A great deal of trust is required when launching a drug’s clinical development – trust in a molecule, a process, facilities and teams, and a therapy’s ultimate potential. And this trust is built at the earliest stages, while a solid business case and fundamental science are inspiring confidence and encouraging investment.
The business case for any therapeutic starts with a chemistry, manufacturing, and control (CMC) developability assessment, according to Dr. Gene Lee, Vice President of Technical Development at AltruBio. Dr. Lee says Performing a CMC assessment is not unlike building a car. Both require taking a concept from design to prototype. He shares, “You build several versions of those early designs. See if they work; put them out on the racetrack; see what kind of range they have. Not all designs are going to work well.”
Dr. Lee discussed getting the developability question right and why it’s important to understand your end game as early as discovery in a recent episode of The Business of Biotech, produced by BioProcess Online and supported by Cytiva.