Drug Developers Are Aggressively Changing the Way They Do R&D, According to Tufts Center for the Stu
With dozens of prescription drugs due to lose their patent protection in the next few years, and few likely blockbusters in company pipelines to replace declining revenue, developers are aggressively changing the way they do R&D, according to the Tufts Center for the Study of Drug Development.
Noting that developers are looking to reduce development time, cut costs, and improve operating efficiency, Tufts CSDD Director Kenneth I Kaitin said, "The research-based drug industry, in the United States 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."
He made his comments in connection with the release today of the Tufts Center's Outlook 2011 report on pharmaceutical and biopharmaceutical trends.
According to Tufts CSDD, the cost of developing a new drug is higher than ever -- about $1.3 billion. While it's difficult to predict which drugs could become so-called blockbusters -- yielding annual revenue of at least $1 billion -- Kaitin said the challenge to create such products is expected to become increasingly daunting in the next few years.
Actions that will help improve R&D productivity, according to Tufts CSDD, include greater reliance on translational science to help identify the right disease targets for new molecules; greater use of partnering with external service providers to share risks, reduce cycle times, lower costs, and improve resource management; and greater use of sophisticated portfolio management techniques.
Among near-term trends highlighted in the Tufts CSDD Outlook 2011 are the following:
The U.S. Food and Drug Administration (FDA) will exercise its new activism to confront a serious public health problem reaching critical mass: shortages of antibiotics, emergency drugs, anesthetic agents, drugs for cognitive disorders, and newer and better pain medications.
Although more than half of all FDA-regulated clinical trials in 2010 were conducted outside the U.S., sponsors will seek to decrease the number of countries hosting development activity in an effort to reduce global logistical and regulatory complexity.
The pharmaceutical and biotechnology industries will continue to dedicate resources to develop monoclonal antibodies (mAbs), as annual global sales of these products currently approach $40 billion.
Among private payers in the U.S., risk-sharing agreements to manage uncertain outcomes and costs -- where pharmaceutical companies and payers agree to share the risk regarding a newly approved product's cost effectiveness in clinical practice -- will become more common.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.