Biomark My Words

Biomarkers are playing an increasingly important role in the development of new drugs to fight disease. In this revealing interview, Dr. Werner Kroll, Global Head of Biomarker Development at Novartis, gives us his view on the development of this exciting new area of medicine.

NGP. In your opinion how do does the development of biomarkers help match proper diagnosis with the right treatment?
WK. I think we’re in an area of redefining disease. We understand much more about disease now the data from the demonic revolution is coming in – we see disease totally different now on a molecular level. We’re moving further and further away from a monological description of disease towards a description for the conditions based on a molecular level. This revolution has also brought the need for new molecular markers to us, helping us to do exactly that job. We need new assays in order to measure those parameters, which will help us to define new diseases, and to define diseases more specifically, more differentially.

NGP. Do you think biomarkers will play an increasingly important role in all stages of drug development in the future?
WK. The development of new drugs and new diagnostics, or new assays for the diagnosis, has to go in parallel. We don’t have yet a good public example on this parallel development of new drugs and new assays though. We only have any assays after the pack, and that is a non-optimal situation. This is what I think we are still coping with, that these assays aren’t really designed to fit the needs of the drug. What I do see in the future is a parallel way of assay development, which will see a development of tests for use in the marketing of the drug at the same time that the drug itself is developed. The assay is then tested, qualified and validated during clinical trials. So I do see the growing knowledge about a marker being reflected over time as we have growing knowledge of the drug. I also do see that the companies are reaching out for growing support into the community for these new ethics, so that they are much more recognised and their value emphasised.

NGP. How do you personally feel the impact that the emerging field of biomarkers has on the diagnosis, prognosis and monitoring of the disease in progression?
WK. I think prognosis is probably the area with the biggest doubt because we are dealing with probability, whereas the fields of responder identification and monitoring are much more understandable and convertible into action. If I have a certain prognosis, quite often it is difficult to have certain actions follow this with the announcement of that result. Whereas if I am doing responder testing I know that this patient will respond or not respond to that specific drug, and if I have monitoring I can get information to see if this patient is responding or not responding so there is a very clear action afterwards. Whereas with the prognosis it is I think just the next generation of healthcare we are going into, which means we are looking for prevention rather than treatment.

NGP. How do you feel the industry is approaching research for new diagnostic markers and biomarkers and where do you see the industry going in terms of its approach to this research?
WK. I think a lot of our knowledge is coming out of research for pharmaceutical targets, whatever we learn there will be applied in diagnosis and that’s where most of our knowledge will come from. But after this ‘starting point’ – having a certain marker discovered or identified – I have to prove its validity and its usefulness, and there I think the industry is using clinical trials where you have the wide modification but I think what should be even more important is the wide phenotypical characterisation of those patients for correlation between the marker and the phenotype. So that’s where you see the strengths and the flaws of basic research and targets which give us, so to say, pheno-products, and then the ability to verify and qualify markers during clinical trials. I think the more general these markers go, the more we have also to rely on institutions or on consortia where we succeed in contravening a certain number of patients so we can get to the statistical relevant base number, which one company could not come to on its own. So I think consortia will play another very important role in the qualification process so far.

NGP. On a final note, is there anything you would like to add as far as where the industry is going or any advise you would like to give.
WK. I am convinced that personalised medicine is coming, we’re in the middle of the realisation of the concept of personalised medicine.

Dr Werner Kroll is the Global Head of Bio Marker Development at Novartis.