James E. Valentine Associate 202-724-1745
James E. Valentine


James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine also works with clients on clinical trials operations and compliance matters.

Before joining the firm in 2014, Mr. Valentine worked in FDA’s Office of Health and Constituent Affairs (previously Office of Special Health Issues) where he facilitated patient input in benefit-risk decision-making and served as a liaison to stakeholders on a wide range of regulatory policy issues. Mr. Valentine administered the FDA Patient Representative Program, facilitated stakeholder consultations during the reauthorization of PDUFA and MDUFA, launched the Patient-Focused Drug Development program, and developed the FDA Patient Network.

Mr. Valentine also worked at the Center for Drug Evaluation and Research’s (CDER) Office of Regulatory Policy where he coordinated the implementation of the medical gases certification scheme that was established in FDASIA and handled a variety of postmarket safety issues including REMS and safety labeling changes.

Education & Admissions


J.D., University of Maryland Carey School of Law
M.H.S., Johns Hopkins Bloomberg School of Public Health
B.A., University of Maryland, Baltimore County


District of Columbia


Prescription Drugs and Biologics
Provides strategic advice on matters involving product development and marketing approval, including clinical trial design, expedited programs, and incentives programs.
Counsels clients on submission strategies, as well as preparing for meetings with FDA and Advisory Committee meetings.
Prepares requests for orphan drug designation, breakthrough therapy and  RMAT designation, and priority review vouchers.

Patient Engagement
Provides strategic advice for patient and patient group engagement with sponsors and FDA.
Plans and moderates Externally-Led Patient-Focused Drug Development meetings.
Counsels clients on development of ‘patient experience data’ to inform product development and review , including patient narratives, surveys of patient experiences and preferences, and focus groups.
Develops Voice of the Patient reports, draft benefit-risk frameworks, and Draft Guidance for submission to FDA.

Clinical Trials Enforcement and Compliance
Provides counsel on clinical trials operations and compliance matters, including informed consent, reporting adverse events, and registration and results reporting.
Assists with responses to BIMO inspection reports, warning letters, and clinical investigator disqualification proceedings.

Corporate Transactions
Conducts FDA regulatory due diligence related to financings, mergers and acquisitions, and licensing deals involving pharmaceutical and biotechnology companies.

Honors & Awards

  • FDA Outstanding Service Award
  • FDA Commissioner’s Special Citation
  • CDER Team Excellence Award
  • FDA Group Recognition Award
    2011, 2012, 2013, 2014
  • Global Genes RARE Champion of Hope Nominee

Speaking Engagements

  • DIA Global Annual Meeting, The Patient’s Assessment of the Patient-Focused Drug Development Meeting Initiatives and Global Rare Disease Town Hall, June 24-28, 2018
  • BIO International Convention, Patient-Focused Drug Development 2.0: Implementation Update under 21st Century Cures & PDUFA VI, June 4-6, 2018
  • World Orphan Drug Conference 2018, FDA & High Performance Communities: Understanding Compliance and Patient Experience Data, April 25-27, 2018
  • American Society for Experimental Neurotherapeutics Annual Meeting, Dinner Symposium: Patient Involvement in Drug Approval, March 7-10, 2018
  • Food and Drug Law Institute Patient Organizations: An Introduction to U.S. Drug Law and Regulation, Panelist: Question & Answer Panel, November 7-8, 2017
  • Food and Drug Law Institute Patient Organizations: An Introduction to U.S. Drug Law and Regulation, Submission of Marketing Applications & the FDA Approval Process, November 7-8, 2017
  • CDER Rare Diseases Public Workshop: Strategies, Tools and Best Practices for Effective Advocacy in Rare Diseases Drug Development, So you want to engage with CDER at FDA? Strategies for effective engagement, October 30, 2017
  • Fourth Annual Rare Disease Summit, ADVOCACY INNOVATION: Harness Patient Reported Outcomes for FDA Interactions and Enhancement of Clinical Development, October 23-24, 2017
  • Leerink Partners Roundtable Series: Rare Disease & Immuno-Oncology, Assessing the Regulatory Approval Landscape for Orphan Drugs, September 27-28, 2017
  • Tuberous Sclerosis Complex (TSC) Patient-Focused Drug Development Meeting, June 21, 2017
  • DIA 2017 Conference, Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory, June 19-20, 2017
  • DIA 2017 Conference, Integrating the Patient’s Voice Across the Development Program of Rare Diseases: At the Table – Where to Sit?, June 19-20, 2017
  • 2017 Rare Patient Advocacy Symposium: Sharing Patient Voices Throughout the Drug Research and Development Process, No Longer Just the Research Subject: New Roles for Patients in Clinical Trials, May 19, 2017
  • Food and Drug Law Institute Annual Conference, Patient Engagement in Regulatory Decision-Making – Navigating the FDA & its Medical Product Centers, May 4-5, 2017
  • 8th Annual Biomedical Sciences Day, May 3, 2017
  • Spinal Muscular Atrophy (SMA) Patient-Focused Drug Development Meeting, April 18, 2017
  • 6th Annual Health Law Regulatory & Compliance Competition, March 4, 2017
  • Webinar: 21st Century Cures Act – Pharmaceutical and Biologic Product Development Provisions, January 12, 2017
  • Strengthening Patient Advocacy Relations Conference, Legal Review in Trends in Regulations Affecting Advocacy, July 14, 2016
  • DIA 2016 Annual Meeting, The Utility of Natural History Studies in Drug Development and Approval, June 28, 2016
  • BIO International Conference, Drug Development for Mitochondrial Disease: Examining the Current Landscape and Scientific/Regulatory Gaps, June 6, 2016

J.D., University of Maryland Carey School of Law
M.H.S., Johns Hopkins Bloomberg School of Public Health
B.A., University of Maryland, Baltimore County


District of Columbia

Practice Areas
FDA Regulatory Categories