Science at the FDA: Update for the Science Board Jesse L. Goodman, MD, MPH Chief Scientist and Deputy Commissioner for Science and Public Health November.

Slides:

Advertisements

Similar presentations

Parallel Session 9 Contemporary Challenges in Statistical Evaluation of Diagnostic Products Chairs:Gene Pennello (CDRH) Lakshmi Vishnuvajjala (CDRH) Stuart.

Advertisements

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

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.

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

Local Education and Training Boards Adam C Wardle Managing Director, Yorkshire and the Humber Local Education and Training Board.

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

CANADA’S ENGAGED UNIVERSITY: STRATEGIC DIRECTIONS FOR YORK UNIVERSITY PATRICK MONAHAN, VICE-PRESIDENT ACADEMIC & PROVOST ACADEMIC PLANNING FORUMS.

FDA and Communication about Regulated Products Nancy M. Ostrove, PhD Senior Advisor for Risk Communication Risk Communication Advisory Committee August.

Institute for Health and Society Institute for Health and Society Improving Health and Advancing Health Equity Through Community and Academic Partnerships.

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.

1 Webinar on: Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity Sponsored by Partnership.

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

“Critical Path” for Food and Nutrition Science Board November 5, 2004 Alan M. Rulis.

Outcomes of Public Health

Dr. Anna Palmisano, Deputy Administrator, Competitive Programs The Cooperative State Research, Education and Extension Service Competitive Programs.

1 Day 2, Track 1, Session 1 INNOVATION WITHOUT BORDERS: INTERNATIONAL NETWORKS TO SOLVE GLOBAL CHALLENGES Vanessa Campo-Ruiz, ESF (Chair) Claire McNulty,

Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA ACPS Subcommittee on Manufacturing Science: Identification and Prioritization.

A. H. Carim, Co-chair, NSET Subcommittee of NSTC1 Activities in the National Nanotechnology Initiative Dr. Altaf H. Carim Co-chair Nanoscale Science, Engineering,

FDA Science Board Drug Safety Initiative April 15, 2005 Rockville, MD RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research.

Indiana Institute For Personalized Medicine David A Flockhart MD, PhD Professor of Medicine, Genetics and Pharmacology Indiana University.

“History is a set of lies agreed upon.” Napoleon Bonaparte.

A Proposal to Develop a Regulatory Science Program under Carleton University’s Regulatory Governance Initiative Presentation to the fourth Special Session.

North Carolina Area Health Education Centers AHEC in 2015… The Road Ahead Warren P. Newton, MD, MPH Vice Dean & Director, NC AHEC September 11, 2015.

AAMC Council of Faculty and Academic Societies (CFAS) Pamela N Peterson, MD MSPH Associate Professor of Medicine Kevin Lillehei, MD Professor and Chair,

Update From FDA: Office of the Commissioner and Center for Drug Evaluation and Research Janet Woodcock, M.D. Acting Deputy Commissioner for Operations.

1 Investing in America’s Future The National Science Foundation Strategic Plan for FY Advisory Committee for Cyberinfrastructure 10/31/06 Craig.

District Improvement Plan August 10, 2015.

Ann Campion Riley University of Missouri

1 SEAB Task Force on EM Technology Development Gerald Boyd Task Force Member September 29, 2015.

National Capital of Healthcare Executives and George Mason University Proudly Present The Patient Protection and Affordability Care Act: Optimizing Opportunities.

Women in Medicine and Science Symposium The Women in Medicine and Science Symposium will highlight the collaborations and achievements of women faculty.

Public Health Data Standards Consortium

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

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

HANC and Community Partners Overview November 20, 2007 Michael Petillo, Project Coordinator.

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

Annual Meeting of the ASADI – Science Academies as Partners for Improving the Impact of Policies in Africa Session V: Partnership Themes for Development.

Current Plan for Critical Path Initiative Janet Woodcock, M.D. Acting Deputy Commissioner For Operations November 5, 2004.

, 2003 Overview of FDA’s Food Security Program Joseph A. Levitt Director, Center for Food Safety and Applied Nutrition November 6, 2003.

1 Investing in America’s Future The National Science Foundation Strategic Plan for FY OPP Advisory Committee 10/26/06.

External Peer Review of the FDA Office of Regulatory Affairs Pesticide Program FDA Science Board Advisory Committee Meeting March 31, 2006.

Wishwa N. Kapoor, MD, MPH, Director Doris M. Rubio, PhD, Co-Director Multidisciplinary Clinical Research Scholars Program.

A NEW REIMBURSEMENT STRUCTURE FOR AMERICA ADVANCED DISEASE CONCEPTS.

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.

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

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.

1 Estimating CDER Resources Devoted to Safety Theresa M. Mullin, Ph.D. Office of Planning, Office of Commissioner April 15, 2005 Presentation to: FDA Science.

Title Page Quality Mo Samimi, Ph.D. CMQ/OE Presented at the ASQ Biomedical Division Northern California Discussion Group. May 2011.

Advisory Forum, July 2005 Outcome of the first retreat of ECDC Management Team (EXC) 4-5 July 2005 Krägga Herrgård Zsuzsanna Jakab Director ECDC.

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

Strategic Plan Development Status Technical Analysis Forum meeting October 11, 2007.

EHealth Initiative Business and Clinical Motivator Work Group January 21, :00 p.m. EDT.

Laurie E. Locascio, Ph.D. Director, MML/NIST NIST/MML: Measurement Assurance for Biological Systems.

Environmental Research Seminar Chicago, IL July 14, 2004 William H. Farland, PhD ORD Acting Deputy Assistant Administrator for Science and Chief Scientist.

OVERVIEW OF THE WORKFORCE DEVELOPMENT DOMAIN TASK FORCE APRIL 16, 2015 Joan D. Nagel, M.D., M.P.H. Program Director, Division of Clinical Innovation National.

Science for Global Health: Fostering International Research Collaboration James Herrington, PhD, MPH Director Division of International Relations Fogarty.

UT Strategic Planning Fall Discussions Groups

Best wishes from B.P.Koirala Institute of Health Sciences Dharan, Nepal Dr. Nilambar Jha, MBBS, MD, Diploma in Health system Management (Israel) Professor.

College Organisation – November 2016

Annual Business Meeting & Class of 2017 Fellows

Public Health England – Our progress under the Sendai Framework

Outline: OCS Overview: Organizational Structure USDA Coordination

Introduction to TransCelerate

Allen Chan U.S. Government Accountability Office October 2, 2018

National Institutes of Health, USA Office of Extramural Research

Trial Funding and Engagement: The NIH Sponsored CTSA Program

Imperial College Business School

Presentation transcript:

Science at the FDA: Update for the Science Board Jesse L. Goodman, MD, MPH Chief Scientist and Deputy Commissioner for Science and Public Health November 15, 2010

Updates Thanks to “retiring” members and Chair! NIH/FDA Leadership Council Activities –September 28, NIH/FDA Joint Regulatory Science Awards –Leadership Council Update Critical Path Grant Awards on TB – Sept. 30 FDA Clinical Investigator Course – Nov Chemical and Environmental Science Council New FDA wide Scientific Professional Development Calendar with online links and including relevant NIH events

Sample: Today’s FDA Scientific Development Calendar Time: 12:00 pm – 1:00 pm Title: Challenges in Developing Process Analytical Technologies for Antibody Quality Attributes Speaker: Erik Read, Ph.D. Sponsored by: CDER, OBP, Division of Monoclonal Antibodies Location: NIH Building 29B, Conference Room C Point of Contact: Dr. Gerald Feldman; Time: 1:00 pm – 2:00 pm Title: Contact Lens Related Eye Infections: How We Got Here, Where We are Going Speaker: Megan Shoff, PhD Sponsored by: Office of Science and Engineering Laboratories, CDRH Location: Building 66, Room G514 Point of Contact: Dr. Joyce Whang, Moving Forward in the Efficient Management and Use of Core Facilities - Day 1 Monday, November 15, 2010, 8:30 AMMoving Forward in the Efficient Management and Use of Core Facilities - Day 1 TRACO: RNAi and Lung Cancer Monday, November 15, 2010, 4:00 PMTRACO: RNAi and Lung Cancer

Updates (cont.) 2008 Fellows graduation and follow-up statistics –Key figure: 38/48 (~80%) retained at FDA Continuing development of major partnerships with academic institutions October 6, Release of FDA White Paper: Advancing Regulatory Science for Public Health and Commissioner’s National Press Club event PACES/CER progress – presentation later Medical Countermeasures progress – presentation later Science and Innovation Senior Advisory Council (SISAC) –Leadership retreat, development of draft strategic priorities

SISAC: Draft Strategic Scientific Priority Areas Transforming development of medical countermeasures against threats to US and global health and security Innovation in product development and evaluation: biomarkers, personalized medicine and effective clinical studies Harnessing diverse data through information sciences to improve health outcomes Modernizing toxicology and risk assessment to better predict safety

Draft Strategic Scientific Priority Areas (cont.) Supporting new approaches to improve product manufacturing and quality Protecting the food supply Ensuring FDA’s readiness to evaluate new and emerging technologies Advancing behavioral science to empower informed decision making and use of products by professionals and consumers

Going forward Not intended to replace Center plans but to provide overarching framework, priorities, ensure coordination and drive agency-wide and collaborative projects and shared resource use Being refined by Senior Science Council and engaging all Centers and major cross-cutting projects and outcomes being defined in each priority area as strategic plan is developed Input sought now and in future Thanks!