Earlier this decade, a respected and widely cited study from Tufts University’s Center for the Study of Drug Development came up with the astounding figure of $1.2 Billion as the average cost of bringing novel medicinal drugs to commercialization from the earliest R&D stages of discovery biology. Understandably, this large figure was met with shock and disbelief. Shortly thereafter, several business journals embarked on the investigative task of verification of the calculation and data. What they uncovered was even more surprising. Actual R&D spending over a 15-year period (to smooth out annual fluctuations) divided by the number of new drug approvals indicated company-specific estimates in the range of $3.7 Billion (best) to $11.8 Billion (worst) per drug for a cohort consisting of a dozen major companies representing the pharmaceutical industry. The journalists concluded that even after taking allowance that these figures are crude estimates, the pharmaceutical industry had an unsustainable R&D model.
In a dynamic, free-market based society, inefficiencies on such a large scale attract innovators with disruptive models and the pharmaceutical R&D ecosystem is no exception. An analysis of the pharma industry’s R&D workflow suggests that the stage between discovery biology and clinical development, known as (preclinical) lead optimization chemistry, is a major bottleneck. There is now ample evidence that R&D innovation in lead-optimization chemistry can reduce significantly the above cited development cost per drug and this presentation will analyze (via information in the public domain) the modified R&D workflows that incorporate a network of innovation. This development is important to chemical engineers as well as the AICHE by association because discovery research in big pharma is the domain of those trained in the “standard” fields of the biomedical sciences whereas the entities in the network of innovation are embracing the integrative and multiscale talents of chemical engineering graduates.
See more of this Group/Topical: Topical Conference: Chemical Engineers in Medicine