OREANDA-NEWS. June 27, 2008. 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, according to research launched today by PricewaterhouseCoopers, entitled Pharma 2020: Virtual R&D, which path will you take?, reported the press-centre of PricewaterhouseCoopers.

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. Along with changes underway in the regulatory and socio-political environment, this will enable Pharma to overcome one of the most fundamental issues it needs to resolve over the next decade.

As outlined in PricewaterhouseCoopers 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 Pharma very exposed and only four out of the top 10 companies have enough products in their pipelines to fill the impending revenue gap.

Steve Arlington, global pharmaceutical and life sciences industry advisory leader, PricewaterhouseCoopers, 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 remain at the forefront of medical research, help patients live longer healthier lives and deliver the revenue returns shareholders have come to expect, Pharma needs a faster, more predictive way of testing molecules before they go into humans.

“Equally as a society we must acknowledge that we cannot afford to suffocate the investments made by the pharmaceutical industry into R&D; a concern that should be high on the socio-political agenda. We have to face the issue that if Pharma is no longer financially capable of this, there is a question where the next new medicine will come from?”

‘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.

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.

By 2020, decisions about reimbursement and licensing will fall within the remit of regulatory bodies that are much more aligned. By 2020 the cumbersome, all-or-nothing approach will be replaced by a cumulative process, based on the gradual accumulation of data. Once there is sufficient evidence to show that a medicine genuinely works and is cost-effective in the initial trial population, the regulator will be able to issue a ‘live licence’ allowing the sponsoring company to market the treatment on a restricted basis. With each incremental increase in evidence of safety, efficacy and value, the regulator will extend the licence to cover more patients, different indications or different formulations.

The pharma industry requires assistance in the form of better incentives to research and develop medicines that prevent disease 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.

Alina Lavrentieva, Partner, Pharmaceutical Leader, PricewaterhouseCoopers, concluded:

“New technologies can play a major role in helping Pharma move forward - enhancing its ability to produce treatments which deliver measurable improvements in safety, efficacy and ease of compliance — treatments which have value in the eyes of healthcare payers as well as those of the companies making them. They will also deliver substantial savings — they could collectively halve development times and attrition rates, thereby reducing costs per drug dramatically.

“Technology is not the answer to all Pharma’s problems. Many companies as well as the infrastructure of regulators and vendors that support the industry will have to make significant strategic, organisational and behavioural changes. Overhauling R&D requires a decision on whether the organisation wants to produce mass-market medicines or speciality therapies, where they want to be located geographically to have access to the best skills or cost base and whether they want to outsource most of their research and development or keep it in-house. The choices they make will have a profound bearing on the business models and mix of skills they require as well as the skills of those who support them.

“Connectivity — technological, intellectual and social — will ultimately enable us to make sense of ourselves and the diseases from which we suffer.”