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COMMERCIAL INSIGHTS FOR THE C-SUITE
VOLUME 39, NUMBER 6
WORLD
BEATERS
LEADING THROUGH ORGANIZATIONAL DISRUPTION
THE FUTURE OF
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n August, Pharm Exec is highlighting Gene Another upcoming issue where June serves
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JUNE 2019 PHARMACEUTICAL EXECUTIVE Table of Contents 5
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Medical Affairs
Med Affairs: A New Blueprint
By Robert Groebel
Changing customer preferences and a growing
need for specialized knowledge are challenging
the traditional scope of the medical affairs
function. Learn about six ways pharma MA
departments can drive more collaborative
relationships with caregivers.
24
Market Access
HTA Evidence Boost
2019 Pharm Exec 50 By Barbara Arone
An analysis of 10 years of decision-making by
Michael Christel, Managing Editor health technology assessment (HTA) agencies
Pharm Exec’s 19th annual listing of the top global biopharma players reveals shows that the use of external comparators could
some interesting maneuvering of ranks, as companies focus on provide a clearer picture of the economic benefit
diversification, big-brand expansions, and positioning a new wave of profile of more “common” drugs—and better
products to compete in an advancing but complex future treatment market. inform HTA and payer determinations.
30
‘Vision’ Quest: Leading Through Change
By Lauren Seufert
Exploring the critical go-to strategies for biopharma C-suite executives
in navigating organizational disruption and the impact of global change
and volatility on their employees and business.
Opinion
Global Report
36 Need Innovation Now in
10 Predicting the Future of Antibiotic Development
European Health Policy By David Roblin
Reflector, Brussels Correspondent
Back Page
Country Report: France 51 Building the Startup
38 Better Together Dream Team
By Chris Coe
Focus Reports, Sponsored Supplement
After several years of losing pace to many of its European peers when it
comes to pharma production and R&D, France’s life sciences market, sparked
by a renewed spirit of reform, is now squarely back on the radar of the
international investor community.
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6 this month on PharmExec.com PHARMACEUTICAL EXECUTIVE JUNE 2019
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Reader Feedback
Profile: HBA’s 2019
Woman of the Year Q I 1,000% agree. It’s my duty to call out this common
April issue online
Christen Harm and highly problematic oversight that us pharma
bit.ly/2IkrJsZ marketers routinely overlook. Pharma marketers, Compliance Report
take heed. Those that pay little attention to this vital Headlined by an executive
roundtable at CBI’s
segment of the pharma value food chain, ignore at Pharmaceutical Compliance
your own peril. Congress, Pharm Exec
George Tsiolis explores the ever-changing
Most-read stories online: “Are Pharma Marketers Fighting the Last War?” world of corporate compliance
April 25, 2019, to May 24, 2019 bit.ly/2UkDq9K in the biopharma industry.
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Cué, and a Slovenian MP, Vio- decision will be the result of a the health department now
leta Tomic, back equal access to complex compromise forged carry out could be redistributed
health through modernized pub- among more than two dozen among other more vigorous
lic services with guaranteed confl icting national views. Com mission depar tments
social rights, but their manifesto responsible for research, indus-
for t he Eu rop ea n L ef t I n Lost in shuffle? try, digital, or social affairs. A
Europe—which has not been Meanwhile, a coherent EU new Commission boss is entitled
updated since 2004—is overtly health policy is conspicuous by to shuffle the Commission cards
hostile to “globalized capital- its absence, and the prospects for wh ichever way he or she
ism” and “big capital and lob- seeing one emerge remain slen- chooses.
bies” that seek to make health
“subject to market rules.”
By contrast, the right-wing The limited activities that the health department now
European Conservatives and
Reformists group is represented
carry out could be redistributed among other more
by a Czech MEP, Jan Zahradil,
who opposes compulsory vacci-
vigorous Commission departments responsible for
nation, and insists on the merits research, industry, digital, or social affairs
of a common market as a means
to promote prosperity but that
“must not be used as a pretext der. For the last two months, the The signs were not promising
for creating additional regula- EU has not even had a commis- when the leaders of the EU met
tion such as attempts to harmo- sioner for health, since the for a set-piece discussion of the
nize taxes, as well as social and incumbent, Vytenis Andriu- future of the EU in early May.
healthcare systems.” kaitis, took time off to contest Health was not even mentioned
Depending on the political (unsuccessfully) the presidential in the main preparatory docu-
arithmetic of the new European election in his native Lithuania. ment that the current Commis-
Parliament, on the ability of The few health-related initia- sion provided for the confer-
MEPs to reach a clear view tives undertaken by the health ence, “Preparing for a more
among themselves, and on the department are either insignifi- united, stronger, and more dem-
readiness of EU leaders to accept cant—such as gathering statis- ocratic Union in an increasingly
that view, Weber, or Timmer- tics or discussing health service uncertain world.” There were
mans, or Vestager might well be performance assessments—or passing mentions of health in
putting together a new Commis- blocked by broader political con- other more detailed policy doc-
sion by midsummer, ready for flicts, which is the fate of the uments, but they were hard to
launch in the autumn. proposal on health technology fi nd among the more substantial
But there are some dark assessment or the planned review passages on defense, sustainable
horses that may still appear. of research incentives. consumption and production, or
The most conspicuous non- The very idea of an EU health a multilateral, rules-based
declared candidate is Michel policy lives under the perpetual global order.
Barnier, who has won wide shadow of the limits that the
admiration (except perhaps in treaties impose on EU powers in Pivotal stretch
the UK) for his role as the Euro- this area. For two years now, The coming six months, while
pean Commission’s Brexit nego- uncertainty has reigned over the leadership of the new Euro-
tiator over the last two years, whether the health department pean Parliament and the new
and more of a technocrat than Andriukaitis is responsible for Eu ropean Com m ission are
an ideologue. will even continue to exist in the agreed and policies are formu-
Another longer shot might be new Commission. That has left lated, will determine many of
Josep Borrell, foreign minister its recently-appointed director- the options and opportunities
of Spain’s socialist government, general apparently paralyzed, for pharmaceutical and life sci-
and a former president of the EP. with no scope for new initia- ences executives through to the
As always in the EU, the fi nal tives. The limited activities that late 2020s.
12 Pharma 50 PHARMACEUTICAL EXECUTIVE JUNE 2019
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Pharm
2019
Exec 50
Tryfonov – stock.adobe.com
Pharm Exec’s annual listing of the top global biopharma players
reveals some interesting maneuvering of ranks, as companies focus on
diversification, big-brand expansions, and positioning a new wave of
products to compete in an advancing but complex future treatment market
By Michael Christel
he top spot in our annual scorecard updating In data again provided in partnership with life
the drug’s sales dropped 16% in Novartis, which posted a report on page 8). After first
Europe last year, and potential 3.8% rise in drug revenue on our deeming Zolgensma not cost-
US competition looms this year list, has received a lot of recent effective at the $2.1 million price
from biosimilars from Celltrion attention around its own gene tag, the Institute for Clinical and
and Teva, Pfi zer, and Mylan. If therapy product, Zolgensma, E conom ic Rev iew ( IC E R)
the deal goes through, Roche approved by FDA late last month reversed course last month based
will add sales and pipeline assets to treat children under two years on review of new data and value-
via its February acquisition of of age with spinal muscular atro- based payment plans. According
Spark Therapeutics for $4.8 bil- phy, a potentially deadly disease. to published reports, Novartis
lion (as of press time, the offer Novartis priced the one-time says it has ample manufacturing
was in its second extension infusion at $2.1 million, a sticker capacity to meet Zolgensma
period). In late 2017, Spark won price that has turned heads, and launch demands. Production hur-
approval for Luxturna, the fi rst- is illustrative of the new waters dles contributed to a slower roll-
ever targeted gene therapy, gene therapies in general pose for out for Novartis’s cell therapy
which treats inherited retinal healthcare systems and payers, Kymriah, the world’s first CAR-T
blindness. Spark also focuses on and government and regulators, drug, which gained its first
gene therapies for hemophilia, in figuring out how to cover and approval in August 2017. Kym-
lysosomal storage diseases, and fund these products (see our riah targets acute lymphoblastic
neurodegenerative disorders. Washington correspondent’s leukemia (ALL).
How the listings were compiled: 2018 Rx Sales and R&D Spend analyses were provided by life science market intelligence firm Evaluate Ltd via its EvaluatePharma® service, www.
evaluate.com. Pharm Exec would like to thank EvaluatePharma for assisting in the development of this year’s Pharma 50 listing. PLEASE NOTE: 2018 figures represent prescription
pharmaceutical sales from the named company only, and exclude revenues from royalties, co-promotions, etc., as well as sales from non-prescription pharmaceuticals. Evaluate’s Sales
and R&D Spend figures represent the fiscal year that ended in 2018. For most American and European companies, that means the year ending December 31, 2018. For many Japanese
companies, the fiscal year ending March 31, 2019, was used. Historic averages were used in the conversion of companies’ native currency to USD.
14 Pharma 50 PHARMACEUTICAL EXECUTIVE JUNE 2019
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With less fanfare than the but to anchor drug assets across flagship Keytruda, the cancer
CAR-T wave received, but per- six therapeutic areas (in recent immunotherapy. Sales of the
haps with greater blockbuster reports, Novartis claims to have drug rose 88% in 2018, to $7.2
potential in the near-term, 25 blockbuster candidates in the billion. (Keytruda is projected
Novartis won regulatory clear- clinic). Predictions published by to reach annual sales of $10
ance last month for Piqray, the Yahoo and FiercePharma say billion in its fifth year). It won
fi rst drug designed specifi cally Novartis will be the world’s top FDA approval in April as a
for HR+/HER2- breast cancer drug seller by 2024. Could the fi rst-line treatment for patients
patients with a PIK3CA muta- Swiss-based giant leapfrog Pfizer with stage III non-small cell
tion. It’s also the fi rst novel drug and Roche in our Pharma 50 lung cancer (NSCLC) who are
approved under the FDA’s Real- rankings in the next few years to not candidates for surgical
Time Oncology Review pilot secure the top perch for the fi rst resection or defi nitive chemo-
program. Mainstay Gilenya time since 2015? radiation. Keytruda was also
generated $3.3 billion in sales Other notable shifts in top 10 greenlighted in combination
in 2018, but reports state that positioning include: with Pfi zer’s Inlyta for previ-
dermatology drug Cosentyx » Johnson & Johnson’s move up ously untreated kidney cancer.
eclipsed Gilenya in the first one spot to No. 4, behind drug » AbbVie flipped spots with
quarter of this year to become sales growth of 12.8% com- GlaxoSmithKline—jumping to
Novartis’s top-selling product. pared to the previous year. seventh on the list. The com-
The company’s philosophy » Merck & Co., though ceding pany posted a 15.6% gain in
has been not to rely on one or way to J&J, posted a 5.6% gain Rx drug revenue behind $19.9
two treatments to drive growth, on the steam of its expanding billion in sales of Humira.
Though Humira’s EU patent one spot to No. 10. The bio- some by BMS’s voluntary with-
expired last year, AbbVie has tech’s overall prescription drug drawal earlier this year of its
reached settlements to fend off revenue dropped 15.5%, due application for Opdivo in com-
US biosimilar competition in large part to continued bination with Yervoy as first-line
until January 2023. In prepa- declines in its hepatitis C virus treatment for advanced non–
ration, however, the company (HCV) drug franchise, where NSCLC patients with tumor
is attempting to bolster sales the once-pioneering medicines mutational burden, and Opdi-
for its newer drugs Skyrizi and Harvoni and Sovaldi—which vo’s failure in a Phase III brain
upadacitinib; for example, it’s cure patients of HCV after one cancer study, announced last
offering discounts on Humira course of treatment—have lost month. Eliquis, which BMS
to secure favorable formulary market share to rival drug manufacturers in partnership
coverage for Skyrizi, a mono- launches in recent years. with Pfizer, continued to grow at
clonal antibody approved in a more than 30% annual clip.
the US and Europe in April for Rest-of-field observations BMS is poised to climb up
psoriasis (it boasts advantages Just outside of the top 10, Bris- the rankings ladder in the com-
in less-frequent dosing and had tol-Myers Squibb claims the 11th ing years after its $74 billion
better skin clearance rates dur- spot in our rankings, with Key- merger with Celgene, which
ing clinical testing than similar truda PD -1 inhibitor rival, after months of wrangling, was
drugs on the market). Opdivo, pulling in $6.7 billion fi nally approved by BMS share-
» Gilead, which despite strong in sales, a 36% increase. The holders in April. The deal is
sales from its HIV drugs, fell momentum may be squelched expected to close in the third
22 Mylan
CANONSBURG, PENNSYLVANIA [MYLAN.COM]
$11.144 $586 EpiPen
Ethinyl Estradiol;
246
Norelgestromin 207
Xtandi 3.004
23 Astellas Pharma
TOKYO, JAPAN [ASTELLAS.COM]
$11.036 $1.909 Prograf 1.431
Myrbetriq 1.328
Tecfidera 4.274
24 Biogen
CAMBRIDGE, MASSACHUSETTS [BIOGEN.COM]
$10.887 $2.587 Avonex 1.915
Tysabri 1.864
Privigen 2.294
25 CSL
MELBOURNE, AUSTRALIA [CSL.COM.AU]
$8.270 $724 Hizentra 942
Human albumin 929
Lixiana 1.061
26 Daiichi Sankyo
TOKYO, JAPAN [DAIICHISANKYO.COM]
$7.033 $1.888 Nexium 706
Namenda 453
Rebif 1.699
27 Merck KGaA
DARMSTADT, GERMANY [MERCKGROUP.COM]
$7.001 $1.928 Erbitux 964
Glucophage 866
Samsca 817
28 Otsuka Holdings
TOKYO, JAPAN [OTSUKA.COM]
$5.726 $1.863 Abilify MAINTENA 797
Rexulti 629
Cimzia 1.708
29 UCB
BRUSSELS, BELGIUM [UCB.COM]
$5.138 $1.371 Vimpat 1.272
Keppra 751
Diamicron 548
30 Les Laboratoires Servier
NEUILLY-SUR-SEINE, FRANCE [SERVIER.COM]
$5.103 N/A Vastarel 500
Aceon 416
Source: EvaluatePharma® May 2019, Evaluate Ltd, www.evaluate.com *USD in billions, lower numbers in millions
16 Pharma 50 PHARMACEUTICAL EXECUTIVE JUNE 2019
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quarter of this year, adding sev- in this year’s rankings. Accord- Dealing and diversifying
eral new drug candidates from ing to Evaluate’s data, BMS and The BMS-Celgene and Pfizer-
Celgene’s pipeline, including Celgene increased their R&D Spark deals, along with Eli Lilly’s
potential multiple sclerosis spend in 2018 by 6.4% and $8 billion acquisition of Loxo
blockbuster ozanimod. BMS will 35.4%, respectively. Celgene’s Oncology, may signal the start
also gain the rights to Revlimid, spike was the highest among of a wave of M&A activity in the
Celgene’s longtime big seller for companies investing at least $1 industry that will last into 2020,
cancer, and its CAR-T portfolio, billion in R&D. Another notable analysts say, as companies look
which the biotech acquired last R&D output was Regeneron’s, to increase diversifi cation into
year through its $9 billion take- who despite ranking 38th in new areas and put more R&D
over of Juno Therapeutics. Rev- drug sales, spent the 21st most resources into therapeutic niches
limid continues to expand into on R&D, investing $2.2 billion. with strong pricing power, such
new patient populations, win- New entrants this year in the as rare diseases. According to a
ning FDA approval in late May, Pharma 50 include Hong Kong- report by Evaluate, rare and
paired with Roche’s Rituxan, as based Sino Biopharmaceutical at orphan drugs will make up one-
a chemotherapy-free combina- 42nd; Boston’s Vertex Pharma- fi fth of worldwide prescription
tion drug for patients with previ- ceuticials at 43rd; and French sales in 2024, amounting to $242
ously treated follicular or mar- biopharma Ipsen and China- billion in spend.
ginal zone lymphomas. headquartered Jiangsu Hengrui Takeda’s acquisition of rare
In Rx drug sales, Celgene Medicine at 46th and 47th, diseases specialist Shire, first
leapt from the 21st spot to 17th respectively. announced in March 2018, was
34 Fresenius
BAD HOMBURG, GERMANY [FRESENIUS-KABI.COM]
$4.328 $631 Heparin Sodium 79
Absorica 155
Sun Pharmaceutical Atorvastatin
35 Industries $4.222 $321 Calcium
Ciprofloxacin
143
Source: EvaluatePharma® May 2019, Evaluate Ltd, www.evaluate.com *USD in billions, lower numbers in millions
JUNE 2019 PHARMACEUTICAL EXECUTIVE Pharma 50 17
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officially closed in early January prescription and over-the-coun- prescription drugs overall, per-
for $62.2 billion, making it the ter products in Australia and haps surprisingly, has been rela-
largest biotech employer in Mas- New Zealand for $130 million; tively flat, at least according to
sachusetts and thrusting the and Mallinckrodt, ranked 48th, government and private industry
company into the top 10 of announced plans to spin off its sources. MarketWatch reported
pharma revenue producers. In generic drug business as a sepa- in March that the cost of Rx
other mega deals, GSK last year rate unit and rename the remain- drugs over the preceding year had
bought out Novartis’s stake in ing specialty branded drugs busi- dropped by 1.2%—the biggest
their consumer health joint ven- ness to Sonorant Therapeutics 12-month decline since 1972.
ture for $13 billion, and merged Plc. Mylan and Teva are among
its consumer business with Pfizer, 20 generics makers named in a World gains, mission
as part of GSK’s plan to split into lawsuit issued last month by 44 Another driver impacting our
two separate businesses; and US states for alleged price-fixing. numbers are the growth rates of
Sanofi completed its acquisition A likely influencer in this multinational drugmakers in
of Bioverative, a US biotech year’s Pharma 50 is the continued emerging markets. According to
focused on hemophilia and other boom of the specialty pharma published reports, in the first
rare blood disorders, for $11.6 market. Recent numbers issued quarter of this year, emerging
billion. by the Peterson-Kaiser Health markets growth averaged 13.3%
On the generics front, Mylan, System Tracker found that among among a selection of big phar-
ranked 22nd in our list with commonly used specialty drugs, mas, with 29% in China—com-
$11.1 billion in 2018 drugs sales, bra nded d r ug prices have pared to 8.2% growth in the US.
agreed in May to buy Aspen increased by 57% since 2014. With the pharma industry fac-
Pha r mac a re’s por t fol io of M e a nwh i le , sp e nd i n g for cing rising demands to improve
50 Ferring Pharmaceuticals
PARSIPPANY, NEW JERSEY [FERRINGUSA.COM]
$2.461 $357 N/A N/A
Source: EvaluatePharma® May 2019, Evaluate Ltd, www.evaluate.com *USD in billions, lower numbers in millions
18 Pharma 50 PHARMACEUTICAL EXECUTIVE JUNE 2019
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global health and preserve their landscapes, Seufert emphasizes These trends illustrate the
public health missions, a new the importance of pharma execu- growing number of new drug
study by the Access to Medicine tives in preparing their companies approvals sponsored by smaller,
Foundation found that drug- to thrive in this future VUCA clinical-stage developers—many
makers “are taking seriously the world (volatility, uncertainty, funded by private equity and
problems people face in low- and complexity, and ambiguity). venture capital. IQVIA found
middle-income countries when Meanwhile, pharma C-suite that emerging biopharma com-
accessing healthcare,” but the leaders continue to deal with the panies patented almost two-
progress has been sporadic with larger industry’s reputation and thirds of new drugs launched in
often only a few diseases in a trust challenges. That’s particu- 2018, and they accounted for
small number of countries being larly true in the US, where public 72% of the late-stage pipeline,
targeted. The study, which ana- sentiment regarding the industry compared with 65% in 2013 and
lyzed 10 years of data, does note actually improved some this 52% in 2003.
that the R&D pipeline has more year, according to Edelman’s Overall, the late-stage pipe-
than doubled since 2014 for a set annual trust barometer. Its line grew by 11% in 2018, the
of 47 high-burden and priority research reported an increase of IQVIA report says, and the total
diseases, including HIV/AIDS, six points in the US, bringing number of clinical trials started
malaria, and tuberculosis, and pharma’s total up to 44 (a score last year was up 9% over the
prior year and 35% over the past
five years. According to the Tufts
The pharma industry’s overall global trust Center for the Study of Drug
Development (CSDD), half of all
rating increased four points to 67, ranking in drugs in the R&D pipeline—and
the lower half of the 15 industries studied about 80% of all investigational
drugs for cancer-related dis-
that pharma companies are using of 60 or more is considered eases—now rely on biomarker
pricing, licensing, and donations “trusted” under the Edelman and genetic data to target thera-
more frequently than before as ratings). The pharma industry’s peutic agents. Ken Getz, the
tactics to improve access in low- overall global trust rating director of sponsored research at
and middle-income countries. increased four points to 67, Tufts CSDD, notes in a new col-
It’s these dynamics in global ranking in the lower half of the umn in Pharm Exec sister pub-
healthcare that bring us to this 15 industries studied. lication Applied Clinical Trials
year’s special Pharma 50 accom- that there are now more than
panying feature by guest author R&D reshaped 11,000 active molecules in devel-
Lauren Seufert, the founder of A shifting climate and opera- opment—a 5% to 7% year-over-
emOcean Coaching & Consult- tional environment for clinical year growth rate across the span
ing (see page 20). In setting the research could begin to start of two decades.
stage for a piece on biopharma inf luencing the Pharma 50 Addressing 2018’s record
leadership strategies amid change, sooner than later. In 2018, the number of US approvals, Getz
Seufert points to the organiza- FDA approved 59 new molecular notes that 73% were approved
tional disruption taking place on entities, the highest annual num- under “priority review” status,
a global scale. Examples she cites ber in history (see chart on facing and that one-third of the new
are trade wars with the East and page), with 27% of those preci- approvals were first-in-class
the continuing debate around sion medicines to treat cancer drugs offering new ways of treat-
global vs. national focus in many and its symptoms, according to ing certain diseases.
regions. Combined with disrup- a report by the IQVIA Institute. “This is a remarkable achieve-
tions from technology advance- In addition, 46% of the ment, particularly in light of the
ment and digitalization, new approvals were cleared based on anemic number of annual approv-
business models governing all data from trials with fewer than als that we saw in the 2005 to
parts of the value chain, economic 500 patients and 42% were 2010 period,” Getz states.
fluctuations around the globe, approved on the basis of only But, of course, even amid the
and evolving social and political one trial. reveling over pharma’s innovation
JUNE 2019 PHARMACEUTICAL EXECUTIVE Pharma 50 19
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Source: FDA
resurgence, drug development and practices that are largely the platform to organize and
remains essentially a high-risk insular and sequential, supported activate health information from
investment. A recent study by by redundant resources and per- electronic health records, sen-
Accenture did find that treat- sonnel and that underutilize key sors, and other digital sources.
ments considered more innova- assets and expertise,” he writes. Pharma’s interest in RWE has
tive—tied in with things like “The growing prominence of pre- grown considerably. Both Pfi zer
genomics, biomarkers, compan- cision medicines and treatments and BMS, for example, recently
ion diagnostics, and new delivery for rare diseases and targeted struck strategic agreements with
methods—are actually more patient subpopulations—all Concerto Health A I , which
likely to reach the market, requiring more complex clinical focuses on cancer-specific real-
slightly bucking the long-held trial designs and longer durations world data (RWD) and advanced
belief that about nine out of 10 to identify and recruit patients— artificial intelligence (AI) for
drugs that enter clinical testing intensify the pressure on drug RWE generation. The companies
fail (in analyzing 60,000 prod- developers to accelerate this will use Concerto’s platform and
ucts from 2000 to 2017, Accen- transformation.” A I models to identif y and
ture reported a successful clinic- Some in big pharma seem to develop precision oncology
to-market range of 6% to 40%). be responding. Last month, drugs, as well as better under-
While pinpointing exact fail- Novartis, Otsuka, Pfizer, and stand how medicines are used to
ure rates may not be an exact sci- Sanofi all formed alliances with help improve patient outcomes.
ence, Getz, nevertheless, reminds Verily, Alphabet’s life sciences Overall, the industry has
us that drug development pro- unit, in hopes of reshaping clin- increased its adoption of AI and
cesses are highly complex and ical trials in disease areas such machine learning on numerous
inefficient, and have done little to as cancer, mental health, diabe- fronts. A recent analysis by Tufts
improve durations. He contends tes, dermatology, and heart dis- CSDD and DIA found that the
as well that, on average, the typ- ease. The pharmas will develop clinical operations function
ical drug generates a relatively clinical research programs using makes the highest use of AI, fol-
low and declining return on its technology developed under Ver- lowed by pharmacovigilance/
development investment, given ily’s Project Baseline. The Base- safety/risk management, and
the high capitalized cost of bring- line platform is designed to information technology. The
ing a drug through FDA approval. engage la rger nu mbers of promise of cloud technology is
Getz says that about $150 billion pat ient s a nd cl i n icia ns i n also building momentum in
was spent on global R&D activ- research and collect more com- pharma R&D circles to help pro- MICHAEL CHRISTEL is
ity in 2018. prehensive, higher quality data. cess the large volumes of data Pharm Exec’s Managing
“To remain viable, drug devel- The partners will also explore and multiple and disparate data Editor. He can be
opers must transform long-stand- novel approaches to generating sources now involved in clinical reached at mchristel@
ing R&D operating processes real-world evidence (RWE) using research. mmhgroup.com
20 Pharma 50 PHARMACEUTICAL EXECUTIVE JUNE 2019
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T ph a r m a , biot e c h , or
he a lt hc a re i ndu st r ie s
know that change is con-
stant. In order to stay relevant,
companies need to continuously
sions of large and small compa-
nies across all parts of the value
chains. In order to remain com-
petitive, organizations need to
stay alert, agile, and ready for
strategy on how to enhance pro-
cesses, services, and, most
importantly, our customer’s
experience, enabling our cus-
tomers to improve the health of
innovate, stay current with new opportunities. patients around the world. The
upcoming trends, and reinvent The landscape is also chang- integration remains challenging;
themselves in order to best serve ing socially and politically. We however, in my view it is being
their customers. Not only is the are faced with democratic uncer- very well managed. It has cre-
world’s population increasing tainty in a large part of Western ated a much broader path full of
dramatically, access to medicine society. Trade wars with the East opportunities for both our cus-
and healthcare is now thankfully remain and we continue to debate tomers and our employees.”
becoming available to regions global vs. national focus in many Strategies across many com-
that may have struggled econom- regions. Employees have gone panies and divisions are being
ically in the past. We are able to from a more traditional “com- reconsidered and rewritten as
get medication to more people pany-minded” focus to working change continues and organiza-
faster, and more effectively. in the rising gig economy. More tion identities are modified. Com-
However, there are several people work remotely and virtu- panies are becoming increasingly
other factors having a dramatic ally. There are more virtual free- agile, focusing more on automa-
impact on the industry and lancers, more service-oriented tion, improving their internal and
increasing the frequency of jobs, and a much more agile external communication tools,
change exponentially. Techno- workforce. This will dramatically and creating an overall better
logical advancement and digita- change the way life sciences com- customer experience. With these
lization are disrupting the way panies do business in the future. changes, there is a desire to
companies conduct business, not increase speed and reliability—
only in research, but across man- Leadership in a VUCA world all while attempting to reduce
ufacturing, supply chain, mar- Top executives are well aware of costs and improve effectiveness
keting, and sales. Data mining, this VUCA (volatile, uncertain, in serving their markets.
block chain, and artificial intel- complex, ambiguous) world and,
ligence (AI) are only a few exam- amid the disruptions, are taking Change and the
ples of why we cannot continue the appropriate steps and actions impact on employees
to do business as we have in the to prepare their companies for the Of course, while focusing on
past. Processes will become future. For example, John Upper- strategy and processes are
more efficient, job roles will man, vice president for Procure- important, it is also crucial to
change, and industries will be ment, pharma services at Thermo remember the impact on the
impacted dramatically. Fisher Scientific, said the follow- individuals within an organiza-
In addition to the technolog- ing regarding Thermo’s $7.2 bil- tion when disruption occurs. HR
ical changes that companies lion acquisition of contract devel- and people strategies are becom-
face, we are also dealing with opment and manufacturing ing more of a priority across sev-
economic disruption around the Organization Patheon in 2017: eral industries. These strategies
globe. Competition remains “We have gone through not only include hiring, retain-
fierce and while access to medi- major changes in several areas as ing quality talent, and ensuring
cine increases, so does access to former Patheon employees. there is a pipeline of strong can-
pro du c t ion a nd ad e qu at e However, I believe we now have didates to lead the company into
JUNE 2019 PHARMACEUTICAL EXECUTIVE Pharma 50 21
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Figure 2: A Steady-Eye Formula or sales department. What will be the transformation triangle.
done with those positions or even Communication can be chal-
full departments? As anxiety, lenging; it becomes even more
particularly around job security difficult when you mix in differ-
or employment, starts to infiltrate ent cultures, value systems,
an organization, the job of senior experiences, and beliefs. Orga-
leaders is to establish more dia- nizations are becoming more
Strategic logue with employees, not less. diverse, but this does not always
Vision We tend to avoid the situation make dialogue easier.
until we have clear answers. In order to bridge cultural,
However, the less vocal or pres- racial, gender, and generational
ent leadership is during times of gaps, companies need to be
uncertainty, the more focus is open, empathetic, and inclusive.
Transformation
Triangle put on these topics by the orga- This requires time, patience,
nization. This results in rumors and curiosity. Biases, confl icts,
and, in most cases, a decrease in and misunderstandings can
Relational Refined performance and the overall occur, sometimes leading to
Dialogue Processes well-being of the company. teams being hesitant to provide
During times of uncertainty, open feedback and enter into
it is critical that leaders engage dialogue. With added deadlines
Source: emOcean Coaching & Consulting
employees in the process of defin- and the time pressure most
pay off, allowing the organization ing the future. There may be ideas organizations are under today,
to focus on customers and imple- that employees have as to how it is no wonder that individuals
mentation. they can modify their roles or tend to avoid the elephants in
adapt in order to add the most the room.
Refined processes value. They may request training “We need to remember that
These are all of the areas where to support them in developing the people in our organizations
roles and responsibilities are skills geared toward a specific each have their own worries,
impacted by change. It can be the direction. Investing in the employ- hopes, dreams, and personal
rollout of a new tool or a desired ees that are willing to learn and issues,” says Upperman. “I try to
change of how people work adapt can create tremendous always apply three things when
together either within or across value for the future. It may also leading through change: under-
functions and operating divisions. help to avoid potential compla- standing the emotional state of
One small rollout can have mas- cency of the employees, if they my people, exercising a high
sive impact across various parts of feel their value-add is declining. level of empathy, and being the
an organization. When things In addition to the dialogue, it calm leader that people can
don’t work as they used to, people is important for life sciences always go to with their fears.”
get frustrated and performance leaders to focus on and empha- Dialogue is not always easy
tends to suffer as a result. There- size the areas and processes that and sometimes may result in
fore, making clear to all company are working well. “When things confl icts, especially when topics
divisions what will be different are working, we like to give our are challenging, emotions are
going forward, how it will affect employees the freedom and involved, and stakes are high.
their activities, and why, are criti- autonomy to continue doing However, conflict or negative
cal parts of any change process. what they have done in the past,” feedback, if presented in a
In most cases, it is not yet clear says Upperman. “This gives peo- healthy way, can move teams
to upper management how the ple confidence and the ability to forward and allow them to ele-
particular change will impact realize there may be some quick vate to another level of perfor-
processes, positions, or job wins to celebrate.” mance.
descriptions. For example, the When working with organi-
rollout of a new data mining tool Relational dialogue zations on relational dialogue,
will eliminate the need for more This is probably the most criti- the focus should be on these crit-
traditional roles in a marketing cal, yet most overlooked part of ical areas:
JUNE 2019 PHARMACEUTICAL EXECUTIVE Pharma 50 23
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» Inclusive listening and curiosity. be made. Who is the ultimate curiosity, innovation, healthy
Making sure that the voices of decision-maker and for which dialogue, and resilience to
all employees are heard not topics? Do we need a full team change among the employees?
only creates a culture of taking buy-in, or is it ultimately the » Is the company investing
risks and of people wanting decision of one, with expecta- enough in soft skills across its
their ideas to be known, it gen- tion of full commitment? If leadership and broader organi-
erates a more innovative dia- this decision process is not zation?
logue, which may ultimately talked through and under- » Is dialogue, in particular
help contribute to a better, stood, organizations have the where there are differing opin-
thought-through solution. risk of either moving too slow ions, healthy and appreciated
» Enabling an open feedback culture. and not making decisions fast on all levels?
People can always grow and enough, or steam-rolling the » Is there not only a diverse envi-
learn, and that usually hap- organization with decisions ronment of individuals in the
pens with the support of exter- that, in the end, will not be organization, but does it have
nal observation and feedback. implemented. There are ways an inclusive environment,
However, giving feedback can in which decision processes where all viewpoints are
be a tricky, especially when it’s can be better understood, dis- respected and heard?
not positive feedback. To that cussed, and implemented » What behaviors are expected
end, there are techniques that across companies. Committing from employees and, even
have proven to work well and time early on to this topic, par- more so, the C-suite that peo-
that can be applied within ticular with new teams, pays ple look up to?
organizations. Ultimately this off greatly in the long run. » Is the organization focusing on
creates more vulnerability, not only the awareness and
open communication, higher Leading through change recognition for a need to
trust, and tremendous growth. As a company institutes its own change, but also creating desire
In many cases, conducting a practices around the three pil- for the employees to do things
first-group feedback round lars of the transformation tri- differently?
with a trained facilitator can angle, several questions emerge
be useful. that perhaps should be at the Defining success for future
» Facilitating conflict when stakes are top of the leadership agenda. organizations
high. Typically, when conversa- Going through the following Many top business leaders and
tions get tough, we sometimes checklist can be helpful for an executives raise the question:
tend to table them for another organization. What will differentiate the good
time. But are we revisiting the » Is the company vision clearly from the great companies of the
topics that really need ultimate communicated to the broader future? In times of change in the
discussion and conflict resolu- organization? life sciences and healthcare
tion to get issues hashed out? » Is the vision communicated in industries, it is critical that we
W hen orga n i z at ions c a n various ways where all people put organizations and their peo-
address these areas openly will feel a connection and ple at the forefront.
without fear of feelings getting clearly understand their ability While strategies, processes,
hurt or emotions running high, to contribute to the greater and business models may differ,
they can make tremendous purpose? one thing that most companies
progress. Emotions are normal. » Are there certain roles chang- share in common is the rela-
Bringing well-managed emo- ing in the organization, and is tional elements of their employ-
tions more into business envi- there enough investment going ees. As investments in technol-
ronments can lead to greater into how things will develop ogy, new production, and supply
commitment, and ultimately for these individuals in the chain infrastructure continue, it
more sustainable results. future? is the asset of human capital and
» Understanding how decisions are » Is the organization’s values the larger organization’s com-
made. It sounds obvious, but, clear to everyone? mitment to it that will likely LAUREN SEUFERT is the
in many cases, companies are » If so, do they represent what determine future success within founder of emOcean
not clear how decisions should w i l l re su lt i n i nc re a s e d corporations large and small. Coaching & Consulting
24 Medical Affairs PHARMACEUTICAL EXECUTIVE JUNE 2019
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everythingpossible - stock.adobe.com
s medicine grows more complex and tar- physicians and bring those insights back to the
these symptoms often or at all,” says Jennifer their performance, all while establishing more
Vernazza, director, medical operations and strat- credibility in the medical community.
egy at Sanofi Genzyme. “In these cases, espe-
cially, doctors turn to MSLs fi rst for help with 2. Tailor patient-centric data
a medical inquiry.” The overwhelming growth of clinical data require
As the industry shifts toward more complex, life sciences companies to better align patient-
precision drugs and new generations of HCPs seek reported information gathered from across differ-
deeper collaborations, medical affairs teams must ent stages of the patient’s journey. A greater under-
embrace a broader and more data-driven approach. standing of the patient experience throughout
Here are six ways these teams can build a stronger treatment, combined with clinical data, allows life
blueprint for collaboration in today’s changing sciences companies to better tailor their engage-
environment. ment with HCPs and other stakeholders, including
payers. Through the delivery of more meaningful
1. Engage deeper with scientific experts information, including disease knowledge, emerg-
Only one-third of top physicians or scientific ing data, and outcomes, MSLs provide doctors with
experts are satisfied with their MSL experience. 3 a greater understanding of new interventions in
One way MSLs can improve engagement is by order to make well-informed therapeutic decisions.
developing a richer understanding of the individual
interests of scientific experts. In the past, compa-
nies drove engagement through general data dis-
“The insights that MSLs
tribution, events, advisory boards, and clinical tri- bring back in to the
als. However, 81% of physicians prefer specifi c
information and are more likely to engage when company are critical
provided relevant communications through pre-
ferred channels.4 because they are real-world
“MSLs must provide more than just knowl-
edge,” says Vernazza. “The most successful MSLs and happening in real time.”
are excellent storytellers who can present scientific
evidence in a way that tells a story about a new MSLs can support a life sciences company’s
product centered on the patient while also nurtur- development processes by bringing real-world evi-
ing the physician relationship at the same time.” dence back from key experts about how different
MSLs who understand physicians’ scientifi c therapies are being accepted by patients. This is
interests, patients, and therapeutic focus can tailor particularly important with rare disease therapies
their interactions. It’s also important to offer clin- that are being fast-tracked through regulatory
ical evidence that demonstrates the value of new approval and, therefore, spend less time in con-
therapies in comparison with existing treatment trolled clinical settings where data is collected. The
options. A successful engagement is often based on ultimate goal is to improve the speed at which
an MSL’s familiarity with an HCP’s latest research
and the ability to align study opportunities to clin-
ical interests. Companies that deliver more useful FAST FOCUS
information will succeed in building more mean- » The way physicians consume medical information is evolving, with many
embracing the convenience of digital channels that provide content on
ingful relationships.
demand. Reportedly, by 2025, only 13% of oncologists will be baby boomers
To achieve this goal, medical affairs depart- who prefer face-to-face engagement with medical science liaisons (MSLs).
ments must hire and retain MSLs with a more stra-
tegic mindset that takes into consideration corpo- » There is a growing recognition of the need to hire and retain MSLs who
rate objectives and patient needs, while providing have a more strategic mindset—focused on balancing corporate objectives
and patient needs, while providing scientific value to top doctors.
scientific value to top doctors. Some organizations
are implementing new MSL training programs that
» Some pharma companies have instituted new MSL training programs and
focus on how to conduct richer peer-to-peer coaching strategies to foster deeper peer-to-peer exchanges with doctors.
exchanges with HCPs. Improved training strategies Some are also emphasizing increased real-time response; for example, creat-
and coaching will help MSLs develop a better ing libraries of information that are tagged to help MSLs quickly answer ques-
tions, and an online portal staffed by medical information reps and MSLs.
understanding of their responsibilities and increase
26 Medical Affairs PHARMACEUTICAL EXECUTIVE JUNE 2019
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emerging data and evidence of information that are tagged to global locations. These additional
translates to clinical practice. help MSLs quickly answer ques- options give organizations an edge
“The insights that MSLs bring tions. One pharmaceutical com- as they compete for the attention
back in to the company are criti- pany is building reactive decks of HCPs.
cal because they are real-world based on frequently asked ques- Technology also helps with
and happening in real time,” says tions that MSLs can access to proper timing of engagement. For
Vernazza. “The goal is to share present more focused presenta- example, companies could lever-
these insights with other parts of tions or provide better answers to age de-identified claims data to
the organization like R&D, mar- questions.5 deploy MSLs in real time. Claims
ket access, and commercial, but Another pharma organiza- data shows that a diagnostic test
much of it is done manually. This tion recently created an online has been ordered, signaling a
process is starting to evolve, and portal staffed by medical infor- potential rare disease patient in
becoming more automated and mation reps and MSLs to imme- the doctors’ office—an MSL
more structured with the help of diately answer physician inqui- could engage at that time and add
new technologies.” ries. By leveraging inquiries even greater value and relevance
captured across engagement to the physician relationship.
3. Provide real-time response channels, organizations can cre-
Rather than distributing new ate more meaningful content for 5. Broaden collaboration
drug information to doctors future engagements. among different stakeholders
through engagements that may or Precision medicine requires
may not be relevant to their cur- 4. Adopt better engagement with more than just
rent patients, medical affairs communications technology key physicians, driving MSLs to
teams must become more respon- By 2025, only 13% of oncolo- capture insights from a broader
sive to specialty therapeutics- gists will be baby boomers who array of stakeholders (see Figure
related inquiries from leading prefer face-to-face engagement, 1). For example, MSLs can pro-
physicians. Considering MSLs as while the remaining 87% will vide information to payers on the
trusted sources of information on consist of younger generations economic impact of diseases and
complex drugs, doctors contact that prefer multichannel and the progress of their therapies to
them directly instead of waiting remote engagement.6 Even today, address them. They share infor-
for the next introduction of infor- many doctors prefer mobile and mation with patients and patient
mation. “MSLs have their top interactive platforms. advocacy groups. Many MSLs
doctors’ personal cell phone To better collaborate with work with oncology nurses to
numbers and receive calls all newer generations of physicians in learn greater details about the
times of the day and even into the their preferred communication patient’s experience with a drug
evenings,” explains Vernazza. modes, MSLs must become more or chemotherapy. Developing
Medical affairs are starting to adept with an expanded set of tech- relationships with all critical
build new competencies to nology solutions. Technology also stakeholders expands therapeutic
expand therapeutic area and makes it possible to reach geo- knowledge and insight-oriented
health-economic knowledge and graphically disperse care teams discussions throughout the
address inquiries with timely that are difficult to meet face-to- changing scientific landscape.
responses that align with specific face. Online meetings, webinars, Some organizations are estab-
stakeholders. For example, some chats, and events enable the distri- lishing a new, specialized role in
companies have created libraries bution of timely information to medical affairs called Medical
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28 Medical Affairs PHARMACEUTICAL EXECUTIVE JUNE 2019
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Outcome Liaisons (MOLs). Med- stakeholders in a more granular wise, physicians will continue to
ically trained like MSLs, MOLs way by revealing actions, evi- increase demands on medical
bring scientific expertise to con- dence, and insights in real time. affairs teams for more real-time
versations with the payer mar- For instance, AI can serve as a and detailed information in their
ket—including formulary com- virtual mentor in guiding MSL preferred communication chan-
mit tees and managed care engagements by making sugges- nels. To effectively meet the
organizations. “This strategy is tions on the next best message industry’s growing expectations,
especially valuable in therapeutic or channel and right evidence for medical affairs must evolve cur-
areas where there is less medical MSLs to use for specific individ- rent business processes to sup-
knowledge about certain indica- ual specialists. port future models for success.
tions,” says Vernazza. “With Further, AI will provide more “These changes are only
many rare diseases having just a structured insights—something going to accelerate,” says Toron.
few thousand patients, formulary often lacking in medical affairs “The industry must adopt solu-
committees need to be educated organizations—to improve strat- tions that directly address the
on the disease as well as the ther- egy. With AI, medical affairs unique needs of medical affairs
apeutic intervention and compet- have the opportunity to create a teams, incorporating more
itive differentiators.” critical competitive advantage advanced insight-driven data
analytics, new digital channels,
“The industry must adopt solutions and automated information
sharing.”
that directly address the unique needs To learn more about the chal-
lenges and opportunities facing
of medical affairs teams, incorporating medical affairs leaders, read the
“Medical Affairs 2025” report
more advanced insight-driven data (https://bit.ly/2HR7zox), writ-
ten in conjunction with leading
analytics and new digital channels.” life sciences companies.
REFERENCES
6. Consider the impact of today while developing a struc-
1. ZS Insights, “Medical Affairs’ Data-
artificial intelligence ture for future efforts in an ever- Driven Rise to Prominence,” by Pratap
A recent industry survey shows complex healthcare landscape. Khedkar, Sarah Jarvis, and Dean
nearly half (44%) of life sciences “New AI technologies will Hakanson, ZS Associates (2019).
professionals use or experiment automatically deliver actionable 2. ZS Associates, “Medical Affairs
Outlook Report 2017,” (December,
with artificial intelligence (AI) insights to MSLs,” says Ver-
2017).
technology and 94% expect to nazza. “It will also be able to 3. Pharmaceutical Executive, “The
increase use within two years.7 quickly combine those insights Power of MSL Authenticity,” by
With the exponential growth of with other data and external Paul Meade and Mark Schoeman,
scientific data, organizations data, bringing it all together so (November 30, 2017).
4. Affinity Monitor™ Report, by ZS
leverage AI to more rapidly and we can take a more holistic look
Associates, (2014).
accurately analyze large volumes at the needs of the patient and 5. “MSL Outlook: What is the Future
of data to understand trends, the needs of the doctor and serve of Field Medical Affairs,” by Veeva
identify new insights, and make both better. It’s the next evolu- Systems (2017).
recommendations for next-best tion and it has the potential to 6. Census of Actively Licensed
Physicians in the United States, 2016.
actions. AI also automates the be revolutionary.”
7. Information Week, “Doctors Prefer
optimal use of data and can draw Online Drug Info to Rep Visits,” by
new understanding from previ- High expectations Ken Terry (December, 2013).
ously siloed information to As the life sciences industry rec- 8. Pearson Education, “Active Learning
ROBERT GROEBEL is
improve decision-making and ognizes the need for new compe- Strategies for Today’s Nursing
Vice President, Global Students,” by Susan Wilhelm and
Medical Strategy, generate more actionable insights. tencies, technology solutions,
Kim Rodehorst-Weber (2016).
Veeva Systems. He can For medical affairs, AI pres- and data sources to support bet- 9. Inside HPC, “Survey Shows How AI
be reached at robert. ents an avenue to learn about ter patient outcomes, MSLs will Could Revolutionize Life Sciences.”
groebel@veeva.com leading physicians and other play a more critical role. Like- (2018).
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as compared to 55% (37/67) in for comparing this data to that hope that newer legislation and
studies where the data was pre- of the clinical trial. regulations, as well as increasing
sented without this contextual Understanding HTA familiar- standardization and usage of
information. ity and comfort level with these RWD in the coming years, will
This indicates the impor- approaches will help with these help fi ll the data usage gaps.
tance of showing clinical/eco- decisions, and the industry’s In these interviews, there was
nomic context and benefit to aid knowledge will grow as more also open acknowledgment that
in decision-making. However, it submissions resulting from these observational data (registry,
is important to recognize that decisions reach the conclusion of cohort studies, electronic health
the nature of HTA decision-
making is based on many differ- The increased sub-setting of patients and the
ent inputs and factors, and a
review of HTA decisions dem- subsequent increasing complexity in treatment
onstrates that the quality of the
external data provided, along pathways will likely raise the need for additional
with the applicability of the ana-
lytical method, were important sources of evidence for HTA consideration
considerations.
the regulatory process. Contin- records) will increase in usage
Forward-looking ued analysis and understanding and utility in the next 10 years
application, challenges are needed while waiting for for- and be used more consistently in
There is currently no formal mal guidance. HTA decision-making.
guidance for the use of external The use of this data requires
comparators to contextualize Future direction from HTA that the correct statistical and
data for single-arm trials in reg- and regulatory bodies technical acumen be applied to
ulatory and HTA submissions. In the absence of current guid- control for the unique challenges
And the process of selecting the ance on external comparators, of data and information col-
right comparator is challenging there is acknowledgement that lected for other purposes, includ-
because it can be confounded by new trial designs will produce ing controlling for selection bias
changing standards of care new types of evidence, which and confounding.
regionally and over time. For will eventually become part of
example, a data source may be the HTA value dossiers. In a Industry focus: Build
available but may ultimately be series of interviews of UK-based on the positive
determined to be of insufficient HTA experts documented in We fully expect that HTA bod-
relevance for the product and “The Future of Precision Med- ies will release direction on
therapeutic area at hand. icine,” an article by James external comparators in the
Review of past HTA deci- Love-Koh et al. published in the future. Until that time, biophar-
sions regarding the indication December 2018 issue of Phar- maceutical manufacturers can
can be helpful when selecting macoEconomics, it was noted use the increasing examples of
external comparators; however, that the increased sub-setting of positive decisions associated
the most critical input will come patients and the subsequent with external comparators as
from the HTA stakeholders increasing complexity in treat- their guide. Selection of the
themselves, preferably as part of ment pathways will likely raise appropriate data source and
an early engagement process. If the need for additional sources methods for analysis will be crit-
it is determined that an external of evidence for HTA consider- ical to maximizing the value of
comparator will be helpful to ation. external comparator data to
decision-makers, the next steps While the environment for support access and pricing dis-
are selecting the right compara- the development of that data is cussions with HTA bodies. Con-
tor for the target market and maturing, there is a lack of impe- tinued review and observation of
determining how to source the tus on the part of most bodies HTA decision-making will add
data. Here, fi nal decisions must for establishing the appropriate to our understanding of this
consider the correct methodology use of this data. There is some quickly evolving space.
32 Financial Management PHARMACEUTICAL EXECUTIVE JUNE 2019
WWW.PHARMEXEC.COM
S approximately half of
each clinical trial budget.
That makes them an
obvious target for managing
study risks, costs, and timelines.
quite markedly. Much of the
input that determines payment
status, such as ad hoc invoices
from the sites or approvals from
the project team, depends on
Manual tracking also makes
payment forecasting time con-
suming and, thus, costly. Syneos
Health estimates that manual
forecasting takes four to 20
It also means life sciences fi nan- human schedules and discipline. hours per study depending on
cial managers need reliable pay- As suggested by the “challenge the forecast granularity and the
ment forecasting for setting boxes” in this article, an infi nite study complexity (e.g., number
development priorities and help- range of activi-
ing to ensure their business’ suc- ties beyond the
cess. Given the complexities of financial man-
clinical trials, however, accurate ager’s expecta-
updating of actual (incurred to tions or control
date or inception-to-date) and can affect pay-
forecasted site payments for ment proje c -
real-time reporting remains one tions and cash
of the largest challenges in med- flow.
ical product development. Even though thousands of of countries, sites, and patients;
data points are generated in clin- number and variance of ad hoc
A complex business ical studies, investigator pay- costs; screen failure rates; thera-
Many factors confound pay- ment forecasting currently relies peutic area; etc.).
ments transparency. Clinical tri- on highly simplified inputs. That Despite the challenges, the
als evolve continuously, and each is, fi nancial and project manag- stakes could not be higher, espe-
adjustment to the protocol, work ers—whether with the biophar- cially for small pharmaceutical
order, or vendor mix requires maceutical sponsor or contract or biotechnology companies
new budgeting and forecasting. research organization (CRO)— with limited resources. Unex-
The larger and more compli- primarily work with budgeted, pected fluctuations in costs or
cated the study, the greater the in process, and actual payment costly mistakes in payments can
variance in contracts, transpar- amounts. severely hamper such companies’
ency requirements, procedure Adding to the challenge is that cash flow. Perhaps more devas-
fees, currencies, and more exists sponsors, CROs, and other pay- tating are delays in information
across sites and countries. ments vendors manage payments that may enable the financial
Patient enrollment, enrollment and forecasts via manual systems. manager or project management
timing, site performance, and Whether using spreadsheets or team to resolve study risks ahead
online fill-in- of delays or cost overruns.
the-blank soft- The need for a more timely
ware, these are and precise site payment solution
SHAUN WILLIAMS is
time and labor is driving development efforts
Executive Director, intensive pro- among sponsors, CROs, and
Investigator cesses, highly niche software providers. Their
Management Solutions, prone to errors, collective goal is a solution that
Syneos Health and inflexible. will automate the payments
JUNE 2019 PHARMACEUTICAL EXECUTIVE Financial Management 33
WWW.PHARMEXEC.COM
combination of studies toward product approval investigator payments specialist as part of the
in competing regions, fi nancial officers will help CRO’s project team, and will that individual inter-
drive enterprise success through the ideal forecast- act with the sponsor from project award through
ing solution. study duration?
We give it wings.
You’ve worked tirelessly to demonstrate your
drug’s potential to improve lives. But the path
from prescription to treatment is not always easy.
Enabling patients to get the full benefits from
their therapy means navigating the complex
ins-and-outs of the healthcare landscape —
and helping to overcome steep barriers to care.
© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks of Cardinal Health and may be registered in the US and/or in
other countries. All other marks are the property of their respective owners. Lit. No. 1SS18-1SPS18-874698 (11/2018)
36 Op-Ed PHARMACEUTICAL EXECUTIVE JUNE 2019
WWW.PHARMEXEC.COM
FRANCE
When Emmanuel Macron’s ‘La République En Marche (LaREM)’
movement defied the odds to capture the presidency and na-
tional assembly back in May 2017, it readily became apparent
Bélingard, president of the French Federation of the Health In-
dustry (FEFIS) and former CEO of French IVD icon bioMérieux.
that the pro-business administration would be supporting in- Such sentiment is hardly unfounded. France’s USD 65 billion
novative pharma and attempting to reinvigorate the country’s life sciences market is now squarely back on the radar of the
competitiveness and global reputation for pioneering break- international investor community with multinationals like GSK,
through medical science. “We consider life sciences both as a Novartis, Merck and Aspen all proceeding with big-ticket in-
dynamo of technological advancement and host of some of the vestments and EY calculating that overall FDI has increased 31
great emerging high value-added industries of the future … It percent within the space of only a year. In May 2019, France
is precisely for this reason that we have elevated the sector as even entered the top five of US management and consulting
one of the centerpieces of our new national industrial strate- firm A.T. Kearney’s annual Foreign Direct Investment Confi-
gy,” affirms Minister of Economy and Finance, Bruno Le Maire. dence Index, beating China in the rankings by two places. At
the same time, the local innovation ecosystem seems to be
Many industry actors appear suitably charmed. “After several flourishing once again with the association, France Biotech,
years in which French pharmaceutical production and R&D had identifying some “386 drug candidates in clinical development
frankly been losing pace relative to many of our peer markets, I last year, over 720 in-country biotechs and average R&D invest-
and my members salute the renewed spirit of reform that drives ments per firm coming in at an admirable EUR 9 million (USD
and infuses the incumbent government,” declares Jean-Luc 10.1 million).”
This sponsored supplement was produced by Focus Reports. Report Publishers: Diana Viola, Laurent Libano Cover ©: Geneviève Claisse, Losange, 1970 © ADAGP, Paris
Report Director: Crystelle Coury Graphic Assistance: Miriam León
Assistants: Joseph Kun, Felix Klein, Eugenia Benazar
Senior Editor: Louis Haynes For exclusive interviews and more info, please log onto
Editor: Patrick Burton www.pharmaboardroom.com or write to contact@focusreports.net
SPECIAL SPONSORED SECTION HEALTHCARE & LIFE SCIENCES REVIEW FRANCE
NON-2018-0977
Date of Preparation: June 2018
trend that has been fast gathering pace. “Two years ago
the position of many players in the medical device industry
was that the purchasing decisions would always lie in the
physicians’ hands. However, recent events have demon-
strated this not to be true. While, in the past, we adopted
the classic sales model of the medtech industry – which can
best be described as ‘try it and if you like it, buy it’ – we
anticipate this as gradually becoming obsolete. Instead it
is increasingly essential to take into account a healthcare
provider’s overall KPIs and to approach the sale more in
B2B mode,” he opines.
The new rules of the game will not just bring threats
but fresh opportunities as well. “Right now it’s almost im-
possible to measure the cost of treatment for one patient of
one disease across the entire value chain, which renders the
switch over from volume to value-based pricing notoriously )<4)68%2(%+-0)'(134%682)6
tricky. One of the overarching goals of Ma Santé 2022 is *SVGPEWWMGERHGSQTPI\SVEPWSPMHHSWEKIJSVQW
interestingly to establish a process from which this figure
can be extracted and this will open doors to those medtech
players and tech integrators with the capabilities to really
improve healthcare management,” adduces Stéphane Reg-
nault, president of the second largest domestic medtech
player, Vygon.
The reforms will likely unlock new avenues for risk
sharing as well. “There is a conscious acknowledgment to
try and contain the estimated 30 percent of treatment ac-
tions in hospitals that are considered useless or redundant. %X7O]ITLEVQESYVHIHMGEXIHERHVIWYPXSVMIRXIHXIEQTVSZMHIWXEMPSVQEHI
Already there have been some preliminary trials to analyze WSPYXMSRWJSVXLIHIZIPSTQIRXQERYJEGXYVMRKERHTEGOEKMRKSJSVEPWSPMH
the impact of transferring risk to healthcare providers. The JSVQWXSXLILIEPXLGEVIMRHYWXV]XLVSYKLWXEXISJXLIEVXJEGMPMXMIWWGMIRXMJMG
logic is to flip over from fee-for-service to pay-for-perfor- I\TIVXMWIERHSTIRXVERWTEVIRXVIPEXMSRWLMTW
mance,” exclaims Claude Le Pen, healthcare economist at
IQVIA.
to the social security budget,” decries “Our fear is that the drastic price
Philippe Chêne, president of Winn- slashing that hitherto affl icted the phar-
care. “We detect a blatant lack of co- ma industry is now about to hit medtech
herence in France between short-term as well,” regrets Chêne. “Drug develop-
and long-term approaches to the ers were generally able to balance the
overall health strategy: the current damage and reduce their risk exposure
goals of decentralizing health provi- by leveraging their strong international
sion, developing ambulatory surgery presence. In medical devices, however,
and rationalizing care pathways are Eric Le Roy, director general, SNITEM;
over 90 percent of the French sector
all at odds with attempts to squeeze Philippe Chêne, president, Winncare comprises SMEs with predominantly
the margins of the very medtech local footprints. As a consequence for
players that are striving to facilitate us, France today is not about growing,
fresh approaches like home care and patient autonomy,” but rather managing profitability. Winncare possesses 200
he warns. employees in France and a majority of the group’s manu-
Eric Le Roy, director general of the national syndicate facturing base is in-country. The real question we are thus
of the medical technology industry (SNITEM) whole- facing is not so much should we stay in France, but can we
heartedly concurs. “Budgetary pressures risk thinning stay?” he wonders.
out the medtech SMEs and consequently harming the sec- “Margins are thin: France already stands out as having
tor’s offering,” he counsels. “We want to draw attention some of the lowest prices for medical equipment in Europe
to the underlying unfairness of the fact that an industry and yet we see our clients, the hospitals, asking for ever-
responsible for less than one percent of expenditure is now more integrated and sophisticated solutions in optimizing
being called upon to contribute to ten percent of economic their organization. There is a contradiction between rising
cuts,” he asserts. demand and depreciating reward. The big conundrum for
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extend out the repertoire to cover other interesting to see how patients react,”
products,” argues Vincent Pont, presi- predicts Pont.
dent of Laboratoire Arrow, the French
subsidiary of Aurobindo. DIFFERENTIATION RULES
“Indeed, pharmacies are already
working well to substitute what they As it stands, the French generics market
can and policy reform is going to be remains a challenging domain where ro-
needed if the large, untapped savings bust returns hinge upon having a well-de-
potential that French generics repre- Jean-Louis Anspach, general manager, TEVA; fined, balanced and adeptly differentiated
sent can be truly unlocked,” concurs Vincent Pont, president, Laboratoire Arrow business model. “Teva sees decent oppor-
Jean-Louis Anspach. tunities to develop in the local market,
While, like many of his peers, he but not at any cost… at the end of the
is lobbying for a broadening out of the registry, Anspach is day this is a segment that is rather fragile in terms of profitabil-
nonetheless much encouraged by the Macron administra- ity after repeated price cuts and cost increases so it’s necessary
tion’s moves to normalize physicians’ prescribing behavior. to tread carefully and wisely,” confides Anspach.
“While other European countries have successfully applied Indeed Teva’s local footprint is surprisingly heterogeneous.
pressure on physicians via fi nancial penalties, our govern- “Although we are often assumed to be a pure generic play-
ment is thankfully looking to foster greater generics usage er, the reality in France is that Teva maintains a 50/50 split
by reducing the number of ‘do not substitute’ prescriptions between its specialty and generic business activities. One of
available to physicians and determining a reimbursement our core strategic objectives is to manage a relatively mature
cap,” he observes. portfolio with key specialty brands like Copaxone® in neu-
Many welcome these developments. “We are broadly op- rology while simultaneously preparing for the arrival of Fre-
timistic because we are gradually seeing more general prac- manezumab®, a new biologic to treat migraine,” he reveals.
titioners prescribing by International Nonproprietary Name Mylan’s formula, meanwhile, is not entirely dissimilar
(INN) and the change in the regulation that the authorities in the sense of spreading risk exposure. “In France, we
are working on would mean doctors would have to justify are neither a generic company, an OTC outfit, or a Rx
‘non-substitutable’ prescriptions something they are not obli- entity, but rather a healthcare organization encompassing
gated to do by today’s standards,” affi rms Mylan’s Bertrand all these elements. In 2018, we actually sold around 400
de Lavenne. million units meaning that, in general, any French patient
Moreover, “as the new regulations are put in place, will have six Mylan products in their home!” opines de
the patients might well be pushed to pay the difference Lavenne. “We thus feel we have a major role to play as one
in price. Our understanding is that drugs could be reim- of the key actors interacting across the entire health eco-
bursed up to the price of the most expensive generic, but if system: for instance on top of our strong track record sup-
a customer insists on the specialty brand, the shortfall will plying a wide range of antiretrovirals for AIDS patients,
become an out-of-pocket expense, so it’s going to be rather we simultaneously enjoy the distinction of having been the
few years, but this has simultaneously One contract manufacturer that
occurred in tandem with a bit of a fil- has been bold enough to take the
tering out of the weaker CMOs that plunge is molecule production and
are not managing to make the leap to purification player, Novasep. “Look-
CDMO and are finding themselves ing at the maturity curve of some of
left behind,” he perceives. these biologics, demand for mono-
“A good portion of this growth is clonal antibodies has been skyrock-
being driven by pharma multinationals eting, antibody drug conjugates have
selling off their production facilities Michel Spagnol, CEO, Novasep; Patrick
been gaining momentum and gene
to instead be managed by CDMOs,” Mahieux, general manager, ABL Europe therapies are increasingly in vogue,”
notes Pierre Banzet, CEO of Synerlab. suggests CEO, Michel Spagnol. “The
“On the one side, these clients are of- latter is an area in which Novasep wa-
ten keen to streamline the number of contract manufacturers gered on several years ago and it fortunately turned out to
that they work with so as to easily ensure quality control. On be the right bet. At the time we made this decision, gene
the other hand, as pharma M&A activity heats up and cli- therapies were still an uncertain playground as there were
ents mass scale, we are witnessing the volume of production only a small handful of products that had actually gained
for a single customer shooting up…This, in turn, is altering FDA approval,” he recalls. “However, we can clearly un-
the client-provider relationship with greater attention to au- derstand today that biologics are becoming the shapers of
diting and also encouraging the CDMOs to become more the industry.”
specialized and diversified,” he believes. The bottom line therefore is that the new breed of
Consequently, Synerlab, in an attempt to carve out CMOs are having to get creative and adapt to the evolv-
its own niche, has been investing heavily in soft gelatin ing marketplace if they are to remain ahead of the game.
capsules and lyophilization conscious of the paucity of Advanced BioScience Labs (ABL Europe) an Institut
competitors in those areas. “We are detecting considera- Mérieux-backed CMO, for instance, not only developed
ble demand for outsourced biologics production as well, mastery in the highly specialized viral vector niche where
because, similar to lyophilization, there is a shortfall of there are fewer than 20 peer outfits in the world, but also
certified manufacturing capability for biologic products, devised a solution to one of the drawbacks of the classic
but the only way to break through into that niche would pharma model. “We were attentive to ensure that there is
be to build a brand new, expensive facility from scratch no segregation between product development and GMP
and that represents a significant barrier to entry for a manufacturing – a practice which does not exist in big
mid-sized CDMO,” he admits. pharma organizations,” says general manager, Patrick
Mahieux.
Skyepharma, for its part, leverages its own patented
technologies – Geomatrix®, Geoclock®, and Soctec® –
FMD: Survival of the Fittest to deliver a strong differentiation from its competitors.
“These platforms allow us to build controlled release for-
In accordance with the Falsified Medicines Directive mulations to adapt to patient dosing schedules or adjust
(FMD), all drugs were to be serialized across the EU API intake. Such technologies allow us to better manage
by February 2019. “I would say that the FMD presents side effects, which is a capability much prized by our cli-
CDMOs with parallel opportunities and threats result- ents,” says Lescuyer.
ing in a natural selection of actors, between those
who are prepared to meet the regulatory requirements
and those which are not,” reflects Skyepharma’s Da- BRACED FOR CHANGE
vid Lescuyer, pointing out that remaining compliant
with the regulation will be a repeated cost each year All in all, hopes and expectations are thus riding high right
and that without a sufficiently big enough scale and across the life science value chain as France enters this ex-
resource pool, firms might struggle to adapt. “For citing new period in its development trajectory when the
a company possessing the size and capabilities of rules of the game are being reshuffled and in which for-
Skyepharma, however, serialization and aggregation tunes can be established (or indeed surrendered). “We are
represent favourable entry doors to expanding client manifestly living through unprecedented times when the
networks and we will thus be looking to leverage the
wave of innovation in life science is absolutely exception-
incoming regulation to fashion new business activi-
al… and France’s own internal transformation is absolutely
ties such as supply chain improvement projects,” he
remarks. tapping in to this vibe,” exclaims the president of Novartis’
affiliate, Frédéric Collet.
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