Reducing Risk, Speeding Development — a CDMO Model Including GCP-sponsorship to Better Meet the Needs of Pharma Companies

The oral drug development landscape is changing fast. Pharmaceutical companies are racing to embrace user-friendly dosage forms to better meet patient needs. Developing and bringing a new oral medicinal product to market is no easy feat — especially when it comes to user-friendly dosage forms. But companies are increasingly turning to those dosage forms and are demanding more support than ever from CDMO partners.

In response, a new CDMO offering has emerged — one that is small, flexible, and oversees formulation development as well as directly sponsoring good clinical practice (GCP) clinical studies.

In this Q&A published with Drug Development & Delivery (October 2023 Vol 23 No 7) experts Dr Martin Koeberle and Dr Bernice Wild discuss:

  • The challenges of bringing an innovative oral medicinal product to market
  • The growing pressure on manufacturers to develop more user-friendly medicines
  • The risks and responsibilities of clinical trial sponsorship for pharmaceutical companies
  • How a new good clinical practice (GCP)-capable CDMO offering is carving a faster, reduced-risk route to market for portfolio-enhancing user-friendly dosage forms