There are many factors underlying the reduced productivity seen in drug development, but clearly innovation is necessary to restore productivity levels seen in decades past. It is important to put innovation in the pharmaceutical and biotechnology industries into context. When we began using the Internet to conduct clinical trials 15 years ago, technology wasn’t just underutilized in drug development, it was almost entirely unutilized. Today it seems hard to believe that just a few short years ago, a typical paper NDA weighed about 10 tons and was delivered to the FDA by tractor trailer. Since electronic submissions became mandatory, that same task can be accomplished with a handful of CD-ROM discs.
From electronic publishing to electronic data capture, and the use of CRM and Project Management systems, the industry has incorporated many technologies that revolutionized other industries ten years ago. The need for standards and guidance before adopting new technologies within drug development is at least partially to blame for the delay. What hasn’t changed is the way those technologies are used. Rather than finding new ways to operate based on the efficiencies made possible by technology, drug development largely uses these new technologies to recreate processes established on paper many years ago.
We think this has created a major opportunity for disruptive innovation simply by starting with integrated and cutting-edge technology, and then building drug development processes on top of that. In this way, we have reduced cost, improved visibility, and increased the quality of drug development process. It is hard to overstate the challenge and significance of trying to bring all of the various drug development stakeholders into a single, integrated platform for study management and collaboration. From here, we believe that further and more significant innovation becomes possible. Once you have achieved this level of integration within your drug development organization, then it becomes easy to plug new stakeholders into the system, such as patients, caregivers, and advocacy organizations.