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Robert J. Desnick – Scientific Advisor

Robert J. Desnick, Ph.D., M.D., is a human geneticist whose research accomplishments include significant developments in disease gene discovery, inherited metabolic diseases, and the treatment of genetic diseases, including the development of enzyme replacement therapy for Fabry disease.

Desnick is the Dean for Genetics and Genomics, and Professor and Chairman Emeritus of the Department of Genetics & Genomic Sciences at The Icahn School of Medicine at Mount Sinai in New York City. Additionally, he is Professor of Pediatrics, Professor of Oncological Sciences, and Professor of Obstetrics, Gynecology and Reproductive Science at The Mount Sinai Hospital.

Desnick is the author of more than 600 peer-reviewed articles in scientific journals, 200 book chapters and is the editor of nine books. He holds 13 patents[3] and is included in Castle Connelly's lists of Best Doctors in America and Best Doctors in New York and New York Magazine’s list of the Best Doctors every year since the inception of the rating. He was elected to the Institute of Medicine in 2004.

Mark Hayes – Regulatory Strategy Advisor

Mark Hayes has over 25 years of experience in research and development of protein therapeutics.  Through the end of 2015, he was Senior Vice President of Regulatory Affairs and Pharmacovigilance at Synageva Biopharma prior to their acquisition by Alexion Pharmaceuticals, where he led efforts to support the approval of Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency, a rare genetic lipid metabolic disorder affecting children and adults, and provided strategic regulatory leadership for additional pipeline products for other serious and life-threatening rare genetic diseases affecting predominantly pediatric patients. Prior to Synageva, Dr. Hayes was Group Vice President of Regulatory Affairs at Genzyme Corporation, where over 11 years he led the regulatory function for the Oncology and Biosurgery business units as well as the CMC regulatory organization for all of Genzyme’s therapeutic products.  While at Genzyme, he played a critical role in securing global regulatory approvals for a number of innovative products for rare diseases.  Prior to moving to industry, Dr. Hayes served at FDA for over 9 years at the Center for Biologics Evaluation and Research, Division of Therapeutic Proteins, where he conducted independent research in cytokine biology and managed the review of numerous recombinant proteins under development for a wide variety of indications.  Dr. Hayes received a B.S. from Davidson College and holds a Ph.D. in Immunology and Experimental Pathology from the University of Florida.  He completed post-doctoral fellowship at the National Cancer Institute in Bethesda, MD before joining FDA.

Gerald Siu – Scientific Advisor

Gerald Siu, M.D., Ph.D. is the owner of Gerald Siu Consulting, LLC, which provides professional advice both on specific projects as well as on strategic portfolio design, strategy, and development.  Dr. Siu previously served as Vice President and Chief Scientist for the Biopharmaceuticals Research Unit at Novo Nordisk; Vice President and head of discovery research and translational medicine Discovery Performance Units, Scientific Director and project leader at Amgen; and Professor in the Department of Microbiology at Columbia University’s College of Physicians and Surgeons.  Dr. Siu received his M.D. from and performed his postdoctoral work at the University of California, San Diego, and received his Ph.D. from the California Institute of Technology.