U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke American Society for Experimental Therapeutics Annual Meeting March 04-06, 2010 Therapeutic Development Resources at NINDS Bill Matthew Director, Office of Translational Research; NINDS [email protected]1 -Matthew
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Bill Matthew Director, Office of Translational Research; NINDS bill.matthew@nih
American Society for Experimental Therapeutics Annual Meeting March 04-06, 2010 Therapeutic Development Resources at NINDS. Bill Matthew Director, Office of Translational Research; NINDS [email protected]. 1 -Matthew. Pipeline Principles: 101. Raw Material & Pump. Block Valve - PowerPoint PPT Presentation
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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
American Society for Experimental Therapeutics
Annual MeetingMarch 04-06, 2010
Therapeutic Development
Resources at NINDS
Bill MatthewDirector, Office of Translational Research; NINDS [email protected]
1 -Matthew
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
Pipeline Principles: 101
Basic Research
Therapeutics
Raw Material & Pump
Block ValveStation Final Delivery
2 -Matthew
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
Translational Research: The process of using novel, basic research discoveries to develop clinical applications.
T1
T2
T1
bench
bedside
community3 -Matthew
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
Office of Clinical Research
Office of Translational Research
NINDS Extramural Research
4 -Matthew
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
Basic Research -Target ID
Assay Hit to LeadScreen for Hit
Proof of Principle
Lead Optimization
PreClincal Candidate – Safety/Tox
First in Human
Anti-Convulsant Screening Program
Exploratory/Developmental Projects in Translational ResearchCooperative Program in Translational Research
Translational SBIR
Blueprint Neurotherapeutics Grand Challenge
CounterACT
RAID: Rapid Access to
Interventional Development
Small Molecule
Optimization
Small Business Program: SBIR & STTR
Spinal Muscular Atrophy Project
Molecular Libraries
(Roadmap)
Assay Development (Roadmap)
Drug Discovery for
Nervous System
Disorders
NINDS/OTR Activities in Therapeutic Development: NINDS Multiple ICs
5 -Matthew
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
Anticonvulsant Screening Program (ASP)
Goal: To facilitate the development of drugs for patients with epilepsy, resistant epilepsy and related CNS conditions
• Screening performed via a contract mechanism using a battery of seizure models• Compounds are submitted by a broad base of Investigators: > 500 total
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
Goal: To develop safe and effective therapies and diagnostic technologies for victims of emergency incidents involving exposure to highly toxic chemicals
CounterACT Countermeasures Against Chemical Threats
Assay Development: Molecular Libraries and Imaging Roadmap Program
Goal: Develop assays to identify small molecule interactions via high-throughput screening of compound libraries, and to chemically optimize active compounds as molecular probes
13 -Matthew
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health
National Institute of Neurological Disorders and
Stroke
NIH-RAIDNIH Rapid Access to Interventional Development
• Pre-IND studies
• All diseases
• Access to government expertise and contract resources – Production, bulk supply, GMP manufacturing– Pharmacokinetic/ADME studies– IND-directed toxicology, and more
• 6 successful IND submissions and 4 clinical trials to date