Building bridges to the future of medicine: recommendations for boosting development of novel and companion diagnostics.

ABSTRACT

Evaluating the prospects for 'personalized healthcare' has become topical at the 10-year anniversary of the first results from the Human Genome Project. The coincidence of this milestone with a period of global financial difficulty is unfortunate, but industry has signaled its willingness to invest in this new medical paradigm in order to address the problems of high drug candidate attrition as well as escalating healthcare and R&D costs. For diagnostics manufacturers, justifying the ever-growing costs of development without an appropriate framework to provide reasonable return on investment is extremely challenging. Regulators have made good progress in defining what will satisfy current regulatory mandates, but there is still far to go to create conditions that would stimulate investment. My personal perspective is that personalized healthcare represents a solution rather than a problem and herein I describe the bottlenecks slowing development of novel diagnostics from the perspective of a willing commercial stakeholder.