By David K. Lyon, Ph.D., Senior Fellow, Research, and Conrad Roten, Ph.D., Group Leader, R&D API Chemical Services
With the pharmaceutical industry’s focus on accelerating all aspects of drug discovery and development, it is crucial to reduce the time from initial product concept to first-in-human clinical completion. Numerous factors can slow this process, but challenges can be overcome by aligning with a single, integrated Contract Development and Manufacturing Organization (CDMO) to reduce the time, complexity, risks, and costs associated with engaging multiple partners.
The CDMO choice has never been more important given aggressive development timelines for candidate molecules, especially those targeting specialty and orphan applications. Important considerations include (1) the increasing complexity of drug compounds that may require special processing or “enabling” technologies to meet target product profiles (e.g., to increase bioavailability); and (2) the fact many of the new compounds are being developed by smaller and even virtual companies that may lack access to all of the equipment and expertise needed to bring a product to clinical trials and, ultimately, to market.
One study showed that interacting with a single CDMO service partner may shorten the first-in-human clinical timeline by an average of 14 weeks, reducing costs by nearly $21 million and increasing net revenues by almost $24 million.1 Potential advantages include a streamlined contract process; consistent reporting mechanisms; coordinated design and development for the active pharmaceutical ingredient (API), drug-product intermediate(s), and finished drug product; and simplified data sharing, technology transfer, and validation.