Personalised Medicine
Figure 4: Cancer personalised medicine market segmentation by biomarker studied primarily in current research efforts
MicroRNA markers/profiles 13%
23% Others
DNA methylation markers/profiles 13%
Histone methylation markers/profiles 5%
15% Protein expression profiles 0% Histone acetylation markers/profiles 33% Gene expression (mRNA) profiles Source: Select Biosciences Industry Report
presents the tests recommended/required in the drug label in the US market (ie, these labelling actions have been driven by the US FDA). Note from Figure 3 that various therapeutics are ‘associated’ with a given biomarker(s) – the US FDA recommends or mandates genotyping of patients across the given biomarker(s) and this information can then be used by the physician in therapeutic administration or dosing decisions. It is interesting to note from Figure 3 how few therapeutics are cur- rently subject to biomarker testing. This is a growing space and we expect the number of therapeutic/bio- marker combinations to increase in part because of the recent active role taken by the EMA and FDA in providing regulatory clarity to the industry. Our industry analysis has included understand- ing the types of biomarkers currently penetrant across the personalised medicine field – more specifically, we have evaluated the quantitative penetrance of various classes of biomarkers in can- cer personalised medicine including microRNA expression profiling and epigenetic profiles of key cancer-associated genes. The data are presented in Figure 4.
Note from the data that the most penetrant bio- markers currently in cancer personalised medicine research activities are protein and mRNA expression
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profiles, but note also that microRNA and DNA methylation (epigenetic) profiling are making a small, but measurable, impact in this space. Over time, as more diseases are associated with microRNA profiles (up/down-regulation of specific microRNAs), this will be a driver for the increased utilisation of microRNA profiling in cancer person- alised medicine. In fact, Rosetta Genomics (Rehovot, Israel) has developed three microRNA expression profile-based tests for cancer, and is in development of a fourth test for colorectal cancer based on microRNA expression profiles in serum samples. In the past, the regulatory landscape was less conducive for focused interactions regarding bio- marker development. However, recent advances from both the EMA and the FDA are opening doors for companies that are ready and willing to engage with them on this topic. The new frameworks and structured formal procedures now in place will pave an easier route to gaining acceptance of new biomarkers, thus providing new and exciting mar- ket opportunities for vendors in the personalised medicine space. These recently published guidelines issued by the authorities clarify regulatory expecta- tions, outline a procedure for companies and detail the data packages required. Figure 5 outlines, in brief, the steps involved in the
Drug Discovery World Summer 2010
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