Biotechnology Focus Editor's Pick Article in the Dec 2015/Jan 2016 issue highlights current outsourcing innovations in drug development. GVI-CDS was featured as a CRO with broad clinical development and associated regulatory affairs expertise, coupled with in-depth expertise in clinical development resource procurement and project management.
"Innovations in Drug Development and Outsourcing
New drug development costs have steadily risen in the past four to five decades, approaching $3 billion for one new medicine, including the cost of failures. Expanding regulatory requirements over time has been a major cost driver. Shifting disease targets and changing science to better understand those new disease targets, with resulting complexity of the R&D infrastructure, are other major cost drivers. Failure is inherent in new drug development, but success rates have decreased as costs have risen. It is estimated that approximately 10 per cent of molecules that enter clinical testing gain regulatory approval, and a much smaller fraction than that counting the entire R&D process. Decreased success rates and uncertainty about pricing of new medicines has increased the financial risks. The combination of these challenges continue to raise the stakes for new drug development.
Adaptations to Meet the Challenges
The pharmaceutical industry has gone through dramatic change over the past few decades. Drug companies in the ‘70s and ‘80s had core competencies across a spectrum of functional and operational disciplines that few could replicate. They were the best at and often the only ones capable of discovering and developing new drug treatments. Even if academia or government researchers discovered a new potential treatment, few outside the industry had the know-how, expertise or infrastructure to even think about development, manufacturing, packaging or commercializing the drug product."