James Valentine, J.D., M.H.S., is an associate attorney at Hyman, Phelps & McNamara, P.C. where he 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. He also works with clients on clinical trials operations and compliance matters. James has been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped with the planning of seven such meetings and having moderated six of those, and is also working on developing novel methodologies for capturing patient experiences and preferences. As a thought leader in patient engagement, He served on the Clinical Trial Transformation Initiative’s project team on best practices for patient advocacy group engagement with clinical trial sponsors, which issued recommendations in October 2015 and a publication on best practices in July 2017 (available here: http://www.hpm.com/devitem.cfm?RID=2549). In addition, James speaks regularly on evolving issues surrounding patient engagement in FDA’s regulatory decision-making and testifies at FDA public meetings and workshops on PFDD and patient experience data implementation. He previously worked in FDA’s OHCA 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. He administered the FDA Patient Representative Program, facilitated stakeholder consultations during the reauthorization of PDUFA and MDUFA, launched the PFDD program, and developed the FDA Patient Network. James also worked at the (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.