Nic Scalfarotto, D.V.M.

Senior Vice President, Regulatory Affairs

Dr. Scalfarotto has over 25 years of experience in a wide range of biopharmaceutical and CRO settings. He has held executive roles covering multiple stages of development including solutions for treating rare and ultra-rare diseases. His experience has spanned diverse development programs covering small molecules, novel biologics, biosimilars, bio-betters, follow-on biologics, imaging agents and combination products.

Initially focused on preclinical development, his regulatory career evolved in small and large corporate settings including PAREXEL, Millennium, Bristol-Myers, Eurand, Momenta, EMD Serono, GE Healthcare, Aegerion and X4 Pharmaceuticals. Most recently, he held the position of Senior Vice President, Regulatory Affairs at X4 Pharmaceuticals, focusing on the development of products targeting rare diseases in immune deficiency and immuno-oncology.

He has been responsible for global regulatory development in multiple therapeutic areas including cardiology, oncology, immunology, endocrinology, gastroenterology, dermatology, rheumatology, neurology and biomarker development.

Additionally, Dr. Scalfarotto held General Management responsibilities in three CROs (MetTrials, Chrysalis and Oread), which included strategic and tactical planning, finance, operations, business development, regulatory affairs, quality assurance, information systems and facilities planning.

Dr. Scalfarotto holds an undergraduate degree in biological sciences from Seton Hall University and a degree in veterinary medicine from the University of Bologna.