NCATS Update

1. NCATS Update Mary Purucker, MD, PhD NCATS CC-CHOC Coordinator CC-CHOC Quarterly Webinar 30July 2012

2. New CTSA FOA • RFA-TR-006 for Institutional Clinical and Translational Science Awards (CTSA) released July 6, 2012, http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-12-006.html • Technical Assistance Webinar held July 23, 2012 • Slides & recording will be posted on NCATS website • Key CTSA FOA submission dates: • Letter of Intent Due: December 10, 2012 • Application Due: January 8, 2013 • NIH Peer Review: February/March 2013 • NCATS Advisory Council Review: May 2013 • Earliest Award Start: July 1, 2013 • Sendinquiries to CTSAFOAQuestions@mail.nih.gov. 2

3. Salient Features: New CTSA FOA • Compared to Prior CTSA Funding Announcements: • New application required for all—no Type 2s/renewals • Emphasizes a limited number of cores with focus on strength of CTSA • New budget formula: 3% of total NIH funding for each institutional partner • Three major sections that align with the key CTSA components: • Leadership Section: Integrated Home Leadership & Governance • Resources and Services: To support the full range of translational research • Research Education, Training, and Career Development • Explicit support for child health-focused clinical and translational research: Leadership and Resources and Services sections • CC-CHOC is expected to continue as a leadership committee • Future support for Consortium activities is anticipated 3

4. Therapeutic Repurposing Program (Pilot) PAR-12-203 Pre-application for the NIH-Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules (X02) http://grants.nih.gov/grants/guide/pa-files/PAR-12-203.html Released June 12, 2012 NCATS Contacts: Christine Colvis, PhD, ccolvis@mail.nih.gov Heng Xiu, MD, PhD (FAQs) xiuhe@mail.nih.gov Therapeutics.Discovery@nih.gov mailbox 4

5. Therapeutic Repurposing Program(2) • Pilot: $20 M in FY2013 (Cooperative Agreement) • Phase I: Pre-application (X02) • Based on limited information about the compounds, applicants must propose new therapeutic uses • Explore specific hypotheses to relate one of the compounds to a specific disease • Letter of Intent due July 14 • Applications due August 14 • Phase II: Application (UH2/UH3) by invitation 5

6. 58 Pharmaceutical Compounds • Companies: AstraZeneca, Eli Lilly, Pfizer, Abbott, BMS, Glaxo, Johnson & Johnson, Sanofi, Janssen • Compounds have already undergone extensive testing including animal tox and early phase human trials; most were shelved because of lack of efficacy • Nominal Indications: Arthritis-9, Pain-9, COPD-7, T2DM-6, Asthma-Schizophrenia-Depression-Malignancy 5 each, Anxiety 4, Allergic Rhinitis 3, Alzheimer-GERD 2 each • http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/directory.html 6

7. Examples from Table

8. Other NCATS Announcements • University of Miami received a Clinical and Translational Science Award (CTSA) http://www.ncats.nih.gov/research/cts/ctsa/about/institutions/2012.html • Tissue Chip for Drug Screening program announced 17 awards http://www.ncats.nih.gov/research/reengineering/tissue-chip/tissue-chip.html Other NCATS Funding Opportunities • NIH Support for Conferences and Scientific Meetings (Parent R13/U13)• PA-12-212 • Opportunity to Submit Proposals for the Therapeutics for Rare and Neglected Diseases (TRND) Program• NOT-TR-12-007 • Still no news on permanent director for NCATS or CTSA program 8