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NIH - Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules

NIH - Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules. October 24 , 2012 Christine Colvis, Ph.D. NCATS. NCATS Mission.

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NIH - Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules

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  1. NIH - Industry Pilot Program:Discovering New Therapeutic Uses for Existing Molecules October 24, 2012 Christine Colvis, Ph.D. NCATS

  2. NCATS Mission Catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

  3. The decision to focus the NCATS mission on the actual science of the translational process will distinguish it from other current public or private enterprises and make it abundantly clear that NIH is not attempting to become a drug development company. -- Francis Collins July 6, 2011 Science Translational Medicine

  4. NCATS: Therapeutics Discovery Pilot Goal: To identify new therapeutic uses of proprietary compounds and biologics across a broad range of human diseases in areas of medical need. The pilot initiative will: • Match candidate Agents from 8 pharmaceutical partners with innovative ideas for new indications from the biomedical research community. • NIH provides: template Collaborative Research Agreements (CRAs) and Confidential Disclosure Agreements (CDAs), FOAs, review, funding, and oversight • Pharmaceutical partners provide: compounds, biologics, in kind support, and pertinent data • Academic researchers provide: deep understanding of disease biology, new concepts to test, and access to appropriate patient populations

  5. NCATS: Therapeutics Discovery Pilot NIH Patients Grant MOU Researcher Industry Partner CRA

  6. NCATS: Therapeutics Discovery Pilot 58 Agents made available for this pilot program by 8 pharmaceutical company partners* • Abbott • AstraZeneca • Bristol-Myers Squibb Company • Eli Lilly and Company • GlaxoSmithKline • Janssen Pharmaceutical Research and Development, LLC • Pfizer • Sanofi *listed alphabetically

  7. TIMING Notice of Intent & Request for Information issued; Template CRAs & CDAs Developed First MOUs executed May 3, 2012 Additional companies join; FOAs issued; Info on Agents provided June 12, 2012 TA Webinar June 25 August 14, 2012 X02 applications submitted 1st contact: applicant & company Late September Top tier applicants identified CDA and CRA executed; additional info on compounds provided; full application submitted December 17, 2012 UH2/UH3 and UH3 apps submitted March 2013 Full applications reviewed Finalize milestones July 2013 Awards are made 2 – 3 years Projects conducted/managed

  8. Sample from the Table of Compounds and Biologics http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/directory.html

  9. Sample from the Table of Compounds and Biologics http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/directory.html

  10. The Table of Compounds and Biologics

  11. The Table of Compounds and Biologics

  12. Impact of Crowdsourcing # of Applications Individual compounds

  13. Impact of Crowdsourcing Arthritis Cancer Kidney failure Alzheimer’s PTSD Pain Not actual indications

  14. Top tier applications identified First contact between applicant and Pharma partner Late September Top tier applicants identified CDA and CRA signed, detailed info on compounds provided, Full application submitted

  15. UH3 vs UH2/UH3 Application • Investigator will decide whether to submit a UH3 or UH2/UH3 application based on the existing data on the Agent as it relates to the proposed new therapeutic use. • UH3 supports implementation of proof of concept Phase IIa trials (no feasibility studies needed). • UH2/UH3 supports a two-stage approach, including feasibility studies (pre-clinical and/or Phase Ib trials) prior to a proof of concept Phase IIatrial.

  16. TDP Team NCATS Gavin Wilkom Heng Xie NCATS Holly Atherton Sheryl Brining Bonnie Dunn Bobbi Gardner Irene Grissom Emily Krebbs Terry Lamotte Susan Lowenthal Vicki Maurer Cindy McConnell Amy McGuire Lili Portilla Stephen Seidel Geoff Spencer Jane Steinberg Meryl Sufian Mohan Viswanathan Dawn Walker NIH OD John Burklow David Cabrera Sarah Carr Stephanie Devaney Ann Hammersla Renate Myles Mark Rohrbaugh Pat White Other ICs Jane Acri (NIDA) Linda Brady (NIMH) Marina Broitman (NIMH) Mark Egli (NIAAA) Joanne Fertig (NIAAA) Stephanie Fertig (NINDS) Crina Frincu (NINDS) Mike Kurilla (NIAID) Carson Loomis (NHGRI) Ron Margolis (NIDDK) Barbara Mroczkowski (NCI) Larry Refolo (NIA) Phil Skolnick (NIDA) John Thomas (NHLBI) NIH OGC Barbara McGarey Benjamin Butler Dale Berkley Gina Shin

  17. Thank you ccolvis@mail.nih.gov

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