With the biopharmaceutical industry facing lower levels of productivity and innovation, new collaborative models of research and development offer the promise of increasing economic returns in personalized medicine, a new report from the Ewing Marion Kauffman Foundation finds.
According to Assessing Risk and Return: Personalized Medicine Development & New Innovation Paradigm (34 pages, PDF), industry stakeholders must be open to new R&D models with the potential to reduce the risks of current drug-development processes and increase their combined probabilities of success. Such models also could help bridge some of the funding gaps in early-stage discovery and development of new technologies and could create efficiencies that generate increased economic returns for the personalized medicine sector.
The primary model suggested in the report involves disease-focused nonprofits or foundations establishing and managing the programmatic research of networks of academics and investigators from small biotechnology companies, patient registries, and expert clinical centers. In return, large biopharmaceutical companies would commit to providing some funding and to assuming late-stage development of "de-risked" drugs, taking them to the approval and marketing stages.
"Even after typical 'blockbuster' drugs are marketed, only 30 percent of them achieve sales that match or surpass their multibillion-dollar R&D costs," said Lesa Mitchell, vice president of advancing innovation at the Kauffman Foundation and one of the study's authors. "Based on the high-profile successes of some stratified medicines, however, the biopharmaceutical industry is beginning to realize the deficiencies in the economics of the blockbuster business model. This is one driver of increased interest and investment in developing personalized medicines, a task often best pursued by small biotech companies."