1. 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

2. Updates Thanks to “retiring” members and Chair! NIH/FDA Leadership Council Activities –September 28, 2010 - NIH/FDA Joint Regulatory Science Awards –Leadership Council Update Critical Path Grant Awards on TB – Sept. 30 FDA Clinical Investigator Course – Nov. 8-10 Chemical and Environmental Science Council New FDA wide Scientific Professional Development Calendar with online links and including relevant NIH events

3. 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; Gerald.feldman@fda.hhs.gov Gerald.feldman@fda.hhs.gov 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, Joyce.Whang@fda.hhs.govJoyce.Whang@fda.hhs.gov 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

4. 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, 2010 - 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

5. 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

6. 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

7. 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!