Minal Caron is counsel in Ropes & Gray’s health care practice group and a member of its higher education practice. He has significant experience advising academic medical centers, universities, pharmaceutical and medical device companies, research institutions, and strategic investors regarding a broad range of regulatory, compliance, and transactional issues.
Minal has particular experience counseling clients on legal and regulatory issues relating to scientific research and development, including internal and governmental investigations, complex transactions, and regulatory advice. Minal routinely advises academic institutions and pharmaceutical and medical device companies across the United States and internationally in matters involving allegations of research misconduct (falsification, fabrication, or plagiarism) and other data integrity issues, research security and conflicts of interest, and other issues relating to the regulation of research activities and compliance with federal grants and contracts.
Minal also has extensive experience advising health care organizations and higher education institutions on structuring and negotiating cutting-edge transactions, including affiliations, spin-off transactions, and joint ventures, as well as the formation, governance, and capital financing of for-profit subsidiaries of nonprofit institutions. Minal also advises private equity companies in investments in companies across the health care, higher education, and biomedical research landscape.
Minal is a member of the National Association of College and University Attorneys (NACUA) and serves on NACUA’s Committee on Membership and Member Services. Outside of his legal practice, Minal also serves as a member of United States Tennis Association (USTA) New England’s Good Sport Committee. From 2014-2019, Minal served as a board member for Outdoor Sport Institute, a Maine-based nonprofit organization focused on connecting communities to outdoor sports such as skiing, hiking, and biking in order to enrich the culture and health infrastructure in rural areas.
Prior to joining the firm, Minal served as a law clerk to Chief Judge John A. Woodcock, Jr., U.S. District Court for the District of Maine. During law school, Minal worked as a judicial intern for Judge Kermit Lipez, U.S. Court of Appeals for the First Circuit, and received the Harvard Law School Paul C. Weiler Scholar Award for excellence in Sports Law.
Experience
Scientific Research and Development Regulatory Matters
- Counseled numerous academic medical centers, higher education institutions, and pharmaceutical companies and other biotechnology firms regarding allegations of research misconduct and other issues relating to the integrity or reliability of scientific data and plagiarism.
- 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 academic medical center and university clients regarding individual and institutional conflict of interest issues, including “foreign influence” matters.
- Advised academic medical centers and institutions of higher education regarding research security governance and implementation issues pursuant to National Security Presidential Memorandum 33 (NSPM-33) and the CHIPS and Science Act.
- Advised academic medical centers regarding use of artificial intelligence in scientific research, including with respect to contract negotiations and regulatory advice.
- Advised a large pharmaceutical company in government inquiry into compliance with clinical trial registration and results reporting requirements.
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), clinical research site networks, institutional review boards (IRBs), and digital health companies.
- Advised many types of health care organizations regarding clinical trial contracting negotiations.
- Participated in more than $7 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 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.