For small and mostly virtual pharmaceutical companies who have a precious and limited pipeline, the need to collaborate with a CDMO to advance their programs and assets is critical. Achieving proof of concept and beyond are the primary objectives of most innovative small pharmaceutical companies. While the pharmacological activity of the molecule is certainly important, the CMC aspects of a program can be viewed as the best opportunity for efficiency gains if selection of a CDMO provider offers end-to-end drug development. Coordinating with multiple CDMOs for individual testing or services is no longer viewed as time effective with shortening timelines to IND filings and amendments.
When a true partnership can be established between the customer and the CDMO, the program will advance with the highest scientific and quality integrity. This partnership requires strong two-way communication, scientific guidance, and flexibility to meet challenges and timelines. Dr. John Lynch and Dr. Sarah Bethune will present both challenges and opportunities associated with end-to-end drug development for small molecules. Their webinar will focus primarily on the Cambrex Longmont, CO, USA site which offers drug substance, drug product, and analytical elements all within the same facility. The overlapping benefits and parallel activities of each discipline will be presented and discussed in the context of rapidly addressing the challenges of early stage drug development and the efficiency gained when one site offers all the expertise and services required.
In this webinar you will learn:
How a drug program advances with the highest scientific and quality integrity when a strong CDMO partnership is forged
Both the challenges and opportunities associated with end-to-end drug development for small molecules
How Cambrex's Longmont, CO, USA site can offer drug substance, drug product, and analytical elements all within the same facility
Speaker Information Sarah Bethune, Ph.D., Sr. Director, Pharmaceutics & Formulation – Cambrex Longmont Sarah Bethune brings more than 12 years of industrial experience, spanning both early and late phase drug development within innovator and CDMO pharma. Prior to joining Cambrex, she held positions at SSCI, GlaxoSmithKline, and Avista Pharma Solutions. Throughout her career, Sarah has authored several scientific publications and holds various patents. Her expertise in both solid-state chemistry and formulation development allows her to provide broad CMC expertise and efficient drug development activities for her clients. Sarah received her bachelor’s degree from Drake University and PhD from the University of Michigan in pharmaceutical sciences.
John Lynch, Ph.D., Director, Process Chemistry – Cambrex Longmont
John is an innovative pharmaceutical chemist and scientific manager with over 20 years of experience conducting and leading teams at all levels of pharmaceutical chemistry research. A recognized expert on organic chemistry, medicinal chemistry, process research and development, custom synthesis, and GMP manufacture of active pharmaceutical ingredients. John received his undergraduate degree from the University of Wisconsin and Ph.D. from Harvard University.