Using Prior Knowledge and Platform Manufacturing

Tuesday, February 26, 2013, 2:00pm-4:10pm PST

This session will focus on how best to leverage prior process, analytical and formulation knowledge toward acceleration of drug substance and drug product manufacture. The value of clear understanding of the link between process parameters and CQAs will also be explored. Some examples could be minimal or no process development for phase I material, more efficient process and product development and more streamlined process validation.

Session Co-Chairs:

  • Narendra Bam, GlaxoSmithKline

  • Jon Coffman, Pfizer

Confirmed Speakers

  • Rick Caimi, GlaxoSmithKline: Accelerating Early Phase Development through Efficient Implementation of Molecular Design and Platform Knowledge

  • Jeff Salm, Pfizer: Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process

Rick Caimi

Rick Caimi has nearly 20 years experience in the biopharmaceutical industry spanning virtual biotech organizations through large Pharma. In his current role as Director of Early Phase CMC Development, Rick is responsible for leading development activities supporting Pre-Clinical and Phase I/II manufacturing for all BioPharms in GSKs growing development pipeline. He received his Ph.D. in biochemistry from Cornell University in 1995.Read more

Jeff Salm

Dr. Jeffrey Salm is currently a Senior Principal Scientist in the Purification Process Development group at Pfizer in Andover, MA.  Prior to joining Pfizer in 2007, he worked as a downstream process development scientist at CuraGen. Jeff is a chemical engineer by training and is a graduate of the University of Delaware (B.Che.) and North Carolina State University (Ph.D.) Read more