mating the value generated by these partnerships remain rudimentary. “Pharma[ceutical companies] and academia need to understand how to work together more effectively and demonstrate that they generate value from [partnering],” Davies said.
Despite its promise, a genomic-based approach to drug discovery and development is surrounded by great uncertainties, as noted by each of the speakers in the workshop’s opening session. As FitzGerald pointed out, genomic testing must be shown to influence clinical outcomes to guarantee reimbursement. Adoption will also require substantial physician and patient education, a financial incentive for test development, and patent protection. Davies observed that oncology has been the poster child for a molecular approach to target discovery, diagnosis in the clinic, development of companion diagnostics, and treatment. However, these therapies tend to be expensive, making their value in general medicine uncertain. Furthermore, outside oncology, the value of targeted therapies for the most part remains to be determined. In addition, regulatory constraints are getting tighter, which is an issue for thinking about innovative approaches to bringing medicines to market with companion diagnostics or a targeted approach.
In general, Davies continued, the commercial model for the development of personalized medicines remains immature, with the commercial and marketing organizations within industry retaining a preference to go to market with a more general molecule than with a targeted therapeutic. An analysis by PwC estimates that the companion diagnostic market will reach $42 billion by 2015.2 “There is a huge market for companion diagnostics,” Davies said, “but they are culturally and from a time perspective [off]-kilter with the development cycle and culture of the research and development industry.”
Trusheim added that there are countervailing forces at play. Developing both a drug and a diagnostic can take longer, especially given the need to recruit targeted patient pools and synchronize development of the diagnostic; the resulting market may be smaller than for a more general drug; and developers face an increased risk of failure since the drug approval is dependent upon simultaneous approval of the diagnostic. Further complicating the matter, regulatory requirements differ because therapeutics and diagnostics generally fall under different legislative authorities. In addition, product exclusivity concerns raise profitability questions among companies.