Science at the FDA: Update for the Science Board

Jesse L. Goodman, MD, MPHChief Scientist and Deputy Commissioner for

Science and Public HealthNovember 15, 2010

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

Sample: Today’s FDA Scientific Development Calendar

• Time: 12:00 pm – 1:00 pmTitle: Challenges in Developing Process Analytical Technologies for Antibody Quality AttributesSpeaker: Erik Read, Ph.D.Sponsored by: CDER, OBP, Division of Monoclonal AntibodiesLocation: NIH Building 29B, Conference Room CPoint of Contact: Dr. Gerald Feldman; 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.gov

• Moving Forward in the Efficient Management and Use of Core Facilities - Day 1Monday, November 15, 2010, 8:30 AM

• TRACO: RNAi and Lung CancerMonday, November 15, 2010, 4:00 PM

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

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!