We are Thinkers.

We are Innovators.

We are Velius.

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

Dr. Mason Diamond

Dr. Diamond is a biotech Executive with extensive industry, academic and clinical practice experience encompassing Medical Device, Pharmaceutical, and Biologics development. Developed and managed clinical and regulatory programs across many therapeutic areas, including, stem cell therapy, plastic and reconstructive surgery, regenerative medicine, in vitro diagnostics, orthopaedics, cardiovascular, oncology, etc. Served as Industry representative on the FDA Device Advisory Panel for Dental Products. Served on several ADVAMED committees relating to new legislation (involving Congressional interaction), new regulations, clinical study design, and safety reporting. Served as Director, US Regulatory Affairs for Ferring Pharmaceuticals LLC, Texel Fortis, Integra LifeSciences Corp., and Isolagen Corp.

Mark Kramer - Consulting

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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