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DECEMBER 2018
COMMERCIAL INSIGHTS FOR THE C-SUITE
VOLUME 38, NUMBER 12
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CFO Roundtable
SCIENCE & FINANCE
the Biotech Blend
To maximize your You need wings
product’s success Your breakthrough treatment has the
promise to improve the lives of patients.
But in today’s complex environment,
regulatory approval is no longer enough.
You need to demonstrate to payers and
providers that your product can deliver
improved outcomes and provide value.
You need expertise in evidence gathering,
a deep understanding of all healthcare
stakeholders and actionable real-world
insights. At Cardinal Health Specialty
Solutions, our Real-World Evidence
and Insights team works to critically
analyze data and provide clinically
and scientifically meaningful results to
give you a more precise picture of your
product’s value. We arm you with the
For personal, non-commercial
decisions and guide use
insights you need to make confident
your strategy for
ongoing success.
Learn how we can help your
product soar.
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LOGO and ESSENTIAL TO CARE are trademarks of Cardinal Health and may be
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DECEMBER 2018 PHARMACEUTICAL EXECUTIVE From the Editor 3
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Can New Tech Outsmart Status Quo?
THIS MONTH, I ENCOURAGE THE READERS of Pharmaceutical Executive to read the December issue
of our sister publication, Applied Clinical Trials. The issue focuses on technology and clinical trials
software (eClinical), with an eye on where the clinical trials data collection process may have gone
awry, may have caused inadvertent complications in the clinical trials process, but still with optimism
on how future technologies can improve all aspects of drug development.
n a previous article, Henry Levy, chief strat- in 2019. We don’t discuss clinical trials but we do
I egy officer for Veeva, provided a media
roundtable with a brief history of clinical
data. “Thirty years ago, electronic data
wasn’t common and all of your data was in one
place, and it was ugly, but it was centralized and
look at technology, specifically uses of AI that are
currently in practice and ones that could easily be
adapted to the pharma model. Sanjiv Sharma, VP,
North America commercial operations, HLS
Therapeutics, and Pharm Exec Editorial Advisory
LISA HENDERSON
Editor-in-Chief
managed in one place. And then EDC was a rev- Board (EAB) member, believes that AI is going to lisa.henderson@ubm.com
olution, with companies like Oracle and Medi- creep up faster than we think. “The permutations Follow Lisa on Twitter:
data coming in, which was a massive improve- of AI, and adding in real-world evidence, will @trialsonline
ment—and that was a really good thing. But it have impact on the drug and diagnostic areas for
actually broke everything else, because now you the next four to five years,” he says. John Furey,
had a clinical data management system (CDMS) chief operating officer, Spark Therapeutics, and
that was supposed to clean your data, and then also an EAB member, agreed that AI is already
you had an EDC system that was doing a part being used to find patients as well as in determin-
of the data, which at the time, 70% to 75% of ing the prospective care of patients. EAB member
your data was EDC data.” Jay Galeota, president and COO, G&W Labora-
Recent surveys, along with Levy’s anecdotal tories, says that hospital systems are using phe-
information, report an explosion in the number notypic screening to determine high-responders
of clinical data sources, with EDC comprising for certain drugs so they can make P&T decisions
only 20% to 30% of clinical data, along with based on these algorithms.
ePRO, mHealth, lab data, and more—leaving
CDMS trying to catch up in a decentralized and
not-well-integrated landscape. Technology layers onto
For personal,old
non-commercial
In addition to the plethora of clinical data
sources, David Connelly, CEO of Cmed Group, practices that they use
states, “Over the last decade or so, management
were meant to eliminate
of clinical data has been driven down the com-
modity route, with off-shoring encouraged to
or reduce
save money. In some cases, job roles have been
made narrower to allow for a more task-based
approach with rapid training of less experienced In many industries, it appears that technology
resources. Nothing wrong with reducing costs, and innovation is far surpassing individuals’ and
but with clinical trials becoming more sophisti- companies’ ability to change course and adapt
cated, the number of data sources increasing and to the changes. Technology layers onto old prac-
the types of data more complex, maybe this strat- tices that they were meant to eliminate or reduce.
egy needs to change. Surely we should be apply- Technology that was meant to make efficient use
ing greater expertise and sophistication to derive of resources that then generates its own ineffi-
valuable information from the data, and sooner? cient department. As in the cases cited by our
Clinical trial data is not an ancillary byproduct. EAB members, intelligent uses of technology are
It is the output of the clinical trial and arguably being implemented and will—gradually or
the whole purpose why the trial was conducted extremely quickly—break down the status quo.
in the fi rst place.” I was going to close with a comparison of pro-
Connelly continues with the fact that bio- tecting your archaic model vs. creating new mod-
pharma of all sizes take large risks and spend els with a not-kind comparison to Comcast and
millions to billions of dollars on R&D for new its lack of transparency for its services and prices
and better treatments. And maybe spending listed on its website. However, I have to travel
resources on innovation and management of overseas and call them when I get back, probably
clinical trials would be well spent. devoting one-third of my day to their sales team.
In January’s issue of Pharm Exec, we will take Wish me luck as I try to bridge the new world of
a look at the trends that will impact the C-suite technology with the tried and true status quo.
4 WWW.PHARMEXEC.COM PHARMACEUTICAL EXECUTIVE DECEMBER 2018
VOLUME 38, NUMBER 12
Pharmaceutical Executive’s 2018 Editorial Advisory Board is a distinguished group of thought leaders with expertise in various facets
of pharmaceutical research, business, strategy, and marketing. EAB members suggest feature subjects relevant to the industry,
review article manuscripts, participate in and help sponsor events, and answer questions from staff as they arise.
MURRAY L. AITKEN STEVE GIRLING CHANDRA RAMANATHAN
Senior Vice President, President, Head, East Coast Innovation Center,
Healthcare Insight, IPSOS Healthcare North America Bayer U.S.
QuintilesIMS
ADELE GULFO AL REICHEG
INDRANIL BAGCHI, PhD Chief of Commercial Development, CEO,
Senior Vice President and Head, ROIVANT Sciences Sea Change Healthcare
Global Value Access,
Novartis NICOLE HEBBERT
Senior Vice President, BARBARA RYAN
MICHELLE BARON, MD Head of Patient Services, Founder,
Vice President, Clinical Research, UBC Barbara Ryan Advisors
Chief Medical Officer,
MICHELE HOLCOMB SANJIV SHARMA
Intarcia Therapeutics
Head, Strategy & Corporate Development, Vice President,
FREDERIC BOUCHESEICHE Cardinal Health North America Commercial Operations,
Chief Operating Officer, HLS Therapeutics
BOB JANSEN
Focus Reports Ltd.
Principal Partner, TERESE WALDRON
LES FUNTLEYDER Zensights LLC Director, Executive MBA Programs,
Portfolio Manager, St. Joseph’s University
KENNETH KAITIN
Esquared Asset Management
Director & Professor, PETER YOUNG
JOHN FUREY Center for the Study of Drug Development, President,
Chief Operating Officer, Tufts University Young & Partners
Spark Therapeutics
CARRIE LIASKOS
JAMES J. GALEOTA, JR. (JAY) Vice President,
President and Chief Operating Officer, Market Engagement,
G&W Laboratories Syneos Health
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DECEMBER 2018 PHARMACEUTICAL EXECUTIVE Table of Contents 5
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Real-World Evidence
Securing a Winning RWE Strategy
Julian Upton, European and Online Editor
While the increasing importance of real-world evidence
(RWE) is widely acknowledged, the dramatic shift
required by biopharma companies to embed and
secure an RWE capability effectively across the
organization is still a work in progress.
18
Science & Finance:
The Biotech Blend Market Access
Lisa Henderson, Editor-in-Chief
Pharm Exec convenes a panel of financial leaders from clinical-stage Predicting Access Success
biopharma to discuss the critical role of finance and accounting By Jonathan Chee, Betty Pio, Julia Ehrhardt, and Evelyn Siu
(F&A) in supporting and sustaining the promising science at the There is still no structured method of assessing pricing
forefront of investor engagement. and access risk for drug manufacturers. To that end,
12 authors present a straightforward measure for
integrating pricing and access risk into portfolio
planning and decision-making.
Cover Photo/Porter Gifford. (Left to right, standing) Rhonda Chicko, of Scholar Rock; Ben Stein, of
Ovid Therapeutics; John Lanza, of RSM; Nancy Aubrey, of RSM; Jon Freve, of Spring Bank
Pharmaceuticals; (sitting) Stephen Garbacz, of Spero Therapeutics; Nancy Dong, of ContraFect
23
Corp.; Kim Cammarata, of Virtus Pharmaceuticals; and Amy Diebler, of Chiesi USA.
For personal,
NEWS & ANALYSIS non-commercial
STRATEGY & TACTICS use
INSIGHTS
Washington Report Data Protection From the Editor
8 Challenges to Pharma 28 Pharma Lessons from 3 Can New Tech Outsmart
Pricing Models Escalate Merck Cyber Attack the Status Quo?
Jill Wechsler, Washington Correspondent By Chris Souza Lisa Henderson, Editor-in-Chief
Global Report Back Page
10 Europe’s Digital Health 39 AI’s Potential:
Path Still at Crossroads The Four Hurdles
Reflector, Brussels Correspondent By Steve Arlington
Country Report: Malaysia
30 A Steady Force
Focus Reports, Sponsored Supplement
With a reputation as a reliable, if somewhat unspectacular, marketplace, Malaysia
has long appealed to life science investors lured in by the prospect of generating
consistent returns.
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6 this month on PharmExec.com PHARMACEUTICAL EXECUTIVE DECEMBER 2018
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Top Stories Online Pharm Exec Podcasts
Episode 20: Pipeline Peek that has been
Pharm Exec editors provide a glimpse into the previously
magazine’s 15th Annual Pipeline Report, published shelved—and
in the November issue. Topics include cannabis, share their
CAR-T therapy, opioids, biosimilars, and Alzheimer’s. strategy in
bit.ly/2B6tNkd approaching a
potential
Episode 19: The CEO Career Pivot partner to license their technology.
Pharm Exec speaks with Mei Mei Hu, CEO of United bit.ly/2ImLIW5
Neuroscience, about how being open to pivoting
from your original plan can create a number of Episode 16: Rise of Specialty Pharma
opportunities for an executive and their company. Pharm Exec editors discuss the topic of specialty
2018 Pharm Exec 50 bit.ly/2JqWJGk pharma—featured extensively in our September
June issue online
issue—touching on the areas of marketing, logistics,
Michael Christel
bit.ly/2yOuPSQ Episode 18: Getting ‘Real’ on Data pricing, and other challenges executives in this
Pharm Exec editors sit down with one of this year’s once-niche market face.
Emerging Pharma Leaders, Christopher Boone, the bit.ly/2MMORi
head of real-world data and analytics at Pfizer.
2018 Emerging bit.ly/2Q7JzAz Episode 15: Robotics in Pharma
Pharma Leaders Learn how life sciences companies are using
October issue online Episode 17: Commercializing robotics and AI to enhance patient care, what the
Pharm Exec staff Research funding landscape is in this sector, and what C-suite
bit.ly/2PB6mba Martin Low and Philip Low, CEO and co-founder, members need to do now to be at the forefront of
respectively, of On Target Laboratories, talk with this emerging technology.
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new technologies in order to empower workforces Pharm Exec explores the
and allow the industry to move forward. #labeling trends that will shape
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EXECUTIVE DEVELOPMENT CENTER For personal, non-commercial use
8 Washington Report PHARMACEUTICAL EXECUTIVE DECEMBER 2018
WWW.PHARMEXEC.COM
Attack Mounts on to reduce spending by Medicare
Part D plans by limiting coverage
requirements for “protected drug
Biopharma Drug Prices classes,” and it is authorizing state
Medicaid programs to enter into
Efforts intensify to bring outlays more in line with global trends value-based payment arrange-
ments with manufacturers.
hallenges to pharma pric- tral healthcare systems able to con-
C ing models have escalated
this past year, and now
threaten to impose signif-
icant changes on industry market-
ing and new drug development.
trol drug coverage and spending.
The mounting campaign to
bring pharma prices more in line
with global trends has produced
a range of strategies for reshaping
On the defense
Industry is mounting strong oppo-
sition to the Part B reform and the
IPI model, but may find limited
support. In the fall, pharma com-
The imperative to reduce spend- biopharma coverage and reim- panies failed to scale back an ear-
ing on prescription drugs is one bursement in the US. Congress lier Medicare policy change that
area of agreement between Dem- considered dozens of drug pricing increased manufacturer discounts
ocrats and Republicans, and with bills over the past year, but only for Part D drugs covered by the
control of Congress now split approved measures to eliminate “donut hole” by an estimated $4
between the two parties, political “gag clauses,” which prevent billion over five years.
leaders are looking to curb out- pharmacists from informing Several leading pharma com-
lays to promote public health and patients of cheaper alternative panies reduced prices or delayed
patient access to medicines. medicines. In May, the Trump rate hikes this year in an effort to
This past year brought kudos administration announced a quell the mounting outcry. In July,
to biopharma companies, as man- broad blueprint to lower drug according to press reports, Novar-
ufacturers tested, and FDA prices that attacks rebates paid by tis and Pfizer said they would
approved, multiple innovative manufacturers to pharmacy ben- defer mid-year price increases
medical products, including efit managers (PBMs) and payers until the end of the year. Merck
For personal, non-commercial use
important new gene therapies,
cancer treatments, vaccines, and
and proposes notable changes in
how the Centers for Medicare
& Co. and Amgen similarly
announced price cuts on certain
complex generics and biosimilars. and Medicaid Services (CMS) products and delays in increases.
Such advances have benefited pays for drugs. A recent proposal But such voluntary action is
from FDA efforts to streamline aims to increase “transparency” isolated and uncertain. More
clinical testing methods, clarify in drug costs by requiring manu- reports and public hearings on
regulatory policies, and accelerate facturers to disclose list prices in drug pricing will come as House
application reviews to speed new direct-to-consumer (DTC) ads. Democrats take over key investi-
therapies to market. A main target is to reform gative and health policy commit-
Despite these achievements, Medicare Part B drug reimburse- tees. A recent report from a bipar-
industry faces ever more severe ment, which primarily affects tisan Congressional caucus
criticism for setting prices based injectables administered in doc- attacks high prices for insulin and
on marketing and financial strate- tors’ offices and hospital clinics to urges payers to eliminate rebates
gies and not actual costs. Tradi- treat cancer, rheumatoid arthritis, and shift to outcomes-based pay-
tional claims that high returns on eye disorders, and immune dis- ment contracts for diabetes drugs.
investment in R&D are needed to ease. A new “International Pricing Even though Republicans main-
support costly research programs Index” (IPI) payment model links tained their majority in the Sen-
have lost credibility. Leading man- Part B reimbursement to the aver- ate, leaders of both parties agree
JILL WECHSLER is
ufacturers and industry critics age price paid in foreign industrial on the importance of making new
Pharmaceutical
alike acknowledge that list prices nations and is projected to save medicines more affordable for
Executive’s
Washington
reflect what the market will bear, more than $17 billion over five public and private payers and for
Correspondent. She and not underlying research and years. The Trump administration consumers. The larger challenge
can be reached at production outlays, and that drug proposes to launch it as a pilot for all sides is to maintain incen-
jillwechsler7@gmail. prices in the US greatly exceed plan to avoid waiting for Congres- tives for biomedical innovation in
com those in other countries with cen- sional approval. CMS also looks such an anti-pharma climate.INTRODUCING
“Sana” is Latin for healthy. So when service leaders, spanning
the patient experience to global channel distribution,
combined into one powerful platform, we became EVERSANA.
Together, we will ever evolve and always advance life science
services toward a healthier world.
As our industry shifts to patient-centered, value-based care,
we must:
• Bring forward-looking commercial thinking to the world
of innovation.
• Apply scientific excellence (and the data created in
it) across the product lifecycle.
For personal, non-commercial use
That’s how we can accelerate the process from development to
distribution to ongoing adherence support – by combining our
services and always focusing on what matters most, patients.
Only then – value is realized. eversana.com10 Global Report PHARMACEUTICAL EXECUTIVE DECEMBER 2018
WWW.PHARMEXEC.COM
Europe’s Digital Health passing reference to the EU’s
own limited research and IT
support programs—but as an
Path Still at a Crossroads expression of optimism rather
than commitment.
There has been plenty of lip-
The Commission’s gestures toward enacting formal standards to service over the last few years
digitize health records are masking wider policy gaps to the perceived potential of dig-
ital health. A European Parlia-
ment request back in 2015
he subject of health merits standards—and, of greater sig- urged “improving patient safety
T only one mention in the
European Commission’s
entire planning for next
year—and that relates to elec-
tronic health records. Advo-
nificance for pharmaceutical
executives, it wants the infra-
structure future-proofed to take
account of the use of data for
research.
to be explored, inter alia, via
electronic health records.” The
EU Health Council remarked in
December 2017 on the need to
“remove obstacles to data
cates of digital health might The aim is to link EHRs to exchange and sharing between
argue that this shows a belated the currently scattered national health professionals for the
European Union (EU) recogni- and regional banks of -omics safety and continuity of care.”
tion of the ever-widening oppor- data, biobanks, and other reg- And a Commission think-paper
tunities of digitalization. Cynics istries across the EU. Already in April criticized the “incom-
might counter that the choice there are officials within the patible formats and standards
shows how little the EU cares Commission who are talking of in electronic health record sys-
about health in general, and access to one million sequenced tems (that) continue to be used
that it has merely taken the easy genomes in the EU by 2022, and across the EU.” It mooted pro-
option of a nod toward a small to a prospective population- moting interoperability of mem-
corner of its wider strategy on based cohort of at least 10 mil- ber states’ EHR systems “by
For personal, non-commercial use
the digital economy.
Both could be right.
lion people by 2025. They see
the scope for links to integrated
supporting the development and
adoption of a European EHR
The formal recommendation molecular profi ling, diagnostic exchange format.”
in the 2019 action plan is to imaging, lifestyle, microbiolog- Now, all that has emerged is
establish a format for a Euro- ical genomics, and environmen- a skeletal item in the work plan
pean electronic health record tal data. for what is, in any case, a lame-
(EHR) as from the fi rst quarter duck administration. This is the
of the year. This certainly fi lls Action lacking last year in office of the current
an obvious gap in EU planning. All very ambitious—in theory. European Commission, before a
Europe’s embryonic eHealth The problem is, there is no real new set of commissioners—and
infrastructure is at present lim- mandate for the EU to act here, a new president—is appointed to
ited to patient summaries and and no real money either. Some take over for five years from next
e-prescriptions, and does not E U c ou nt r i e s — E s to n i a i s November. So the EHR initiative
cover E H R s. E xcha nge of always cited as the poster- is as easy to depict as a glass half
patient data from one EU coun- child—are already heavily com- empty as a glass that is half full.
tr y to another cu rrently mitted to taking advantage of
depends on the voluntary coop- digitalization in general, and on Curious omissions
eration of health authorities, health in particular. Many show What is absent from the Com-
and is subject to all the chal- little enthusiasm. Most do not mission work plan for 2019 is
lenges of non-standardized sys- inject the resources into digital perhaps as revealing as what is
REFLECTOR is
tems. health to make a reality of it— included in it—and particularly
Pharmaceutical So the Commission is push- and without that, no EU encour- for pharmaceutical company
Executive’s i ng for ag re ement a mong agement can make much differ- executives.
correspondent in national authorities on an EHR ence. The Commission’s action There is nothing, for instance,
Brussels exchange format based on open plan makes only an imprecise on what is going to happen to theDECEMBER 2018 PHARMACEUTICAL EXECUTIVE Global Report 11
WWW.PHARMEXEC.COM
EU’s drug-research incentive underlying science they depend urgency of building on real-
schemes. Despite all the fevered on. world evidence, even in small
debate since the Netherlands Nor is there anything on populations, and on opening up
suggested back in 2015 that how the Commission intends to the rigid frameworks of 20th
pharmaceutical companies were square the circle of Europe’s century regulation.
abusing orphan drug therapy health technology assessment Innovative efforts, particu-
awards or the benefits offered (HTA) debate. larly in rare and complex dis-
under the pediatric medicines Its proposal of streamlining eases, could benefit from a more
scheme or the supplementary the multiple national HTAs into flexible and benign climate, but
protection certificate, uncer- a single agreed joint assessment opposition from national regu-
tainty will continue to hang over at EU level is stridently opposed lators and payers, anxious over
the future. by national governments and relinquishing their habits, seems
A C om m i s sion of f i c i a l t h e E u rop e a n Pa rl i a m e nt to have stymied for the present
involved in these lengthy reflec- demanding any number of get- the thinking that had been pio-
tions confi rmed in November out clauses t hat wou ld i n neered not just by industry but
that no moves toward decisions
would even begin to be dis-
cussed until 2020.
The Commission’s action plan makes only an
There is nothing either on imprecise passing reference to the EU’s own limited
what the EU should or should
not do in respect of drug pric- research and IT support programs—but as an
ing—despite increasingly loud
clamoring for tighter controls, expression of optimism rather than commitment
particular on high-priced inno-
vative products. Hardly a day essence perpetuate the current also by the European Medicines
goes by in Brussels without a duplication, and defeat the Agency (EMA).
new call from some influential object of the exercise. In other words, on many of
For personal,
Future feasibilitynon-commercial use
quarter for radical change, prin-
cipally a stricter reimbursement
the strategic issues of concern
to the pharmaceutical industry
system. The debate rumbles on without right now, the Commission has
There is nothing on how to any sign of a breakthrough, little or nothing to say. In its
reconcile the confl icts facing the leaving pharmaceutical execu- defense, it must be acknowl-
research-based industry, which tives facing persistent uncer- edged that the Commission’s
feels—as senior executives can- taint y over when they can own powers are limited, and
didly admitted at a conference expect a more rational Euro- especially on health. Much of it
on pediatric medicines in Brus- pean approach to evaluation of remains under national con-
sels in late October—under their products. trol—and therefore subject to
g row i ng pre s su re , c au g ht And there is nothing to sig- agreement within the European
between governments and soci- nal any clear pathway toward Council of Ministers.
ety demanding cheaper drugs, adapting regulatory procedures But those fi ner constitutional
and physicians and patient that can accommodate the distinctions matter little to a
advocates urging increased needs of the growing number of company facing real-time deci-
investment in R&D. new therapeutic approaches, sions about its European future.
The pressure is intensified by where classic randomized clini- Regardless of which EU institu-
the wave of concerns now sweep- cal trials may no longer be the tion or national government is
ing European activist circles that best procedure for evidence gen- to blame, the situation for com-
society is paying twice for new eration to support marketing panies seeking a conducive
medicines—not only in reim- authorization applications for operating environment is always
bursing pharmaceutical and bio- new treatments. going to be judged on feasibil-
technology manufacturers, but For more than five years, the ity—and right now, feasibility
in subsidizing their research discussions f lashing across is difficult to judge in European
through public funding of the Europe have illuminated the health policy.12 Executive Roundtable D DIAL HEAD PHARMACEUTICAL EXECUTIVE DECEMBER 2018
WWW.PHARMEXEC.COM
Photos/Porter Gifford
For personal, non-commercial use
(Left to right, standing) Rhonda Chicko, of Scholar Rock; Ben Stein, of Ovid Therapeutics; John Lanza, of RSM; Nancy
Aubrey, of RSM; Jon Freve, of Spring Bank Pharmaceuticals; (sitting) Stephen Garbacz, of Spero Therapeutics; Nancy
Dong, of ContraFect Corp.; Kim Cammarata, of Virtus Pharmaceuticals; and Amy Diebler, of Chiesi USA.
Biotech Business Ramp-Up:
Adding Credibility to Narrative
Financial leaders from clinical-stage biopharma gather to discuss the
critical role of finance and accounting (F&A) in supporting and sustaining
the science at the forefront of engagement with investors
t the recent CBI Finance and Accounting serving at a larger pharma manufacturer. They
A for Bioscience Companies conference,
professionals from small- to mid-sized
biopharma gathered to learn from each
other and discuss their unique challenges. Typi-
cally, smaller-staffed organizations, with their
wear multiple hats, get involved with diverse proj-
ects, and make decisions impacting the future
fi nancial vitality of their respective organiza-
tions—and their scientific prospects as well.
RSM, hosting a breakfast roundtable for these
smaller-staffed departments, require their execu- professionals, graciously allowed Pharm Exec to
tives to be accountable for much more than those moderate “The Role of the Finance Leader inDECEMBER 2018 PHARMACEUTICAL EXECUTIVE Executive Roundtable 13
WWW.PHARMEXEC.COM
Scaling the Biotech Business.” to understand our budgeting all competitive landscape is
W h a t f o l l ow s a r e e d i t e d and cash position, and making changing. Our lead target is
excerpts from a very insightful sure that the decisions we’re designed for the treatment of
and robust discussion. making today will enable us to chronic HBV (hepatitis B virus),
be viable in 18 months to two which is a highly competitive
PE: How do you stay on top of both years out. area following the recent success
the financial insights as well as the Even for the early stage com- with the treatment of HCV.
science information needed to do panies, and perhaps it’s actually That said, we are strong believ-
your job effectively? more important, to make sure ers that the HBV treatment par-
STEPHEN GARBACZ, Spero Thera- that you bring on the FP&A adigm will be a multi-mecha-
peutics: In terms of obtaining the (fi nancial planning and analysis) nism approach that will require
latest financial information, I skillsets to instill financial collaboration working with
use online systems like NetSuite responsibility throughout the other companies and their
and Coupa, where I can access organization. Because from the mechanisms.
up-to-the-minute information to
stay informed on where we are. “It’s not only staying on top of our internal
For the science, I talk to the pro-
fessionals in our organization, developments with our own science and
many of whom are leaders in
their field. I also read select pub- our own clinical trials, but really continuing
lications like Pharmaceutical
Executive and a number of
to monitor the overall landscape.”
blogs, such as the Luke Timmer- —JON FREVE, SPRING BANK PHARMACEUTICALS
man Report, Life Sci VC, and
Endpoints. science standpoint, you need to Not only do I need to cur-
NANCY DONG, ContraFect Corp.: know, are we really going to be rently monitor our internal
In our company, we’re relatively able to do a trial with this num- progress and clinical develop-
For personal, non-commercial use
small still, about 30 people in
the offi ce. And because I have
ber of patients? What does a
CRO cost? What does a CMO
ments, but I’m regularly looking
at the emerging issues and/or
responsibility for HR, I have cost? Try to make sure that you developments in the overall HBV
become more aware of the start that process very, very early space.
staff’s needs. Over the last two on or else companies might fi nd With regards to our lesser-
years, we have had a Lunch and themselves in some pretty tight known programs, we’re contin-
Learn and invited our staff sci- situations. uously monitoring organiza-
entists to talk about what they JON FREVE, Spring Bank Pharma- tions that develop targets or
do. In the past, I would try to ceuticals: On top of what every- focus on indications where we
pick up the science in the hall- body else already brought up, are active. For example, our
way or get myself invited to our core management team secondary program, a STING
clinical team meetings or the meets at least twice a month to agonist for the potential treat-
project team meetings. continually assess how the over- ment of certain cancers, is also
But the Lunch and Learns
have been very successful for
everyone. Roundtable Participants
RHONDA CHICKO, Scholar Rock: I Nancy Aubrey, Risk Advisory Services, Life Sciences Industry, RSM US LLP
consider what the company will Kim Cammarata, Controller, Virtus Pharmaceuticals
Rhonda Chicko, CFO, Scholar Rock, Inc.
need to finance and fund the
Amy Diebler, VP of Finance and CFO, Chiesi USA
operations for the long term. We
Nancy Dong, VP Finance & Administration, ContraFect Corp.
will regularly consider what Jon Freve, CFO, Spring Bank Pharmaceuticals, Inc.
resources are required to con- Stephen Garbacz, SVP, Finance & Operations, Spero Therapeutics
tinue progressing the science. I John Lanza, National Life Sciences Industry Leader, RSM US LLP
try to look well beyond the cur- Ben Stein, Accounting Manager, Ovid Therapeutics
rent plan. I am always looking Lisa Henderson [moderator], Editorial Director, Pharmaceutical Executive14 Executive Roundtable PHARMACEUTICAL EXECUTIVE DECEMBER 2018
WWW.PHARMEXEC.COM
in a very competitive space. whether it’s non-deal road shows the company’s cash position and
There are many companies that or actively raising funds—that’s runway, and if the company’s
have started to enter the clinic, how we attract new investors. fi nancing strategy can credibly
but we have not yet done so. And if we can’t communicate support its narrative.
This timing allows us to look that story effectively, we’re not AMY DIEBLER, Chiesi USA: The
for their data to guide us a little going to be able to bring in the Chiesi story is a very important
bit. additional funds necessary. component of these conversa-
It’s not only staying on top Similarly, with existing inves- tions, because most are focused
of our internal developments tors, we have to continue to keep on collaboration and partner-
with our own science and our them engaged and show them ship, where trust is at the center.
own clinical trials, but really where their investment is going, Chiesi is a family-owned
company, and after more than
80 years, the second and third
“If we’re going to develop therapeutic generations of the family still
solutions that improve the quality of life and work here. So, when we’re talk-
ing about acquiring assets, or
health of people, we’ve got to be financially collaborating with a biotech
company on its R&D, or becom-
and operationally healthy as well.” ing its commercial partner, our
—AMY DIEBLER, CHIESI USA history of fi nancial stability and
commitment to the science are
continuing to monitor the over- which allows us to continue to front and center.
all landscape. That’s important progress the science. And if The fact that our owners
as we make decisions as to we’re not telling that story in an want to see medical innovation
where we’re going to look to effective way, we’re going to lose advanced to the next level is
spend our funds over the course certain investors if they’re not meaningful. In fact, more often
of the next 18 to 24 months. happy with either the speed of than not, our story is the reason
For personal, non-commercial use
PE: How important is your com-
development or the direction
that we’re taking the develop-
we are chosen as partner.
DONG: We have a deck our
pany’s narrative — your stor y ment plan. Also, if you have team uses, but every so often we
when you speak to investors, delays, be able to explain those present it to the entire company
stakeholders, or potential busi- delays. Talk about challenges so that our team inside knows
ness partners? and how you’re overcoming what we’re saying out there in
FREVE: It’s critical. We have a them and moving the programs the market. Our teams on the
complex story, so it takes a little forward. inside really enjoy them, espe-
longer to tell. Sometimes I’d pre- The story is critical. I’m on cially our team in the lab. They
fer to have a 60-second elevator the road quite often and that used to say, “Oh, the corporate
pitch, but we are a dynamic, story evolves regularly. That’s a world does a lot of things that
young company with a platform big part of being able to continue we don’t know about. We don’t
of targets, and we have to to stay ahead of things; adapt even know if they know the sci-
explain it well—and that’s not your story to where not only the ence.” But now they know and
as straightforward as you might competitive landscape is going it’s a lot of fun because we have
think. It’s not, “we’ve got one but where your company is received very particular ques-
pill that’s going to cure it all.” going. I think that’s important tions about the science from our
It’s, “we’ve got to work with for all of us as fi nancial execu- internal staff.
multiple mechanisms and col- tives—being able to tell that BEN STEIN, Ovid Therapeutics:
laborate with a few other com- story effectively. Because we’re in the rare orphan
panies and hopefully we’ll be the GARBACZ: T he company’s disease area, engagement with
backbone therapy in those mixes story is very important. The the patient community is an area
that eventually move forward investors are interested in the sci- that we really strive to be a part
and provide a functional cure.” ence and the portfolio’s pros- of. That provides something to
When we’re out on the road— pects. They are also interested in the employees as well.DECEMBER 2018 PHARMACEUTICAL EXECUTIVE c.bit.ly/abcdef Executive Roundtable 15
WWW.PHARMEXEC.COM
We try to communicate with GARBACZ: What is interesting new office space where we were
the staff as often as we can about is that a lot of the security ana- moving two locations, consoli-
what’s going on with the clinical lysts now have PhDs and know dating into one; that entailed
trials and get them involved with the science inside out, so you building out a 10,000 square
the patient community as well. need someone that is respected foot lab facility.
Whether that’s through Face- and can credibly talk with this Although the scientists are
book, LinkedIn, online, other community. the most knowledgeable about
social media— getting them CHICKO: We also have a couple lab requirements and where they
involved is something that different approaches and a cou- want to build certain aspects of
strengthens the engagement and ple different levels of our story. the chemistry lab versus the
the story. One of the things we do is assess biology lab versus the NMR
GARBACZ: I think one of the to make sure we know our audi- (nuclear magnetic resonance)
great advantages of a small com- ence. Who are we talking to? room, etc., it was ultimately me
pany is that everybody is a bit Sometimes even before we start, that ended up participating in
closer to the science. And a lot we have a conversation about all the meetings, helping transi-
of the scientists and research their backgrounds and ask them tion everything over to our con-
people love explaining what about their level of scientific tractor in working through the
they’re doing and what’s going knowledge. build-out.
on, almost like a professor. Someone mentioned during I learned more about the lab
Actually, some of them are pro- the conference that you have to than I ever thought I would,
fessors. be careful whenever you speak. which was great, but I think it’s
JOHN LANZA, RSM: All of your If you start throwing out medi- having the ability to really just
companies are different. I’ve cal buzzwords, be careful in case put on that different hat and
always wondered, if the founder
is the scientist, do they talk dif- “A lot of the security analysts now have
ferently versus a non-founder
scientist? About numbers, cash, PhDs and know the science inside out, so
For personal,
runway and spend, and all
that? non-commercial
you need someone that use is respected and
DIEBLER: Our founder, Gia-
como Chiesi, was a scientist, and
can credibly talk with this community.”
the second generation of the — STEPHEN GARBACZ, SPERO THERAPEUTICS
family has scientists among them
as well. But what’s interesting someone calls you on it. Our focus on the task at hand and do
about Chiesi is that the family CEO is excellent at making sure what needs to get done. That’s
has always been visionary about he understands the scientific critical, especially in a small
how to achieve their ultimate background for whomever he is company world. It’s being able
goal. If we’re going to develop speaking with and making sure to adapt and work with what-
t herap eut ic solut ions t hat the person is responding—and, ever aspect is coming my way
improve the quality of life and if not, then take a different that particular day and take that
health of people, we’ve got to be approach. Having a couple of challenge head on.
financially and operationally different pitches works well. GARBACZ: I’ve had the same
healthy as well. experience early on in the com-
As the company grew, Chiesi PE: What leadership skills do you pany—needing somebody that
hired non-family members in draw on most in your role? can do just about everything
senior leadership to provide FREVE: For me, it’s adaptabil- and is comfortable with the
additional business acumen and ity. It’s critical. We’re a small uncertainty that comes with
balance. They knew they needed company, 25+ employees. I wear biotech. And the organization
to have a CEO and CFO who many different hats, whether it’s evolves over time. First, the
would pursue the scientific fi nance, HR, investor relations, company is a relatively simple
vision from a business point of IT, facilities. Just recently we early stage research organiza-
view. built out a new lab space and a tion. So you initially focus on16 Executive Roundtable PHARMACEUTICAL EXECUTIVE DECEMBER 2018
WWW.PHARMEXEC.COM
accounts payable and managing ficult to manage the costs. As a contractor who works a couple
expenses. Next, you may have smaller player, we don’t have the days a week on quality or even
collaborations or government same leverage as a large pharma. in the fi nance department, can
g rants, and then financial We bid all our CRO work make sense for an early stage
reporting becomes more com- through a competitive proposal company. And for Spero, as we
plex because you have to work process. It’s a challenge to keep go back to the discussion about
with your collaboration partner them on budget as they’re rarely how the company evolves over
and provide them with timely incentivized for effi ciency. It’s time, our decision to have out-
planning and reporting. defi nitely an area that will be sourced a lot of the early stage
If successful, the company difficult to improve on as a small research, as opposed to bringing
will then progress into clinical player in the space. it in-house, was beneficial,
trials and the early stage research CHICKO: It is hard. And we are because we subsequently shifted
may become relatively less challenged, as you said, because our focus to clinical develop-
important. At this point, the we’re small companies. We don’t ment and reduced our need for
company will need to begin hir- have all the resources and the early stage research.
Rhonda is right, you really
need to closely manage third-
“Some of the bigger mistakes that party providers and stay on top
of them.
companies make is they assume that
when work is contracted out, it happens PE: You all have different pathways
to your current role in a smaller
seamlessly. …It’s not easy. It’s a biopharma. How do you feel about
working in this industry?
balancing act.” GARBACZ: I really enjoy my job
— RHONDA CHICKO, SCHOLAR ROCK and really love working in bio-
tech. Cambridge is like the cen-
For personal,
ple that have a different skillset. non-commercial
ing clinical and regulatory peo- infrastructure to be able to do a
lot of this work, so we need to use ter of the universe in that
respect—there’s so many oppor-
That changes the culture as well contract out. I think some of the tunities and interesting things to
because the company becomes a bigger mistakes that companies do, and great people as well.
little more organized and regula- make is they assume that when Everyone that you work with
tory oriented, and a little bit less it’s contracted out, it happens and meet with are intelligent,
academic. Once the company seamlessly. It’s my experience nice people.
approaches commercialization, that when companies apply an FREVE: Biotech, from my per-
you will then need to bring in the internal resource to manage spective, is by far the most col-
salesforce, which is an entirely these relations, you have better laborative industry out there.
different group with a new per- luck. But for many small start- We’re all rooting for each other,
sonality. ups, it’s almost a luxury to bring because it’s for the right reason.
I think successful senior exec- in someone to provide oversight Even though we may be com-
utives must be able to provide to these different contracts and petitive in a certain space, we
effective leadership across that contractors. It’s not easy. It’s a want to see others succeed,
continuum, adapt to each new balancing act. because the outcome obviously
phase of the business, and recruit GARBACZ: We’ve seen that as benefits a broader group. From
people that embody the compa- well. When a company is small that perspective, it’s exciting to
ny’s core culture. and developing, there are often be a part of the entire biotech
a number of jobs that are not yet space.
LISA HENDERSON is
PE: How much do you outsource to full-time positions. Outsourcing GARBACZ: You’re doing some-
Pharm Exec’s third-party providers and how does to a third-party provider, or thing that benefits people.
Editor-in-Chief. She can that experience go? contractors, can be used to fi ll DIEBLER: Our work is impor-
be reached at lisa. FREVE: CROs are our largest the current gaps and provide tant and rewarding. We’re
henderson@ubm.com source of cost and it’s very dif- scale as the company grows. A changing lives.LEARN MORE ABOUT
PATIENT ASSISTANCE
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General Manager, IQVIA US Patient Access
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Dave MacDougall
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For personal,Join
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For technical questions about this webinar,
please contact Kristen Moore at kristen.moore@ubm.com18 Real-World Evidence PHARMACEUTICAL EXECUTIVE DECEMBER 2018
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Securing a Winning Strategy
for Real-World Evidence
While the increasing importance of real-world evidence (RWE) is widely
acknowledged, the dramatic shift required by pharma to embed meaningful
and holistic benefits from this capability is still a work in progress
By Julian Upton
Culture shift
n Deloitte’s Second Annual Real-World Evi- While the increasing use and importance of RWE
I dence (RWE) Benchmarking Survey, pub-
lished earlier this year, the authors high-
lighted how the proliferation of healthcare
data, advancing technology and analytics capa-
bilities, and an increased regulatory/pricing focus
is widely acknowledged, the shift required by bio-
pharma companies to embed and secure an RWE
capability effectively across the organization is
still a work in progress. For Qin Ye, associate prin-
cipal and global RWE lead at ZS
on value showed how “the use and importance” Associates, in developing effec-
of RWE in the life sciences industry had evolved tive strategies, pharma companies
in just 12 months. More specifi cally, this year’s still face a big hurdle “to over-
report pointed to how “RWE initiatives are come product-development-cen-
increasing at the executive level,” not just in tric business models and be a lot
regard to generating evidence, but also in support- more connected with the value
ing other research, corporate, and commercial Qin Ye they’re trying to bring to market
objectives. Almost all (90%) of the survey’s and the problem they’re trying to solve for their
respondents, Deloitte reported, “have either stakeholders.”
For personal, non-commercial use
established or are currently investing in building
RWE capability for use across the entire product
Addressing this, he says, involves a fundamen-
tal culture shift. Companies tend to have a need to
life cycle,” with 70% building or increasing their compartmentalize their functions to gain the nec-
internal RWE capabilities. “As a result,” the essary focus and efficiency, but that is at the
authors wrote, “RWE spending on talent and expense of a more holistic approach. While pharma
technology in the future is anticipated to companies need talented teams with specialized
increase.”1 training and knowledge, these highly skilled teams
tend to base a lot of their decision-making on their
experiences in the past.
“It can be difficult to change that mindset to
FAST FOCUS one that is more data-driven,” says Ye.
» By 2020, large pharmaceutical, biotechnology, and contract research or-
In helping companies implement an effective
ganizations (CROs) are expected to increase the number of staff working on RWE strategy, ZS sees “the change management of
collecting and analyzing real-world evidence by 25%, according to a survey culture shift as the key priority.” A lot of pharma
by Tufts Center for the Study of Drug Development. companies currently have a siloed approach to gain-
ing access to and leveraging data. “Looking end to
» RWE challenges for companies include collecting the data and integrating
it with other data sources, extracting the value and interpreting data with an end,” says Ye, “the question should be, how do you
emphasis on causality, evaluating the RWE contribution to the drug approval leverage data to help you to make decisions and
process, and convincing outside parties, such as regulators and payers, of better position your product from the very begin-
the value of RWE. ning of the development process?”
This view is echoed by Saama Technologies, a
» Experts believe there will be more standards created around the inter-
changeability and exchangeability of data sets as the RWE space evolves. A clinical data integration platform company, who
key, they say, will be putting standards in place for how patient records are this year partnered with Informa Pharma Intelli-
used for insight generation and how blockchain and other technologies can gence’s Citeline to bridge clinical trial information
store that kind of data securely. to RWE. Nekzad Shroff, Saama’s VP of field prod-You can also read
