• Leader in global regulatory affairs for biosimilars; shaped the US biosimilar pathway.
• Under his leadership at Mylan, the first biosimilar (trastuzumab) was approved in the US.
• Led regulatory affairs at Sandoz Inc. and involved in the approval of the first US biosimilar and additional biosimilar BLAs.
• Vice Chairman of the Biosimilar Council.
• Chair of the AAM Biosimilars Working Group and the Biosimilar Forum Regulatory Committee.
• Represented AAM during Biosimilar User Fee Negotiations with the FDA.
• Roles at Pfizer, Aventis, and Sanofi focusing on novel drugs, biologics, and 505(b)(2) products.
• Pharmacist and graduate of Rutgers College of Pharmacy.
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