Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.- Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical- Contains the most pertinent international regulatory guidance documents for nonclinical evaluation- Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"- A multi-authored book with chapters written by qualified experts in their respective fields

About the Author

Dr. Lisa M. Plitnick is a Distinguished Scientist in Nonclinical Drug Safety, Merck Research Laboratories, Merck and Co., Inc. Lisa joined Merck in 2002 and currently serves as the Therapeutic Area Lead for Vaccines and a Nonclinical Safety Leader on vaccine and biologic development teams spanning early and late development. Lisa is also the Scientific and Regulatory Advisor for the in Vivo Biologics Release Testing Group in the Merck Manufacturing Division. Lisa co-edited the first edition of this book, Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics and has written and/or contributed to book chapters and peer-reviewed journal articles on biologics and vaccines. Lisa received a M.S. and Ph.D. in Immunology from the Albany Medical College. Following her graduate work she did a postdoctoral fellowship with a focus on Immunotoxicology in the Curriculum in Toxicology at the University of North Carolina in cooperation with the US Environmental Protection Agency, Dow Chemical and DuPont.