With dozens of prescription drugs soon to lose patent protection and few likely blockbusters in industry pipelines, drug developers are “aggressively” changing the way they do research and development (R&D), according to the Tufts Center for the Study of Drug Development (CSDD).
“The research-based drug industry, in the US and globally, is not sitting still, but the question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable,” Kenneth I. Kaitlin, director at the CSDD, said in a press statement. In particular, companies are looking to reduce development time, cut costs, and improve operating efficiency.
According to the Tufts CSDD, actions that will help improve R&D productivity include greater reliance on translational science to help identify the right disease targets for new molecules; greater partnering with external service providers to share risks, reduce cycle times, and lower costs; and greater use of sophisticated portfolio-management techniques.
The Tufts CSDD also notes a number of trends that will be important for drug developers to keep an eye on. For instance, according to the Tufts CSDD Outlook 2011, FDA will seek to confront the problems of shortages of antibiotics, emergency drugs, aesthetic agents, and drugs for cognitive disorders. FDA will also seek newer and better pain medications.
Another important issue relates to the location of clinical trials. More than half of all FDA-regulated clinical trials in 2010 were conducted outside of the US, but sponsors are now looking to decrease the number of countries hosting their development activities to reduce problems relating to logistics and regulatory complexities.