Barry Rosenblatt, Ph.D., President, SME Biotech Consulting; is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotherapeutics with a proven 30+ year track record in biotechnology and the pharmaceutical industry. Developed, transferred and validated purification processes and assays for multiple new molecular entities through all stages of drug development, including licensure. Currently serving as a consultant to the industry as President/sole proprietor of SME Biotech Consulting. The proven presenter who has served as an instructor, presenter, as well as Chairperson for conferences and courses. Previously served as associate director of Process Development for Centocor/JNJ (18 years) and 8 years as head of Analytics, Process Evaluation, Contract Manufacturing, and Sterile Services at Charles River Laboratories, Malvern PA... Academic credentials include a Ph.D. in Cell Biology/Immunology from the Albert Einstein College of Medicine, Bronx, NY.
18 March 2019
11 : 00 AM EST
This session explores the elements required for a successful technology transfer between various sites. It is intended for anyone who may be involved in the transfer of information between groups or sites. This includes both internal transfers as well as transfers to a third party. Upon completion of this session, the attendee will have a greater understanding of the process and what is required to ensure a..
29 April 2019
01 : 00 PM EST
This session explores the complexities surrounding the development of a biosimilar molecule. It is intended for anyone who may be involved in the oversite and participation in the development, manufacturing, and distribution of a potential biosimilar product. Upon completion of this session, the attendee will have a greater understanding of the process and what is required for a higher probability of succes..