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Office of Blood Research and Review: An Overview

Office of Blood Research and Review: An Overview. Presented to Blood Products Advisory Committee May 2, 2008. C.D. Atreya, Ph.D. Associate Director for Research OBRR, CBER, FDA. Office of Blood Research and Review (OBRR). Organizational Structure Regulatory Responsibilities

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Office of Blood Research and Review: An Overview

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  1. Office of Blood Research and Review:An Overview Presented to Blood Products Advisory Committee May 2, 2008 C.D. Atreya, Ph.D. Associate Director for Research OBRR, CBER, FDA

  2. Office of Blood Research and Review (OBRR) • Organizational Structure • Regulatory Responsibilities • Managed Research Initiative • Current Research Priorities

  3. Director Jay S. Epstein, M.D. Deputy Director Jonathan Goldsmith, M.D. Associate Director for Research C.D. Atreya, Ph.D. Associate Director for Regulatory Affairs Alan Williams, Ph.D. Associate Director for Policy J. Scharpf, M.P.H. Policy and Publications 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 Susan Abbondanzo, M.D. Division of Blood Applications Director (Acting) Elizabeth Callaghan, M.S. OBRR Structure & Staff

  4. Vision for CBER INNOVATIVE TECHNOLOGY ADVANCING PUBLIC HEALTH • Protect and improve public and individual health in the US and, where feasible, globally • Facilitate development, approval and access to safe and effective products and promising new technologies • Strengthen CBER as a preeminent regulatory organization for biologics

  5. OBRR Responsibilities I OBRR is the primary FDA component that: • Facilitates the development, approval, and access to safe and effective blood products • Product application review, standards development, policy setting, assessment of adverse event reports, pre-license inspections, lot release, investigation of product failures and toxicities • Evaluates promising new technologies related to blood safety and retroviral testing OBRR is charged to regulate • Blood and blood derived products • Medical devices used to collect, test, process or store donated blood • Retroviral diagnostic tests

  6. OBRR Responsibilities IIProducts 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 computer software • Blood grouping and HLA reagents

  7. The Critical Path for Medical Product Development

  8. OBRR Managed Research Initiative IIdentifying Key Scientific Needs • Anticipated regulatory science needs are identified by analyzing the recent (1–2 year) product application submissions, public health needs and policy portfolio: • Regulatory review workload by product class • Guidance documents • Analysis of product failures and safety reports • Observations at inspections • Input from scientific workshops • Interactions with regulated industry, other HHS agencies and international partners (e.g. WHO) • Research is targeted to identified scientific needs where the output could lower regulatory barriers to product development, or improve product safety, efficacy, consistency and availability

  9. OBRR Managed Research Initiative IIDeveloping the Research Portfolio Based on • Identified scientific needs • Available resources and expertise • Feasibility of success and public health significance of the expected outcomes OBRR has identified six high priority areas for the current research program

  10. Current Research priority Areas I • 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, including “blood substitutes”

  11. Current Research priority Areas II • Development of predictive models for preclinical evaluation of blood components, blood derivatives and their analogues including blood substitutes, and to study pathogenesis of blood borne EID agents • Development of methods to evaluateefficacy of immune globulins of pandemic and BT importance

  12. Vision for research in OBRR Supports the “Critical Path” for product development through: • 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)

  13. 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

  14. Thank you!!

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