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Drug Development Professional

Serves Pharmaceutical Companies Developing Drug Products

LVM Pharmaceuticals Consulting, LLC is headed by an experienced drug development professional. Our company aims to consistently provide the scientific and regulatory support that pharmaceutical companies require in order to succeed in bringing safe and effective drug products to market. We are proud to introduce our principal consultant.

Get to Know Our Drug Development Professional

Lydia I. Gilbert-McClain, MD, FCCP

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Dr. Lydia I. 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, for the last 10 years, Deputy Division Director in the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). As a senior FDA reviewer, Dr. Gilbert-McClain was directly involved in the broad range of drug development programs and therapeutic drug classes managed in DPARP and other review divisions and centers (Center for Devices and Radiological Health [CDRH] and Center for Biologics Evaluation and Research [CBER]). In addition to her regulatory and supervisory experience, Dr. Gilbert-McClain has presented at numerous conferences and workshops, including the American Thoracic Society (ATS), the Pharmaceutical Education and Research Institute (PERI), NIH, and the Association of Inhalation Toxicology (AIT), as well as Scientific Advisory Committee meetings.

Dr. Gilbert-McClain received her MD from Instituto Superior de Ciencias Médicas de la Habana, in Havana, Cuba. She completed an internship and residency program in Internal Medicine at Howard University Hospital in Washington, DC, followed by a 3-year fellowship in Pulmonary disease and Critical Care Medicine at Indiana University Medical Center in Indianapolis, IN. As a senior staff fellow at NIH in the National Heart, Lung, and Blood Institute (NHLBI), (1997-1999), her research focus was on phosphodiesterase inhibitors and pulmonary sarcoidosis. She started her FDA tenure as a primary reviewer at the pulmonary division in April 1999. Dr. Gilbert-McClain is also an alumna of the Council for Excellence in Government (CEG) Leadership program (class of 2003) and is a recipient of numerous awards from the FDA.

Dr. Gilbert-McClain is a diplomate of the American Board of Internal Medicine (ABIM), is board-certified in Internal Medicine, Pulmonary Disease, and Critical Care Medicine, and is a practicing clinician. She is also a fellow of the American College of Chest Physicians (ACCP) and has published numerous articles in peer-reviewed journals.

See Our Pharmaceutical Consultation Services

Should you have questions about our pharmaceutical consultation services, don’t hesitate to get in touch. You may reach LVM Pharmaceuticals Consulting, LLC through the contact information provided to speak with our drug development professional today about your needs. We can certainly provide the assistance that your company desires.