Whatever choices these companies make on their future direction, they will have to make fundamental changes in the way they work, the report said.
The industry now recognizes that if it has to produce therapies and treatments that cater to the needs of the patients, payers and providers, it must clearly comprehend how human beings function at the molecular level and the changes that disease brings in.
The report says that by 2020, predictive computer models, built with the use of semantic technologies, nanotechnology and genetic engineering will help the industry develop new forms of treatment which improve compliance and outcomes. It cites ongoing R&D in the form of the Step Consortium developing a technological structure for investigating the human body as a single system and the Living Human Project’s model of the musculoskeletal apparatus; and the Physiome Project’s computational framework for understanding the integrative function of cells, organs and organisms.
Once the virtual man is built, it will be possible to screen candidate medicines in a digital representation of the human body adjustable to common genetic variations and disease traits.
While molecules will still need to be tested on real people, the development process will fundamentally change. Common data standards and electronic health records will change the way trials are designed. Adopting a cumulative approach where evidence is electronically submitted will help regulators issue licenses in a short time. This will in turn help pharmaceutical companies recover their costs faster and reinvest in R&D in developing new therapies for different types of the same disease.