Dr. Barbara Mounho-Zamora is a Senior Consultant with ToxStrategies, Inc., and is based in Bend, Oregon. She is a board-certified toxicologist with more than 17 years of experience in the biopharmaceutical and pharmaceutical industry.
Dr. Mounho-Zamora has extensive experience developing and overseeing comprehensive toxicology programs to support the development and, ultimately, approval of drug candidates in various therapeutic areas, including oncology and inflammation (autoimmune indications). As a toxicologist in the pharmaceutical and biopharmaceutical industry, she has been responsible for designing, monitoring, and interpreting toxicology studies to support the development of biopharmaceutical (biotechnology-derived) therapeutics (e.g., vaccines, monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, fusion proteins), including screening and mechanism-of-action studies; repeat-dose, bridging, and chronic studies; embryo/fetal development; reproductive toxicity; and carcinogenicity assessment studies.
Dr. Mounho-Zamora specializes in addressing the scientific challenges related to the development of biological products (novel and biosimilars), such as selection of relevant animal species, immunogenicity (anti-drug antibodies), alternative models for safety assessment (e.g., homologous proteins), immune-mediated toxicity, and embryo/fetal development, reproductive toxicity, and carcinogenicity assessment of these molecules. In addition, she has been responsible for developing the nonclinical comparability studies to support manufacturing process changes (e.g., host cell line, manufacturing facilities, excipients/formulation) that occur during the life cycle of a biopharmaceutical (pre-market and post-market). Dr. Mounho-Zamora has also served as the toxicology representative for due diligence meetings for in- and out-licensing biopharmaceutical/pharmaceutical products in various therapeutic areas (e.g., oncology, inflammation, cardiovascular indications), as well as company acquisitions and partnerships.
Dr. Mounho-Zamora has been involved in developing various biosimilar products in different therapeutic areas (e.g., inflammatory disease; oncology) and has experience in addressing the scientific, regulatory, and business-related challenges associated with the global development of biosimilars. She has expertise in addressing the nonclinical in vitro and in vivo studies (e.g., pharmacology, PK, toxicology) necessary to support global applications for different biosimilar products, including biosimilars of recombinant proteins and monoclonal antibodies. She has also participated in the development of industry and trade-association comments in response to concept papers and draft guidance for biosimilar products issued by global authorities worldwide. She has written the pharmacology/toxicology sections for numerous regulatory documents, including pre- Introduction of a New Drug (IND) packages, INDs/ Clinical Trial Authorisations (CTA)s, Biologic License Applications (BLAs)/New Drug Applications (NDAs), investigator brochures, and annual reports, as well as the safety information on product labels and package inserts.
Dr. Mounho-Zamora has extensive experience meeting with regulatory authorities in different regions (e.g., US, Europe, Canada) representing the nonclinical safety assessment package in support of the global development of drug candidates and biosimilar products (e.g., pre-IND meetings, clinical hold issues, pre-BLA, label negotiations). She also supports clients in addressing programs that have been placed on Full Clinical Hold by the FDA, and in developing the scientific and regulatory strategy to meet the Agency’s concerns and remove the Full Clinical Hold. Dr. Mounho-Zamora has experience in developing risk assessment/ toxicology monographs that can be used to evaluate the safety implications for an active pharmaceutical ingredient (API), including formulation excipients, product- and process-related impurities, or raw materials for both small-molecule and biological products. In generating toxicology monographs, she has experience in the determination of risk-based limits (e.g., occupational exposure limits [OELs] and/or permissible daily exposure [PDE]), depending on the intended use of the monograph (workplace risk assessment or risk to human health/patients in the context of how the product is used).
Prior to joining ToxStrategies, Dr. Mounho-Zamora was at Amgen, Inc. (Director, Regulatory Affairs Biosimilars Policy and Strategy; Scientific Director, Toxicology Department), and Genentech, Inc. (Scientist, Toxicology Department). She is a Fellow of the Academy of Toxicological Sciences (2013), a Diplomate of the American Board of Toxicology, and a member of the American College of Toxicology (Council member, 2005–2008; Continuing Education Committee, 2003-2005) and the Society of Toxicology (Continuing Education Committee, 2006–2009; President of the Biotechnology Specialty Section, 2010–2011). Dr. Mounho-Zamora is recognized in the biopharmaceutical industry for her strong working knowledge of biological/biosimilar products, and is the author of numerous journal articles and book chapters on the challenges associated with these products.