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Mark Tracy, Ph.D.

Member, Gene Therapy SAB

Dr. Mark A. Tracy is Founder and President, Tracy BioConsulting, LLC, a specialty biopharmaceutical consulting firm dedicated to helping clients advance their scientific research into and through the clinic. Dr. Tracy is known internationally for developing innovative first-in-class complex injectable and nucleic acid therapeutics. Dr. Tracy played a key role in developing Onpattro®, the first RNAi therapeutic approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies worldwide. He also played an important role in the development of lipid nanoparticle technology used in mRNA COVID-19 vaccines granted regulatory approval worldwide. Previously, he developed several complex injectable sustained release products that have been commercialized including Vivitrol®, Bydureon®, and Nutropin® Depot, which was the first long acting protein product approved by the FDA. Dr. Tracy has extensive experience in the development of nano and microparticle-based products and other sterile injectable formulations from research through IND filing and commercialization. He has been recognized by peers internationally for accomplishments and leadership in the pharmaceutical product development, bioengineering, and delivery fields. Dr. Tracy is a Past-President and Fellow of the Controlled Release Society (CRS) and a Fellow of the American Institute for Medical and Biological Engineering (AIMBE).