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

RESEARCHERS

• Provide new

therapeutic use ideas

• Access patient

populations

• Conduct

clinical trial

PHARMA

• Create drugs
• Provide agents

AGREEMENTS

COLLABORATION

ALLIANCES FUNDING NIH/NCATS

• Post agent information
• Develop agreement templates
• Crowdsource ideas

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 Krieger/UWash Sanofi Lymphangioleiomyomatosis Baylor AstraZeneca Peripheral Artery Disease U Virginia AstraZeneca Smoking Cessation VCU/Pittsburgh Janssen Schizophrenia (2) Indiana U Lilly Yale Pfizer

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 JW1, Nygaard HB, Heiss JK, Kostylev MA, S

tagi M, Vortmeyer A, Wisniewski T , Gunther EC, S trittmatter S M.

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