The Clinical Liver Safety Assessment Best Practices Workshop: Rationale, Goals, Accomplishments and the Future

Excerpt

The pharmaceutical industry has entered challenging economic times, and some analysts have questioned the long-term sustainability of its current business model [1]. The average cost of taking a new drug from the chemist’s bench to the pharmacist’s shelf now exceeds $4 billion by some estimates, with almost two-thirds of the costs being related to clinical trials [2]. The economic burden presented by rising development costs will likely be compounded by future reduced market revenues. Improved understanding of disease pathogenesis should allow physicians, perhaps with the aid of genetic testing, to identify potential responder subgroups among larger patient populations (i.e., the rise of “designer drugs”). However, treatment with such drugs will be indicated in smaller percentages of patients with the indicated medical condition so that high volume, blockbuster sales would likely decrease. Society may no longer tolerate rising drug prices, which would be needed to maintain revenues despite reductions in the number of pills sold. Hence, the pharmaceutical business model would strongly benefit from reduced drug development costs, particularly those associated with the conduct of large and prolonged clinical trials. Beyond the operational costs these trials entail, each additional year taken to attain marketing approval represents one year less patent protection during the commercial phase. …