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