Digital Pathology Insights Comment:
Another article describing the positive impact of biomarkers for personalized medicine. Two points that I note:
1. Dr. Stephen Little, VP Personalized Healthcare from Qiagen mentions the negative economics of co-developing a companion diagnostic as part of a PIII trial. I agree 100% that at the moment, this is somewhat prohibitive in the current construct of clinical development. MD Anderson recently showed us that there is a better way and that is through studies like BATTLE which are adaptive, and seek to quickly determine which patients will have a better chance at favorable response. So, the current clinical development dynamic really needs to become less linear, and more adaptive in order for the promise of biomarkers to finally lift off. Additionally, the FDA really needs to finally come to some sort of streamlined approval process where expectations are clearly set, and where diagnostic or drug developers can work with one point of contact as a partner to help manage expectations and the process towards approval.
2. More strategic use of biobanks! I have often wondered: In a PII trial, why is it not more prevalent to create a higher “N” by supplementing patient numbers with FFPE tissue samples from past trials that have similar patient inclusion criteria? This would serve to bolster statistical confidence in the results for whatever biomarker studies are being performed, leading to more confidence for prospective trials going forwards. This approach could very well make PIII clinical trials SMALLER, and LESS EXPENSIVE, which would help the issue that Dr. Little mentions above. Once again, digital pathology image analysis to the rescue! Not only could we supplement smaller clinical trials with annotated FFPE patient tissue materials from past trials, but the ability to data mine these tissue samples comprehensively for biomarker localized expression and cellular morphology (for example with Definiens Tissue Studio) would certainly yield important insights which have clinical utility.
At the “BIO International Convention” in Chicago, there were ten breakout sessions on biomarkers; intellectual property, commercialization, reimbursement, drug development, and diagnostics were among the topics discussed. This explosive new technology niche, which requires the co-development of diagnostics and drugs, has tremendous potential to exploit breakthroughs in the molecular basis of disease. Genomics has transformed biology, and as biomarker research advances we will likely see a similar impact on drug development.
Cancer Markers on a Fast Track
Cancer and Alzheimer disease are two disease areas that can be significantly advanced by biomarker research. Cancer is a priority because targeted drugs like Herceptin (trastuzumab), Gleevec (imatinib), and Iressa (gefitinib) are already on the market and can benefit from a more targeted therapy utilizing biomarkers.
In a session chaired by Bernward Garthoff, Ph.D., chair of cluster biotechnology of the Federal State of North Rhine-Westphalia, Germany, the use of biomarkers in the diagnosis and treatment of breast cancer and other tumors was explored. Breast cancer was highlighted because it is believed that biomarkers could help reduce the use of chemotherapy after surgery. As an example, it was noted that in the treatment of node-negative breast cancer, research has shown that only 30% of patients benefit from chemotherapy treatment.