James E. Valentinejev
Hyman, Phelps & McNamara, P.C
Team Member


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. He is admitted to practice in Maryland and the District of Columbia.


Before joining Hyman, Phelps & McNamara, P.C. 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.


James will be one of the distinguished speakers at the 5th Annual Strengthening Patient Advocacy Relations Conference.


Why do you find the role of patient advocacy to be important?
Patients and caregivers provide a unique perspective about their disease and how the experience it that researchers and clinicians cannot bring to the table. Having patient advocates engaged in the clinical trials enterprise can help ensure it takes into account these experiences of patients and their needs and desires, which I believe will result in more efficient and effective development programs, leading to a greater number of treatment options coming to market.


Why do you find your particular topic to be of importance to this years’ agenda?
In my work with the Clinical Trials Transformation Initiative, in looking to identify best practices for engagement between clinical research sponsors and patient groups, we identified perceived laws and regulations as a barrier to effective engagement. However, in the United States, our legal and regulatory framework provides a great deal of opportunity for engagement with patients and patient groups. In fact, FDA encourages industry and the patient community to work more collaboratively. Having an understanding of this framework can help all stakeholders ensure compliant engagement that will still further the mutual interests: the development of safe and effective treatments.