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most disruptive innovations
Top 10
in eHealth for Pharma
I
am currently in the early stages of producing our eHealth
Forum 2015 (co-located with our Big Data in Clinical
Development event) and what struck me was that there is a
massive enthusiasm in the pharmaceutical industry for the
application of these technologies – for their clinical pipelines,
improving patient care, and even as a platform for discovery –
but when searching for real-world examples; examples which
show proven success between these manufacturers and the
healthcare systems, it can be a little thin on the ground. This is a
disruptive technology for the pharma market and we are just
reaching the Tipping Point. This is not just about mobile apps,
this is about how eHealth will fundamentally change the drugs
industry and the drug industry knows it.
Top 10 most disruptive innovations in eHealth for Pharma
The US eHealth Initiative quotes 4 key themes
or “treatments” of ehealth within the clinic.
E
Health drivers in the US
including monetary incentives
paid to providers for
compliance with IT “meaningful
use”. The larger health reform
legislation wraps around this IT
program.
Within the pharma business model,
these themes are inevitably leading
to some unique implications. I’ll
begin with a 2008 paper to
demonstrate this year’s ‘Open-Play’
in eHealth and the industry’s own
growing ambition. “Opportunities for
electronic health record data to
support business functions in the
pharmaceutical industry-a case
study” – was published by Pfizer to
describe how the healthcare
informatics team had interviewed 35
senior company leaders (Pfizer) to
assess why they had a desire for
electronic health records access
(EHR – those real-time, patient-
centered records providing details
of care and a fundamental part of
‘eHealth’). The top responses had
been for “Drug Safety &
Surveilliance”, “Clinical Trial
Recruitment” and “Support
Regulatory Approval”. As shown by
our above ‘healthcare themes’, the
subsequent years have seen an
expansion of the role of eHealth in
provider systems and this has
potential for application into the
drugmakers business model:
• Drug discovery direction including
from real-world observations
• Clinical research [eg. EURECA,
Linked2Safety (EHR
interconnection), GRANATUM
(“Facebook for biomedical
researchers”, Salus Project,
SemanticHealthNet, TRANSFoRm
(“rapid learning healthcare
system”)]
• Repurposing of drugs, the
application of the “Internet of
Things” (IoT – wifi in portable
technology such as transplants) in
medical devices and its
interaction with therapeutics, HTA
evidence portfolios, chronic
disease management, medicine
adherence and improved patient
outcomes, the list goes on.
And so, to illustrate how eHealth is
disrupting how we approach
patient care – and inevitably the
focus of Big Pharma within this – I
have put together a top 10.
Note – Ranking is in relation to
technologies which have an
established record, probability of
success, eventual goals of
particular projects and the
ramifications of a run-away success.
It also weights the ranking
favourably towards what areas will
cause a fundamental change in
how the drug industry “works” and
impact on public health.
• Digitization of health information (HIS, EMR, PACS adoption)
• Longitudinal HER (sharing data between existing systems)
• Chronic disease management (home health, devices, etc)
• Consumer empowerment (personally controlled electronic
health records, online scheduling and prescriptions, etc)
“Patients. Here
be Big Data.”
Join us at
and
10Top 10 most disruptive innovations in eHealth for Pharma
Smart watches have moved on; as mentioned in
this article ‘Google’s Smartwatch to Be Fueled By
Google Now, “In Late-Stage Development”’
10.Wearable technology,
it’s in the blood.
A
s the worldwide eagerly
awaits Google Glass 2.0 (and
its application in changing
the way we view the world), Google
has filed a patent application with
the World Intellectual Property
Organization (WIPO) for a wrist-worn
device that could destroy cancer
cells in the blood. The patent
application, which has the name
"Nanoparticle Phoresis", describes a
wearable device that "can
automatically modify or destroy one
or more targets in the blood that
have an adverse health effect".
These targets could include
enzymes, hormones, proteins, cells
or other molecules that, when
present in the blood, may affect a
medical condition or the health of
the person wearing the device. The
wearable device is designed to
modify or destroy the cells by
transmitting energy into the blood
vessels. The transmitted energy
could be a radio frequency pulse [a
cutting edge, area of medical
research – March 2015 paper –
‘Radio frequency responsive nano-
biomaterials in cancer therapy’], a
time-varying magnetic field, an
acoustic pulse, an infrared or visible
light signal. Google used the
example of proteins implicated as a
partial cause of Parkinson's disease.
"As a further example, the target
could be cancer cells; by selectively
targeting and then modifying or
destroying the cancer cells, the
spread of cancer may be
diminished," it said in its patent
application.
This patent application follows the
company’s October 2014
application for developing a pill
filled with tiny iron-oxide
nanoparticles that enter the
bloodstream, can identity cancer
tumour cells. By “painting” the
infected cells and with an attached
wearable device creating a
magnetic field, the theory is target
cells could be detected. The
device was designed to be focused
on proactive detection rather than
reactive treatment.
Google likes to think outside
of the box and so to start our
list, we look at what the
Silicon Valley team is up to.
Yes it may be at the early
stages, but it is eHealth
innovation at its best.
“From the
dawn of
civilisation to
2003, five
exabytes of
data were
created. The
same amount
was created in
the last two
days.”
Eric Schmidt, CEO, Google
ponders on the possibilities of Big
Data and eHealth
9
Top 10 most disruptive innovations in eHealth for Pharma
9.Drug Delivery
E
lectronic monitoring devices
(EMD) for asthma inhalers
beyond ‘simple recording of
actuations to providing adherence
promotion features and detailed
information about patterns of
medication use [Chan A et al 2013];
examples include 3M’s metered
dose inhalers, Philips’ expansion into
respiratory drug delivery
technologies. It’s important to note
that inhalation drug delivery systems
have been shown to improve the
administration of drugs to treat
pulmonary and non-pulmonary
diseases (eg. CNS therapeutics in
order to cross the blood brain barrier
(Upadhyay RK 2014), Influenza
vaccine), with the biggest single
problem often being incorrect use
of a device [Ibrahim M et al 2015].
Inhalation devices, critically, have
been shown to better induce bodily
reactions, such as the immune
system, because it is the natural
route of an outside antigen.
• Cloud-based privacy-preserving
remote ECG monitoring and
surveillance (eg. Aerotel medical
systems, Mega ECG, Express
Diagnostics) and of course this
feeds into drug safety studies by
pharma – eg. Evoke Pharma’s
lead product EVK-001, which is
currently in Phase III; or wider
pharmacovigilance studies.
• Wireless device technology that
treats heart failure without
needing patient to visit a clinic
• There was a very interesting
example in November 2014 of
collaboration between Servier
and Boston-based startup, Intarcia
Therapeutics, on a tiny drug-
loaded implantable pump for the
treatment of devices. Although it
doesn’t appear to offer
communication (wirelessly)
between patient and clinician, it
demonstrates things to come for
eHealth, devices and pharma.
Of course, for drugmakers, pill
counters can start the process of
better patient compliance with
medication regimens and thus
improve clinical outcomes. Yet if we
are trying to think outside of the box
when it comes to pills, digital
medicines are not only being
utilized as ‘biosensors’ (as
mentioned in the Google entry
above) but also as ingestible sensors
of a patients’ medication taking
behaviour and treatment
adherence (Proteus Digital Health
work being a prime example with it
being the first company to receive
approval by the FDA for a digital pill
to monitor drug dosing; this year
they also announced a
collaboration with computer giant
Oracle). We should also get excited
about the applications of ‘ePills’ in
the field of drug absorption – both in
the clinic and the real world. I was
particularly interested to find a
company called Matesy offering
the use of a magnetic capsule
MAARS, in combination with the
magnetic monitoring system 3D-
MAGMA, allowing drugs to be
delivered precisely into the
gastrointestinal tract in humans and
animals – obviously a game-
changer in the world of drug
delivery and formulation.
The applications of eHealth
technology in the medical
device industry are well-
known
Matesy - Separated capsule
elements after release by a
short magnetic impulse
Mobile networks are revolutionizing multiple aspects of
healthcare delivery in both the developing and
developed world. mHealth systems can send SMS alerts to
remind patients to take their prescriptions drugs at the
appropriate time, a development which is becoming
important with aging populations across the world.
Researchers, clinicians are starting to strategize mobile
communications as a channel of providing medical care,
particularly to patients with little access to physicians. For
example, the London-based start-up Cupris has
developed a system – consisting of a low-cost medical
device to clip up on a smartphone with an attached app
– to enable remote diagnosis of Ear Nose and Throat
conditions without the patient seeing the doctor in person.
This month (April) there was news of a novel biosensing
platform from Florida Atlantic University, to give in-house
diagnostic testing for a host of bacterial and viral
conditions (eg. HIV, E-coli, Staphylococcus aureas).
Decision-making in eHealth drug delivery systems is
complex and so when we are considering their
development we must also consider diagnostic tools,
usability, uptake and current regulatory constraints.
T
he advantage is to drive down
the overall cost of the
development process, including
trial concept and protocol design,
recruitment and randomization,
“concluding with actionable data”.
Clinical trial cost is a huge thorn in
the side of the staggering pharma
giant (Tufts Center for the Study of
Drug Development estimated it to
stand, as of November 2014, at
$2.558billion for a new prescription
medicine) and even after all these
efforts it is estimated that 30% of
collected data is not used in FDA
applications. No wonder this is a
major priority and key disruptive
enterprise for eHealth TODAY.
Not to be pushing a particular
service provider, but Medidata has
been very vocal in the application
of “Clinical Cloud” solutions to drive
down clinical trial costs (their 2013
whitepaper can be found HERE). The
value of these ‘eHealth’ web
systems include:
• Communication software allowing
scientists and physicians to work
with data whenever they need to
and from wherever.
• Location and device indepen-
dence allowing drugmakers to
share resources across a large
pool of users and provide
‘scalability of service on a self-
serve, just-in-time basis’.
• Viewing data on multiple devices.
The output format is independent
of the API.
• Automatic data feeds providing
clean data from a single point of
data entry.
During the critical drug process, pharma is exploring new eHealth technologies to speed up
collaboration between researchers, physicians, patients and government agencies. This can
stretch from video conferencing to the clinician mobile imaging software.
Clinical trial participants are
always in one room
8.eHealth in Clinical trials
speeding up the truly staggering
cost of inventing new drugs
A
s a consequence, companies
are diversifying their portfolios
and exploring new disease
areas and pathways to enhance
pipeline value, including the
targeting of orphan and/or rare
diseases. The traditional blockbuster
model including the challenges
from large scale patent expiration,
competition from generics &
biosimilars, escalating clinical trial
cost, global healthcare reform has
become less viable whilst there is
huge revenue generating potential
for orphan drugs. I point to the
example of the yearly budget for
the NHS’ Cancer Drug Fund
(GBP280million) and the axing of 16
drugs from this for 2015. At the same
time, National Institute for Health
and Care Excellence (NICE) called
for the inclusion of the £58 million-a-
year Soliris into the NHS treatment
plans (with only a maximum of 200
patients to benefit). Across the
industry, data suggests that
compound annual growth rate of
launched orphan drugs will continue
to outstrip that of non-orphan drugs
for the period 2010 - 2030 (25.8%
compared to 20.1%) and using
revenue analysis, the present value
of an orphan drug sample set was
US $1041 billion compared with US
$3344 billion for the nonorphan drug
market.
As we are all well aware, pharma lives in a world where
increased pipeline attrition coupled with increased R&D
spending means their R&D productivity is becoming
increasingly challenging.
7.The
critical
role
of rare disease care
needs to be more
prominent
Orphan drug cartoon from
the FDA
Top 10 most disruptive innovations in eHealth for Pharma
Top 10 most disruptive innovations in eHealth for Pharma
So, orphan drugs are valuable.
Projects are starting to evolve in
the Rare Disease - eHealth space.
The Institute of Medical Biostatistics,
Epidemiology and Informatics
(IMBEI) in Mainz University listed a
collection of working groups in this
area: Se-Atlas aims to provide an
innovative overview of the
healthcare options for people with
rare diseases in Germany via a
central information portal and
interactive map; ZIPSE is a project
focusing on a determined target-
group-specific information path-
ways and reference routines in a
central, web-based information
portal; The NIRK database was
developed for the Network for
Ichthyosis and Related Keratinisation
disorders, and uses a telemedicine
platform to simplify location-
independent centralised collection
and distribution of patient data.
The simple fact is that patient
recruitment is a major cost factor in
the development of clinical trials, so
when an eHealth technology allows
a company to give ‘healthcare
options’ it can also find & recruit
patients. For rare diseases – and yes,
broader trials – there is a clear
challenge in recruiting for very small
patient populations. Pfizer, for
example, launched a mobile app
and online platform (in
collaboration with Sanguine
Biosciences) called Sangre to find
and recruit people suffering from an
ultra-rare condition called
congenital angalgesia (congenital
insensitivity to pain – only 40 people
have been diagnosed worldwide).
Image credit:
www.medicalpress.es
O
ne of clear recent trends in
the drugs industry,
particularly with the famous
patent cliff beginning in 2011, is the
need for real world evidence
generation – including evaluations
of effectiveness, safety and quality
of care - for evolving stakeholder
needs. Amongst all the challenges
– geographic regions, varying
access and availability practicalities
– pharma are starting to apply
eHealth to this trend.
The article “Looking ‘beyond the
pill’? Start with an app – and then
follow this to-do list?”,from Decision
Resources, is a good guide to what’s
going on. A company such as
Novartis (with its multiple sclerosis
symptom tracker, SymTrac) or Sanofi
(blood sugar tracking device plus
app, IBGStar) will develop an app
which allows a patient to self-
report/self-track and possibly send
information to their doctors. With
regards to legislative limitations,
these drugmakers don’t get
involved with the data from these
apps (its private medical
information) but instead hire a IT
partner who specializes in handling
sensitive data; linking the patient to
the healthcare provider. Finally we
have convergence, whereby
clinical trial results and the
experiences registered through
‘eHealth’ come together to show a
drug-plus-assistance combo and
(fingers crossed) a favourable
pricing point with payers. In relation
to discussions with payers and
regulators, these Apps are utilized in
expansive late stage clinical trials,
where a large patient pool will give
safety, efficacy and quality of life
feedback.
It must be noted, however, that
the role of eHealth in drug
safety/pharmacovigilance/adverse
events is not limited to mobile
apps. The EU-ADR project exploits
*cough* to provide evidence
from patient outcome data
for HTA bodies, regulators
and healthcare payers.
6.Why we have
Apps……
Telemedicine still plays an
important role
advanced ICT to develop new
ways of using existing clinical and
biomedical data sources to detect
Adverse Drug Reactions (ADRs) as
early as possible. The platform
using anonymous EHRs for more
than 30 million EU citizens has
already been successful in
detecting relationships between
specific drug classes and specific
adverse events.
Finally, for pharma there is also the
added advantage of using real
world data to seek expanded
indication approval – such as
Genentech’s Actemra being used in
active rheumatoid arthritis in adults
who have had an inadequate
response to one or more disease-
modifying antirheumatic drugs. An
interesting study in December 2014
(published in the American Medical
Informatics Association) from
Vanderbilt University Medical
Center proposed, by studying the
EHRs of 32,000 cancer patients
since the mid-1990s, that metformin
(a diabetes drug that patients
generally find easy to tolerate)
could be used in the treatment of
some types of cancer. This could
be a sign of things to come. I
believe an intriguing insight, and
prediction, into things to come for
EHRs and pharma.
T
he Salford drug trial was the
world’s first pre-license
“pragmatic” randomised
controlled drug trial for asthma and
chronic obstructive pulmonary
disease. It was a pioneering
collaboration between GSK, Salford
Royal NHS Foundation and
University of Manchester, where
data was collected using
Graphnet’s CareCentric electronic
patient record to provide real world
insight into how patients use and
benefit from their medication.
Interestingly, Dr John New, a
consultant physician at Salford
Royal and one of the study’s
directors, said that data on-site
showed that “only 50-60% of
people regularly take their
medication”, an implication for the
correlation between patient care
and therapy administration.
Overall the study authors
anticipated that the initiative
would serve as a brenchmark for
further pharmacovigilance and
phase IV studies.
5.
Obtaining real
world evidence in
Chronic obstructive
pulmonary disease (COPD).
Top 10 most disruptive innovations in eHealth for Pharma
Chronic obstructive pulmonary disease (COPD) is the 4th leading cause
of death in the United States, affects 24 million people and is responsible
for up to $32 billion annually in direct and indirect health care costs
[University of Colorado, 2012]. There is clearly a huge value in pharma
demonstrating the effectiveness of their interventions and the role of
their eHealth technology to payers in this focus area – particularly as
these patients can often be associated with the highest disability and
mortality. As the WHO supports:
“The delivery of healthcare services, where distance is a critical factor,
by all health professionals using ICT [eHealth tech] for the exchange of
valid information for diagnosis, treatment and prevention of disease and
injuries, research and evaluation, and for the continuing education of
healthcare providers, all in the interest of advancing the health of
individuals and their communities”
44.in Alzheimer’s
P
atrick Vallance, GSK’s Head of
R&D, told Reuters that the goal
of finding an effective
treatment for Alzheimer’s and other
forms of dementia by 2025, was
“hugely ambitious” but that pooling
resources to back promising ideas
from academic groups and small
biotech firms would help to
accelerate research.
One of the difficulties of producing
a treatment for Alzheimer’s is that
the cognitive symptoms only start to
appear in the late stages and so to
identify disease-modifying therapies
it has been necessary to assess
clinicopathlogic and biomarkers.
eHealth is leading from the front in
this field, with technologies that are
monitoring disease progression and
improving patient quality of life.
VPH-DARE-at-IT is the clinical
decision support platform being
used to recognize the early
differential diagnosis of dementias
and its evolution. Constitutes of this
modelling system include
biochemical, metabolic, and
biomechanical brain substrates,
plus genetic, clinical, demographic
and lifestyle determinants.
PredictND is a research project
attempting to make better
predictions, diagnostics and
management of memory disorders
such as Alzheimer’s. Like VPH-DARE-at-
IT, this is part of the “Virtual
Physiological Human” (VPH) initiative
by the EU, and combines information
from several sources, such as clinical
tests, imaging and blood samples,
whilst comparing to previously
diagnosed cases. The project recently
won €3 million to better predict and
diagnose memory disorders (from
2014-2018). Finally we have the
NoTremour project creating tools to
predict Parkinson’s disease and wants
to develop patient specific virtual,
physiological and computational
models of the coupled brain and
neuromuscular systems. It aspires to
establish a link between brain
modelling and neuromuscular systems
which give a holistic representation of
the physiology of PD patients.
Only this March, GSK, Pfizer, Lilly, J&J and Biogen Idec (along
with Alzheimer’s Research UK and the UK government)
backed a $100m venture capital fund.
Top 10 most disruptive innovations in eHealth for Pharma
Clinical development
A
s quoted in “Translating
cancer ‘omics’ to improved
outcomes”, the genomics era
has yielded great advances in the
understanding of cancer biology. It
is revealing an immense complexity
in cancer genomics and its
correlation to patient outcomes. At
the same time, a vast expanse of
multi-omics and patient electronic
health record databases are
becoming available, with a huge
potential to translate the information
sourced from high-through omics
and treatment history to directly
improve clinical outcomes. A key
example of this in the hospital care
(2015) is the plan by the for-profit
HCA to marry the molecular profile
of tumours with a patient’s
electronic health record, pushing for
better, targeted therapies. Sarah
Cannon (an arm of the HCA which
runs 75 cancer centers) used this
approach to profile the tumours of
1,000 late stage cancer patients
and match them to early phase
clinical trial data; results which were
subsequently presented at the
American Society of Clinical
Oncology. Of course all this data –
including the profiles of each
cancer patient – had to be
aggregated and displayed on a
grand scale and in a format that
doctors could understand. To make
this possible the HCA employed
Syapse, a venture-backed start-up
which counts Intermountain
Healthcare, University of California
San Francisco and Stand University
as clients.
Across the pond, eHealth projects
in the cancer field include TUMOUR
(which ran from 2011-2013) a EU
initiative to implement a cancer
model/data repository and develop
tools for collection, validation and
customization of existing models. This
has progressed – with the injection
into the “Virtual Physiological
Human” initiative – into projects such
as VPH-PRISM - a project to give
insight into environment-tissue
interactions in breast cancer and
give quantitative assessment of drug
efficacy, surgery planning and
treatment outcome prediction;
“Computational Horizons In Cancer”
(CHIC) - a project to develop meta-
and hyper-multi-scale models and
repositories for In Silico Oncology
(funding 2013-2017) and OraMod –
focusing on oral cavity cancer and
designed to improve the early
prediction of reoccurrence of this
disease. Additionally, and for the
device enthusiasts more exciting,
eHealth in the EU has also stretched
into imaging: DR THERAPAT – a
platform to integrate available
knowledge on tumour imaging,
image analysis and interpretation,
Relative to other parts of the healthcare system, oncology brings
high levels of uncertainty – including therapeutic efficacy in a
specific patient group, reimbursement levels amongst payers,
3.Oncology
therapeutics
2
radiobiological models and
radiation therapy for planning into a
robust multi-scale digital
representation – and my personal
favourite, FUSIMO – ultrasound
surgery in moving organs.
And of course this is all feeding into
how Pharma is slowly approaching
data-sharing in their cancer drug
development, either through clinical
trial databases or EHR. Historically
pharma gathered patients’ de-
identified data from insurers,
pharmacies and public records
(often to improve marketing
strategies) but with these proven
benefits emerging from the
healthcare system, drug companies
are starting to morph some
collaborations. The Project Data
Sphere initiative (which began in
2012 to improve clinical trial
transparency) has been joined by
Pfizer, Sanofi, AstraZeneca, Bayer,
Celgene and J&J (plus Memorial
Sloan-Kettering Cancer Center) to
evaluate comparator-arm data
from 9 clinical trials. One of the most
progressive examples of a Pharma
company using ‘real-world’ data –
other than the Salford Lung Study –
is Merck’s collaboration with
Practice Fusion to alert doctors or
patients for an overdue vaccination
or test. This forms part of the
company’s initiatives to make a
mark in digital health, alongside its
Global Health Innovation Fund, a
top investor in health IT start-ups.
Sachin Jain, Merck’s Chief Medical
Information and Innovation Officer,
who was recruited specifically for
these initiatives and spearheaded
the partnership with Practice Fusion,
said “This is a clear opportunity to
collaborate. [It’s] clinical decision
support that is actionable, targeted
and delivered to clinicians at the
point of care.”
I fully expect that the Merck
initiative, alongside GSK’s Salford Lung
study earlier, will lead by example for
Pharma to get more involved in
eHealth initatives in Oncology, which
are already underway.
Vaccination technology has
changed
Top 10 most disruptive innovations in eHealth for Pharma
T
he philanthropist even opened a
mock Ebola field hospital at the
TED conference in March to call
for “germ games not war games”]
How ePatients may one day save
the world.
As we know from the West African
Ebola/SARS outbreak the accelerated
implementation of smartphone-based
health applications and the use of big
data analytics will have a massive role
on global public health surveillance.
One of the most striking articles I
have come across (and this was
released in October 2014) was ‘We
could’ve stopped Ebola if we’d
listened to the data’– in which it
describes how computational
epidemiologists foresaw the
approaching holocaust. Indeed we
have a dedicated blog on our Big
Data Conference on ‘How Big Data
could have stopped Ebola’.
E-patients are allowing researchers
to develop multiple models to show
the explosive growth – now,
importantly, in real-time - of a
contagion and allow information to
be relied to medical teams on the
ground. Even in the business world
of pharma, controlling an epidemic
has to be a top priority – certainly
the WHO wasn’t happy with their
response – and that’s why it makes
number two on our list.
“We’re making a global
effort to reduce the threat of
nuclear war. Shouldn’t we
do the same to prevent the
next epidemic?” – Bill Gates
2.Epidemic
control
Integrating data sets from
anonymized mobile phone
usage and demographic
indicators, researchers are
building maps like this one
that model mobility within
countries of West Africa.
Image Credit: PLOS Currents.
1.E-Patient movement
A
round 40% of the world's
population has an internet
connection today…….
3 billion people. Slowly this
‘connected world’ is becoming
accustomed to being attached to
the Internet at all times. We are
becoming a world in which its
inhabitants find it almost impossible
to go anywhere without wanting to
have this ‘Internet’. Between email,
social networks, settling arguments,
and messaging with friends, we all
feel like the Internet is not optional
at this point.
The consequence for the
healthcare/drug industry of course
is that our lonely patient in their
hospital bed doesn’t now just take
the doctors word to be gospel. They
are more ‘engaged’ with the
treatment choices of their care and
‘empowered’ through the critical
use of leveraging data throughout
the world-wide-web. A ‘Google’
phenomenon. As one blogger put
‘Epatients are the hackers of the
healthcare world’ and this doesn’t
just mean our patient is taking more
responsibility for their conditions -
through apps, real-world tracking,
as mentioned earlier – but also
voicing their opinion on new
therapies, including those in clinical
trials, and drug treatment options.
There are even organizations that
aim to spur on this evolution in
medical care, such as the Society of
Participatory Medicine and the
Center for Advancing Health, and
Mayo Clinic even named a patient
as a Visiting Professor for 2015 –
Dave deBronkart, or ‘e-Patient
Dave’ – which highlights the
increased importance placed on a
“union of forces” between providers
and patients. You can see a short
video on his appointment HERE.
For the Pharmaceuticals
companies, this means they have to
take an active role in networking
with bloggers, patient communities
and the medical community to
recognise concerns and trends
patients notice, and ultimately use
it as a platform for patient
marketing. The ePatient will have a
deciding impact on everything from
drug approval, patient recruitment,
drug sales (I can’t stress how much
the influence of a blogger can
impact a multi-billion pound
business), interaction with payers,
medical community, drug discovery
and patient databases. Additionally
the US Affordable Care Act
restricted access to doctors by drug
companies so the cyber-world
could be an avenue to get into the
community behind the medical
industry’s closed doors.
“An e-patient is someone
who is equipped, engaged,
empowered and enabled to
actively participate in his or
her care.” – e-Patient Dave
The Internet is everywhere in
the clinic
Today’s examples
include:
• [December 2014] When Genzyme’s multiple sclerosis drug –
Lemtrada – got rejected by the FDA in 2013, the patient
community mobilized. It is now approved for the treatment
of patients with relapsing forms of MS.
• [April 7, 2014] PatientsLikeMe has a 5-year agreement with
Genentech on exploring online networks to research
patients’ real world experience, including giving them a
clinical trial awareness tool so they have access to
information on on-going studies. Bruce Cooper, SVP, Medical
Affairs, Genentech commented that “We hope our
participation will encourage broader engagement of others
involved in the delivery of healthcare and support a stronger
voice for patients”.
Join the debate this autumn at:

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Ebook - Top 10 most disruptive innovations in eHealth for Pharma

  • 1. most disruptive innovations Top 10 in eHealth for Pharma I am currently in the early stages of producing our eHealth Forum 2015 (co-located with our Big Data in Clinical Development event) and what struck me was that there is a massive enthusiasm in the pharmaceutical industry for the application of these technologies – for their clinical pipelines, improving patient care, and even as a platform for discovery – but when searching for real-world examples; examples which show proven success between these manufacturers and the healthcare systems, it can be a little thin on the ground. This is a disruptive technology for the pharma market and we are just reaching the Tipping Point. This is not just about mobile apps, this is about how eHealth will fundamentally change the drugs industry and the drug industry knows it.
  • 2. Top 10 most disruptive innovations in eHealth for Pharma The US eHealth Initiative quotes 4 key themes or “treatments” of ehealth within the clinic. E Health drivers in the US including monetary incentives paid to providers for compliance with IT “meaningful use”. The larger health reform legislation wraps around this IT program. Within the pharma business model, these themes are inevitably leading to some unique implications. I’ll begin with a 2008 paper to demonstrate this year’s ‘Open-Play’ in eHealth and the industry’s own growing ambition. “Opportunities for electronic health record data to support business functions in the pharmaceutical industry-a case study” – was published by Pfizer to describe how the healthcare informatics team had interviewed 35 senior company leaders (Pfizer) to assess why they had a desire for electronic health records access (EHR – those real-time, patient- centered records providing details of care and a fundamental part of ‘eHealth’). The top responses had been for “Drug Safety & Surveilliance”, “Clinical Trial Recruitment” and “Support Regulatory Approval”. As shown by our above ‘healthcare themes’, the subsequent years have seen an expansion of the role of eHealth in provider systems and this has potential for application into the drugmakers business model: • Drug discovery direction including from real-world observations • Clinical research [eg. EURECA, Linked2Safety (EHR interconnection), GRANATUM (“Facebook for biomedical researchers”, Salus Project, SemanticHealthNet, TRANSFoRm (“rapid learning healthcare system”)] • Repurposing of drugs, the application of the “Internet of Things” (IoT – wifi in portable technology such as transplants) in medical devices and its interaction with therapeutics, HTA evidence portfolios, chronic disease management, medicine adherence and improved patient outcomes, the list goes on. And so, to illustrate how eHealth is disrupting how we approach patient care – and inevitably the focus of Big Pharma within this – I have put together a top 10. Note – Ranking is in relation to technologies which have an established record, probability of success, eventual goals of particular projects and the ramifications of a run-away success. It also weights the ranking favourably towards what areas will cause a fundamental change in how the drug industry “works” and impact on public health. • Digitization of health information (HIS, EMR, PACS adoption) • Longitudinal HER (sharing data between existing systems) • Chronic disease management (home health, devices, etc) • Consumer empowerment (personally controlled electronic health records, online scheduling and prescriptions, etc) “Patients. Here be Big Data.” Join us at and
  • 3. 10Top 10 most disruptive innovations in eHealth for Pharma Smart watches have moved on; as mentioned in this article ‘Google’s Smartwatch to Be Fueled By Google Now, “In Late-Stage Development”’ 10.Wearable technology, it’s in the blood. A s the worldwide eagerly awaits Google Glass 2.0 (and its application in changing the way we view the world), Google has filed a patent application with the World Intellectual Property Organization (WIPO) for a wrist-worn device that could destroy cancer cells in the blood. The patent application, which has the name "Nanoparticle Phoresis", describes a wearable device that "can automatically modify or destroy one or more targets in the blood that have an adverse health effect". These targets could include enzymes, hormones, proteins, cells or other molecules that, when present in the blood, may affect a medical condition or the health of the person wearing the device. The wearable device is designed to modify or destroy the cells by transmitting energy into the blood vessels. The transmitted energy could be a radio frequency pulse [a cutting edge, area of medical research – March 2015 paper – ‘Radio frequency responsive nano- biomaterials in cancer therapy’], a time-varying magnetic field, an acoustic pulse, an infrared or visible light signal. Google used the example of proteins implicated as a partial cause of Parkinson's disease. "As a further example, the target could be cancer cells; by selectively targeting and then modifying or destroying the cancer cells, the spread of cancer may be diminished," it said in its patent application. This patent application follows the company’s October 2014 application for developing a pill filled with tiny iron-oxide nanoparticles that enter the bloodstream, can identity cancer tumour cells. By “painting” the infected cells and with an attached wearable device creating a magnetic field, the theory is target cells could be detected. The device was designed to be focused on proactive detection rather than reactive treatment. Google likes to think outside of the box and so to start our list, we look at what the Silicon Valley team is up to. Yes it may be at the early stages, but it is eHealth innovation at its best. “From the dawn of civilisation to 2003, five exabytes of data were created. The same amount was created in the last two days.” Eric Schmidt, CEO, Google ponders on the possibilities of Big Data and eHealth
  • 4. 9 Top 10 most disruptive innovations in eHealth for Pharma 9.Drug Delivery E lectronic monitoring devices (EMD) for asthma inhalers beyond ‘simple recording of actuations to providing adherence promotion features and detailed information about patterns of medication use [Chan A et al 2013]; examples include 3M’s metered dose inhalers, Philips’ expansion into respiratory drug delivery technologies. It’s important to note that inhalation drug delivery systems have been shown to improve the administration of drugs to treat pulmonary and non-pulmonary diseases (eg. CNS therapeutics in order to cross the blood brain barrier (Upadhyay RK 2014), Influenza vaccine), with the biggest single problem often being incorrect use of a device [Ibrahim M et al 2015]. Inhalation devices, critically, have been shown to better induce bodily reactions, such as the immune system, because it is the natural route of an outside antigen. • Cloud-based privacy-preserving remote ECG monitoring and surveillance (eg. Aerotel medical systems, Mega ECG, Express Diagnostics) and of course this feeds into drug safety studies by pharma – eg. Evoke Pharma’s lead product EVK-001, which is currently in Phase III; or wider pharmacovigilance studies. • Wireless device technology that treats heart failure without needing patient to visit a clinic • There was a very interesting example in November 2014 of collaboration between Servier and Boston-based startup, Intarcia Therapeutics, on a tiny drug- loaded implantable pump for the treatment of devices. Although it doesn’t appear to offer communication (wirelessly) between patient and clinician, it demonstrates things to come for eHealth, devices and pharma. Of course, for drugmakers, pill counters can start the process of better patient compliance with medication regimens and thus improve clinical outcomes. Yet if we are trying to think outside of the box when it comes to pills, digital medicines are not only being utilized as ‘biosensors’ (as mentioned in the Google entry above) but also as ingestible sensors of a patients’ medication taking behaviour and treatment adherence (Proteus Digital Health work being a prime example with it being the first company to receive approval by the FDA for a digital pill to monitor drug dosing; this year they also announced a collaboration with computer giant Oracle). We should also get excited about the applications of ‘ePills’ in the field of drug absorption – both in the clinic and the real world. I was particularly interested to find a company called Matesy offering the use of a magnetic capsule MAARS, in combination with the magnetic monitoring system 3D- MAGMA, allowing drugs to be delivered precisely into the gastrointestinal tract in humans and animals – obviously a game- changer in the world of drug delivery and formulation. The applications of eHealth technology in the medical device industry are well- known Matesy - Separated capsule elements after release by a short magnetic impulse Mobile networks are revolutionizing multiple aspects of healthcare delivery in both the developing and developed world. mHealth systems can send SMS alerts to remind patients to take their prescriptions drugs at the appropriate time, a development which is becoming important with aging populations across the world. Researchers, clinicians are starting to strategize mobile communications as a channel of providing medical care, particularly to patients with little access to physicians. For example, the London-based start-up Cupris has developed a system – consisting of a low-cost medical device to clip up on a smartphone with an attached app – to enable remote diagnosis of Ear Nose and Throat conditions without the patient seeing the doctor in person. This month (April) there was news of a novel biosensing platform from Florida Atlantic University, to give in-house diagnostic testing for a host of bacterial and viral conditions (eg. HIV, E-coli, Staphylococcus aureas). Decision-making in eHealth drug delivery systems is complex and so when we are considering their development we must also consider diagnostic tools, usability, uptake and current regulatory constraints.
  • 5. T he advantage is to drive down the overall cost of the development process, including trial concept and protocol design, recruitment and randomization, “concluding with actionable data”. Clinical trial cost is a huge thorn in the side of the staggering pharma giant (Tufts Center for the Study of Drug Development estimated it to stand, as of November 2014, at $2.558billion for a new prescription medicine) and even after all these efforts it is estimated that 30% of collected data is not used in FDA applications. No wonder this is a major priority and key disruptive enterprise for eHealth TODAY. Not to be pushing a particular service provider, but Medidata has been very vocal in the application of “Clinical Cloud” solutions to drive down clinical trial costs (their 2013 whitepaper can be found HERE). The value of these ‘eHealth’ web systems include: • Communication software allowing scientists and physicians to work with data whenever they need to and from wherever. • Location and device indepen- dence allowing drugmakers to share resources across a large pool of users and provide ‘scalability of service on a self- serve, just-in-time basis’. • Viewing data on multiple devices. The output format is independent of the API. • Automatic data feeds providing clean data from a single point of data entry. During the critical drug process, pharma is exploring new eHealth technologies to speed up collaboration between researchers, physicians, patients and government agencies. This can stretch from video conferencing to the clinician mobile imaging software. Clinical trial participants are always in one room 8.eHealth in Clinical trials speeding up the truly staggering cost of inventing new drugs A s a consequence, companies are diversifying their portfolios and exploring new disease areas and pathways to enhance pipeline value, including the targeting of orphan and/or rare diseases. The traditional blockbuster model including the challenges from large scale patent expiration, competition from generics & biosimilars, escalating clinical trial cost, global healthcare reform has become less viable whilst there is huge revenue generating potential for orphan drugs. I point to the example of the yearly budget for the NHS’ Cancer Drug Fund (GBP280million) and the axing of 16 drugs from this for 2015. At the same time, National Institute for Health and Care Excellence (NICE) called for the inclusion of the £58 million-a- year Soliris into the NHS treatment plans (with only a maximum of 200 patients to benefit). Across the industry, data suggests that compound annual growth rate of launched orphan drugs will continue to outstrip that of non-orphan drugs for the period 2010 - 2030 (25.8% compared to 20.1%) and using revenue analysis, the present value of an orphan drug sample set was US $1041 billion compared with US $3344 billion for the nonorphan drug market. As we are all well aware, pharma lives in a world where increased pipeline attrition coupled with increased R&D spending means their R&D productivity is becoming increasingly challenging. 7.The critical role of rare disease care needs to be more prominent Orphan drug cartoon from the FDA Top 10 most disruptive innovations in eHealth for Pharma
  • 6. Top 10 most disruptive innovations in eHealth for Pharma So, orphan drugs are valuable. Projects are starting to evolve in the Rare Disease - eHealth space. The Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI) in Mainz University listed a collection of working groups in this area: Se-Atlas aims to provide an innovative overview of the healthcare options for people with rare diseases in Germany via a central information portal and interactive map; ZIPSE is a project focusing on a determined target- group-specific information path- ways and reference routines in a central, web-based information portal; The NIRK database was developed for the Network for Ichthyosis and Related Keratinisation disorders, and uses a telemedicine platform to simplify location- independent centralised collection and distribution of patient data. The simple fact is that patient recruitment is a major cost factor in the development of clinical trials, so when an eHealth technology allows a company to give ‘healthcare options’ it can also find & recruit patients. For rare diseases – and yes, broader trials – there is a clear challenge in recruiting for very small patient populations. Pfizer, for example, launched a mobile app and online platform (in collaboration with Sanguine Biosciences) called Sangre to find and recruit people suffering from an ultra-rare condition called congenital angalgesia (congenital insensitivity to pain – only 40 people have been diagnosed worldwide). Image credit: www.medicalpress.es O ne of clear recent trends in the drugs industry, particularly with the famous patent cliff beginning in 2011, is the need for real world evidence generation – including evaluations of effectiveness, safety and quality of care - for evolving stakeholder needs. Amongst all the challenges – geographic regions, varying access and availability practicalities – pharma are starting to apply eHealth to this trend. The article “Looking ‘beyond the pill’? Start with an app – and then follow this to-do list?”,from Decision Resources, is a good guide to what’s going on. A company such as Novartis (with its multiple sclerosis symptom tracker, SymTrac) or Sanofi (blood sugar tracking device plus app, IBGStar) will develop an app which allows a patient to self- report/self-track and possibly send information to their doctors. With regards to legislative limitations, these drugmakers don’t get involved with the data from these apps (its private medical information) but instead hire a IT partner who specializes in handling sensitive data; linking the patient to the healthcare provider. Finally we have convergence, whereby clinical trial results and the experiences registered through ‘eHealth’ come together to show a drug-plus-assistance combo and (fingers crossed) a favourable pricing point with payers. In relation to discussions with payers and regulators, these Apps are utilized in expansive late stage clinical trials, where a large patient pool will give safety, efficacy and quality of life feedback. It must be noted, however, that the role of eHealth in drug safety/pharmacovigilance/adverse events is not limited to mobile apps. The EU-ADR project exploits *cough* to provide evidence from patient outcome data for HTA bodies, regulators and healthcare payers. 6.Why we have Apps……
  • 7. Telemedicine still plays an important role advanced ICT to develop new ways of using existing clinical and biomedical data sources to detect Adverse Drug Reactions (ADRs) as early as possible. The platform using anonymous EHRs for more than 30 million EU citizens has already been successful in detecting relationships between specific drug classes and specific adverse events. Finally, for pharma there is also the added advantage of using real world data to seek expanded indication approval – such as Genentech’s Actemra being used in active rheumatoid arthritis in adults who have had an inadequate response to one or more disease- modifying antirheumatic drugs. An interesting study in December 2014 (published in the American Medical Informatics Association) from Vanderbilt University Medical Center proposed, by studying the EHRs of 32,000 cancer patients since the mid-1990s, that metformin (a diabetes drug that patients generally find easy to tolerate) could be used in the treatment of some types of cancer. This could be a sign of things to come. I believe an intriguing insight, and prediction, into things to come for EHRs and pharma. T he Salford drug trial was the world’s first pre-license “pragmatic” randomised controlled drug trial for asthma and chronic obstructive pulmonary disease. It was a pioneering collaboration between GSK, Salford Royal NHS Foundation and University of Manchester, where data was collected using Graphnet’s CareCentric electronic patient record to provide real world insight into how patients use and benefit from their medication. Interestingly, Dr John New, a consultant physician at Salford Royal and one of the study’s directors, said that data on-site showed that “only 50-60% of people regularly take their medication”, an implication for the correlation between patient care and therapy administration. Overall the study authors anticipated that the initiative would serve as a brenchmark for further pharmacovigilance and phase IV studies. 5. Obtaining real world evidence in Chronic obstructive pulmonary disease (COPD). Top 10 most disruptive innovations in eHealth for Pharma Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United States, affects 24 million people and is responsible for up to $32 billion annually in direct and indirect health care costs [University of Colorado, 2012]. There is clearly a huge value in pharma demonstrating the effectiveness of their interventions and the role of their eHealth technology to payers in this focus area – particularly as these patients can often be associated with the highest disability and mortality. As the WHO supports: “The delivery of healthcare services, where distance is a critical factor, by all health professionals using ICT [eHealth tech] for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of healthcare providers, all in the interest of advancing the health of individuals and their communities”
  • 8. 44.in Alzheimer’s P atrick Vallance, GSK’s Head of R&D, told Reuters that the goal of finding an effective treatment for Alzheimer’s and other forms of dementia by 2025, was “hugely ambitious” but that pooling resources to back promising ideas from academic groups and small biotech firms would help to accelerate research. One of the difficulties of producing a treatment for Alzheimer’s is that the cognitive symptoms only start to appear in the late stages and so to identify disease-modifying therapies it has been necessary to assess clinicopathlogic and biomarkers. eHealth is leading from the front in this field, with technologies that are monitoring disease progression and improving patient quality of life. VPH-DARE-at-IT is the clinical decision support platform being used to recognize the early differential diagnosis of dementias and its evolution. Constitutes of this modelling system include biochemical, metabolic, and biomechanical brain substrates, plus genetic, clinical, demographic and lifestyle determinants. PredictND is a research project attempting to make better predictions, diagnostics and management of memory disorders such as Alzheimer’s. Like VPH-DARE-at- IT, this is part of the “Virtual Physiological Human” (VPH) initiative by the EU, and combines information from several sources, such as clinical tests, imaging and blood samples, whilst comparing to previously diagnosed cases. The project recently won €3 million to better predict and diagnose memory disorders (from 2014-2018). Finally we have the NoTremour project creating tools to predict Parkinson’s disease and wants to develop patient specific virtual, physiological and computational models of the coupled brain and neuromuscular systems. It aspires to establish a link between brain modelling and neuromuscular systems which give a holistic representation of the physiology of PD patients. Only this March, GSK, Pfizer, Lilly, J&J and Biogen Idec (along with Alzheimer’s Research UK and the UK government) backed a $100m venture capital fund. Top 10 most disruptive innovations in eHealth for Pharma Clinical development A s quoted in “Translating cancer ‘omics’ to improved outcomes”, the genomics era has yielded great advances in the understanding of cancer biology. It is revealing an immense complexity in cancer genomics and its correlation to patient outcomes. At the same time, a vast expanse of multi-omics and patient electronic health record databases are becoming available, with a huge potential to translate the information sourced from high-through omics and treatment history to directly improve clinical outcomes. A key example of this in the hospital care (2015) is the plan by the for-profit HCA to marry the molecular profile of tumours with a patient’s electronic health record, pushing for better, targeted therapies. Sarah Cannon (an arm of the HCA which runs 75 cancer centers) used this approach to profile the tumours of 1,000 late stage cancer patients and match them to early phase clinical trial data; results which were subsequently presented at the American Society of Clinical Oncology. Of course all this data – including the profiles of each cancer patient – had to be aggregated and displayed on a grand scale and in a format that doctors could understand. To make this possible the HCA employed Syapse, a venture-backed start-up which counts Intermountain Healthcare, University of California San Francisco and Stand University as clients. Across the pond, eHealth projects in the cancer field include TUMOUR (which ran from 2011-2013) a EU initiative to implement a cancer model/data repository and develop tools for collection, validation and customization of existing models. This has progressed – with the injection into the “Virtual Physiological Human” initiative – into projects such as VPH-PRISM - a project to give insight into environment-tissue interactions in breast cancer and give quantitative assessment of drug efficacy, surgery planning and treatment outcome prediction; “Computational Horizons In Cancer” (CHIC) - a project to develop meta- and hyper-multi-scale models and repositories for In Silico Oncology (funding 2013-2017) and OraMod – focusing on oral cavity cancer and designed to improve the early prediction of reoccurrence of this disease. Additionally, and for the device enthusiasts more exciting, eHealth in the EU has also stretched into imaging: DR THERAPAT – a platform to integrate available knowledge on tumour imaging, image analysis and interpretation, Relative to other parts of the healthcare system, oncology brings high levels of uncertainty – including therapeutic efficacy in a specific patient group, reimbursement levels amongst payers, 3.Oncology therapeutics
  • 9. 2 radiobiological models and radiation therapy for planning into a robust multi-scale digital representation – and my personal favourite, FUSIMO – ultrasound surgery in moving organs. And of course this is all feeding into how Pharma is slowly approaching data-sharing in their cancer drug development, either through clinical trial databases or EHR. Historically pharma gathered patients’ de- identified data from insurers, pharmacies and public records (often to improve marketing strategies) but with these proven benefits emerging from the healthcare system, drug companies are starting to morph some collaborations. The Project Data Sphere initiative (which began in 2012 to improve clinical trial transparency) has been joined by Pfizer, Sanofi, AstraZeneca, Bayer, Celgene and J&J (plus Memorial Sloan-Kettering Cancer Center) to evaluate comparator-arm data from 9 clinical trials. One of the most progressive examples of a Pharma company using ‘real-world’ data – other than the Salford Lung Study – is Merck’s collaboration with Practice Fusion to alert doctors or patients for an overdue vaccination or test. This forms part of the company’s initiatives to make a mark in digital health, alongside its Global Health Innovation Fund, a top investor in health IT start-ups. Sachin Jain, Merck’s Chief Medical Information and Innovation Officer, who was recruited specifically for these initiatives and spearheaded the partnership with Practice Fusion, said “This is a clear opportunity to collaborate. [It’s] clinical decision support that is actionable, targeted and delivered to clinicians at the point of care.” I fully expect that the Merck initiative, alongside GSK’s Salford Lung study earlier, will lead by example for Pharma to get more involved in eHealth initatives in Oncology, which are already underway. Vaccination technology has changed Top 10 most disruptive innovations in eHealth for Pharma T he philanthropist even opened a mock Ebola field hospital at the TED conference in March to call for “germ games not war games”] How ePatients may one day save the world. As we know from the West African Ebola/SARS outbreak the accelerated implementation of smartphone-based health applications and the use of big data analytics will have a massive role on global public health surveillance. One of the most striking articles I have come across (and this was released in October 2014) was ‘We could’ve stopped Ebola if we’d listened to the data’– in which it describes how computational epidemiologists foresaw the approaching holocaust. Indeed we have a dedicated blog on our Big Data Conference on ‘How Big Data could have stopped Ebola’. E-patients are allowing researchers to develop multiple models to show the explosive growth – now, importantly, in real-time - of a contagion and allow information to be relied to medical teams on the ground. Even in the business world of pharma, controlling an epidemic has to be a top priority – certainly the WHO wasn’t happy with their response – and that’s why it makes number two on our list. “We’re making a global effort to reduce the threat of nuclear war. Shouldn’t we do the same to prevent the next epidemic?” – Bill Gates 2.Epidemic control Integrating data sets from anonymized mobile phone usage and demographic indicators, researchers are building maps like this one that model mobility within countries of West Africa. Image Credit: PLOS Currents.
  • 10. 1.E-Patient movement A round 40% of the world's population has an internet connection today……. 3 billion people. Slowly this ‘connected world’ is becoming accustomed to being attached to the Internet at all times. We are becoming a world in which its inhabitants find it almost impossible to go anywhere without wanting to have this ‘Internet’. Between email, social networks, settling arguments, and messaging with friends, we all feel like the Internet is not optional at this point. The consequence for the healthcare/drug industry of course is that our lonely patient in their hospital bed doesn’t now just take the doctors word to be gospel. They are more ‘engaged’ with the treatment choices of their care and ‘empowered’ through the critical use of leveraging data throughout the world-wide-web. A ‘Google’ phenomenon. As one blogger put ‘Epatients are the hackers of the healthcare world’ and this doesn’t just mean our patient is taking more responsibility for their conditions - through apps, real-world tracking, as mentioned earlier – but also voicing their opinion on new therapies, including those in clinical trials, and drug treatment options. There are even organizations that aim to spur on this evolution in medical care, such as the Society of Participatory Medicine and the Center for Advancing Health, and Mayo Clinic even named a patient as a Visiting Professor for 2015 – Dave deBronkart, or ‘e-Patient Dave’ – which highlights the increased importance placed on a “union of forces” between providers and patients. You can see a short video on his appointment HERE. For the Pharmaceuticals companies, this means they have to take an active role in networking with bloggers, patient communities and the medical community to recognise concerns and trends patients notice, and ultimately use it as a platform for patient marketing. The ePatient will have a deciding impact on everything from drug approval, patient recruitment, drug sales (I can’t stress how much the influence of a blogger can impact a multi-billion pound business), interaction with payers, medical community, drug discovery and patient databases. Additionally the US Affordable Care Act restricted access to doctors by drug companies so the cyber-world could be an avenue to get into the community behind the medical industry’s closed doors. “An e-patient is someone who is equipped, engaged, empowered and enabled to actively participate in his or her care.” – e-Patient Dave The Internet is everywhere in the clinic Today’s examples include: • [December 2014] When Genzyme’s multiple sclerosis drug – Lemtrada – got rejected by the FDA in 2013, the patient community mobilized. It is now approved for the treatment of patients with relapsing forms of MS. • [April 7, 2014] PatientsLikeMe has a 5-year agreement with Genentech on exploring online networks to research patients’ real world experience, including giving them a clinical trial awareness tool so they have access to information on on-going studies. Bruce Cooper, SVP, Medical Affairs, Genentech commented that “We hope our participation will encourage broader engagement of others involved in the delivery of healthcare and support a stronger voice for patients”. Join the debate this autumn at: