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
• 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
• 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
• Friedreich’s Ataxia (FA) Patient-Focused Drug Development Meeting, June 2, 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
see more blog entries
• Congress Releases a (Near) Clean Draft User Fee Bill; Includes Restructured Assessment of Fees & Very Limited Policy Riders,
April 20, 2017
• Jury Rules on Charges against Owner and Head Pharmacist of NECC,
April 4, 2017
• HP&M’s Frank Sasinowski and Kurt Karst Highlight Regulatory Innovations in Neurotherapeutics at the ASENT 19th Annual Meeting,
March 20, 2017
• Rare Disease Week Recap: HP&M’s Frank Sasinowski Briefs the Rare Disease Congressional Caucus,
March 6, 2017
• Do President Trump’s Regulatory Freeze-Out and “1-in-2-Out” Orders Affect the Regulation of Compounding?,
February 20, 2017