January 28, 2023

Volume XIII, Number 28

Marylana Saadeh Helou

Marylana Saadeh Helou is an Associate in the Health Care and Life Sciences practice, in the Boston office of Epstein Becker Green. She focuses her practice on advising academic medical centers, hospitals, universities, pharmaceutical and medical device companies, and other health care and research organizations on issues related to human subjects research and data privacy.

Ms. Helou’s experience includes:

  • Assisting clients in navigating requirements under the Common Rule, HIPAA, and other federal, state, and international data protection and privacy laws, including the GDPR

  • Advising on FDA requirements for clinical investigations, treatment with investigational products pursuant to FDA’s expanded access program and “Right to Try” laws, and FDA Part 11

  • Counseling on the structure of research agreements for industry-sponsored, investigator-initiated, and collaborative research studies, and assisting clients in the drafting and negotiation of such agreements and related forms and authorizations

  • Assisting with the design of repositories for data, genomic, and tissue research, including navigating secondary uses of stored materials 

  • Counseling on matters related to individual and institutional conflicts of interest, and assisting clients in reviewing and updating their policies and procedures to appropriately identify and manage such conflicts

Articles in the National Law Review database by Marylana Saadeh Helou