Bringing a novel drug or a medical device to market is becoming more and more expensive, time-consuming and complicated. Yet the urgent need for more cures to both treat well-known diseases more effectively as well as fight more rare diseases calls for faster and cheaper drug and device development processes, not slower and costlier ones.
Likely reasons for the recent rises in drug and device development times and costs seems rooted in the need to safeguard public health through more rigorous regulatory oversight, as well as to protect drug investments through more likely-to-succeed development processes. However, public safety and health as well as drug and device development companies’ bottom lines all benefit when more patients can access more cures at lower costs.
How should societies negotiate those apparent contradictions between safety and efficacy on one side, and speed and cost on the other? We believe that recent advances in a variety of technologies will allow us to do both: lower the cost of development so more drugs and devices can be brought to market by more organizations more cheaply, as well as increase those device and drug development efforts’ safety and efficacy.
In fact, we believe that we have never before been at the threshold of such a profound revolution in drug development capabilities that carries the promise of eradicating many if not most diseases within the foreseeable future. This paper explores some of these exciting possibilities, hopefully to the benefit of all.