Mark A. Tobolowsky

Mark A. Tobolowsky focuses on drug development counseling and helps developers troubleshoot and find creative solutions to unexpected challenges to create as smooth a pathway to success as possible.

He assists clients on a wide range of pre- and post-approval FDA legal and regulatory matters for drugs and biologics, including development strategies, meeting planning and preparation, submissions to FDA, life cycle management, and guiding clients through applicable requirements. Mr. Tobolowsky also provides counsel to clients in order to achieve and leverage legal and regulatory incentives.

Prior to joining the firm, Mr. Tobolowsky worked for more than ten years in the FDA legal and regulatory field, primarily at another FDA-focused law firm and for a gene therapy company, where he developed an interest in, and significant experience with, regenerative medicine therapy development. He has worked with pharmaceutical and biotech companies of differing sizes, areas of medicine, and at all different stages of the product lifecycle.

Mr. Tobolowsky has authored, in whole or in part, citizen petitions, comments on guidance documents, and expedited program applications. He has also drafted and shaped portions of meeting requests, meeting packages, INDs, NDAs, BLAs, and other submissions to the FDA.

He writes frequently on drug development, FDA and regenerative medicine. Mr. Tobolowsky earned his J.D. from Washington University in St. Louis School of Law and his undergraduate degree from Rice University