Jack M. Ferdman

/My focus

I handle intricate regulatory, transactional, and enforcement matters, drafting and reviewing contracts, and advising on licensure and accreditation requirements, while also supporting corporate compliance strategies. My experience includes matters in connection with:

• Drug and vaccine development
• IRB policy and clinical trial agreements
• FDA Submissions
• eCTD
• Healthcare regulatory law, including fraud and abuse
• Healthcare compliance
• Defense of government agency investigations
• Contract drafting and review
• Licensing and accreditation
• Legal and regulatory research
• Drafting appellate briefs, memoranda, and internal resources regarding litigation strategy
• Global clinical trial and pharma regulation
• Regulatory support (including antitrust issues) for multimillion-dollar healthcare transactions, including those involving change of ownership (CHOW) and certificate of need (DON/CON)
• Policy analysis and legislative drafting
• Cross-functional client collaboration

In addition to a Juris Doctor, I hold a Master’s in Public Health Policy, a Regulatory Affairs Certification, and am board-certified in Public Health. My unique experience has empowered me to develop cross-functional insights not only as a healthcare attorney, but also as a regulatory analyst and scientific researcher at biotech and clinical institutions.

Since 2019, I have served on the Leadership Council of Boston Scores, a New England nonprofit charity focused on student development. I have also authored dozens of peer-reviewed publications and presentations spanning both law and science, and recently contributed an invited textbook chapter in the sixth edition of Health Politics & Policy (Cengage). My diverse background makes me a valuable asset to clients at the intersection of law, science, and public health.

/Looking ahead

Existing at the vanguard of scientific discovery, drug and device development often push the boundaries of what the law is presently structured to accommodate, and shifting priorities from one administration to the next can cause the enforcement landscape to change rapidly. Companies at any stage of the clinical development pipeline should maintain ongoing relationships with regulatory counsel to help ensure their products get to market safely and are postured for commercial success.