By 2020, the pharma R&D process may be shortened by two-thirds, success rates may dramatically increase and clinical trial costs could be cut substantially. And how? New computer based technologies will create a greater understanding of the biology of disease and the evolution of ?virtual man? to enable researchers to predict the effects of new drug candidates before they enter human beings.
According to a research launched by PricewaterhouseCoopers, entitled `Pharma 2020: Virtual R&D, which path will you take??, the industry is at a pivotal point in its evolution, particularly in relation to R&D. The patents on many of the medicines launched in the 1990s will expire over the next few years, leaving it very exposed and only four out of the top 10 companies have enough products in their pipelines to fill the impending revenue gap.
Reduced productivity of effective novel treatments in the lab means that additional improvements to R&D are no longer enough. The resulting commercial deficit in pharma has enormous ramifications for industry, society and governments as a whole. In order to remain at the forefront of medical research, help patients live longer healthier lives and deliver the revenue returns that shareholders have come to expect, pharma needs a faster, more predictive way of testing molecules before they go into humans.
Says Sujay Shetty, associate director in PricewaterhouseCoopers for the pharmaceutical practice in India: ?Investments made by the pharmaceutical industry into R&D should not be allowed to suffer, and this issue should be at the forefront of the socio-political agenda in India. As a society we have to be conscious that any financial constraints in pharma leading to reduction in R&D will also lead to reduction in new and improved medication.?
?Virtual man? could ultimately evolve from the deployment of existing technologies that are connected in a new way. Models of the heart, organ, cells systems and musculoskeletal architecture are already being developed by academics around the world. Such technologies can be used to simulate the physiological effects of interacting with specific drugs and identify which drugs have a bearing on the course of a disease. Some companies using virtual technology have reduced clinical trial times by 40% and reduced the number of patients required by two thirds.
Of course, virtually-modelled molecules will still have to be tested in real human beings. However as a complete picture is developed of human biology and reliable biomarkers for identifying and monitoring patients become widely available, pharma companies will be able to optimise their trial designs and minimise the number of patients on whom new medicines are tested. They will develop treatments which have value in the eyes of patients, healthcare payers and for the companies themselves.
?New technologies will help pharma move forward, and will augment its capability of producing treatments which have measurable improvements in safety, efficacy and ease of compliance. ?Such treatments are valuable not only to healthcare spenders but also to companies creating them. They will result in considerable savings, and could also halve development time and attrition rates, thereby reducing the costs per drug radically?, says Sujay.
The necessary in-depth knowledge about the human body and the pathophysiology of disease will be generated through a collaborative research network of pharmaceutical companies, academia, independent research houses, IT providers, industry regulators, payers and providers. For the first time, pharma will have to consider sharing intellectual property (IP) with other research bodies and potentially new entrants such as IT providers.
Pharma industry across the globe is witnessing two significant trends: Stagnating R&D pipelines and Generic erosion on big pharma?s revenues. MNC pharma companies will see their business eroded due to generic competition by as much as 13% to 40% in the coming five years. Most exposed are Pfizer, Lilly, BMS and Astra Zeneca. The other area where MNC pharma will have to reform is R&D. These are future models which apply to drug development in the western world and which India pharma who have aspirations to become drug discovery companies may do well to study, he added.