Nonclinical Development of Biologics, Vaccines and Specialty Biologics

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. Dr. Claudette Fuller is currently Vice President, Global Head of Non-Clinical Safety & Toxicology at Genmab where she leads an exceptional international team in the development of oncology and immunology biologics. She is deeply committed to the advancement of new approach methods (NAMs) to replace in vivo toxicology with robust in vitro and in silico/AI approaches. Previously, she was an Executive Director, Therapeutic Area Leader for the Immunology and Infectious Disease Portfolios, and Compound Leader for immuno-oncology biologics and vaccines in Nonclinical Drug Safety at Merck Research Laboratories, Merck & Co., Inc. She was an Immunotoxicology and Nonclinical Lead at GSK where her focus was therapeutics for autoimmune disorders. Dr. Fuller completed her PhD in immunology at the University of Virginia and her postdoctoral work at the National Cancer Institute. She’s also had the opportunity to serve as an ad hoc instructor at both Baylor, College of Medicine and Johns Hopkins, Bloomberg School of Public Health.

Preface Section I: Development of Biopharmaceuticals 1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development 2. Nonclinical Development of Monovalent and Polyvalent Biopharmaceuticals 3. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines 4. Early De-risking Strategy for Novel Biotherapeutics 5. Pharmacokinetics, Pharmacodynamics, and Bioanalytics Section II: Vaccines 6.  Introduction to Vaccines and Adjuvants 7. Global Regulatory Guidelines for Vaccines 8. Special Considerations for the Nonclinical Safety Assessment of Vaccines Section III: Specialty Biologics and Indications 9. Gene Therapy 10. Cell Therapy 11. Biological Therapies for Cancer 12. Considerations in the Development of Pluripotent Stem Cell-based Therapies