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Clinical Trials & Research

  • Serve as general counsel to a 501(c)(3) organization engaged in research and education in peripheral vascular disease, including advice on the initial structure and ongoing management of its entire research program; drafting, reviewing, and negotiating agreements and consent forms; and assisting with audits and other inquiries.
  • Served as counsel to the IRB of a large, academic medical center with a research program averaging 200 active protocols annually and ranging from late-stage drug studies to xenotransplantation.
  • Advised a teaching hospital’s investigators on the NIH grant application process and counseled its NIH funded researchers on all manner of regulatory and compliance issues raised by NIH funding.
  • Counseled a pharmaceutical company on the post-mortem acquisition of tissue samples and associated clinical data to support its research program.
  • Advised the Institutional Animal Care and Use Committee of a large, academic medical center on a variety of preclinical studies, including studies involving a primate model.
  • Counseled a large clinical diagnostics company on the design and implementation of a tissue banking and outcomes research program, including acquisition of clinical data within regulatory confines to support an outcomes research program.
  • Assisted a private company in the establishment of a stem cell research oversight committee to support its stem cell research program, in compliance with state and federal standards.
  • Advised a teaching hospital in connection with its participation in NCI-funded cooperative group studies (NSABP, CALGB, etc.).
  • Convinced the federal government to decline to intervene in a False Claims Act case alleging that a recipient of NIH grants committed grant fraud.
Mintz Guides Company Through Clinical Trials Program Case Study
Mintz serves as general counsel to a privately held pharmaceutical R&D company focused on inflammatory, metabolic, and affective disorders. Mintz handles the company’s corporate, transactional, and IP work, including supporting the company’s preclinical and clinical research program.
Lab Establishes Data Repository to Support Cancer Care Case Study
Mintz represents a clinical laboratory provider of complex pathology testing with an R&D program focused on personalized medicine. Mintz helped the client establish a collaborative data repository model for health care providers and researchers.
Biotech Client Initiates Two Phase 1b/2a Clinical Trials Case Study
Mintz provides FDA, data privacy, and clinical compliance advice to a publicly traded biotechnology company developing nucleic acid therapeutic candidates for rare genetic diseases, including Huntington’s disease and Duchenne Muscular Dystrophy. Mintz also helped the client expand its R&D program.