How To Deal With The Complexity Of Drugs In Clinical Development

When it comes to clinical development, time is of the essence. In a study conducted by Tufts University in 2017, researchers found that a single-source outsourcing model has the potential to shorten the drug development cycle by as much as 14 weeks; this acceleration, in turn, can result in cost savings of as much as $45 million. These gains can be attributed to time and cost savings and reduced complexity attributable to a single-source CMO partnership. Likewise, these integrated models can prove especially useful for applications utilizing expedited regulatory pathways, providing comprehensive support from feasibility studies to clinical trials through commercial operations.

The increasing complexity of the drugs currently in clinical development has created mounting pressure for companies hoping to surmount the myriad challenges that typify these therapeutic modalities. Central to this pursuit is partnering with a contract development and manufacturing organization (CDMO) with capabilities and flexibility necessary to achieve the clinical milestones necessary to a drug’s ultimate commercial success. In a recent webinar, “How to Deal with the Complexity of Drugs in Clinical Development,” experts from Lonza, a premier CDMO with a global footprint, offered insight into how Lonza is able to offer its customers leading active pharmaceutical ingredient (API) development services, advancing new compounds and increasingly complex chemistries with an emphasis on manufacturability, yield optimization, and safety and efficacy.