Video: Reducing Risk in Small Molecule API Development From Discovery to Commercialization, by Dr. Stephen Houldsworth

In this interview, Dr. Steven Holdsworth, SVP, Commercial Head – BU Innovative Synthesis at CordenPharma, shares how biotechnology companies can accelerate development and reduce risk by partnering with an experienced CDMO. Drawing on nearly a decade-long collaboration with one customer, he illustrates the challenges many emerging biotechs face as they move from academic research and early discovery into clinical development.

Steven recounts how the company first approached CordenPharma as a university spin-out with limited manufacturing and development experience. While the initial goal was to produce material for toxicology studies and First-in-Human trials, the project quickly revealed challenges related to analytical methods, process development, scale-up, and product performance. At one critical stage, changes introduced during process optimization altered the physical characteristics of the API, resulting in unexpected pharmacokinetic results. By rapidly identifying the root cause and implementing a solution, CordenPharma helped the customer overcome the setback and keep the program on track.

As the partnership evolved, trust grew and CordenPharma became a strategic development partner rather than simply a manufacturing provider. Together, the teams addressed process validation, dosage form considerations, bioavailability optimization, and long-term development planning. The collaboration ultimately supported the advancement of multiple programs and contributed to the customer’s growth and success.

The interview also explores how CordenPharma continues to invest in its global small molecule network through expanded hydrogenation capacity, advanced analytical capabilities, flow chemistry, crystallization expertise, and digital infrastructure. Steven explains how CordenPharma’s integrated drug substance and drug product offering enables customers to simplify project management, improve knowledge transfer, reduce development risk, and accelerate timelines by working with a single partner throughout the product lifecycle.