Russell Pagano Joins Enable Injections as VP, Regulatory Affairs
We are pleased to announce Russell Pagano, PhD, has joined Enable Injections as Vice President of Regulatory Affairs. Dr. Pagano will lead Enable’s enFuse® to its first regulatory submission and approval.
Dr. Pagano has over 27 years of regulatory affairs experience in various sectors including the FDA, consulting, medical device start-up, and pharma. He joined Enable from Baxter Healthcare, where he was most recently the Global Regulatory Lead for their Advanced Surgery business unit. In this role, he led a team in gaining approval for new products and geographical expansion as well as supporting renewals for an approximately one-billion-dollar portfolio, including multiple combination biologic/device applications.
Prior to Baxter, Dr. Pagano held positions covering urological, neurological, orthopedic, and cardiovascular devices at the FDA Office of Device Evaluation. After the FDA, he co-founded a regulatory and clinical consulting company, MSquared Associates, in the DC area, where he served as a consultant for a variety of medical device firms until he left to become Vice President of Clinical and Regulatory Affairs at BioMimetic Therapeutics, a medical device start-up company. Russ earned a Bachelor of Science, Master of Science, and Doctor of Philosophy in Mechanical Engineering and Materials Science from Duke University.
“We are very excited to have someone with Russ’ broad background and experience in regulatory affairs, and we look forward to the value that he can add to Enable and our pharma partners.”
– Mike Hooven, President and CEO, Enable Injections.
To learn more about the enFuse, contact us.