Quality Institute Advisory Group

Leaders in the science of quality and public health guide the Quality Institute’s research agenda.

Advisory Group Members

deb-autor-headshot.jpgDeb Autor
Head of Strategic Global Quality & Regulatory Policy, Mylan
USP Advisory Group

Deb Autor is Head of Strategic Global Quality and Regulatory Policy at Mylan, one of the largest generics and specialty pharmaceutical companies in the world. In this role, Ms. Autor represents Mylan’s diverse and complex operations to government officials globally and advises Mylan’s most senior leaders on how to navigate and influence the regulatory landscape. Previously, as Mylan’s Global Head of Quality, Ms. Autor managed thousands of personnel around the world, driving quality improvements across scores of manufacturing sites.

Prior to joining Mylan in 2013, Ms. Autor served for 12 years at the U.S. Food and Drug Administration (FDA), most recently as Deputy Commissioner for Global Regulatory Operations and Policy, where she supervised more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs in their efforts to confront the challenges of globalization and import safety. She also served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research, where she led policymaking and enforcement for key programs for drugs, including current good manufacturing practices, human subject protection, and marketed unapproved drugs.

thierry-bourquin-headshot.jpgThierry Bourquin
Senior Vice-President Global Chief Quality Officer, Sanofi
USP Advisory Group

Thierry Bourquin has been Senior Vice-President Global Chief Quality Officer at Sanofi since 2009. He joined Sanofi in 2001 as Head of Industrial Quality and Compliance. In 2004, he took the lead of Global Quality Industrial Operations for Sanofi. After serving in Hospitals and at Paris University, he held several positions in Quality Control, Quality Assurance, Analytical Development and Manufacturing in the pharmaceutical industry (Pfizer, Cooper, RPR, Aventis).

During more than 15 years, Mr. Bourquin has been a member of the French Pharmacopoeia Commission and expert in different groups. At the European level, he was expert of the European Pharmacopoeia and member of the Quality Ad Hoc Group of EFPIA. He also served as Chairman of the Quality Committee of LEEM, French Association of Pharmaceutical Industry. A pharmacist, Mr. Bourquin, graduated with degrees in biology and drug product control, is member of the French National Academy of Pharmacy.

Susan-Hershenson-headshot.jpgSusan Hershenson, Ph.D.
Deputy Director, Chemistry, Manufacturing and Controls, The Bill and Melinda Gates Foundation
USP Advisory Group

Susan Hershenson, Ph.D., has more than 25 years of experience in drug development. She joined the Bill and Melinda Gates Foundation in 2013 as Deputy Director, Chemistry, Manufacturing, and Controls, where she works closely with the Foundation’s strategy teams and partners to provide technical expertise and strategic guidance for the therapeutics projects.

Prior to joining the foundation, Dr. Hershenson founded Pharmaceutical Transformations LLC, a consulting service for the pharmaceutical, biotechnology, drug delivery, and related industries. Before starting her own practice, she served in a variety of roles in the biopharmaceutical industry, including most recently Vice President of Pharmaceutical and Device Development at Genentech and Vice President of Pharmaceutics at Amgen.

Ramanan-Laxminara-headshoyan-headshot.jpgRamanan Laxminarayan, Ph.D., M.P.H.
Director and Senior Fellow, The Center for Disease Dynamics, Economics & Policy
USP Advisory Group

Ramanan Laxminarayan, Ph.D., M.P.H., is director and senior fellow at the Center for Disease Dynamics, Economics & Policy (CDDEP) in Washington, D.C., and a senior research scholar and lecturer at the Princeton Environmental Institute at Princeton University. He is an affiliate professor at the University of Washington and a visiting professor at the University of Kwazulu Natal. Dr. Laxminarayan is a co-founder of HealthCubed, which works to improve access to healthcare and diagnostics.

Since 1995, Dr. Laxminarayan has worked to improve the understanding of antibiotic resistance as a problem of managing a shared global resource. His work encompasses extensive peer-reviewed research, public outreach, and direct engagement in eleven countries in Asia and Africa through the Global Antibiotic Resistance Partnership. Through his prolific research, active public outreach (including a TED talk that has been widely viewed) and sustained policy engagement, he has played a central role in bringing the issue of drug resistance to the attention of leaders and policymakers worldwide and to the United Nations General Assembly in September 2016.

John-Lim-headshot.jpgJohn Lim, M.D., M.S., S.M.
Executive Director, Duke-NUS CoRE
USP Advisory Group

John Lim, M.D., M.S., S.M., serves as Executive Director of the Centre of Regulatory Excellence (CoRE) at the Duke-National University of Singapore Medical School (Duke-NUS). He is also Deputy Director of Medical Services at the Ministry of Health Singapore.

Dr. Lim is a Specialist in Public Health Medicine, a Fellow of the Singapore Academy of Medicine, Professor of Practice at Duke-NUS, and Adjunct Associate Professor at the NUS Saw Swee Hock School of Public Health. He is also Chairman of the Singapore Clinical Research Institute, a national Academic Research Organization under MOH Holdings, Singapore. He previously served as Chief Executive Officer of Singapore’s Health Sciences Authority.

Gail-Wilensky-headshot.jpgGail Wilensky, Ph.D.
Senior Fellow, Project HOPE
USP Advisory Group

Gail R. Wilensky, Ph.D. joined Project HOPE in 1993. She is an economist and Senior fellow at Project HOPE. Prior to joining Project HOPE, Dr. Wilensky directed the Medicare and Medicaid programs and served in the White House as a senior advisor on health and welfare issues to President George H.W. Bush. She was also the first chair of the Medicare Payment Advisory Commission. Her expertise is on strategies to reform health care in the United States, with particular emphasis on Medicare, comparative effectiveness research and military health care.

Dr. Wilensky testifies frequently before Congressional committees, serves as an adviser to members of Congress and other elected officials and speaks nationally and internationally. She received a bachelor’s degree in psychology and a Ph.D. in economics from the University of Michigan.

USP Board of Trustees Sponsor

susa-winckler-headshot.jpgSusan C. Winckler, J.D., FAPhA
President, Leavitt Partners Consulting
USP Board Sponsor

Susan Winckler, J.D., is the President of Leavitt Partners Consulting and Chief Risk Management Officer of Leavitt Partners. Ms. Winckler leads the 100+-person LP Consulting team, individually advises clients on how to succeed in the evolving value-driven health care economy, and leads new product development to ensure clients have the latest intelligence and tools needed for strategic planning and positioning of organizational assets. She also oversees the firm’s corporate compliance program, conflict of interest procedures, and legal record management.

A pharmacist and attorney by training, Ms. Winckler is the former Chief of the Staff for the U.S. Food and Drug Administration within the Department of Health and Human Services, and former President and CEO of the Food and Drug Law Institute, a nonprofit organization based in Washington, D.C., which provides a marketplace for discussing food and drug law issues through conferences, publications, and member interaction.

Quality Institute Fellowship Mentors

fouad-atouf.jpgFouad Atouf, Ph.D.
Vice President, Science—Global Biologics, USP

Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products.

jesse-goodman-headshot.jpgJesse Goodman, M.D., M.P.H
Director, Georgetown University COMPASS
Quality Institute GUMC Fellowship Mentor

Jesse Goodman, M.D., M.P.H., is Professor of Medicine at Georgetown University and Director of Georgetown’s Center on Medical Product Access, Safety and Stewardship (COMPASS), which focuses on informing science based policy to address public health needs in product development and access, the supply chain, and antimicrobial resistance. He is also an Attending Physician in Infectious Diseases at the Georgetown University, Washington DC Veteran’s Administration and Walter Reed National Military Medical Centers.

Dr. Goodman previously served as the Chief Scientist and Deputy Commissioner of the U.S. Food and Drug Administration (FDA), where he worked with industry, academia, government and global public health partners to prepare for and respond to major public health threats, emerging infectious diseases and terrorism. Prior to his role as Chief Scientist, he founded and co-chaired the first U.S. Task Force to Combat Antimicrobial Resistance, and directed the Center for Biologics Evaluation and Research. Before working in government, he was Professor and Chief of Infectious Diseases at the University of Minnesota. He has served on the Decade of Vaccines Research and Development Group and on numerous CDC, NIH, DOD and WHO Advisory Committees and is currently on the Scientific Advisory Board of the Coalition on Epidemic Preparedness Innovation (CEPI). He has been elected to the National Academy of Medicine of the National Academy of Sciences.

Paul-Roepe-headshot.jpgPaul Roepe, Ph.D, M.A.
Professor, Georgetown University
Quality Institute GUMC Fellowship Mentor

Paul Roepe, Ph.D., M.A., is a Professor in the Department of Chemistry and the Department of Biochemistry and Cellular & Molecular Biology at Georgetown University. He is also a co-director of the Georgetown Center for Infectious Disease. The primary interest of his research group is the molecular basis of drug resistance phenomena, particularly in malarial parasites.

Prior to moving his laboratory to Georgetown University in 1997, Dr. Roepe served joint appointments at Memorial Sloan-Kettering Cancer Center and the Department of Pharmacology at Cornell University Medical College, where he studied pharmacology and worked on several problems related to tumor drug resistance and the transport of chemotherapeutic drugs across tumor cell membranes.