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.
Narendra Bam, GlaxoSmithKline
Jon Coffman, Pfizer
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