James E. Valentine
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
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James Valentine assists medical product industry 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.
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 designation, and priority review vouchers.
• Provides guidance on engaging patients and patient groups during development, with a focus on patient interactions with 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.
• Conducts FDA regulatory due diligence related to financings, mergers and acquisitions, and licensing deals involving pharmaceutical and biotechnology companies.
Awards & Recognition
FDA Outstanding Service Award, 2010
FDA Commissioner’s Special Citation, 2012
CDER Team Excellence Award, 2013
FDA Group Recognition Award, 2011, 2012, 2013, 2014
Articles / Publications
• The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials,
July 27, 2017
• Room for Flexibility in FDA's "Gold Standard" of Drug Approval,
July 16, 2015
• Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory Science,
April 27, 2015
• Bringing Your Pharmaceutical Drug to Market,
April 1, 2015
see more speaking engagements
• Patient Organizations: An Introduction to U.S. Drug Law and Regulation, Panelist: Question & Answer Panel, November 7-8, 2017
• ; 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
see more blog entries
• A Spark Points the Way Forward on Gene Therapy,
October 12, 2017
• Regenerative Medicine Advanced Therapy: FDA’s Newest Expedited Program Evolves to Keep Pace with Recommendations,
September 27, 2017
• Accelerating Accelerated Approval & Other Drug Development Signals from FDA’s Approval of 1st Therapy for Chagas,
September 13, 2017
• CDRH Schedules Inaugural Meeting of Patient Engagement Advisory Committee,
August 7, 2017
• FDA Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations: A Holdover until Rulemaking,
July 31, 2017