Nonclinical Development of Biologics, Vaccines and Specialty Biologics

Contents
Contributors
Preface
Acknowledgments
I. Development of biopharmaceuticals
	1. Overview of biopharmaceuticals and comparison with small-molecule drug development • Christina de Zafra, Eric Harstad, and Amy Kim
	2. Nonclinical development of monovalent and polyvalent biopharmaceuticals • Karin Staflin, Chandrashekhar K. Korgaonkar, Padma Kumar Narayanan, Rodney A. Prell, Donna W. Lee, Wendy G. Halpern, and Anu Connor
	3. Regulatory guidelines and their application in the nonclinical evaluation of biological medicines • Claudette L. Fuller, Maggie Dempster, and Marque D. Todd
	4. Early de-risking strategy for biotherapeutics • Padma Kumar Narayanan, Anna Dahlman, and Ping Peng
	5. Novel biopharmaceuticals: Pharmacokinetics, pharmacodynamics, and bioanalytics • Sieto Bosgra and Manish Gupta
II. Vaccines
	6. Introduction to vaccines and adjuvants • Deborah L. Novicki
	7. Regulatory aspects of nonclinical vaccine development • Lisa M. Plitnick
	8. Special considerations for the nonclinical safety assessment of vaccines • Jayanthi J. Wolf
III. Specialty biologics and indications
	9. Preclinical development of viral vector gene therapies • Mary S. Newman, Eloise Hudry, Jacqueline Brassard, and Justine J. Cunningham
	10. Considerations for nonclinical studies conducted to support the development of cellular therapies • Michael W. Bolt and Padma Kumar Narayanan
	11. Biological therapies for cancer • Gautham K. Rao, Claudette L. Fuller, and Karen D. Price
	12. Considerations in the development of pluripotent stem cellebased therapies • Justine J. Cunningham, Alexandra Capela, Catherine Priest, and Eugene P. Brandon
Index