M. Masaya Seltzer

Counsel | He/Him/His

Overview

An experienced transactional attorney, Masaya (Max) Seltzer counsels clients on a wide range of clinical development and supply chain matters related to small molecule drugs, cell therapy, gene therapy, and medical device research.

Max’s prior in-house experience enables him to advise clients efficiently and pragmatically on R&D, clinical trials, data privacy, Software-as-a-Service (SaaS), and product manufacturing transactions and issues.

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.

Career & Education

    • 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.
    • 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.
    • University of California, San Diego, B.A., Mathematics, Visual Arts
    • Brooklyn Law School, J.D.
    • University of California, San Diego, B.A., Mathematics, Visual Arts
    • Brooklyn Law School, J.D.
    • New York
    • New York

Representative Matters

  • Drafted, negotiated, and counseled numerous venture-backed clients on complex supply chain agreements for small molecule, gene therapy, and biologic products.
  • Drafted and negotiated a medical diagnostics company’s complex clinical trial collaboration agreement with a multinational healthcare company, 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 an innovative oncology product 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.