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Review of OBRR’s Research Program: Introductory Comments

Karen Midthun, M.D. Deputy Director Center for Biologics Evaluation and Research BPAC Subcommittee Meeting July 22, 2005. Review of OBRR’s Research Program: Introductory Comments. CBER’s Vision: Innovative Technology Advancing Public Health.

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Review of OBRR’s Research Program: Introductory Comments

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  1. Karen Midthun, M.D. Deputy Director Center for Biologics Evaluation and Research BPAC Subcommittee Meeting July 22, 2005 Review of OBRR’s Research Program: Introductory Comments

  2. CBER’s Vision: 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

  3. Organization

  4. Products Regulated by CBER • Blood, blood components and derivatives • Vaccines (preventive and therapeutic) • Allergenics • Cell and Gene Therapies • Tissues • Xenotransplantation • Related Devices (including certain IVDs)

  5. Critical Path Research Initiative • Identify and focus on regulatory and scientific opportunities to improve product development and availability • Opportunity to promote and preserve a science-based CBER and FDA • Seeking input to identify opportunities, collaborators, and priorities • October 2004 workshop • Site visits with advisory committees

  6. Unique Role of FDA in Critical Path • FDA scientists are involved in review during product development and see the successes, failures, and missed opportunities • FDA guidance documents are science-based and foster innovation and improve chances of success • Scientific expertise in certain areas is critical to making informed decisions about the safety and effectiveness of products and whether clinical studies of investigational products are safe to proceed

  7. Goal of OBRR Research Program Review • Subcommittee of BPAC • Assess strengths, weaknesses, opportunities, and needs of the OBRR research program • Make recommendations that further dynamic and responsive research programs intended to facilitate development of safe and effective biological products

  8. Objectives of OBRR Research Program Review • Increase visibility and transparency of how research program is integrated into regulatory process • Identify contributions of OBRR research to product development and availability • Determine opportunities for research expansion, redirection, new collaboration • Identify needs and strategies for future biologics research • Recommendations for attracting qualified science and medical experts to OBRR

  9. CBER: Innovative Technology Advancing Public Health • CBER has responsibility for some of the most important medical products: blood, vaccines, and tissues • CBER has a critical role in facilitating development of innovative medical products that contribute to individual health, public health & counterterrorism • Expertise, partnership, and wise use of resources are essential • We welcome and appreciate your input!

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