Minal M. Caron

Experience

Scientific Research and Development Regulatory Matters

• Counseled numerous academic medical centers, higher education institutions, and pharmaceutical companies regarding allegations of research misconduct and other issues relating to the integrity or reliability of scientific data, including allegations of data falsification against several prominent researchers.
• Advised pharmaceutical companies and academic institutions on regulatory and compliance issues relating to clinical research, including COVID-19 products (both vaccine and therapeutic), rare disease products, and Software as a Medical Device products.
• Advised clients on the reporting implications of research misconduct and other research compliance issues, including communications with governmental and private funding sources and scientific journals.
• Advised a large pharmaceutical company in government inquiry into compliance with clinical trial registration and results reporting requirements.
• Advised multiple academic medical centers regarding federal grants and contracts matters.

Transactions

• Advised multiple higher education institutions in structuring and negotiating novel transactions to facilitate greater innovation and collaboration with industry relating to scientific research and development, including spin-off transactions and formation of joint ventures.
• Advised multiple health care and higher education institutions on forming and operating for-profit subsidiaries focused on activities supporting scientific research and development.
• Advised higher education institution regarding evaluation and negotiation of potential “spin-off” transactions for its controlled teaching hospital with both for-profit and non-profit potential acquirers.
• Represented research institute in developing wholly-owned foreign entity for purposes of collaborating with health care and scientific research organizations in China.
• Conducted regulatory diligence for numerous private equity sponsors in connection with their planned investments in businesses across the health care landscape, including pharmaceutical companies, contract research organizations (CROs), institutional review boards (IRBs), and digital health companies.
• Advised many types of health care organizations regarding clinical trial contracting negotiations.
• Participated in more than $4 billion in various tax-exempt and taxable bond offerings for multiple health care and higher education clients in Massachusetts as borrower’s and underwriter’s counsel.

Health Care Regulatory and Compliance Matters

• Advised a large nonprofit health system in an investigation by the U.S. Attorney’s Office for the District of New Jersey regarding the system’s interactions with the sales and marketing personnel of a drug manufacturer.
• Advised multiple health care providers in connection with the resolution of federal False Claims Act qui tam actions.
• Advised multiple health care providers in preparing and submitting self-disclosures of overpayments to Medicare Administrative Contractors and various state Medicaid programs.
• Advised large regional health system on developing complex plans of correction for significant CMS survey statements of deficiencies.
• Advised a leading specialty hospital in conducting internal investigations regarding controlled substances prescribing practices.
• Advised a major university in assessing and refining its compliance program.
• Advised a large pharmaceutical company on designing and refining its U.S.-based compliance program.
• Advised multiple pharmaceutical companies on developing or revising existing compliance policies and procedures to represent industry best practices.