Medical Device Submissions Series: Investigational Device Exemption (IDE) Workshop

Tony Blank is the Senior Director of Regulatory Affairs at AtriCure. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Previously, Blank spent 12 years at Boston Scientific Corp. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired).

Amrin Chowdhury is a Health Scientist in CDRH’s Office of Clinical Evidence and Analysis (OCEA) at FDA. She joined the FDA in 2022 serving as a Policy Analyst within OCEA and currently, a member of the CDRH Bioresearch Monitoring Program (BIMO). Her work in BIMO focuses on bioresearch monitoring review and directing inspection of Premarket applications, which can include Premarket Approval Applications (PMAs), Premarket Notifications (510ks), Humanitarian Device Exemptions (HDEs), and De Novos. Prior to joining the FDA, Amrin served roles as a Project Manager, Clinical Research Associate, and Data Manager for various Phase I – Phase III drug clinical trials across different organizations, including Foundation for the National Institutes of Health, Leidos Biomedical, Inc., and EMMES Corporation.  

Amrin received a bachelor’s degree in biology from George Mason University and a master’s in health science from George Washington University. 

Anne Talley is a Chemical Engineer in the Division of Clinical Policy and Quality within the Office of Clinical Evidence and Analysis (OCEA) in the Center for Devices and Radiological Health (CDRH) at FDA. Anne has over 7 years of experience at FDA, both as a Lead Reviewer/Team Lead in the Office of Orthopedic Devices (OHT6) and within OCEA.

Blake Wilson helps medical device, drug, and biologic companies successfully navigate FDA’s evolving regulatory landscape. With a focus on premarket submissions and clinical trial design and conduct, Blake helps sponsors plan their product development strategy and minimize regulatory risks.  

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.