By Janet C. Walkow and Grace C. Lee
The development of new drug therapies has stagnated over the past decade. In 2013, 27 new molecular entities were approved, comparable to the average numbers during the past decade. The process of developing novel drugs can take up to 10–14 years and $2 billion, with failure rates exceeding 95 percent. While new technologies and tools lead to breakthroughs in some areas, the impact of rising costs, increased regulations, and a growing number of innovations originating from academia and startups is changing the landscape of traditional drug development. Translational research has emerged as a valuable approach for advancing medical research into clinical trials and to patients with greater speed.
The ability to expedite the development and commercialization of new medical products is shared by researchers, patients, and regulators. In the digital age of rapid communications and instant feedback, the public similarly expects faster results when research dollars are invested to yield new medical solutions. Translational research is not magical but plays an important role in expediting the availability of new medicines.
In broad terms, translational research encompasses all aspects of developing a new medical treatment, from basic science and preclinical studies to clinical application and public policy. However, the meaning of “translational research” lacks shared interpretations. Because translational research means different things to different people, there is confusion of the intended meaning within a given context. Too often, the pivotal preclinical portion of the cycle is excluded from translational research models, shifting the focus to the clinical trials. Basic research leads to great discoveries and is the basis for new therapies. However, the pharmaceutical sciences utilize their preclinical expertise to turn a basic discovery into a clinical candidate. Preclinical scientists play an essential role in moving compounds from proof of concept to clinical viability. Contributions in material characterization, formulation, stability, analysis, scale-up, and in vitro/in vivo testing provide the foundation for clinical studies, manufacturing, and commercialization.
The progress and importance of pharmaceutical sciences with respect to translational research are discussed more fully in the January issue of the AAPS Newsmagazine. Read Translational Research: Closing the Gap Between Research and Commercialization, from the PPB section, and then participate in the discussion point below.
What is the role of translational research in the drug development process? What are best practices to foster academia-industry collaborations for translational research?