NIAID Resources to Facilitate Medical Countermeasure Development

Transcription

1 NIAID Resources to Facilitate Medical Countermeasure Development Paula Bryant, Ph.D. Senior Scientific Officer Concept Acceleration Program Biodefense, Research Resources, and Translational Research (OBRRTR) Division of Microbiology and Infectious Diseases (DMID) NIAID, NIH, DHHS 8 June 2016

2 NIAID Focus & Capabilities Basic research Discovery & early stage product development Address existing public health threats Slide Source: A. S. Fauci

3 Division of Microbiology & Infectious Diseases (DMID) the Director Clinical Research Coordination International Research in Infectious Diseases Regulatory Affairs Clinical Research Affairs Clinical Research Resources Biodefense, Research Resources, and Translational Research Genomics and Advanced Technologies Scientific Coordination and Program Operations Bacteriology and Mycology Branch Enteric and Hepatic Diseases Branch Sexually Transmitted Infections Branch Respiratory Diseases Branch Parasitology and International Programs Branch Virology Branch

4 NIAID-DMID Strategy Emphasize broad spectrum solutions Emphasize innovative (expression/delivery) platform technologies Concept identification and development (Concept Acceleration Program CAP) Target the full spectrum of development needs Maintain resources for product development Necessary regulatory science (in partnership with FDA)

5 Overlapping Funding Mechanisms Basic Translational Product Development Licensed Products Grants SBIR Partnerships Phase IV NIAID Scientific Activities Contracts Phase II Private Commercial Development Activities

6 DMID Resources & Services Product Development Pathway Basic Research Hypothesis Development and Testing Discovery Preclinical Development IND-Enabling Activities Research Tools and Biological Materials Research Tools and Technologies Clinical Evaluation Trials Diagnostics Vaccines Therapeutics

7 Preclinical Services to Support Product Development Animal Models of Infectious Disease Vaccine Development Services: In vitro & in vivo immunogenicity & efficacy Process dev. & GMP mfg Tox Basic Research Hypothesis Development and Testing Discovery Preclinical Development IDE- and IND- Enabling Activities Research Tools and Biological Materials Clinical Evaluation Trials Diagnostics Vaccines Therapeutics Therapeutic Development Services Med chem & scale-up chem/mfg, formulation, incl. GMP Biopharmaceutical development, incl. GMP ADME & tox, incl. GMP in vitro & in vivo potency & efficacy

8 Clinical Services to Support Product Development Product Development Pathway Basic Research Hypothesis Development and Testing Discovery Preclinical Development IDE- and IND- Enabling Activities Research Tools and Biological Materials Clinical Evaluation Trials Diagnostics Vaccines Therapeutics Phase 1 Clinical Trial Units for Therapeutics Vaccine & Treatment Evaluation Units (Ph I-IV) Clinical sample access, e.g., for diagnostics validation Clinical Research Network Antibacterial Resistance Leadership Group

9 NIAID Funding Opportunities Grants: RFA-AI-16-03: Partnerships for Countermeasures Against Select Pathogens PAR : Rapid Assessment of Zika Virus (ZIKV) Complications RFA-AI : Partnerships for Structure-Based Design of Novel Immunogens for Vaccine Development RFA-AI : Human Tissue Models for Infectious Diseases Contracts: RFP-NIAID-DMID-NIHAI : Pre-Clinical Models of Infectious Diseases BAA-NIAID-NIHAI : Advanced Development of Multivalent Vaccine Candidates for Filovirus and Lassa Fever

10 Thank you!