SBC Opportunities for AD Translational Research Funding Discovery/Preclinical Development STTR/SBIR Drug Discovery for Nervous System Disorders Alzheimer’s Drug Development Program NIH Target ID Assay Development Screening Hits to Leads Lead Optimization Candidate Selection IND-enabling studies IND Phase I Assay Development and Screening Chemical Probe Development Blueprint Neurotherapeutics Program Clinical Development AD Pilot Ph1/Ph2 AD Ph3 Phase I Phase II Phase III SBIR

Other Funding Opportunities Open to SBCs PAR 14-284: HTS to Discovery Chemical Probes (R01) PAR 14-279: Discovery of in vivo Chemical Probes PAR 14-292: Blueprint Neurotherapeutics Network :Small Molecule Drug Discovery for Disorders of the Nervous System (UH2/UH3) PAR 15-174: Alzheimer’s Drug Development Program (U01) PAR 16-041: Drug Discovery for Nervous System Disorders PAR 16-365: Pilot Clinical Trials for the Spectrum of Alzheimer’s Disease and Age-related Cognitive Decline (R01) PAR-16-364: Phase III Clinical Trials for the Spectrum of Alzheimer’s Disease and Age-related Cognitive Decline (R01)

Program Contacts Dr. Lorenzo Refolo Email: RefoloL@nia.nih.gov Dr. Michael-David A.R.R. Kerns Email: Michael-David.Kerns@nih.gov