Dr. Mark Levi is a scientific leader with a unique blend of early-phase product development, regulatory strategy, and thought leadership focused on client growth and regulatory success by translating goals/ objectives into actionable operating plans. Dr. Levi has more than 19 years of experience as a pharmacology/toxicology researcher, chemist, and regulatory affairs professional. He is trained in small molecule medicinal chemistry and pharmacology/toxicology. He has worked as a consultant on all aspects of regulatory strategy across multiple therapeutic areas encompassing biologics and biologic-device combination products. Dr. Levi has subject matter expertise in biologics, hematology, oncology, neuropharmacology, neurotoxicology, drug discovery, vaccines, cell and gene therapy, data integrity, and biologic-device combination products, as well as significant expertise with novel biologics, biosimilars, and blood products. He has U.S. Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) review experience in the Office of Compliance and Biologics Quality and in the area of chemistry, manufacturing, and controls (CMC)-lot release. Dr. Levi has expertise in managing all types of regulatory submissions and meeting types as an FDA reviewer and a Regulatory Project Manager. He has review and development experience in multiple indications, including immune deficiencies, hematology, hematologic oncology, rheumatoid and osteoarthritis, neurology, endocrinology, gastroenterology, and rare diseases. He has led preparation and submission of foreign and FDA investigational new drug (IND) applications, biologics license applications (BLAs), and requests for expedited designations (including regenerative medicine advanced therapy [RMAT], breakthrough, and fast-track), specifically driving strategy for and data integrity within these submissions.