With dozens of prescription medicines due to lose patent protection over the next few years, and company pipelines currently containing few likely blockbusters with the potential to replace declining revenues, developers are aggressively changing the way they do R&D, says a new study.

“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,” according to Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development (CSDD).

Speaking yesterday at the release of the Tufts Center’s Outlook 2011 report on pharmaceutical and biopharmaceutical trends, Dr Kaitin noted that pharmaceutical developers are looking to reduce development times, cut costs and improve operating efficiency.

At around $1.3 billion, the cost of developing a new drug is now higher than ever, according to Tufts CSDD. Mr Kaitin acknowledged the difficulty of predicting which new products could become blockbusters, ie, yielding annual revenues of at least $1 billion, and said that the challenge to create such products is expected to become increasingly daunting in the next few years.

According to advice from the Center, 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 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 the near-term trends highlighted in the Tufts CSDD latest Outlook report are that:

• the US Food and Drug Administration (FDA) will exercise its new activism in order to confront a serious public health problem reaching critical mass. Such issues include shortages of antibiotics, emergency drugs, anesthetic agents, treatments 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 US, 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 the development of monoclonal antibodies (mAbs), as annual global sales of these products currently approach $40 billion; and

• among private payers in the US, 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.