office of vaccines research and review center for biologics evaluation and research michael j....
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OFFICE OF VACCINESRESEARCH AND REVIEW
Center for Biologics Evaluationand Research
Michael J. Brennan, Ph.D.Associate Director for Research
OVRR Site Visit May 19, 2006
CBER
OVRR
CBERADR
OVRRADR
DivisionDirectors
Research Reviewers
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
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
I. Address Regulatory Issues for Approved Products
VACCINE SCIENTIFIC EXPERTISE
DBPAPDTAcP Pertussis, Bacterial toxins, serological assays
Pneumococcal Polysaccharide conjugation, humanHaemophilus serological assays, outer membrane proteinsMeningococcal
DVPInfluenza Flu virology, potency assaysPolio, Flu Cell Substrate program- identify adventitious
agents, oncogenes, new cell lines
Prioritizing Research:
II. Anticipate Regulatory Issues for New Products
VACCINE SCIENTIFIC RESPONSE
DVPHIV Discovery of novel HIV peptides for
discriminating HIV infection from immunization with new vaccines
DBPAPMeningococcal 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:
III. Respond to Public Health Emergencies
VACCINE SCIENTIFIC 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 Flu Avian flu libraries, non-egg basedtechnologies, broad coverage
vaccines
Prioritizing Research:
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
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
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
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]
COMMUNICATION
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