Building Value Through Biomarkers: The “Smarter Development” Imperative

An increased focus on biopharmaceutical product differentiation has altered the business environment, placing the industry under immense pressure to reengineer a flawed business model that relied principally on inefficient internal research and development (R&D) programs. Companies are working to deliver safer and more effective treatments for disease targets that are increasingly complex, all the while having to contend with the considerable challenges of declining R&D productivity, increasing development costs, diminishing returns on sales, and lower earnings. Regulatory and reimbursement demands present yet another challenge. According to an Outlook 2009 report on pharmaceutical and biopharmaceutical trends from the Tufts Center for the Study of Drug Development, it still takes, on average, 8 years to bring a new drug to market. The industry’s survival depends in large part on its ability to select compounds with a high probability of clinical success and develop them very efficiently. Regulatory authorization of a product is only the first hurdle for biopharmaceutical sponsors to clear. The second hurdle, which should be taken into consideration further upstream in clinical development programs, is the ability to substantiate the product’s value on launch and to optimize the reimbursement status with real-world research. Proof of a medicine’s safety and efficacy will also be demanded as never before in this new environment, with the performance of new products being assessed against alternative treatments and their market viability determined by multiple stakeholders able to evaluate those treatments in ways never before possible.