Dr. Shawna Weis is a Senior Managing Scientist with ToxStrategies, located in Massachusetts. Prior to joining ToxStrategies, Dr. Weis was with the FDA Center for Drug Evaluation and Research (CDER) for more than 6 years, and prior to that engagement, she was a pharmaceutical toxicologist in private industry for more than 8 years.
As a toxicologist in the biopharmaceutical industry, Dr. Weis developed both biopharmaceuticals and small molecules in a variety of therapeutic areas, including psychiatry and drug addiction, neurology, autoimmune disease, rheumatology, GI disease, antivirals, pulmonary disease (including development of inhalation products), and oncology. She gained extensive experience in the design, oversight, and interpretation of toxicology and pharmacology studies intended to support Investigational New Drugs (INDs) and designed and interpreted data needed for ongoing product development. She has written nonclinical sections of numerous regulatory filings, including pre-IND briefing documents, INDs/Clinical Trial Approvals (CTAs), investigator brochures, annual reports, and marketing applications, and has extensive experience in the development of product labeling for small molecules and biopharmaceutical products. She also produced numerous risk assessment monographs using original and published toxicology data to support permissible daily exposures (PDEs) of various excipients, process-related impurities, metals, and solvents in small-molecule and biopharmaceutical products. She has also written monographs to support waivers of carcinogenicity studies for biologics and small molecules.
While at the FDA, Dr. Weis served as a pharmacology/toxicology reviewer for the Office of Hematology and Oncology Products, where she was responsible for reviewing nonclinical data packages to support the administration of small molecules and biopharmaceuticals for the treatment of patients with advanced cancer. In this role, she participated in industry meetings with sponsors (e.g., pre-IND, end-of-Phase-2, pre-BLA/NDA [New Drug Application / Biologic License Application], Type A meetings, and Type C advice meetings), and reviewed numerous INDs and marketing applications (BLAs/NDAs) for drugs used to treat patients with advanced cancer. During this time, Dr. Weis gave presentations at local and national meetings, contributed to guidance documents, and collaborated on an Agency-wide survey of toxicology data submitted in support of biosimilar INDs.
Dr. Weis is a member of the Society of Toxicology and the American College of Toxicology.