While patent expirations on many top selling medicines is spurring the research-based drug industry to embrace new development paradigms to replenish sparse R&D pipelines, drug developers need to more fully identify and address root causes of R&D inefficiency, according to the Tufts Center for the Study of Drug Development.
“Many companies are taking steps to improve clinical success rates and reduce the cost of new product development, including utilizing enhanced clinical trial designs, making greater use of biomarkers, and adopting sophisticated statistical analyses,” said Kenneth I Kaitin, director of Tufts CSDD. “It’s a good start, but in a world shaped by increased patent expirations, diminished cash flow and fewer promising breakthrough products, companies will need to hone their efforts to streamline development.”
Kaitin, whose comments were made in connection with the release of the Tufts CSDD Outlook 2013 report on pharmaceutical and biopharmaceutical trends, said he is optimistic about the future of bioinnovation.
“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,” he said.
Near-term trends highlighted in Outlook 2013 include the following:
Drug companies will accelerate their move from traditional trial-and-error approaches to exploratory drug development and adopt new R&D paradigms based on biomarkers, modeling and simulation, novel formulation techniques and adaptive clinical trial designs.
In an effort to simplify clinical trial operating complexity, sponsors and CROs will scale back the number of investigative sites they operate and the number of countries where they locate their trials.
The biosimilar market is poised for significant growth following the creation of an abbreviated approval pathway for biological products that are demonstrated to be “interchangeable” with an FDA-approval biologic, as required by the Patient Protection and Affordable Care Act.
Prescription drug policy will be shaped by global concerns to a greater degree than ever before, with international coordination growing in relation to the development of personalized medicines as well as drugs for neglected diseases.
