The Valley of Death (VoD) is defined as the transition of a company from pre-clinical stages to human trials, which most efforts do not survive. In order to cross the VoD, a molecule needs to show favourable safety and first signs of efficacy in patients.
Despite the ominous presence of the VoD, there are a variety of institutions and early-stage companies that are working to deliver new discoveries to patients, whilst simultaneously working creatively to overcome the financial challenges associated with bringing a new therapy to market.
These new innovations cover all disease areas; however, oncology has seen a large amount of activity in new modalities in addressing various types of cancer. Some of these innovations include small molecule drugs that block the effects of cancer genes, viral therapy to target tumours (here the virus hitches a ride on a red blood cell to the tumour site) and the targeted killing of cancer cells using enzymes called nucleases.
Whilst all the science is exciting, it is currently struggling to get beyond the lab. The translation of recent findings into therapeutic advances has been far slower than expected, and the return on investment has been limited in terms of clinical impact. In the current economic environment, funding for cancer research has slowed as governments, charities and venture capitalists all feel the pinch. The slow movement in the translation of basic scientific findings in a laboratory setting into human applications and potential treatments for disease is a widely recognised both in academia and industry.
So, if the problem is widely recognised, why are we unable to find a solution? In recent years, scientists and early-stage companies have begun to turn to not-for-profit organisations, who can play an increasingly important role in drug discovery as they can carry out risky, early-stage research, before partnering with a pharmaceutical company to bring the drugs to market, and ultimately patients. Therefore, the answer might lie in a partnership between the industry, government, and not-for-profit organisations to each individually tackle a stage of clinical development to bridge the VoD between excellent science and pharmaceutical development. There is only one way to find out, and that is through the continuous development of scientific research, and the work we do here at RIG to enable the commercialisation of new therapeutic modalities.