Dr. Lisa Plitnick received a BA in Biology from The State University of New York at Oswego and an MS and a PhD in Immunology from the Albany Medical College in Albany, New York. In 2002, she joined the Department of Safety Assessment and Laboratory Animal Resources in Merck Research Laboratories where she worked as a Study Director and currently serves as the Preclinical Safety Lead on drug development teams and as the Therapeutic Area Lead for Vaccines. She is the Scientific and Regulatory Advisor for the In Vivo Biologics Release Testing Group in the Merck Manufacturing Division and the Scientific Advisor for the Immunotoxicology Laboratory. Dr. Plitnick has edited a book, contributed to several book chapters on biologics and vaccines, and peer-reviewed journal articles. She is a member of the HESI ILSI Immunotoxicology Technical Committee, the BioSafe Specialty Biologics Expert and MoA/MoT working groups, and the Merck Immunotoxicology Council.
...brings nonclinical testing of biological and follow-on biological drugs, vaccines plus cell and gene therapy drugs right up to date. It is written in a very readable, yet highly scientific manner and most of the relevant publications...on the topic are referenced...Overall, a 'must read' book for all in the nonclinical field of developing biological drugs. --btsNews, June 2014 Researchers in pharmaceuticals, toxicology, and other biological sciences summarize the current status of developing medicines from biological material, pointing out where the process is different from developing small-molecule medicines and where it is the same. The topics include regulatory guidelines and their application in the non-clinical evaluation of biological medicines, early de-risking strategy for novel biotherapeutics... --Reference & Research Book News, December 2013