Marylana Saadeh Helou, J.D. is a health care and life sciences Partner at the law firm Epstein Becker & Green, P.C.  She advises academic medical centers, pharmaceutical and medical device companies, digital health companies, and other health care technology companies on a comprehensive range of issues affecting biomedical research. Attorney Helou’s experience includes counseling on the structure of research agreements for multi-site global industry-sponsored clinical trials and strategic research collaborations, and assisting clients in the drafting and negotiation of such agreements and related informed consent forms and authorizations. She advises clients on complex and evolving regulatory issues and considerations related to structuring decentralized clinical trials, mobile app/device research, and repositories for health data, genomic, and biospecimen research, including navigating secondary uses of stored materials, and psychedelic research. She also regularly advises clients on FDA requirements for clinical investigations, treatment with investigational products under the FDA’s Expanded Access Program and Right to Try laws. A large portion of her practice includes advising on research compliance and misconduct investigations.  Marylana graduated from both Boston University School of Law and the American University of Beirut.