Blake E. Wilson

When advising companies, Blake draws on years of experience practicing in front of the FDA. He has assisted clients across a wide range of submissions (e.g., presubmissions, investigational products, combination products, humanitarian/orphan products, marketing applications, breakthrough requests) with a focus on novel treatments . When feedback from the agency is needed, Blake helps sponsors craft a well-tailored regulatory strategy and is effective at presenting the plan to FDA. He also prepares sponsors for advisory panel hearings.  

Leveraging his prior experience in clinical research and biostatistics, Blake advises sponsors on study design considerations and reporting study outcomes. By stress testing clinical evidence through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project. He also prepares sponsors for FDA Bioresearch Monitoring (BIMO) audits, and can host the inspection. Whether crafting a regulatory strategy, preparing a submission, or negotiation a solution with the agency, Blake provides technical acumen and creativity to help companies achieve their goals.

Blake also advises on due diligence and other corporate matters related to medical products (e.g., mergers and acquisitions). He also assists companies with compliance challenges, including government and internal investigations, and 483 and Warning Letter responses.

While at Penn Law, Blake was an executive editor for the Journal of International Law and published a comment regarding the use of foreign clinical trials in the FDA's drug marketing approval process. He also served as a judicial intern to the Honorable Leonard P. Stark of the U.S. District Court for the District of Delaware. Prior to becoming a lawyer, Blake was a lead research assistant at Brown University, where he managed phase I and II pharmaceutical clinical trials; he later went on to obtain a master’s degree in biostatistics from Columbia University.