Pharmaceutical companies must change the way they conduct R&D if they are to ride out pressures to develop new prescription medicines more swiftly and at lower cost, warns the director of the US Tufts Center for the Study of Drug Development.

“The pharmaceutical industry essentially has not changed its R&D paradigm in more than four decades, while nearly every other global industry has undergone major change within the last decade,” said Kenneth Kaitin as the Tufts Center prepared to launch its Outlook 2008 report on near-term pharmaceutical and biopharmaceutical trends. “The drug industry has little choice than to change the way it does business,” he added.

In the near- and medium-term, Kaitin suggested, the most successful drug developers would be those that “evolve their management and information systems to improve access to new development platforms and tools”. Longer-term winners would be companies that radically overhauled their approach to business, all the way from R&D to project management, manufacturing and marketing.

Among the Tufts report’s near-term predictions are that drug sponsors will pay more attention to simplifying and streamlining clinical study protocols in order to reduce delays and improve adherence and performance at investigative sites. The Tufts Center also believes US policymakers will increasingly look to post-marketing studies that assess comparable clinical- and cost-effectiveness when they make decisions on prescribing guidelines and drug reimbursement.

Other near-term trends cited in the report include:

- Companies will continue to step up investment in developing personalised drugs and biologics, which will increase the attractiveness of diagnostics players as potential partners and takeover targets.
- The US Food and Drug Administration will be challenged to implement the FDA Amendments Act of 2007 – signed into law by President Bush last September – in the wake of large staff turnovers, under a new administration, and in the face of a “vigilant and concerned” general public and Congress.
- Interest in commercial cancer vaccine development will wane in the short term as more targeted cancer therapeutics, such as monoclonal antibodies and protein kinase inhibitors, reach the market.
- The FDA and the European Medicines Agency will continue their efforts to harmonise regulatory approaches in areas of common interest, such as pandemic vaccines, medicines for children, rare diseases and cancer.