SpeakerSarah Bethune, Ph.D., Sr. Director, Pharmaceutics & Formulation and , John Lynch, Ph.D., Director, Process Chemistry – Cambrex Longmont
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