With so many blockbuster drugs falling off the patent cliff, research-based drug companies are now embracing new development paradigms to increase R&D productivity. However, drug developers need to fully identify and address root causes of R&D inefficiency if they want to replenish their sparse R&D pipelines, according to the Tufts Center for the Study of Drug Development (CSDD).
“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 in a press release. “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’s comments were made in connection with the release of Tufts CSDD outlook 2013 report on pharmaceutical and biopharmaceutical trends which highlighted the following near-term trends:
- Exploratory drug development will replace conventional trial-and-error approaches. Drug companies will adopt new R&D paradigms based on biomarkers, modeling and simulation, novel formulation techniques, and adaptive clinical trial designs.
- Sponsors and contract research organizations will try to cut back on the number of investigative sites as well as the number of countries where trials are conducted to simplify clinical trial operating complexity.
- The biosimilar market is expected to grow significantly, especially with the abbreviated approval pathway for biological products that have been shown to be “interchangeable” with an FDA-approval biologic, which is required by the Patient Protection and Affordable Care Act.
- Global concerns will shape prescription drug policy more than ever before, with international coordination growing in relation to the development of personalized medicines and drugs for neglected diseases.
Kaitin is, however, optimistic about the future of bioinnovation and said, “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.”