The Velius Team

Our team has vast and varied industry experience.  Successful in his or her own field, each member’s pursuit of and reputation for excellence results in a whole that is greater than its parts.

 FDA Advisory Team

 

Jonathan Wilkin, MD, FAAD
Dr. Wilkin is the founding director of the Division of Dermatology and Dental Products at the US Food and Drug Administration. Dr. Wilkin remains active in regulatory matters, of American Academy of Dermatology’s Ad Hoc Task Force on Academy’s Efforts with the FDA. Prior to FDA, he served as Director, Dermatology Division and Professor of Medicine and Pharmacology Departments, of The Ohio State University. Prior to Ohio State University, he served as Chief of Dermatology section, Hunter Holmes McGuire Veterans Administration Medical Center in Richmond, Virginia. Dr. Wilkin served as the Chairman of medical advisory board for the National Rosacea Society from 1998 to 2012. Dr. Wilkin is a fellow of both the American College of Physicians and American Academy of Dermatology. He is a diplomate of both the American Board of Clinical Pharmacology and the American Board of Dermatology. He has over 130 publications in dermatology and clinical pharmacology.  
Mark Kramer
Mr. Kramer established and led FDA’s Office of Combination Products from its inception in 2002 until 2007, when he left the Agency to become Regulatory Affairs Executive at GE Healthcare, a position he held through July 2010.  Since that time he has consulted for many companies. Mark’s experience both as a regulator and as a regulatory affairs leader at a $17B global medical products company, gives him a comprehensive understanding of the complex laws, regulations, regulators, and review processes, as well as the practical experience that can only be gained in the “real world.” Mark currently serves on the Board of Directors of the Regulatory Affairs Professional Society (RAPS). 

 

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