7
Examples of NINDS Funding Opportunity Announcements Cooperative Program (U01, U54, U44) Exploratory Translational Grants (R21) Tool Compound Discovery (R01) Tool Compound Optimization (R01) Phase I Trials Target ID Assay Screening Hit to Lead Proof of Concept Pre-clinical Safety Lead Optimization Tom Miller [email protected] Rebecca Farkas [email protected] ov Contacts: David Jett [email protected]. gov

Session 6 part 3

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Page 1: Session 6 part 3

Examples of NINDS Funding Opportunity Announcements

Cooperative Program(U01, U54, U44)

Exploratory Translational Grants (R21)

Tool Compound Discovery (R01)

Tool CompoundOptimization (R01)

Phase I Trials

Target ID Assay Screening Hit to LeadProof

ofConcept

Pre-clinical

SafetyLead

Optimization

Tom [email protected]

Rebecca [email protected]

Contacts: David [email protected]

Page 2: Session 6 part 3

Molecular Libraries HTS Services

Screening centers offer: Technical assistance in adapting assays for HTS

Technical assistance for developing screening plan

Library screening with your assay

Med chem optimization of your probe

… AT NO COST TO YOU!

http://mli.nih.gov/mli/

Assay Screening Hit to Lead

Page 3: Session 6 part 3

Provides FREE ACCESS to contract services for:

● Production/bulk supply

● GMP manufacturing

● Formulation

● Pharmacokinetic testing

● Animal toxicology

● Manufacture of clinical trial supplies

● Product development planning and advice in IND preparation

http://nctt.nih.gov/bridgs

Bridging Interventional Development Gaps (BrIDGs)

Pre-clinical Safety

Page 4: Session 6 part 3

Blueprint Neurotherapeutics Network

• Goal: phase I clinical success

• Any nervous system indication

• “Virtual pharma” structure

• Free access to drug development services + funding for biology

• For novices and experts seeking additional capacity

• PI retains control of IP

Lead Development Team

MedicinalChemistry

PK/ToxPhase ITrials

Bioactivity/EfficacyStudies

Principal investigator Industry consultants

NIH staff

GMP/Formulation

NIH ContractsU01s

Blueprint NeuRx

Phase I Trials

Pre-clinical

SafetyLead

Optimization

Page 5: Session 6 part 3

Current Projects

Blueprint NeuRxBlueprint Neurotherapeutics Network

Principal Investigator Institution Disorder

John Bixby University of Miami Optic Neuropathy

Raymond J. Dingledine Emory University Stroke

Marcie A. Glicksman Brigham and Women’s Hospital ALS

Michael Lark Trevena, Inc. Depression

Konstantin Petrukhin Columbia University Macular Degeneration

Edwin W. Rubel University of Washington Hearing Loss

Steven Lee Wagner UC San Diego Alzheimer’s

Page 6: Session 6 part 3

Disease biology• Novel target for the disease• Strong biological validation• Feasible path to the clinic

Assays• Robust in vitro assay for optimization• Strong confirmatory assays

Compounds• Amenable to chemistry• IP free of obvious roadblocks

Deadline:June 2012

Entry Criteria

Blueprint NeuRxBlueprint Neurotherapeutics Network

Jill [email protected] [email protected]

vhttp://neuroscienceblueprint.nih.gov/bpdrugs/

Page 7: Session 6 part 3

Contact Program Staff

Rebecca [email protected]

?Provide the following info to help NIH staff help you:

• Where does your project fall within the discovery/development pipeline?

• What is the disease indication?

• What kind of therapeutic are you developing (drug, biologic, device, etc.)?

• Would you prefer to do the work yourself or utilize NIH research services?