Dr. Janice Lansita is the Biopharmaceutical and Pharmaceutical Practice Leader with ToxStrategies, located in Kennett Square, PA. She is a board-certified toxicologist with over 13 years of experience, both in the biopharmaceutical industry and with the Food and Drug Administration (FDA). As a regulatory toxicologist in the biopharmaceutical industry, Dr. Lansita has developed multiple biological products, including monoclonal antibodies, fusion proteins, and cytokines, for various indications (e.g., oncology, asthma, rheumatology, and multiple sclerosis). She has extensive experience in the design, monitoring, and interpretation of nonclinical toxicology studies (GLP and non-GLP). In addition, she authored the nonclinical sections of various regulatory documents, including pre-IND (investigational new drug) packages, INDs/CTAs, Investigator Brochures, annual reports, BLAs/NDAs, and package inserts/product labels for biopharmaceuticals.
Dr. Lansita has specialized expertise in the nonclinical development of biologic therapeutics, including pharmacologically relevant species selection, immunogenicity, immune-mediated toxicity (e.g., complement, anti-drug antibody, autoimmunity, cytokine-release), surrogate animal models, immunotoxicology endpoints, and study design. She also has ocular toxicology nonclinical development expertise for small molecule and biologic ophthalmic drugs (intravitreal and topical routes of administration), including nonclinical study design (rodents, rabbits, dog, and non-human primate), overall nonclinical development strategy, developing regulatory briefing packages, and providing representation at regulatory authority meetings.
Dr. Lansita has experience with both the FDA and pharmaceutical/biopharmaceutical companies in developing risk assessment/toxicology monographs that can be used to evaluate potential safety issues for active pharmaceutical ingredients (APIs), including excipients, product- and process-related impurities, or raw materials for both small-molecule and biological drug products. In generating toxicology monographs, she has experience in the determination of risk-based limits such as the permissible daily exposure (PDE).
At the FDA’s Center for Drug Evaluation and Research (CDER), Dr. Lansita served as a pharmacology/ toxicology reviewer and was responsible for reviewing the nonclinical data packages (i.e., pharmacology, pharmacokinetics, and toxicology) of small molecule and biologic products submitted by sponsors to support the safety of various drugs: anti-virals, special pathogens, transplant, and ophthalmology products. In this role, Dr. Lansita participated in meetings with sponsors (e.g., pre-IND, Type A, and Type C) and reviewed pre-IND packages, INDs, and NDAs/BLAs for both small molecule and biological products. She has a comprehensive understanding of the regulatory requirements, as well as the Agency’s current expectations for nonclinical drug development. Additionally, she has worked with sponsors to address scientific challenges related to the development of drug candidates, including clinical hold issues, or issues that may affect clinical development, and she has insight into the current FDA regulatory perspectives relevant to the review of nonclinical studies for biopharmaceuticals/ pharmaceuticals. During her time with the FDA, Dr. Lansita contributed to the nonclinical sections of various FDA guidance documents (including the draft guidances for Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, HIV: Developing Anti-Retroviral Drugs for Treatment; also assisted in addressing the public comments on the S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, and the draft guidance for HCV: Developing Anti-Retroviral Drugs for Treatment), taught an educational course to FDA reviewers on the nonclinical review of biologic products, and served as Co-Chair of the Pharmacology/Toxicology Coordinating Committee’s Nonclinical Biologics Subcommittee, composed of pharmacology/toxicology reviewers with expertise in biological products across the CDER review Divisions.
Prior to joining ToxStrategies, Dr. Lansita was with the FDA (CDER) for more than five years, and prior to the FDA, she was a toxicologist at Biogen. She is a Diplomate of the American Board of Toxicology, and a member of the American College of Toxicology and the Society of Toxicology.