The end of the industry as we know it?


The future does not look bright, at least for those big pharma companies unable to adapt
to its new realities. The expiry of blockbuster drug patents, rising research costs and
falling product approval rates are some of the familiar woes facing the sector, but
speakers at a recent conference in Japan were in no doubt that a diagnostics-led
revolution in disease management would place further pressure on traditional business
"The next 10 years will be revolutionary for the practice of medicine, with more change
in this period than in the last 50 years," predicted Dr Michael Ramsay, president of the
Baylor Research Institute in the US. Reactive "sick care" will be replaced by proactive,
preventative health care, driven by fundamental changes to the way diseases are
diagnosed and treated, he said in a keynote address to the BioExpo/Interphex Japan
meeting in Tokyo.
In remarks echoed closely by another keynote speaker, Dr Lee Hood of the Institute for
Systems Biology in Seattle, Dr Ramsay foresaw a much closer melding of diagnostic and
therapeutic technologies, with a focus on early detection before symptoms appear. This
would be accompanied by personalised, tailored treatments aided by low-cost,
individual genomic profiling, he suggested.
The convergence would lead to a seismic shift in how diseases are tackled, with key new
technologies such as DNA sequencing and blood-based molecular disease fingerprinting
at the forefront, the speakers posited. Dr Hood put forward the view that improved
knowledge of complex biological systems, along with procedures which could generate
"billions of data points on each individual patient", would lead to the "P4" medicine
model - predictive, personalised, preventive and participatory.
While healthcare is already beginning to see the emergence of effective, molecular-
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targeted biologic therapies, particularly in oncology, the new technologies would
dramatically improve outcomes and cut healthcare costs by ensuring the optimal
treatment of responsive patients, the speakers said. The ability to determine disease
states from small quantities of blood, and the digitisation of such data, would also trickle
down to benefits for the developing world, Dr Hood proposed.
Both he and Dr Ramsay saw these changes, should they indeed come to pass, as spelling
dramatic changes for the pharma industry. There would be a demise of the "one size fits
all" blockbuster drug, which in reality is often truly effective in only a relatively small
proportion of patients, they noted. Put simply, "many drugs don't work for specific
patients because they are all genetically different", Dr Ramsay explained.
Dr Hood put it to delegates that, in such an environment, some conventional drug
companies would not survive, while others "would have a very hard time". But the
technical challenges of this vision of healthcare should not be underestimated, he
warned, pointing to the need to validate biomarkers, properly correlate disease
fingerprints with actual disease states and ensure the security of personal data, for
example. The effective integration of disparate disciplines will also necessitate extensive
international partnerships, he said.
Speaking in another keynote address to the meeting, former Teva Pharmaceutical
Industries president and CEO Israel Makov (now chairman of Given Imaging) said he
was in broad agreement with these views. "The successful CEO of the future will be able
to juggle many balls," and bring together a range of different disciplines. Successful new
companies would be smaller and more agile and big pharma risks being "a prisoner of
its history", he cautioned.
He also pointed to the important role that the generic, rather than innovative, industry is
already playing in terms of the provision of healthcare today. Generics now account for
around half of the world's prescriptions but at around one-tenth of the cost of the $433
billion a year branded sector. Based on 2004 data, generics save the global society $330
billion a year, he said.
To help companies address some of their more immediate R&D challenges, Dr Arun
Chandavarkar, chief operating officer at the Indian company Biocon, advocated the path
of "affordable innovation". Firms should be looking for a return on innovation rather
than a return on investment, measured in terms of reduced risk, cost and speed, he said,
adding that more research needs to be directed towards emerging markets where drug
access and affordability are key issues.
The emergence of targeted drugs for smaller patient populations is also driving the need
to lower the cost of innovation, he told the meeting. SCRIP - World Pharmaceutical
News - www.scrippharma.com FILED 04 July 2008 COPYRIGHT Informa UK Ltd

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