Today, it typically takes 17 or more years to get from the basic science stage to commercializing and introducing a new clinical product into the market. Innovation can be complex, but for many patients and families, this is just too long.
Many stakeholders are trying to get out of this 17-year “valley of death” – federal agencies charged with protecting and improving public health, private industry facing multiple challenges in research and development (R&D) productivity, nonprofit advocacy organizations who represent patients, and many others in the research and academic community.
There are many hurdles keeping these stakeholders from speeding the process of “bench-to-bedside.” These include finding strategies to do more effective evaluation of the science, more effectively disseminate research and train the workforce, improving stakeholder connectedness and partnerships, and using “big data” to generate evidence and inform decision-making.
What will it take to overcome these hurdles and climb out of the 17-year valley of death? How can we speed translational medicine (the process of taking an observation in the laboratory to the commercialization of a product that can improve the health of individuals and the public)? Organizations are using four key accelerator areas to achieve milestones and success stories:
One example of an organization that is working with partners to move the needle is the Crohn’s and Colitis Foundation of America (CCFA). CCFA has a goal to overcome the research problem that information about patients with inflammatory bowel disease (IBD) is stored in disparate locations, which limits the ability to access information across study cohorts. To address this issue and to accelerate discoveries and improve patient care, CCFA aims to develop a large IBD Research Database that will create an interconnected collection of patient information, biosamples, and derived multi-omic data (genomic, proteomic, metabolomic) to advance the understanding of IBD. With funding from the Helmsley Charitable Trust to launch the initiative, CCFA and Deloitte are designing, building, and implementing a patient registry. Key stakeholders interviewed academic researchers, clinicians, industry, and patient stakeholders to understand the needs of the respective communities and define user requirements and the technical design of the registry. CCFA now has a roadmap that will help provide investigators with access to resources needed to support their research, enable sharing of knowledge rapidly, promote collaboration among academia and industry, and serve as an educational venue for clinicians, researchers, and patients with IBD.
In another example, the National Heart, Lung, and Blood Institute (NHLBI) is working to accelerate the commercialization of biomedical technologies. NHLBI seeks to foster public and private relationships by allocating funds to technology development programs housed in academic consortiums across the US. The NHLBI established the National Centers for Accelerated Innovations (NCAI) program, among similar initiatives, which consists of three academic consortia “Centers” to facilitate the translation of early-stage biomedical technologies.
NHLBI has created grants that enable innovators to form relationships with industry and strategic partners and perform additional R&D activities in order to take the product they have developed to market. Innovators are linked with resources to enable commercialization, including expertise from government agencies to avoid regulatory complications and get help in filing for intellectual property rights. The NCAI program also connects innovators with industry representatives and venture capitalists to assist them in preparing a strong business and marketing plan and raising additional rounds of capital. NHLBI is connecting the many facets of this complex process through the translational medicine ecosystem.
I am confident that there is a way out of the 17-year valley of death. The 21st Century Cures Act, which passed in the House this spring and may be up for vote in the Senate this fall, and the President’s Precision Medicine initiative announced at the start of the year, offer encouraging signs that there will be mechanisms in place to enable industry to capitalize on these accelerators.
The President has included $215 million in the proposed FY2016 budget for the Precision Medicine initiative. Long-term objectives of that initiative are focused on building a large research cohort for longitudinal studies, and ensuring regulations are appropriate to facilitate sharing of patient data (especially genomic data) across institutions and agencies. Ultimately, the goal is to get more targeted treatments for a variety of diseases to patients faster. While few details have been decided on at this early stage, collaboration among government, academic, and commercial entities – players in the translational medicine ecosystem – will be essential to its success.