TORONTO, Aug. 7 /CNW/ - By 2020 the R&D process for life science
companies may be shortened by two-thirds, success rates may dramatically
increase, and clinical trial costs could be cut substantially, according to
research launched by PricewaterhouseCoopers (PwC), entitled Pharma 2020:
Virtual R&D, which path will you take? 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 life science
companies to overcome one of the most fundamental issues it needs to resolve
over the next decade.
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 Pharma very exposed. Only four
out of the top 10 companies have enough products in their pipelines to fill
the impending revenue gap.
"Plummeting productivity of effective novel treatments in the lab means
incremental improvements to R&D are no longer enough," says Gord Jans, leader
of the Canadian Life Sciences practice. "The resulting commercial deficit in
Pharma has enormous implications for the industry, society and governments as
a whole. Without a successful and vibrant pharma sector in Canada there could
be a long-term adverse impact across the entire value chain. To remain at the
forefront of medical research, help patients live longer healthier lives and
deliver the revenue returns shareholders have come to expect, the industry
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 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, where will the next new
medicines 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 optimize their trial designs and
minimize 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
The life science 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.
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.
Jans concludes, "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, organizational
and behavioural changes. Overhauling R&D requires a decision on whether the
organization 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."
For a copy of Pharma 2020: Virtual R&D, which path will you take? or for
more information about PricewaterhouseCoopers activity in the pharmaceutical
and life sciences industries, please visit www.pwc.com/pharma
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For further information:
For further information: Carolyn Forest, PricewaterhouseCoopers, (416)