API Manufacturing requirements for CMOs throughout the drug lifecycle
The development of small molecules for their use in modern day medicine has existed since the 19th century and has developed into a 1 trillion dollar pharmaceutical industry. Small molecules represents the vast majority of drugs dispensed today and exciting advances in their use and ability to treat and cure disease will ensure they will thrive well into the next century.
Despite their ubiquity, small molecule drug development is a highly specialised industry, and each successful blockbuster that makes the journey to market has been beset on all sides by risk and failure. Such a journey requires a great understanding from contract manufacturing organisations (CMOs) to be active and dynamic to respond to pharmaceutical customers during the process.
In this webinar, an overview of the development and lifecycle of a small molecule drug is presented. Attention is then turned to the typical needs and requirements for an API manufacturer at each stage of the lifecycle. We then present a case study of how a CMO, such as Cambrex, has the expertise to support customers at all stages from early development to commercial launch.
Presented by
Daniel M. Bowles, Ph.D.,
Senior Director, Chemical Development
Dr. Bowles currently serves as Senior Director of Chemical Development at Cambrex High Point (formerly PharmaCore), with responsibility for the Chemical R&D, Analytical R&D, QC/stability, and Site safety groups.
Prior to joining CHP, he worked for 11 years with Pfizer Global R&D as a team leader in chemical development, building robust processes toward pilot plant manufacture. He has experience with process validation, large scale column chromatography, in-situ reaction monitoring, and high-throughput screening.
He received his Ph.D. at the University of Kentucky with Prof. John Anthony, followed by a postdoctoral fellowship in medicinal chemistry at Research Triangle Institute in Durham N.C. He is an author or co-author to over 20 scientific publications/presentations/patents.
Michael Tracey, Ph.D.,
Principal Scientist, New Product Development
Michael Tracey grew up in Minnesota and received his BS in chemistry from Denison University (Ohio) in 2000. He returned to Minnesota to attend the University of Minnesota and under the direction of Professor Richard Hsung earning his PhD in 2005.
Michael then moved on to a post-doctoral position at Stanford University with Professor Barry Trost. Staying in California, he joined the Process R&D group at Theravance in South San Francisco.
In 2008, Michael returned to the Midwest to the CD group at Cambrex Charles City where he is a Principal Scientist who has worked on many projects that were transferred to production ranging from 10 g to 700 kg.
