Health care and life sciences organizations rely on attorney Melissa D’Arcy for advice on a range of transactional and regulatory compliance issues.
With a strong background in mergers and acquisitions and experience drafting and implementing regulations for a federal financial regulator, Melissa has the skills to help clients work through business challenges and regulatory issues. She understands how to support clients, especially health care and life sciences entities, in complex transactions. She guides her clients through mergers and acquisitions, including the drafting and negotiation of commercial agreements and related filings and disclosures. She also keeps her clients informed about new or proposed regulatory changes from federal regulatory agencies.
Melissa applies her deep interest in human subjects research to her work counseling clients on requirements under the Common Rule (45 CFR 46) and Food and Drug Administration requirements. She also assists them in structuring and negotiating agreements that govern research studies, including data use agreements in compliance with the Health Insurance Portability and Accountability Act, the European Union General Data Protection Regulation, and other privacy laws.
As a member of an institutional review board, Melissa has evaluated informed consent forms, research protocols, and data privacy concerns. Her practice is guided and informed by this experience and perspective.
Before joining Epstein Becker Green, Melissa was a Special Counsel for nine years with the Commodity Futures Trading Commission, where she coordinated policy responses to cybersecurity and business continuity threats, participated in international policy discussions, and was a key contributor to various rulemakings. Prior to that, she worked at an international law firm, advising a range of clients, including health care and life sciences companies, on internal investigations, compliance, and transactional matters. During law school, Melissa was a summer intern in the office of the Michigan Department of Attorney General.