Drug developers need to make capacity planning for clinical trials a core competence, regardless of how much they outsource to contract research organisations, a panel of pharmaceutical and biotechnology executives agreed at a recent US forum.
At the Executive Forum Roundtable convened by the Tufts Center for the Study of Drug Development (Tufts CSDD), industry leaders acknowledged that success in getting drugs to market more quickly and efficiently would depend on coming up with accurate forecasts from the start of each development project, with the goal of minimising delays, disruptions and cost overruns.
Previously, in an era when a company’s financial health was tied much more to the expectation of blockbuster sales once a new product hit the market, there was little incentive to develop consistent cost measures across the drug development industry, noted Kenneth Kaitin, director of Tufts CSDD.
“Most drug companies historically decentralised their approach to capacity forecasting, which made it difficult to co-ordinate scarce resources,” he commented. “Going forward, companies recognise the need to transform capacity planning into a core competence based on an accurate understanding of resource costs.”
Now companies are under pressure to bring more products to market with tighter budgets, Kaitin pointed out. Yet clinical trial protocol designs have become more complex over the last decade and the trials take longer to complete.
According to a recent Tufts CSDD study, for example, the total time from protocol design readiness to data lock increased from 460 to 780 days between the early and the mid 2000s.
