PME Feb.

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PME
PHARMACEUTICAL MARKET EUROPE
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UNDER
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The forces shaping pharmas evolution
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Interview:
Takedas Marc Princen
Health education
The NME class of 2015
Paging
Dr Millennial...
European life sciences
New EU trial summaries
What if
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Shakespeare stopped
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No Romeo and Juliet

No Hamlet
No Macbeth
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Healthcare Communications
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THE TEAM
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Editorial:
Editorial director Dominic Tyer
Commissioning editor Iona Everson
Junior reporter Rebecca Clifford
Studio:
Creative director Karl Equi
Middleweight graphic designer Laura Slater
Junior graphic designer Helen Penfold
PME
PHA RMA CEU TICA
L MAR KET EUR

OPE
UNDER
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Sales:
Business manager Tara Lovegrove
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The forces shaping

pharmas evolutio
n
Production:
Production director Keith Shilson
Production manager Samuel Hamilton
EDITORIAL ADVISORY BOARD

Philip Atkinson
Head, scientic communications, Roche
Dr Diana Barkley
Pharmaceutical consultant, Independent
Uday Bose
Corporate vice president, head of global
marketing oncology, Boehringer Ingelheim
Dr Luc Hermans
VP commercial planning and operations
Europe, Asia, Middle East, Gilead Sciences
Stefan Janssens
President EMEA, Cegedim Dendrite
John Morris
Partner, KPMG
Interview:
Takedas Marc Princen
Health education
The NME class of 2015
PME_Cover-Feb1
6-final.indd 1
Paul Pay
Vice president, corporate & business
development, Norgine
Paging
Dr Millennial...
European life sciences
New EU trial summaries
Mark Rothera
Chief commercial ofcer, PTC Therapeutics
PUBLISHED BY
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Ian Talmage
Senior vice president, global marketing,
general medicine, Bayer Pharmaceuticals
Adapt or die?
PMGroup
Mansard House, Church Road,
Little Bookham, Surrey, KT23 3JG, UK
Tel: +44 (0)1372 414200
Fax: +44 (0)1372 414201
Transformation is, once again, in

the pharma air this month, with a
shakeup at Novartis as it revamps its
business and looks to reinvigorate its
underperforming eyecare division Alcon.
CONTACT US
General enquiries: info@pmlive.com
Editorial: editor@pmlive.com
Advertising: sales@pmlive.com
Subscriptions: subscriptions@pmlive.com
The theme of change continues with our

cover feature, Under Pressure, which
sees Dr Brian D Smith pick apart six
inexorable forces shaping the evolution
of our industry - from the value shift
to the information shift and beyond.
Views expressed by the contributors

do not necessarily represent those
of the publisher, editor or staff.
2016 PMGroup
All rights reserved. No part of this
publication may be copied, reproduced,
transmitted, photocopied, recorded or
stored on any retrieval system without the
prior written consent of the publishers.
We hear from Takedas president for

Europe and Canada, Marc Princen,
on his companys plans to evolve its
traditional focus on primary care to one
that encompasses specialty care in the
form of oncology and gastroenterology,

with vaccines not far behind.
You can find more than a hint of
what market changes to expect this
year in our special focus on the new
molecular entities approved last year,
when the class of 2015 was headed
up by rare disease therapies.
Strikingly, across all therapies, nearly
40% of the NMEs approved in 2015
worked in a new way to prior therapies,
continuing the recent trend towards the
development of innovative therapies and
moving away from the clusters of me
too drugs all too often seen in new drug
approval lists from the 1990s and 2000s.
The magazine is also available at the

following subscription rates: 120
UK, 180 Europe, 210 RoW
Dominic Tyer, editorial director
Pharmaceutical Market Europe February 2016
www.pmlive.com
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See the results and photos from the night at
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Contents
FEBRUARY 2016
6-7. Novartis shakes
up Alcon unit; Sano
hunt for Zika virus
SANOFIS ZIKA
VIRUS HUNT
26. New regulation will

require both a trial summary
and a lay persons summary
INTERVIEW - TAKEDA
30. Marc Princen on the
rms speciality care plans
UNDER PRESSURE
NEW PATHWAYS
32. Six inexorable

forces shaping our
industrys evolution
01
WHO DONT NEED

NO EDUCATION?
0.
EU LIFE SCIENCE SITES
36. Looking at health

education and pharmas
risk-averse traditions
26
EU TRIAL SUMMARIES
DIGITAL INTELLIGENCE
42. EU eyes mHealth apps;
FDA issues guidance against
medical device hacking
igh
15. Johnson & Johnsons

portent of purity
22
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CLASS OF 2015
Al
18
DARWINS MEDICINE
PAGING DR MILENNIAL
ts
EMAS ACCELERATED
PATHWAYS
30
TAKEDAS
MARC PRINCEN
44
44. How do milennial

doctors compare to previous
generations of doctors?
PAGING DR
MILENNIAL
PHARMA BRANDS
AND AWARDS
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THE ITALIAN JOB
res
16. New model will drive

corporate strategy and
industry innovation
THE NEW EU CLINICAL

TRIAL LAY SUMMARIES
UNDER PRESSURE
p2
16
12-13. Novos Tresiba

gains trial boost; Rise due
for glioblastoma market
14. Mismanagement of
UKs Cancer Drugs Fund
unacceptable, say MPs
32
ou
10. French investigation

into fatal study; Pharma
search for new antibiotics
Gr
8-9. First Enbrel biosimilar

cleared for EU marketing;
FDA backs opioid implant
PM
NEWS
17. Efcacy rebates
46. Why dont big pharma

brands win creative awards?
CLASS OF 2015
APPOINTMENTS
18. Rare diseases therapies

head approvals of NMEs
48. Changes at Celgene,

GSK, Roche and Novartis,
among others
EUROPEAN SITES
22. What makes a country
in Europe attractive to
life science companies
46
PHARMA BRANDS
AND AWARDS
www.pmlive.com
News
Novartis shakes up underperforming Alcon unit

Begins revamp of its business, beginning with changes at its eyecare division
ovartis has started a

revamp of its business
- including changes at
the top of its Alcon eyecare
division - after missing sales
and earnings targets in its
fourth quarter results.
The company has said it
will strip out the ophthalmic
drug business from Alcon and
transfer products either to its
pharmaceuticals or generics
divisions, after a 13% fall in
sales at the unit to $2.3bn.
Overall revenues at the group
fell 4% to $12.5bn.
The poor performance of Alcon
dragged down operating income
at the Swiss group - falling 64% to
$132m - but it was not the only
reason for its poor showing.
Reported pharma sales were
at at $7.9bn - although its
multiple sclerosis therapy
Gilenya (ngolimod) and the
cancer drugs recently acquired
from GlaxoSmithKline did well,
revenues at generic unit Sandoz
fell back 8% to $2.3bn.
There was also disappointment
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includes the appointment of new

leadership at Alcon, with former
Hospira chief executive Mike
Ball taking over from Jeff George
with a remit to return the unit to
prot before the end of the year.
After the bulk of its
pharmaceutical products are
transferred elsewhere, Alcon will
focus on vision care products
such as contact lenses and its
eye surgery product lines.
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for the company on sales of new

heart failure therapy Entresto
(valsartan/sacubitril), which
mustered just $5m in sales in
the fourth quarter thanks to a
slow take-up into formularies.
The company is expecting
accelerating growth from
the drug in 2016 now that
prescribing barriers for
Entresto have started to fall.
Novartis response to its sales dip
Sano embarks on Zika vaccine hunt
Begins research programme as WHO declares the virus a global emergency

Sano has begun research
into a vaccine against the Zika
virus, which has been called a
global emergency by the World
Health Organization (WHO).
The virus - which may be linked
to a cluster of microcephaly and
other neurological disorders
such as Guillain-Barr Syndrome
(GBS) in Brazil - is a public
health threat to other parts of
the world, according to WHO
Director-General Margaret Chan.
www.pmlive.com
Novartis chief executive Joe

Jimenez said the problems at Alcon
related to a lack of innovation - not
replacing products succumbing to
generic competition - insufcient
efforts on surgeon education and
training, and a lack of scale.
With a more focused unit,
the emphasis will now be on
spending sales, marketing and
development cash to make the
most of the current portfolio
and new launches, and Jimenez
expects a turnaround in the
latter half of the year.
Meanwhile, Novartis also plans
to restructure its drug development
operations and centralise
manufacturing to lower our
cost base, said Jimenez. All told,
Novartis wants to cut $1bn off its
annual operating spend by 2020.
The R&D shake-up will follow
a similar pattern to Novartis
well-received integration of its
business services operations and
will see multiple groups that are
doing the same work - for example
safety, pharmacovigilance and
regulatory - combined into one.
The agency debated the latest

outbreak in Brazil at an emergency
committee meeting and said the
priority is to protect pregnant
women and their babies from the
virus and to control the Aedes
mosquitoes that spread the disease.
Sano Pasteur said that it would
draw on experience in developing
vaccines for similar viruses such as
yellow fever, Japanese encephalitis
and dengue to accelerate the
search for a Zika vaccine. The
company secured regulatory
approval for the rst dengue
vaccine - Dengvaxia - last year.
Like dengue, Zika virus (ZIKV)
is a member of the Flavivirus
genus - which includes a number
of viruses that are spread by insect
vectors and cause encephalitis.
Sano Pasteur said its
experience with dengue can
be rapidly leveraged to help
understand the spread of ZIKV and
potentially speed identication
of a vaccine candidate for
further clinical development.
While it has not been proven

that Zika causes microcephaly
and GBS, Chan said medical
experts and WHO advisors
agreed that a causal relationship
is strongly suspected.
Normally a rare condition,
microcephaly results in an
abnormally small head impairing
brain development, and there
has been a cluster of 4,000 cases
in Brazil since the start of 2015.
Patterns of recent spread and the
broad geographical distribution
of mosquito species that can
transmit the virus, as well as the
lack of vaccines and rapid and
reliable diagnostic tests, and the
absence of population immunity
in newly affected countries were
cited as major causes for concern.
Sano Pasteur is responding
to the global call to action to
develop a Zika vaccine given
the diseases rapid spread and
possible medical complications,
said Nicholas Jackson, Sano
Pasteurs global head of research.
Prices stopped
J&J acquisitions
Johnson & Johnson looked at
possible acquisitions during 2015
but was put off by high valuations,
according to Alex Gorsky.
Speaking at its fourth quarter
results call, the rms CEO
intimated to investors and analysts
that with valuations starting to fall
back we intend to be quite active
as we look at 2016 and beyond.
Aside from some small deals,
J&J has not joined in with the
surge in M&A activity that swept
pharma in 2014 and 2015, losing
out to AbbVie in a tug of war
to buy Pharmacyclics. Last year
the group embarked on a $10bn
share buyback - although it
insisted this would not scupper
its ability to make deals.
The company is also sitting
on a fairly hefty cash pile - albeit
with a large proportion overseas
- and according to Gorsky is
looking at opportunities across
all three of its business sectors:
pharmaceuticals, medical
devices and consumer health.
News
Nestl continues its drive into pharma
In brief
Food giant to investigate potential inammatory bowel disease treatments
ood giant Nestl has

continued its push into
pharma with a $1.9bn
partnership with Seres
Therapeutics to develop
drugs for inammatory
bowel disease and a common
gastrointestinal infection.
The deal includes a $120m
upfront payment to Massachusettsbased Seres, which focuses on
developing therapies based
on the manipulation of the
microbiome - the population
of trillions of microorganisms
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that live within humans.

The agreement gives Nestl
Health Science rights to four Seres
programmes for Clostridium
difcile infection (CDI) and
IBD - which includes Crohns
disease and ulcerative colitis outside the US and Canada.
These include CDI treatments
SER-109 and SER-262, which
account for a large part of
Seres active pipeline.
SER-109 is in phase II trials
and has already shown efcacy
against CDI in a phase I/II proof-
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of-concept study in 30 patients

which revealed a 97% cure rate.
The therapy - and follow-up SER262 - takes the form of a complex
mixture of spores and bacteria that
are designed to restore the normal
balance of microorganisms in
the GI tract and prevent recurring
CDI in patients who suffer from
repeated attacks of the infection.
CDI is the leading cause of
hospital-acquired infection in
the US and is responsible for
the deaths of approximately
29,000 Americans each
year, according to Seres.
The deal with Nestl reects
the growing interest in three-yearold Seres, which was among the
ranks of biopharma companies
that successfully closed initial
public offerings (IPOs) during
2015, raising some $140m.
The company has been led by
former Merck & Co executive
Roger Pomerantz since 2014.
Meanwhile, Nestl Health
Science has made a series of
acquisitions in the last few years as
it builds what it describes as a new
industry between the traditional
nutrition and pharma industries.
Empliciti set for EU approval in multiple myeloma
Roche reported worse-thanexpected annual prots,

although sales growth
was solid thanks to its
cancer drugs. Correcting
for the strong Swiss franc,
a 5% increase in sales
to CHF48.1bn ($47.5bn)
was matched by a 5%
decline in net income to
just over CHF9bn.
AbbVie has started enrolling

patients into phase III trials
of a new hepatitis C virus
(HCV) therapy that aims to
treat all genotypes of the
virus with an all-oral, oncedaily, ribavirin-free regimen.
The co-formulated drug
combines NS3/4A protease
inhibitor ABT-493 with NS5A
inhibitor ABT-530 and will be
tested in six phase III trials.
AbbVie and Roches

investigational BCL-2 inhibitor
venetoclax could be on the
market within the next few
months after US and EU
regulators kicked off reviews
of the new drug. The US
FDA has granted a priority
review to venetoclax and in
Europe the EMA has started a
standard review for the drug.
CHMP backs BMS and AbbVies therapy after an accelerated assessment

market for multiple myeloma
therapies from $8.9bn in 2014 to
an estimated $22.4bn by 2023,
according to GlobalData.
Despite the increasingly crowded
market, the market analysis rm
predicts Empliciti could reach peak
sales of $4.2bn ahead of Darzalex
with sales of $3.7bn in that year.
According to the European
Medicines Agency (EMA), in 2012,
around 39,000 people had multiple
myeloma in the EU. Only half of
patients diagnosed with the disease
are still alive after ve years with
currently available treatment.
The CHMPs positive opinion
is based on a 646-patient phase
III study of Empliciti plus
lenalidomide and dexamethasone
against lenalidomide and
dexamethasone. In patients with
relapsed or refractory multiple
myeloma the disease progressed
around four months more slowly
in patients on Empliciti.
Robert Califf has passed

another hurdle on his way to
take up the top job at the US
FDA, with the US Senates
Health, Education, Labor and
Pensions (HELP) Committee
voting in his favour. Califf still
has to pass a full Senate vote,
but is now rmly on course
to replace Margaret Hamburg,
who resigned last March.
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market leader Revlimid which

costs around $14,000.
It is one of four new multiple
myeloma therapies that saw their
rst marketing approvals last
year, along with Janssen Biotechs
Darzalex (daratumumab), Takedas
Ninlaro (ixazomib) and Novartis
Farydak (panobinostat).
These new products are
expected to help drive the global
ts
Bristol-Myers Squibb and AbbVies

multiple myeloma therapy
Empliciti has been recommended
for approval in the EU after
an accelerated assessment.
The Committee for Medicinal
Products for Human Use (CHMP)
issued a positive opinion on
Empliciti (elotuzumab) for use
in combination with Celgenes
Revlimid (lenalidomide) and
corticosteroid drug dexamethasone
as a second-line therapy for
multiple myeloma patients.
Empliciti targets Signaling
Lymphocyte Activation Molecule
Family member 7 (SLAMF7) and is
thought to work by activating the
bodys immune system to attack
and kill multiple myeloma cells.
The immuno-oncology
drug was rst approved in
the US last November and
launched the following month
at a price of around $10,000
per month, undercutting
NME approvals and the

class of 2015 p18
www.pmlive.com
News
First Enbrel biosimilar cleared for EU marketing

Biogen-Samsung plan to launch the treatment in its rst markets in the coming weeks
he rst biosimilar version of

Pzer/Amgens big-selling
tumour necrosis factor
(TNF) inhibitor Enbrel has been
given a green light in Europe.
The European Commission
approved Samsung Bioepis
Benepali version of Enbrel
(etanercept) for the treatment of
adults with moderate to severe
rheumatoid arthritis, psoriatic
arthritis, non-radiographic
axial spondyloarthritis and
plaque psoriasis. The drug was
previously known as SB4.
Enbrel is one of the top-selling
drugs in the TNF inhibitor class
and the fourth-biggest selling
medicine in 2014, bringing in
more than $9bn in sales for Pzer
and Amgen in that year. It is
second only to AbbVies $13bna-year Humira (adalimumab)
in the anti-TNF market.
Samsung Bioepis - a joint
venture between South Korean
electronics group Samsung
and Biogen - said it plans to
launch the product onto its
rst European markets within
PM
according to the company, which

is also developing biosimilar
versions of both Remicade
(SB2) and Humira (SB5).
Biogens head of biosimilars
Alpna Seth told PME recently: We
were very attracted to Europe and
these three drugs because we think
this was the right time and the
right portfolio to get started with.
She added: Europe is most
attractive right now from a
biosimilars perspective, because
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the next few weeks. It is already

available in South Korea, where
it is marketed as Brenzys.
Once launched it will be the
second biosimilar anti-TNF drug
available in Europe, after Celltrion
and Hospiras Inectra/Remsima,
approved last year as the rst
biosimilar versions of Janssen/
MSDs Remicade (iniximab).
It will also be the rst
biosimilar in the class available
as a subcutaneous injection,
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FDA panel backs rst opioid addiction implant
igh
Probuphine was developed by Titan Pharma and partner Braeburn Pharma
Hints of Humira
slowdown weigh
on AbbVie
Despite a healthy rise in revenues,
signs that AbbVies big-selling
Humira drug may be showing
its age dragged down its share
price late when its fourthquarter results were released.
The company reported revenues
of $6.3bn - up more than 18% with Humira (adalimumab) rising
13% to $3.8bn which did not
meet some analysts expectations.
The worlds biggest-selling drug
consolidated its position at the
top of the tree with total annual
sales of over $14bn - roughly
in line with the companys
forecasts - although an ex-US
growth rate of less than 10%
raised further eyebrows.
Meanwhile, management
suggestions that the drugs growth
outside the US could continue to
slow during 2015 thanks to indirect
competition from biosimilars of a
Humira rival - Enbrel (see above
story) - added to investor anxieties.
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www.pmlive.com
favour of approval of the product,

noting that there was evidence of
efcacy and no evidence of risk,
although not all were convinced
of the robustness of the clinical
data on non-inferiority.
The implant could potentially
help prevent the diversion and
misuse of oral buprenorphine
products - said to be a big
problem in the US, with
reports of addicts selling
prescribed doses to help fund
the purchase of illegal drugs.
Titan and Braeburn attempted
to secure US approval for their
product in 2013 but were knocked
back by the FDA, which asked for
more information on the effect
of the product at higher doses as
well as the insertion and removal
of the implant, which requires
a minor surgical procedure.
At the committee meeting,
Braeburn presented summary
safety ndings with a particular
focus on the Probuphine
insertion and removal.
res
treatment, according to Titans

executive chairman Marc Rubin.
At the moment the drug is only
available in oral formulations
that require daily dosing, and
making an implant available
could make it easier for patients
to comply with addiction therapy,
according to the two companies.
In trials, Probuphine was
shown to be non-inferior to daily
treatment with oral buprenorphine,
which is a partial opioid receptor
agonist. The drug is designed to
provide some of the euphoric
effects of drugs like heroin,
helping patients come off the illicit
substances without experiencing
withdrawal symptoms.
The FDA committee voted 12
to ve in favour of approval of
Probuphine as an alternative to
oral therapies in patients currently
taking 8mg or less of the active
drug per day, setting up a possible
approval by the US regulator
before the end of next month.
Overall, panellists were in
ts
An FDA panel has backed

approval of a long-acting
buprenorphine implant for the
management of opioid addiction
developed by Titan Pharma and
partner Braeburn Pharma.
If approved by the FDA, the
implant - which has the proposed
trade name Probuphine - would
be the rst product providing
continuous around-the-clock
levels of buprenorphine for
six months following a single
there is regulatory clarity and

an anti-TNF biosimilar has
already been approved. Then
there is also some intellectual
property on the major biologics
expiring - so theres a great deal
of interest and opportunity
there from that perspective.
All told, the European
market for anti-TNF therapies
is estimated at around $10bn.
Benepali was granted a positive
opinion by the Committee for
Medicinal Products for Human
Use (CHMP) last November.
For more than 15 years, antiTNF therapies have revolutionised
the care and outlook for
patients living with chronic
inammatory diseases such as
RA, said Professor Peter Taylor,
a rheumatology specialist based
at the University of Oxford.
However, access to these
highly-effective treatments has
been restricted by high costs [and]
the development of biosimilar
drugs is a welcome solution to
help alleviate some challenges
with access, he added.
News
FDA review of Humira biosimilar begins

Regulators verdict on the version of AbbVies blockbuster is due in September
he US FDA has started its

review of Amgens biosimilar
version of big-selling antiinammatory drug Humira, with
an action date of September 25.
Amgen led its biologics licence
application (BLA) for the biosimilar,
called ABP501, on November 25
based on a clinical data package
supporting the drugs equivalence
to AbbVies Humira (adalimumab)
in moderate-to-severe plaque
psoriasis and rheumatoid arthritis.
In addition to RA and
psoriasis, Humira is also licensed
to treat psoriatic arthritis and
ankylosing spondylitis.
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Tumour necrosis factor (TNF)

inhibitor Humira was the biggestselling pharmaceutical in the
world in 2014, with revenues of
$13bn, and the drug accounts
for 60% of AbbVies revenues.
However it is also facing patent
expiration at the end of 2016 in
the US and in 2018 across Europe.
Sean Harper, Amgens executive
vice president of R&D, said: If
approved, we believe ABP 501
could serve as an important
additional approved therapeutic
option for patients with chronic
inammatory conditions.
The active ingredient of ABP
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501 is an anti-TNF monoclonal

antibody that has the same amino
acid sequence as adalimumab, said
Amgen, which expects to launch its
rst biosimilar products next year.
At the end of last year, patients
in India were the rst to receive a
Humira biosimilar launched by
Zydus Cadila. Meanwhile, other
companies developing biosimilar
versions of Humira include
Samsung Bioepis - the joint venture
between Samsung and Biogen as well as Novartis Sandoz unit
and Boehringer Ingelheim.
Amgens biosimilar pipeline
also includes a version of Roches
breast and gastric cancer therapy
Herceptin (trastuzumab) and
Avastin (bevacizumab), used
in several solid tumour types
including colorectal and non-small
cell lung cancer (NSCLC). These
are both in phase III testing.
It also has biosimilars of Roches
arthritis and haematological
cancer therapy MabThera/
Rituxan (rituximab), Janssen
Biotechs anti-TNF drug Remicade
(iniximab) and Eli Lillys
colorectal/head and neck cancer
therapy Erbitux (cetuximab) in
earlier-stage trials, as well as three
other undisclosed projects.
UCB wins European approval for Briviact
In brief
Baxaltas aspirations in
oncology have received a
boost after the European
Commission approved
Oncaspar, its treatment for
a rare form of leukaemia.
Its the rst EU-wide
approval for the product,
which Baxalta acquired
last year from Sigma-Tau
in a deal worth $900m.
NICE has backed the use of

BMS Opdivo for advanced
melanoma on the NHS,
despite its recent rejection
of the drug for lung cancer.
Final draft guidance from
the UKs cost-effectiveness
watchdog recommends PD-1
inhibitor Opdivo (nivolumab)
for melanoma at its current
price of around 5,300
(around $7,540) per month.
Lilly has led its highlyanticipated rheumatoid

arthritis treatment baricitinib
in the US, setting the clock
ticking on a possible approval
later this year. The orallyactive drug is considered a
blockbuster contender on the
back of clinical trials in which
it outperformed AbbVies
Humira (adalimumab)
The epilepsy drug will provide a new treatment option for patients
for epilepsy medicines that

effectively control seizures
and are also well tolerated
by patients, said Dr Manuel
Toledo, an epilepsy specialist at
the Vall dHebron Hospital in
Barcelona who was involved in
the Briviact trials programme.
A new treatment that enables
patients to receive a therapeutic
dose from the very rst day
without titration, represents a big
step forward to further helping
people with epilepsy, he added.
The new drug binds to synaptic
vesicle protein 2A, which is also
targeted by levetiracetam so is a
well-established treatment target
in epilepsy. It will be launched in
three formulations - lm-coated
tablets, oral solution and an
injectable/infusion solution.
Briviact was submitted
for approval in the US in
January 2015 but remains
under review by the FDA.
The FDA has started a

priority review of Eisais
Lenvima as a treatment for
the most common form of
kidney cancer, setting up a
possible approval before the
summer. Lenvima (lenvatinib
mesylate) is already approved
for some forms of thyroid
cancer, but this new approval
could greatly widen its use.
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erv
res
same period despite losing patent

protection in most major markets.
Unlike many current epilepsy
treatments brivaracetam does not
require dose titration, so patients
can get a full therapeutic dose
to help control seizures from
day one, according to UCB.
There is an unmet need
ts
Briviact (brivaracetam) will

provide a new treatment
option for the third of epilepsy
patients who suffer seizures
despite current medications,
according to UCB, which notes
there are around seven million
epilepsy patients in Europe.
The drug has been approved
by the European Commission as
an adjunctive therapy for partialonset seizures - with or without
secondary generalisation - in
people aged 16 and above. In trials,
brivaracetam signicantly reduced
the frequency of seizures compared
to placebo, with a 50% reduction
in seizures seen in up to 40% of
patients treated with UCBs drug.
The drug adds to an epilepsy
treatment portfolio at UCB
currently represented by Vimpat
(lacosamide) - with sales of 495m
in the rst nine months of 2015 along with Keppra (levetiracetam)
which brought in 565m in the
What makes European

countries attractive to life
science companies? See p22.
www.pmlive.com
News
French investigation into fatal study continues

The rst-in-man trial of experimental medicine left one dead and ve hospitalised last month
he French government is
continuing its investigation
after a clinical trial of
an experimental medicine
left one man dead and ve
other patients desperately
ill in hospital last month.
Exposure to the drug in the
rst-in-man (FIM) trial - conducted
by clinical research organisation
Biotrial of a compound in
development at the Portuguese
pharma company Bial-Portela
- seems to have caused serious
neurological adverse reactions.
The drug has been administered
to around 90 test subjects,
with approximately another 30
receiving a placebo, since the
trial started in early January.
The other ve hospitalised
patients have neurological
problems of varying gravity,
according to doctors at the
University Hospital of Rennes.
The orally-active drug - BIA
10-2474 - was intended to treat
mood and motor disorders
associated with neurodegenerative
disorders and anxiety and is a
fatty acid amide hydrolase (FAAH)
PM
Gr
ou
p2
inhibitor. It has previously been

tested in non-human primates.
Speaking to reporters, Frances
Health Minister Marisol Touraine
said an incident of exceptional
gravity happened during a phase 1
clinical trial in Rennes involving
men aged between 28 and 49.
She stressed that contrary
to preliminary news reports
the drug was not based on
cannabis but interacts with the
endocannabinoid system.
The families are devastated
01
0.
Al
[and] we will make sure they

are given all the answers,
particularly as at the moment I
am not aware of any comparable
events, continued Touraine.
Frances National Agency for the
Safety of Medicines and Health
Products (MSNA) and InspectorateGeneral of Social Affairs (IGAS) are
spearheading the investigation.
Meanwhile, EUFEMED - the
federation representing those
involved in early-stage medicine
development in Europe - said:
lr
Pharma sector musters for new antibiotic search
igh
Calls for greater government-industry collaboration on resistant infections
Alkermes
depression drug
misses targets
Alkermes has suffered a major
setback in its late-stage pipeline
after depression candidate
ALKS 5461 failed to pass muster
in two late-stage trials.
The Ireland-domiciled
company insists it is not giving
up on its lead drug development
project, however, and says
it will press on with a third
phase III trial in the hope of
showing a benet of the drug.
The two phase III trials FORWARD-3 and FORWARD-4
- involved patients with major
depressive disorder (MDD)
who had failed to respond to
established antidepressants.
ALKS 5461 failed to show an
improvement over placebo in
both studies, although Alkermes
said there was a trend towards
efcacy in FORWARD-4, while
an unexpectedly high placebo
response in FORWARD-3 may have
masked any benet for the drug.
erv
ed
www.pmlive.com
public health by safeguarding

our current antibiotics and
developing new antibiotics
or vaccines is an important
priority now more than ever.
The emergence of socalled superbugs ... forces our
attention to the inadequacy of
our therapeutic arsenals and
the need for new incentive
frameworks for antibiotics to
stimulate the level of R&D
investments so critically needed.
The signatories to the
declaration pledge to encourage
the better use of existing
antibiotics, increase investment in
R&D to nd new antimicrobials,
diagnostics and vaccines and
other interventions, and ensuring
affordable access to highquality antibiotics for all.
The declaration will be
updated every two years, to take
account of the evolving global
landscape of antimicrobial
resistance and changing
challenges and priorities.
res
10
The industry is calling on

governments around the world to
now go beyond existing statements
of intent and take concrete action,
said GlaxoSmithKline (GSK), one
of the signatories of the document.
The UK pharmaceutical
company said governments should
work with companies to support
investment in the development of
antibiotics, diagnostics, vaccines
and other products vital for
the prevention and treatment
of drug-resistant infections.
Over the past decade, there
has been an alarming increase in
the number of microorganisms
that have become resistant to
antimicrobials. An independent
UK review in 2014 estimated
that by 2050 the rise of drugresistant infections could claim
10 million lives a year and
result in a cumulative loss from
global output of $100trn.
Peter Piot, director of London
School of Hygiene & Tropical
Medicine, said: Protecting
ts
Companies from the

pharmaceutical, vaccine and
diagnostics sectors have
signed a declaration calling for
greater collaboration between
industry and governments on
antibiotic-resistant infections.
The Declaration on Combating
Antimicrobial Resistance - unveiled
during the World Economic Forum
in Davos, Switzerland - lays out
a framework for partnerships
to tackle the challenges of
rising drug resistance.
[We will] continue working with

other clinical trials stakeholders
- regulators, innovators, patients
and researchers - to minimise
risks in early development of
much needed new medicines.
In a statement Biotrial said: The
trial has been conducted in full
compliance with the international
regulations. Procedures were
followed at every stage throughout
the trial, in particular the
emergency procedures for the
transfer of subjects to the hospital.
Incidents of this type are very
rare, but there is at least one
precedent outside France.
Several years ago, an FIM
trial in the UK of TeGeneros
immunomodulatory drug TGN1412 left six men ghting for their
lives with multiple organ failure,
and while there were no deaths
some patients were left maimed.
The trial by CRO Parexel was
investigated by the Medicines
and Healthcare products
Regulatory Agency (MHRA),
which eventually concluded
that it had been conducted in
accordance with agreed protocols.

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p2
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Im going
to need
a new
contract
team
Proven contract solutions

that drive brand performance.
Let Chase help your team
achieve more.
Sales / Market Access
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0131 553 6644
connect@chasepeople.com
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*Better talk to Chase
News
Novo: Tresiba safer than insulin glargine

Trial compares its basal insulin with Sanos blockbuster rival Lantus
iabetics treated with

Novo Nordisks basal
insulin Tresiba have a
lower risk of developing low
blood sugar compared to Sanos
Lantus, according to a new trial.
The SWITCH 2 study found
that type 2 diabetics taking
Tresiba (insulin degludec) were
less likely to have symptoms of
low blood sugar (hypoglycaemia)
compared to those taking Lantus
(insulin glargine), the mostprescribed basal insulin product.
Tresiba was as good as Lantus at
reducing haemoglobin A1c levels
- a marker for glucose control.
However, the rate of symptomatic
hypoglycaemia was 186 events
per 100 patient years for Novo
Nordisks drug, a 30% reduction
on the 265 events per 100 patient
years seen with insulin glargine.
Similarly, nocturnal low blood
sugar episodes were reduced
42% with Tresiba compared to
Lantus, although there was no
signicant difference between
the two drugs in the rate of
severe hypoglycaemic episodes.
Hypoglycaemia is one of the
PM
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biggest concerns for diabetics

and, taken together, the results
could give Novo Nordisk
additional power as it tries
to wrest market share away
from $7bn-a-year Lantus.
Moreover, it could also
differentiate Tresiba from
biosimilar copies of Sanos
drug that are starting to reach the
market and threaten to disrupt
the basal insulin category.
Novo Nordisk had been held
01
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Al
back in its efforts to compete

with Lantus by a delay to US
approval of Tresiba, with the
FDA rejecting its marketing
application for the drug in 2013,
although it has been launched
in most other major markets.
Last October however the
Danish drugmaker nally won
US approval for Tresiba and
combination product Ryzodeg
(insulin degludec and insulin
aspart), prompting analysts
lr
EU launches action plan to target HIV
igh
Aims to signicantly contribute to elimination of HIV in EU by 2020
Merck & Co
buys immunooncology rm
Merck & Co has agreed to
acquire privately-held Scottish
biopharma company IOmet
in a deal that supplements the
pharma groups early-stage
cancer immunotherapy pipeline.
Merck (known as MSD outside
North America) has not disclosed
publicly how much it is paying for
Edinburgh-based IOmet, which
focuses on a set of molecular
pathways that can encourage the
immune system to recognise and
attack malignant cells, although
a BBC report suggested the gure
could be as high as 280m.
In particular, IOmet has
a preclinical pipeline of
compounds that inhibit IDO1
(indoleamine-2,3-dioxygenase
1) and TDO (tryptophan-2,3dioxygenase) two enzymes
that are often over-expressed
in tumour cells, particularly
in glioma, melanoma, lung
ovarian and colorectal cancers.
erv
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www.pmlive.com
of HIV, TB and viral hepatitis.

HA-REACT outlined its
plans at a meeting in Vilnius,
Lithuania earlier this month.
Dr Emilis Subata, director
of the Vilnius Centre for
Addictive Disorders, said the
project will build alliances
among government institutions,
municipalities and NGOs in
improving the EU-wide response
to HIV, TB and viral hepatitis
among people who inject drugs.
The Word Health Organization
last year voiced its serious concern
about the HIV situation in Europe,
announcing that the number of
new HIV cases in the region hit
its highest ever level in 2014.
With HIV infection diagnosed
in over 142,000 people in that
year, the virus transmission
through drug injection remains
substantial according to the WHO,
which wants more early testing
for HIV and suggests that all
people living with HIV should be
started on antiretroviral therapy.
res
12
department for infectious disease

at Finlands National Institute for
Health and Welfare, said that the
project was a real opportunity to
eliminate debilitating infections
among vulnerable people in
Europe within a decade.
He added: By working together
the HA-REACT partners and the EU
Commission will support the focus
countries to achieve this goal.
The initiative, which will
also focus on the treatment
for people who inject drugs
(PWID), will ultimately be
implemented across 18 EU
member states, working with a
range of partners that includes
the European Centre for Disease
Protection and Control (ECDC).
HA-REACT wants to focus on
member states with obvious
gaps in effective and evidenceinformed interventions.
It also aims to implement a
harm reduction programme
as part an EU-wide strategy to
improve prevention and treatment
ts
A three-year project to address

the gaps and discrepancies in
existing HIV, tuberculosis (TB)
and viral hepatitis prevention
has been launched in Europe.
The European Unions Joint
Action on HIV and Co-infection
Prevention and Harm Reduction
(HA-REACT) will initially focus
on Latvia, Lithuania and Hungary
with a view to preparing guidelines
and toolkits for the rest of the EU.
Mika Salminen, HA-REACT
coordinator and director of the
at Sydbank to increase their

peak sales predictions for the
franchise to around $3bn.
In some markets the drug has
achieved solid gains in market
share - for example in Japan it now
claims around one third of the
basal insulin market almost three
years after its launch in 2013.
A second phase III trial of Tresiba
in type 1 diabetes patients - called
SWITCH 1 - is due to generate
results in the next few weeks,
according to Novo Nordisk and
if positive will reinforce the
hypoglycaemia data. Tresiba
has a hypoglycaemia claim on
the label in some other markets,
but not as yet in the US.
Novo Nordisk has another
important US launch in the ofng
this year as it is anticipating
approval shortly for Xultophy
(insulin degludec plus
liraglutide) - a combination
basal insulin/GLP-1 agonist
that could have equal
earning power to Tresiba.
The combination has already
started rolling-out in Europe and
some other world markets.
News
Glioblastoma market set for meteoric rise

Sales of treatments for rare form of brain cancer predicted to reach $3.3bn by 2024
its own and in combination

with BMSs own Yervoy
(ipilimumab) versus Avastin.
Bourgognon added:
Immunotherapies have
shown signicant efcacy in
other oncology indications,
and as they affect the tumour
microenvironment rather than
directly targeting the tumour,
they make attractive candidates
for glioblastoma treatments.
Currently, Avastin dominates
the market, working by inhibiting
angiogenesis and disrupting
the blood-brain barrier,
which in turn leads to tumour
starvation. Patients who are
resistant to the drug, however,
have few treatment options,
and Opdivo addresses this.
Of the seven major markets
covered by GlobalDatas report,
the rm says Japan will see
the most impressive relative
growth, with sales expanding
from $47m in 2014 to $268m
million in 2024, driven by
higher pricing for Opdivo.
ales of drugs to treat a rare

and aggressive form of
brain cancer are expected
to see considerable growth
over the next eight years, with
Bristol-Myers Squibbs Opdivo
tipped to lead the way.
The combined glioblastoma
market for the US, UK, Spain,
France, Germany, Italy and Japan
will see a meteoric rise, expanding
from $659m in 2014 to $3.3bn
by 2024, according to research
and consulting rm GlobalData.
Its analyst Maxime Bourgognon,
who covers oncology and
haematology, said: Although
glioblastoma is a rare disease,
such high levels of unmet need
in the market have created
ample opportunities for players
with effective therapies.
However, developing
drugs which effectively treat
glioblastoma has proved
exceedingly challenging to
date, predominantly due to the
presence of the blood-brain
barrier, which prevents many
PM
Gr
ou
p2
01
drugs from entering the brain

and attacking the tumour.
GlobalData predicts that
current pipeline drugs could
offer a way through this, and says
BMS immunotherapy Opdivo
(nivolumab) is a particular
contender to become the primary
standard of care by 2024.
First approved in 2014, last
0.
year BMS joined forces with

Lilly for phase I and II studies of
Opdivo and Lillys galunisertib
in advanced glioblastoma
and other solid tumours.
There is also hope that Opdivo
could treat patients resistant to
Roches Avastin (bevacizumab),
and to that end BMS is running
a phase III trial of Opdivo - on
Al
lr
res
erv
Brian Robinson, chief marketing and strategy ofcer, Aptus Health
segmentation strategies leverage condition

prevalence, insurance access and behavioural
indicators to offer healthcare marketers a
highly effective way to reach both professional
and consumer audiences in the mobile space
with messages that resonate and engage.
All available under one roof, our complete
digital health engagement solutions help life
science companies achieve their business and
marketing goals, increase share of mind and
empower better decision-making among their
target audiences to support better outcomes.
So we welcome the challenges the changing
commercial landscape presents, knowing that
our expertise and capabilities will land our
clients on the right side of that tipping point.
ed
With our decades of collective intelligence in health engagement

and our digital and mobile channel expertise, we are uniquely
positioned to serve as a global partner to our clients - offering
insight-driven design, development and deployment of
innovative digital solutions that empower people to make
better decisions and drive our clients business results.
ts
Pharma marketers have reached a tipping

point. For one, healthcare professionals
are increasingly inaccessible to sales reps
- and are increasingly turning to web and
mobile resources for their information. Yet
with the proliferation of digital information
out there, its tougher than ever to ensure
that key messages are getting through to
the right target. Add to that the growing
pressure that pharma marketers have to
deliver value to their various constituents,
and its obvious that the existing
commercial models no longer work.
Aptus Health is tackling these challenges
head-on, helping our clients re-evaluate their
approach and create an integrated, engaging
digital experience for their targets that breaks
through the noise with relevant content that
drives better decisions ... whenever and
wherever they need it most. For example,
our clients have access to online healthcare
communities that their targets already use
and value, including Univadis, the worlds
largest healthcare professional community,
and MedHelp, the worlds largest consumer
online health community and platform.
Meanwhile, our smart, geo-targeting
igh
Cutting through todays digital noise
For more information, visit

www.aptushealth.com
www.pmlive.com
13
News
Mismanagement of Cancer Drugs Fund

unacceptable, say MPs
Inuential committee nds government still unable to assess its patient benet
he UKs Cancer Drugs

Fund was poorly managed
and - more than ve
years after the ring-fenced
budget was established - its
benets to patients remain
unclear, according to an
inuential committee of MPs.
The Public Accounts
Committee (PAC) said the lack
of patient outcomes data severely
hindered the governments
ability to adequately assess
the impact of the Fund.
The Cancer Drugs Fund (CDF)
was set up in 2010 by the then
Conservative-Liberal Democrat
coalition government as a
temporary measure to improve
patient access to cancer drugs not
routinely available on the NHS.
But its initial 650m budget
was soon exceeded, and the last
two years alone saw spending
increase by 138%. New
arrangements for the CDF are
due in April, by which point it
is expected to have had a total
lifetime budget of 1.27bn.
Meg Hillier MP, who chaired
the committee, said: Its clear
the Fund requires signicant
and urgent reform if it is to
be sustainable. A vital step
in addressing the nancial
challenges must be to properly
evaluate the health benets of
drugs provided through the Fund.
If cancer patients seeking
its support are to get the best
possible treatment then there
must be condence that public
money is being spent on the right
medication, and at a fair price.
Around 80,000 people have
received drugs via the CDF, but
for the two years 2013-14 and
2014-15 NHS England overspent
its 480m budget by 167m.
Although NHS England did
stop funding a number of drugs
via the CDF last year, 2015
also saw the National Audit
Ofce conrm the Fund was
unsustainable in its current form.
PM
help manage costs and ensure our

medicines are routinely available
on the NHS, as is the case in
other European countries.
But he said the current CDF
reform proposals would limit,
rather than improve, access by
imposing even greater barriers.
This will have a signicant
impact on the availability of
many new cancer medicines
and we are very worried for
patients in England, he added.
ts
igh
NICE arrangements
Responsibility for the CDF was

transferred from the then ten
strategic health authorities to
NHS England in April 2013 and
it continued to pay for drugs
that had either failed to win
a NICE recommendation or
had yet to be assessed by the
cost-effectiveness watchdog.
Proposals in the current
consultation would see the
CDF turned into a managed
access fund to provide new
treatments to patients before
they have enough data to
support a recommendation
for routine prescribing.
He said: We agree with

the Committee that the
Cancer Drugs Fund requires
signicant and urgent reform
and share their concerns
that NICE is not adequately
resourced to implement the
proposed new changes.
Our primary concern is
for patients to be given faster
and earlier access to the best
innovative medicines, in line
with patients across Western
Europe. We have offered, and will
continue to offer, the NHS and
NICE a number of options to
NHS Englands plans would

see provisional coverage
decided based on a preliminary
assessment by NICE, after
which real world evidence
would be collected for up to
two years on how well the
drugs work in practice.
But the PAC said when the
reformed CDF comes online
NHS England must have clear
objectives for it, be prepared to
take tough decisions to ensure
it does not overspend and
look at whether more flexible
pricing arrangements covering
a number of medicines could
improve value for money.
Regarding health benets,
the PACs new report calls on
NHS England to come back to
the Committee by June 2016
on what the available data
indicate about the impact of the
Fund on patient outcomes.
The PAC concluded: We
expect NHS England, in making
changes, to take account of our
recommendations and apply the
clear lessons from the last ve
years to ensure that the new Fund
is managed better in the future.
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PAC chair
Meg Hillier MP
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0.
14
01
There remains industry concern

over patient access to new
oncology treatments as well as
the future shape of the Fund, with
a consultation on its future shape
p2
Industry concern
ou
Gr
due to close on 10 February.

UK trade body the ABPI said
it shared the Public Accounts
Committees desire to achieve a
sustainable, affordable solution
that provides rapid access to new
medicines for NHS patients.
Dr Paul Catchpole, director
- value and access, said: At the
moment too many patients
miss out on access to new
treatments. As the consultation
on the way forward for the
Cancer Drugs Fund comes to
an end, we urge Government
to seize the opportunity and
transform the way cancer drugs
are assessed by NICE to achieve a
sustainable, affordable solution
that provides rapid access to new
medicines for NHS patients.
Janssen UK & Irelands
managing director Mark
Hicken appeared as a witness
before the PACs hearing.
Darwins medicine
0.
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p2
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PM
J&Js portent of purity

BRIAN D SMITH
talk about the heterogeneity

of the business model and the
transparency, or lack of it, of the
risk-adjusted rate of return.
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QIBSNBmSNT
visible. Other companies, such as

Abbott and Baxter, have of course
already yielded to such pressure.
But follow that logic beyond
J&Js break-up. Even within those
three divisions, J&Js famously
autonomous business units
include models that are relatively
high risk/high return and relatively
low risk/low return. The same is
true of most other large life science
companies, whose portfolios
range from relatively low tech,
low risk to more innovative,
riskier businesses. Splitting
into innovative and mature,
as Abbott did, will make each
unit more homogenous but still
leaves a lot of intra-business risk
heterogeneity. In evolutionary
terms, investor pressure for
transparency is a selection
pressure favouring business
models that are homogeneously
high or low risk and disfavouring
those that are portfolios of very
different risk/return levels.
Back to the practical
implications. This selection
pressure for investor transparency
points towards business models
that are small and address only
a single product and market. But
that pressure is balanced by a
selection pressure for economies
of scale and scope. Together,
these selection pressures favour
business models that combine
a number of product/market
strategies that, although they may
vary in technology or disease area,
share very similar levels of risk
and return. In other words, J&Js
travails portend the evolution
of business models that are, in
investors eyes, pure play. Shire/

Baxalta may be an early example
of this because most rare disease
models have similar risk/return
proles. But pure play business
models neednt mean all rare
disease or all one therapy area.
It simply means a business
model in which every part of
the business has a similar level
of risk and return. This makes
the investors view easier and
reduces their uncertainties. By
contrast, a conglomerate model
will always give a blurred view,
which investors will punish with
a reduced valuation - the socalled conglomerate discount.
So evolution points to a future
of life science companies that may
or not be smaller - thats not what
break-ups are telling us. Rather,
life science companies are likely
to be ever more homogenous
within their organisation and, as
a corollary, ever more different
from other organisations. We
face a future of purer, more
differentiated rms. Whether J&J
and other heterogeneous rms will
move in that direction voluntarily
or will be dragged, kicking and
screaming, by activist investors,
is another question entirely.
.
ed
erv
res
ts
igh
lr
Al
ctivist investors are

currently agitating for
a restructure or even a
break-up of Johnson
and Johnson, the worlds
largest healthcare products
company. This adds to a pattern
of shareholder pressure that
we see across the sector. Both
Amgen and GSK have faced
the same challenges. And we
see similar patterns in diverse,
non-healthcare companies
too. Look at Xeroxs recent
announcement of a split, for
example. To an evolutionary
scientist like me, such patterns
indicate an emerging property
of the business environment
that will inexorably reshape the
industry. As usual in this column,
allow me to talk about the
science a little before returning
to the practical implications.
On the surface, activist investors
press for a break-up when they
perceive negative synergy. That
is, the whole creating less value
than the sum of its parts. In the
media, investors are critical of
senior management and often
claim that the group is too large or
too diverse to manage effectively.
But drill down and interview the
investors, as I have, and a more
fundamental reason appears. The
attentions of activist investors are
not well correlated with company
size. Their focus is better, but
still imperfectly, correlated to the
diversity of rm. This tells us that
something other than the size
or spread of business activity is
concerning them. Ask directly and
investment bankers and analysts
The future of corporate structures is emerging before our eyes
What investors mean by this

is that it is not necessarily the
product or market diversity that
bothers them; it is that a large
business like J&J contains multiple
business models that span a large
range of different risk levels and
offer correspondingly different
returns. They are, in effect, old
fashioned conglomerates even
if they are focused around
healthcare. Investors dont
like rms that bundle together
different levels of risk-adjusted
rates of return. They like to be able
to clearly see the risk and return
of each business and make their
portfolio management decisions
accordingly. In the eyes of activists,
conglomerate CEOs are doing
the investors job for them. And
less well than the investors could
for themselves. So the calls of
investment managers to split
J&J into devices, consumer and
pharma is a demand to make
the key investment factors more
Professor Brian D Smith is an

authority on the pharmaceutical
industry and works at SDA
Bocconi University and
Hertfordshire Business School.
He welcomes comments and
questions on this column at
brian.smith@pragmedic.com
www.pmlive.com
15
Regulatory
EMAs Accelerated Pathways:
New models will drive corporate

strategy and industry innovation
PM
0.
The company is targeting entry

to the European market with
conditional approval in 2018.
trials will be re-directed towards

working with the EMA to gather
and monitor post-authorisation
real-life data and to develop
plans for larger population rollouts and for new indications.
Smaller drug makers need to

make accelerated access a critical
strategic advantage. This would
allow them to move more
nimbly to develop a promising
indication. The reduced time to
market can engage the areas of
corporate development, partnering
and investor relations. The
possibility of a more rapid path
to market is no small commodity
in an industry where failure
regularly ravishes biotechnology
companies, and progress moves
at a seemingly glacial pace.
And there is no greater source
of morale than improving
the life of a patient.
Companies would be well
served to avoid the mindset
that acceptance into such
an accelerated pathway is
some type of short-cut. The
programmes do not encourage
new drugs at the expense of
safety but seek to replace the
current binary approval process
in favour of an incremental,
conditional approach.
The EMAs Pathways project
ts
does not limit its guidance to

trial development. It challenges
companies to consider potential
HTA questions and future payer
arrangements, issues that small
early-stage drug companies usually
do not have the luxury to consider.
Whereas clinical trial work
can seem at times adversarial,
perhaps necessarily so, Pluristems
relationship with the EMA has
been collaborative in spirit.
A recent Bain & Company report
on private equity investment in
the healthcare sector stated that
investors had splintered into two
camps: those willing to invest in
companies dependent on payer
reimbursement decisions and
those that will keep their distance.
Such companies, the report
continued, would need to mitigate
reimbursement, technology,
and regulatory risk and deliver
precise post-market execution.
The EMA is working to
create a system that helps
early-stage therapies navigate
these very challenges.
Other regulatory bodies
are beginning to follow
the EMAs lead.
Tasked with balancing
the risks and rewards when
authorising new medicines, it
has become obvious to them that
the biggest risks to healthcare
will be risks to innovation.
ed
erv
res
This could potentially be

achievable because conditional
approval of a life-threatening
unmet medical need would
require data from a single positive
mid-stage clinical trial, thus
accelerating the potential time to
market by three years, compared
to the traditional regulatory route.
The time, money and energy that
would be spent on large, late-stage
Improving access
igh
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www.pmlive.com
01
16
p2
Pluristem is one of the earliest

companies to have been selected
to participate in the EMAs
Adaptive Pathways project, for
development of a treatment of
Critical Limb Ischaemia (CLI).
This is a malady in which
cholesterol build-up constricts
arterial blood ow to the legs,
leading to gangrene, amputation
and death. The Pathways project
has given support to its clinical
development programme as
the company prepares its trial
protocol and application for
conditional marketing approval.
ou
New treatments
Gr
overnment and
insurance payers
have raised the bar
when it comes to
drug reimbursement, and
containment of healthcare
costs has become a global
mandate. Their calls for an
outcome-based payment model
along with advances in the
lab have changed the business
model of modern medicine.
While critical on many
levels, these changes may
have a negative impact in the
area of drug development, as
escalating costs threaten the
participation of new entrants
and thus, threaten innovation.
Any industry that curtails
opportunities for smaller rms to
innovate will encourage efforts to
make existing treatments for the
largest populations incrementally
better, but will not foster the
discovery of new treatments that
may offer signicantly better
outcomes for severely ill patients.
The European Medicines
Agency (EMA) has realised that
the traditional drug approval
process needs to be adapted
to t the new business model
and to encourage innovation.
It is working to provide an
opportunity for accelerated market
approval for early stage medicines
that address unmet medical needs.
Karine Kleinhaus is divisional

vice president, North America
at Pluristem Therapeutics
Efcacy rebates
ROHIT KHANNA
The Italian Job
n my August column in this

publication, I spoke about
the need for establishing
a mechanism that would
allow stakeholders to gain
some sort of reimbursement
for ineffective medications.
The challenges, of course, are
myriad. How much of a discount?
Who gets the discount if the therapy
involves an insurance component
and an out-of-pocket component?
How do we determine a therapys
effectiveness? How do we follow
patients in order to validate this
lack of efcacy? How long do we
wait for a patients response (or
lack thereof) for a therapy to be
deemed ineffective? How do we
know if the lack of efcacy is due
to the drug or some other factor?
Apparently these questions have
not stopped manufacturers and
stakeholders from striking deals.
Novartis, for instance, wants
to strike deals on its heart failure
drug Entresto, which reduced
hospital visits for patients in
clinical trials. Hospital visits
are costly. So, Novartis wants to
be paid more if Entresto keeps
patients out of the hospital, and
less if it fails to do so. Amgen
arranged an outcomes-based
arrangement on its cholesterolghter Repatha. The company and
Harvard Pilgrim Health Systems
agreed on LDL cholesterol targets
for various patient groups, and if
Repatha doesnt help patients hit
those goals, the insurer collects
bigger rebates. More rebates are
due if Harvard Pilgrims spending
on the drug surpasses an agreedupon threshold. Express Scripts
PM
0.
01
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Al
200 million euros - representing

1% of its national health
budget - on utilisation of over
90 different medications. In fact,
Italy seems to be so smitten with
this approach that it has more
than quadrupled the number of
treatments under this innovative
risk-sharing scheme (see Figure 1).
Back to the long list of
questions at the beginning of this
column. How do we account for
risk-adjustment? In other words,
what if were talking about a
cholesterol-lowering medication
and weve established LDL targets
that would trigger the rebate. So,
how do we account for patients
that have different proles at
baseline? What if one patient is a
smoker and one isnt? Or one has
a sedentary lifestyle and the other
doesnt? In other words, when
is it about the drug and when
is it about the patient? It will
also be interesting to see how all
these publicly-traded companies
manage these rebates from an
annual reporting perspective
and whether that changes their
appetite for such deals. Imagine a
manufacturer with 10-15 different
deals across multiple product
lines in multiple jurisdictions.
ts
igh
lr
The total sum of potential rebates

owed could be, arbitrarily, 500
million euros in any given year.
Maybe more or maybe less. But
lets go with this number. What
happens when the paper number
is less than or more than expected
and the impact on earnings and
protability is affected. Will these
eager risk-sharing actors still want
to construct these deals? And
nally, lets not lose sight of what
the Italian model means. When
a country gets rebates totalling
1% of their drug budget, it means
that a lot of therapies did not
work for a lot of patients. When
a lot of therapies do not work for
a lot of patients, we have a lot of
patients who are still sick. And
when we have a lot of patients
who are still sick, no one wins.
ed
erv
res
p2
Figure 1.
ou
Gr
will launch a new value-based

reimbursement model next
year, using comparative data
and indication-specic pricing
to favour clinically superior
meds. The pharmacy benets
manager will roll-out the
approach in cancer rst, with
anti-inammatory meds close
behind. This Express Scripts
idea builds on initiatives by the
American Society of Clinical
Oncology - which is rolling-out a
drug-evaluation framework that
rates the benets, side-effects and
costs of various treatments - and
Memorial Sloan Ketterings Center
for Health Policy and Outcomes,
which advocates pricing drugs
according to their results in
individual indications. It also
builds on a unique approach
taken by the Italians towards
out-of-control drug pricing.
The Italian Medicines Agency
has devised deals with pharma
companies that set payment based
on how well a patient responds
to treatment, and in some cases
where the medication fails to
help, the drugmaker gives a full
refund. The medicines agency responsible for drug regulation
in Italy - established national
registries in 2005 that track all
patients treatments and their
outcomes, which provide the basis
for the assessments and allow the
agency to renegotiate contracts
based on new data every two
years or so. And were not talking
about a handful of products
or an insignicant amount of
money either. Italy was able to
get a rebate of approximately
Rohit Khanna is managing

director of Catalytic Health, a
healthcare communications,
advertising and strategy
agency. He can be reached at:
rohit@catalytichealth.com
www.pmlive.com
17
Regulatory
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www.pmlive.com
igh
18
notable rst-in-class therapies are

for diseases that affect millions of
people worldwide, and as a result
have blockbuster sales potential.
One class - the PCSK9 inhibitors
for elevated cholesterol - actually saw
two new entrants, namely Regeneron/
Sanos Praluent (alirocumab) and
Amgens Repatha (evolocumab),
which became the rst new
cholesterol therapies to enter the
market in more than a decade.
Indicated for use in patients
who cannot meet treatment targets
with statins (as well as for a rare,
genetic form of elevated cholesterol),
the two drugs are predicted to
eventually achieve sales of several
billion dollars a year as an estimated
two-thirds of people with elevated
cholesterol fall into this category.
2015 also saw the rst completely
new class of drug for chronic heart
failure for many years with the
approval of Novartis Entresto,
which combined the established
angiotensin II receptor antagonist
valsartan with sacubitril, the rst in
a new class of neprilysin inhibitors.
Also tipped as a blockbuster, Entresto
has been shown in trials to reduce
the risk of cardiovascular death and
hospitalisations in CHF patients,
improving survival by around 15%
lr
Al
n 2015, a total of 44 New

Molecular Entities (NMEs) were
approved for marketing in countries
around the world, maintaining the
high output from pharma industry
pipelines of the last few years.
While a little shy of the 2014
tally of 49 NMEs - the highest level
for almost 20 years - last years
collection (see table) includes
a similarly impressive array of
new drugs, including a number
of rst-in-class compounds and
therapies for rare diseases.
By PMEs reckoning, 17 (39%)
of the 44 NMEs approved in 2015
worked in a new way to prior
therapies, continuing the recent
trend towards the development of
innovative therapies and moving
away from the clusters of me too
drugs that was often seen in NME
lists from the 1990s and 2000s.
There was also once again
a preponderance of drugs for
orphan or rare diseases, which
have become increasingly popular
targets for the pharma industry as
they can command high prices,
despite having small patient
populations. All told, 19 NMEs
were in this category, accounting
for 43% of the total for the year.
Interestingly however, some of the
0.
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Gr
-BTUZFBSTBQQSPWBMTJODMVEFEB
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Pharmaceutical Market Europe Febuary 2016
2015 NME approvals
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igh
lr
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ed
erv
res
compared to current therapies.

GlaxoSmithKline (GSK) also
scored a big new approval in the
form of Nucala (mepolizumab),
the rst in a new class of asthma
medications that work by inhibiting
interleukin-5. It will be used as
an add-on therapy for the sizeable
proportion of eosinophilic asthma
patients who experience breakthrough
attacks despite current treatment.
Many of the new NMEs in 2015
were for rare and orphan diseases
that promise to make a massive
impact for the patients involved
as they often have few or no drugs
available to treat their conditions.
Highlights of the year include
a brace of approvals for Alexion.
These were Kanuma (sebelipase
alfa), the rst-ever treatment for the
rare, inherited disorder lysosomal
acid lipase deciency - and Strensiq
(asfotase alfa), the rst enzyme
replacement therapy for patients
with infantile- and juvenile-onset
hypophosphatasia, a serious and
sometimes fatal bone disease.
There was also good news for
patients with hereditary orotic
aciduria (HOA) - a condition that
can result in blood abnormalities,
urinary tract obstruction, failure to
thrive and developmental delays who nally have a treatment option
in the form of Wellstat Therapeutics
Xuriden (uridine triacetate).
While not working via new
molecular pathways, two other drugs
are also worthy of mention. Kythera
Biopharma created a new therapeutic
category in the pharma/cosmetic
area with Kybella (deoxycholic
acid), the rst drug for reducing
double chin, while Sprout Pharma
chalked up the rst approval for
female Viagra after the FDA backed
www.pmlive.com
19
Regulatory
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2015
COMPOUND
TRADE NAME
INDICATION
MECHANISM / TYPE
COMPANY
REGION OF
FIRST
REGISTRATION
PM
Praluent
hypercholesterolaemia
PCSK9 inhibitor
Regeneron/Sano
USA
Aristada
schizophrenia
atypical antipsychotic (D2

partial agonist)
Alkermes
USA
asfotase alfa
Strensiq
hypophosphatasia
alkaline phosphatase
replacement
Alexion
Japan
avibactam
Avycaz
bacterial infections
(with ceftazidime)
beta-lactamase inhibitor
Allergan
USA
brexpiprazole
Rexulti
depression /
schizophrenia
serotonin 5-HT1a / dopamine

D2 partial agonist
Otsuka/Lundbeck
USA
cangrelor
Kengrexal
percutaneous coronary
intervention (PCI)
P2Y12 inhibitor
The Medicines Company
EU
cariprazine
Vraylar
schizophrenia / bipolar
disorder
dopamine D3/D2 receptor

partial agonist
Gedeon Richter/Allergan
USA
cholic acid
Cholbam
bile acid synthesis

disorders
cholic acid
replacement therapy
Retrophin
USA
cobimetinib
Cotellic
BRAF V600-positive
malignant melanoma
MEK inhibitor
Roche/Exelixis
Switzerland
daratumumab
Darzalex
multiple myeloma
anti-cd38 antibody
Genmab/Janssen Biotech
USA
Kybella
submental contouring
(double chin)
destruction of fat cells
Kythera Biopharma
USA
Gr
alirocumab
aripiprazole lauroxil
deoxycholic acid
Unituxin
neuroblastoma
anti-GD2 antibody
United Therapeutics
USA
elotuzumab
multiple myeloma
anti-SLAMF7 antibody
AbbVie / Bristol-Myers
Squibb
USA
eluxadoline
Viberzi
diarrhoea-predominant
irritable bowel syndrome
mu opioid receptor
agonist / sigma opioid
receptor antagonist
Allergan
USA
South Korea
Empliciti
evogliptin
Suganon
type 2 diabetes
once-daily DPP-4 inhibitor
Dong-A
evolocumab
Repatha
hypercholesterolaemia
PCSK9 inhibitor
Amgen
EU
ibanserin
Addyi
hypoactive sexual
desire disorder
serotonin 5-HT1a agonist /

5-HT2a antagonist
Sprout Pharmaceuticals
USA
Praxbind
Pradaxa reversal agent
anti-dabigatran antibody
Boehringer Ingelheim
USA
Cresemba
invasive aspergillosis /
mucomycosis
triazole antifungal
Basilea/Astellas
USA
idarucizumab
isavuconazole
multiple myeloma
oral proteasome inhibitor
Takeda
USA
Lenvima
thyroid cancer
multikinase inhibitor
Eisai
USA
lesinurad
Zurampic
gout
xanthine oxidase inhibitor
AstraZeneca
USA
lumacaftor
Orkambi
cystic brosis
(with ivacaftor)
CFTR protein
misfolding
Vertex Pharma
USA
lusutrombopag
Mulpleta
thrombocytopenia in
chronic liver disease
oral thrombopoietin
receptor agonist
Shionogi
Japan
mepolizumab
Nucala
severe eosinophilic
asthma
GlaxoSmithKline
USA
necitumumab
Portrazza
lr
anti-interleukin-5 antibody
non-small cell
lung cancer
EGFR inhibitor
Eli Lilly
USA
omarigliptin
Marizev
type 2 diabetes
once-weekly DPP-4 inhibitor
Merck & Co
Japan
osimertinib
Tagrisso
non-small cell
lung cancer
EGFR inhibitor
AstraZeneca
USA
palbociclib
Ibrance
ER+/HER2breast cancer
CDK 4/6 inhibitor
Pzer
USA
Farydak
multiple myeloma
Natpara
hypocalcaemia in
hypoparathyroidism
Veltassa
hyperkalaemia
Varubi
chemotherapy-induced
nausea and vomiting
(CINV)
sacubitril
Entresto
chronic heart failure

(in combination with
valsartan)
Novartis
USA
Shire
USA
potassium ion binder
Relypsa
USA
neurokinin-1 receptor
antagonist
Tesaro
USA
ed
erv
patiromer
rolapitant
HDAC inhibitor
parathyroid hormone
replacement
res
panobinostat
parathyroid hormone
(recombinant)
ts
igh
Ninlaro
lenvatinib
Al
ixazomib
0.
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dinutuximab
neprilysin inhibitor
Novartis
USA
Xadago
Parkinson's disease
MAO-B inhibitor
Newron Pharma
EU
Kanuma
lysosomal acid lipase

deciency
recombinant lysosomal
acid lipase
Alexion
EU
selexipag
Uptravi
pulmonary arterial
hypertension
IP prostacyclin receptor
agonist
Actelion
USA
sanamide
sebelipase alfa
sonidegib
Odomzo
basal cell carcinoma
SMO receptor antagonist
talimogene laherparepvec
Imlygic
malignant melanoma
oncolytic virus
Novartis
Amgen
Switzerland
USA
tenofovir alafenamide
Genvoya
HIV (in combination with

cobicistat, emtricitabine
and elvitegravir
nucleotide reverse
transcriptase inhibitor
Gilead Sciences
USA
trelagliptin succinate
Zafatek
type 2 diabetes
once-weekly DPP-4 inhibitor
Takeda
Japan
uridine triacetate
Xuriden
hereditary orotic aciduria

(HOA)
uridine prodrug
Wellstat Therapeutics
USA
vonicog alfa
Vonvendi
von Willebrand disease
von Willebrand factor

(Recombinant)
Baxalta
USA
vonoprazan fumarate
Takecab
acid-related diseases
potassium-competitive
acid blocker
Takeda/Otsuka
Japan
SOURCE: PME RESEARCH
20
www.pmlive.com
2015 NME approvals
PM
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during 2015 were given the nod by

the US regulator rst, with just ve
cleared in Japan and four in the EU.
One contributory factor could be
the FDAs efforts to accelerate the
review times for new medicines in
order to get them to patients more
quickly. For example, the number
of approvals for drugs designated
as breakthrough therapies by the
FDA - and therefore qualifying
for expedited review - was eight,
exactly in line with 2014.
Around half were granted a
priority review by the FDA, with
nearly two-thirds making use of
expedited review processes (ie
breakthrough, priority review
accelerated approval or fast-track).
The NMEs were split between
40 companies - with only a few
drugmakers managing to bring more
than one new drug to market in 2015.
Leading the pack on this measure
were Novartis and Takeda - with
three new approvals - while Amgen,
AstraZeneca, Alexion, Allergan and
Otsuka each managed two apiece.
COUNTRIES AND
COMPANIES
Once again, the importance of the
US market was underscored by the
sheer number of drugs that were
rst approved by the US FDA. All
told, 31 of the 44 NMEs approved
ed
erv
res
to be registered in the US.

Imlygic is a genetically modied
live herpes virus used to treat
melanoma lesions that cannot be
removed completely by surgery, and
works by replicating inside cancer
cells, causing them to rupture and
die. It is not the rst oncolytic
virus to be approved worldwide
however - that distinction goes to
Rigvir, a therapy for melanoma that
was registered in Latvia in 2004.
The tally of cancer drugs was
well ahead of cardiovascular and
cholesterol therapies (six NMEs),
central nervous system (CNS)
therapies (four) and antidiabetic
agents (three), and in general the
spread of indications is very broad,
perhaps to be expected given the
high preponderance of orphan
diseases. Notably, after a urry of
activity last year. antimicrobials
had something of a lean year disappointing given the ongoing
concerns about drug resistance.
lr
Addyi (ibanserin) for hypoactive

sexual desire disorder in women.
Looking at the approvals by
therapeutic category, the largest
grouping was for new oncology drugs,
which account for 13 (around 30%)
of the 2015 crop of NMEs, with
no fewer than four new therapies
for multiple myeloma. The four
are Genmab/Johnson & Johnsons
Darzalex (daratumumab), AbbVie/
Bristol-Myers Squibbs Empliciti
(elotuzumab), Takedas Ninlaro
(ixazomib) and Novartis Farydak
(panobinostat), the rst HDAC
inhibitor to be approved for myeloma.
Among the other notable new
cancer drugs is Pzers Ibrance
(palbociclib), rst-in-class cyclindependent kinase (CDK) 4 and
6 inhibitor, a new candidate for
oestrogen receptor-positive/HER2negative breast cancer. Around
60% of breast cancer patients
have this receptor prole - which
is poorly addressed by current
therapies - and could be eligible
for treatment with the new drug.
A product in a new class of cancer
therapies that harness the cellkilling power of viruses also debuted
in 2015 in the form of Amgens
Imlygic (talimogene laherparepvec),
the rst oncolytic virus therapy
Phil Taylor is a freelance journalist

specialising in the pharmaceutical industry
www.pmlive.com
21
Company strategy
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European sites
What makes a country in Europe attractive
to life science companies?
urope offers exciting
opportunities for international
life science companies. Besides
being the second largest market
for high-margin drugs and medical
devices thanks to a well-established
public healthcare system, the very
large European life science industry
offers a fertile ground for investments,
collaboration and acquisitions.
The high density of universities and
research institutes throughout Europe
and well-trained employees in the
European life science industry enable
international life science companies
to build up a broad network within
Europe and to evaluate national and
international market possibilities.
However, Europe can look
amazingly complex to a life sciences
executive looking at it from outside
the continent. Despite most
European countries being part of the
22
www.pmlive.com
European Union, there seem to be

more differences than similarities.
The variety of tax systems and
incentives as well as different labour
laws and immigration regulations
(with some countries being in the
Schengen area and others not) make
it difcult to decide where and how
to set up a European structure.
Adding to the complexity is
the fact that completely different
business cultures exist within Europe;
from the Anglo-Saxon free market
approach to the Nordic country social
market models and the French-style
centralistic planning. The varying
market sizes in regards to the
number of life science companies
or number of employees in the
life science industry emphasise
the differences even more.
An additional point not to be
forgotten is the existence of the
Euro currency block which does

not include all European memberstates, which means that various
currencies still exist within Europe.
5IFDIBMMFOHFXIFSF
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In order to help decision-makers in

multinational life science companies
better understand the complexity of
the European life science landscape,
KPMG Switzerland, in collaboration
with Venture Valuation, has released
its 2015 Report on site selection
for life science companies in
Europe. It offers facts and gures for
international life science companies
looking to expand, restructure or
consolidate their activities in Europe.
The report compares seven European
countries (Belgium, France, Germany,
Netherlands, Ireland, Switzerland
and the UK), among others, with
strong life science clusters and/or

important attractiveness to Foreign
Direct Investors (FDIs) on how they
support life science companies in:
t Strengthening their capabilities
by collaborating with peers and
universities for various activities
such as R&D, supply chain
management or marketing through
clusters of life science companies
t Improving their agility to react
quickly to changing market
environments, client needs,
regulations and technologies
t Increasing their values by
beneting from tax planning
and incentive models.
,FZmOEJOHT
t In total there are roughly 11,000
life science companies (biotech,
pharma, medtech) across 14
European countries and in Israel
European sites
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'JOMBOE
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'SBODF
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138
160
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572
103
*SFMBOE
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18
39
11
*TSBFM
334
154
545
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*UBMZ
518
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104
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/FUIFSMBOET
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/PSXBZ
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Going forward, the report draws a
mixed picture of the outlook for the
seven countries covered in detail.
t Currently, the UK and Switzerland
clearly stand out from the rest
of the countries in regards
ts
igh
lr
Diligent and forward-looking tax

strategies are important tools
to increase the value of a life
science company. Particularly
important are tax rates for income
generated by intellectual property,
as well as incentives for R&D. The
countries covered in this report

apply various strategies to remain
competitive in this eld. However,
ongoing discussions on Base
Erosion and Prot Shifting (BEPS)
which focus on substance for
sustainable tax planning will limit
certain tax planning strategies.
Al
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91 (54%)
49 (29%)
16 (10%)
#FMHJVN
170 (32%)
308 (59%)
41 (8%)
%FONBSL
125 (45%)
100 (36%)
28 (10%)
'JOMBOE
55 (42%)
55 (42%)
21 (16%)
'SBODF
523 (47%)
479 (43%)
149 (13%)
(FSNBOZ
696 (37%)
995 (53%)
178 (9%)
*SFMBOE
72 (54%)
68 (51%)
6 (5%)
*TSBFM
476 (45%)
485 (45%)
24 (2%)
*UBMZ
365 (48%)
418 (54%)
39 (5%)
/FUIFSMBOET
273 (42%)
254 (39%)
71 (11%)
/PSXBZ
85 (45%)
67 (36%)
7 (4%)
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329 (51%)
269 (42%)
43 (7%)
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388 (45%)
411 (48%)
68 (8%)
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323 (45%)
327 (45%)
55 (8%)
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652 (40%)
561 (35%)
196 (12%)
Total

Dening where to set up European

HQs, an acquisition vehicle, an R&D
centre or manufacturing plan should
be based on a detailed analysis of
the value drivers which drive growth
or value and the goals which want to
be achieved by entering or expanding
into Europe. While certain projects
involving a presence in Europe
focus on strengthening innovation
or gaining market access, others are
geared towards improving processes
and organisational structure (which
can lead to lower effective tax rates).
The authors of the report suggest that
the value drivers should be assessed
rst, in regards to their contribution
for general prot generation or for
reaching the goals of an (expansion)
project, and then should be divided
into key value drivers and secondary
value drivers. The different locations
in play should then be compared
ed
erv
Note: On average, the study shows that 43% of European countries keep their
R&D in their own country and 45% still manufacture in their own countries
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res
which inuence the agility of a life

science company are, among others,
exibility of labour laws and the ease
of attracting qualied staff. Here the
Anglo-Saxon countries, along with
Switzerland, fare especially well.
01
t The largest concentration of life

science companies is found in
Germany, the UK and France.
Germany leads in medtech,
while the UK is the leader in
pharma and in biotherapeutics
t Switzerland is the leader in
workforce in the life science
industry compared to the
size of its population
t Strong macroeconomic data
in Germany and Switzerland is
complemented by exceptionally
strong labour productivity. Germany
has the highest labour productivity
in Europe, followed by Switzerland
t In terms of Foreign Direct
Investments, the UK clearly
leads the group with 37 regional
HQs of foreign-owned life
science multinationals, but
other smaller countries such
as the Netherlands, Belgium or
Switzerland are equally attractive
when taking into account the size
of their respective economies
t The UK has the largest number
(eight) of top-ranked universities.
Compared to the size of their
population, however, Switzerland,
the Netherlands and Belgium
(with four each) are ranked
better at a worldwide level
t Switzerland is rated the most
innovative country in Europe,
followed by Germany, Belgium
and the Netherlands
t Annual wage growth over the
next ve years is expected to
be highest in the UK, Germany
and Ireland, medium in the
Netherlands, France and Belgium
and lowest in Switzerland.
Key business environment factors
p2
Note: The total number of life science companies analysed in the new report is 10,737, across 14
European countries. The greatest concentration is in Germany at 1,876, closely followed by the UK
at 1,610 and France at 1,112
to attractiveness for regional

HQs, complex manufacturing
and R&D centres. The main
challenges for the UK are low
productivity, increasing salaries,
appreciating currency and political
uncertainties. Switzerlands main
challenges are high salaries and
uncertainty about immigration
t Ireland, Belgium and the
Netherlands are attractive for
regional HQs, manufacturing and
certain R&D activities, due to
their appealing tax and incentive
systems. However, they lack
clusters of life science industry
when compared to the size of
Switzerlands life science sector.
Ireland, the Netherlands and
Belgium will have to prove that
they have the capacity to host
true value-driving substance such
as R&D or complex management
or manufacturing operations
t Germany and France have large
life science clusters but for
many fast-growing overseas
life science companies their
business and tax environments
are not exible enough.
Instead of purely focusing on taxes,
in the future life science companies
will have to also consider other
factors for selecting their ideal
site. BEPS requirements will force
companies to align prots, risks and
actives with qualied substance.
This might provide opportunities
for countries such as France and
Germany, if they are able to offer
more exible business conditions.
The UK and Switzerland will
have to ght to maintain taxes at
competitive levels while keeping
salaries under control and
reducing political uncertainties.
www.pmlive.com
23
Company strategy
in regards to their capacity to
host these key value drivers.
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Austria
76.7
33
4.12
47
Belgium
63.7
84
3.55
51
Denmark
92.1
7.5
Finland
54.8
120
3.7
49
France
43.5
157
2.36
57
Germany
51.2
134
4.31
41
Ireland
76.2
37
5.9
18
Italy
55.4
118
3.46
52
Luxembourg
42.1
164
5.67
22
Netherlands
66.3
73
4.2
45
Norway
48.2
144
5.85
19
Portugal
42.9
161
31
Spain
52.6
127
4.29
43
Sweden
54.0
122
4.3
42
Switzerland
75.3
43
7.89
UK
75.6
41
15
Note: According to the Index of Economic Freedom the UK, Ireland and - as an exception in
continental Europe - Switzerland have reasonably exible labour markets, including immigration
regulations. The rankings are similar when addressing only labour regulations (hiring/ring
practices, minimum wages, etc) where Anglo-Saxon countries and Switzerland again rank at the
top of the European list
ts
igh
lr
Al
4XJU[FSMBOE
UK
25.00%
24.40%
21.00%
20.00%
11.40%
20.00%
12.50%
5.00%
8.50%
10.00%
12.50%
n/a
5.00%
n/a
#FMHJVN
'SBODF
(FSNBOZ
*SFMBOE
/FUIFSMBOET
Ord. high
33.99%
38.00%
33.00%
25.00%
Ord. low
24.50%
15.00%
22.80%
12.50%
6.8%
15.00%
n/a
n/a
n/a
n/a
IP
Trading
ed
erv
res
www.pmlive.com
'MFYJCJMJUZPGMBCPVSNBSLFUBOEMBCPVSSFHVMBUJPOT
0.
24
Andr Guedel is head of sales and business

development TAX for KPMG Switzerland.
Download the full report at:
www.kpmg.ch/siteselection
01
Key value drivers which are of

specic importance for the life
science industry are research and
development, operational excellence,
procurement, manufacturing, sales
and marketing. Depending on the
project, each value driver is weighted
differently and different locations
might prove to be ideal for re-locating
these value drivers. In particular,
potential adjustments to an existing
value chain should take the following
key trends into consideration, as
they affect key value drivers:
t Manufacturing: A key trend
is creating standardised
manufacturing platforms which
optimise existing manufacturing
facilities. Also, increasingly the
so-called continuous modular
processing is gaining traction
against the classical batch
manufacturing system with a
series of stop-and-start steps.
These two trends support an
life science business agility,
which can be a huge determinant
of success in todays rapidly
changing technological and
scientic landscape
t Operational excellence: There is
a clear trend in the life science
industry towards complementing
internal capabilities with external
resources. Demand peaks and
troughs, such as for transportation
or stafng, can be managed with
the collaboration of suppliers,
peer companies or specialised
outsourcers. Another key trend in
operational excellence is the proper
alignment of tax planning with the
underlying value chain. National tax
policies have a signicant impact
p2
ou
Gr
on the competitiveness and value

of an life science company, and
only a tax-compliant model can
deliver sustainable value over time
t Research and Development:
The possibility of collaborating
with universities continues to be
important. By strengthening ties
with academic institutions, life
science companies can improve
their attractiveness to qualied
researchers while simultaneously
enhancing their capabilities to
deliver commercially relevant
research results. Another key trend
in the eld of R&D is the increased
focus on certain tax-planning tools
such as the benecial taxation
of income from patents or the
tax-efcient treatment of R&D
costs. Such instruments can
signicantly improve the return on
investment for R&D activities and
therefore the value of a company.
Note: A rst step towards analysing a location is to compare the ordinary corporate tax rates of each country applied to general business activities.
Reasonable taxation of IP income from patents, technology or trademarks is an important consideration for LS companies that own mature incomeproducing IP. Trading income is also taxed at a lower level in some countries such as Ireland and Switzerland, whereas in other countries, trading
income is generally subject to ordinary taxation
In association with
Measurement:
Its time to get with the real world
PM
eve known for years

how important it
is to exercise, to
manage the amount
of calories we eat and to sleep
well. Over the last ve years, we
have been bombarded with a
wealth of digital solutions that
tell us how many steps were
doing, how many calories were
eating and if were getting a
good nights sleep. The idea is
that these things will ultimately
change our behaviour and
improve our health. And they do.
There is no doubt that
technology is making its way
into our world of healthcare
communications. It will bring
more empowerment to patients
to help them understand
their conditions better. It will
also enable us to improve
measurement and help healthcare
professionals understand a
patients disease and the effects
of treatment better. It will also
enable us to understand if our
medicines, services or education
are improving outcomes for
patients. It will provide a wealth
of data: which patients respond
best and when, and how theyre
doing while at home. Moving
forward, the FDA and other
health authorities will take
more interest in real-world data
than in clinical-trial data.
0.
Al
ts
outcomes than anything else?

And not just the medicine, but
also the service you provide
through your patient education
and medical communications?
So how do we do it?
Its not difcult. But it does
require a change in thinking, as
well as a strategic relationship
with clients who trust us to build
great programmes that match the
value of their brand to patient
outcomes. The measurement
is actually simple once youve
established the strategic goal.
Technology is exciting. But
lets not wait for it before getting
in the mindset of measuring
patient outcomes for our
programmes and services.
ed
erv
res
There are some great examples

in our industry. Examples where
organisations have committed to
changing a treatment paradigm
thats grounded in evidence, have
improved referral pathways or
have worked alongside each other
in a particular area to improve
services, referrals and prescribing,
and have demonstrated improved
patient outcomes. For all of
these programmes, we need
a strong strategic purpose
alongside a willingness to not
always focus on our brand.
At Lucid, were always talking
about making a contribution
and a change to healthcare. Our
metrics have evolved. Where
once the industry used to think
the number of delegates was a
good metric, combined with
the level of satisfaction, we now
know that this isnt enough.
If were going to engage with

technology in years to come,
we need to get used to thinking
about change and outcomes.
In recent years, weve worked
with some really ambitious clients
and weve created programmes
where we have been able to
demonstrate that healthcare
professionals want to change their
behaviour, that they have changed
and that this change has improved
patient outcomes. This has been
without any special technology.
We have created these programmes
by engaging strategic clients and
experts, while ensuring we dont
lose sight of what our purpose
is. Weve measured perceived
behaviour, actual behaviour and
patient outcomes. What weve
realised is: if youre clear about
the outcome, you can prioritise
the behaviours needed to improve
care and then make sure the
programme affects these changes.
Well feel well-placed when the
technology arrives, because it
will only make our job easier.
Can you imagine being able
to demonstrate that your brand
generates better real-world
igh
Examples that show it works
DENNIS OBRIEN
lr
01
If were honest with ourselves,

our real-world metrics are still
in development. Most of our
work is to drive the uptake of
medicines, or the awareness of
medicines, with limited activities
to improve patient outcomes
or service conguration.
It is time to demonstrate the
value of our medicines and the
value of our communication
programmes in the real world.
As Shaun Smith and Andy
Milligan explain in their book,
On Purpose, purposeful leadership
is about setting a goal that goes
beyond the sales picture and the
organisation, and demonstrates
a difference to our customers
lives. This means going beyond
8FOFFEUP
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p2
Real-world metrics
ou
Gr
were going to be the numberone brand in cardiology to

were going to improve the
lives of patients with ischaemic
heart disease. Furthermore,
as Shaun and Andy say, it is
important to always anchor every
programme and initiative that
supports the brand to that goal.
Contact Dennis OBrien

at Lucid on +44 (0)1494 755712,
via dennis@lucid-group.co.uk
or visit www.lucid-group.co.uk
www.pmlive.com
25

PM
0.
01
p2
ou
Gr
ts
igh
lr
Al
ed
erv
res
For campaigns that Ignyte change
.
At Hamell Ignyte, we specialise in award-winning creative campaigns
designed to initiate and drive sustained behaviour change.
Building lasting connections between brands and their audience.
We believe that to engage with your audience, you need to truly understand them.
And when you know what motivates them, anything is possible.
Call Fiona Hammond on 020 7978 5206 or email her at ona@hamell.co.uk
to nd out how Hamell Ignyte can help you deliver game changing results.
www.hamell.co.uk
Ignyte
In association with
Changing behaviour
by design
PM
Are we underestimating the power of design in encouraging

behaviours for the good of our health?
a sign prompting consumers to
buy more fruit and vegetables,
increased the amount purchased
signicantly (Payne, 2010). These
simple non-intensive, cost-effective
measures promote better decisionmaking, without restricting
choice or imposing regulations.
p2
#ZSFEFTJHOJOH
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0.
01
gains in quality of life, survival or

disease-free progression etc, and
when conveying options to their
patients. The principle of reciprocity,
alternatively suggests that messages
are more inuential when people
feel that they owe something. For
example the Behavioural Insights
Team (2013) conducted one of the
largest Randomised Controlled
Trials performed in the UK into
different messages to promote
organ donation and found that a
message based on reciprocity, If
you needed an organ transplant,
would you have one? If so please
help others, was most effective.
These are just a few of the principles
one could utilise when considering
behaviour design and demonstrate
quite remarkably how small
changes can result in large effects.
While creativity is vital in
changing behaviour through
design, it is also imperative to
ground interventions in robust
research evidence and psychological
literature. For example, in another
study attempting to increase
organ donation the Behavioural
Insights unit tested three messages.
During trials, one message
decreased the sign-up rate despite
predictions that it would be highly
inuential through tapping into
the unconscious motivation
of normative behaviour, ie our
need to be like everyone else.
In this case, pre-testing saved
thousands of potential donors,
reminding all of its necessity.
It will be interesting to see how
the governments plan to state a
medicines price, along with the
statement funded by the UK tax
payer on all medication will fare
in this light. While incentives and
principles of reciprocity, eg I must
take this medication as I have paid
for it may suggest this will decrease
wastefulness, it could equally
be that patients take medication
less regularly than prescribed
to, in their eyes, save money.
Behavioural design may
not therefore be as simple as
ts
igh
'JPOB)BNNPOE
once proposed and an experts

complete understanding of human
behaviour is therefore required.
Utilising these principles, the
Behavioural Insights team is
thought to have saved British
taxpayers millions of pounds
and unsurprisingly, private
companies are now rapidly
adopting these methods. With
the power of behavioural design
to create large effects from simple
changes, this is an opportunity
the world cant afford to miss.
At Hamell Ignyte we continue
to fund such innovation as a
priority, assessing persistent and
recurring health issues, determining
ways to challenge such harmful
behaviours. With technological
advancements increasing
exponentially, it is vital to cast our
eyes to mHealth as it continues
to provide new opportunities in
which we may utilise behavioural
design to assist audiences, in
a much broader context.
ed
erv
res
While the previous examples

utilise more traditional design
features, behaviour can also be
changed through design in the
framing of information. This may
utilise principles such as hyperbolic
discounting, loss aversion and
reciprocity. Hyperbolic discounting
for instance suggests that people
show greater motivation towards
short-term rewards than longterm, partly due to difculties in
projecting the future. Consequently
health goals are more effective
when framed as immediate and
concrete, an application thought to
be especially useful in promoting
healthy eating or the treatment
of chronic diseases by focusing
patients on short-term, positive
habit formation (Voyer, 2015).
Goal setting may also benet from
loss aversion, which suggests that
individuals are more motivated to
avoid a loss compared to achieving
an equivalent gain. Loss aversion
may also be applied to physician
decision-making, while determining
medication risk in relation to
lr
Al
ou
Gr
hile the well-worn

adage states that
men cant multitask, all of us it
seems are doomed to limited
cognitive capacity. Thats not
to say we all arent very capable
but there is a limit to the
amount of information anyone
can process at any one time.
To combat this social
psychologists suggest we have
become motivated tacticians.
If the situation allows we can
be thoughtful and thorough in
processing information, however
if it does not we resort to more
economical tactics that use
less cognitive resources - acting
automatically without fully thinking
through our decisions. These
mental shortcuts we rely upon to
help us make decisions and form
judgements are called heuristics.
By understanding heuristics we
can explain how people, while
complex, are incredibly predictable
in their behaviour. By redesigning
our environment to make good
decisions easier or seem more
appealing according to these
shortcuts, we can encourage
our audience to make better
decisions for the good of their
health and that of others.
An amazingly simple yet effective
example by Dominic King and his
colleagues (2014) is the suggested
changes in the choice architecture
of hospital prescription charts.
Prescribing errors are frequent in
hospital inpatients, partially due to
errors in legibility. By making simple
changes to prescription charts such
as using colour to direct attention
to important areas, gridlines to
encourage clear block capitals
and utilising check boxes, they
found physicians were signicantly
more likely to enter correct dose
entries and specify the frequency
of medication administration. In
another example, a simple line of
tape along the bottom of a shopping
trolley, designating the area for
fruit and vegetables, together with
Fiona Hammond is managing

director at Hamell, a full service
behaviour change agency. Contact
her on +44 (0)20 7978 5206, via
Fiona@hamell.co.uk or visit
www.hamell.co.uk
www.pmlive.com
27
Regulatory
The new
EU clinical
trial lay
summaries
PM
ou
Gr
p2
New regulations will require both a trial

summary and a lay persons summary
s we continue to have
greater access to healthrelated information, there
are increasing examples of patients
who have become self-educated to
the point that they are instructing
their physicians. And beyond that,
there are patients who arent waiting
for the next healthcare innovation;
theyre inventing their own. These
include a diagnostic test for
pancreatic cancer, remote updates
from a continuous glucose monitor
and sensor technology for stoma
care.
Evidence suggests that the
pharma industry is responding
to increasingly engaged patients
and their thirst for information,
particularly in the areas of diagnosis,
treatment initiation and adherence.
0.
01
ts
igh
lr
Al
res
$MJOJDBMUSJBMT
In a ground-breaking change to
the status quo of complex medical
language being a barrier to
understanding valuable information
for many stakeholders, the European
Commission has now recognised
this information gap and clinical
trial lay summaries will soon
become a legal requirement.
5SJBMTVNNBSJFT
The new Clinical Trial Regulation
(EU No 536/2014)5 comes into
effect no earlier than May 2016.
It requires trial sponsors to provide
two summaries one year after
the end of the trial in the EU: a
trial summary and a lay person
summary. The European Medicines
Agency (EMA) will manage an EU
database, hosting these summaries.
Kaisa Immonen-Charalambous,
the EPFs Director of Policy, says,
The regulation will support patient
organisations in educating their
members about the research and
development of medicines and the
regulatory process. But more could
be done. For example, securing free
access for patient groups to journals
and introducing lay summaries of
publications. Kaisa also hopes
that gathering patient input into
lay summaries could inspire more
pharma companies to work with
patients at an earlier stage in the
clinical development of a product,
beginning with the design of clinical
trials. We share these hopes. The
new regulation is a start and we
might just see a ripple effect.
28
www.pmlive.com
ed
erv
An area that is surprisingly late to

the table however is the cornerstone
of medical research: the clinical trial.
It seems fairly obvious that patients,
and the general public, should
be able to access and understand
clinical trial results, and there have
been increasing demands for these
results to be provided in a patientfriendly format. The European
Patients Forum (EPF) believes this
would have a number of benets:
t *ODSFBTJOHQBUJFOUBOEHFOFSBM
public awareness and condence
about the clinical trial process
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participants in the trial
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latest scientic research in the eld
t 4VQQPSUJOHEPDUPSTJO
communicating trial
ndings to patients
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communities who are often
particularly interested in medicines
that are undergoing trials.
Clinical trial summaries
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DMJOJDBMUSJBM
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PM
When it comes to actually

writing a lay summary, Annex V
of the regulation lists the content
requirements (see Box 1).
Unfortunately and perhaps
surprisingly for a piece of patientfocused legislation, the European
Patients Forum reported that this
list was developed without any
consultation with patient groups.
The EPF published a position
statement on the matter, arguing
that EU guidance was required
to ensure summary results are
unbiased, comprehensive, relevant
and understandable to patients.
"OOFY7
Gr
Annex V also raised a lot of questions

about how to actually write a lay
ou
p2
#PY CONTENT OF THE SUMMARY

OF THE RESULTS OF THE CLINICAL
TRIAL FOR LAYPERSONS
DRAFT GUIDANCE
1 Clinical trial identication (including
6. Description of adverse reactions

and their frequency
. Comments on the outcome of the clinical trial

9. Indication if follow-up clinical
trials are foreseen
10. Indication where additional

information could be found.
JANE NEALE
JO FEARNHEAD-WYMBS
Jane Neale is a multichannel director and

Jo Fearnhead-Wymbs is an account director
at Asheld Healthcare Communications
They can be contacted at jane.
neale@asheldhealthcare.com and
Jo.Fearnhead-Wymbs@gcc-global.com
7. Overall results of the clinical trial
We await the guidance and were

curious about how industry will
respond to the new legal regulation.
Our hope is that it will be seen as
a positive step towards genuine
transparency between the industry,
patients and society, rather than
as a box ticking exercise.
Weve already been inspired by
some of our clients who are being
proactive, and are starting to produce
lay summaries now. These companies
have the advantage of getting their
internal processes in place ahead
of schedule and receiving early
feedback from the EMA. Most
importantly, they demonstrate that
they believe in, and want to deliver,
transparency and patient-centricity.
ed
erv
5. Investigational medicinal products used
workshop, it was highlighted that

patients could be advised to discuss
the lay summary with their doctor.
t 4JNJMBSMZ FBDIDMJOJDBMUSJBM
needs to be understood in the
context of drug development
stages. Information could be
added to each lay summary or
there could be master overview
documents available on the EU
database, alongside a glossary.
t 8IJMFUIFSFJTBUSFOEPGJODSFBTJOHMZ
engaged patients, there are many
that do not fall into this category.
Patients who are not engaged,
or indeed the general public, are
unlikely to seek out clinical trial lay
summaries on an EMA database.
Guidance on wider distribution
of the lay summaries would help
realise the benets of open access,
patient-friendly clinical trial results.
res
on the number of subjects included in

the trial in the Member State concerned,
in the Union and in third countries; age
group breakdown and gender breakdown;
inclusion and exclusion criteria)
ts
. Population of subjects (including information
igh
3. General information about the clinical trial

(including where and when the trial was
conducted, the main objectives of the trial and
an explanation of the reasons for conducting it)
lr
2 Name and contact details of the sponsor
In addition to the questions

above, well be interested to
see if the following issues
are covered and resolved:
t 4JNQMJmDBUJPOBOEFNQIBTJT
of key points could bring
unconscious bias. Simplication
needs to be balanced with
accuracy and transparency.
t 5IF&1'IBTIJHIMJHIUFEUIF
importance of a lay summary
section on limitations of the study,
how potential sources of bias
and imprecision were addressed,
and caveats (as included in the
technical summary). This will help
patients evaluate the results and
manage their expectations.
t "EWJDFBCPVUQBUJFOUJOQVUJT
needed, as well as information about
how the quality of lay summaries
will be ensured. Ideally there would
be patient input or review of every
lay summary but this would be
unfeasible. There should at least be
encouragement to bring patients
into the process where possible,
particularly as each company
produces its rst lay summaries.
Kaisa Immonen-Charalambous, EPF,
points out that there are numerous
industry commentators who will
no doubt take it upon themselves
to carry out a quality review.
t 1PJOUPG"OOFY7SFGFSTUP
additional information. It will be
important that patients understand
that a lay summary is just one set of
results, which need to be looked at
in the broader context of a products
risks, perceived value and benets
and where that product ts in the
treatment landscape. At the EFGCP
Al
title of the trial, protocol number, EU

trial number and other identiers)
0.
01
5IFTVNNBSZPGUIFSFTVMUTPGUIF
DMJOJDBMUSJBMGPSMBZQFSTPOTTIBMMDPOUBJO
JOGPSNBUJPOPOUIFGPMMPXJOHFMFNFOUT
summary. When rst reading the

list, it all sounds sensible. But when
you start to write one, theres a lot
more you need to consider such as:
Will there be a dened template
broken down by the Annex V sections
(which would aid consistency and
therefore comprehension)? Will
the format be text only or allow for
creativity and visuals? What is the
reading age that the summary should
be aimed at? Which language(s)
should it be provided in? Will
there be a master glossary?
The European Forum for Good
Clinical Practice (EFGCP) held
a workshop in May 2015 with
representatives from clinical
researchers, patient groups
(including the EPF) and pharma to
debate a meaningful future for lay
summaries. Following the workshop,
a working group has been developing
a European Commission guidance
document. The draft guidance is
expected this month, followed by
a public consultation period.
KAISA IMMONENCHARALAMBOUS
Special thanks to Kaisa
Immonen-Charalambous,
from the European
Patients Forum, for
her valued insight
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29
Interview
Forging
a path in
specialty
PM
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care
lr
Al
for new and existing people in

these areas is enormous.
Shifting the focus from primary
care to speciality care has meant
that we have had to change our
priorities to address new internal
and external challenges, such
as a more complex stakeholder
landscape and new digital
technologies which enable broader
engagement, higher connectivity
and better understanding of
patients and their needs . One
way we are meeting these new
challenges, is by expanding the
depth of key account management,
which provide a more effective way
of interacting with a developed
healthcare economy, as well as
bolstering the digital systems that
drive customer-focus. This approach
encourages the development of
long-term relationships with strategic
customers whose clinical and
non-clinical needs are understood
in-depth, and therefore are able
to offer a tailored approach that
demonstrates an advantage
ed
erv
www.pmlive.com
0OFXBZXFBSF
NFFUJOHUIFTF
OFXDIBMMFOHFT
JTCZFYQBOEJOH
UIFEFQUIPG
LFZBDDPVOU
NBOBHFNFOU
res
30
with vaccines not far behind.

Leading the transformation is
president of Takedas Europe and
Canada Region, Marc Princen. He
joined the company from MSD in
November 2014 and hes excited
by the task, and the process.
Speciality care requires that we
have different capabilities in order
to reach a more specic group of
medical specialists. In particular
it requires strong Medical Affairs
and Market Access, supported
by the latest digital engagement
platforms. Building up these
capabilities is the key to success
in our new areas. Weve already
made key appointments in these
areas and were still recruiting for
new talent who play an important
role in the specialty care setting.
One of the great strengths at
Takeda is our people, and thats
why this is such an exciting time.
We need the right mix of external
recruitment and development of
the people we already have. The
learning and growth opportunities
ts
hange is the name of the

game in most pharmaceutical
companies as they struggle to
adapt to the new, post-blockbuster
world. Thin pipelines, increasing
price pressures, tough regulators and
erce generic competition mean the
business principle adapt or die has
never been more relevant. When the
Greek philosopher Heraclitus said
Change is the only constant he
could have been talking about early
21st century pharma.
At Takeda theyve gone one
step further. Theyre completely
transforming the company. In
business, transformation is a
process of profound and radical
change that orients an organisation
in a new direction and takes it
to an entirely different level of
effectiveness. Thats precisely
their aim. Theyre moving from a
primary care focus to speciality care.
So the company with a reputation
in diabetes and cardiovascular
is aiming to become known for
oncology and gastroenterology,
igh
Takedas Marc Princen on the companys plans to build a

reputation in oncology, gastroenterology and vaccine
Marc Princen
0OFXBZXFBSFNFFUJOH
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FYQBOEJOHUIFEFQUIPGLFZ
BDDPVOUNBOBHFNFOU
PM
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over the other competitors.

Takedas got off to a ying start
with important speciality care
products. Adcetris (for Hodgkin
Lymphoma), Entyvio (for ulcerative
colitis and Crohns Disease) and
future compound Ninlaro (an oral
protease inhibitor for relapsed/
refractory multiple myeloma)
which was approved by the FDA in
November and is currently under
review by the European Medicines
Agency. The last two products
were developed in-house. Our
scientists developed these last
two exceptional new compounds
providing a blueprint for the future.
Innovative products addressing
genuine unmet needs dene
the shape of the speciality care
company we are becoming.
In recent years the Europe and
Canada region has been a prime
mover in the nancial performance
of the 230-year-old Japanese
company. Princen is determined to
keep it there. Globally, the company
is aiming to launch ve new products
over the next ve years, and is
promising strong annual growth in
the region during that time. In his
region, he estimates that more than
90% of the growth will be from
speciality medicines. Thats higher
than anywhere else in Takeda. In
North America, for example, the
gure is just over 50%, and its
about 25% in Asia. So Europe/
Canada will set the pace in the
transformation towards specialty.
The European region is the second
largest pharma market in the world,
and we are ideally placed to take
advantage of all the changes we
have identied. Thats another
reason this is such an exciting
place to be, at an exciting time.
In recent years Takeda has joined
in the industrys enthusiasm for
mergers and acquisitions, notably of
Millennium in Boston, Massachusetts
and Nycomed headquartered in
Zurich, Switzerland. The former,
now known as Takeda Oncology,
gave the company an instant
presence in oncology, and the latter
increased its European reach at a
stroke. Around the world theyve
Al
ts
igh
lr
are beneting from treatment.

So what does Takedas focus
on speciality care mean for the
companys traditional primary care
business? Its still important. We
have a broad-based business in
primary care and in many countries
our products are the standard
of care. Globally, were aiming
to maintain and even increase
the protability over time. This
is particularly true in emerging
markets, where health systems are
beginning to use our medicines more
and more. In Europe and Canada our
growth will come from speciality care
and this drives the reorganisation
of our business. Our medicines are
becoming more and more important
to these health systems and the
patients they help. In order to
deliver our speciality medicines to
more patients in Europe we need to
foster and develop the best talent
in market access, medical affairs
and digital specialists. We have
a growth trajectory to be excited
about and great medicines that
address a real patient need. Thats
our heritage, and our future.
ed
erv
res
launched in a number of new

markets, including Israel, which
comes under Princens remit a
strange geographical choice.
Geography is not always
the determining factor. What is
important is the similarity between
markets, and where people can
benet most in terms of best
practice. Israel is a very innovative
country with a lot of people with
ideas, so it is much closer to Western
developed countries than anything
else. Thats why were happy to
embrace it within our region.
The big challenges for Takeda
are the same as those facing every
pharmaceutical, biologics and
vaccine company. Getting a good
price for their new medicines is top
of the list. Princen is bullish on this
point. Europe has demonstrated a
willingness to reimburse innovation
especially if theres a patient need,
and an exceptional treatment for
addressing it. The best example
is Entyvio. It meets both of those
criteria. Weve launched it in 15
markets in Europe and its already
been reimbursed in 14 of them.
We will launch in more than 10
new markets in 2016 and the need
for this drug is supported by the
fact that already 30,000 patients
John Clare is a journalist and chief

executive of LionsDen Communications
www.pmlive.com
31
Company strategy
UNDER
PRESSURE
PM
Gr
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Six inexorable forces shaping

our industrys evolution
ts
igh
lr
Al
www.pmlive.com
32
globalisation. Secondly, it would not

allow for the interaction between
environmental factors. To really
understand, we need to take a
complexity approach. First, collate
thousands of individual market facts
about how the market environment
is changing then repeatedly sort,
shufe and structure that data
until regular patterns - emergent
properties in the jargon - appear.
When this is done for the life
science industry, those six great
shifts emerge. Those shifts favour
and disfavour certain strategies,
structures and other traits and lead
to the evolution of new business
models, just as natural habitats
favour certain biological traits
and lead to new species. The
six shifts and their concomitant
selection pressures are described
in the following paragraphs.
ed
erv
the life science sector. The answer,

emerging from years of research
by my University of Hertfordshire
research group, is that six
fundamental shifts in our industrys
environment are silently but
effectively deciding which business
models will thrive and which will go
the way of the dodo.
Before describing those ndings,
its worth being clear about what
we are and are not looking for. Its
tempting to focus on one or more
of the many dramatic technological
changes we see occurring, such
as the internet of things or any of
the omics revolutions in biology.
But this would be simplistic
in two ways. Firstly, it would
consider only the technological
environment and ignore equally
important sociological factors such
as demography, economics and
res
s Voltaire said, to nd good

answers we have rst to ask
good questions. Nowhere
is this more true than in the life
science industry, in which everyone
from CEOs downwards is asking
what future business models will
look like. So what are the good
questions that might help us
answer this important question?
The clue lies in the complex
adaptive nature of our market.
Such systems cant be predicted
by simple extrapolation; they
operate by the non-linear, chaotic
rules of Darwinian evolution. In
evolutionary terms, business models
are analogous to species and
selection pressures either favour or
disfavour variations in their traits,
leading to speciation or extinction.
So the right question to ask is what
selection pressures are at work in
Pharmaceutical Market Europe Febuary 2016
Under pressure
THE VALUE SHIFT
PM
A shift in the denition of

the value from improved
clinical outcome as dened
by healthcare professionals
to a complex, context-specic
denition of value dened in
terms of clinical, economic
and other factors by a
combination of healthcare
professionals, payers and
patients or their proxies
0.
01
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The value shift is a change both in

how value is dened and by whom. It
is also an increase in the complexity
of value denition. It arises from the
interaction of a number of separate
social factors such as demographics,
healthcare ination, rising
expectations and disease patterns.
The value shift creates a selection
pressure in favour of business
models that can understand
multi-dimensional, customerperceived value and can create that
context-specic value through a
combination of product, services
and pricing. At the same time,
the value shift creates a selection
pressure against models that
understand value only in terms of
clinical outcomes as dened by
healthcare professionals and valuecreation only in terms of products.
It represents a
move from ...
treating illnesses
by symptoms
to ... managing
individual wellbeing
models that can understand market
heterogeneity and deliver value
to targeted segments on a global
basis. At the same time, the global
shift creates a selection pressure
against models that view market
heterogeneity only in clinical terms,
are unable to focus their resources
appropriately and cannot deliver
customer-specic value globally.
THE HOLOBIONT SHIFT
THE GLOBAL SHIFT
A shift in our understanding

and management of
physical and mental health
from reactive, populationbased and hierarchical to
proactive, personalised
and participatory
The systeomic shift is a change in
the sectors scientic paradigm. It
represents a move from a 19th century
view of medicine as treating illnesses
by symptoms to a systems approach
managing individual well-being. It
is based on technologies, such as
bioinformatics, gene sequencing,
biomarkers and synthetic biology
that make systems biology and
systems medicine possible.
The systeomic shift applies a
selection pressure in favour of business
models that can translate system
medicine into an improvement of
returns or a reduction risk at any
point in the value chain. Conversely,
it creates a selection pressure
against business models that
remain based on a reductionist,
hierarchical, population-based
understanding of disease or injury.
THE INFORMATION SHIFT

A shift in the collection,
storage, use and
communication of information
from small-scale, fragmented,
unidirectional and deductive
to large-scale, integrated,
pervasive and inductive
The information shift is a change in
how we collect and use information.
Importantly, it inuences not only
how we discover and develop
drugs, devices and other medical
technologies but also how we produce
products, deliver services and
understand our customers needs. It
is based upon platform technologies
such as biosensors and improved
chips, memories and batteries.
These enable connectivity, wearable
technology, articial intelligence and
new data analytical capabilities.
The information shift applies
a selection pressure in favour
of business models that use
information to improve returns or
reduce risk, whether that is in R&D,
operations or sales and marketing.
The obverse is that the information
against models that continue
to use information in a smallscale, fragmented, unidirectional
and deductive manner.
ed
erv
res
The holobiont shift is a change in the

way rms structure themselves and
work with other rms. It involves both
a reduction in what rms do
themselves and an extension of what
they do with partners. In essence, it is
a shift from big, self-contained rms
to networked organisations that are
more complex, more uid and less
well dened than we are used to. It
arises from the combination of
changes in capital markets, changes
in transaction costs within and
between companies, the
specialisation of corporate
capabilities and the increasing need
to mitigate business risk.
The holobiont shift applies a
selection pressure in favour of
business models that can build
and manage dynamic, symbiotic
networks of complementary
organisations and use that structure
to improve returns, reduce risk
or some combination of the two.
At the same time, the holobiont
against models that persist in
having unicentric structures
and simple supplier networks.
ts
The global shift is a change in

customers and competitors location,
needs and behaviour. Importantly,
it includes not just globalisation of
demand but also fragmentation of
customer needs to accommodate
many non-clinical factors such
as aesthetics and convenience. It
creates multiple, diverse global
segments within any disease area. It
arises from the interaction of trade
internationalisation, multinational
corporations, increasing and
polarising global wealth and
subsequent maturation and
fragmentation of customer needs.
The global shift applies a selection
pressure in favour of business
igh
A shift in the demand and

supply patterns for healthcare
from western-oriented with
limited heterogeneity based
on clinical requirements to
global geographic spread
that is heterogeneous in
clinical requirements, payer
preferences and patient needs
lr
Al
A shift from organisations with

predominant centres and welldened, stable boundaries
and scope to polycentric
networks with uid, ill-dened
boundaries and scope
THE SYSTEOMIC SHIFT
www.pmlive.com
33
Industry evolution
PM
Al
SELECTION PRESSURES
The six great shifts identied by our
research are fundamental, emerging
properties of the complex adaptive
system that is the life science
industry. They create selection
pressures that are pervasive, acting
on every change in strategy, structure
and process to either favour it or
disfavour it. Over time, they lead
to the emergence of new business
models and the disappearance of
old ones. However, these selection
pressures act in a complex
and uneven manner. All six act
simultaneously on every rm and
they also interact with each other.
But they do not act evenly across
the industry. The systeomic and
information shifts, for example, act
strongly on innovative companies
but, arguably, less so on follower
companies. The trimorphic and
holobiont shifts act more strongly
on smaller companies, who can
form holobionts that allow them
to compete with industry giants.
The global shift and value shift
affect the whole industry but
the details of their effects vary
between disease areas. To add to
this complexity, business models
can adapt to selection pressures
in a number of ways. They can
react to the value shift by reducing
costs or by creating more effective
ts
igh
products. They can respond to the

systeomic shift by developing their
technology further or by integrating
it with other technologies. They
can adapt to the holobiont shift by
becoming a network hub, a spoke
or a bridge between networks.
These complexities mean that the
net result of the six great shifts will
be a mass speciation of business
models in the life science industry.
Just like the explosion of biological
species in the Cambrian Explosion,
there will be many more types of
business model in the future than
there are now and they will be more
diverse, more specialised and more
effective than those of today. Asking
and answering the question about
what selection pressures are acting
on our industry is the rst step in
predicting that complex, speciated
future. The next, identifying and
describing the business models
that will emerge, is the subject of
the second article in this series.
ed
erv
res
The net result

of the six great
shifts will be a
mass speciation
of business
models in the
life science
industry
lr
www.pmlive.com
0.
34
01
The trimorphic shift is a three-way

polarisation of resource focus within
companies. It involves research-based
rms becoming more innovative, lowcost rms becoming more efcient
and customer-centric rms becoming
excellent at tailoring their value
propositions. It arises from advances
in supply chain architectures, research
and development technologies and
sales and marketing methodologies. It
is complemented by the polarisation
and specialisation of corporate cultures
in line with their business model.
The trimorphic shift applies
a selection pressure in favour of
business models that focus on
creating value by either product
excellence, operational excellence or
customer intimacy and by targeting
the parts of the global market that
will respond to such a specialised
offer. Similarly, the trimorphic
shift will apply a selection pressure
against models that straddle
across the three approaches. Such
rms, who may have good products,
efcient operations and effective
sales and marketing processes will
nd themselves at a disadvantage
to those more focused rms with
either excellent products, hyperefcient operations or the ability
to identify and satisfy very small
and specic customer segments.
p2
A shift from organisations

that are relatively similar
in how they distribute
effort across their value
chain to organisations that
are strongly focused on
either customer intimacy,
operational excellence
or product excellence
ou
Gr
THE TRIMORPHIC SHIFT
The articles in this series are based on the

forthcoming book Darwins Medicine: The
Future of the Pharma and Medtech Industry.
Professor Brian D Smith welcomes comments
and questions at brian.smith@pragmedic.com
0.
01
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PM
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igh
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Al
.
ed
erv
res
In association with
Harnessing customer insight

to develop personalised
multichannel medical education
PM
Designing medical education programmes

that meet todays highly individual needs
0.
Dale states that the greater the

level of interaction with content,
the more information will be
retained and behaviours adapted;
in practice, this means that realworld clinical cases and hands-on
experience are more effective in
embedding learning. There are
many examples of increasing
levels of interactivity to support
healthcare. One excellent example
is the use of Google Cardboard
to map complex heart surgery on
an infant in Miami. This use of
highly interactive technology in a
real-world setting marks a change
in the use of virtual reality, moving
from congress-booth attraction to
real-world educational tool. Nudge
theory acknowledges that while
behavioural impact is unlikely
to be achieved through a single
interaction, a series of nudges
(ie multiple touchpoints) can
provide positive reinforcement and
encourage reective thinking; over
time, this can lead to behaviour
change. Applying these theories
in a blended multichannel
user journey allows you to add
interactivity across multiple
touchpoints and to maximise both
knowledge retention and evidencebased behavioural change.
ts
DAVID HOGBEN
Gaining an understanding of
how long audiences interact with
your content (online and ofine),
time spent with eld force staff
and attendance at meetings or
symposia provides insight into
the level of engagement across
channels. To measure behavioural
change we need to look beyond
the touchpoint metrics to wider
trends such as a shift in online
sentiment, increasing the number
of shares of key content, patient
adherence and - potentially
- prescribing behaviour.
To navigate the complex
and demanding education
environment successfully there
needs to be an acceptance that
there is no single magic bullet.
Instead, success will be based on
developing a strong multichannel,
audience-driven strategy, providing
each audience type with a unique
experience and utilising formats
and channels that suit their needs.
Understanding the value
As with any communication

approach, understanding and
measuring the success of an
education strategy is fundamental.
Not only does this provide great
insight into your return on
investment; it also allows you
to optimise and improve the
strategy based on real-world data.
To measure a truly multichannel
experience it is important not to
simply review how many unique
visitors arrive at your website.
Instead, track metrics, which, for
example, provide a greater depth
of insight across both digital and
more traditional touchpoints.
ed
erv
res
By using audience persona proles

combined with behavioural
mapping, pharma can develop a
range of personalised user journeys
optimised for each audience or
patient type. The blend of channels
mapped out in the user journey
will be different for each persona
type and could include face-to-face
meetings with pharma personnel
and eld force teams, interactions
at medical congresses (symposia,
booths etc), online tools owned
or sponsored by pharma (or using
other trusted online sources to
disseminate information) and
the more traditional publications
and printed materials.
Although the key educational
messages should be the same
no matter which channel or
format is used, the application
of adult learning principles
and behavioural science
can increase knowledge
retention and application.
There are numerous different
theories; however, we have seen
success combining Dales cone
of experience with nudge theory.
igh
Personalised multichannel
user journeys
lr
Al
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01
36
.FUSJDTQSPWJEF
BHSFBUFSEFQUI
PGJOTJHIUBDSPTT
CPUIEJHJUBMBOE
NPSFUSBEJUJPOBM
UPVDIQPJOUT
p2
One of the rst challenges is to

understand your audience. This
should include an appreciation
of different learning styles and
behaviours and of the channels
used to discover information, as
well as an understanding of the
depth and nature of information
required to have a positive
impact on patient outcomes.
Developing a range of persona
proles for each of your target
audiences is a powerful approach
that can be utilised to guide the
development of multichannel
education and ensure that
user journeys align with the
specic learning behaviours
of individuals. It is possible to
create behaviour maps for each
persona type, highlighting how
they currently learn and providing
insight into the opportunities
to make learning more effective.
Persona prole development
and behavioural mapping have
been common practice in other
industries, such as retail and
fast-moving consumer goods,
but remain under-utilised within
pharma. To unlock the value of
this approach, a new focus is
needed on gathering insights into
learning behaviours and channel
preferences, beyond the more

routinely assessed healthcarerelated attitudes and behaviours.
ou
Understanding the audience
Gr
he healthcare
education environment
continues to grow in
scale and complexity,
reecting the proliferation
of medical information,
the multitude of channels
healthcare professionals use
to access information, and the
increasingly diverse groups of
healthcare professionals and
patients with medical education
needs. Meeting these highly
individual needs can present
a daunting challenge for
some when designing medical
education programmes.
Complete HealthVizion is a leading

global multichannel healthcare
communications agency.
For more information,
contact David Hogben:
david.hogben@complete-hv.com

PM
0.
01
p2
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Gr
lr
Al
healthcare stakeholders cry out
for reliable health information, the
wall needs to be knocked down.
Its time for pharma to have its
Berlin moment. In 1979, perhaps
we didnt need no education.
But almost forty years later,
as communications channels
proliferate and information overload
prevails, people dont just need
education - they need advice on
the best place to study and help
understanding the curriculum.
ts
igh
*UTUJNFQIBSNBSFCFMMFEBHBJOTU
JUTPXOSJTLBWFSTFUSBEJUJPOT
The current challenge of health

education is being created by
another wall - a wall of noise.
Nowadays theres just too much
information within our reach.
We dont know what to discard
and what to trust. Healthcare
stakeholders, both professional and
consumer, need reliable, credible
and accessible information. Pharma
has never enjoyed a reputation as a
trusted source of information, but
perhaps it could. Indeed perhaps
health education could become a
mechanism to drive levels of trust
in pharma by solving the growing
problem of infoxication. HCPs
8BMMPGOPJTF
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ontrary to popular belief, Pink

Floyds hit Another Brick in
the Wall is not about students
rebelling against the education
system. The Wall is apparently
the self-isolating barrier we build
for ourselves over the course of our
lifetimes - and the Bricks are the
people or events that make us turn
inward and away from others. So
whats this got to do with pharma?
Well its quite possible that,
largely through regulatory fear,
the industry has built a similarly
isolating wall around itself thats
become a self-inicted barrier to
customer communications. And
every new engagement solution
thats killed before birth due to
unchallenged regulatory fears is
just another brick in the wall.
But as the world moves on and
certainly believe its possible.

Theres a common acceptance
that wed all benet from having
more and better quality educational
resources for all stakeholders in
healthcare, says Tim Ringrose,
CEO at M3 (EU). Evidence shows
that a strong majority of doctors
believe pharma should be investing
more in educational resources for
patients and HCPs. One-to-one
discussions with individual HCPs
consolidate that view; physicians
and consultants typically decry the
bewildering amount of information
that exists online, and bemoan
how the patients they see are being
misinformed by its variable quality.
The take-home? Theres a growing
need for a trusted repository of
high-quality health education - and
pharma should be a key player
in delivering it. The benets to
patients, doctors and healthcare
systems would be signicant.
So whats stopping progress?
For one, pharma is famously riskaverse. Theres widespread fear
within brand teams about what can
(and cant) be done, not only from
a marketing perspective but also
from an educational one, says
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37

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Wanted
Forward-thinking clients who

share our passion for healthcare
and our values for delivery
Contact
Sarah Strachan
sarah.strachan@hayward.co.uk
+44 (0)1638 723560
www.hayward.co.uk
Hayward Medical Communications

INSIGHT | EXPERIENCE | FLEXIBILITY | PARTNERSHIP | INTEGRITY
Health
Sizeeducation
matters?
Tim. ABPI and EFPIA guidelines

are interpreted differently from
company to company and too
often compliance fears prevent
teams from pushing forward with
innovative solutions. However, theres
a realisation that investment in
education may be a sensible move.
Were beginning to see companies
shifting budget from marketing to
education in an attempt to nd
new ways to engage customers.
PM
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In the absence of cross-sector

collaboration, how can pharmas
approach to education improve? We
need to focus not on the disease,
not on the patient - but on the
person, says Rhiannon. The
disease is just one part of a persons
life. Education needs to be aligned
to truly meaningful outcomes and
have behavioural change at its core.
It must be relevant and useful - for
the patient and the HCP. If we
involve patients upfront and focus
on whats important to them, well
get it right at the outset and deliver
more powerful change as a result.
To understand the patient,
we need to walk in their shoes,
understand how they think, and how
effective disease management and
treatment will change their lives. If
we dont then our education wont
speak to the challenges they face
because the emotional context will
be missing. All too often we see
situations where the tactic was the
ts
$VTUPNFSFYQFSJFODF
igh
a strong argument for EFPIA or the

ABPI, in partnership with trusted
publishers, to lead on education to
ensure all appropriate stakeholders
in a disease are working together
to produce high quality resources,
rather than everyone attempting
their own separate initiatives.
lr
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The drivers for change are clear.

The urban dictionary tells us were
all suffering from infobesity were growing fat on information.
Thats certainly the case with
health. Experts call it empowering
patients, but thats only the case if
the information is credible. Were
seeing the increased empowerment
of patients able to monitor, interact
with and self-manage their own
health, says Rhiannon Meaden,
Head of Commercial Development,
Complete HealthVizion. They can
instantly access a stream of personal
data and education about their
health. But health tech isnt always
created, validated or managed by
clinical experts. While patients
may embrace new technologies,
HCPs question whether theyre
accurate, reliable or supportive,
and whether they take into account
the idiosyncrasies of a disease
and its treatments. Its vital that
clinical evidence sits alongside
information generated via new
technologies when developing
any educational programme.
The explosion in health tech is
a positive for pharma. But it means
we need to go beyond the pill and
be present throughout the treatment
journey. We need to work more
closely with patient advocacy groups
and societies, and include patients
across the spectrum of activity
- from clinical trial development
through to the implementation of
patient education. Patient, HCP and
pharma co-creation of educational
content should be our Nirvana.
However, in terms of multistakeholder collaboration to build
credible repositories of disease
information, pharmas risk-averse
prole extends beyond regulation.
Pharmaceutical companies are
notoriously reluctant to work with
each other, says Tim. Consequently,
we end up with lots of different
educational initiatives. They all
contain high-value content - but
the user experience is yet more
confusion. The patient with diabetes,
for example, doesnt know which
resource to go to - and the wall of
noise just becomes louder. Theres
[EDUCATION]
MUST BE RELEVANT
AND USEFUL FOR THE PATIENT
AND THE HCP
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39
Company
Health
education
strategy
.
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N
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COULD HELP
IMPROVE
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#SJDLTJOUIFXBMM
wider conversation - and start giving

patients the trusted information
they desperately need. Pharma
companies need to stop worrying
that the world questions their
reputation and motives - and realise
that patients and HCPs want them
involved in providing solutions for
healthcare, says Tim. And if that
involvement can be collaborative,
the education that emerges will
be so much more powerful.
Greater collaboration would
certainly be a step towards
demolishing the barrier that has
long isolated pharma from important
stakeholders. Pink Floyds classic
may not be about rebelling against
the education system, but perhaps
its time pharma rebelled against
its own traditions and worked
together for the common good. If
it cant, its allowing its propensity
to be risk-averse to become just
another brick in the wall.
Theres no doubt that pharma has

the knowledge and capability to
develop educational programmes
that can improve health outcomes.
The challenge is to raze the selfbuilt wall that historically has
prevented pharma from joining the
Chris Ross is a freelance writer specialising

in the pharmaceutical and healthcare industry
ts
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www.pmlive.com
particularly in chronic disease

where the dialogue is a longerterm partnership, says Rhiannon.
We can also use technology to
intelligently and proactively enhance
the conversation when patients
return for consultation. But there
needs to be a greater focus on
linguistics. We have to understand
how HCPs talk to their patients and
how patients talk about their own
disease - before we can address
barriers to effective communication
with impactful medical education.
To progress, pharma companies
need to partner with experts that
understand the complexities and
can overcome them to create
compelling, credible and accessible
medical education. The best
programmes will be underpinned
by a clear strategy and have a rm
grounding in behavioural science.
igh
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motivation rather than the outcome.
If we ignore the patient context
then education wont resonate
and technology wont be used.
Another important area to explore
is HCP-patient interaction. The
HCP is vital to patient education,
says Tim. We know that when
patients visit their doctor, theres
a huge amount they may have
forgotten or misunderstood by the
time they leave the consultation.
This is simply the nature of
communication within difcult
time constraints. One thing that
would help is if HCPs were able to
deliver an educational prescription,
whereby they recommend resources,
contacts and materials that can
help the patient once they get
home. Theres little doubt pharma
could help create these resources
and, if produced independently
and to a high standard, neither
the patient nor the HCP would
question their credibility.
Supporting patient interaction
at the point of care could also
help drive medicines adherence.
Education centred on HCPpatient interaction could help
improve treatment compliance,
In association with
Online learning:
The key to customer centricity
for pharma and doctors?
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Successful digital educational campaigns need audiences to be fully engaged
medics, whose engagement

is entirely dependent on the
perceived quality and value of
the education. This is where
digital takes on a new aspect for
digital natives who expect things
to be available online and will
switch over to other things if the
value is not immediately clear.
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RESULTS SUMMARY OF QUESTIONNAIRE ON EDUCATIONAL PREFERENCES
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igital done properly

is transformative
and I believe 2016
is the year that
pharma has no other option
than to embrace it across all
activities - and education is a very
important one. Digital education
programmes have so much in
common with traditional face-toface education; instant feedback,
live discussion and debate
and post-course evaluations,
but what is lacking from most
digital educational campaigns
is the fully engaged audience.
The audience havent changed.
They still want high quality,
independent teaching, and
they still want to learn how
to improve their practice and
the health of their patients.
Digital offers on demand,
but it also offers accessibility
and endless possibilities for
personalisation. For education
this means personal education
programmes tailored to their
exact identied need, and
in their preferred medium,
whenever and wherever they
want it. Despite the talk about
Big Data, for most organisations
insights are just not being used
in a meaningful, strategic way to
improve educational outcomes
and result in the ultimate
success of an education-based
promotional campaign.
The use of digital in continuing
medical education (CME) is
growing. In a recent study of
doctors across Europe by M3
Global Research, online CME
activities were cited as one of the
most valued forms of education,
following society conferences,
self-study and peer learning
sessions, and rated ahead of
case presentations, pharma-run
conferences, and independent
and/or industry-run courses (see
chart). Digital offers a level of
exibility hitherto unseen for
time-poor, highly discerning
Its no longer enough

to publish an educational
module and then start the next
project. The really interesting
insights come from peeling
back the layers of engagement
and discovering the real user
journey. Analytics tells us how
long they spent on the module,
how they found it and what
they did next. Now we know at
what point they clicked away,
how many questions they got
right, what they retained, what
their knowledge gaps are and
how the learning impacts their
practice. We should benchmark,
compare and learn. This way we
become more agile, we adapt
more quickly, and we share that
learning across all programmes.
As part of a jigsaw of feedback,
qualitative and quantitative
data paints a multilayered
picture, but insights derived
from data are the real story.
This consumer centricity is
pivotal to the success of digital
pharma. If we dont give them
what they want, theyll switch

off. We need to invest in learning
about our audience. Every day,
their interactions with your
content, your programmes
and your teams provide us
with information. We need to
hear everything they say (both
explicitly and implicitly, via their
behaviour and emerging trends)
and let it inform every decision
we make as we approach the
planning phase. We should dig
as deep as we can, and ensure
we dont underestimate the
value of tacit knowledge and
experiential learning, even if it
takes time - this is important
work. Talking to colleagues about
their experiences of a particular
cohort or the quirks of a specic
demographic can be vital; our
aim is to know our customer
inside out. We need to do this
early, while we still have time to
change the agenda and have the
drive and appetite to support it.
Why hasnt this happened
already for pharma? After all,
digital campaigns have been
around in one format or another
for at least the last ten years. Put
simply, it takes forward-thinking,
innovative companies to put the
needs of the consumer rst, and

no-ones been brave enough yet
to start planning a programme by
asking questions. How can I make
Dr Xs life easier? What can we
tell Dr Y about this therapy area
that she doesnt already know?
Why was the engagement with
our last campaign lower than
anticipated? Who is integral to
the success of this programme? If
your answer to the last question
wasnt the end-user, then digital
may still be a bit of a mystery to
you. There is much to learn and
many opportunities for pharmas
role in online education to grow.
Kuljeet Sohanpal is business

director - M3 Education.
Contact him at Kuljeet.
Sohanpal@eu.m3.com if you
would like more information
or to share your opinion
www.pmlive.com
41
Digital intelligence
EU forms mHealth app working group

Tasks it with drafting guidelines for assessing the validity and reliability of the data collected
he European Commission is
working towards improving
the safety and transparency
of health information
collected by mobile apps.
Its newly set up mHealth app
working group will be tasked
with assessing the validity and
reliability of the data that is
collected and processed.
The Commission also wanted
it to produce draft guidelines
for the area, which it says
should be ready to be published
by the end of this year.
The promise of health app
guidelines follows the Green
Paper on mobile health issued
by the Commission in 2014,
when it outlined the technologys
potential to empower citizens to
manage their own health, improve
quality of care and comfort
for patients and assist health
professionals in their work.
The Paper also identied safety
and transparency of information
as one of the main issues that
limited mHealth uptake.
The European Commission
said: The large number of
lifestyle and wellbeing apps
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available, combined with no

clear evidence on their quality
and reliability, is raising concerns
about the ability of consumers
to assess their usefulness.
This could limit the effective
uptake of mHealth apps to the
benet of public health.
The 20 members of its mHealth
working groups represent civil
society, research and industry
organisations and include the
European Society of Cardiology,
Kings College London, and
Hannover Medical School.
Also taking part are MSD
(Europe), French assessment
body Medappcare, UK-based
NGO the Digital Health and
Care Alliance and PatientView.
Last year two stakeholder
meetings found an appetite
to work towards common
assessment methodologies for
mHealth, to aid with areas such as
linking apps to electronic health
records and for their effective
uptake in clinical practice.
Health professionals need
the reassurance about the
reliability of the apps, in order
to be able to recommend apps
Its been a long road to get

to this stage - the Commission
rst outlined its plans for more
health systems to use digital
technology back in 2012,
following this up with the 2014
Green Paper. Nevertheless, it
says the working group will have
its rst meeting in March and
guidelines will be forthcoming
before the end of the year.
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to their patients and take apps'

data into consideration in a
treatment/monitoring process,
the Commission said.
The new working group is
expected to build on existing
initiatives and best practices
in Europe to provide common
quality criteria and assessment
methodologies for a variety
of different stakeholders.
Growing threat of medical device hacking

FDA issues new cybersecurity guidance to help minimise risks
The FDA has told medical device
rms to take a proactive approach
to planning for, and assessing,
the cybersecurity of products
once they reach the market.
The US regulator says the threat
of medical devices being hacked
is a growing concern and has
issued new draft guidance on
the steps rms should take.
As more and more devices
that can connect to each other
and other computer systems
reach the market the FDA
wants rms to continually
evaluate their potential risks.
The exploitation of
cybersecurity vulnerabilities
presents a potential risk to the
safety and effectiveness of medical
devices, the FDA noted.
Suzanne Schwartz serves as
acting director of emergency
preparedness/operations and
medical countermeasures in
the FDA's Center for Devices
and Radiological Health.
She said: All medical devices
42
www.pmlive.com
that use software and are connected

to hospital and health care
organisations' networks have
vulnerabilities - some we can
proactively protect against, while
others require vigilant monitoring
and timely remediation.
[The] draft guidance will
build on the FDA's existing
efforts to safeguard patients from
cyber threats by recommending
medical device manufacturers
continue to monitor and address
cybersecurity issues while their

product is on the market.
The new guidance builds on the
FDA's 2014 recommendations for
medical device rms to address
cybersecurity risks in the context
of pre-market submissions.
Under the new draft guidance,
manufacturers should put
in place a structured and
systematically comprehensive
cybersecurity risk management
programme and ensure they
respond in a timely manner to any

vulnerabilities that are identied.
The FDA also said it was
essential that companies consider
improvements during the
maintenance of their devices, as the
evolving nature of cyber threats
means risks may arise throughout
a device's entire lifecycle.
The regulator said it would
not need advance notication of
actions by manufacturers to address
any vulnerabilities, unless the
threat could compromise a device's
essential clinical performance
and present a reasonable
probability of serious adverse
health consequences or death.
The FDA is encouraging medical
device manufacturers to take a
proactive approach to cybersecurity
management of their medical
devices, Schwartz said. Only
when we work collaboratively and
openly in a trusted environment,
will we be able to best protect
patient safety and stay ahead
of cybersecurity threats.
Digital intelligence
NHS tests 'connected' patient projects

One pilot will see Google's Verily unit work with MSD on a telehealth initiative
Just 6% of pharmaceutical
companies currently employs a
chief digital ofcer, according
to a new report. The 2015
Chief Digital Ofcer Study
did nd that the numbers
in this executive position
were growing and - perhaps
unsurprisingly - larger
companies tended to be ahead
of the curse with this trend.
BM, Philips, Hewlett Packard

and Google's Verily unit are
set to work with the NHS on
a range of projects looking at
how technology can help patients
stay well and out of hospital.
The drive - announced by NHS
England chief executive Simon
Stevens at the World Economic
Forum in Davos on Friday - aims
to address 'some of the most
complex issues facing patients
and the health service'.
The projects will test the use
of wearable devices, remote
monitoring and new ways
of analysing data in order to
help patients and their doctors
monitor their health from home.
If successful, the pilot projects known as 'test beds' - will be rolled
out to other areas of the NHS.
"Over the next decade major
health gains won't just come from
a few 'miracle cures'," said Stevens
in Davos. Progress will come from
"combining diverse breakthroughs
in elds such as biosensors,
medtech and drug discovery, mobile
communications and articial
intelligence (AI) computing".
The test beds tie in with a drive
in healthcare towards the 'selfcare era', with connected devices
and 'big data' crunching used
to take pressure off increasingly
stretched healthcare services.
Examples of the projects in
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the pipeline include a Verily and

MSD-backed initiative in Rochdale
that will use predictive analyses
to identify patients at risk of
serious condition such as heart
failure and chronic obstructive
pulmonary disorder (COPD),
using telehealth technologies.
Philips and other companies
will work with local healthcare
services on measures that can keep
frail elderly people in Lancashire
and Cumbria living independently
by identifying those who need
additional support, while a North
London project will make use
of online tools and social media
to promote healthy ageing.
In Shefeld, IBM is one of a
number of partner companies
working to set up an 'intelligence
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centre' tasked with helping patients

with long-term conditions such as
diabetes, mental health problems,
respiratory disease and high blood
pressure to live independently.
Another scheme in Birmingham,
which will allow people at risk of
serious mental illness to make
use of technology and apps to
manage their condition, is linked to
a hub which can despatch the right
specialist staff if a crisis looks likely.
Finally - in two Internet of
Things-focused projects - HP
is contributing to a remote
monitoring and care system for
diabetics in the west of England,
while a Surrey initiaitve aims to
improve dementia care through
the use of sensors, wearables,
monitors and other devices.
Merck expands its digital health accelerator
co-working tech hub the Nairobi

Garage, and coaches and mentors
from Merck's global network.
Merck has also opened the
second round of its three-month
accelerator programme. Graduates
from its 2015 scheme included
digital pharmacy app Apoly, which
provides pharmaceutical advice
and a medication delivery service.
The programme's next
round comes with equity-free
funding of 25,000, regular
coaching and ofce space at
the Merck Innovation Center at
its Darmstadt headquarters.
The company said the
programmes would be strongly
connected in terms of expertise
and knowledge exchange to grow
a global accelerator network.
The EMA will launch its new

clinical trials portal and
database in October 2017
as part of its commitments
under the 2014 European
Clinical Trial Regulation. The
service will allow for the
submission, authorisation and
supervision of trials in the EU
and serve as an information
source for the public.
Celgene has launched a

new disease awareness
initiative to raise awareness
of psoriatic arthritis (PsA).
The centrepiece of the Be
Counted! campaign is a
series of videos that combine
with a map that tallies their
views, something the rm
says will show how disease
awareness is increasing
across the country.
Sano's specialty care business

Genzyme has been rebranded
as Sano Genzyme, and the
unit took the opportunity to
join Facebook. Its presence
on the social network adds
to the rms use of YouTube,
LinkedIn and Twitter
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Merck has updated its periodic

table of elements mobile app.
The previous version of its free
PTE app racked up more than
one million downloads and the
new version, again aimed at
a audience that encompasses
school students or professors,
lay people or professional
technicians, looks to provide a
greater depth of information
and improved usability.
for three startups to support with

equity-free funding of $15,000.
Merck Innovation Center head
Michael Gamber said: Africa
is one of the most promising
and dynamic markets for digital
health, driven by a vibrant and
innovative startup culture. With
our accelerator programme,
we aim to become part of it.
With our programme in Nairobi
and our growing international
network, we made a rst big step to
go truly global with our accelerator.
We want to create a platform
where the potential to execute
ideas is not limited by location.
In addition to funding, those
selected to take part in the
programme will also be able to
make use of working space at
res
Will run new startup support programme in Nairobi

Merck has expanded its
digital health accelerator
programme, opening it up in
the rst country outside its
home territory of Germany.
The company picked Kenya for
the new programme, which will
run for three months and look
In brief
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43
Healthcare
PM
One could argue that the vast

majority of what has been said and
written describes the millennials people reaching adulthood around
the turn of the 21st century - from
western hemisphere countries in
developed economies. The general
consensus is that millennials exhibit
the following characteristics:
t engage in multiple careers
over their lifetime
t highly entrepreneurial
t team-oriented and collaborative
t compassionate and
socially conscious
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t seek great work-life balance

t have a sense of entitlement
t digitally native.
But what about millennial doctors?
What characterises them? Are
they like other millennials? What
is their attitude toward their
profession? And what are the
similarities and differences in the
rising generation of physicians
across different countries?
To this end, we conducted a global
study in eight key healthcare markets
of doctors who are already practicing
and are 35 years and under. The
study included an extensive analysis
of over 100 sources, one-on-one
interviews and a quantitative
study of 200 doctors across both
developed and developing countries.
Before we delve into the trends
we observed, there is context that
needs to be set. Every generational
group is shaped and dened by
the timeframe during which they
were born and by their shared
experiences. For millennials,
there are shared experiences
that drive global commonalities 9/11, the 2008 economic crisis,
smartphones, Facebook and
Google, for example. In the case of
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ver since the term millennial

was coined by historians Neil
Howe and William Strauss
almost 30 years ago, a veritable
torrent of things have been said
and written about the generation
that is powering our workforce
- and our culture - today. Some
of it is inspiring, a lot of it is
disparaging and oversimplied.
Peel away both the hype and
the hysteria, however, and you
discover a set of characteristics
that distinguishes this generation
from those that came before.
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millennial doctors specically, ve
key inuences come into play:
t their broader generational trends
t the norms of where they trained
t the inuence of older
teachers and mentors
t the rapidly evolving
technology, and
t the healthcare system of the
country in which they live.
Importantly, however, there are
marked differences arising from
local experiences. Country-specic
approaches to the ve inuences
noted above, local culture and
customs and level of economic
development all lead to millennial
nuances at the country level.
With this context, here are
the very high-level trends and
implications from the study.
The research showed that millennial

doctors are more doctor than
millennial - they are more
dened by the qualities and
characteristics of their profession
than those of their generation.
Like doctors before them (and
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environments with other doctors.

They use digital technology
intuitively. The vast majority goes
online for medical education: 73%
to keep up to date with medical
literature, 71% to seek information
about treatments and 61% for
continued education. Social media
apps are used by 70% in their
practice and professionally. They
also use social media platforms
such as Google+, WhatsApp and
Facebook to stay connected with
colleagues (61%) and seek advice
from other doctors (40%).
Yet they are hungry for more.
63% say technology is not currently
being utilised to its fullest potential
for patient treatment and care,
and want to more fully integrate
it at their place of work.
Perhaps not surprising, but certainly

not encouraging to hear, was the
widely shared lukewarm perspective
on pharma. More than half of study
participants believe that pharma has
an important role to play, and well
over a third think pharma should
be providing more services and
education to patients. This signals a
desire for positive engagement and
an openness to what pharma can
deliver in support of their practice
and their patients better health.
This is a generation that came of
age with the advent of organic, fair
trade, ethically sourced products and
greater desire for transparency from
the corporate world. It is only natural
they expect the same from pharma.
There is also an opportunity to
improve HCP-facing promotional
materials. Millennial doctors around
the world are simply not sold on the
materials they are currently exposed
to - the question remains whether
this is due to how materials are
developed and executed, or whether
it is more a result of general distrust.
Al
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There were three notable

differences between physicians
in developing versus developed
countries:
1) developing country doctors are
more entrepreneurial;
2) they make greater use of
technology (for example, text
messaging with patients or using
more quantifying devices); and
3) they are more altruistic, being
more likely to perform pro bono work.
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unlike their millennial cohort),

millennial doctors are highly
committed to their profession, and
do not wish to jump from one career
to another. The majority (76%)
intend to treat patients, while the
rest want to teach (40%) or do
research (30%). Millennial doctors
are highly focused on patient care.
The most exciting thing for them
is the possibility of giving patients
better outcomes, specically to
improve a patients quality of
life. Interestingly, in developed
countries, the focus is more on the
quality of patients lives, whereas
in developing countries, it is both
on the quality of patients lives
and giving patients a longer life.
Contrary to what one might believe
based on broad assumptions about
this generation, millennial doctors
as a whole are not keen to engage
in entrepreneurial endeavours.
And while as a generation they
may be hooked on their smartphones,
constantly communicating with
friends and family, millennial
doctors are mixed on their use
of technology when it comes to
communicating with patients.
Despite all this, millennial
doctors share a number of
characteristics with the broader
millennial population.
They are very team-oriented and
collaborative, preferring to work in
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While these trends might be

interesting in themselves, it is
essential to understand the rapidly
evolving healthcare world these
doctors are entering, because it
will continue to shape them and
should inform how we serve them.
The world that millennial doctors
are entering is younger overall than it
was a generation ago. Almost 50% of
the worlds population today is under
25 years old, which means that
family planning, womens health and

pediatrics will be growing elements
of the worlds healthcare needs.
At the same time, the world is
older and sicker. Declining fertility,
and improved health and longevity,
have swelled the older population
dramatically. This means a rise in
chronic diseases, dementia and
other age-related disorders.
Another factor that will shape
the way physicians engage is the
high demand and low supply of
doctors. There is estimated to be
a shortage of 4.3 million qualied
physicians worldwide, with the
greatest decits being seen in the
developing world and rural areas.
This will exert tremendous
pressure on the time a doctor will
spend in under-served areas, and we
will continue to see the rise of other
healthcare workers lling the gap by
taking on responsibilities previously
held only by doctors. Additionally,
a vast majority of the routine work
currently undertaken in hospitals will
shift to primary care ofces, retail
outlets or even the patients home.
Finally, the impact of technology
will continue to be tremendous.
It is transforming every aspect of
medicine at an unprecedented rate.
From high-tech imaging to innovative
devices, from robot-assisted surgery
to remote patient monitoring, from
e-records to tele-health, no area of
healthcare is being left untouched.
Mariana Sanchez de Ovando is SVP,

global executive director of Indigenus and
Stephanie Berman is a partner at The Bloc,
a founder member of the Indigenous health
and wellness communications network
www.pmlive.com
45
Creativity
Why dont big

pharma brands
win creative
awards?
0.
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p2
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PM
.
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igh
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Theres a striking lack of correlation

between commercial and creative success
here are more creative

award shows than ever
before. Creative standards
in pharma advertising have, by
general consent, never been
higher. But the awards are not
going to the brands that attract
the big advertising budgets.
Compare the worlds top 100
pharma brands with the top
100 winners in the past years
pharmaceutical/healthcare
creative award shows.
Only 2% of the top
creative awards went to the
worlds leading brands.
The lack of correlation between
commercial and creative success
is striking. Isnt advertising
supposed to create and sustain
successful brands? Shouldnt the
biggest brands have the benet
of the most creative campaigns?
We asked some senior people in
46
www.pmlive.com
pharma companies and agencies

for their opinions about this
paradox. To encourage candour,
we assured them of anonymity.
Below are some of their responses.
Big brands dont need

creativity to succeed
My brand is not built on
advertising but on clinical
evidence and sales effort.
Marketing Manager
There is ample evidence from

consumer advertising that
creatively-awarded brands
perform better than brands that
dont win awards. The most
effective campaigns have little
rational content but are based on
powerful, emotion-based brand
reminders. These lessons have
not ltered through to pharma.
In our world people seem
Source: Drugs.com
Source: Global Awards, Clio Healthcare,

Lions Health, IPA/Best of Health, Rx Club,
Creative Floor, PM Society Awards
Rewarding brands
unconvinced about the
link between creativity and
effectiveness. They point out that
many big brands do very well
despite uninspired campaigns.
That may be true. But what
could we achieve if we married
the best clinical performance
with the best creative ideas?
Global branding is the

enemy of creativity
Does it matter?
Charity / Fundraising
Corporate
Disease Awareness,
Health Education,
Social Issues
Brand Advertising
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Id love to do a more
creative campaign but my
hands are tied by Global.
UK National Manager, top

ve pharma company
Global branding produces

vanilla concepts to suit all
markets, reduced to the lowest
common denominator to
cause the least offence.
Agency CEO
There is a widespread belief that the

rules which govern other business
sectors do not apply to pharma.
This notion is not borne out by
facts. Healthcare decision makers,
like the rest of us, are subject to the
laws and aws of human behaviour.
Their decisions are inuenced by
non-rational factors and biases,
which advertisers can leverage if
they are given the opportunity.
Big pharma decisionmaking discourages

creativity
The approval process makes

it harder than ever to get
good work through.
Creative Director
Creativity works
best for challenger
brands, not leaders
A good campaign can build the
prole of a new brand, but once
it is established the job is done.
People are frightened of making

a claim that attracts a complaint
or a decision that their managers
frown upon. Hence you get
decision by committee.
Sales & Marketing Director
Agency Planning Director
Great campaigns have given

many new brands a leg-up to
fame and fortune. Creativity
is also required to maintain
successful brands. When Apple
became the worlds most
successful company, it didnt stop
advertising; it spent even more.
Many agencies believe that
smaller companies and brands
give them more creative freedom.
In fact some agencies target
non-mainstream companies
with the express intention
of garnering awards.
Creativity means taking risks,

and Big Pharma is risk averse.
Creativity is difcult to dene
and quantify, and marketers are
nervous about anything they
cant see, touch and measure.
Market research doesnt
help because it applies in
vitro methodology to in vivo
behaviour. Concept testing
may highlight communication
problems but it wont identify
the most creative idea.
Pharma is different from

consumer advertising
We have to sh where the sh

are. Most awards today are
won by issue-driven entries,
not brand campaigns.
What works for soap

powder doesnt work for a
monoclonal antibody. Doctors
make decisions based on
facts, not gimmicks.
International Brand Manager
Awards are going to

causes, not campaigns
Executive Creative Director

Agencies have always done pro
bono work, partly to exercise
their creative chops and partly

because they want to do some
good as well as shift goods.
As the gure above shows, the
majority of awards are going to
entries that fall under the categories
of disease awareness, health
education or social issues. So have
ad agencies grown a conscience? Or
is altruism the new self-interest?
Whatever the motivation, it raises
the question: how can agencies run
a business if they are doing their
best work for next to nothing?
An agency spokesperson
explained: Our agency has two
types of accounts. With type
A accounts, the clients trust us
and give us creative freedom.
With type B accounts we do
exactly what the client says and
send them the invoice. Type
A accounts win awards, type
B accounts pay the bills.
How do we x
the problem?
Pharma marketers could learn
from other business sectors about
how to get maximum value
from advertising. They need to
revise their attitude to risk, from
avoiding failure to pursuing
success. They should treat agencies
as business partners, which
means learning to trust them.
Agencies need to earn that
trust by demonstrating a better
understanding of client strategy. We
need to demonstrate the benets
of creativity in terms that clients
will accept. We have to shift our
focus to long-term brand growth.
Above all, we need to dispel the
impression that we are gonghunters in pursuit of awards.
Bridging the trust gap is vital
to restore a healthy relationship.
Whos ready for the challenge?
.
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Global branding started out by

focusing on brand identity, to
ensure that the look and feel of
the brand was the same in all
markets. But the principle has
spread to brand campaigns.
The goal of global branding
is consistency and uniformity,
while the aim of creativity is to
be different and stand out. The
best of both worlds, surely, is to
combine globalised branding
with localised campaigns. But
how often is this implemented?
Source: Global Awards, Clio Healthcare, Lions Health, IPA/Best of Health, Rx Club, Creative Floor, PM Awards
The gulf between brand advertising

and creative awards is symptomatic
of a growing distance between
agencies and their clients.
Our agency is part of the
second most creatively awarded
network in the world, so we fully
support the role of awards. But
we are witnessing a disconnect
between our core competency
(creativity) and our core clients
(big pharma companies).
A weaker relationship between
pharma companies and agencies
means that accounts come up
for pitch more frequently and
fewer agencies are on longterm contracts or retainers.
Both parties are losing out from
this lack of collaboration. Big
brands are not utilising the power
of emotional engagement. Agencies
are not offering their creative
skills to their bill-paying clients.
Creative awards are

irrelevant to realworld marketing
Ad agencies live in a make believe

world. I work in the real world.
Global Brand Manager
There are two types of

creativity: the type that generates
sales and the type that wins
awards. I prefer the rst.
Marketing Manager
Many pharma companies maintain

an arms-length relationship
with agencies. Some deter their
employees from attending
award ceremonies, which
devalues their view of awards.
Some agencies have made
the decision to sidestep awards
judged by customers in favour of
those judged by their peers. This
reinforces the perception that
agencies are more interested in selfpromotion than supporting brands.
Reg Manser is chief creative officer,

Life Healthcare Communications
www.pmlive.com
47
Appointments
Sponsored by
Celgene
PM
MARK ALLES
Gr
Celgene has promoted Mark Alles

(pictured) to chief executive ofcer,
effective 1 March, as part of a
senior leadership team reshufe.
He moves from his current role
as president and chief operating
ofcer and has been with
Celgene since 2004, overseeing
the integration of its corporate
ou
p2
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operational functions in support of

its global commercial franchises.
Meanwhile, current chairman and
CEO Bob Hugin will take on the
role of executive chairman, from
1 March, and continue to lead the
companys board of directors and
manage its strategic direction.
Jacqualyn Fouse has also
UCB
(MBYP4NJUI,MJOF
been promoted and will take on

the roles of president and chief
operating ofcer in March.
Meanwhile, Scott Smith,
currently president of
Celgenes I&I franchise, has
been appointed chair of the
companys global management
committee, effective 1 March.
.FSDL,(B"
01
0.
Merck KGaA has appointed Udit
Batra (pictured left) and Walter
Galinat to its executive board.
Galinat joined Merck in 1976 and
became CEO and president of the
Performance Materials business in
2010. Meanwhile, Batra started his
career with Mercks US namesake,
before joining Novartis and then
joining Merck in 2011. In March
2014 he was appointed CEO
and president of its life science
business Merck Millipore.
res
MATTHEW PFEFFER
ROHAN PALEKAR
US-based biotechnology rm
Noxilizer has appointed David
Theil as its chief nancial
ofcer. He has over 25 years
of life sciences experience in
nancial, administrative and
operational management. He
has held senior management
positions at IGEN International,
Speciality Pharmaceuticals
and Supernus Pharmaceuticals
and worked with healthcare
clients at Deloitte & Touche.
California-based MannKind
has appointed Matthew Pfeffer
as its chief executive ofcer
to replace Alfred Mann, who
had held the role ad interim
since November. Pfeffer will
continue to serve as Mannkinds
chief nancial ofcer and has
also been nominated to the
board of directors, lling an
existing vacancy. Prior to joining
Mannkind in 2008, Pfeffer
served as CFO for VaxGen.
US-based biopharma rm Avanir

Pharmaceuticals has appointed
Rohan Palekar as president
and CEO. He joined Avanir as
senior vice president and chief
commercial ofcer in March
2012 and was promoted to
executive vice president and chief
operating ofcer three years later.
He previously worked as chief
commercial ofcer for Medivation
and in senior management roles at
Johnson & Johnson and Centocor.
www.pmlive.com
DR STUART COLLINSON
Silence Therapeutics has

appointed Dr Stuart Collinson
as its new non-executive director
and chair of its remuneration
committee. The move follows
Simon Sturges resignation as
non-executive director to focus on
other commitments. Dr Collinson
has held senior management roles
at the likes of GlaxoWellcome,
Baxter International and
Cabrellis Pharmaceuticals,
now part of Celgene.
DAVID THEIL
4JMFODF5IFSBQFVUJDT
ed
"WBOJS1IBSNBDFVUJDBMT
erv
.BOOLJOE
UCB has appointed Pascale

Richetta to lead its new bone
patient value unit. In her new role
Richetta will also serve at UCB
as an executive vice president
and member of the Belgiumbased companys executive
committee. Richetta most recently
served as vice president for
Western Europe and Canada for
AbbVie. Prior to this, Richetta
held managerial positions at
Abbott, GSK, Ipsen and Servier.
ts
GlaxoSmithKline has appointed

Birgitte Volck has its new head of
rare diseases R&D. She will join
GSK after working her six months
notice at Swedish Ophan Biovitrum
(Sobi), which she joined four
years ago and where she served as
its chief medical ofcer. Prior to
joining Stockholm-based Sobi Volck
spent ve years at Amgen, where
she served as executive development
director, bone, neuroscience and
inammation, international R&D.
UDIT BATRA, WALTER GALINAT
igh
MSD Germany has appointed Dr

Susanne Fiedler as its new CEO,
ofcially replacing Hanspeter
Quodt on 1 February. Dr
Fiedler rst joined the German
operations of Merck & Co in
1997 and took on various roles
in the marketing division before
becoming global brand leader
for diabetes treatments Januvia
and Janumet in the US and
then managing director of MSD
Australia and New Zealand.
PASCALE RICHETTA
lr
BIRGITTE VOLCK
/PYJMJ[FS
48
Al
DR SUSANNE FIEDLER
Appointments
Sponsored by
.FSDL
"LJOJPO
"NZMZY1IBSNBDFVUJDBMT
CELEBRATING THE
PEOPLE BEHIND OUR
AWARDWINNING
PROGRAMMES
DR RICHARD JONES
DR WALTER GILBERT
Merck has appointed Dr Jessie

English as its new VP of discovery,
transnational innovation platform
immuno-oncology. From 16
February she will lead the discovery
teams efforts in exploring disease
targets and translating them into
patient care. Dr English joins
Merck from the Belfer Institute
for Applied Cancer Sciences at
Havard Medical Schools DanaFarber Cancer Institute where
she had been head of research.
Privately-held Swedish biotech

rm Akinion has appointed Dr
Richard Jones as its new CEO. He
will oversee the companys focus
on acute myeloid leukaemia and
its lead candidate drug AKN-028,
a small molecue kinase inhibitor
currently in a phase I/II clinical
trial. Dr Jones joins Akinion
from Novartis where he served
as vice president, medicines
commercialisation leader,
haematology, global oncology.
Amylyx Pharmaceuticals has

elected Dr Walter Gilbert to its
board of directors. The US-based
pharmaceutical rm specialises
in developing disease-modifying
treatments for neurodegenerative
diseases. Dr Gilbert founded
Biogen, serving as its CEO and
chairman between 1981 and 1985,
and Myriad Genetics where he
continues to serve as vice chairman
of the board. He received the
Nobel Prize in Chemistry in 1980.
PM
DR JESSIE ENGLISH
Gr
ou
p2
/VSJUBT
(BMCSBJUI8JHIU
Ify Onyeaso
Ifys scientic and strategic
insights have supported
industry-leading programmes
during her 6 years at Lucid. Ify
has won the PMEA Excellence
in Customer Focus and
Communiqu Excellence
in Professional Education
Programmes, as well as
being highly commended
for Communiqu Excellence
in Communications via
Meetings. This adds to Ifys
other awards, taking her total to
six in six years at Lucid.
(BMCSBJUI8JHIU
01
0.
Al
Boyds has appointed Dr Nick

Meyers as programme director
and Nastasha Nesterova-Smith as
an associate director in regulatory
affairs. Dr Meyers previously held
senior management positions
with Daiichi Sankyo and PPD
and has over 20 years of industry
experience. Meanwhile, NesterovaSmith brings experience as a
regulatory professional at Amgen,
Genzyme, Parexel and Wyeth.
DR ROBERT REEKIE
ClinTec International has

appointed Dr Robert Reekie as its
chief operating ofcer and senior
vice president. Dr Reekie brings
30 years of drug development
and commercialisation expertise,
recently serving as COO at
inVentiv Health Clinicals
phase II-IV division. He will be
responsible for supporting the
senior team, operational delivery
and the development of two
new provider partnerships with
Meg Davies, Principal Medical

Writer, joined Lucid in 2013.
Megs scientic expertise and
faultless delivery have been a
winning combination for her
clients which saw PEER (Psoriasis
Expert Exchange FoRum) win
the Excellence in Physicians/
Healthcare Provider Support
Programmes at the PMEA
awards last year. PEER focused
on changing clinical behaviour
on a global scale to improve
standards of care in the
management of psoriasis.
Natasha Giordano has joined PLx

Pharma as its new president and
chief executive ofcer. Giordano
has also been appointed to the
US specialty pharma companys
board of directors, of which her
predecessor Ronald Zimmerman
will remain a member. Prior to
Giordanos time at Clear Point
Learning, she served as president
and CEO of both Healthcare
Corporation of America and
Xanodyne Pharmaceuticals.
DR NICK MEYERS,
NASTASHA NESTEROVA-SMITH
$MJO5FD*OUFSOBUJPOBM
Meg Davies
ed
NATASHA GIORDANO
#PZET
erv
1-Y1IBSNB
Steve Mazzarese has joined

GalbraithWight as a global
business development director,
in a role that will see him based
in New Jersey in the US. He
previously served with Wolters
Kluwer, Cegedigm and IMS,
and in his new role at the UKbased market access consultancy
Mazzarese will be responsible
for GalbraithWights new launch
excellence planning web-based
application Apollo LX.
res
GalbraithWight has appointed

Eithne McShane (pictured) as
global business development
director to develop its business
with global and regional clients
in Europe. She brings experience
to the role from Bayer, Novartis
Oncology and Therabel Europe.
Also joining GalbraithWight are
senior consultant and account
manager Ilsu Labat-Camy, senior
consultant Lup Yee Yau and senior
consultant Andrea Schatke.
ts
Nuritas has appointed Dr

George Gunn as chairman of
its board of directors. He joins
the Dublin-based biotech startup from Novartis where he
was head of its animal health
division. Prior to this, he also
served as division head for
consumer health and head of
corporate social responsibility
at Novartis, as well as occupying
senior roles at Johnson &
Johnson and Pharmacia.
STEVE MAZZARESE
igh
EITHNE MCSHANE
lr
DR GEORGE GUNN
www.pmlive.com
www.pmlive.com
49
Appointments
8FCFS4IBOEXJDL
PETER GAY
BARBARA BOX
PM
Weber Shandwick has appointed new

leaders for its global and North American
divisions as well as to its Chicago,
Minneapolis and New York healthcare
practices.
Peter Matheson Gay becomes the
communications rms global executive
creative director for healthcare with a remit
to drive creative solutions for clients across
Weber Shandwicks network and boost new
global business. He joined the company
in 2011 as executive vice president, North
JAMIE DOWD
CORI ASHFORD
Gr
ou
American creative director for healthcare and

previously held roles at Cohn & Wolfe, Hill &
Knowlton and PraxisPR.
Meanwhile Barbara Box, who joined
Weber Shandwick in 2004 from Golin, has
been appointed as executive vice president,
North American healthcare strategy lead. She
will work with Weber Shandwicks INCITE
teams to promote the creative strategy process
to new and existing clients. Box previously
served as head of the companys New York and
Chicago healthcare teams, a role that has now
/PWBSUJT
p2
(JMFBE4DJFODFT
been divided into two distinct practices.

Jamie Dowd and Cori McKeever Ashford
have been appointed as the new executive vice
presidents and practice leads for the New York
healthcare practice and Chicago healthcare
practice respectively. Kristen Thistle has also
been promoted to executive vice president and
is now head of the Minneapolis healthcare
practice. Dowd will continue in her role
as a global client relationship leader and
all three will be tasked with overseeing the
development and output of each practice.
.FSDL
3PDIF
01
0.
SILVIA AYYOUBI, CRISTINA WILBUR
Germanys Merck has made two

new appointments to its senior
leadership team, promoting Gary
Zieziula (pictured) and Marc
Horn. Zieziula has been appointed
president and managing director
for Mercks North American
biopharma, which operate as
EMD Serono, replacing Paris
Panayiotopoulos, and Horn will
take on the role of managing
director for Mercks biopharma
business in China from 1 April.
Silvia Ayyoubi (pictured) is to

step down as head of group
human resources at Roche in
March. She joined Roche in 1987
and served as head of group
human resources and a member of
its corporate executive committee
from 2008. Ayyoubi will be
succeeded by Cristina Wilbur,
who is currently head of human
resources for Roches
diagnostics division,
based in Basel.
ts
res
DAVID KENDALL
GRAHAM BELGRAVE
SUZANNA GAMWELL, WILL MOORE
Alimentary Health has appointed

David Kendall to the newlycreated position of UK business
development director. Kendall will
be responsible for implementing
the Irish healthcare companys
development plans following
its UK launch. He brings to the
role over 25 years of commercial
experience, having held positions
at Chefaro Pharmaceuticals,
GlaxoSmithKline, Quest Vitamins
and Stiefel Laboratories.
Cmed Clinical Services has

appointed Graham Belgrave as
its chief operations ofcer. He
joins the UK-based rm from
Grunenthal GmbH where he was
senior vice president and global
head of clinical development,
science and operations. During
his 30 year pharma career,
Belgrave has held positions at
GSK, Pzer and Vernalis as well
as working in consultancy and
interim management positions.
UK online research consultancy

Creation Healthcare has appointed
Suzanna Gamwell as client
advocate and Will Moore as chief
evangelist. In her newly-created
role, Gamwell will function as
a healthcare and pharma client
ambassador to coordinate and
drive campaign expectations and
outcomes. Meanwhile, Moore has
a remit to create new business
opportunities and position the
company for future growth.
3FE%PPS6OMJNJUFE
ANDREW LAMB
Andrew Lamb has been appointed

head of digital strategy at
Red Door Unlimited, part of
the Health Unlimited group.
He moves to the healthcare
communications agency from
Remedy Digital where he was
digital strategy director, and
prior to that served at Ketchums
Inspired Science as a senior
digital healthcare strategist and
Ogilvy Healthworld as a digital
manager in medical education.
$NFE$MJOJDBM4FSWJDFT
ed
"MJNFOUBSZ)FBMUI
www.pmlive.com
$SFBUJPO)FBMUIDBSF
erv
Novartis has handed new roles

to Michael Ball, Vas Narasimhan
and Andr Wyss (pictured).
Ball becomes the new division
head and chief executive ofcer
of Alcon, replacing Jeff George,
and joins from Hospira. Vas
Narasimhan takes on the newlycreated role of global head of
drug development and chief
medical ofcer, and Andr Wyss
becomes president of operations.
GARY ZIEZIULA, MARC HORN
igh
50
MICHAEL BALL, VAS NARASIMHAN

AND ANDR WYSS
lr
Gilead Sciences John Martin

(pictured) has stepped down
as chief executive ofcer, a role
he had held since 1996, and
moved to a new role as executive
chairman. His replacement
as CEO, from 10 March, will
be John Milligan who joined
Gilead in 1990 as a research
scientist and has since held
several senior management
positions at the company
including chief nancial ofcer.
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JOHN MARTIN, JOHN MILLIGAN
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The NME class of 2015

New EU trial summaries

No Romeo and Juliet

Here at PCM Healthcare,

NO WONDER WE ARE WORKING ON SOME OF THE LARGEST PROGRAMMES IN EUROPE

Now with added reach!

L MAR KET EUR

The forces shaping

EDITORIAL ADVISORY BOARD

The NME class of 2015

New EU trial summaries

Transformation is, once again, in

The theme of change continues with our

Views expressed by the contributors

We hear from Takedas president for

form of oncology and gastroenterology,

The magazine is also available at the

Dominic Tyer, editorial director

Pharmaceutical Market Europe February 2016

See the results and photos from the night at

26. New regulation will

32. Six inexorable

WHO DONT NEED

36. Looking at health

15. Johnson & Johnsons

44. How do milennial

THE ITALIAN JOB

16. New model will drive

THE NEW EU CLINICAL

12-13. Novos Tresiba

10. French investigation

8-9. First Enbrel biosimilar

17. Efcacy rebates

46. Why dont big pharma

18. Rare diseases therapies

48. Changes at Celgene,

Pharmaceutical Market Europe February 2016

Novartis shakes up underperforming Alcon unit

ovartis has started a

includes the appointment of new

for the company on sales of new

Sano embarks on Zika vaccine hunt

Begins research programme as WHO declares the virus a global emergency

Novartis chief executive Joe

The agency debated the latest

While it has not been proven

Pharmaceutical Market Europe February 2016

Nestl continues its drive into pharma

Food giant to investigate potential inammatory bowel disease treatments

ood giant Nestl has

that live within humans.

of-concept study in 30 patients

Empliciti set for EU approval in multiple myeloma

Roche reported worse-thanexpected annual prots,

AbbVie has started enrolling

AbbVie and Roches

CHMP backs BMS and AbbVies therapy after an accelerated assessment

Robert Califf has passed

Pharmaceutical Market Europe February 2016

market leader Revlimid which

Bristol-Myers Squibb and AbbVies

NME approvals and the

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