Biographies Speakers

Deputy Director – Integrated Delivery and Lead for Global Regulatory Systems Initiatives at the Bill and Melinda Gates Foundation from January 2014 to present. These initiatives are focused on working with partners such as WHO, PAHO, regulatory regionalization initiatives, and NRAs to make more efficient and effective (without sacrificing product safety, efficacy, or quality) the regulatory processes through which products must pass in order to be developed, legally marketed, and overseen appropriately after marketing authorization in low- and middle-income countries. 24-year career U.S. FDA official
2011-2014 - Commissioner’s Senior Advisor & Representative for Global Issues
2001-2011 – Associate, then Deputy Commissioner for International and Special Programs (2005-2011)
1993-2000: Deputy Center Director for Review Management at U.S. FDA’s Center for Drug Evaluation and Research (CDER)
1989-1993: Director - Division of CDER’s Anti-infective Drug Products.
Academic training / Post-graduate studies
Post-graduate fellowship in pediatrics and pediatric infectious diseases at the Mayo Clinic
Fulbright Scholar to the United Kingdom - M.Sc. in medical parasitology and Diploma in Tropical Medicine and Hygiene at the London School of Hygiene and Tropical Medicine (University of London)