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 May 19, 2006

2. CBER OVRR CBER ADR OVRR ADR Division Directors Research Reviewers

4. OVRR Laboratory Mission and Function Ensure the safety and efficacy of vaccines and related biological products for human use –Bacterial vaccines –Viral vaccines –Parasitic vaccines –Allergenic products Facilitate the development, evaluation, licensure and use of new vaccines and related products that positively impact the public health

5. 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

6. I. Address Regulatory Issues for Approved Products VACCINESCIENTIFIC EXPERTISE DBPAP DTAcP Pertussis, Bacterial toxins, serological assays Pneumococcal Polysaccharide conjugation, human Haemophilus serological assays, outer membrane proteins Meningococcal DVP Influenza Flu virology, potency assays Polio, Flu Cell Substrate program- identify adventitious agents, oncogenes, new cell lines Prioritizing Research:

7. II.Anticipate Regulatory Issues for New Products VACCINESCIENTIFIC RESPONSE DVP HIV Discovery of novel HIV peptides for discriminating HIV infection from immunization with new vaccines DBPAP Meningococcal New polysaccharide conjugation technology transferred to Meningococcal Vaccine Initiative TB Post-infection assay to evaluate Safe use of new TB vaccines in Infected individuals. Prioritizing Research:

8. III. Respond to Public Health Emergencies VACCINESCIENTIFIC RESPONSE Counterterrorism Developing Assays and Animal Models to evaluate vaccines for Anthrax, Tularemia, Smallpox, etc Immune assays to measure potency of new CT vaccines Pandemic FluAvian flu libraries, non-egg based technologies, broad coverage vaccines Prioritizing Research:

9. Workshops Co-sponsored by OVRR “Assaying Potency of Novel Vaccines” with DAIDS, DMID, VRC October 2005, Bethesda, MD “The 14th International Pathogenic Neisseria Conference”, September 2004, Milwaukee, WI “NIAID/NIH – CBER/FDA TB Vaccine Regulatory Workshop”, December 2003, Bethesda, MD “Fourth International Conference on Tularemia”, September 2003. Bath, UK Global Activities WHO Collaborating Center – eg. annual Flu strain selection, TB standards WHO/PAHO Expert Advisors BioTechnology Engagement Program [Former Soviet Union collaborations] CBER Global Vaccine Initiative OVRR OUTREACH ACTIVITIES

10. Sources of Funding for OVRR Research National Vaccine Program Office Awards - 6 in FY 05, 4 in FY 06 Biodefense related awards – ORDC, DARPA, DOD - 9 ORDC in FY 06 Intraagency Agreements – NIH, CDC - Cell Substrates IAA w NIAID CRADAs – Universities, Foundations - TB assay, AERAS Foundation

11. Evaluation of OVRR Research Programs Performed on at least an annual basis Process begins in Divisions -Evaluation of PI Res Prog by Lab Chief-Division Director -Evaluates research progress (pubs; presentations; outreach) and Regulatory Workload (INDs, BLAs, Meetings w/ Pharma) Evaluation of Division Research Programs by OVRR to address: - FDA regulatory needs - emerging issues - future issues ( 2 - 5 years ) -recommendations made by external Advisory groups Individual PIs evaluated for promotions by CBER PCE committee

12. Major Challenges to OVRR Management: Expansion / Recruitment Promoting Outstanding Junior Scientists Limited opportunities for outside funding Travel to scientific meetings Communication of research successes [visibility]

13. COMMUNICATION

14. 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