{"product_id":"translational-medicine-joy-a-cavagnaro-9780367644451","title":"Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals","description":"\u003cp\u003eTranslational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody-drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety.\u003c\/p\u003e\u003cp\u003eKey Features: \u003c\/p\u003e\u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eDefines best practices for leveraging of discovery research to facilitate a development program\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eIncludes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eDiscusses rare diseases\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eDiscusses \"What-Why-When-How\" highlighting different considerations based upon product attributes.\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eIncludes special considerations for rare diseases\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eAbout the Editors\u003c\/p\u003e\u003cp\u003eJoy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies.\u003c\/p\u003e\u003cp\u003eMary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Joy A. Cavagnaro\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0367644452\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780367644451\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/27\/2024\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 542\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.66lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 11.00h x 8.25w x 1.10d","brand":"Joy A. Cavagnaro","offers":[{"title":"Paperback","offer_id":45897879486719,"sku":"9780367644451","price":77.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_966ff128-dbb2-4ad6-8b6d-3fb1a7ce3a64.jpg?v=1721374970","url":"https:\/\/www.whiterainbookhouse.com\/products\/translational-medicine-joy-a-cavagnaro-9780367644451","provider":"WR Book House","version":"1.0","type":"link"}