A New Approach to Assess Drug Development Performance
Successful innovation in biopharmaceuticals is strongly related to the ability of firms to move compounds forward along the drug pipelines, Innogen researchers have found
Successful innovation in biopharmaceuticals is strongly related to the ability of firms to move compounds forward along the drug pipelines, researchers have found.
Bringing a new drug from bench to bedside is a very lengthy and expensive process, encompassing proof-of-concept, clinical trials, safety and efficacy tests and regulatory scrutiny. This process can last as long as 12 â€“ 15 years and cost up to $1.7 billion. However, over the past two decades, research and development (R&D) expenditures have substantially increased in the pharmaceutical industry, but this increase has not been matched by an increase in R&D outputs, in particular newly filed applications to test new drugs. As such, we are now facing a productivity crisis.
To better understand this crisis, the Innogen Instituteâ€™s Dr Alessandro Rosiello has led an empirical analysis of the 28 largest biopharmaceutical companies that looks beyond standard indicators for innovation, and tests the ability to predict per-capita growth of biopharmaceutical firmsâ€™ revenues.
Findings have shown that there is strong impact from strategic decisions being made about the allocation of R&D investments, and that the concentration of such investments, in a restricted number of areas, is positively related to financial performance. Therefore, financial performance at the firm level depends on each firmâ€™s ability to move compounds forward faster that its competitors, within a defined therapeutic area.
Additionally, this research has led to the creation of a new empirical method for assessing drug development performance, which helps to estimate how many compounds a given firm is expected to move forward, across clinical phases and over a certain period of time. This allows comparison of the performance of different firms on the basis of their ability to move compounds through the development pipeline. The approach is flexible enough to represent the performance of any portfolio and has a wide scope for application.
Dr Alessandro Rosiello, Research Fellow at the Innogen Institute (University of Edinburgh), developed the research in tandem with Dr Nicola Dimitri (University of Siena) and Dr Filippo Fiorini (Novartis Vaccines).
Rosiello's paper was published in Drug Discovery Today in May 2013: