 Pharmaceutical companies will use virtual R&D to increase innovation and reduce commercial deficit
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? 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.
Anthony Farino, US pharmaceutical and life sciences advisory 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.”
Notes to Editor:
- 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.
About PricewaterhouseCoopers
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industry-focused assurance, tax and advisory services to build public
trust and enhance value for its clients and their stakeholders. More
than 146,000 people in 150 countries across our network share their
thinking, experience and solutions to develop fresh perspectives and
practical advice.
'PricewaterhouseCoopers' refers to the network of member firms of
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