OFFICE OF VACCINES RESEARCH AND REVIEW Center for Biologics Evaluation and Research Michael J. Brennan, Ph.D. Associate Director for Research OVRR Site.

Slides:

Advertisements

Similar presentations

CDCs 21 Goals. CDC Strategic Imperatives 1. Health impact focus: Align CDCs people, strategies, goals, investments & performance to maximize our impact.

Advertisements

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDAs website for reference purposes only. It.

Center for Biologics Evaluation and Research

Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products Carolyn.

Felicia Barnett Ronald B. Landy USEPA Office of Research and Development Office of Science Policy Regional Science Program.

Laboratory of Immunobiochemistry Site Visit

The Division of Monoclonal Antibodies Kathleen A. Clouse, Ph.D., Director CTGTAC - July 26, 2007.

Christa-Marie Singleton, MD, MPH Associate Director for Science

Overview Division of Viral Products Office of Vaccines Research and Review Laboratory of Methods Development Site Visit January 9, 2003.

Office of Biotechnology Products

The Agricultural Research Service Steven R. Shafer Deputy Administrator Natural Resources and Sustainable Agricultural Systems.

Overview of the Division of Viral Products

Overview of the Division of Viral Products VRBPAC Presentation of the Site Visit Report for the Laboratories of Retrovirus Research, Immunoregulation,

Introduction to Regulation

An Overview of Mission-related Research Office of Blood Research and Review C.D. Atreya, Ph.D. Associate Director for Research OBRR, CBER BPAC, Dec

CBER Regulatory Laboratory Planning & Preparedness for SARS-related Biologics Products Kathryn M. Carbone MD Associate Director for Research, Acting, Center.

Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products Carolyn.

Center for Biologics Evaluation and Research FDA Overview Site Visit Carolyn A. Wilson, Ph.D. Associate Director for Research.

Health Departments and Healthcare-Associated Infection Prevention Research: A New Land of Opportunity? Matthew Wise, MPH, PhD Epidemiologist, Office of.

Building Public Health / Clinical Health Information Exchanges: The Minnesota Experience Marty LaVenture, MPH, PhD Director, Center for Health Informatics.

Center for Biologics Evaluation and Research, FDA Site Visit Introduction Michael J. Brennan, Ph.D. for Kathryn M. Carbone, M.D. Associate Director for.

The NIH Roadmap for Medical Research

Critical Path Opportunities for Biologics Products Jesse L. Goodman, M.D. M.P.H. Director Kathryn M. Carbone, M.D. Associate Director for Research Center.

Colorado Springs Utilities Environmental Services Functional Assessment Presentation for the American Public Power Association’s 2001 Engineering & Operations.

Future Directions for the Public Health Division Future Directions for the Public Health Division Presentation to the Annual General Meeting Association.

NCI Review of the Clinical Trials Process 6 th Annual National Forum on Biomedical Imaging in Oncology James H. Doroshow M.D. April 7, 2005 Bethesda, Maryland.

Overview of ARS National Programs Steven Kappes Deputy Administrator Animal Production & Protection National Program Staff Agricultural Research Service.

Center for Biologics Evaluation and Research Carolyn A. Wilson, Ph.D. Associate Director for Research Applying Regulatory Science to Advance Development.

1 Disaster Behavioral Health Advisory Committee DBHAC Began is 2006 as Terrorisms and Disaster Behavioral Health Advisory Committee (TADBHAC) Revitalized.

Local Public Health System Assessment using the NPHPSP Local Instrument Essential Service 4 Mobilize Community Partnerships to Identify and Solve Health.

Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products Carolyn.

Research Peer-Review at CDER Past and Present Jerry M. Collins, Ph.D. Director, Laboratory of Clinical Pharmacology, OTR Acting Director, Division of Applied.

Public Health Issues Associated with Biological and Chemical Terrorism Scott Lillibridge, MD Director Bioterrorism Preparedness and Response Activity National.

Center for Biologics Evaluation and Research Carolyn A. Wilson, Ph.D. Associate Director for Research Applying Regulatory Science to Advance Development.

1 Overview of the Division of Viral Products February 28, 2014 VRBPAC Discussion of the August 28, 2013 Site Visit for the Laboratory of Respiratory Viral.

Peter B. Bloland, DVM, MPVM Director Division of Public Health Systems and Workforce Development Global Health Leadership Forum November 10, 2011 National.

Review of Site Visit Report Laboratory of Molecular Virology DETTD/OBRR/CBER March 18, 2005 Hira L. Nakhasi, Ph.D. Director, DETTD.

Office of Research and Development National Exposure Research Laboratory, Atmospheric Modeling and Analysis Division S.T. Rao Director, NERL/AMAD U.S.

Biologics and Genetic Therapies Directorate Health Products and Food Branch HEALTH CANADA Helping Canadians maintain and improve their health. Agnes Klein.

National Vaccine Advisory Committee Report from the Chair Gus Birkhead, MD, MPH NVAC Chair February 3, 2010.

Center for Biologics Evaluation and Research, FDA Kathryn M. Carbone, M.D. Associate Director for Research.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

FDA’s Critical Path Research Initiative & Intro to the CBER Research Program Kathryn M. Carbone, M.D. Associate Director for Research CBER/FDA.

The Importance of a Strategic Plan to Eliminate Health Disparities 2008 eHealth Conference June 9, 2008 Yvonne T. Maddox, PhD Deputy Director Eunice Kennedy.

DESIGNING A PROGRAM FOR REVIEW OF CDER LABORATORY RESEARCHERS Keith Webber, Ph.D. Acting Deputy Director OPS/CDER/FDA.

Assessing Hospital and Health System Preparedness and Response Paul Halverson, Dr.P.H. Director Division of Public Health Systems Development and Research.

FDA’s Role in Facilitating the Availability of Influenza Vaccine Norman W. Baylor, Ph.D. Director, Office of Vaccines Research and Review CBER/FDA.

Laboratory of Immunobiochemistry Ronald L. Rabin, MD Allergenic Products Advisory Committee 18 March 2009.

OBRR Response to BPAC Recommendations on the Office Research Program Office Site Visit: July 22, 2005 BPAC Recommendations: February 10, 2006 C.D. Atreya,

SACS/CASI District Accreditation  January 2007  April 2007  May 2007  January – April 2008  Board Approval for Pursuit of District Accreditation.

OFFICE OF VACCINES RESEARCH AND REVIEW Center for Biologics Evaluation and Research Michael J. Brennan, Ph.D. Associate Director for Research OVRR Site.

Office of Vaccines Research and Review

Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.

Site Visit Report Review of Intramural Research Office of Blood Research and Review CBER, FDA Date of Site Visit: July 22, 2005 Date of Report: February.

Introduction to FDA’s Office of Vaccines Research and Review Norman W. Baylor, Ph.D. Director, Office of Vaccines Research and Review.

OSH research for safe new technologies Gérard Lasfargues Deputy Director General, Anses 1.

CBER Research: OBRR Office Site Visit Kathryn M. Carbone, MD Associate Director of Research CBER/FDA.

Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.

Center for Biologics Evaluation and Research, FDA Site Visit Introduction Kathryn M. Carbone, M.D. Associate Director for Research.

Peer Review of OBP Research Division of Monoclonal Antibodies

FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of.

CBER Research: OCTGT Office Site Visit Carolyn A. Wilson, Ph.D. Associate Director of Research (Acting) CBER/FDA.

AcademyHealth Research Meeting Barbara Greenberg, Ph.D. Office of Science and Data Policy Research ASPE, HHS June 8, 2004.

David M. Murray, Ph.D. Associate Director for Prevention Director, Office of Disease Prevention Multilevel Intervention Research Methodology September.

Randall (Randy) Snyder, PT, MBA Division Director January 27, 2016

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

CDRH 2010 Strategic Priorities

Introduction of New Technology: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Innovation: A Priority for FDA

Center for Veterinary Medicine Strategic Planning, 2002

Presentation transcript:

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

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

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

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

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

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