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NEW THERAPEUTIC USES (NTU) PROGRAM Christine Colvis, Ph.D. June 18, - PowerPoint PPT Presentation

NEW THERAPEUTIC USES (NTU) PROGRAM Christine Colvis, Ph.D. June 18, 2015 Accelerating Therapeutic Development New Therapies for Patients PHARMA RESEARCHERS Create drugs Provide new therapeutic Provide agents AGREEMENTS use


  1. NEW THERAPEUTIC USES (NTU) PROGRAM Christine Colvis, Ph.D. June 18, 2015

  2. Accelerating Therapeutic Development New Therapies for Patients PHARMA RESEARCHERS • Create drugs • Provide new therapeutic • Provide agents AGREEMENTS use ideas • Access patient populations • Conduct COLLABORATION clinical trial FUNDING ALLIANCES NIH/NCATS • Post agent information • Develop agreement templates • Crowdsource ideas

  3. Pilot Program Awards Issued June 2013 Disease Academic Partner Pharma Partner Alzheimer’s Disease Yale AstraZeneca Alcoholism U Rhode Island/NIAAA Pfizer Calcific Aortic Stenosis Mayo Clinic Sanofi Duchenne Muscular Dystrophy Kennedy Sanofi Krieger/UWash Lymphangioleiomyomatosis Baylor AstraZeneca Peripheral Artery Disease U Virginia AstraZeneca Smoking Cessation VCU/Pittsburgh Janssen Schizophrenia (2) Indiana U Lilly Yale Pfizer

  4. Alzheimer’s Disease Project Timeline • 2012  June – NTU FOAs published  July – S t rit t mat t er Nat ure Neuroscience paper on Fyn in AD ePub  August – pre-applicat ion due Alzheimer amyloid- β oligomer bound to postsynaptic prion protein activates Fyn to impair neurons. • Nat Neurosci. 2012 S ep;15(9):1227-35. doi: 10.1038/ nn.3178. Epub 2012 Jul 22 . • Um JW 1 , Nygaard HB, Heiss JK, Kostylev MA, S tagi M, Vortmeyer A, Wisniewski T , Gunther EC, S trittmatter S M.

  5. Alzheimer’s Disease Project Timeline • 2012  June – NTU FOAs published  July – S trittmatter Nature Neuroscience paper on Fyn in AD ePub  August – pre-application due • 2013  June – award made  August – first subj ect dosed for Phase 1b • 2014  Dec/ Jan – Phase 2a begins • 2015  Feb – animal data epub ahead of print  March – S en. Mikulski visits NCATS  April – human phase 1b results published  June – Presentation to council

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