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Delivered as a Hybrid Event December 6 - 10, 2021
In-Person: December 6-7 | Virtual: December 9-10Boston, MA

Janet Maynard
Director at FDA/CDER/OND/ORDPURM

Profile

Dr. Janet Maynard is an Internist and Rheumatologist and the Acting 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.

Agenda Sessions

  • Navigate FDA Updates on Rare Disease Product Development

    10:15am