Personalised Medicine
personalised medicine market and regulatory landscape
Over the past several years, there has been continuing interest in the deployment of personalised medicine via the development of companion diagnostics/therapeutics. The leading edge of this discipline is in the cancer personalised medicine arena where a number of therapeutics are associated with a diagnostic entity that serves to stratify those patient populations who can benefit from the given therapeutic. Not only does this ensure optimal treatment options for patients but also streamlines costs associated with expensive therapeutics whose effects may be sub-optimal in some patients, along with the challenges of toxicity and other adverse responses.
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n this article, we present the current state of the cancer personalised medicine marketplace and recent actions from the regulatory authorities, European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), that are now providing much-needed guidance and newly intro- duced procedures to the vendors offering products into this space. Select Biosciences has been tracking the personalised medicine marketplace for a number of years and published its first market report on this topic in 2007. Our most recent market report on this topic was published in July 2009 entitled Select Biosciences MicroRNA Diagnostics, Therapeutics, and Cancer Personalized Medicine 2009. Ever since, our industry coverage has focused on the various sub-segments of personalised medi- cine – à la cancer personalised medicine, and per- sonalised medicine driven by microRNAs as strati- fication elements. We present some of our industry analysis focused on cancer personalised medicine, while ERA Consulting Group addresses the newly introduced procedures available for interacting with the regulatory authorities, offering companies the chance to gain regulatory acceptance of their biomarker development strategy for use in com- panion diagnostics and therapeutic development. ERA Consulting Group specialises in regulatory affairs and product development consulting servic-
Drug Discovery World Summer 2010
es and has been focusing on characterising the reg- ulatory requirements for biomarkers that can be validated as tools for personalised medicine. In January 2009, the EMA issued a formal qualification process outlined in the guidance doc- ument EMEA/CHMP/SAWP/72894/2008. This procedure provides a much-needed framework and opportunity for companies to engage with the European regulatory authorities to obtain ‘buy-in’ on biomarker development. ERA encourages com- panies to interact with the authorities at all levels and seek regulatory advice as early as possible in biomarker and product development strategies, thereby reducing regulatory risk at later stages. In the US, the FDA has modified its approach to facilitating and accepting biomarkers into drug development. Its introduction of the biomarker qualification process, Voluntary Exploratory Data Submission (VXDS), provides companies with the opportunity to discuss biomarker development from an early stage. Advice on study design and data on samples can be obtained through formal processes for integrating biomarkers into drug development and eventually into clinical practice. While the challenges for gaining acceptance of biomarkers into drug development are evident, the regulatory authorities are increasing their visibility and taking active steps by offering more structured
By Dr Enal Razvi and Dr Patricia Hurley
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