Session 6 part 3


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Session 6 part 3

  1. 1. Examples of NINDS Funding OpportunityAnnouncements Proof Lead Pre-clinical Phase I Target ID Assay Screening Hit to Lead of Optimization Safety Trials Concept Exploratory Translational Grants (R21) Cooperative Program Tool Compound (U01, U54, U44) Discovery (R01) Tool Compound Optimization (R01) David Jett Rebecca Farkas Tom MillerContacts:
  2. 2. Molecular Libraries HTS ServicesScreening 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! Assay Screening Hit to Lead
  3. 3. Bridging Interventional DevelopmentGaps (BrIDGs)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 Pre-clinical Safety
  4. 4. Blueprint Neurotherapeutics Network• Goal: phase I clinical success Principal investigator Lead• Any nervous system indication Industry consultants Development NIH staff• “Virtual pharma” structure Team Bioactivity/ Phase I Medicinal PK/Tox GMP/ Efficacy Trials Chemistry Formulation Studies U01s NIH Contracts• Free access to drug development services + funding for biology• For novices and experts seeking additional capacity• PI retains control of IP Lead Pre-clinical Phase I Optimization Safety Trials
  5. 5. Blueprint Neurotherapeutics Network Current Projects 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
  6. 6. Blueprint Neurotherapeutics Network Entry Criteria Disease biology • Novel target for the disease Deadline: • Strong biological validation June 2012 • Feasible path to the clinic Assays • Robust in vitro assay for optimization • Strong confirmatory assays Compounds Jill Heemskerk • Amenable to chemistry • IP free of obvious roadblocks Rebecca Farkas
  7. 7. ? Contact Program StaffProvide 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? Rebecca Farkas