Transforming A Generic Into A Best-In-Class New Drug

By Andrea Franks, Senior Development Services Manager, Pfizer CentreOne

Pharma’s innovators, supported by more flexible regulatory pathways, have been blazing new trails to meet patients’ unmet needs by turning to outsourcing partners in greater numbers than ever before due to costs, timelines and technical requirements.

In 2020 approximately 26% of the world’s pharmaceuticals were manufactured by contract development and manufacturing organizations (CDMOs).

Pharma is asking its contract manufacturing partners to play an increasingly important role in commercializing intellectual property (IP). Most drug developers understand that program success starts by engaging commercial partners with the experience and capabilities that best suit a drug.

With so much at stake, securing the right CDMO partner is the first of many milestones. Once that threshold is crossed and technical transfer begins, a project can become very interesting.

At Pfizer CentreOne, we have experience helping customers with the development and commercial manufacture of its Marketing Authorization (MA) IP. One example we can share is from 2016 when a pharmaceutical developer specializing in leveraging common compounds for new indications approached Pfizer CentreOne to help with an exciting new patient-centered approach.