From Orphan Drugs to Oncology: CDMO Capabilities to Accelerate Small Molecule Development

Pharmaceutical companies of all sizes are often challenged to identify a CDMO partner that can truly grow with their candidates in early development. An organization may kick off drug development with one proposed indication and smaller production volumes in mind but, as clinical results emerge and indications are added, additional API demands may begin to outstrip their partner’s capacity.

For drug developers commercializing orphan drugs, the search to find small-scale commercial partners presents another unique challenge.  Over the past two years, the FDA has approved more orphan drugs than non-orphan drugs, often with fast-track status.  To meet this need, CDMOs must be able to scale quickly within their facilities to help their clients progress therapies from early clinical toward validation and commercial launch.

Cambrex recently invested $30 million in the expansion of its API development and small-scale commercial capabilities in High Point, North Carolina.  On this webinar, Brian Swierenga, VP of Operations and Site Director, High Point and Dan Bowles, Senior Director of Chemical Development, High Point, will discuss how their facility and the Cambrex network are evolving to enhance capabilities and accelerate API development.

Featured Speakers

Brian Swierenga
Vice President, Operations and Site Director, High Point (North Carolina)
Cambrex

Brian is an experienced pharmaceutical R&D scientist and executive with over 30 years in clinical API manufacturing within the pharmaceutical and CDMO industries. Brian has led teams across the manufacturing value chain, including Operations, Development Engineering, Pilot Plant Operations, and Process Development. Brian currently leads the Cambrex site in High Point, North Carolina as the Vice President of Operations and Site Director.

Dan Bowles
Senior Director, Chemical Development, High Point (North Carolina)
Cambrex

Dan Bowles is a veteran R&D scientist with over 20 years of experience in Chemical Process Development within the pharmaceutical and CDMO industries. Dan brings nearly 11 years of experience at the Cambrex High Point facility and currently leads the Chemical Development team, which includes Chemical R&D, Analytical R&D, Engineering R&D, and Project Management teams.

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