Editor: What To Know
- Michele's biosimilars expertise is enhanced by her role on the Therapeutic Biologics and Biosimilar Staff in the FDA's Office of New Drugs, where she focused on supporting review of biosimilar products and participated in guidance and policy initiatives related to the biosimilar development pathway.
- A 10-year veteran of FDA, Michele's career includes more than 15-years of regulatory experience across the product quality lifecycle, including her most recent role as President of DataRevive, a legacy brand of ELIQUENT Life Sciences.
- Led by John Taylor, ELIQUENT's team of respected professionals, along with a network of ready to deploy global experts, bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to sustainable quality and regulatory excellence.
John Taylor
ELIQUENT Life Sciences, a global regulatory consulting firm for the life sciences industry, today announced the appointment of John Taylor as head of the firm’s Quality & Compliance Practice and Michele Dougherty as head of the firm’s Regulatory Affairs Practice.
ELIQUENT’s integrated suite of services deliver the answers and solutions that global life sciences innovators need to gain and maintain market authorization for their products. The ELIQUENT team works cross-functionally to support pharmaceutical, biotechnology, medical device, combination product, and cosmetics innovators across therapeutic modalities, phase-based pathways, and major global markets.
Role
Head of ELIQUENT’s Quality & Compliance Practice
Led by John Taylor, ELIQUENT’s team of respected professionals, along with a network of ready to deploy global experts, bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to sustainable quality and regulatory excellence.
John Taylor brings more than 30 years of regulatory experience to his role at ELIQUENT, including a distinguished 20-year career at the U.S. Food and Drug Administration (FDA), where he served in multiple leadership positions, including as FDA’s Acting Deputy Principal Commissioner, FDA Counselor to the Commissioner, Acting Deputy Commissioner for Global Regulatory Operations and Policy, and Associate Commissioner for Regulatory Affairs.
John’s extensive experience also includes roles within regulated industry, including service as Executive Vice President for Health at the Biotechnology Industry Organization (BIO) and as Divisional Vice President for Federal Government Affairs at Abbott. Most recently, John served for 10-years as President and Principal of Compliance & Regulatory Affairs at Greenleaf Health, a legacy brand of ELIQUENT Life Sciences. John received his J.D. from the College of William and Mary and is a graduate of Pennsylvania State University. Learn more about John Taylor.
Michele Dougherty, Ph.D.
Head of ELIQUENT’s Regulatory Affairs Practice
Led by Michele Dougherty, ELIQUENT’s Regulatory Affairs Practice supports life science innovators from the earliest phases of development, through regulatory submissions, to post-approval support, and beyond.
A 10-year veteran of FDA, Michele’s career includes more than 15-years of regulatory experience across the product quality lifecycle, including her most recent role as President of DataRevive, a legacy brand of ELIQUENT Life Sciences.
Michele joined FDA in 2008 as a product quality reviewer in the Office of Biotechnology Products (OBP). During her FDA tenure, Michele developed expertise across the manufacturing and product quality lifecycle and held multiple leadership roles, including OBP Team Lead and Review Chief. Michele managed a diverse portfolio of products including monoclonal antibodies, antibody-drug conjugates, antibody cocktails, growth factors, enzymes, and biosimilar products.
Michele’s biosimilars expertise is enhanced by her role on the Therapeutic Biologics and Biosimilar Staff in the FDA’s Office of New Drugs, where she focused on supporting review of biosimilar products and participated in guidance and policy initiatives related to the biosimilar development pathway.
Michele received her Ph.D. from Georgetown University and completed her post-doctoral training in the Laboratory of Cell and Developmental Signaling at the National Cancer Institute. Learn more about Michele Dougherty.
