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Dr. Lydia Gilbert-McClain is an accomplished leader in regulatory science and drug development with over 21 years of experience in government at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Dr. Gilbert-McClain dedicated 19 years of professional service to the FDA serving in various review roles as primary clinical reviewer, Clinical Team Leader, Cross-Discipline Team Leader (CDTL), and subsequently, Deputy Division Director in the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). As a former senior FDA reviewer, Dr. Gilbert-McClain has a broad range of experience in drug development programs across multiple therapeutic areas including pulmonary diseases, Critical Care, allergic disorders, and inflammation, as well as experience in inhalation drug delivery systems, and drug-device combination products.
Dr. Gilbert-McClain has presented at numerous conferences and workshops including the American Thoracic Society ( 2002-2017), the Pharmaceutical Education and Research Institute (2002-2005), the Association of Inhalation Toxicology (2014), and the 6th IPF Summit (2022). She is member of the American Thoracic Society, the American College of Chest Physicians (Fellow), and the American Medical Association. She is an alum of the Council for Excellence in Government (CEG) leadership program (class of 2003). Dr. Gilbert-McClain has published several articles in peer-reviewed journals and has been the recipient of numerous awards.
Since 2018, Dr. Gilbert-McClain has been an independent consultant to the biotechnology and pharmaceutical industry providing regulatory and scientific support across all areas of drug development from preIND to late-stage development and NDA submission.
Dr. Gilbert-McClain is a graduate of the Instituto Superior de Ciencias Medicas De La Habana, Cuba. She completed internship and residency training in Internal Medicine (Howard University hospital) and fellowship training in Pulmonary and Critical Care medicine (Indiana University School of Medicine and Affiliated hospitals). She is a diplomate of the American Board of Internal Medicine and is board-certified in Internal Medicine, Pulmonary Disease, and Critical Care Medicine.