While patent exhaustion, reduced cash flow and weaker pipelines are prompting the research-based pharmaceutical industry to embrace new paradigms of drug development, companies still need to hone their efforts towards streamlining the process, warns the director of the Tufts Center for the Study of Drug Development (CSDD).
Many companies are taking steps to improve success rates in clinical trials and reduce the cost of new product development, such as enhanced study designs, greater use of biomarkers and sophisticated statistical analyses, notes Kenneth Kaitin.
“It’s a good start,” he comments. But in the current climate, drug developers must more fully identify and address root causes of R&D inefficiency, Kaitin believes.
Commenting as the Boston, US-based Center released its Tufts CSDD Outlook 2013 report on pharmaceutical and biopharmaceutical trends, he expressed optimism about the state of drug development along with his concerns over closing the efficiency gap.
“The emergence of open innovation models, where scientists worldwide openly share knowledge, and novel partnerships and alliances hold significant promise to transform the nature, pace, and cost of new drug development – to the benefit of patients, as well as to drug sponsors, their development partners, and investors,” Kaitin suggested.
Among the near-term trends highlighted in the Outlook 2013 report are:
• Drug companies will increasingly move away from traditional trial-and-error approaches to exploratory drug development and will adopt new R&D paradigms based on biomarkers, modelling and simulation, novel formulation techniques, and adaptive clinical-trial designs.
• In an effort to reduce the operating complexity of clinical trials, sponsors and contract research organisations will scale back the number of investigative sites they use as well as the number of countries in which they place their trials.