PME

November 2019 • www.pmlive.com

PHARMACEUTICAL MARKET EUROPE

Combining hard
technology with
human skills

Interview with GSK’s

Steve Yancey p18

Innovation in the Asia

Pacific region p26

Drug prices and competition Clinical trials Digital health trends AI and healthcare
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 COMMENT

THE TEAM
Editorial:
Group Managing editor Iona Everson
Reporter Lucy Parsons

Studio:
Executive director Karl Equi
Middleweight graphic designer Helen Penfold

Sales:
Business director Tara Lovegrove

Production:
Production director Keith Shilson
Production manager Samuel Hamilton

EDITORIAL ADVISORY BOARD

Philip Atkinson
Founder of Hive-Logic, Lifescience Transformation
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
Paul Pay
Chief business development officer, Norgine
Mark Rothera
Chief executive officer, Orchard Therapeutics
Ian Talmage
Senior vice president, global marketing,
general medicine, Bayer Pharmaceuticals

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Patience and persistence
Welcome to the November issue of PME.
In our cover article, Chris Ross explores
why pharma’s multichannel maturity
isn’t just about hard technology. Looking
at the Across Health Multichannel
Maturometer 2019 study, the results
reveal that 87% of respondents think
their companies are still some distance
from being ideal organisations in
terms of their ability to use digital to
improve customer engagement and
business impact. The key to success
depends on ‘human’ enablers such
as skills and organisational culture to
capture customers’ hearts and minds.
In this issue we also have an in-depth
interview with Steve Yancey, vice
president and medicines development
leader at GSK. While patience and
persistence are the prime disciplines
of drug development, knowing when
to keep the fuse burning or simply
walk away takes a confounding
blend of science and emotion. Steve
talks about how challenging drug
development is and finding ways to
overcome the bumps in the road by
improving the probability of success.
While politicians continue to disagree in
parliament and the country tries to make
some sense of what is happening with
Brexit, new analysis by the Royal Society
shows that uncertainty around Brexit has
already significantly affected scientific
research and its workforce in the UK.
As the first December general election in
almost a century looms, all eyes are on each
party’s election manifesto, and it will be a
tough fight to the finish to see who has the
best plan for the UK in 2020 and beyond.
Iona Everson
Group Managing Editor

Pharmaceutical Market Europe November 2019 www.pmlive.com 3

 2 0 1 9
Recognising excellence in improving patient outcomes

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Wednesday 27 November 2019, Royal Lancaster London

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Mark proudly describes his journey and that, whatever the setbacks, the
human spirit is an unbreakable thing.

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UPTAKE
STRATEGIES
P L A N N I N G C A P A B I L I T Y L A U N C H

NOVEMBER 2019
NEWS
6-8. Agreement reached for
Orkambi; Biogen and Eisai
in shock turnaround
10. UK AI partnership seeks
to support people living
with chronic conditions:
QiC Diabetes Awards 2019
BREXIT NEWS
11. Another day,
another Brexit delay
12-13. Uncertainty surrounding
Brexit is harming UK science;
Brexit delay makes freight
contracts uncertain
DARWIN’S MEDICINE
14. The end of pharma –
a very different world
THE UNHAPPINESS
PROJECT
15. How come I can’t find
anyone who is ‘happy’
with healthcare?
PHARMA BRAND
PLANNERS’ BLOG
16. Setting the right metrics
and KPIs in your brand plan
GSK’S LONG AND
WINDING ROAD
TO ASTHMA
BREAKTHROUGHS
18-19. PME talks to Steve
Yancey, the company’s vice
president and medicines
development leader
DRUG PRICES AND
COMPETITION
20-22. How the CMA is tackling
high prices for essential drugs
Pharmaceutical Market Europe November 2019
6 BIOGEN AND EISAI IN
SHOCK TURNAROUND 34
13 FREIGHT UNCERTAINTY
AMID BREXIT DELAY
20 DRUG PRICES AND
COMPETITION 26 INNOVATION IN THE
ASIA PACIFIC REGION
18 STEVE YANCEY, GSK
CONTENTS
COMBINING HARD TECHNOLOGY
WITH HUMAN SKILLS
INNOVATION IN THE
ASIA PACIFIC REGION
26-29. A first-of-its-kind
study paints a vivid picture
of the APAC region’s future
RETHINKING TRIALS
30-31. The pros and cons of
protocol amendments
A SNAPSHOT OF…
MICROBIOTICA
32. PME talks to CEO
Mike Romanos
COMBINING HARD
TECHNOLOGY
WITH HUMAN SKILLS
34-36. Why pharma’s
multichannel maturity isn’t
just about hard technology
DIGITAL HEALTH TRENDS
38 DIGITAL HEALTH TRENDS 38-39. Why AI is set to
transform the nature
of healthcare
AI: OPPORTUNITIES
AND BARRIERS TO
IMPROVING HEALTHCARE
40-41. How AI is shaping
the future of healthcare
HEALTHCARE COMMS
40 AI AND HEALTHCARE 45. McCann Worldgroup
named European Agency
Network of the Year;
ONEHEALTH acquires
Bartlett Davis; BioMarin
opens new Dublin offices
PEOPLE
46. Q&A with Vicky Bramham
APPOINTMENTS
46 VICKY BRAMHAM 42. Changes at Eli Lilly,
Gilead, Smtih+Nephew,
Amgen and Vertex
www.pmlive.com 5
 TOP TEN NEWS STORIES
1. Vertex, NHS England and NICE
finally reach agreement for Orkambi
Vertex and NHS England have
finally reached an access
2. Biogen and Eisai revive
agreement for cystic fibrosis
drug Orkambi, as well as its
abandoned aducanumab
other CF treatments Smykevi
and Kalydeco. in shock turnaround
The news will be long In a surprising twist, Biogen has said that
overdue for CF patients; after it plans to file its experimental therapy
campaigning for access to aducanumab for Alzheimer’s disease, months
Orkambi, they will now able to after abandoning the drug in phase 3.
access the drug within 30 days. The Eisai-partnered drug was scrapped in
The drawn-out agreement phase 3 earlier this year following advice from an
has been met with criticism, independent data monitoring committee to halt
the majority of which has been trials. The news was a huge blow for the field of
aimed at Vertex for its apparent Alzheimer’s research, which has suffered sustained
inflexibility on pricing and a late-stage failures in drug research. It also hit
reluctance to comply with the Biogen hard, with its share price plunging 25%.
NICE appraisal process. The initial failure of the drug also fuelled the
The definitive agreement means that around 5,000 eligible NHS patients in England will now sentiment that the ‘amyloid hypothesis’ of targeting
have full access to the medicines. The negotiation has been finalised because Vertex finally agreed beta amyloid had finally been exhausted. However,
to the ‘confidential commercial terms’ of the agreement – and importantly, it also agreed to submit that theory has now been revived thanks to
its drugs for a full NICE appraisal. The agreement also extends to all future licence extensions of the Biogen’s announcement that it plans to go ahead
drugs as well as the current licensed indications. with regulatory filings for aducanumab after all.
NICE, who initially rejected Orkambi because of its cost, has been able to support the agreement, According to Biogen, the results from a subset
due to a binding condition of the deal that Vertex will have to submit its full portfolio, including its of patients in the phase 3 ENGAGE study of
new triple therapy, for a full NICE appraisal in due course. The triple therapy, which has just received the drug warrant taking it forward. It said that
approval from the FDA in the US, is thought to be effective in up to 90% of CF patients. patients who received sufficient exposure to
The agreement provides hope that the lengthy agreement process will not be repeated for high doses of the drug experienced significant
Vertex’s future CF therapies, which could be groundbreaking for those suffering with the debilitating benefits on measures of cognition and function,
genetic disease. including memory, orientation and language.
The decision to file aducanumab with the
FDA is based on this new analysis, conducted
by Biogen in consultation with the FDA.
If Biogen does receive approval for the
3. Roche inches towards approval of Spark takeover drug, it can expect billions of dollars in annual
revenues. However, if the drug is rejected by
The Federal Trade the FDA, the ‘amyloid hypothesis’ will most
Commission is poised to likely be well and truly tossed to the side,
approve Roche’s $4.3bn and Biogen will face the consequences of
takeover of gene therapy reviving hope only for it to be dashed again.
specialist Spark Therapeutics,
according to press reports.
Roche has had to delay the expected date therapies – including BioMarin, Sangamo and
for completing the transaction as the FTC and UniQure – that should not be considered
UK’s Competition and Markets Authority (CMA) overly dominant.
probe antitrust issues raised by the deal. The CMA has set a deadline of mid-December
It is thought that the regulators have been for a decision on the first phase of its review
scrutinising the deal because Roche’s antibody of the acquisition, which could be the end of
drug Hemlibra (emicizumab) has been growing at the process if it decides there is no need to
a phenomenal rate since its launch last year, and is investigate further. If it decides to continue the
firmly on course to become a blockbuster this year probe, a lengthier second phase would kick off,
with sales of $925m in the first nine months. making an end of 2019 completion date unlikely.
Adding Spark’s SPK-8011 and earlier-stage On 29 October, Roche once again extended
follow-up SPK-8016 would give Roche a strong its tender offer to Spark shareholders, with a
position in the market, although analysts at new deadline of 25 November, citing a need
Jefferies previously suggested that with a to give regulators more time to review the
number of other companies developing gene proposed $4.3bn merger.

6 www.pmlive.com Pharmaceutical Market Europe November 2019

 NEWS

4. Ohio opioid trial averted by last-minute settlement

The first federal trial in the US litigation over
the opioid epidemic was prevented by last-ditch
negotiations which reached a $260m settlement.
US District Judge Dan Polster was due to start
hearing the trial in Cleveland, Ohio in the US
and was pushing for an out-of-court settlement
to save all parties the hefty cost of litigation.
Polster had been busy handling meetings
between state attorneys general, lawyers for local
authorities and top executives of the US’ largest
three wholesalers – AmerisourceBergen, Cardinal
Health and McKesson – as well as drugmaker Teva
and pharmacy group Walgreen Boots Alliance.
The last-minute deal will see McKesson, Cardinal
Health and AmerisourceBergen pay $215m to the
Ohio counties of Summit and Cuyahoga. Teva is also
due to pay $45m in cash and addiction treatments.
Polster is presiding over thousands of
lawsuits alleging that companies fuelled
a healthcare crisis responsible for roughly
400,000 US deaths from 1999 to 2017,
according to US government statistics.
However, the last-minute deal does not
resolve the additional nationwide litigation.
The details of a wider settlement on the table
differs depending on the source, but is thought to
include roughly $22bn in cash and $29bn in products
and distribution intended to help tackle the epidemic
of opioid addiction that affects every US state.
The three wholesalers are offering $18bn over 18
years, with Johnson & Johnson adding another $4bn
to the tally. Teva is in the midst of a challenging
time financially at the moment so is trying to avoid
a cash settlement, opting instead to provide $15bn
worth of drugs and some distribution services.

5. Merck KGaA launches €13m 6. AZ reports growth again in Q3,

seed fund for Chinese start-ups
Merck KGaA has announced a new
RMB 100m (€13m) seed fund to
foster startups in China – with
an aim at identifying innovations
in health and life sciences.
The investment will be made
through M Ventures, Merck KGaA’s
corporate strategic venture arm, with
intended investments to be made
in Chinese seed-stage companies
with individual investments ranging
between €500,000 and €1m.
The initiative focuses on
early innovations developed
within the Chinese ecosystem,
that are focused on healthcare,
life sciences, performance
materials or new businesses.
“Our seed fund initiative aims
to deliver strategic returns so as
to underscore our position as an
innovator in China and to strengthen
our ties to the dynamic Chinese
innovation ecosystem,” said Stefan
Oschmann, CEO and chairman of
the executive board of Merck.
Merck has also opened its new
innovation hub in Shanghai, where
it will invite start-ups, academic
institutions and other industry
players to become involved in
joint innovation projects.
Six start-ups from China and other
Asian countries have successfully
taken part in the first phase of the
Merck Accelerator in China. This
programme helps Chinese start-ups
to connect with global innovation
networks and further develop research.
Merck also announced plans for a
second innovation hub in Guangdong
in Southern China in late 2018.
driven by oncology and China sales
AstraZeneca has raised its full-year sales prediction again, with product
sales rising for the fifth successive quarter following a growth of 18%
at constant exchange rates to an impressive $6.1bn in Q3.
This was driven by a strong growth of AZ’s oncology medicines, which
saw an overall 48% growth to $2.3bn. Sales growth in 2019 for this area to
date has reached 54%, driven by Tagrisso, Imfinzi and Lynparza.
Its Merck & Co-partnered PARP inhibitor Lynparza, which AZ recently
flaunted at ESMO 2019, has reported an impressive growth of 98% to $847m,
driven by an 86% increase in the US and a 227% increase in emerging markets.
Its cardiovascular, renal and metabolism (CVRM) franchise was also up
11% to $1.1bn, with growth in sales of Brilinta and Farxiga paving the way.
AZ’s respiratory franchise also grew 18% to $1.3bn – although the
company saw a 4% decline in sales of Symbicort, this was offset by the
growth of Pulmicort and Fasenra, and also a growth of these medicines in
emerging markets.
The London-listed drugmaker also reported strong growth in emerging
markets, especially China, where it saw a sales growth of 40% to $1.2bn. In
China, AZ reported oncology sales growth of 67% to $1bn and new CVRM
growth of 88% to $359m. It also reported a return to growth of its Europe
sales, which were up 1% to $1.1bn.
The company has now forecast its product sales to increase by a low- to
mid-teens percentage, up from a low double-digit percentage increase.

Pharmaceutical Market Europe November 2019 www.pmlive.com 7

 NEWS

TOP TEN NEWS STORIES

7. Novartis grows in Q3 thanks to stellar performance of key drugs
Novartis has raised its full-year guidance thanks to
the growth of a number of its key medicines and its
generics unit Sandoz.
The Swiss pharma reported net sales of $12.2bn, a
growth of 13%, and a core net income of $3.2bn. This is
well above the consensus revenue estimate of $11.68bn.
Leading the way with $937m in sales was psoriasis
drug Cosentyx (secukinumab), which grew 27% over the
quarter. Following Consentyx is heart failure drug Entresto
(sacubitril/valsartan), which grew 61% to bring in $430m
sales in the quarter. Sales of the drug have been growing
rapidly, but a recent blow in a trial of patients with
preserved ejection fraction (HFpEF) has created doubt over
potentially billions of dollars of revenue.
The third highest sales growth was of SMA gene therapy
Zolgensma (onasemnogene abeparvovec), which brought
in $160m in sales in the third quarter, following its launch
earlier this year. The therapy is currently under regulatory
review in Europe and Japan, with decisions expected in
2020.
Following the growth of these products, Novartis has
now revised its net sales, with expected growth now in the
high single-digit percentage rate, up from the mid to high
single-digit range predicted in the last quarter.

8. GSK takes new-class 10. Astellas stays ahead

antibiotic into phase 3 of FLT3 rivals with EU
for serious infections nod for Xospata
GlaxoSmithKline has started two phase 3 trials Japan’s Astellas Pharma has won EU
of the first drug in a completely new class of approval for Xospata, a drug to treat
antibiotic that could provide a much-needed acute myeloid leukaemia associated with
option for severe, resistant infections. a mutation in the FLT3 gene, keeping
The new drug, called gepotidacin, is being it ahead of rival Daiichi Sankyo.
developed initially to treat uncomplicated urinary The approval comes after an accelerated
tract infection (UTI) and urogenital gonorrhoea. review of Xospata (gilteritinib) as a
The EAGLE-1 trial will enrol 600 patients If gepotidacin is shown to be effective monotherapy for relapsed/refractory FLT3-
with gonorrhoea, while EAGLE-2 has a target in the phase 3 programme, a big question positive AML, and just a few days after the
population of 1,200 people with UTIs which is how it will be used commercially. EMA’s main advisory committee rejected
are confined to the lower urinary tract. Pharma companies have exited antibiotic research Daiichi Sankyo’s marketing application
Gonorrhoea is the second most common in droves, put off by the paradox that lies at the for quizartinib in the same indication.
sexually transmitted infection (STI) around heart of antimicrobial drug development: the newest, The EU regulator has given a green
the world, and fears are rising of a so-called most effective drugs are typically kept in reserve light for the use of Xospata in patients
super-gonorrhoea that is resistant to the for infections that don’t respond to older agents. with two of the most common FLT3
recommended first-choice treatment – a That means they are used the least, delivering mutations – internal tandem duplication
combination of azithromycin and ceftriaxone. little payback for the cost of their development. (ITD) and tyrosine kinase domain (TKD).
All told, 20-30% of people with AML
have FLT3 mutations, which are associated
with poorer outcomes, including a
9. Merck CFO: we’re not only about Keytruda higher relapse rate, faster progression
and shorter overall survival times.
Merck & Co’s Keytruda topped $3.1bn in sales in the third-quarter – Xospata has already been approved for
almost a quarter of group revenues – but management insists there is this indication in Japan and the US, based
more to the company than the cancer blockbuster. on the results of the ADMIRAL study that
Predictably, discussion of Keytruda’s massive clinical trials programme compared Xospata to salvage chemotherapy.
dominated Merck’s third-quarter results call. However, chief financial The results of that study showed Xospata
officer Rob Davis stressed that “while Keytruda is truly a foundational extended overall survival (OS) to 9.3
product, we are a lot more than just Keytruda”. months from 5.6 months in the control
He said the performance of other cancer drugs like Lenvima (lenvatinib) group. After one year, 37% of patients
and Lynparza (olaparib), revenue from which doubled in the quarter – as taking Astellas’ drug were still alive, versus
well as the vaccine portfolio headed by cervical cancer vaccine Gardasil and 17% of those in the chemotherapy arm.
HIV franchise – is evidence there is “a lot internally…to be excited about”.
There’s no denying that Keytruda is the story of the moment
however, with its 62% sales increase helping Merck post a 15%
rise in group revenues to $12.39bn and shrug off a 12% decline
for diabetes treatment Januvia (sitagliptin) on pricing pressure.
Turning to its other products, Gardasil grew 26% in the quarter
to $1.3bn, while chickenpox vaccine Varivax rose 19% to $623m.
Alliance revenues from Eisai-partnered Lenvima and AZ-partnered
Lynparza reached $109m and $123m respectively.

8 www.pmlive.com Pharmaceutical Market Europe November 2019

When the big dog wants a big idea.

...IS THE DOG’S

Altogether more magic.

 NEWS
UK AI partnership seeks to support The best in the UK
people living with chronic conditions healthcare system
Reason Digital has teamed up with four UK
health charities on a project which aims to
develop artificial intelligence (AI) as a coaching
tool to support people living with long-term
health conditions.
The digital social enterprise has partnered with
Parkinson’s UK, the Stroke Association, Muscular
Dystrophy UK and the MS Society on the project.
These organisations will seek to transform the way
medical advice and information is delivered to
approximately half a million people in the UK living
with chronic conditions.
This will be achieved through the development
of the Digital Health Assistant (DHA), which will
use machine learning to develop an understanding
of the person to be supported, and will continually
adapt to an individual’s needs based on interactions
over time.
McCann Health New York launches
Parkinson’s awareness campaign
McCann Health New York has launched a new
campaign to raise awareness and increase early
diagnosis of Parkinson’s disease.
The campaign, named Parkinscents, was created with
a focus on tackling Parkinson’s via early detection.
10 www.pmlive.com
“Diagnosis of a serious health condition such
as Parkinson’s, Muscular Dystrophy or multiple
sclerosis, or experiencing a stroke, naturally
generates an abundance of questions for the person
receiving the news,” said Reason Digital co-founder
Matt Haworth.
“Online research so often results in unanswered
questions and out of date, generic information which
just adds to the stress and anxiety of an individual’s
situation. What people want is curated information
and updates from a trusted source,” he added.
The DHA tool is designed to help tackle
commons issues that people with chronic
conditions in the UK experience – including a
lack of tailored and up-to-date information for
those who have been recently diagnosed with a
long-term health condition, and healthcare staff
shortages.
The company highlighted the fact that many
people with the neurodegenerative disease
start with treatable symptoms which can go
undiagnosed for years. It also brings attention to
and encourages the early diagnosis of Parkinson’s,
which can in turn lead to earlier treatment and
improved health outcomes for patient.
The Parkinscents campaign focuses on one of the
earliest signs of Parkinson’s – the loss of the sense
of smell. This particularly affects certain scents,
including peppermint, anise and coffee. For National
Coffee Day in the US, McCann partnered with coffee
shops across the country to increase awareness with
informative coffee sleeves, lids, posters, tent cards,
coasters and an interactive website.
Through these tools, people could learn more about
the early signs of Parkinson’s and when symptoms
should prompt a visit to a healthcare professional.
The activation of this campaign followed
a successful pilot programme at the World
Parkinson’s congress in Japan, which targeted both
consumers and healthcare professionals.
celebrated at QiC
Diabetes awards 2019
The programme recognised the best initiatives
and professionals leading practice in diabetes
management, education and patient care across
the UK.
“QiC Diabetes provides a great opportunity to
celebrate, and learn from, new ways of working to
drive up quality of care. I’m impressed and inspired
by the class and breadth of the award winners and
finalists,” said Professor Jonathan Valabhji, national
clinical director for obesity and diabetes, NHS
England.
The awards ceremony opened with a talk from
keynote speaker Dr Sam Rice, Consultant Physician
and Endocrinology, on empowerment for people
living with diabetes. Dr Rice went on to win a
surprise NHS Wales Outstanding Contribution
Award for Services in Diabetes, for developing a
research and innovations portfolio focused on
patient support on education.
Another recipient of an award for excellence was
Dr Lalantha Leelarathna, who won the NHS England
Outstanding Contribution Award for Services in
Diabetes for his work to improve diabetes care and
research in diabetes technology.
The People’s Award, supported by Diabetes UK,
recognises an individual who has supported or
cared for people with diabetes in 2018. Winning
this special award was Stefan Haest (pictured
above), a champion for peer support who was
diagnosed with type 1 diabetes at the age of 11.
Since then, he has been committed to helping other
children and young people with the condition.
The awards also celebrated the hard work of NHS
teams working to promote hypo awareness, with
the Hypo Awareness Week 2019 Excellence Award.
The winner of this coveted award was Cambridge
University Hospitals NHS Foundation Trust.
Elsewhere, North West Anglia NHS Foundation
Trust won the Insulin Safety Week 2019 Excellence
Award, demonstrating its hard work and dedication
to improving safety in diabetes care.
Winning the coveted Diabetes Team of the Year
award was West Green Surgery, for its Personalised
SMS Care Plan for Diabetes.
Pharmaceutical Market Europe November 2019
 BREXIT

Another day, another Brexit delay

What happens now?
n Westminster, the Brexit uncertainty continues,

I and despite vehement assurances to the

contrary, the UK did not leave the EU on 31
October, either with or without a deal.
The EU met on 28 October to consider a Brexit
extension until 31 January 2020, with an option
for the UK to leave earlier if a deal is ratified.
This ‘flextension’ would allow the UK to leave
before the new deadline if a deal is approved by
Parliament.
There was talk that EU27 leaders favoured a
short technical extension, to allow Prime Minister
Boris Johnson more time to win support for his
withdrawal agreement, over a lengthier delay
that might have given the UK time to unlock the
impasse in the Commons.
However, on 28 October, European Council
president Donald Tusk announced that the
European Council has agreed to a Brexit delay
until 31 January 2020.

What happens now?

This ‘flextension’ allows time for a snap election –
Johnson’s favoured option given the Conservative’s
lead in the polls over Labour.
Former PM Tony Blair had suggested a
simultaneous general election and a second
referendum, saying there was nothing to stop both
being organised at the same time.
Election battle
Following a motion to debate and vote on a
general election in December, MPs have backed a
general election on Prime Minister Boris Johnson’s
preferred 12 December election date, rather than
the alternative 9 December date that Labour and
the Liberal Democrats had been pushing for. This
means that the UK is now facing its first December
election in almost a century.
It will be a fierce fight between the two main
party leaders, with Conservative’s Boris Johnson
and Labour’s Jeremy Corbyn set to battle it out as
they begin their respective campaigns.
The smaller political parties may look to strike
deals with each other – Deputy Lib Dem leader Ed
Davey said that the party is in talks with both Plaid
Cyrmu and the Green Party, according to the BBC.
There can be no definitive answer as to what will
appear on the election manifestos, but it is likely
that Brexit will be at the forefront as each party
attempts to win over voters ahead of the new 31
January 2020 deadline.
The outlook for pharma
In a series of votes last month, Johnson’s revised
withdrawal agreement was voted down by
Parliament, then given support in principle, only
to be effectively placed on hold by a subsequent
rejection of his proposed three-day timetable for it
to be debated in the house.
The new version of the withdrawal agreement
retains the transition period in Theresa
May’s version of the deal in which medicines
and devices regulations would stay aligned
with the EU. That means, for example, that
companies could continue to carry out batch
release testing in the UK and manufacturing
and distribution licences would continue
to be recognised until the end of 2020.
There would no longer be UK participation
in EU institutions like the EMA and while the
Medicines and Healthcare products Regulatory
Agency (MHRA) would be excluded from the EU
regulatory network, it would still have access to
EU databases. The future relationship would be
negotiated as part of the Free Trade Agreement
negotiations.
Health Secretary Matt Hancock told the
Bioscience Forum in October that the intention
is for regulatory collaboration with the EMA
to continue, including mutual recognition of
products produced in the UK and the EU,
according to a BioIndustry Association (BIA)
Brexit webcast on 25 October.
A new Northern Ireland problem?
From a pharma perspective, the new withdrawal
agreement, which aims to tackle the issue of the
Northern Ireland backstop, raises an important
consideration.
If no trade deal is agreed before the transition
period comes to a close, medicines regulation
in Northern Ireland would be aligned to the EU,
which might mean the MHRA would have to
enforce EU legislation there, but with possibly
divergent UK rules on the mainland, said BIA
chief executive Steve Bates.
Meanwhile, no-deal preparations continue
as the country prepares for a general
election, with the only certainty being
that a Brexit deal that can be agreed upon
and voted for by the necessary majority
has once again not been achieved.

Pharmaceutical Market Europe November 2019 www.pmlive.com 11

 BREXIT
Uncertainty surrounding
Brexit is harming UK
science, says new report
UK’s annual share of EU research funding
has fallen by nearly a third since 2015
ew analysis by the Royal Society has
N demonstrated that uncertainty around Brexit
has already significantly affected scientific
research and its workforce in the UK.
According to the analysis, the UK’s annual share
of EU research funding has fallen by almost a third
since 2015. Figures also suggest that the UK has
become a less attractive place for top international
science talent, reflected in a 35% drop in
scientists coming to the UK via the EU’s Marie
Sklodowska Curie Fellowships (MSCA).
“We have seen a dramatic drop in the number of
leading researchers who want to come to the UK.
People do not want to gamble with their careers,
when they have no sense of whether the UK will
be willing and able to maintain its global scientific
UK life sciences industry has suffered ‘a lost decade’
Brexit uncertainty could exacerbate the stagnation in the industry
The life sciences sector has often been the focus
of the UK government – this is unsurprising given
the fact that, according to IPPR analysis, it employs
almost 200,000 people and supports 482,000 jobs.
The new analysis shows that even before the
Brexit referendum in 2016, the UK life sciences
industry had faced a sustained period of stagnation.
According to IPPR, in 2011 the UK attracted over
10% of all life sciences R&D spend globally – so,
‘for every £10 spent on life science research,
12 www.pmlive.com
leadership,” said Venki Ramakrishnan, president
of the Royal Society.
“UK science has also missed out on around
€0.5bn a year because of the uncertainty around
Brexit. The potential paralysis of a no-deal Brexit
and the current state of chaos are hurting UK
science and that is hurting the national interest,”
he added.
Traditionally, the UK has performed well
above other EU nations in attracting scientists
through the MSCA programme – since the Brexit
referendum, this has been significantly affected.
In 2015, before the referendum, 515
individuals took up the MSCA Individual
Fellowships in UK institutions. By 2018, this had
fallen to 336 individuals.
£1 was spent in the UK’. Pharmaceuticals also
captured 10% of the gross value added by the UK
manufacturing industry overall.
For both, the trend has been toward stagnation
since 2010/2011 – this reflects a ‘missed
opportunity to deliver progress against a backdrop
of scientific advance’.
For example, R&D spending in the UK suffered
a loss of £15bn between 2011-2016. This is
particularly alarming, given the fact that the US’
Horizon 2020 is an EU Research and
Innovation programme which has nearly £70bn
of funding available between 2014 and 2020.
UK researchers have reported that soon after the
referendum, they were frozen out of new Horizon
2020 grant applications, which prompted then
Chancellor Philip Hammond to underwrite EU
grants to counteract the uncertainty around Brexit.
However, the new analysis demonstrates that
this did not have its desired effect – figures from
EU databases show that the UK’s share of Horizon
2020 funding fell from 16% in 2015 before the
referendum, to a little over 11% in 2018. The
number of UK applications to Horizon 2020 also
fell from 18,127 to 11,746 – a drop of around
40%.
share of the global market has risen from just over
50% to almost 60% in the same time.
The analysis also highlights that Brexit presents
a ‘cliff edge’, which without intervention strategies
could cause a difficult recovery from the ‘decade of
stagnation’, or even cause further decline in R&D
funding.
According to the IPPR, Brexit has impacted life
sciences most significantly because it has created
uncertainty in the UK market. It highlights the
freedom of movement, access to research funding,
cross-border collaboration and common regulations
as attractive features for potential investors. With
the UK leaving the EU, these could change and
make the UK a less attractive place for investment.
The government has also been unclear as to
whether it will uphold those benefits post-Brexit,
says the IPPR. This makes it even harder to justify
long-term investment in the UK.
‘Should Brexit happen, particularly in a no-deal
form, our economy will need to rely on strength
industries like life sciences to stabilise. If the
government moves to mitigate Brexit, implement
the life sciences industrial strategy with more
urgency, and make the NHS a more active partner
in innovation, these gains are as possible as they
are important,’ states the report.
Pharmaceutical Market Europe November 2019

Status of government freight contracts
uncertain following Brexit delay
Unclear whether ferries will be kept on hold
t the beginning of October, the UK government
A signed freight capacity contracts with a
number of freight companies as a contingency
to ensure the continuation of the vital medicine flow
to the UK in the event of no-deal Brexit.
The EU has announced it will approve a Brexit
extension until 31 January 2020, after Prime
Minister Boris Johnson was required to request
an extension after Parliament could not reach an
agreement on a Brexit deal.
The Department of Transport may now have to
change its plans for the contracts, which are in place
for six months and collectively worth up to £86.6m.
The contracts were awarded to Brittany Ferries,
DFDS, P&O and Stena Line.
According to the government, the framework
will be in place for the next four years and will
UK bans some drug exports to preserve NHS stocks
Insists the move is not related to Brexit
The UK has published a list of medicines that
must not be exported because of shortages in the
NHS, but insists the move is not related to Brexit.
The ban applies to the so-called ‘parallel
trade’ of medicines – the buying and selling of
products between countries in order to profit from
price differentials. It applies mainly to hormone
replacement therapies but also includes adrenaline
pens, hepatitis B vaccines and the influenza drug
oseltamivir, sold by Roche as Tamiflu, among others.
The Association of the British Pharmaceutical
Industry (ABPI) has welcomed the news, saying
it will “stop some medicine wholesalers from
taking advantage of the present circumstances by
parallel exporting”.
Pharmaceutical Market Europe November 2019
continue to be used to help quickly deliver any future
procurement if necessary.
Currently, the status of the contract remains
unchanged, and it is not clear whether the ferries will
be kept on hold while Parliament agrees a deal or
holds a general election.
According to The Financial Times, the contract
has a cancellation fee of £11.5m. It is uncertain as
to whether the ferries will be kept on hold for the
duration of the Brexit extension.
In response to the initial freight capacity
announcement, the Association of the British
Pharmaceutical Industry’s chief executive Mike
Thompson said: “Industry will continue to do
everything it can to make sure people get their
medicines in all Brexit scenarios, as we have been
doing for many months.”
The list isn’t new and is regularly updated by the
Medicines and Healthcare products Regulatory Agency
(MHRA) as medicine shortages occur in the NHS.
The ABPI has previously called for a temporary
restriction on parallel exports in the run up to Brexit
as currency fluctuations such as a fall in the value
of the pound could make exporting medicines to
the EU more profitable.
The trade body said the Department of Health
and Social Care (DHSC) has also invited ABPI
members to identify when parallel export could lead
or contribute to supply problems in the UK.
Traders who ignore the ban and export a
medicine on the restricted list could have their
wholesale dealer licence revoked by the MHRA.
BREXIT
UK rations AZ’s
paediatric flu vaccine
after delivery delays
Supplies may be limited
as flu season begins
Delays in the release of some batches of
AstraZeneca’s paediatric flu vaccine – Fluenz Tetra
– means supplies may be limited as the 2019-2020
flu season gets underway.
The delay means available stocks of the live,
attenuated influenza vaccine (LAIV) will have to
be reserved for vulnerable children with underlying
medical conditions.
AZ says the delays have been caused by routine
testing on some of its Fluenz Tetra production
batches that will have to be repeated – it doesn’t
think the efficacy or safety of the vaccine is at risk.
It’s hoping to deliver the affected batches in
November, but further delay could threaten Public
Health England’s plan to make the nasal spray
vaccine available free of charge to all primary school
children for the first time this year.
The new policy has added another 600,000
children to the 25 million people eligible for free flu
vaccines in England, as part of a strategy to ‘help
keep people well and ease pressure on urgent care
services over the colder months’, according to PHE.
Both Scotland and Wales have also announced
plans to prioritise children with eligible health
conditions, as well as the two- to five-year-old
programme, in response to the delay.
In August, NHS leaders warned that a no-deal
Brexit could make delays in the flu vaccine supply
this year more likely, and there has been a rush for
all producers of the vaccines to make sure sufficient
supplies are in stock for the winter months.
“I know how distressing medicine shortages can
be for those who rely on drugs like HRT and it’s
absolutely crucial patients can always access safe
and effective treatments through the NHS,” said
Health Secretary Matt Hancock.
www.pmlive.com 13
 BRIAN D SMITH
DARWIN’S MEDICINE
THE END OF PHARMA
Some parts of our industry may go the way of the kitchen display cabinet and the word processor
A
lthough most of my time is taken
up with research and writing,
about a third of it is spent applying
Darwinian science to help companies
evolve. It provides very practical solutions but
it often demands a level of thinking beyond the
typical strategic planning charades. As usual in
this column, allow me to reach my practical
conclusion via a little amble into the science.
Environment selection
A big, sometimes contentious, debate among
evolutionary scientists is about where evolution
happens. The question debated is this: since
evolution is a process of selection by the
environment, what exactly is it that is selected?
‘Using multi-level selection,
it becomes obvious that the
market of the future will not
choose drugs or devices,
it will choose systems’
At one extreme of this debate stands the great
Richard Dawkins, who sees ‘the selfish gene’
as the unit of selection. At the other end
stand scientists like David Sloan Wilson, who
think that selection occurs at multiple levels,
from the gene to the organism to the group.
Its not an esoteric debate: Wilson’s work, for
example, helps to explain why and how we
humans developed our altruistic habits. Simply
put, altruism or, more broadly, prosocial
behaviour makes more sense when you see it
as favouring the survival of the group, rather
than the individual. For a Darwinian geek
like me, these ideas are wonderful tools for
understanding how the world changes.
Higher-level selection
Here are two examples of multi-level selection
that might seem mundane, but they serve
to make a point. When I began my working
life, my secretary used a word processor – a
typewriter with a tiny screen that showed one
sentence at a time. And when I was young,
my mother bought a kitchen display cabinet,
a free-standing piece of furniture. Both items
were highly desirable in their time and they
14 www.pmlive.com
have not been superseded by direct
replacements. Yet I’ve never bought
either, and nor have I used either for
many years. That is because they have
both been replaced by higher level
things. The word processor has been
replaced by the computer with an
all-purpose office suite of software.
And the last time we renewed our
kitchen we bought an entire fitted
room, complete with cupboards
and appliances. In both cases, the
function of the smaller, lower-level
entity was absorbed by a higher-level
entity. And why did this happen?
Because the selection pressures form
the market environment, which
included both functional and economic factors,
selected in favour of the higher-level entity.
The market liked PCs and fitted kitchens so
much, it was less concerned with their parts.
This is an example of higher-level selection,
just as much as the Palaeolithic environment
favouring tribes of altruistic humans.
Multi-level selection
So, how is the concept of multi-level selection
useful in the life sciences market? Well, twice
in recent weeks I’ve worked with companies
in chronic diseases – diabetes and asthma.
Both began their thinking worrying about
how to evolve their product – in the first case
a continuous blood sugar monitor, in the
second an asthma drug. In both cases, it is
difficult to see how to adapt to the market’s
dominant selection pressure, which favours
lower costs and therefore commoditisation.
Difficult that is until one reframes the
problem as one of multi-level selection. Using
that perspective, it becomes obvious that the
market of the future will not choose drugs or
devices, it will choose systems. This is directly
analogous to the market no longer choosing
kitchen cabinets but choosing kitchens instead.
Through the lens of multi-level selection,
the question becomes how to evolve the
system, rather than the product. And that
lens also allows us to make sense of what we
see happening around us. Various respiratory
companies are developing smart inhalers as part
of their offer. Glucose monitoring companies
cooperate with diabetes pharma companies. In
the market for medical technology, companies
like Philips, Siemens and GE Healthcare
sell integrated systems that optimise health
economic outcomes. Rivals who try to compete
with stand-alone products rarely succeed, other
than when they construct tiny, defended niches.
A different world
When one uses multi-level selection to look
at the future of the industry, rather than a
single business, it predicts a very different
world. Our market might follow the path of
word processors, kitchen cabinets or, easier
to imagine, medical technology; companies
in some market sectors like respiratory or
diabetes will cease to be pharma companies
in our current understanding of the term.
They will develop, provide and maintain
disease management systems that incorporate
pharmaceuticals but also diagnostic and
delivery devices and, probably, patient-flow
management systems. Looking back from
the future, companies that marketed, say,
insulin or LAMA/LABA drugs will seems like
strange historical artefacts from another age.
So, yet again, I argue that a Darwinian
view of the life sciences market is not only
intellectually rigorous but also practically
useful. It is only surprising, in a science-
based industry, that we don’t make more
use of Darwin’s wonderful ideas.
Professor Brian D Smith works at SDA Bocconi
and the University of Hertfordshire. He is a
world-recognised authority on the evolution of the
life sciences industry and welcomes questions at
brian.smith@pragmedic.com
Pharmaceutical Market Europe November 2019
 HEALTHCARE

ROHIT KHANNA
THE UNHAPPINESS PROJECT
How come I can’t find anyone who is ‘happy’ with healthcare?

H
appiness, or subjective well-being
as some refer to it, has long been
associated, on some level, with
beneficial health outcomes at
the individual level. There are a multitude
of studies that have shown a relationship
between an individual’s subjective well-
being and some measure of improvement
in overall morbidity or mortality. Simply
put, we know that happier people have
been reported to be healthier people.
But, then, why is everyone in
healthcare so miserable?
I mean, patients are unhappy with the whole
thing – prices, access, quality of care. I cannot
recall a single chronic patient that I have ever
met who has raved about the health system
and how efficiently it operates. Occasionally,
one will meet a patient who went through an
acute scenario and was pleasantly surprised at
how it turned out. Caregivers are exhausted and
equally disconsolate with the never-ending red WORLD
tape of insurance paperwork and lengthy wait HAPPINESS
times as they shuttle their loved ones to and
from appointments. Doctors are burnt out and
REPORT
despondent with a system that is nothing like 2017
they imagined. Ditto for nurses and pharmacists.
Politicians are exasperated with spiralling costs
and voter backlash at every turn. Insurance happiness is one of the factors that contributes level in contributing to population-level health
companies and pharmacy benefits managers to the efficiency of a country’s health system. as well as overall health system efficiency, why
are crestfallen at the venom directed their way Others have also published similar results are so many people so unhappy with the state of
as they are blamed for the egregious costs on the topic of happiness and health. healthcare. And if so many people are unhappy
being imposed on the system. Patient advocacy And then there’s the United Nations 2017 with the state of healthcare, how is it that we are
groups, while doing incredibly important work, World Happiness Report (see chart), which producing this efficiency in certain countries?
often struggle for funding and to find a clear shows that among the top 20 happiest nations Maybe, the answer is that other variables related
voice that resonates and can move the needle on the planet, a healthy life expectancy matters to happiness (like income, education, housing,
on meaningful policy change on behalf of in the overall ‘happiness equation’ but accounts good government, security, religious freedom,
their membership. And manufacturers – both for less of a nation’s overall happiness than, etc) mask or overwhelm the low numbers
medical device and pharmaceutical – are no less perhaps, we think. This doesn’t necessarily associated with happiness from healthcare.
miserable as they face a barrage of questions contradict any of the peer-reviewed work Or maybe there is some reverse causality
from lawmakers about their costs and pricing out there, as the empirical data is very clear happening – it’s not entirely that happiness
practices, and a slew of disapproving looks that happiness is only one of the factors leads to a healthier life and a more efficient
from the general public about their perceived associated with health and health system health system but that a healthier life and a
greed and callous approach to patients’ lives. efficiency. What the UN World Happiness more efficient health system lead to happiness.
In 2018, See and Yen published a paper Report reinforces is that the impact of Regardless of these important nuances, I
showing that happier nations have better health happiness might be even less than we think. have not been able to find any stakeholder
system performance as measured by efficiency. Of course, there are methodological issues group that is truly ‘happy’ with the state of
They used the ‘happiness index’, which is with all these papers and reports. How do we healthcare today. I’m betting you haven’t either.
a comprehensive indicator that includes measure happiness? And how do we measure
several important components, such as caring, both health and health system efficiency? Is
freedom, generosity, honesty, health, income there an inherent selection bias in our data? Rohit Khanna is the Managing Director of
and good governance. And they measured Or other biases that we are not aware of? Catalytic Health, a healthcare communication,
efficiency as a function of life expectancy and But it is all confusing, isn’t it? If happiness is advertising & strategy agency. He can be reached
inverse mortality rates. The findings show that important at an individual level and a societal at: rohit@catalytichealth.com

Pharmaceutical Market Europe November 2019 www.pmlive.com 15

 HEALTHCARE

STEPHANIE HALL
PHARMA BRAND
PLANNERS’ BLOG
Part 6: Setting the right metrics and KPIs in your brand plan

T
his month we tackle one of the most
important and most frequently
neglected parts of the brand plan:
the metrics and KPIs that give you
valuable, regular feedback on your progress
towards your brand plan goals and the
operational effectiveness of your tactics.
In my marketing excellence work across the
industry over the years, KPIs and measurement
repeatedly come up as one of the most important
topics for training or support. Some marketers
just run out of time when it comes to this final
section of the brand plan, others shy away
from giving numbers and targets from a lack of
confidence in setting the right target or being seen
to fail. But with a bit of time and practice, the
measurement section of your brand plan can take
on a clear shape and structure, and then be used
for some quality operational brand team reviews.
There is a clear disconnect between
accepted marketing measurement theory
and the definition and use of KPIs and
metrics in practice. In a recent audit of clear objectives to include: number of patients How do you know if you have created a strong
ten brand plans (global and local) across treated, number and frequency of prescribers by KPI/measurement section in your brand plan
ten different pharma/biotech companies segment where possible, desired attitude and and have incorporated measurement into your
from 2015-2018, I found the following: behaviour change, access levels, sales, market brand team’s practice? If you can answer yes to
share, advocacy levels and patient/prescriber these five questions, you are in good shape!
• Only one out of the ten brand plans had experience objectives, to name but a few.
SMART objectives linked to their KPIs Once you have a clear set of objectives, you 1. Are your KPIs directly aligned to SMART
• Only four out of the ten brand plans contained can then create a set of strategic KPIs aligned commercial, financial and marketing objectives?
KPIs, and only one of these brand plans to each objective, to give you feedback over 2. Do your KPIs have clear targets and different
contained KPIs with a clear timeline and target time on how you are progressing. There are sources of information and will they be
• Only three out of the ten brand plans three key elements of a strategic KPI: reading out at different points in the year
included a budget for market research, to help with course-correction decisions?
measurement and tracking. • Use a variety of sources of information 3. Do you have budget in place and
• Set targets at various time points during the year a clear owner for research, tracking
So let’s start with a couple of definitions: what • Ensure the KPIs have a clear target that will and reporting against your KPIs?
is a metric and what is a KPI? Essentially a metric ultimately align with the year-end objective. 4. Have you assigned owners for each KPI as
is any measure that we can define to give us a clear leader to monitor progress and any
feedback on our brand plan’s effectiveness, while Some teams find Kaplan’s balanced scorecard decisions needed during the course of the year?
a KPI is just that; they are the few key metrics useful to organise and present the strategic KPIs 5. Have you set up regular KPI and performance
that we define as being the most important to across four quadrants: customer/patient, financial, review reporting processes and meetings
focus on. You may have many metrics within competition, organisational learning/processes. with your cross-functional brand team
your plan but only eight to ten KPIs that will Next you will need to define your operational on a monthly or quarterly basis to take
form the basis of your research, tracking and KPIs: the metrics and KPIs for your major proactive decisions to optimise your brand’s
reporting as a cross-functional brand team. programmes and tactics to give you important performance through the course of the year?
The starting point for creating a good feedback on whether your programmes are
measurement section in your brand plan being implemented effectively, engaging For more, see Measure What Matters in Pharma/
rests with the quality of your commercial, your target audience(s) and contributing Biotech at www.uptakestrategies.com
financial and marketing objectives earlier in to a change in attitude and behaviour. Next time, we’ll be looking at how
your plan. Many brand planning frameworks Select five to six of your biggest programmes to manage change, uncertainty and
don’t actually stipulate the need to create one- and create three to four metrics for each risk within your brand plan.
to three-year SMART (specific, measurable, programme to give you valuable feedback
achievable, relevant, time-bound) objectives. on that programme’s effectiveness,
If you haven’t already done so, I would including specific pieces of content, Stephanie Hall is MD of the award-winning brand
strongly recommend that you create some channels and types of tactic or activity. planning healthcare consultancy Uptake Strategies

16 www.pmlive.com Pharmaceutical Market Europe November 2019

 SAY HELLO TO OUR

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and create bigger ideas than ever before.

That’s why we’ve moved into our new bigger offices

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 The long and winding road
to asthma breakthroughs
Respiratory biologics are booming thanks to scientists
who refused to be derailed by early research setbacks
atience and persistence are the prime disciplines
P of drug development, but knowing when to keep
the fuse burning or simply walk away takes a
confounding blend of science and emotion.
The raw balance sheet imperatives are often the
final arbiter but playing a long game, and funding
it, does bring rewards as Steve Yancey, GSK’s vice
president and medicines development leader,
knows so well.
The company’s severe eosinophilic asthma
biologic Nucala (mepoluzimab), an Interleukin-5
inhibitor, has been buoyed by a real-world
evidence study – presented at the recent European
Respiratory Society’s International Congress in
Madrid – which reported a 69% reduction in the
annual rate of clinically significant exacerbations.
Nucala, which has the market boost of being
licensed for home administration via self-
administered auto-injector and prefilled syringe, is
running smoothly with approval for the rare disease
EGPA in several countries. GSK is also anticipating
data in hyper-eosinophilic syndrome and nasal
polyposis which could lead to commercial
approvals in both by the end of 2020.
Its sales-ringing performance chimes with GSK
R&D chief Hal Baron’s strategy to concentrate on
the immune system and genetics – Nucala was cited
as a prime example of the company’s reinvigorated
approach when it was unveiled last year.
Biologics are exquisite
For Yancey and his development team, the
spotlight comes after a long and, at times,
dispiriting journey stretching over 20 years. Early
research in biologics for respiratory diseases did
not fare well, with disappointing clinical trials and
a danger that the promise would run out of steam.
“Biologics are exquisite in what they can do,”
he said. “But it wasn’t that obvious 20 years
ago. We were using the dogma and paradigms
of one-size-fits-all and that is where we failed.
18 www.pmlive.com
By Danny Buckland
The early clinical studies with mepoluzimab were
unsuccessful, which was disappointing but there
were signals in the data that indicated to both the
GSK scientists and the wider scientific community
that we were beginning to understand more about
subtypes, phenotypes and endotypes, which gave
us the encouragement to have a long, backward
look at our data.
‘A third of patients with severe
asthma are hospitalised at
least once a year, more than
half have at least one urgent
care episode annually, while
25% may have had at least
one near fatal experience’
“We spent a lot of hours reviewing our data and
the data the academic community was providing
and that allowed us to reassess the medicine and
understand that we needed to focus on specific
populations such as those with serious eosinophilic
inflammation. This was the turning point for the
development programme.”
The late nights interrogating the science and
unpicking data sets prompted the switch from
a drug for the broad asthma community to a
therapy targeted at a subtype representing around
10% of the asthma population. Nucala had the
springboard and the splashdown target.
If the drug’s birth was slow and difficult, its
ascent to maturity has been fast-tracked – keeping
pace with the wider biologics discovery field – and
full of firsts, according to Yancey.
Gold standard
“The development programme pulled through
efficacy and safety but we also blazed some new
trails, being the first to use patient-reported
outcomes to measure the quality of life in these
patients where traditional QALY instruments did
not work,” said Yancey, who is based at GSK’s
Research Triangle in North Carolina, USA. “We
also developed specific protocols to spare oral
corticosteroids for those who use them daily,
which has become a gold standard study
followed by others.
“We have studied more than 3,000 patients
in 21 clinical trials and 60,000 patients have
received Nucala since it was licensed.”
Severe eosinophilic asthma (SEA) impacts
between 5-10% of the population but they, and
other severe asthma subtypes, represent 50% of
the cost of asthma care expenditure. A third of
them are hospitalised at least once a year, more
than half have at least one urgent care episode
annually, while 25% may have had at least one
near fatal experience.
“These figures make us get out of bed every
morning,” Yancey says. “Knowing that I am
helping patients in some small way to breathe
better and to live every breath makes coming to
work pretty easy for me.”
The high unmet need was reinforced by a report
issued in October by the European Federation
of Allergy and Airways Diseases’ Patients’
Associations (EFA), which revealed there were
30 million children and adults under the age of
45 living with asthma in Europe and approximately
10% of those adults suffer severe and life-
threatening symptoms. It also voiced patient
concern that asthma and Chronic Obstructive
Pulmonary Disease were not getting enough
attention compared to other chronic diseases
and that patients should play a larger role in
medical research.
Pharmaceutical Market Europe November 2019

‘Severe eosinophilic
asthma impacts
between 5-10% of the
population but they, and
other severe asthma
sub-types, represent 50%
of the cost of asthma
care expenditure’
“We are slightly on a pedestal in that we were
the first to approach eosinophilic inflammation in
patients with SEA, which allowed us to have the
largest breadth of data – five years of safety data,”
Yancey added.
Rapid acceleration
Advances in respiratory biologics have opened
the door for a move from daily inhaled steroids to
monthly injections, delivering greater relief and
reducing the condition burden on everyday life
– unsurprisingly, studies have shown that 96% of
patients prefer self-dosing at home.
But GSK is not alone in the IL-5 inhibitor arena.
AstraZeneca’s Fasenra is making waves with its
eight-week dosing schedule and $296m in first-half
sales – a 244% increase over the same period in
2018. Respiratory biologics is a bustling market.
Pharmaceutical Market Europe November 2019
“There has been a tremendous amount of
progress in target respiratory biologics over the
last 20 years, but really it has been in the last ten
where we have seen the most rapid acceleration,
and this has been driven by an evolution in how we
think about asthma,” said Yancey.
“Back in the days of small molecules, we
thought about large populations and homogenous
conditions but, as we move to think about
stratified or targeted medicine, we have also
come to move the science forward. We recognise
that asthma is really a complex heterogeneous
disease and it really consists of a number of sub-
types and, depending on your sub-type and your
expression of the disease, how you will respond to
a medicine will vary. This is really the story about
biologics; how to understand to target to get the
right medicines to the right patient.”
GSK’S STEVE YANCEY
Yancey is full of positivity and pragmatism as
Nucala branches out into new applications and
the company extends its collaboration sphere.
“I always expect bumps on the road – drug
development is an incredibly challenging space.
Our aim is to overcome them by finding ways of
improving our probability of success.
“Our biggest challenge is to be more efficient
in picking the winner and not moving as many
products or programmes through progression by
having a very early look at how we do that.
“One of the strengths of GSK is that we are
keen to target genetic links to the disease and
mechanism.”
Danny Buckland is a journalist specialising in the
healthcare industry
www.pmlive.com 19
 Strengthening business
competition and reducing
anti-competitive practices
How the CMA is tackling high prices for essential drugs
By Jonathan Tickner and Hannah Howlett
he Competition and Markets Authority
T (CMA) is tasked with strengthening business
competition and reducing anti-competitive
practices for the benefit of consumers both
domestically and internationally. Since its
inception on 1 October 2013 (as the successor to
the Office of Fair Trading), the CMA has opened
2,028 investigations and inquiries, including
into a number of household names. For example,
earlier this summer Amazon’s potential merger
with Deliveroo was put on hold while the CMA
investigates the deal. JD Sports, Abellio, Viagogo,
Sainsburys, Asda, Rentokil, Visa and Paypal have
also been subject to CMA investigations/inquiries
in recent years.
The pharmaceutical sector is far from immune
to scrutiny. In recent years, the CMA has been
inundated with a steady and increasing influx
of pharmaceutical-related cases. Presently, the
CMA has 75 open cases, 12 of these (or just
over 16%) involve the pharmaceutical sector
and this number only looks set to increase.
The investigations cover a myriad of allegations
including excessive and unfair pricing, anti-
competitive agreements and abusive conduct.
In a July 2018 statement regarding its
investigations into the pharmaceutical sector, the
CMA said: ‘The weight of work we are undertaking
in this area demonstrates the priority we are
giving to tackling high prices for essential drugs
in order to protect the NHS and taxpayers from
being exploited.’
20 www.pmlive.com
These investigations have yielded results. On
23 May 2019, the CMA provisionally found that
between June 2013 and July 2018, Alliance
Pharmaceuticals, Focus, Lexon and Medreich agreed
not to compete for the supply of prescription-only
Prochlorperazine 3mg dissolvable or ‘buccal’ tablets
to the NHS. More recently, in August 2019, drug
company Aspen offered to pay the NHS £8m as part
of a wider package to resolve competition concerns
following an investigation into suspected anti-
competitive arrangements regarding the supply of
fludrocortisone acetate 0.1 mg tablets.
A firm pharma focus
The CMA’s focus on the pharmaceutical industry is
not surprising. This appears to be a global trend,
not least (from a European perspective) since the
European Commission (EC) published its final report
in its pharmaceutical sector inquiry in July 2009.
Sparked by the Commission’s concern that the
market entry of generic drugs was being delayed
and that fewer innovative products were reaching
the market, the inquiry was launched to gain a
holistic insight into the pharmaceutical industry
and identify the sector-specific problems that
were hampering healthy competition. The report
focused on targeting practices used by companies
to impede or block entry of generic products or
the development of competing originator products.
The most prolific practices included: the use
of settlement agreements between originator
companies and generic companies to block
market entry; interventions in national marketing
authorisations regarding the approval of generics
(which on average delayed market entry for generic
drugs by four months); and attempts to discredit
and disrupt the supply of generics by endeavouring
to influence wholesalers or manufacturers. As a
result, the Commission resolved to find a workable
solution to curtail such practices. One of the main
suggestions required all member states to promote
stronger coordination between different national
agencies to avoid differing applications of the
legal framework. National authorities were also
pushed to take firmer action in the aftermath of
discovering a competition infringement.
‘Since its inception on 1 October
2013 (as the successor to the Office
of Fair Trading), the CMA has opened
2,028 investigations and inquiries’
And it seems to have worked. In the ten years
following the publication of the report, national
authorities across the EU have imposed fines
amounting to over €1bn. In addition to disputes
where fines or penalties have been imposed,
national authorities have investigated over
100 other cases and reviewed over 80 merger
transactions, ultimately flagging 19 of these
transactions for anti-competitive concerns.
Pharmaceutical Market Europe November 2019

Settling the score
While the level of financial penalties imposed by
the CMA has not reached the levels imposed by
the EC, they have nevertheless been substantial.
One of the largest was the £84.2m fine against
Pfizer in 2016 for its 2,600% price increase on
an anti-epilepsy drug supplied to the NHS.
Consistent with section 36(7A) of the
Competition Act 1998, the twin objectives of
the CMA’s policy on financial penalties are:
(i) to impose penalties on undertakings which
reflect the seriousness of the infringement; and
(ii) to ensure that the threat of penalties will
deter both the infringing undertakings and other
undertakings that may be considered anti-
competitive activities from engaging in them.
Pharmaceutical Market Europe November 2019
COMPETITION AND DRUG PRICING
With this in mind, the CMA’s stated intention is,
where appropriate, to impose financial penalties,
in particular in respect of agreements between
undertakings which fix prices or share markets,
other cartel activities and serious abuses of a
dominant position, which the CMA categorises
as ‘among the most serious infringements of
competition law’. This is, of course, subject to
the statutory restriction that the financial penalty
may not in any event exceed the maximum
penalty of 10% of the worldwide turnover of the
undertaking.
Set against this backdrop, the CMA encourages
companies to come forward, for example, with
information relating to any cartel activity in which
they are involved, and will, where appropriate,
give lenient treatment to such companies.
All of this means that Aspen’s recent offer to
pay £8m to the NHS as part of a wider package
may be a sign of things to come.
www.pmlive.com 21
 COMPETITION AND DRUG PRICING
According to the CMA’s August 2019 press
statement, the inquiry relates to arrangements
made by Aspen in 2016, to two rival firms,
based on the allegation that Aspen had paid
these competitors to not enter the market. As
a result, Aspen is alleged to have been the sole
and unchallenged supplier of Fludrocortisone (a
drug used to treat Addison’s disease) to the NHS.
In a landmark move, and as the direct product
of the investigation, Aspen approached the CMA
with an unprecedented settlement offer. As part
of a broader package, Aspen has been required
to admit that it was party to an illegal, anti-
competitive arrangement, alongside committing to
making a payment of £8m to the NHS.
The CMA has reacted positively to Aspen’s
approach. Chief executive of the CMA, Andrea
Conscelli, stated that it ‘welcome[d] Aspen
approaching us to find a new way of addressing
the CMA’s concerns. We believe this resolution
will benefit the NHS, patients and taxpayers’.
22 www.pmlive.com
It is little wonder, therefore, that the CMA and
Aspen have taken this innovative approach to seek
to reach agreement swiftly and practically. Court
proceedings, investigations and inquiries are typically
drawn out and expensive for all the parties involved.
‘Settlement deals such as the
one struck by Aspen are likely
to be not just a one-off, but
an option worthy of serious
consideration moving forward’
It makes business sense to move with the tide of
practical change, mitigating the impact of excessive
expenditure of both time and money. The fiscally
prudent and reputationally attractive option of an
early settlement allows all parties to move on at
pace. On that basis, settlement deals such as the
one struck by Aspen are likely to be not just a one-
off, but an option worthy of serious consideration
moving forward.
Jonathan Tickner is a Partner and Hannah Howlett is
an Associate, both at Peters & Peters Solicitors LLP
(and assisted by Amalia Neenan, Legal Researcher)
Time is money
There are some real and considerable
commercial benefits to pharma companies
in reaching a settlement with the CMA (and
potentially the NHS) at an early stage:
1. Cost: both in terms of reduced fines
(settling companies can and commonly do
achieve a maximum discount on potential
penalty of 20%) and saving/better utilising
resources (settling with the CMA means
committing to a streamlined administrative
process rather than protracted and complex
proceedings, which will significantly reduce
the costs associated with facing a CMA
investigation).
2. Brand image: settlement can be the best
way to preserve brand image and market
confidence through:
a. Saving time: by dealing with the problem
quickly it minimises the amount of time
that the public is aware of the issue.
b. Affording some degree of privacy:
settlement discussions in commercial
litigation are typically confidential. While
the position is slightly different in respect
of the CMA, settling at an early stage
minimises the amount of information that
makes it into the public arena (through a
statement of objections in the case of the
CMA, and the particulars of the claim in
respect of civil proceedings).
3. Increased certainty and stability going
forward: settlement allows a company to
plan its way through this difficult time with
greater certainty, both as to its financial
exposure, but also more generally. Of
course, settlement does not bring finality (as
an infringement decision will be published
regardless, which is the basis for follow-on
damages action in the CAT or High Court).
However, it does allow the company to have
a clearer idea of its maximum exposure to a
final penalty throughout the process.
4. Future public procurement work: a
less considered benefit, settlement
may dissuade relevant entities from
excluding the company from future
public contracts. Under EU law, the
public authorities responsible for granting
public contracts have a discretion to
exclude from procurement procedures any
company ‘where the contracting authority
has sufficiently plausible indications to
conclude that the economic operator
has entered into agreements with other
economic operators aimed at distorting
competition’.
Pharmaceutical Market Europe November 2019

We’ll need more than a spoonful of
sugar to counter vaccine hesitancy
By Satinder Phull
‘The need for effective solutions that achieve
increased immunisation rates is vital, as is
the need for individuals and communities to
understand the benefits and risks of immunisation’
N
ews that the United Kingdom,
along with Albania, the Czech
Republic and Greece, have lost
their measles-free status is deeply
troubling, but not surprising. Trust in and
uptake of vaccines in Europe has been declining
for some time, making disease outbreaks
inevitable. But what is the reason for this
distrust and how can this be turned around?
In the UK, in 2017-18, uptake of the
MMR vaccine decreased for the fourth
year in a row. It now stands at 91.2%,
the lowest level since 2011-12.
In the US, uptake of the MMR vaccine
among children aged 19-35 months also
decreased in 2017. In some communities,
coverage is very low (eg, 60% among ultra-
Orthodox Jews in New York State where a
measles outbreak was reported in February).
This trend in lower uptake of MMR
vaccine has been observed worldwide,
along with a 30% increase in measles cases
globally, and the sequelae of this infection
– deaths, pneumonia and encephalitis.
It is, therefore, critical that action is taken to
stop the re-emergence of dangerous infectious
diseases. This is a serious public health issue
and it is time for everyone to work together
to counteract the rising distrust in vaccines.
And more importantly, to develop and
implement evidence-based strategies that
rebuild trust and increase immunisation rates.
Vaccine hesitancy
A delay in the acceptance or a refusal of
vaccines despite availability of vaccination
services (vaccine hesitancy) is a crucial element
in the rise of vaccine refusal. While this
hesitancy may be due to a loss of trust in the
effectiveness and safety of vaccines, it could also
be due to loss of trust in healthcare systems
and those who deliver medical services.
Pharmaceutical Market Europe November 2019
Last year’s report by the London School
of Hygiene and Tropical Medicine’s Vaccine
Confidence Project found that countries in
which GPs had a higher confidence in vaccines,
tend to have a larger proportion of the public
expressing positive vaccination beliefs. Other
studies exploring levels of trust in institutions,
such as governments and science in general,
also show that the higher the levels of trust,
the higher the rates of vaccine uptake.
As high confidence in vaccination programmes
is crucial in maintaining high coverage rates,
the need for effective solutions that achieve
increased immunisation rates is vital. One way
to overcome hesitancy is to address the vast
amounts of misinformation on social media.
The wide-reaching and instantaneous nature
of the medium means that anti-vaccination
messages are accessible to a much wider
audience than ever before. In some parts of
rural India, for example, there have been reports
of sophisticated anti-vaccinations campaigns
shared via WhatsApp, targeted according to
language and location of the recipients.
Anti-vaccination messages
Some platforms have changed their guidelines
and are limiting access to channels that promote
anti-vaccination messages. Facebook is rejecting
adverts with misinformation about vaccines,
as well as down-ranking anti-vaccination
content. Twitter launched a new tool that
directs users searching for vaccine-related
keywords to trustworthy public health sources.
Instagram will not show or recommend content
with misinformation about vaccinations
in Instagram’s Explore, hashtag and search
pages, while YouTube has removed the ability
to advertise anti-vaccination content.
This is a good start but promoting
vaccination-positive messages and demoting
anti-vaccination messages will not be enough.
IN ASSOCIATION WITH
Trust will need to be at the heart of any
turnaround. In different communities, those
who are trusted will vary, and building trust
will be a complex interplay of sharing evidence
and personal experiences. Trust in government,
healthcare institutions and professionals,
as well as trust in the views of parents, are
all important factors in rebuilding trust.
Rebuilding trust
A powerful example of rebuilding trust comes
from Italy, where a lone parent sparked a
campaign that reached thousands. Miriam
Maurantonio, fearful for her son’s well-being
and concerned about low vaccination coverage
and the growing visibility of anti-vaccination
movements, used social media to mobilise
other parents to post selfies on social media
with the hashtag #iovaccino (#Ivaccinate).
Maurantonio’s single-handed campaign
to encourage vaccine uptake shows the
power of social media, but these platforms
are not the only influencers. A multi-
stakeholder approach from governments
to the pharmaceutical industry to frontline
primary care providers to educators and
academics and scientists is needed to ensure
that individuals and communities understand
the benefits and risks of immunisation and
view it as both their right and responsibility.
There isn’t a one-size-fits-all answer
and effectiveness of approaches will vary
from person to person and community
to community, but one thing is certain,
we all have an important role to play
in rebuilding trust in vaccines.
Satinder Phull is Director of JPA Health
Communications
www.pmlive.com 23
 DEEP

Whatever your specialty, you need a partner that knows healthcare inside out, from every angle.
A partner that can draw on expertise from multiple resources.
At OPEN Health, our strength is how we connect the expertise across our whole organisation
to provide you with a deep, measured solution tailored to your unique environment.
Learn more at openhealthgroup.com

DEEP • BROAD • CONNECTED


Patient journey mapping: exploring
the clinical and the emotional journey
By Richard Jones, Sumira Riaz, Neil Rees and Melanie Liautard
‘Overlaying the clinical journey with the
emotional journey will provide brand teams
with a truly holistic view of the patient journey’
W
hile we can all agree that
the value of developing a
patient journey map cannot
be underestimated when
exploring the care pathway for a patient,
there appear to be inconsistencies within
the same pharmaceutical organisations as
to how patient journey mapping is defined.
There can often be a dichotomy in scope,
content and delivery; for some, mapping the
patient journey is to determine the clinical
transactional pathway, while for others, the
focus is to define the psychological experience
of the emotional journey of patients and
caregivers from diagnosis and beyond.
The adoption of one approach over another
is entirely dependent on the needs of the
stakeholders and the business requirements
within the organisation. However, by
considering both rational and emotional
parameters, creating a patient journey map
that fuses the clinical and psychological
experience of the patient and relevant
influencers can provide the organisation
with a basis for a blueprint to enhance the
journey with appropriate interventions.
As a starting point, understanding how
patients proceed through the healthcare delivery
system, using validated real-world data is
essential. The production of a clinical pathway
can be achieved by analysing Hospital Episode
Statistics (HES) data: a records-based system
that covers all NHS Trusts in England. While
all data is pseudonymised to ensure patient
confidentiality, the data collected follows
patients’ clinical touchpoints during their time
under the care of a physician based in the NHS.
The data collected in HES
includes, but is not limited to:
• Patient details – age, sex,
ethnicity and location
• Clinical details – diagnoses,
investigations/tests, operative
procedures, consultant and specialty
Pharmaceutical Market Europe November 2019
IN ASSOCIATION WITH
• Administrative details – NHS Trust,
GP, admission/discharge date
and method and referrer.
Mapping patients along the entirety of
a pathway, from initial referral through
further diagnostics to first definitive
treatment, enables an understanding of
the efficiency of care delivery and where
opportunities exist for improvement.
There are various aspects of the patient
journey elicited from HES data that can
shape any subsequent exploration into
the psychological experience, such as:
• The approximate time between the first and
last step?
- from first appointment to
diagnosis to first treatment
• Where are the longest delays?
• The approximate time between each step?
• How many steps are there?
Identifying aspects such as time to diagnosis
and time to initiation of treatment can shape
how you approach developing a picture of
the psychological journey of the patient.
The clinical pathway can highlight the HCP
types involved in the journey, gathering their
perception along with patients, carers and
PAGs to help to identify and define the variety
of emotions experienced at each touchpoint,
thereby providing the psychological dimension.
A starting point to build the emotional
perspective of the journey is to collate available
information. Immersing yourself in existing
information, such as previous market research
or exploring the disease area on social media
platforms supports an initial data immersion
exercise that can feed into a bespoke
qualitative research approach. Using tailored
methodologies and projective techniques to
elicit deep-rooted feelings throughout the
journey will help us understand the lived
experience of the patient and specifically the
psychological impact of clinical milestones
previously identified. Furthermore, it can be
extended to include the emotional response
of caregivers at each key milestone, thereby
permitting a further layer of insight beyond that
of the patient and the healthcare professional.
In addition to mapping clinical patient
pathways, the use of HES data can support the
development of innovative solutions and service
improvement, track outcomes and provide real-
world evidence. These data sets are used for the
purposes of providing supporting information
for business cases, epidemiological research,
burden of disease analysis, health economic
research, predictive analytical modelling,
NICE submissions and quality & outcome
analysis. The aim is to improve patient care
and support enhanced access to services and
innovative solutions, which is additionally
supported through an understanding of
the patient’s emotional well-being.
The data immersion and bespoke market
research used to better understand the
psychological journey can aid identification of
unmet needs, leverage key information points
and assist in facilitating tactical solutions
around services to improve patient care and
support healthcare professional education.
Overlaying the clinical journey with the
emotional journey will provide brand teams
with a truly holistic view of the patient journey.
Understanding the unmet needs, drivers and
barriers for change along the journey will
enable brand teams to develop interventions,
for patients, healthcare professionals or
other relevant stakeholders. Such support
can improve the journey for the patient,
leading to improved patient outcomes.
Richard Jones is Patient Engagement Managing
Director, Sumira Riaz is a health psychologist,
Neil Rees is Head of Research and Melanie
Liautard is a Senior Account Manager, all at
Open Health
www.pmlive.com 25
 Pharmaceutical innovation
in the APAC region
A first-of-its-kind study paints a vivid picture
of the APAC region’s future
By Jamie Munro

he Asia Pacific (APAC) region has been a
T strong contributor to the pharmaceutical
industry’s global market growth for several
years. Can such growth be sustained? And to
what extent will it be driven by innovation?
While various studies have examined innovation
more broadly – at the global level and/or with a
methodology applicable to multiple industries –
none has been sufficiently focused to paint a vivid
picture of the APAC region’s future.
The following fresh perspective on innovation
in the APAC pharma market is excerpted from a
data-driven analysis that ranked companies on
their degree of innovation, using a methodology
expressly developed for less mature markets. The
full report is free to download and is available from
Clarivate Analytics.
A quantitative approach
As the goal was to measure innovation at
the company-level, the first challenge was
to determine the parameters that would best
measure innovation in less mature markets.
The resulting quantitative measures were
primarily related to pre-development
conditions and decisions (see sidebar: A multi-
faceted approach to measuring innovation).
The extensive analyses applied a
customised scoring mechanism to rank-order
a cohort of 929 companies out of a universe
of 46,509. The analysis was confined to
pharmaceutical and biopharmaceutical
products, with innovation in drug delivery,
devices and diagnostics considered as out
of scope.
A mixed macro environment
The degree of innovation in a country is necessarily
influenced by a variety of social, economic
and regulatory factors – some that encourage
innovation and others that inhibit it. We examined
these factors for Mainland China, Japan and South
Korea, concluding, very broadly:
• In Mainland China, innovation is spurred
by several conditions: the sheer size of the
population, an increase in lifestyle diseases, the
shift away from state-ownership of enterprises,
and the government’s investment in healthcare
and regulatory reviews. Tempering this, the
country relies almost exclusively on generics, is
still overcoming counterfeiting issues, regulates
prices heavily and lags behind other countries in
the percentage of GDP spent on healthcare.

The study used data collected until the first

A multi-faceted approach to measuring innovation quarter of 2019 to understand the following
when looking at 14 APAC countries/regions:
There is no agreed-upon definition of what constitutes innovation in the pharmaceutical industry
and there is no accepted surrogate marker for it. Even the most general definition of innovation • Which countries are most conducive to
(the creation of a new good or service that generates value) is not easily applied. How is ‘newness’ innovation?
defined? How is the value of a therapy measured? • Which companies are leading the way?
We therefore developed a bespoke methodology based on a set of largely quantitative parameters
that encompassed a company’s broad innovation ecosystem. These included factors ranging from • Which companies are on the cusp of
academic alliances to the degree to which R&D is translated into actual drug pipeline. We then seizing growth fueled by innovation?
grouped the individual data parameters into three major indices: early-stage partnering, drug • How does a company’s innovation profile
development and maturity. affect its success?

26 www.pmlive.com Pharmaceutical Market Europe November 2019


• Japan is the scene of opposing incentives for
innovation. On the one hand, the government
aims to accelerate R&D and is funding projects
that make use of artificial intelligence (AI),
is reviving the research-based industry and is
promoting drugs of Japanese origin in global
markets. At the same time, the economy is
facing challenges, the population is ageing,
punitive pricing schemes are impacting smaller,
domestic companies and the government has set
a target of 80% generic substitution by 2020.
• South Korea is an innovation-friendly
environment, as the government is driving growth
in the pharmaceutical and medical instrument
sector and is pushing for an expanded presence
in the global biotech market. The government
provides policy loans and tax incentives for
innovation and is striving to reduce approval
times and increase its share of the global market,
while the Korea Pharmaceutical and Bio-pharma
Manufacturers Association (KPBMA) is investing
in an AI platform for drug development.
Pharmaceutical Market Europe November 2019
Strong regional pipeline
Pharmaceutical companies are prolific in the
APAC region. At the time of our analysis, there
were 5,547 drugs in active development in the
region and 1,509 that have been launched. Of
all countries we studied, Japan has the highest
number of drugs in active development (nearly
2,000), which is not surprising given the country’s
market maturity. Less predictable is the large
number of drugs in development in both Mainland
China (1,598) and South Korea (1,088).
As Figure 1 shows, Japan earned the highest
score on a country/region level, having achieved high
scores in all three innovation indices. South Korea
is a strong challenger to Japan’s dominance, lagging
INNOVATION IN APAC REGION
Map not true to size
behind only slightly in terms of drug development
and early-stage partnering. The country’s low maturity
innovation score indicates that it has yet to deliver on
its potential. The other APAC countries/regions, while
relatively strong in drug development, are weaker in
early-stage partnering.
Within our data set, Mainland China has by far
the largest number of pharmaceutical company
headquarters (325), followed distantly by South
Korea (151), Japan (140) and Australia (130).
www.pmlive.com 27
 Figure 1: Ranking by country/region
Company-level results
We separated the larger, more established
companies – for our purposes, defined as those
that have launched ten or more products (this
included many multinational companies).
We labelled this grouping as ‘top-tier’ companies
and ranked them by their overall innovation score,
(the upper quartile of this list appears in Table 1).

‘The APAC region is a rich

source of innovation and
collaboration opportunities
abound for APAC-based
and Western companies to
accelerate innovation’

All of the top-tier companies garnered high

marks across all three innovation indices. These
companies scored the weakest on early-stage
partnering, which suggests there is still an
Source: Cortellis Competitive Intelligence, Derwent World Patents Index, Derwent Patent Citation Index, Web of Science opportunity for them to increase the number of
The three major innovation indices are indicated here: drug development on the horizontal axis, early-stage partnering their partnerships with academic institutions.
on the vertical axis and maturity in the size of each bubble. ‘Other’ includes Hong Kong, Indonesia, Malaysia, New Three observations were immediately apparent
Zealand, The Philippines, Singapore, Taiwan, Thailand and Vietnam. from the list of top-tier companies:

Table 1: Top-tier company rankings, upper quartile

Rank Company Country/region Early-stage Drug Maturity Total score

partnering development

1. Daiichi Sankyo Co Ltd Japan 410 320 135 865

2. Takeda Pharmaceutical Co Ltd Japan 395 320 135 850

3. Eisai Co Ltd Japan 350 320 135 805

4. Astellas Pharma Inc Japan 345 320 135 800

5. Otsuka Holdings Co Ltd Japan 325 315 135 775

6. Shionogi & Co Ltd Japan 320 315 125 760

6. CSL Ltd Australia 345 310 105 760

8. Ono Pharmaceutical Co Ltd Japan 320 310 125 755

9. Mitsubishi Chemical Holdings Corp Japan 300 315 125 740

9. Kirin Holdings Co Ltd Japan 315 300 125 740

Source: Cortellis Competitive Intelligence, Derwent World Patents Index, Derwent Patent Citation Index, Web of Science

28 www.pmlive.com Pharmaceutical Market Europe November 2019

 INNOVATION IN APAC REGION

• There is a link between innovation scores and
revenue. All of the companies in the upper
quartile fall within the top 50 global companies
in terms of revenue.
• Japanese companies dominate. Nine out of the
top ten are headquartered in Japan, as are more
than half of all companies on the list.
• Mainland China is underrepresented – for now.
Only one company headquartered in Mainland
China is among the top 40 innovative companies
in APAC, even though there were more
companies from Mainland China in the sample
than from any other country.
Those companies with fewer than ten marketed
products were considered ‘small and medium-
sized enterprises’ (SMEs) (the top ten from the list
of 100 appears in Table 2). Given the rank-ordered
list of the top 100 SMEs, we noted that:
• The correlation between each of the three
indices is less pronounced in this tier (many on
the list have yet to bring a product to market or
expand internationally).
• Companies in Mainland China figure most
prominently with more than a quarter of the
entrants.
• The top-ranked SMEs score especially high
on early-stage partnering, suggesting that this
element is integral to their success.
• All of the top ten SMEs earned high scores on
drug development.
• The top ten SMEs show much greater variability
between their maturity and composite scores
than on other measures.
Innovation outlook
As the macro-environment within the region
changes, the scores for the parameters measured
in this study will likely shift.
Although there will be continued pressure
on healthcare spending in Mainland China, the
future looks promising overall for R&D there, and
the number of innovative drugs introduced is
likely to increase. In particular, Mainland China’s
heavy investment in cancer therapies should pay
dividends in terms of new product launches and
government regulatory reforms should speed new
drug approvals.
In Japan, we expect that ranking scores for
companies will differ more widely by company
size, with market pressures affecting SMEs more
dramatically than top-tier companies. There
may be a drop in the country’s scores for early-
stage partnering and drug development. Cancer
will remain a growth market, although Japan is
currently experiencing price containment pressures
that other countries will also ultimately face.
The outlook for innovation in South Korea is
largely positive, thanks to government incentives to
encourage foreign investment. For the country to
raise its Maturity score, it will need to carry more
drugs successfully through to commercialisation,
a goal that should be helped by the government’s
growth targets and support for investment in AI
systems.
Conclusion
The APAC region is a rich source of innovation,
but in most countries/regions – Japan being
the exception – this is not translating into a
strong global footprint. Currently, the world as
well as local entities are not benefiting fully
from companies’ innovative activities. However,
collaboration opportunities abound for APAC-based
and Western companies to reverse this trend and
accelerate innovation.
Jamie Munro is Executive Director at the Centre
for Innovation in Regulatory Science (CIRS)
and the Centre for Medicines Research (CMR)

Table 2: Highest-ranked SME companies, top ten

Rank Company Country/region Early-stage Drug Maturity Total score

partnering development

1. Lee’s Pharmaceutical Holdings Ltd Hong Kong 295 270 115 680

2. Takara Holdings Inc Japan 325 250 90 665

3. Jiangsu Hengrui Medicine Co Ltd Mainland China 215 300 110 625

4. BeiGene Co Ltd Mainland China 210 255 110 575

5. Nitto Denko Corp Japan 260 215 90 565

6. Glenmark Pharmaceuticals Ltd India 205 260 100 565

7. Betta Pharma Inc Mainland China 200 265 90 555

8. CanSino Biologics Inc Mainland China 215 235 100 550

9. JCR Pharmaceuticals Co Ltd Japan 180 250 110 540

10. Genexine Co Ltd South Korea 215 240 80 535

Source: Cortellis Competitive Intelligence, Derwent World Patents Index, Derwent Patent Citation Index, Web of Science

Pharmaceutical Market Europe November 2019 www.pmlive.com 29

 Rethinking trials:
the pros and cons of
protocol amendments
Protocol amendments occur often and can be beneficial,
but the steps involved can be complex
rotocol amendments make it more likely
P that trials will complete successfully,
but they can be risky, burdensome and
expensive. Understanding why and when to make a
modification is vital, say experts.
A protocol change can work wonders – just ask
AstraZeneca. In August, AstraZeneca’s systemic
lupus erythematosus candidate anifrolumab
achieved the primary efficacy endpoint in an
amended trial called Tulip-2.
Originally Tulip-2 was the same endpoint
as a prior study called Tulip-1. However, when
anifrolumab fell short in the earlier trial, the firm
opted to rejig the protocol with a new endpoint,
BICLA.
AstraZeneca spokesman Matthew Kent said:
“The BICLA was chosen as the primary endpoint
for TULIP 2, following a full evaluation of the
previous phase e trial TULIP 1, which did not meet
its primary endpoint of SRI4.
“Systemic lupus erythematosus is a complex,
heterogenous disease with many unanswered
questions about what drives disease activity, and
both the SRI and the BICLA are widely used for
assessing disease activity.
“An analysis of anifrolumab data supported the
BICLA as a more appropriate measure to assess
the potential of anifrolumab in TULIP 2,” Kent
said.
All change?
Most clinical trial protocols are changed at some
point. Analysis by the Tufts Center for the Study of
Drug Development (Tufts CSDD) indicates nearly
60% of studies are subject to amendments.
AstraZeneca’s motivation for amending was
obvious, but there are many reasons to make a
change. In some cases, patient eligibility criteria
are modified to speed recruitment. In other
instances, evolving standards of care prompt
amendments.
30 www.pmlive.com
By Gareth Macdonald
The nature and number of protocol revisions
usually depends on the study phase, said Chris
Learn, Senior Therapeutic Strategy Lead Director,
Therapeutic Science and Strategy unit at IQVIA.
“Earlier phase studies, such as phase 1 a/b,
first-in-human or dose escalations with or without
combination, typically require fewer amendments
than trials in later phases of development,” Learn
said, explaining that this is mainly by design.
Late phase clinical trials are more complex and
involve more patients, which makes amendments
– including relating to patient safety – more likely,
Learn continued.
‘Analysis by the Tufts Center for
the Study of Drug Development
(Tufts CSDD) indicates
nearly 60% of studies are
subject to amendments’
“The patient sampling size increases, as well,
increasing the degrees of freedom within phase 2
and 3 trial parameters that may need to be better
controlled and or accounted for in terms of safety,
efficacy and beyond.”
Trials in children
Protocol amendments are also common in trials
involving children. The European Medicines Agency
is not responsible for approving or overseeing the
conduct of clinical trials, and therefore is not
involved in clinical trial protocol amendments.
However, when it comes to paediatric trials, the
agency does get involved, according to spokesman
Henry Fitt.
Flitt said: “Sponsors of paediatric
implementation plans (PIPs) need to contact
EMA’s Paediatric Committee (PDCO) in case
changes are foreseen for a study included in
a PIP for which they would then possibly have
to submit a modification of an agreed PIP and
apply for a change in protocol through the
national clinical trial authorisation procedures.
“These modifications occur regularly,” he
continued, adding that in 2018, the PDCO dealt
with 223 requests for such a modification.
Challenges
So protocol amendments occur often and can
be beneficial. However, the steps involved in
making such a change are complex, according
to Kenneth Getz, recently appointed Deputy
Director at Tufts CSDD.
“There are many challenges associated with
substantial amendments, including suspending
the trial and all external service support,
modifying the protocol, resubmitting it to the
ethical review committee, re-consenting study
volunteers and re-engaging investigative site and
contract service staff.”
All these processes take time and cost money.
According to research by FDAMap, a protocol
amendment can cost between $72,000 and
$500,000.
These figures are roughly in keeping with
Tufts’ analysis, according to Getz, who said:
“Our 2016 study of nearly one thousand
protocols found that two-thirds of phase 3
protocols and 77% of phase 2 protocols have
at least one amendment with 2.3 (phase
3 protocols) and 2.2 (phase 2 protocols)
amendments on average.
“Each phase 2 amendment costs $141,000
on average in direct costs to implement,
and $535,000 on average in direct costs to
implement a phase 3 amendment.”
Pharmaceutical Market Europe November 2019

Product complexity
The drug industry’s evolution from a provider of
chemical-based medicine into a developer of larger
molecule drugs and cell and gene therapies is likely
to result in an increase in protocol amendments.
Trials of such products are usually more complex
than trials of small molecule drugs and, according
to Kenneth Getz, more complex protocols are
associated with a higher incidence of amendments.
“We typically see more amendments in
oncology and CNS. We also see a higher
incidence and average number of amendments
in later stage phase 2 and 3 studies.
He added: “There are many factors that
contribute to complexity, including more
targeted and stratified patient populations,
emerging safety issues, crowded drug classes
and even the duration of time that multiple
functions can provide design input.”
This view is shared by Chris Learn, who
said immunotherapy studies are more prone to
amendments than other types of research.
Pharmaceutical Market Europe November 2019
‘The drug industry’s evolution
from a provider of chemical-
based medicine into a developer
of larger molecule drugs and
cell and gene therapies is
likely to result in an increase
in protocol amendments’
“In comparison to other therapeutic platforms,
my observation has been that these trials
experience more amendments due to the unknown,
unexpected impacts that the host’s immune
system brings into play, in addition to those
resulting purely from the drug and or drug product
alone.”
PROTOCOL AMENDMENTS
Flexibility
Protocol amendments provide drug developers
with the flexibility needed to conduct scientifically
robust research, said Jenny Fam, Associate
Director, Global Regulatory Affairs, IQVIA.
Fam said: “Innovation in drug research does
come with new challenges. All stakeholders
(clinicians, patients, regulators, etc, not just
sponsors, should be prepared for unexpected
outcomes and build contingencies.”
Fam also said the ability to amend protocols is
particularly important in emerging areas of research.
“For example, in the case of a failing lot of
autologous cell therapy, sponsors need to ensure
reserve samples are available, clinicians need
to ensure patients are not at risk for missing a
dose and regulators need to allow for flexibility in
treatment protocols to ensure risk-benefit measures
are implemented under such challenges.”
Gareth Macdonald is a journalist specialising in
the life sciences industry
www.pmlive.com 31
 MICROBIOTICA

A snapshot of…
MICROBIOTICA
n this month’s issue of PME, we take an

I in-depth look at Microbiotica and talk to

CEO Mike Romanos about the company’s
technologies and the obstacles it faces in the
biotech sector.
Cambridge, UK-based Microbiotica is part
of a new wave of pioneering firms focused on
developing novel therapeutics based on the
microbiome – the bacteria which live in the
human body and whose role in regulating health
is only now becoming better understood.

What is the central focus of Microbiotica’s

research?
We are focused on the microbiome, which are
trillions of resident microbes, mainly bacteria, in
our gut. It is clear that many diseases in every
part of our body, not just the gut, are caused by
an imbalance in a healthy microbiome and can be
corrected by readjusting the microbial balance to
a healthy one.
An area of high interest is the discovery
that responses to cancer immunotherapy are
dependent on gut bacteria. This represents a new
branch of biology that will revolutionise medicine.

How is Microbiotica advancing life sciences with

its technology?
Microbiotica is a leading expert in the
microbiome and is using its technology to identify
the good and bad microbiomes in patients.
The company can then use this information
to produce oral medication that contains live
bacteria.
This approach has the potential to deliver novel
medications that can address the underlying
cause of disease with few or no side effects.
What makes the company’s technologies stand
out in a crowded field?
Microbiotica’s capability is founded on ground-
breaking research from ten years of investment in
the microbiome at the Wellcome Sanger Institute.
Trevor Lawley, our chief scientific officer, led
the group which addressed several fundamental
barriers to exploring this field, including being
able to isolate all the bacteria and thus being
able to create a database of reference genomes.
These technologies have been enhanced
and industrialised by Microbiotica, which now
has the world’s leading capabilities in these
areas. These capabilities attract collaborations
with leading groups from around the world to
provide the clinical data and samples to feed
the process, including a University of Adelaide
ulcerative colitis FMT study. There is also a
$534m collaboration with Roche’s Genentech
and an investment from Paris-based microbiome
specialist VC Seventure.
Why will Microbiotica make it in the high-risk,
highly competitive biotech field?
The company has a combination of leading science
and platform and highly experienced biotech/
pharma management. Our platform and products
are highly differentiated.
What are the R&D obstacles that the company is
currently facing?
The biggest R&D obstacle is in manufacturing
the products. In the first instance we will use
contract manufacturers rather than establishing
our own facility, and there is a limited number
of CMOs in the world who can do this work, with
none in the UK.
What are the practical business issues the
company is facing?
The biggest recent issue for us has been space. In
two-and-a-half years we have built an organisation
of over 35 people with all the key disciplines and
have outgrown our space at the Wellcome Genome
Campus. Lab space in Cambridge is at a premium
and we have been constrained as we grow.
What impact will Brexit have on the business?
A very large proportion of our staff are continental
EU citizens and it has been a major recruitment
source. As a result, our ability to hire key talent
from Northern Europe has been affected.
Of greater concern is the university sector – the
UK biotech sector is what it is because of the
increasing excellence of the university sector over
the last 20 years. At Cambridge University, 25%
of its staff are continental EU citizens. The UK’s
pre-eminent scientific position is due in large part
to the single market and free movement. We know
this has had an impact.
Microbiotica has generated therapeutic products
comprising multiple isolated gut bacteria as
treatment for C difficile, ulcerative colitis and
cancer. These products are undergoing testing and
are set to be in the clinic in the next few years.

32 www.pmlive.com Pharmaceutical Market Europe November 2019

 MARKETING & COMMS

34
COMBINING HARD TECHNOLOGY
WITH HUMAN SKILLS
Why pharma’s multichannel maturity
isn’t just about hard technology

38
DIGITAL HEALTH TRENDS
Why AI is set to transform the nature of healthcare

46
PEOPLE
Q&A with Vicky Bramham

Pharmaceutical Market Europe November 2019 www.pmlive.com 33

 Combining hard technology
with human skills
Chris Ross explores why pharma’s multichannel maturity isn’t just about
hard technology – success depends on ‘human’ enablers like skills and
organisational culture to capture customers’ hearts and minds
harma’s road to omnichannel engagement The need to master omnichannel engagement That’s the definition of omnichannel excellence –

P excellence is paved with opportunity

and risk. Current progress is variable,
with leaders making impressive strides but
laggards – incredibly – only just beginning to dip
their toes in the water. In the crowded middle
ground between them, many organisations
are experimenting with new technologies and
attempting multichannel campaigns. However,
their use of digital innovation is too often
driven not by coherent strategy, but by the fear
of missing out. It’s the wrong motivation. The
potential for digital to transform the customer
experience is significant – but suboptimal
practices, piecemeal tactics and channel-first
thinking means that many companies are at risk
of squandering the opportunity. There’s still a
long way to go.
is pressing. Consumer expectations have been
redefined by digital disruption, dramatically
reshaping the buyer’s journey and forcing
businesses to reimagine their commercial model.
Research suggests that the average B2B buyers are
now two-thirds of the way through their purchasing
journey before they talk to sales, highlighting the
importance of high quality digital engagement
earlier in the buying cycle to usher prospects
through the ‘funnel’. But digital marketing isn’t
simply a factory for marketers to generate leads
then pass the baton on to sales. Customers
need support at every touchpoint along – and
beyond – the buying journey, with online channels
permanently on hand to deliver timely and relevant
content. The challenge is to deliver a seamless
experience as customers move between channels.
and it’s the holy grail in B2B.
Naturally, pharma’s engagement with its
customers has its own unique complexities – but
the basic principles of modern-day communication
naturally transcend all sectors. Traditionally,
pharma’s dialogue with prescribers has started with
the sales rep and been driven by a ‘share of voice’
model. However, a widespread shift in customer
behaviours is forcing companies to extend the
operational role of marketing to bolster engagement
at every touchpoint of the buyer journey. With the
clinical market now dominated by digital native
healthcare professionals (HCPs) – and with access
to traditional customers reducing – it’s clear that
the effective and co-ordinated use of personal and
non-personal (digital) channels is key to commercial
success. So how is pharma getting on?

Figure 1: Digital allocation in marketing budgets

If you oversee a product or marketing budget, which percentage of

the marketing budget is allocated to digital initiatives this year?

Source: Across Health Multichannel Maturometer 2019

34 www.pmlive.com Pharmaceutical Market Europe November 2019


Multichannel maturity 2019
According to the Across Health Multichannel
Maturometer 2019 study, the pace of digital
transformation across pharma is as slow now as it was
in 2015. Moreover, while 90% of the industry believes
pharma will be disrupted by digital technologies,
well under half think their companies are preparing
adequately for the inevitable. It’s a perception that
provides powerful context for the multifaceted
multichannel challenges facing pharma in Europe.
The Maturometer study, now in its 11th year, allows
companies to benchmark their own multichannel
performance against their peers in four core areas:
people, strategy & organisation; business processes
and technology; measurement; multichannel
integration. The 2019 results reveal that 87% of
respondents think their companies are still some
distance from being ideal organisations in terms
of their ability to use digital to improve customer
engagement and business impact. Furthermore,
satisfaction with digital is simply not increasing; little
more than 10% are satisfied with their company’s
digital/multichannel activities, mirroring satisfaction
levels reported in 2010.
However, despite the apparent failure to gain
ground, pharma’s investment in multichannel
has reduced in the past 12 months. After three
consecutive years of robust growth, digital marketing
budgets have fallen to 2017 levels – with 57%
allocating less than 15% of their marketing budget
on digital. The average allocation – 19.1% – is lower
than in 2018 (Figure 1). But the law of averages
disguises a digital dichotomy: there are lots of laggard
beginners with small budgets being hidden by the
more advanced companies that are spending a lot.
Figure 2: Marketing tactics/channels
How often did you use the following multichannel marketing tools today?
Pharmaceutical Market Europe November 2019
TECHNOLOGY AND HUMAN SKILLS
Investment in digital
So where is that investment going? The
‘multichannel rep’ is growing in strength, with reps
increasingly equipped with digital tools like tablet
e-Detailing and approved email. However, remote
detailing and eRep capabilities continue to lag. On
the marketing side, product/disease websites and
eNewsletters are the most popular tactics (Figure
2), while web banners on third party media remain
a prominent approach. Patient websites and HCP
self-service portals are already standard practice
in almost half of companies, while the number of
pilots in these areas suggests penetration is likely
to increase further.
‘The leaders of tomorrow will be
those who align their businesses
around the customer to deliver
personalised journeys and
omnichannel experiences that
are fit for the 21st century’
In terms of the adoption of digital technologies,
content management systems are by far the most
widely used, while marketing automation tools
are rising fast. However, health tech solutions
like AI, chatbots, wearables and predictive
analytics are only just on pharma’s radar. The use
of technologies to help personalise content – a
key area for pharma as customers reject ‘noise’
and look for more targeted content – is standard
practice in less than a fifth of organisations.
If pharma is to reap the benefits of personalisation
and harness the opportunities of marketing
automation, companies need to strengthen their
customer insight capabilities and build a 360
degree view of the customer through better
integration of marketing and sales.
Strategy and skills
However, to focus on investment in channels
and technologies is to start in the wrong place.
Companies need to think customer-first not
channel-first, and this should be reflected
in a clearly defined upfront strategy. “Some
organisations still make the mistake of starting with
tactics,” said Fonny Schenck, CEO, Across Health.
“However, best practice begins with defining
strategic imperatives then identifying the proxies
that will translate them into something actionable.
For example, what are the behavioural objectives,
leverage points and associated messages needed to
generate the greatest impact? Then it’s a matter of
determining how you will achieve conversion; which
content or services will drive the action/change you
want? It’s only once you’ve been through these three
steps that you can begin to consider tactics and
channels. Unfortunately, many companies start in
the wrong place.”
The 2019 Maturometer backs this up. When
asked about their priorities, digital teams believe
their companies should focus much more on
strategy than on enablers like technology, tactical
content and campaign development. Suboptimal
strategy is highlighted as one of the biggest
barriers to digital transformation in pharma;
managers believe that the absence of a clear
Source: Across Health Multichannel Maturometer 2019
www.pmlive.com 35
 TECHNOLOGY AND HUMAN SKILLS
strategy is a real obstacle, while the perceived
lack of internal knowledge around digital is
another cause for concern. The strategy void is
even stronger in ‘emerging’ digital functions like
medical and sales, where ‘lack of strategy’ and
‘no clear business case’ for digital are the top two
bottlenecks.
The digital skills gap is a long-standing problem.
Less than a quarter of respondents (23%) believe
their companies have strong digital/multichannel
teams (with board support), while only 7%
completely agree that their staff are well trained
in digital skills. “In order to define and execute a
solid strategy, you of course need motivated and
skilled people who know the business and how
technology can galvanize and transform it,” said
Fonny. “This key condition for success remains
elusive in pharma: in 2019, less than 10% of the
business functions – marketers (9%), medical
(8%) and sales (6%) – feel they are digital experts.
For digital/multichannel teams the picture is
– perhaps surprisingly – only marginally better
(15%).”
Remarkably, almost two thirds of marketing
(63%) don’t believe they have sufficient knowledge
of digital opportunities (Figure 3).
One of the biggest areas of perceived
weakness is the ability to make decisions around
‘channel mix’; just 8% fully believe that this
challenge has no secrets for them. This clearly
illustrates the need to reinforce capabilities
in this vital area. However, while digital teams
increasingly believe that they’re well integrated
within their business, more than half (52%)
Figure 3: The digital knowledge gap
Do you feel that you have sufficient knowledge of all the opportunites
offered by the internet for your business activities?
36 www.pmlive.com
don’t think they’ve got robust processes in place
to help them define the right channel mix. And
less than a fifth think their company has robust
technology (17%) and strong SOPs (15%) to
enable its digital strategy.
The key to digital transformation
So what does all this mean? The Across Health
study once again reveals huge variation in digital
maturity across the industry. A surprisingly high
number of companies are still not doing digital
activities at scale, preferring to invest in third-party
media or isolated activities that suffer through a
lack of integration. Others have progressed further,
adopting approaches ranging from single-channel
pilots or cross-channel campaigns to the use of
multiple sales and marketing channels in glorious
isolation. The most advanced have created a
platform for more coordinated sales and marketing
activity, marking a shift from ‘share of voice’ model
to a ‘quality of voice’ approach based on a 360
degree view of the customer. This is the gateway to
omnichannel excellence.
However, technology alone is not enough.
“Success is about focusing on the ‘hard and the
heart’,” said Fonny. “Many of the ‘hard’ enablers
are already in place; multichannel rep technology
is omnipresent and most basic channels are
commonplace; sizeable digital teams exist at
both international and local level, and even
marketing automation is beginning to rise through
the ranks. However, the missing enablers are the
human ones; the skills, culture and organisational
capability that help to win hearts and minds.”
Fundamentally, says Fonny, there are four key
components that must be in place to ensure a
successful digital transformation. “Primarily,
you need a robust, quantified business case –
a ‘burning platform’. Secondly, this must be
underpinned by a solid strategy, roadmap and
vision. Thirdly, you need a coherent set of
technological, organisational and skills enablers –
the ‘hard’ and the ‘heart’. Often companies believe
that if they invest in the tech, the rest will follow.
It won’t. You have to invest in both. And finally,
you have to work out where you’re going to start.
This crucial aspect is often overlooked. Companies
want to see quick wins, so it’s important to plan
‘multiple shots at the goal’ and short time-to-
impact first steps. The most successful companies
embrace agility; they experiment, learn, grow and
adapt, and empower their teams with the hard and
soft enablers to make change happen.”
The 2019 Multichannel Maturometer confirms
that pharma still has work to do in all four areas –
not least the all-important component of capability-
building at all levels. The digital dichotomy at the
budget level shows that the market is moving at two
speeds, with leaders going from strength to strength
and laggards failing to move forward. The leaders of
tomorrow will be those who align their businesses
around the customer to deliver personalised
journeys and omnichannel experiences that are fit
for the 21st century.
Chris Ross is a freelance writer specialising in the
pharmaceutical and healthcare industries
Source: Across Health Multichannel Maturometer 2019
Pharmaceutical Market Europe November 2019
 www.pmlive.com/t40

T40
TOP FORTY
CREATIVE
HEALTHCARE
AGENCIES UK

Creative
companions

PMLiVE’s T40 list aims to identify the creative

agencies which have had the most impact on
advertising, branding, creative and design projects
in the UK healthcare sector in 2018.*
Visit www.pmlive.com/t40 to inspect the pedigree of those creative
agencies leading the way in the UK healthcare sector. Using data verified
by the agencies that took part, you can compare on a number of different
metrics and view Top 10 lists for smaller agencies, independent agencies,
young agencies, UK focused agencies and agencies with the waggiest tail**

Creativity comes in all shapes and sizes, so

whether you’re looking for your new best
friend or checking on your current creative
companion - it’s worthwhile sniffing out this
year’s T40.

You can also find out online how the list was
put together, what metrics were used and
how the agencies submitted their data.

*PMLiVE does not recommend or approve any of the agencies on the T40 list and does not guarantee the validity of any of the data shown. The T40 is not a
comprehensive list of all agencies working in this sector. Agencies not shown may be outside of the top 40, may have declined to participate or provide any data
and there may be some agencies PMLiVE were not aware of when generating the initial shortlst.
**Waggiest tail, glossiest coat, most adorable eyes and cutest smile top 10 lists will not be released to the public.
 Four digital health trends set to
reinvent and re-energise pharma
Why AI is set to transform the nature of healthcare
hen British Secretary of State for Health
W and Social Care Matt Hancock addressed
the Public Health England annual
conference in September, his speech provided
valuable backing for the prediction that AI is set
to transform the nature of health provision.
His observation that ‘personalised prevention’
enabled by the ‘data-crunching power of AI’ will
become the guiding principle of public health
in the 2020s, and the increasing dominance
of digital health in general, presents huge
opportunities for pharma companies, and not just
in terms of cost savings.
It has the potential to help pharma firms
transform their relationships with the end users
of their products, aiding the creation of more
meaningful connections with consumers.
So how will this happen? There are four
initiatives that pharma companies can adopt to
benefit from the digital technologies reinventing
consumer health:
Use voice recognition to power
consumer connections
Voice recognition technology is now a critical
dimension of device design. Leading analyst
Emarketer predicts that over a third of Americans
will be using a voice assistant like Siri or Alexa
this year, up 9.5% from 2018. As such, it offers
a multiplicity of possibilities for improving patient
care.
Removing the need to read a screen or type
on a keyboard is clearly of huge physical benefit
to older people and those who are unwell. So,
for pharma companies, a big opportunity is to
programme AI assistants to act like a virtual
health companion, using voice to remind users to
take medication or attend medical appointments.
This is particularly appealing for chronic
conditions like diabetes, where patients need to
undertake numerous steps. But it is also a potent
tool for people affected by memory issues.
On a purely product-related level, voice-enabled
38 www.pmlive.com
By Amanda Glasgow
interaction with patients offers the chance for
better success rates for drugs if outpatients
can be helped to take them consistently.
However, thinking more broadly, people suffering
unexpected new symptoms (eg shortness of breath
or sharp bouts of pain) could use voice to record
their nature and frequency. Voice is so simple that
people could build an accurate pattern of their
condition before making their doctor appointment.
And there are other possibilities. Changes in an
individual’s mental health, for example, could
be monitored, as some early research has shown
potential for detecting depression via speech.
‘Becoming visible, active partners
in consumers’ management of
their health might feel like an
ambitious target at the moment,
but tech evolves fast – in just
a few years, the early health
tech-adopting pharma companies
may have earned the right to sit
beside consumers in their homes’
All the above are opportunities for pharma
companies to forge an authentic, proactive
relationship with people long before they are
waiting in line to pick up their prescription. Rather
than just being a provider of drugs, enlightened
pharma firms can create a holistic relationship
with patients based around helping them take
responsibility for their long-term health. Given that
the pharma industry is prevented from advertising
directly to consumers in most countries, voice is
potentially a revolutionary communication channel.
Implicit in all this is that pharma companies can
develop a distinctive personality, making them
relatable to end users and driving brand trust/loyalty.
For pharma, the risk of not harnessing voice is
that others will. One of the first in-home voice-
controlled health assistants has already been
launched this year by US firm Stanley Black
& Decker. Its Pria system – a physical device
that is linked to an app – can schedule up to
28 medication doses, provide reminder alerts,
dispense the correct medication at the correct
time, track caregiver visits and provide 24/7
customer service. This is a space pharma needs to
become involved in.
Harness IoT to create real-time
interactive relationships
The monitoring and management of health
conditions is moving forward with the help of AI.
Apps in conjunction with physical devices – either
worn by the user or sited within the home – can
create a comprehensive system for tracking
patients’ movements and behaviour, feeding back
data to medical professionals and/or friends and
family. On an immediate level this allows for better
patient support as the dynamic analysis of this
data could allow for instant adjustments to care.
For example, Abilify MyCite is the first ‘digital
medicine’ approved by the FDA in the US. It’s a
combination of antipsychotic drug aripiprazole and
an ingestible sensor made by Proteus Digital Health.
When patients swallow the drug, the sensor sends
a message to a patch worn on their skin, recording
the date, time and physiological information. This is
then fed to an app on the patient’s mobile.
Although much of the development of AI health
products so far has been by tech or hardware
specialists, pharma companies are waking up
to the possibilities offered by the ‘Internet of
Medical Things’. Pfizer appears to be the furthest
ahead, putting the company in pole position to
both enhance patient care and strengthen its
connection with end users.
Pharmaceutical Market Europe November 2019

The US firm is collaborating with IBM on a
fascinating project (BlueSky) that has equipped a
house with masses of sensors on everything from
kitchen cupboards to fridge handles. It has been
designed to track disease progression in Parkinson’s
sufferers. They are invited to spend time in the house
and the data collected helps physicians understand
their condition via their patterns of movement.
Personalise and improve
products through big data
Alongside the benefits of real-time tracking
outlined above, another key benefit of projects like
Pfizer’s BlueSky is the vast amount of rich and
relevant data generated. Once this data has been
analysed and fed back into the drug production
process, it allows the company to fine-tune
treatments for patients in the house by showing
how medication affects physiological changes.
This is a fine illustration of the new era of
personalised medicine – and the advantages
aren’t just for the small number of patients in the
pilot project house. Once the data is aggregated,
this will enhance the creation of all Pfizer’s
medications for Parkinson’s.
Right now, there are three main challenges for
drug firms like Pfizer operating at this cutting
edge. Firstly, the significant cost of investing in
and experimenting with IOMT projects to discover
how best to use the technology. Secondly, the
issue of patient data privacy. Decisions over how to
ask for consent to use data and the limits of what
the data is used for will take time to evolve.
Pharmaceutical Market Europe November 2019
Meanwhile, companies must ensure that
even where legislation hasn’t yet kept up with
developments, they remain on the right side of the
ethical line without incurring unnecessary costs.
‘The increasing dominance of
digital health presents huge
opportunities for pharma
companies, with the potential
to help them transform their
relationships with end users’
Finally, pharma companies aren’t the only ones
with amazing data. The company that owns Fitbit,
for example, now has nine billion nights of sleep
data available to analyse. But the Pfizer example
is an indication of the prize available for pharma
companies that can harvest in health data, either
through bespoke, value-add experiments or apps/
devices that capture the public imagination.
Shift mindset/culture from pill
pusher to life partner
What seems to be evident from each of these
trends is that they give pharma companies an
unprecedented opportunity to connect with
consumers in a completely new way.
DIGITAL HEALTH TRENDS
No longer just manufacturers and suppliers of
pills, these digital health trends will enable
pharma to develop a service-based model and
take an active role in patient education and
holistic care on a daily basis.
In the same way, fintech companies are using
technology to shift from offering banking to
becoming partners in their customers’ financial
management, pharma firms – either alone or in
partnership – can become service providers (with
all of the new revenue streams that potentially
unlocks).
Becoming visible, active partners in consumers’
management of their health might feel like an
ambitious target at the moment, but tech evolves
fast. In just a few years, the early health tech-
adopting pharma companies may have earned the
right to sit beside consumers in their homes.
Investing in emerging technologies isn’t
without risk. And for pharma firms in particular
there are regulatory considerations: firms will
need to ensure they are not breaching strict
UK regulations when adopting AI-powered
technologies such as voice, IoT and data.
But this is not a reason to hold back from
experimentation and careful implementation. As
Pfizer’s leadership has recognised, sometimes
it’s important to get involved early to reap the
benefits.
Amanda Glasgow is Head of Experience, EMEA, at
digital consultancy Appnovation
www.pmlive.com 39
 AI: opportunities and barriers
to improving healthcare
How AI is shaping the future of healthcare
he advancement of AI and machine learning
T in providing better healthcare is already on
the rise across the UK. Increasingly clinicians
are conscious that machine or automation-based
healthcare enable a host of benefits due to the
many innovative projects that are underway.
The NHS’ long-term plan has ambitions to
drive its digital transformation to maximise the
very practical benefits AI can provide. Currently,
the main barriers to progress are the difficulties
that some innovators encounter when negotiating
unfamiliar regulations, lack of clinical safety and
efficacy evidence, data curation standards, talent
and skills, fear of change and concerns about the
impact of working practices and relationships with
patients.
Despite this, perception is increasingly
changing. As wider society embraces new
technologies, such as Amazon’s Alexa, there is a
noticeable shift in attitude. Smart speakers are
a brilliant example of an innovative piece of tech
that although they haven’t been designed with
healthy ageing in mind, will develop and support
us as we get older.
From predicting risks in illness to streamlining
resources, through our work at UKRI, we support
innovators from a range of different fields,
including fintech and engineering as they turn
their attention to finding solutions to ease the
pressure on our national health service. Some of
these solutions are already making an impact in
the field.
Freeing up clinician resource, E-Observations
(eObs) allow doctors to observe patients digitally
through hand-held devices and send them
automatic alerts when patients are identified as
being ‘at risk’. Similarly, to increase efficiency,
Gendius is developing apps and artificial
intelligence to measure and improve outcomes for
patients with diabetes. The app, which is already
available on Apple and Android, uses machine
learning to predict disease progression and then
help manage risk.
40 www.pmlive.com
By Kath Mackay
Both of these innovations, of course, lessen
the burden on clinicians, but they could also
contribute to far earlier diagnosis, meaning
better and faster care, and fewer long-term
health complications. Similarly, AI can deliver
exceptionally tailored treatment plans that will
have the same effect. Snoozeal has developed a
device to treat obstructive sleep apnoea, which
contracts muscle at the rear of the tongue, through
the use of a 20-minute daily toning regime of mild
electric pulses. The device aims to be connected
to an intelligent platform to collect biosensor data
of tongue tone, which will be classified by machine
learning, and AI-based to deliver personalised
treatment regimes.
‘AI should be viewed as a tool
to drive efficiency and accuracy
in the healthcare system by
enhancing decision-making,
and not as a replacement for
human interactions between
medical staff and patients’
One of the most exciting developments is within
one of the biggest challenges of our generation,
dementia. In less than 20 years, the number of
people aged 65 and over in the UK will increase by
more than 40%. One in four of the population will
be in this age bracket, and the rate of dementia
sufferers will increase with it, testing the structure
of our health service, but technology can help in
the battle against the disease, and it already is.
Mind over Matter MedTech is improving early
diagnosis in dementia by trialling novel, low-cost
and portable brain imaging technology. This tests
patients’ personalised risk for developing the
condition at least a decade before any clinical
symptoms would appear, potentially reducing the
chance of a cycle of irreversible neuronal death.
Importantly, all of these innovations free up
time, allowing practitioners to concentrate tight
resources on the most serious cases.
Introducing more innovation into the ‘problem’
of providing healthcare to our ageing society isn’t
just an opportunity to provide a more efficient and
cost-effective service to the end user, but also an
opportunity for tech companies to fulfil an ever-
increasing need.
However, to ramp up the support for AI, we do
need to address the very natural human hesitancy
to adopting artificial intelligence. There are a
range of concerns, many of which are justified,
including the issue of data and privacy, as the new
partnership between the NHS and Amazon’s Alexa
exemplified. Naturally, data security needs to be
addressed when handing our private information
online and people are reluctant for AI to have too
much information about what our profiles look like.
Given the importance of data security, guidance
has been developed and a code of conduct for
data-driven health and care technology has been
drawn up by the NHS.
The diminished number of human touchpoints is
also a concern for many. The practice of medicine
aims to be an exact science, but lived experience
tells us there is an art in diagnosis, because
human bodies rarely follow a rule book.
For older patients, the potential lack of face-to-
face interaction could have serious consequences
– with isolated individuals already experiencing
loneliness, this could take away an important lifeline.
What AI can do, however, is give medical staff
more time to concentrate on the more human
elements of their roles, as complicated, boundary-
breaking cases are as important as taking the time
to talk. AI, therefore, should be viewed as a tool
to drive efficiency and accuracy in the healthcare
system by enhancing decision-making, and not
as a replacement for human interactions between
medical staff and patients.
Pharmaceutical Market Europe November 2019

The possibilities of what we can achieve could
expand with AI. The potential that AI promises
for early detection of disease and helping people
before symptoms appear means the speed and
efficiency with which results can be delivered is
increased. This ultimately means patients can be
moved out of a hospital setting and treated in the
community, addressing the wider goals of lowering
costs and increasing efficiency in the NHS, while
also leading to a longer, healthier life.
The Government is increasingly backing the
need for innovation in the future of healthcare.
The formation of NHSx, a new joint organisation
for digital, data and technology progression and
the £250 million funding that the Prime Minister
recently pledged to an artificial intelligence
laboratory to boost dementia research shows the
growing interest in the area.
In addition, the £98m Industrial Strategy
Challenge Fund (ISCF) Healthy Ageing Challenge
has just launched its first funding competitions,
looking for innovative solutions for healthier,
happier and more independent lives as we age.
Both of these funding opportunities give an
insight into the growing national interest in AI,
opening a door for the UK to potentially be a world
leader in both its use and application.
To achieve this, it is important that we have
experts on board from a wide range of industries
Pharmaceutical Market Europe November 2019
who have the opportunity to be ambitious in
developing products which meet forward-thinking
but necessary requirements. Specialists such as
doctors, business leaders and academics will be
key to reaching our full potential.
‘Understanding and embracing
the enormous potential of
digital technologies and AI
is fundamental to creating a
healthcare system suitable
for 21st century demands’
There is also a large opportunity for businesses
and investors who have vital knowledge to offer
expertise on the practical side of bringing AI
products to market.
There are now hubs in the UK that are driving
forward technological advancements in healthcare.
We have five new centres of excellence for digital
pathology and imaging, including radiology, which
use AI medical advances; they have already been
established in Leeds, Oxford, Coventry, Glasgow
and London – each with partners across many
parts of the UK. The centres will develop more
AI AND HEALTHCARE
intelligent analysis of medical imaging, leading
to better and more efficient clinical decisions for
patients, and therefore giving more staff time for
direct patient care in the NHS.
Each of the new centres can enable companies,
in particular small- and medium-sized enterprises,
to develop rapidly, and trial and implement
products and tools through the NHS, for example,
testing the use of AI to highlight potential
disease in a chest x-ray. Through the centres,
businesses will work with academics, doctors,
patients and health economists, who can provide
their experience in the industry to support new
treatments and medicines that can save and
sustain lives.
Understanding and embracing the enormous
potential of digital technologies and AI is
fundamental to creating a healthcare system
suitable for 21st century demands. As our ageing
population continues to grow, it’s important we keep
innovating and seeking opportunities to improve.
By doing so, we can develop the new tools our
doctors and clinicians need to deliver excellent
standards of patient care and sustain the UK as a
global leader in healthcare innovation.
Kath Mackay is Director of Ageing Society, Health
and Nutrition at Innovate UK
www.pmlive.com 41
 APPOINTMENTS
Gilead
MERDAD PARSEY
Gilead has appointed Merdad
Parsey as chief medical officer.
He will take responsibility for
the company’s global clinical
development and medical affairs
organisations. Parsey joins from
Roche Group’s Genentech, where
he held the position of senior vice
president, early clinical development
in the Genentech Research and
Early Development group. Prior to
Genentech, he served as president
and CEO of 3-V Biosciences.
Sirtex Medical
KEVIN SMITH
Sirtex Medical has appointed Kevin
Smith as chief executive officer,
based on his proven leadership
and expertise in the healthcare
and pharmaceutical sectors.
Prior to becoming the interim
CEO of Sirtex, Smith served as
executive vice president, sales
and marketing for the Americas
at the company. Before Sirtex, he
served as executive vice president
of business development at Gel-e.
42 www.pmlive.com
Eli Lilly
MIKE MASON
M
ike Mason is set to take
on the role of senior vice
president of Lilly and
president of Lilly Diabetes and
Lilly USA. He will succeed Enrique
Conterno, who will retire from the
role at the end of the year. Mason
is a 30-year Lilly veteran, and has
experience across the company,
Gilead
ANDREW DICKINSON
Also joining the senior leadership
team at Gilead is Andrew
Dickinson, who has been
appointed as chief financial
officer. Before being promoted
to CFO, Dickinson served as
Gilead’s executive vice president,
corporate development and
strategy. Prior to joining Gilead in
2016, Dickinson worked at Lazard
Frères & Co. for almost a decade,
and served as global co-head of
healthcare investment banking.
Vertex
CARMEN BOZIC
Vertex has promoted Carmen
Bozic to executive vice president,
global medicines development
and medical affairs, and also
as its new chief medical officer,
effective 1 April 2020. Bozic
has been leading the clinical
development of the company’s
cystic fibrosis and alpha-1
antitrypsin deficiency programmes.
Prior to joining Vertex, she
spent 20 years at Biogen.
with significant expertise in its
diabetes business. He currently
serves as senior vice president,
connected care & insulins, and
began his career as an engineer
making insulin. During his
time at Lilly, Mason has led
its connected care business,
which leverages technology to
Smith+Nephew
ROLAND DIGGELMANN
Smith+Nephew has appointed
Roland Diggelmann as the
company’s new chief executive
officer. Diggelmann joined
Smith+Nephew’s board as a
non-executive director in March
2018, after departing from his
position as chief executive officer
of Roche Diagnostics. Prior to his
time there, he spent 12 years in
the orthopaedics sector, serving
in strategy and leadership roles at
Sulzer Orthopaedics and Zimmer.
Amgen
PETER GRIFFITH
Peter Griffith has been appointed
as executive vice president, finance
and chief financial officer of
Amgen, succeeding current CFO
David Meline on 1 Jan 2020. He
joins Amgen from Sherwood
Canyon Group, a private equity
and advisory firm, where he
served as president. Previously,
he retired from EY following a
distinguished career, including
almost 22 years as a partner.
Pharmaceutical Market Europe November 2019
enhance insulin delivery and
improve user experience. He also
steered Lilly’s efforts to improve
insulin affordability, including
the creating the Lilly Diabetes
Solution Center, which supports
people in need of less expensive
alternatives to their insulin, which
will continue under his leadership.
Zosano
STEVEN LO
Zosano has appointed Steven Lo
as its new president and chief
executive officer. He was most
recently the chief commercial
officer at Puma Biotechnology,
and previously worked as
senior vice president and chief
commercial officer at Corcept
Therapeutics. Earlier in his
career, Lo spent 13 years at
Roche Group’s Genentech, and
started his career in the pharma
industry at AstraZeneca.
Achilles Therapeutics
BEVERLEY CARR
Beverley Carr has been
appointed as chief business
officer of Achilles Therapeutics,
a UK-based biopharmaceutical
company. She brings over 20
years of business development
experience in global pharma and
biotechnology companies. Prior to
joining Achilles, she served as vice
president, business development
for the immuno-inflammation
therapy area at GlaxoSmithKline.

Sensydia
ANTHONY ARNOLD
Sensydia Corporation has
appointed Anthony Arnold as
president and chief executive
officer, and to the company’s
board of directors. Arnold has
expertise in bioelectronic medicine
and surgical navigation, and has
more than 20 years’ experience
from a number of medical
technology companies, including
SetPoint Medical, Smith+Nephew,
Medtronic and Boston Scientific.
Kintai Therapeutics
FRANCESCA BARONE
Kintai Therapeutics has appointed
Francesca Barone as its new
head of experimental medicine.
Over the past six years, Barone
has worked across academia and
industry to establish collaborative
partnerships to accelerate drug
development. Prior to joining
Kintai, Barone was a reader
and academic head of business
engagement for the College of
Medical and Dental Science at the
University of Birmingham, US.
BiomX
MERAV BASSAN
BiomX has appointed Merav Bassan
as chief development officer. She has
extensive experience in developing
therapeutics from early discovery
stages through to clinical trials
and marketing, and will oversee
BiomX’s pre-clinical and clinical
development. Bassan was vice
president head of translational
sciences at Teva Pharmaceuticals,
where she managed projects in
multiple therapeutic areas.
Pharmaceutical Market Europe November 2019
NBE-Therapeutics
STEFFEN HEEGER
Swiss biopharma company
NBE-Therapeutics has appointed
Steffen Heeger as chief medical
officer. He will lead the clinical
development of the company’s
first lead programme. Heeger has
over 15 years' industry experience
in the clinical development of
targeted cancer therapies. He has
held senior medical positions at
Merck-Serono, MorphoSys and most
recently served as CMO at Selvita.
Alexion
TANISHA CARINO
Alexion Pharmaceuticals has
appointed Tanisha Carino as
executive vice president and its
first chief corporate affairs officer.
Prior to joining Alexion, Carino
served as the executive director
of FasterCures – a centre of the
Milken Institute. Before taking the
lead there, she was an executive
at GlaxoSmithKline, where she
led the US policy function,
and previously spent over a
decade with Avalere Health.
Akouos
RABIA GURSES OZDEN
Akouos has appointed Rabia Gurses
Ozden as its chief development
officer. She brings over 15 years’
clinical development operations and
medical affairs experience with novel
therapeutics and medical devices.
She served as chief medical officer at
Nightstar Therapeutics, which was
acquired by Biogen this year. Prior
to this, she held leadership positions
at Applied Genetic Technologies
Corporation and GlaxoSmithKline.
BioMarin
LON CARDON
BioMarin Pharmaceutical has
promoted Lon Cardon to chief
scientific strategy officer, a newly
created role aimed at enriching the
company’s pipeline. Prior to joining
BioMarin, Cardon was senior vice
president of alternative discovery
and development, and head of
target sciences at Glaxo SmithKline.
Previously, he was a professor and
Wellcome Trust principal fellow
at the University of Oxford.
Metabolon
KARL BRADSHAW
Karl Bradshaw has been appointed
as Metabolon’s vice president of
biopharma strategy and partnering.
He joins from AstraZeneca, where
he most recently served as senior
director of corporate strategy and
development. Bradshaw had
various roles during his time at
AZ, including head of competitive
intelligence for infection,
neuroscience and GI. Prior to this
he worked as vice president of
equity research at Morgan Stanley.
Abzena
KIMBALL HALL
Kimball Hall has been appointed
as chief operating officer at
Abzena. She joins Abzena from
Genentech, where she served
for four years as SVP and global
head of drug substance. Hall
worked for 16 years at Amgen in
a number of roles of increasing
responsibility. She has held various
board and advisory positions,
including being a member of the
Genentech Executive Committee.
APPOINTMENTS
Lyra Therapeutics
DANA WASHBURN
Dana Washburn joins Lyra
Therapeutics as its new chief
medical officer. Washburn has
almost 20 years' experience in
the pharmaceutical and medical
device industries and has expertise
in leading teams to achieve
clinical trial milestones. Most
recently, Washburn held the role
of corporate vice president and
head of global medical services
for Paraxel International.
Mundipharma
MATTHEW HOMENT
Mundipharma, a global network
of privately owned independent
companies focused on medicine
development, has appointed
Matthew Homent as Ireland
Country Manager. He joins from
Napp Pharmaceuticals, where he
served as director of commercial
operations. Homent has been
with the Mundipharma network
for over 20 years, moving to Napp
in 2003, where he progressed
through a number of roles.
Magenta Therapeutics
JAN PINKAS
Magenta Therapeutics has appointed
Jan Pinkas as senior vice president,
translational sciences. Pinkas
has expertise in leading drug
development programmes. He
was head of translational research
and development at Immunogen,
where he led non-clinical and
translational research and
development related activities for all
programmes in discovery through
to late-stage clinical development.
www.pmlive.com 43
 APPOINTMENTS
Life Healthcare Communications
CAITLIN MCMASTER
Strengthening the team at Life
is Caitlin McMaster, who has
been appointed to the role of
associate copywriter. McMaster
initially joined Life as an account
executive, so brings client services
experience to her new role. She
also brings a wealth of creativity
and scientific knowledge, having
graduated with a Masters in
Chemistry with Forensic Analysis
from the University of Reading.
Sudler London
FAISAL AHMED
Faisal Ahmed has joined Sudler
London as director of innovation
and business transformation.
In this role, he will oversee
innovation and business
transformation at the company,
and will be responsible for
accelerating innovation in health
communications. Ahmed’s career
includes a decade of experience in
health communications, and was
also one of the founding members
of the Amazon UK start-up team.
Wilmington Healthcare
ROGER TOMLINS
Wilmington Healthcare has
appointed Roger Tomlins as a
senior consultant. He has worked
in healthcare for over 16 years,
in both the pharmaceutical
industry and the NHS. He joined
Wilmington Healthcare from
Bristol-Myers Squibb, where he was
senior regional access manager.
Prior to that, Tomlins worked
for Pfizer Essential Health as a
clinical effectiveness consultant.
44 www.pmlive.com
McCann Health
JILL BEENE
McCann Health has appointed
Jill Beene as president of McCann
Health Echo. Most recently, Beene
led H4B Catapult, part of Havas
Health and You, and held senior
strategy and account planning
roles at CDM Princeton and New
York. She previously worked at
Y&R and BBDO, among others.
She will become a member of
McCann Health North America’s
executive leadership team.
Springer Healthcare
ANNA BARTUS
Joining Springer Healthcare is Anna
Bartus, who has been appointed
as associate medical director,
where she will strengthen the
scientific knowledge and creativity
of the services team. She is a fully
qualified medical doctor, with over
six years of experience working
with the pharmaceutical industry,
medical communications agencies
and the National Health Service.
She will be based at the Springer
Healthcare offices in London.
Wilmington Healthcare
SARAH SHIELD
Also joining Wilmington Healthcare
as a senior consultant is Sarah
Shield. She has worked in the
pharmaceutical industry for 14
years, and has experience of
providing consultancy on market
access, strategic partnerships and
government affairs. Previously
Shield was national policy
and partnership lead for
AstraZeneca UK’s cardiovascular
and renal franchise.
Unilabs
ALISTAIR HAMMOND
Unilabs has appointed Alistair
Hammond as director of
communications, making him
responsible for all internal
and external comminations,
including public affairs, executive
communications and public
relations. Previously he was
global director of media relations
and PR at CWT. Hammond has
over 20 years of experience in
media and communication.
Springer Healthcare
SIMON MITCHELSON
Also joining the team at Springer
Healthcare is Simon Mitchelson,
who has been appointed as a
senior business development
manager. In this role, he will
consult with industry clients
across medical education, medical
communication, sales force
training and MSL support. He has
over 15 years’ experience in the
pharmaceutical and healthcare
industry, and has worked for
MSD, Langland and Havas Lynx.
Prime Global
SUE O’LEARY
AND REBECCA MASSEY
Prime Global has appointed Sue
O’Leary as the leader of its market
access practice. She will support
the business across the group’s
six medical communications
agencies. Rebecca Massey joins
as senior director, global market
access & HEOR. Both O’Leary
and Massey have experience of
delivering evidence-based pricing
and market access communications.
Pharmaceutical Market Europe November 2019
Ashfield
RICHARD CLARKE
Richard Clarke has been
appointed as commercial and
patient solutions business
development director at
Ashfield. He has over 30
years of experience in the
pharmaceutical industry, having
held various national and global
roles at GSK and AstraZeneca,
including head of global SFE
and UK head of commercial
learning and development.
Red Consultancy
AVRIL LEE
Red Consultancy has appointed
Avril Lee as a managing director of
its healthcare team – Red Health.
She will look after the day-to-day
leadership of the health comms
division while its managing
director Rebecca Ferguson is on
maternity leave. Lee has over 20
years of global and UK healthcare
experience, in corporate and
brand communications, for
a range of pharma, biotech,
diagnostic and health companies.
Swordfish Advertising
SARAH RUSH
AND SARAH VICKERY
Swordfish Advertising has promoted
two senior members of its client
services team. Sarah Rush has been
appointed as client services director,
and has over ten years’ experience in
healthcare communications. Sarah
Vickery has been appointed as group
account director. She has over ten
years’ experience in the healthcare
sector and has successfully managed
a number of accounts for the agency.

McCann Worldgroup named European Agency
Network of the Year at 2019 Euro Effie Awards
M
cCann Worldgroup has been named
European Agency Network of the Year
for the first time in ten years at the
2019 European Effie Awards, which took place
in Brussels last month.
The Effie Awards are known globally by
advertisers and agencies for recognising all forms
of marketing communications that contribute
to a brand’s success. It celebrates effectiveness
worldwide with the Global Effie, regional Asia
Pacific, Euro, Latin American, North American
and Middle East/North Africa Effie programmes.
The Europe Effie Awards seek to promote
and recognise excellence in marketing
communications among campaigns that have run
in at least two European countries and can prove
effectiveness in those countries.
The award follows McCann Worldgroup being
number one in the European Effie Index for three
consecutive years. Winning entries with multi-market
campaigns that originated from the UK, Spain, France,
Germany, Russia and Greece helped shape McCann
Worldgroup’s performance in the region.
ONEHealth bolstered by
Bartlett Davis acquisition
O
NEHealth, a healthcare marketing
agency, has acquired media specialist
Bartlett Davis Communications.
The acquisition comes on the heels of the
development of ONEHealth’s services and strategy and
comes at a pivotal time for both companies, following
the launch of the NHS Long Term Plan earlier this year.
“This deal will create an extraordinary opportunity
for both us and our clients. We now have an
enviable pool of specialist talent to tap into,
which will not only serve us today, but also create
a strong foundation for the integrated future of
the healthcare landscape,” said Veronique Cotrel,
managing director of ONEHealth Communications.
“Bartlett Davis is an established company with a great
reputation, and the acquisition will add an invaluable
dimension to the ONEHealth offering,” she added.
ONEHealth’s North East England office
has also moved to Newcastle, with resources
and facilities to match its London office.
“One of the things clients regularly say about
working with both Bartlett Davis and ONEHealth is
that they know they can trust us. This trust comes
about from years of experience, a solid understanding
of the needs of the individual and the priorities
and challenges of the companies they represent,”
said Andrew Davis, co-founder of Bartlett Davis.
Pharmaceutical Market Europe November 2019
HEALTHCARE COMMS
“This is a phenomenal
achievement. Not only
have we gained the
number one position, but
we have done so with an
unprecedented number of
markets across our region
contributing to this record-
breaking performance. This
is a huge tribute to our
client partnerships and
our strategic leadership
in the region,” said Pablo
Walker, president of Europe,
McCann Worldgroup.
“We are thrilled with this result which is collective passion to win on behalf of our clients
shaped by work from so many markets, each with work that works,” he added.
proving success in at least two different European McCann Worldgroup is a global marketing
countries,” said Harjot Singh, chief strategy officer, solutions network, and has over 20,000
McCann Worldgroup Europe and UK. employees across more than 100 countries. It
“Victories like these not only cement our comprises McCann, MRM//McCann, Momentum
shared mission to be individually brilliant and Worldwide, McCann Health, CRAFT, Weber
unbeatable as one; they are living proof of our Shandwick and FutureBrand.
BioMarin opens new Dublin
offices to support growth
B
ioMarin, a global biopharmaceutical manufacturing, Robert Baffi, employees,
company, has opened new offices in members of the medical and life sciences
Dublin, Ireland to provide a hub for
its growing operations across Europe, the
communities, public representatives and
patient representative groups, including Avril
Middle East and Africa (EUMEA). Daly, chairperson of Rare Diseases Ireland.
The new offices, located in Earlsfort “BioMarin has grown to a workforce
Terrace, further strengthens BioMarin’s of close to 500 – Irish-based staff now
presence in Ireland. Last year, BioMarin represent almost 20% of their employees
also announced a €38m expansion of its globally, making Ireland its most significant
manufacturing facility in Cork, which is also location outside of the US,” said Coveney.
currently in progress. “Ireland is a major location for BioMarin
The offices were officially opened by and we’re excited to be growing our
AnTánaiste, Minister for Foreign Affairs & business here. BioMarin is investing in our
Trade, Simon Coveney, at an event that future operations in Ireland to support rising
brought together members of BioMarin’s demand for our rare disease therapies,”
global executive team. added Jim Lennertz, SVP of EUMEA
This included president of global commercial operations at BioMarin.
www.pmlive.com 45
 PEOPLE
What gets you out of bed in the morning?
My alarm clock! I get up early, around 5:30am, so
I can enjoy some peace, a cup of tea and plan my
working day before my three children get up!
What’s the best thing about
working in healthcare comms?
Every day is different and the work so incredibly
diverse. I sometimes don’t appreciate the true
significance of what we are doing until I speak
to a friend and tell them what I have been up
to that day. Being able to tell someone that the
communications you are doing is helping bring
access to patients for a new cancer treatment
reminds you of the importance of the work we do.
What’s the worst thing about
working in healthcare comms?
That sometimes our rules and regulations
can stand in the way of how we may want to
communicate a story. But that’s our job – to work
out a way of telling that story and adding the right
amount of colour that will create impact in a way
that doesn’t break the rules!
What’s your favourite bar or eatery?
Anywhere lively with good, unfussy food and great
cocktails! I recently went to Mel e Pere in Soho
and really enjoyed it.
46 www.pmlive.com
Q&A
Vicky Bramham
Which book/film would you recommend
above all others and why?
I am enjoying reading The Heartland by Nathan
Filer. The author is a mental health nurse and
examines schizophrenia to look at various issues
within mental health and its treatment. It’s written
from his own experience and through interviews
with patients and experts. It’s moving and
enlightening. I can’t put it down.
Which buzzwords/office-jargon
get on your nerves?
Blue-sky thinking, touch base, thinking outside
the box, low-hanging fruit, joined-up thinking...
I could go on.
Which person, living or dead, do
you admire the most and why?
Nelson Mandela – need I say more!
Who’s your healthcare comms hero?
Eric Low, the former Chief Executive of Myeloma
UK. Eric is a tireless and passionate advocate
for the improved care of myeloma patients and
integral in driving innovative approaches to how
new treatments are made available on the NHS.
What has been your career
highlight to date?
Joining OPEN Health Patient & Brand
Communications and working in such a multi-
disciplinary environment. I’ve learnt so many
new perspectives in a matter of months working
closely alongside colleagues in advertising, patient
engagement and insights with one common goal.
What’s your golden rule/piece
of advice for someone starting a
career in healthcare comms?
Work as a team, roll your sleeves up and above all
be flexible and resilient – you need to be prepared
to take the occasional negatives with the many
positives.
Vicky Bramham is Managing Director, PR at OPEN
Health Patient & Brand Communications
Pharmaceutical Market Europe November 2019
 Top job this month
Group Account Director/Client Services Director
London, £70,000 to £80,000
This is a great opportunity for a senior account director/group account director looking for a new role. The successful
applicant will be working directly with the founding partners, and will be handling a variety of small and large pharma
and non-pharma/healthcare clients. In this role, the successful applicant will need to be able to design and deliver digital
marketing solutions to support business and marketing objectives. Applicants must have a minimum of six years’ agency
experience, preferably in healthcare communications. The successful applicant will work as part of a highly motivated
and experienced team. Call Kate on 07557 256508 or email kate@chemistrysearch.co.uk for more information.

November highlights*

Group Account Director
London, £60,000 to £75,000
Applicants need to have experience in a healthcare/
pharma advertising agency to at least senior account
manager level. Call Gavin on 07506 050019 or email
gavin.oneill@media-contacts.co.uk for more information.
Editorial Team Leader – Med comms
London, £50,000 to £60,000
An international healthcare consultancy is looking for an editorial
team leader to oversee its writing team. Applicants must have a
life sciences degree, preferably a PhD. Call Sabine on 01932
797963 or email sabine.willms@id-ss.com for more information.
Senior Account Manager
London/Cheshire, £45,000 to £60,000
A global healthcare comms agency is seeking a senior account
manager. Applicants must be an established account manager
in a healthcare communications agency. Call Jon on 01932
797996 or email jon.gawley@id-ss.com for more information.

Stakeholder and Engagement Manager 5EKGNěKĂE#FUKSOR Senior Medical Writer

Cambridge, Salary negotiable
Applicants must have five years’ experience in developing
and implementing strategies that have driven change in a
multi-stakeholder environment. Call Emma on 01293 850800
or email emma@thorpassociates.com for more information.
London, £45,000 to £60,000
Applicants must have line management experience. Editorial
experience in med comms working with pharmaceutical
groups is desirable. Call Julia on 02073 598244 or email
julia.walton@media-contacts.co.uk for more information.
.ONFONVKěJDGNGĂěS
Applicants must have a PhD and medical education
agency experience, ideally working on both UK and
global accounts. Call Richard on 0208 866 2418 or email
richard@chemistrysearch.co.uk for more information.

Senior Medical Writer Principle Communications Advisor Medical Writer/Medical Editor

Surrey, Salary negotiable
Applicants must have a life sciences degree, and a minimum
of two to four years’ experience as a medical writer or
senior medical writer in a healthcare comms agency. Email
Lauren at lgripton@pararecruit.com for more information.
Cambridge, Salary negotiable
Applicants should have at least ten years’ strategic
communications experience in the health and pharma
sectors. Call Emma on 01293 850800 or email
emma@thorpassociates.com for more information.
London, Salary negotiable
A healthcare communications agency is looking for a medical
writer/editor. Applicants must have a life sciences degree and
one to two years’ experience in a med comms agency. Email
Lauren at lgripton@pararecruit.com for more information.

*100s of live vacancies with more added daily

73 Medical communications 7 Healthcare market research 54 Medical education

27 Healthcare PR 45 Pharmaceutical 45 Healthcare advertising

45 Medical writing 6 Market access 13 Healthcare consultancy

Pharma marketing, sales and communications jobs

jobs.pmlive.com
*Job numbers were correct as of 29/10/19
*Featured jobs were live as of 29/10/19
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