M. Masaya Seltzer

Senior Contracts Specialist

NYU School of Medicine

• Advised on, drafted and negotiated clinical trial agreements, investigator-initiated research agreements, collaboration agreements, site sub-agreements and sponsored research agreements
  
• Supported clinical operations and quality assurance in the conduct of industry-supported clinical research for the departments of neurology, psychiatry, cancer, urology, hepatology, nephrology, transplant surgery and orthopedic surgery

• Drafted, negotiated, and counseled numerous venture-backed clients on complex supply chain agreements for small molecule, gene therapy and biologic products
• Drafted and negotiated Spectral Medical’s complex clinical trial collaboration agreement with Baxter, and ancillary agreements for the collaboration
• Advised venture-backed client on modifications to its clinical trial-related agreements and operations required by the terms of upstream collaboration, license and supply agreement with a global pharmaceutical company collaborator
• Managed all contracting in support of the global, pivotal Phase 3 Study of Deciphera Pharmaceuticals’ oncology product Vimseltinib involving over 120 subjects and approximately 50 clinical sites in the United States, Europe, Asia, Australia, Canada and South America, leading to acceptance of NDA and MAA by FDA and EMA
• Drafted and negotiated agreements with service providers for clinical and preclinical studies of therapeutic and medical device products, including multi-million dollar master services agreements with large, multinational contract research organizations

Prior to becoming a lawyer, Masaya spent three years as a Peace Corps volunteer in West Africa. He currently serves on the board of his local Little League chapter.