With biomarker deals and diagnostic collaborations becoming a weekly event, the commercial race to provide the next generation of targeted therapies is well underway. But there are many challenges to be overcome in implementing and reimbursing such new and complex technologies.
Speaking at a recent event hosted by the US-based Personalized Medicine Coalition in May, the FDA’s Director, Center for Drug Evaluation and Research, Janet Woodcock, highlighted the changing pace of drug development when she said that around a third of new entities approved by the FDA last year had some type of genotyped biomarker in their marketing application and that anywhere from an eighth to a half of companies’ drug pipelines are targeted therapies. In her keynote address at the event, she said: ‘Personalised medicine has moved from a goal to an emerging reality... The new challenge will be to assist the larger healthcare community in dealing with this medical and scientific transition.’
In her discussion of how the FDA is dealing with the expanding field of personalised medicine, she highlighted some of the many challenges for industry, regulators and the healthcare community. In particular, there is the problem of targeted therapies having much smaller numbers of patients available for trials, which poses difficulties for both the authorities and drug manufacturers.
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