1. OFFICE OF VACCINES RESEARCH AND REVIEW Center for Biologics Evaluation and Research Michael J. Brennan, Ph.D. Associate Director for Research OVRR Site Visit Review January 25, 2007

2. I Division of Bacterial, Parasitic and Allergenic Products Director: Richard Walker, Ph.D. Deputy: Milan Blake, Ph.D. II Division of Viral Products Director: Jerry Weir, Ph.D. Deputy: Philip Krause M.D. OVRR Divisions with Research Laboratories

3. Researcher-Reviewer Model provides OVRR with: First hand experience with latest technologies applied to biologics Ability to assess risks of new vaccines and therapies Ability to provide a timely response to new or emergency issues Anticipate future needs Suggest new approaches Develop assays Enhanced ability to interact with Pharma, NGOs, WHO, & HHS agencies Ability to retain staff # based on 1998 Science Board Report for Review of CBER Research

4. Prioritizing Research Efforts within OVRR I. Address Regulatory Issues for Approved Products II. Anticipate Regulatory Issues for New Products III. Respond to Public Health Emergencies IV. Maintain Necessary Scientific Expertise V. Implement Recommendations from External Reviews

5. 1] Develop methods and models to assess and predict vaccine and biologics safety and efficacy 2] Facilitate the development and evaluation of vaccines for high priority viral and bacterial diseases, including emerging diseases and agents of bioterrorism 3] Evaluate novel approaches to improve vaccine quality OVRR/CBER Research Priorities

6. Major Challenges for OVRR Research Program: Expansion of Programs/ Recruitment of Staff Promoting Outstanding Junior Scientists Leveraging opportunities for outside funding Communication of research successes [visibility] Travel to scientific meetings