Singapore, 7 July 2008 – By 2020, the Pharma R&D process may be shortened by two-thirds, which could result in the dramatic increase of success rates and the potential of halving clinical trial costs, according to PricewaterhouseCoopers’ (PwC) latest research entitled, Pharma 2020:Virtual R&D, which path will you take? New technologies that help researchers better understand the biology of disease could be the catalyst for an R&D overhaul in the pharma world, which could see companies using virtual R&D to increase innovation and reduce commercial deficit.
PwC’s research also highlights that the evolution of ‘Virtual man’ will enable researchers to predict the effects of new drug candidates before they enter human beings. This could transform the way in which Pharma designs and manages clinical studies, and accelerate clinical development. Along with changes underway in the regulatory and socio-political environment, this will enable the pharma industry to overcome one of the most fundamental issues it needs to resolve over the next decade.
As outlined in PwC’s previous report Pharma 2020:The Vision, Pharma 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 the industry very exposed and only four out of the top 10 companies have enough products in their pipelines to fill the impending revenue gap. This innovation deficit has enormous strategic implications for the industry as a whole.
Pharmaceutical/Healthcare Leader at PwC Singapore, Mr Abhijit Ghosh commented, “Plummeting productivity of effective novel treatments in the lab means incremental improvements to R&D are no longer enough. The resulting commercial deficit in Pharma has enormous implications for the industry, society and governments as a whole. To deliver the revenue returns shareholders have come to expect, Pharma needs a faster, more predictive way of testing molecules before they go into humans.”
Pharma companies need to address the challenges they are facing and remain sustainable by embracing new technologies to reduce drug development time and attrition rates. In addition, the payers, patients, providers and regulators that support the industry will have to make significant strategic, organisational and behavioural changes.
Mr Ghosh elaborated, “Before an organisation makes the decision to overhaul its R&D function, they need to consider issues such as whether to produce mass-market medicines or speciality therapies, how to gain access to the best skills or cost base and whether their research and development should be outsourced or kept in-house. All these will have a profound impact on their business strategies, repertoire of skills they require and ultimately their future bottomline."
Accelerating clinical development by ‘ virtualising’ research
‘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 percent 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.
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.
The pharma industry requires assistance in the form of better incentives to research and develop medicines that prevent or cure disease. Today our IP frameworks do not provide the incentives needed to alter the agenda from one of treatment to that of prevention and cure.
“Keeping in view the government’s strong support for Pharma R&D in Singapore and the existing infrastructure for biomedical sciences, Singapore is well-positioned to take the lead in test bedding and adopting innovative concepts for ‘virtualising’ research,” Mr Ghosh concluded.