Office Director of the Office of Orphan Products and Development
- Janet Maynard, M.D., M.H.S.
Dr. Janet Maynard is an Internist and Rheumatologist and the Director of the Office of Orphan Products Development (OOPD) since October 2018. Prior to OOPD, Dr. Maynard worked in the Center for Drug Evaluation and Research (CDER), where she was a clinical team leader in the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP). Dr. Maynard has been with FDA since 2011, when she joined FDA’s Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) as a Medical Officer, before becoming a clinical team leader in DPARP. At FDA, she has worked with an interdisciplinary team of scientists in evaluating the safety and efficacy of drugs and provided regulatory and scientific guidance to drug developers. She has supported drug development through collaboration with stakeholders in various national and international forums. In addition, she has worked on complex development considerations related to rare diseases, such as rare and serious autoinflammatory diseases. Dr. Maynard received her medical degree from Vanderbilt University and completed a residency in internal medicine at Duke Hospital. Subsequently, she completed a fellowship in rheumatology at Johns Hopkins Hospital. During her fellowship, she completed a Master of Health Science at the Johns Hopkins Bloomberg School of Public Health in the Graduate Training Program in Clinical Investigation.
- CAPT Nicole Wolanski
CAPT Wolanski is the Deputy Director in FDA’s Office of Orphan Products Development (OOPD). CAPT Wolanski joined OOPD in 2017 and has over 25 years of FDA regulatory review experience and oversight knowledge. Prior to joining OOPD, she worked in the Office of Good Clinical Practice (OGCP) for two years. With her background as a biomedical engineer, CAPT Wolanski held various roles in the Center for Devices and Radiological Health before joining OGCP.CAPT Wolanski graduated from the Catholic University of America.
- Debra Lewis, O.D., M.B.A.
Dr.Debra Lewis is the Associate Director of FDA’s Office of Orphan Products Development (OOPD) where she works to advance the development of promising drugs, biologics, devices and medical foods for patients living with rare diseases and orphan conditions. Dr. Lewis has served as the OOPD Deputy Director, Grants Director and Humanitarian Use Device Director. Prior to joining Orphan Products, she served as the Deputy Director for the Office of Health and Industry Programs, in FDA’s Center for Devices and Radiological Health (CDRH); Director of the CDRH Staff College; Branch Chief in Ophthalmic Medical Device Review; Section Chief of the Premarket Approval Application Staff; and as an FDA Clinical/Scientific Reviewer. She has previously served as an officer in the US Public Health Service Commissioned Corps and the US Air Force.
Henry Startzman, M.D.
Director of the Orphan Drug Designation Program
Soumya Patel, PharmD
Supervisory Secondary Reviewer, Orphan Drug Designation Program
Erika Torjusen, M.D., M.H.S.
Director of the Rare Pediatric Disease and Humanitarian Use Device Designations Program and Pediatric Device Consortia Grants Program
Katherine Needleman, Ph.D.
Director of the Clinical Trials and Natural History Grants Program