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Developing
new drugs to fight major diseases can take years and cost billions of dollars Image
copyright: THINKSTOCK
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Developing a drug from a promising molecule to a
potential life-saver can take more than a decade and cost billions of dollars. Speeding this process up - without compromising
on safety or efficacy - would seem to be in everyone's interests. And cloud computing is helping to do just that.
"Cloud platforms are globally accessible and
easily available," says Kevin Julian, managing director at Accenture Life
Sciences, Accelerated R&D Services division. "This allows for real-time collection of
data from around the world, providing better access to data from inside life
sciences companies, as well as from the many partners they work with in the
drug development process."
Clinical trials - testing how a new drug works on
people once you've tested it on animals - are a crucial part of this process.
But they can be very complex to organize and run. There are three main phases, starting with a
small group of healthy volunteers, then widening out to larger groups who would
benefit from the drug. "A big phase three trial will cost anything
from US$30m-US$60m (£24m-£48m) for a pharma company," says Steve Rosenberg,
general manager of Oracle Health Sciences Global Business Unit. These trials may be conducted over 30 to 50
countries and involve hundreds or even thousands of patients - this takes a lot
of time and money.
"Patient recruitment has always been the
number one problem," says Mr Rosenberg.
And as drug development targets more specific
groups of people, largely thanks to the insights coming from genomics, finding
the right patients for such clinical studies is becoming even harder. This is where the cloud can help.
"With cloud and related technologies, we are
now able to mine real-world data to find patient populations better, and utilise
globally available technology to conduct trials in an even more distributed and
inclusive manner," says Mr Julian.
Saving time
Cloud and increasing digitalization is also
helping to improve the efficiency of data collection and analysis.
"Data collection used to be very
inefficient, with data being written on paper forms, faxed and then entered
into computers manually," explains Tarek Sherif, co-founder and chief
executive of Medidata, a company that has developed a cloud platform for
clinical trials.
"Then it had to be double-checked for
errors. It could take up to a year before you could draw any conclusions from
the patient data."
Digitizing the process and automating the
checking process in the cloud has reduced this time to "one to two
weeks," says Mr Sherif.
And cloud offers many additional advantages to
pharma companies, says Mr Rosenberg. "These days health data is coming from a
wide variety of sources, like labs, wearable devices, electronic diaries,
health records. Pharma companies can't necessarily handle all the data that's
coming in to them. So cloud computing helps them do that and
gives them a whole bunch of other advantages - the technology is kept up to
date, you get the latest security, the latest features and so on."
A spokesman for pharmaceutical giant
GlaxoSmithKline (GSK) told the BBC: "Advances in computing and data
analytics are providing new opportunities to improve the efficiency of our
research and increase our understanding of a disease or a patient's response to
medication."
Speeding up the clinical trial process also cuts
costs. "We were able to save one of our clients
about 30% on the cost of running a trial," says Mr Sherif, whose firm
facilitates nearly half of all clinical trials in the world and counts 17 of
the top 25 pharma companies as clients. And Accenture's Mr Julian says: "We've seen
overall savings of 50% - in some cases up to 75% - on the historically
labour-intensive parts of the drug development process."
Of course, not all prospective drugs work, or
they're shown to work but not any better than existing drugs on the market.
"So the Holy Grail is to fail faster so
you're not failing in the very final phases of drug development when you've
already spent most of your money," says Mr Sherif.
Wearables
Winning regulatory approval for a drug is only
half the battle. Pharma companies also have to convince health services and
insurance companies that's it's worth paying for. This means collecting reliable patient data.
In the past, patients were often asked to keep
written diaries of their experiences with a drug being tested, but these were
"horribly inefficient", says Mr Sherif. So the rise of electronic diaries and wearable
devices is helping to improve the evidence a pharma company can present in
defence of their latest drug.
With this is mind, Oracle is helping add
"mHealth" capability to Accenture Life Sciences' cloud platform.
And GSK says: "We've been conducting
clinical studies with biosensors and mobile devices for some time. Today's digital technology is enabling us
to collect and analyse data in new ways - monitoring activity and vital signs
in patients, and collecting patient feedback in real time, improving the
quality of data we use in the development of new medicines."
Collaboration
The cloud is also encouraging more pharma
companies to co-operate on molecule development [the building blocks of a
potential drug], says Mr Rosenberg, as well as on data analysis.
And all this anonymized patient data - historical
and recent - can potentially be shared in the battle to combat disease. "We are seeing clients increasingly use
'virtual studies' - using external and historical data to perform advanced
statistical analysis and reduce the need for complicated, costly site-based
study activity," says Accenture's Mr Julian, citing a collaborative
Alzheimer's project between some of its clients and the Coalition Against Major
Disease.
But while efficiencies in the drug development
process are undoubtedly being found, discovering the initial molecule is still
very difficult, experts warn. Cloud computing is having a big practical impact, but won't
necessarily result in a flurry of "miracle" cures.
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| Tanusree Chaudhuri (centre) with two of her remote-working research colleagues Image copyright: TANUSREE CHAUDHURI |
NEWS
POST: India’s Open Source Drug
Discovery:‘We Should Own Our Own Livelihood And Our Own Dream’
Tanusree Chaudhuri, 38, was pregnant with her
first child when her supervisor told her she would have to give up her dreams. She was doing a doctorate in computational
biology and aspired to improve people's health. "He told me 'you are married now, why do you
need a PhD? You should go take care of your family'," she says.
She'd hoped to work in drug discovery creating
new medicines, after studying at the prestigious Bose Institute in Kolkata,
India. But when she married and moved to Hyderabad for
her husband's job, she encountered cultural resistance. "Married women are expected to take care of
family because without family we are nothing," she says. "We're not
expected to want the privilege of thinking and doing research."
So when she came across an online "virtual
laboratory" enabling researchers to carry out important work from home,
she jumped at the chance to get involved.
The Open Source Drug Discovery (OSDD) platform
was run by the Indian government and enabled scientists to collaborate
remotely, searching for molecules that could be turned into useful medicines. Dr Chaudhuri found she could work from home at
times that suited her and her baby. "I met many different people [virtually]. I
remember one girl was from somewhere very remote. But it was possible to work
with her because I spoke to her through Skype. We never met or visited
face-to-face," recalls Dr Chaudhuri.
There are many other open source platforms in the
scientific community, each with their own specialism, from genomic analysis to
cancer research, and many women across India and other emerging economies are
finding them very liberating.
After the government-run platform closed in 2016,
Dr Chaudhuri and her colleagues began working for another organisation, the
Open Source Pharma Foundation (OSPF), a joint venture between pharmaceutical
industry professionals and academics. It is dedicated to discovering affordable
medicines by enabling remote collaboration around the world.
Ayisha Safeeda, from Kuttichira in the southern
state of Kerala, is from a very traditional Muslim family and lives in a remote
area. But she has been able to pursue her Masters degree through the open
source platform. "Even if I feed my baby I can read research
papers or I can do work on my laptop," she says. "So women who have
high potential but are buried inside the family should come forward."
The work these women do in the virtual lab
involves whittling down the choice of potential molecules that could eventually
be turned into drugs to fight diseases, such as tuberculosis. Dr Chaudhuri develops software for OSPF to help
scientists from different disciplines, such as biology or physics, collaborate
on the platform. Rakhila Pradeep, another virtual researcher from
Tamil Nadu, says she has always loved research but has found it impossible to
get to research centres.
"The daily commute to far-flung universities
from our rural village is a cumbersome journey and not practical for us,"
she says. "We were unable to get away from our children and aged family
members for days on end."
Dr UC Jaleel, an expert in cheminformatics and
computational biology, has supervised many of the projects carried out by these
skilled home workers. He believes they are a massive untapped source of expertise. Recalling his college days, women students
usually outnumbered - and outclassed - their male contemporaries, he says. But
then they would disappear. He analysed the statistics in a district of
Kerala where he is based and the results were "astonishing", he says. "These women were all highly educated, but
the majority of them ended up as housewives after marrying."
Dr Jaleel is a firm believer in OSPF's crowd
sourcing model, particularly if it leads to cheaper medicines for the world's
poorer families. "The common goal is to reduce the time and
cost of drug discovery, connect the disconnected and mobilize neglected human
potential for humanitarian purposes," he says.
Dr Chaudhuri agrees, saying: "Things will
progress further. Rather than make everyone gather at one place like an office,
let's give others opportunities. "You might think at night or you might think
in the morning. You might think whenever you want. We can get the answer and we
will go forward."
Els Torreele, executive director of charity Medecins
Sans Frontieres' access campaign, believes crowd sourcing could have an
important role to play in affordable drug discovery.
"Open source research collaborations are an
important and timely strategy to advance and possibly accelerate medical innovation,"
she says, "including in the area of neglected diseases where knowledge
sharing is even more critical than in other fields."
OSPF is still in its early stages, however, and
it's not without its challenges - poor internet connectivity in many rural areas
being one of them.
Funding is another concern, although it has
received seed funding from Indian foundation Tata Trusts. Much of the work is now being done via several
university servers and social media. But Dr Chaudhuri, who not only has a PhD but is
now an assistant professor, says she and her students plan to work on OSPF to
help it expand. "Dreaming for us Indian girls is prohibited unless we have this kind of opportunity," she says. "We should own our own livelihood and our own dream."
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Discovering
new molecules that could be developed in to drugs is still very difficult. Image
copyright: THINKSTOCK
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