Wayne R. Kubick
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As I write this column, we're midway through the NFL playoff season, when the haves root their competitive, winning teams
through each sudden death round, while the have nots (losers like those of us from Chicago and Philadelphia) are anxiously
following the search for new coaches and innovative plans to rebuild a team to make it playoff worthy in the shortest period
of time. One could call this latter activity translational sports management, where ambition, vision, and hope are ideally
converted into future success on the playing field—or so we can dream when training camp opens again anyway. Coincidentally,
this season of hope also just precedes the salad days of spring training in baseball, where everyone's a winner until the
actual games have to be played.
Clinical development has the somewhat analogous concept of translational research, which, in the simplest sense, means steps
taken to bring new treatments from the academic world to real medical practice—from bench to bedside. The National Cancer
Institute's Dictionary of Cancer Terms defines "bench to bedside" as "a term used to describe the process by which the results
of research done in the laboratory are directly used to develop new ways to treat patients." The definition of "translational
research" is almost identical, though in that case the focus is described as developing new ways to "diagnose and treat disease."
No matter what we call it, the need is obvious. It is estimated that less than 1% of drug compounds discovered by researchers
that are deemed worthy of initial testing ever make it to the pharmacy—pretty much long shot odds. And getting to market typically
costs over a billion dollars over 15 or more years—a span of time that can affect many patient lifetimes.
Fortunately, there are many initiatives already underway that fit under the promising big tent of global translational research.
Nearly a decade ago, the US National Institutes of Health's NIH Roadmap for Medical Research outlined a series of programs
that provided an early boost to translational research, in the hope of addressing roadblocks and knowledge gaps. The NIH Roadmap
was broad and highly ambitious, involving programs ranging from identifying new pathways to discovery in such areas as bioinformatics,
molecular libraries, and nanomedicine, to reengineering the clinical research enterprise. The reengineering research program
involved goals to improve regulatory processes, enable national electronic clinical trials and networks, and introduce new
technologies for assessing disease. A third roadmap area involved activities to develop research teams of the future, by establishing
advanced training programs; building collaborative partnerships involving academics, physicians, and patient communities;
and developing public/private partnerships, a theme that continues to persist today.
Although references to the original NIH Roadmap are not as easy to find anymore, the NIH is now advancing similar goals
through the NIH Common Fund and National Center for Advancing Translational Sciences (NCATS). The mission is "to catalyze
the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics
and therapeutics across a wide range of human diseases and conditions and make translational science more efficient, less
expensive, and less risky."
Many similar activities were further moved along by the FDA through its Critical Path Initiative, which, among other things,
led to public/private partnerships like the Critical Path Institute and the Clinical Trials Transformation Initiative. More
recently, TransCelerate Biopharma's consortium of major pharmaceutical companies was established to sponsor projects with
the intent of improving the efficiency of research, advancing innovation, and solving common R&D challenges and obstacles
in a cooperative, precompetitive environment.
Meanwhile, in Europe, the Innovative Medicines Initiative (IMI), a public/private partnership between the European Union and
the European Federation of Pharmaceutical Industries and Associations, was created to "speed the development of better and
safer medicines for patients," identifying translational research as one of its cornerstone areas for investment. Thus IMI's
European Translational Information and KM Services project (eTRIKS) intends to provide a knowledge management technology platform
to support IMI projects that will analyze and compare diverse collections of shared data for multiple studies and treatments.
eTRIKS is intended as a resource for collaborative research, knowledge discovery, and knowledge management using data from
clinical studies and pre-clinical studies, imaging data, genomics, proteomics, and data sources for biomarker discovery and
validation.
Other comparable national initiatives abound elsewhere around the world, such as the Translational Research Informatics Center
in Japan.
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