Personalised medicine and the use of biomarkers is seen as the way forward in cancer research, but this approach to dealing with a hugely complicated disease is still at a very early stage.
That is the stance taken by Robert Beckman, executive director of clinical development oncology at Daiichi Sankyo, in an interview with events company Hanson Wade. He said that "frankly there is a lot of hype around biomarkers and everybody expects them to be spectacularly successful every time. Of course, the failures don't get published in Nature and Science”._
Dr Beckman states that the main priorities and issues are firstly to increase the use of biomarkers and classifiers in oncology drug development "and how to maximise the efficiency of the clinical development plan". Secondly, he adds, the challenge is "how to manage limited patient availability and financial resources and how to manage risk across a portfolio of drugs and predictive biomarkers and classifiers".
He goes on to say that "we always have a portfolio of potential therapies and putative biomarkers, and just like many drugs do not make it to market, the same thing is true for predictive biomarkers". The science is very complex, Dr Beckman adds, "and we always have only partial information. The question is really where to invest our resources, both in the drugs and in the biomarkers".
Another important point, he says, is that these decisions have to be made "in a cross-functional manner. Biomarkers introduce issues with respect to the timely execution of clinical trials, cost and regulatory issues and "in order to gain the advantages of predictive biomarkers you also have to be able to manage these other issues, and to move forward with plans you require the support of a cross-functional team".