Challenges facing drug development and evidence of financial decline across the biopharmaceutical industry are forcing change. A new approach can be expected that will be capable of shortening the drug development process from 10-15 years to just a few. The reliable generation of evidence of product efficacy and safety following first-in-man studies will be sufficient to speed development of new approaches to diagnose, treat, ameliorate and cure complex disease.
New approaches will be led by modeling, simulation and Bayesian methodologies. When Boeing build the 777, it used computers to design and “fly” the prototype aircraft for millions of miles before a human pilot entered the cockpit. So comprehensive was the simulation that it even included a virtual engineer with the ability to use a torque wrench on any nut in the prototype plane.
By leveraging these tools, the industry will have confidence in the mechanism of action of investigational products from basic science efforts, complex disease knowledge and epidemiological data will be shared openly, results from clinical usage of similar products will be available and clear requirements for proof of value will be more firmly established. Adaptive first in man studies will be grounded in an established foundation of understanding. Ultimately, feedback loops, like PIPELINES described by the Massachusetts Institute of Technology Drug Development Paradigms Initiative (MITNEWDIGS) will naturally develop and further advance our efforts.
We are often asked whether biopharmaceutical companies are capable of working together. They already are. Eli Lilly, Pfizer, AstraZeneca and Sanofi are just a few of the companies to have established collaboration platforms pursuing innovative drug discovery, therapeutic innovation and open access. Foundations, consortia and research groups are advancing open-source solutions (e.g., TranSMART Foundation, The Structural Genomics Consortium, TransCelerate). Up to 20% of the biopharmaceutical R&D pipeline is already being developed in a collaborative environment.
The question is not whether these companies can work together but how can initial collaborative efforts be expanded to further our collective understanding of complex disease and take advantage of resultant opportunities.
