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An Overview of Mission-related Research Office of Blood Research and Review

An Overview of Mission-related Research Office of Blood Research and Review. C.D. Atreya, Ph.D. Associate Director for Research OBRR, CBER. BPAC, Dec 14-15. Director Jay S. Epstein, M.D. Deputy Director Ginette Michaud, MD Associate Director for Regulatory Affairs Alan Williams, Ph.D.

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An Overview of Mission-related Research Office of Blood Research and Review

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  1. An Overview of Mission-related ResearchOffice of Blood Research and Review C.D. Atreya, Ph.D. Associate Director for Research OBRR, CBER BPAC, Dec 14-15

  2. Director Jay S. Epstein, M.D. Deputy Director Ginette Michaud, MD Associate Director for Regulatory Affairs Alan Williams, Ph.D. Associate Director for Medical Affairs Basil Golding, MD (Acting) Associate Director for Research C.D. Atreya, Ph.D. Associate Director for Policy J. Scharpf, M.P.H. Policy and Publication Staff Division of Emerging & Transfusion Transmitted Diseases Director Hira L. Nakhasi, Ph.D. Deputy Director Paul Mied, Ph.D. Division of Hematology Director Basil Golding, M.D. Deputy Director Mahmood Farshid, Ph.D. Division of Blood Applications Director Richard Davey, M.D. Deputy Director Sheryl A. Kochman, Ph.D. OBRR Structure & Staff

  3. OBRR Responsibilities: Products Regulated • Division of Emerging and Transfusion Transmitted Diseases • Blood donor screening tests for infectious agents • Retroviral diagnostics • Division of Hematology • Plasma-derived products (IGIV, albumin, coagulation products, etc.) • Blood and blood component collection devices • Plasma expanders including hemoglobin-based oxygen carrying solutions • Bacterial detection devices • Division of Blood Applications • Blood and plasma licenses • Blood establishment software • Blood grouping and HLA reagents

  4. The Critical Path Initiative (CPI) was launched in March 2004 The Critical Path Initiative (CPI) is FDA's national strategy for transforming the way FDA-regulated products are developed, evaluated, manufactured, and used. The six priority topics are:  Better Evaluation Tools Streamlining Clinical Trials Harnessing Bioinformatics Moving Manufacturing into the 21st Century Developing Approaches to Address Urgent Public Health Needs Specific At-Risk Populations — Pediatrics

  5. Vision for research in OBRR Supports the “Critical Path” for product development • Focus on scientific questions critical to effective regulation • Concentration in areas where our unique role as regulators is most contributory • Provision of an infrastructure for investigation of product limitations and failures • Facilitation of progress towards the goals and promise of 21st century medicine (e.g. genomic and proteomic based medicine; applications of nanotechnology)

  6. OBRR Managed Research • Identify scientific needs • Evaluate • Available expertise and resources • Feasibility of success • Public health significance of the expected outcomes OBRR has identified six high priority research areas

  7. Managed Research: Priorities • Novel methods of pathogen reduction and inactivation in blood and blood products • Multiplex platforms and high-sensitivity methods for pathogen detection including genetic variant EIDs and BT agents • Development of infectious agent panels for assay standardization, and standards and reagents for product lot release testing • Development and evaluation of proteomics and genomics based biomarkers for efficacy, quality, toxicity and consistency of blood components, blood derived products, and their analogues • Development of predictive models for preclinical evaluation of blood components, blood derivatives and their analogues and to study pathogenesis of blood borne EID agents • Development of methods to evaluate efficacy of immune globulins of pandemic and BT importance

  8. Managed Research: Overview Programs: • 26 Investigator (PI) initiated programs located in 7 laboratories (3 labs in DETTD -12 PIs; 4 labs in DH -14 PIs) in 3 bldgs (29, 29A &29B) • Subject expertise include microbiology (Viruses including retroviruses, parasites, bacteria and prions), cell biology, toxicology, immunology, biochemistry, physiology and hematology Budget process: • Individual programs in each Division are evaluated annually for public health impact, mission relevance, feasibility and productivity • Based on a formula developed by the DDs in consultation with the ADR, each program receives a score that translates in to operating budget for the program • Once this process is approved by the OD, funds will be distributed to each PI

  9. Concluding Remarks • Research is integral to the mission of OBRR and CBER • OBRR research facilitates product development and is aligned with FDA’s model of “Critical Path” Research

  10. Thank you!

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