James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters relating to new drug and biologic development and approval. In this capacity, James has helped secure FDA approvals for many new drugs across a wide range of therapeutic areas and treatment modalities, including ERT, ASO, mRNA, and cell and gene therapy. This work is often in areas where there are no well-defined development pathways, much of which is in the rare disease arena. James provides preapproval development and regulatory strategy, including on the use of novel clinical outcome assessments, innovative clinical trial designs and statistical approaches, and leveraging confirmatory evidence to support single study approvals. He has also been involved in a significant proportion of accelerated approvals for non-oncologic treatments, spearheading strategies for novel surrogate biomarkers and intermediate clinical endpoints.
James is also a champion for the patient voice in drug development and review. Before joining the firm in 2014, James worked in the FDA Office of Special Health Issues where he facilitated patient input in benefit-risk decision-making. James helped administer the FDA Patient Representative Program, facilitate stakeholder consultations during the reauthorization of PDUFA and MDUFA, and launch the Patient-Focused Drug Development program. In his current practice, James has helped to plan and moderate roughly 75% of all externally-led Patient-Focused Drug Development meetings and aids patient organizations in planning Patient Listening Sessions and regulatory scientific workshops (e.g., Critical Path Innovation Meetings, Science Focused Drug Development).
In recognition of his contributions to the rare disease patient community, in 2019 Global Genes named James as a RARE Champion of Hope.
In his time at FDA, James also worked at the FDA Center for Drug Evaluation and Research’s (CDER) Office of Regulatory Policy where he handled a variety of postmarket safety issues including REMS and safety labeling changes.