Clinical timelines are seriously under pressure and that is a fact. You just need to work with a handful of pharmaceutical and biotechnology companies of any size to know where the pressure point is. And contrary to what people may think, it is always time, and not always cost. Meeting deadlines, proving or killing projects quickly, moving the product through each phase and getting the product to market as quickly as possible to maximise patent time is what it’s all about in drug development. Speed and time are very much of the essence in drug development and clinical trials.
Nevertheless, cost is still a major driver of any clinical trial project and funds are harder to come by than ever before. For Big Pharma, there is simply less spend and resource in R&D than there was 10 years ago, and higher expectations of better returns on investment. We have all seen the high level executive exits and falling share prices of those deemed not to be performing. And for smaller virtual companies and biotech organisations access to finance from venture capitalists, private investors and banks is not as easily or widely available as in the pre-2009 days. Less time and less money is just the reality of what we are all dealing with in our sector.
When only around 1 in 1,000 compounds make it to human testing, it is understandable that proof of concept becomes a key benchmark to be achieved as quickly as possible with as low an investment as possible, to mitigate the financial risks – all while ensuring the highest possible safety, ethical and regulatory standards are met.