Quintelis New Health Report 2012

Rethinking the Risk Equation in
Biopharmaceutical Medicine
Rethinking the Risk Equation in
Biopharmaceutical Medicine
Overvi ew
expectati Ons and Obstacles i n HealtHcare
pati ents as a part Of tHe system
bi OpHarma s evOlvi ng busi ness mOdel
payers seek mOre parti ci pati On
i nvestOr ambi valence, Opti mi sm
mi ti gati ng ri sk: tHe need fOr new metri cs
cOnclusi On
about The New Health Report
about Quintiles
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ta b l e Of cOnt e nt s
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for a patient, risk largely entails drug safety, such
as concerns over side efects, but patients must
also evaluate the risk of taking one medication
over another, or perhaps none at all. Healthcare
professionals must weigh the risk in using new
drugs versus existing ones. biopharmaceutical
companies, on the other hand, must assess the
risk of moving forward with one investigational
compound or another, proceeding or pausing in
the chain of clinical trials, collaborating with other
stakeholders or going it aloneall of this plus
a host of other concerns. for payers, the risks
involve when and why to reimburse for particular
treatments, while investors seek methods of
analysis to reduce their risks as they decide where
to infuse capital.
The New Health Report 2012 shows, however, that
todays stakeholders often disagreebetween
and within groupson what risks matter
the most. this study arises from a survey of
biopharmaceutical executives; patients living with
a chronic disease in the united kingdom or the
united states; national Health service (nHs)
executives in the united kingdom; managed care
executives in the united states; and investors
with a focus on the life sciences sector. payer and
patient respondents were deliberately culled from
both the united kingdom and the united states
under the premise that attitudinal diferences and
perceptions of healthcare might reveal that an
understanding of risk and beneft is not universal.
further, as the global economic crisis has
produced austerity budgets throughout europe,
cost-conscious payers in these countries need to
make increasingly difcult coverage decisions
that accurately weigh the value and risks of
new treatments.
for stakeholders to make better collective
decisions based on value and risk, they frst
need to assimilate the varying perceptions of the
concept, and then take a systematic approach
in order to better manage it. currently, the tools
used to balance healthcare risk versus reward
remain rather rudimentary, and lessons from
other industries could accelerate improvements
in patient outcomes. for example, making the
most of the available datafrom preclinical
information to patient outcomesrequires new
tools and sophisticated methods to interrogate
the data. with more robust sources of data,
healthcare players can plan the pathways to the
next generation of lower-risk, higher-beneft
medications that balance the needs of all
stakeholders. as the results of this survey reveal,
considerable evidence already suggests a new
pathway. the stakeholders must function like
teammates, instead of opponents, to make the
most of existing opportunities. the resulting
collaboration could spawn a range of improved
methods for reducing and communicating the
risks and benefts of biopharmaceutical medicine.
overview
The essence of healthcare arises from the tradeofs between risk and value. Last
years New Health Report focused on valuepatients, physicians, payers and
biopharmaceutical executives defned this concept in many ways. For example, only
two percent of patients polled mentioned cost and outcomes when defning value as
opposed to 38 percent of biopharmaceutical executives. As with value in healthcare, risk
extends across the constellation of stakeholders, and each group sees risk from a unique
perspective.
www.quintiles.com/newhealthreport
On a fundamental level, risk is always attached to expectations. This idea lies behind the
business concept of the risk-return tradeof, which states that increasing the potential of
the return raises the risk. To understand the risk-return tradeofs in healthcare, The New
Health Report 2012 asked biopharmaceutical executives, managed care executives in the
United States, National Health Service executives in the U.K. and healthcare-focused
investors a series of questions designed to uncover diferent perceptions as to what the
future of healthcare might look like.
In terms of the general health of people born today, most of the respondents see longer
lives ahead. For instance, the majority of biopharma executives and U.K. payers expect
lifespan to reach an average of 90 years, and nearly half of U.S. payers and half of investors
agree. Regarding the health of people in general, just under half of the respondents from
most groups predict improvements, and a slightly higher percentage of U.K. payers agree.
Expectations and Obstacles
in Healthcare
Expectations and Obstacles in Healthcare 5
Investors Sums may not add to 100% or be equal to components due to rounding
in terms of the capabilities of medicines in the
future, the responses are less certain. fewer than
half of the experts from biopharma and u.s.
payers and even fewer of the investors expect
to see cancer becoming a manageable disease
in the near future, but u.k. payers are more
optimistic. when asked about the likelihood of a
cure for alzheimers over the next generation, the
stakeholders answer similarly to their responses
on managing cancer, although the investors rank
alzheimers disease as more likely to be cured.
those medical milestones, however, will come at
a cost. for example, less than one-ffth of u.s.
payers and one-quarter of biopharma experts
expect cost-efective healthcare in the united
states over the next generation in comparison
to other countries. in contrast, about half of
u.k. payers expect cost-efective healthcare
more than twice the amount of their american
counterparts.
r e s t r a i ne d Op t i mi s m f Or a n unc e r ta i n f u t ur e
l e ss tHan One- fi f tH Of u. s.
payers and One- Quarter
Of tHe bi OpHarma e xecs
e xpec t cOs t- effec ti ve
He altHc are i n tHe uni ted
s tate s Over tHe ne x t
gener ati On i n cOmpari sOn
tO OtHer cOuntri e s.
Life expectancy for the average person will be 90 years
Most cancers will become a manageable disease
A cure for Alzheimers will be found
The nation will become healthier overall
US / UK healthcare will be considered cost-eective
compared to other developed countries
64% 45%
45% 45%
45% 40%
68% 50%
55% 37%
59% 51%
43% 41%
24% 19%
59% 47%
45% NA
Biopharma, Payers, Investors | Percent who consider it very or somewhat likely
that in the lifetime of people born today...
I NV E S T OR S B I OP HA R MA PAY E R S
6 2012 | The New Health Report
looking more closely at the elements of
tomorrows healthcare, stakeholders were asked
about their optimism or pessimism related to
future healthcare quality and pharmaceuticals. in
terms of the quality of healthcare a decade from
now, two-thirds or more of biopharma executives,
u.s. payers and u.k. payers, plus nearly three-
quarters of investors express optimism, but less
than half of u.k. and u.s. patients agree. in fact,
fewer than 40 percent of u.k. patients claim to be
optimistic about tomorrows quality of healthcare.
the disconnect between u.k. payers (66 percent)
and u.k. patients (38 percent) is striking and may
indicate an underlying lack of confdence in the
future direction of the nHs.
despite eight out of 10 biopharma executives
being optimistic about the quality of prescription
medications in 10 years, they do anticipate
challenges. foremost, these experts expect to
travel a rough road with regulators from the u.s.
food and drug administration (fda). a lack of
capital and the increased reluctance of payers to
reimburse for new medication are also serious
concerns. in general, investors agree with the
concerns over a changing regulatory landscape,
but show less concern over fnancing, perhaps
because investors live every day in a world of
fnancial risk.
Biopharma, Payers, Investors, Patients | 2012 ; Biopharma, US Payers, Physicians, US Patients | 2011
Percent who are somewhat or very optimistic about the future of healthcare
QUALI1 OF
HFAL1HCARF
IMPROvFD J0 FARS
FROM NOv
QUALI1 OF
PRFSCRIP1ION
MFDICINFS
IMPROvFD
J0 FARS FROM NOv
0 % 2 0 % 4 0 % 6 0 % 8 0 % J 0 0 % 0 % 2 0 % 4 0 % 6 0 % 8 0 % J 0 0 %

US P H S I C I A NS UI P A F R S I Nv F S 1 OR S B I OP HA R MA US P A F R S US P A1 I F N1 S UI P A1 I F N1 S
64%
63%
44%
54%
72%
76%
59%
72%
69%
68%
66%
74%
49%
38%
80%
81%
93%
68%
N]A
N]A
N]A
N]A
N]A
N]A N]A
N]A
N]A
N]A
Expectations and Obstacles in Healthcare 7
29% More dicult FDA
approval process
12% Increased requests
for more data
19% Increased payer
reluctance to cover
new medications
10% Global economic
downturn
20% Lack of funding /
capital
9% Other
Biopharma | Which is the biggest challenge
facing your company? a l ack Of c api tal and tHe
i ncre ased reluc tance
Of payers tO rei mburse
fOr ne w medi c ati Ons are
seri Ous cOncerns.
One could argue that patients take on the most risk in healthcare because their quality of
life hangs in the balance. Consequently, they stand to gain the most from understanding
their own health. Yet when asked to rate their overall health, three-quarters of U.S. patients
consider their health good to excellent which seems unlikely in a country where more
than two-thirds of the population is overweight or obese. By comparison, only about 50
percent of U.K. patients give themselves similar assessments. In short, U.S. patients see
themselves as healthyprobably healthier than they areand U.K. patients are likely
providing somewhat more accurate self-evaluations.
Patients as a Part of the System
Patients as a Part of the System 9
given that the population of patients in this
survey all sufer from a chronic disease, no
surprise comes from their overwhelming response
to being adequately informed about the benefts
of taking their medicines. more than 90 percent
of both u.k. and u.s. patients feel they know the
benefts of taking their medicationan expected
result from respondents in which two-thirds take
at least three prescription medications, and more
than a quarter of them take more than fve (data
not shown).
some variations among the patients start to
appear when examining their beliefs about the
risks behind those prescriptions. although both
patient groups show this drop in confdence when
moving from understanding the benefts of a
medication to assessing its side efects, the data
do reveal diferences between the two cohorts.
for instance, u.s. patients appear far more
confdent than u.k. patients when it comes to
information about side efects, 86 to 69 percent,
respectively. likewise, u.s. patients exhibit a
similar ofset when it comes to knowing about a
drugs potential risk (84 percent), when compared
with the u.k. patients (64 percent).
direct-to-consumer advertising in the united
states may partly explain these diferences, as
patients are bombarded with lengthy disclaimers
about potential side efects and safety concerns.
another explanation may be the litigious nature
of the united states, where physicians are more
apt to discuss the side efects and not just the
benefts of medications. in any case, these data
reveal an opportunity for biopharmaceutical
companies to better communicate the risk-beneft
tradeofs of medicines in terms meaningful
to patients.
in the u.s and the u.k., patients give the
biopharmaceutical industry little credit for making
medications safe and efective. both patient
populations believe that physicians do the best
job of that, followed by patient-advocacy groups.
in addition, fewer than half of the patients feel
like the biopharmaceutical industry does a good
job of making new medications available as
Patients | Percent who feel adequately
informed about...
US PAT I E NT S UK PAT I E NT S
The benets of taking your medication
94%
92%
Side eects
86%
69%
64%
Potential risks of taking it
84%
How the drug works in your body
71%
55%
How it compares to existing medication
66%
51%
u. s. pati ent s appe ar far
mOre cOnfi dent tHan u. k .
pati ent s wHen i t cOme s
tO i nfOrmati On abOut
si de effec t s.
1 0 2012 | The New Health Report
quickly as possible. given that getting new drugs
on the market provides the income that feeds
biopharma, the industry seems unlikely to halt
or slow down drug development for anything
other than risk or beneft concerns. notably, both
groups of patients realize the role of regulators
in the timing of medicines reaching the market.
a misunderstanding of the process is clearly
evident, however, as more than 60 percent of
u.s. patients credit physicians with making drugs
available as soon as possible, and more than
a third of patients in the u.s. and the u.k. feel
patient advocacy groups have signifcant bearing
on drug development.
despite both patient populations showing a
lack of faith in the biopharmaceutical industrys
ability to ensure safe and efective drugs, patients
want the industry to work even faster. nearly 90
percent of u.k. patients think that it takes too
long to get new drugs to patients. some of the
negative responses from u.k. patients, however,
might have been heightened by media coverage
which regularly highlights instances in which the
nHs has declined to fund a new medication.
although the majority of u.s. patients seems to
think that no oneexcept physiciansdoes a
very good job of getting drugs on the market as
fast as possible, only 69 percent of those patients
say that the process takes too long, which is
nearly 20 percent fewer than u.k. patients.
perhaps most interesting of all, a high percentage
of both patient populations express an interest
in taking more risk with medications. more than
70 percent of u.s. patients and four out of fve
u.k. patients believe it should be their right to
take a high-risk medication if they hope for some
improvement in their health. in other words,
these responses indicate that many patients want
Patients | Group does an excellent/ good job of
DOCTORS
PATIENT ADVOCACY
GROUPS
PHARMACEUTICAL
COMPANIES
REGULATORY
AUTHORITIES
HEALTH INSURANCE
PROVIDERS
% % % % % % % % % %
MAKING SURE MEDICATIONS ARE
SAFE AND EFFECTIVE
MAKING SURE NEW DRUGS ARE AVAILABLE
TO PUBLIC AS QUICKLY AS POSSIBLE
Patients as a Part of the System 1 1
medicines faster rather than safer, if they must
choose. nonetheless, half of u.s. patients also
feel that medications get approved too quickly
without balancing safety. taken together, the
responses from u.s. patients highlight some
disconnected thinking regarding risk: they want
and expect medications quickly, but arent fully
aware of the trade-ofs involved.
simply thinking about risk often difers from
acting on it. instead of wondering how patients
respond when faced with the risks related to
prescription pharmaceuticals, their behaviors
provide a much clearer picture. to get at those
behaviors, patients were asked if they ever turned
down or stopped taking a medication because of
safety or side-efect concerns. roughly speaking,
only about one-third of u.k. patients said that
they had, compared to half of u.s. patients. so
even if most u.s. patients want the right to take
a risky medicine if they choose to, at least half
of them might forego the drug for fears related
to safety or side efects. again, the safety- and
side efectladen advertising in the united states
and the related litigious environmentmight
cause some of this diference between the patient
populations.
to explore how patients approach assessing
risk and value, they were presented with several
Patients | Do you agree or disagree that...
The process of getting new drugs to patients
takes too long.
69%
88%
We take too long to make drugs available, which costs lives by
forcing people to go without potentially benecial therapies.
71%
87%
81%
Patients should be able to choose to take potentially risky
medication even if it is not approved for use if they feel
it is their only chance to improve their health.
72%
In this country, we are too quick to approve
new prescription medications without
understanding all of the possible safety issues.
% who agree
50%
31%
Patients | Have you ever.
Turned down a medication that your doctor has prescribed
because of concerns about safety or side eects.
% answering yes
51%
27%
Stopped taking a medication before checking with your
doctor because of side eect or safety concerns.
46%
35%
mOre tHan 7 0 percent Of
u. s. pati ent s and ne arly
9 0 percent Of u. k . pati ent s
bel i e ve i t sHOul d be tHei r
ri gHt tO take a Hi gH- ri sk
medi c ati On i f tHe y HOpe
fOr sOme i mprOvement i n
tHei r He altH.
hypothetical scenarios with varying degrees of
both beneft and risk. in circumstances in which
a cancer drug could extend a persons life by a
decade, the patients considered two side-efect
risks, one related to nausea (a 15 or 75 percent
risk) and another related to heart attack (a 5 or
50 percent risk). across all of these scenarios,
u.k. patients express far more willingness to
accept the risks for the potential 10-year return.
even when facing a 50 percent risk of a heart
attack, nearly 80 percent of u.k. patients still
want the treatment, but less than half of u.s.
patients do.
u.k. patients continue to show less aversion
to risk than u.s. patients when presented with
chronic painbased scenarios, but in almost all
cases patients in both countries were less willing
to accept an increased risk for a lesser beneft.
while nearly six out of 10 u.s. patients and nine
out of 10 u.k. patients would be interested in a
drug that reduced chronic pain to a manageable
level with a 15 percent risk of nausea, the number
of patients interested in the same drug with a 50
percent risk of heart attack drops precipitously
among both groups (26 percent for u.s. patients,
40 percent for u.k. patients).
these fndings have several implications for
the biopharmaceutical industry. as with other
stakeholders, patients go through a process of
assessing risk versus beneft by weighing factors
of varying importance to them. as shown above,
patient tolerance for risk is dependent upon
the perceived value of a medication relative to
its safety profle, although it appears that many
patients struggle with assessing risk based on the
probability of an adverse event. this underscores
the industrys imperative to better communicate
US PAT I E NT S
20%
20%
60%
UK PAT I E NT S
21%
29%
50%
Very/Somewhat Interested
Not sure
Not very/Not at all interested
Patients | If there were a new medication that
was available that could reduce the symptoms
you currently have and improve your day-to-
day life, but had an increased risk of a serious
event like a heart attack, how interested
would you be in it?
US PAT I E NT S
26%
20%
54%
UK PAT I E NT S
20%
33%
47%
Patients | If there were a new medication
that was available that could improve your
condition so much that you would live
longer, but had an increased risk of a serious
event like a heart attack for some, how
interested would you be in it?
Very/Somewhat Interested
Not sure
Not very/Not at all interested
Patients as a Part of the System 1 3
the value and risks of new medications in terms
that are meaningful to patients. further, coupled
with increasing payer scrutiny for demonstrable
proof of a new products superiority versus
existing therapies, the biopharmaceutical industry
must strive to develop more sensitive measures
that incorporate patient-important outcomes into
clinical development.

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We tested a series of 12 scenarios around a hypothetical new medication, which included a condition
(cancer or chronic pain), a benefit (extended life or better QOL) and a risk (safety or side effect). Each
patient indicated how interested he/she would be in the new medication.
C A NC E R / E X T E ND L I F E Y E A R S C HR ONI C PA I N
% who are interested
While patients provide clear but disparate answers about accepting risk, biopharmaceutical
executives paint a much more clouded picture. Asked to assess the level of risk their
company must take when exploring new opportunities, the group as a whole could not
agree. Roughly equal amounts of them respond that they should reduce their risk, keep the
same risk or take on more risk. Although these data seem to suggest confusion, the lack
of a homogenous perception of risk may be partly explained by various companies current
location on the risk tolerance spectrum. Those with stronger pipelines and less patent
exposure may have less of an appetite for risk than those who are facing such challenges.
Biopharmas Evolving
Business Model
Biopharmas Evolving Business Model 1 5
biopharmaceutical executives agree, however,
that regulators should accept more risk. when
asked to indicate which stakeholders should take
on more risk in the healthcare industry, 65 percent
of biopharma execs say government regulators
in the u.s. or the u.k. nearly 60 percent of the
executives also believe that payers should accept
more risk.
perhaps surprisingly, half of the biopharmaceutical
executives point the risk fnger at their own
industry. taken collectively with the previous
indication that only 36 percent of the executives
B I OP HA R MA
E X E C UT I V E S
38% Reduce risk prole
36% Take on more risk
27% Maintain existing risk prole
Biopharma | For your company to be
successful in the future, will it need to...
0 %
2 0 %
4 0 %
6 0 %
8 0 %
J 0 0 %
Biopharma | Which group(s) need to take or accept more risk to
improve pharmaceutical agents and public health?
B I OP HA R MA
1he FDA Health insurance
companies
Pharmaceutical
companies
Investors Physicians
tHi rt y- si x percent Of
bi OpHarma e xecuti ve s feel
tHei r cOmpany sHOul d
take On mOre ri sk . tHi s
fi ndi ng underscOre s tHe
l ack Of agreement wi tHi n
tHe bi OpHarmaceuti c al
i ndus try On i t s rOl e
i n ri sk and wHere tO
tr ansfer i t.
feel their company should take on more risk, this
fnding underscores the lack of agreement within
the biopharmaceutical industry on its role in risk
and where to transfer it.
for the industry to be successful in transferring
or mitigating risk, it is helpful to determine where
in the development process biopharma execs
perceive the most risk.
asked to estimate the risk across the drug
development and clinical testing cycle, 55 percent
of biopharma respondents understandably say
that phase iii testing poses the largest risk. at
both the early and post-marketing stages, the
executives see relatively small risks. the focus on
phase iii as the highest risk makes perfect sense,
given the high cost of this stage of testing, as well
as the overall investment of resources and time
that are on the line at this point.
confdence among biopharma execs to accurately
assess the risk/opportunity ratio at the various
development phases raises some questions,
however. Overall, the executives show high
confdence in their ability to assess risk across the
drug creation cycle. the surprise comes in the
trendindicating higher confdence in their ability
to assess risk versus opportunity at earlier stages
and progressively less as the process moves
forward. it would seem intuitive that biopharma
companies would have more data to assess risk
over time as they gather more evidence and a
better understanding of the drug. but a lack of
confdence in the underlying data used for phase
iii risk assessment is an acknowledgement that
the level of risk is higher. that only 62 percent
of biopharma execs feel they have adequate
information to assess risk at phase iii is likely a
refection of the increasing stakes at this stage
from a fnancial and reputational perspective.
nonetheless, with nearly four out of 10 execs
saying they dont have enough information, the
need for more robust sources of data becomes
very clear.
if the biopharmaceutical industry applied a wider,
more encompassing lens to gathering data and
then relied on more sophisticated tools and
techniques to unearth the true insights embedded
in the data, it could start along a path toward
better decisions about risk-value tradeofs. for
example, better endpoints at early development
stages could make phase iii results more
confrmatory, and thereby less prone to risk.
PHASE I
TES TI NG
PHASE I I
TES TI NG
PHASE I I I POS T
APPROVAL
Biopharma | At what stage(s) of the drug development process do you see the greatest risks?
Biopharma | Percent who feel they have necessary data to accurately assess risk vs. opportunity
for new products
B I OP HA R MA
PRECL I NI C AL
TES TI NG
B I OP HA R MA
B I OP HA R MA
77%
11%
77%
15%
69%
31%
62%
55%
61%
16%
in addition to incorporating better sources of
data into clinical development to alleviate some
of the risk along the development lifecycle, risk-
sharing agreements between biopharmaceutical
companies and payer organizations hold potential
as well. in fact, 60 percent of biopharma execs
expect to see more risk- and cost-sharing
agreements with payers in the next fve years.
further beneftsbeyond the obvious reduction
of risk for the biopharmaceutical industry
should come from such sharing. respondents
see enhanced patient population targeting as the
top potential beneft of such agreements, as data
collected by payers could help biopharmaceutical
companies improve their ability to personalize
prescriptions to a population that would beneft
more than others. likewise, the executives believe
that such agreements would improve access to
drugs and accelerate time to market. such risk-
sharing agreements between drug companies
and payers might also drive earlier interactions
between the two stakeholders, which could
fuel faster, broader access to new drugs. the
collaborations could also enhance outcomes data,
according to 60 percent of the executives.
getting these stakeholders to interact throughout
the process could lead to other benefts. for
example, more than half of them believe that
such risk-sharing would increase sales and nearly
half expect such risk-sharing to improve patient
adherence.
Biopharma | Do you think risk- and/or
cost-sharing agreements with payers
will become more common in the next
five years?
60% YES
r i s k- s Ha r i ng a gr e e me nt s b e t we e n dr ug c Omp a ni e s
a nd p ay e r s mi gHt a l s O dr i v e e a r l i e r i nt e r a c t i Ons
b e t we e n t He t wO s ta k e HOl de r s .
i f tHe bi OpHarmaceuti c al
i ndus try appl i ed a wi der,
mOre encOmpassi ng l ens
tO gatHeri ng data and
tHen rel i ed On mOre
sOpHi s ti c ated tOOl s and
tecHni Que s tO une artH
tHe true i nsi gHt s embed-
ded i n tHe data , i t cOul d
s tart alOng a patH tOward
be t ter deci si Ons abOut
ri sk- value tr adeOffs.
despite the numerous perceived benefts of
risk-sharing agreements with payers, biophar-
maceutical executives appear hesitant to actually
put them into practice. when asked about
potential issues that could cause problems, most
of the executives indicate trouble from all of them.
at the top, 71 percent of the biopharmaceutical
executives say that the agreements will eat up too
much in administrative costs. the executives do
indeed expect improved outcomes data from such
agreements, yet claim that understanding clinical
versus real-world outcomes could be another
obstacle exacerbated by risk-sharing agreements
with payers. the list goes on, and the executives
paint a picture in which such agreements look
far of at best and maybe unlikely at all.
as an overview of the opinions that the
biopharmaceutical executives express, they
appear to see the need for changes in how they
handle risk, but they see no way forward. in fact,
they still perceive regulators as the bottleneck,
while appearing unable to agree on whether the
pharmaceutical industry itself should accept more
or less risk. in addition, the executives indicate
across a variety of metricsthe potential value of
developing risk-sharing agreements with payers,
but then check of virtually every reason that
precludes such forward motion.
Biopharma | Percent saying risk-sharing
agreements would mean significant/slight
improvements in...
B I OP HA R MA
Enhanced patient population targeting
70%
Increased patient access to drugs that otherwise would
not make it to market
65%
Drugs available to patients more quickly
63%
Improved outcomes data
60%
Increased sales for manufacturers
53%
Shorter timeline to market for
manufacturer
52%
Improved adherence
47%
bi OpHarma e xecuti ve s
acknOwl edge tHe
p Otenti al value Of
de velOpi ng ri sk- sHari ng
agreement s wi tH payers,
but tHen cHeck Off
vi rt ual ly e very re asOn
tHat preclude s sucH
fOrward mOti On.
Biopharma | Percent saying these are
somewhat/significant problems with
risk-sharing agreements
B I OP HA R MA
Administration costs too high
71%
Dicult to pre-assess what outcomes will result in real-world
use of agent, rather than clinical trials
69%
Dicult to agree on denition of success with payers / manufacturers
68%
Regulatory risk
63%
Information produced might be useful to competitors
63%
Dicult to accurately measure success in a
performance-based risk-sharing agreement
60%
Have to shift post-marketing resources from enhancing
the product to proving the product
54%
In healthcare, organizations providing coverage most likely perform some of the most
focused analysis of risk. For this study, the payers consist of managed care executives
in the United States (U.S. payers) and National Health Service executives in the U.K.
(U.K. payers). In assessing their own allocation of risk versus opportunity, the majority
of payersnearly two-thirdsexpress confdence that they get the balance about right.
Despite the vast diferences that distinguish the single-payer system in the United
Kingdom and the multi-payer system in the United States, the two payer groups take very
similar views on their organizations current handling of risk.
When it comes to other stakeholders, however, payers want them taking on more risk to
improve pharmaceutical agents and public health. Both U.K. and U.S. payers68 and
77 percent, respectivelywant the biopharmaceutical industry to accept more risk, and
more than half of both groups also feel that regulators should shoulder more risk. Perhaps
surprisingly, particularly given the payers claims of efective risk balancing, nearly half of
U.S. payers and 39 percent of U.K. payers reply that their own groups also need to accept a
higher level of risk to beneft public health. Unlike U.S. payers, half of U.K. payers feel that
investors must risk more, as well. Overall, the payers favor spreading risk across a wide
section of healthcare stakeholders.
Payers Seek More Participation
Payers Seek More Participation 2 1
in addition to a strong preference for spreading
risk among multiple stakeholders, payers also
seek increasing involvement in the entire lifecycle
of a medicine. as a step toward this, the payers
in this survey70 percent of the u.k. payers and
79 percent of u.s. payersexpect more risk- and
cost-sharing agreements between themselves
and the biopharmaceutical industry over the
next fve years. in parallel with that evolution, the
payers want more interaction across the drug-
development cycle.
portions of the payers already indicate some
participation in drug development. among u.k.
payers, for example, one-quarter or less of them
indicate taking part in preclinical and phase i
testing. for phases ii and iii, the percentages
increase, rising to 52 percent for the latter. for
post-marketing surveillance, 59 percent of u.k.
payers claim some level of involvement. so out
of those fve stages of drug development, the
majority of u.k. payers only participate toward
the end. a similar trend appears in the responses
from u.s. payers, although with slightly higher
involvement at the preclinical stage, and then less
involvement at the other stages in comparison
with u.k. payers. for instance, only 31 percent of
u.s. payers21 percentage points fewer than
US PAY E R S
11%
27%
63%
UK PAY E R S
23%
18%
59%
Payers | Which comes closest to your feeling
about how your organization balances risks
and opportunities?
We need to reduce risk by taking
a more conservative approach
We need to take more risks to
capture more opportunities
We do a good job balancing
risks and opportunities
0 %
2 0 %
4 0 %
6 0 %
8 0 %
J 0 0 %
Payers | Which group(s) need to take or accept more risk to improve
pharmaceutical agents and public health?
UI PA F R S US PA F R S
1he FDA,
UK: Government
regulators
Health insurance
companies,
UK: Primary Care
1rusts and other
providers
Pharmaceutical
companies
Investors Physicians Patients
the u.k. onesclaim to participate in phase iii
testing. given the general consensus that phase
iii carries the highest risk of all, payers clearly
desire more involvement at that stage of drug
development.
in fact, this survey fnds that payers want
more involvement at every stage. in a general
comparison of the responses for current versus
desired involvement, the numbers nearly double
in many instances. for preclinical testing, for
instance, only 18 percent of u.k. payers claim
current involvement, but 43 percentnearly two
and a half times as manysay that they should be
involved. as expected, both groups of payers also
show strong interest in gaining more involvement
in phase iii testing.
the lack of involvement by payers in drug
development indicates that the biopharmaceutical
industry does not interact efectively with its
customerswho are increasingly the payers,
more so than physicians and patientsabout the
products that it should be making.
if the payers predicted increase in risk-sharing
agreements does arise in the next fve years, these
stakeholders also expect signifcant returns
particularly for patients. as a group, the payers
believe that risk-sharing between themselves and
the biopharmaceutical industry will give patients
quicker access to drugs. interestingly, u.k payers
respond more strongly on these points than u.s.
payers. indeed, such risk-sharing should return
higher benefts in a single-payer system, where a
Payers | How involved is your organization / how involved should it be at the following stages of
drug development?
I S I NV OL V E D
S HOUL D B E
I NV OL V E D
I S I NV OL V E D
S HOUL D B E
I NV OL V E D

P R E C L I N
I C
A
L

P
H
A
S
E

I

T
E
S
T
I
N
G

P
H
A
S
E

I
I

T
E
S
T
I
N
G

P
H
A
S
E

I
I
I

T
E
S
T
I
N
G

P
O
S
T
A
PPROVAL
2 3 %
4
5
%
2
4
%
4
4
%
2
7
%
4
8
%
3
1
%
6
1
%
4
2
%
76%

PRECLI N
I C
A
L

P
H
A
S
E

I

T
E
S
T
I
N
G

P
H
A
S
E

I
I

T
E
S
T
I
N
G

P
H
A
S
E

I
I
I

T
E
S
T
I
N
G

P
O
S
T
A
P P R O V A L
18%
4
3
%
2
5
%
4
8
%
3
6
%
6
4
%
5
2
%
7
0
%
5
9
%
8 4 %
U S P AY E R S U K P AY E R S
Payers Seek More Participation 2 3
coordinated attack on disease might be easier to
orchestrate than in the u.s. multi-payer system.
somewhat oddly, and like the biopharmaceutical
executives surveyed, about half of payers expect
such risk-sharing agreements to improve patient
adherence, although such a connection does
not seem immediately obvious. moreover,
few strategies can boast making signifcant
improvements in adherence, which is notoriously low.
similar to the biopharmaceutical executives,
the payers convey many concerns that must
be addressed to implement such risk-sharing
agreements. Of signifcant interest, these
responses indicate the diferent level of control
that might be possible in a single- versus a multi-
payer system. for example, u.k. payers express
less concern over related administration costs and
the related parties ability to agree on successful
outcomes. so although both groups of payers
seek more involvement in the drug development
process, neither shows high confdence that
risk-sharing agreements can be developed in the
current climate.
Payers | Percent saying risk-sharing
agreements would mean significant/slight
improvements in...
Increased patient access to drugs that otherwise
would not make it to market
68%
89%
Drugs available to patients more quickly
59%
93%
75%
Improved outcomes data
61%
Increased sales for manufacturers
Shorter timeline to market for manufacturer
Real-world validation of pharmaceutical risk/benet
Improved adherence
61%
77%
69%
70%
US PAY E R S UK PAY E R S
61%
69%
44%
59%
Payers | Percent saying these are
somewhat/significant problems with
risk-sharing agreements
Administration costs too high
72%
59%
Dicult to pre-assess what outcomes will result in real-
world use of agent, rather than clinical trials
64%
59%
64%
Dicult to agree on denition of success with payers / manufacturers
61%
Dicult to accurately measure success in a
performance-based, risk-sharing agreement
Have to shift post-marketing resources from enhancing
the product to proving the product
56%
50%
59%
75%
The healthcare-focused investors surveyed for this report rate the biopharmaceutical
industry as high-risk. In fact, 94 percent of the investors see more risk in placing capital
in the biopharmaceutical industry than in other sectors. Moreover, almost none of the
investorsonly 6 percentrate the biopharmaceutical industry as less risky for investing
than other areas. Consequently, this high-risk expectation forms one of the strongest
examples of consensus in the results of this years survey.
Investor Ambivalence, Optimism
Investor Ambivalence, Optimism 2 5
despite the high risk of investing in the
biopharmaceutical industry, 73 percent of
investors feel optimistic about the prospects for
investments in this area. One-third of investors
even expect to invest more in this industry over
the next three to fve years, and only 17 percent
intend to invest less. still, even more of the
investors65 percentexpect to increase their
investments in biotechnology specifcally, and
only 13 percent expect to invest less in that feld.
given that investors see high risk in investing in
the biopharmaceutical market as it is, one would
imagine that could keep them from suggesting
that the drug industry should take on any more
risk. in fact, 47 percent of the investors feel that
the biopharmaceutical industry does a good job
of balancing risk with rewards. among those who
disagree, however, most of them37 percent
believe that the drug industry should take on
additional risk. with investors always interested
in spreading the risk and feeling that they already
take big risks to invest in this industry, some
of them naturally want to see the drug industry
raising its risk bar, too.
I NV E S T OR S
44% Signicantly greater risk
50% Slightly greater risk
6% Less risk
Investors | Does investment in the
biopharmaceutical sector represent
greater or less risk than other sectors?
Investors | Are you pessimistic or optimistic
about the investment prospects in the
biopharmaceutical industry in the next
5 years?
I NV E S T OR S
73% Optimistic
27% Pessimistic
s e v e nt y t Hr e e p e r c e nt Of i nv e s t Or s f e e l Op t i mi s -
t i c a b Ou t t He p r Os p e c t s f Or i nv e s t me nt s i n t He
b i Op Ha r ma c e u t i c a l i ndus t r y.
Only si x percent Of i nve s-
tOrs r ate tHe bi OpHarma-
ceuti c al i ndus try as l e ss
ri sk y fOr i nve s ti ng tHan
OtHer sec tOrs.
when it comes to risk- and cost-sharing between
biopharma and payers, investors display
ambivalence. Only 42 percent of them expect
such agreements to be common in fve years.
likewise, investors stand largely divided on
the potential benefts of such agreements for
themselves and for patients.
Investors | Increasing / decreasing investment
in specific sectors in the next three to
five years
DE C R E A S E I NC R E A S E S TAY T HE S A ME
P HA R MA C E UT I C A L
COMPA NI E S
B I OT E C HNOL OGY
COMPA NI E S
17%
50%
33%
65%
22%
13%
Investors | Do you think risk/cost-sharing
agreements between biopharmaceutical
companies and payers will become more
common in the next five years?
I NV E S T OR S
42% Yes
58% No
I NV E S T OR S V I E W OF
B I OP HA R MA I NDUS T R Y
They need to reduce risk by taking a
more conservative approach
They need to take more risks to
capture more opportunities
They do a good job balancing risks
and opportunities
Investors | Which statement comes
closest to your feeling about how
the biopharmaceutical industry
balances risks and opportunities?
16%
37%
47%
Investor Ambivalence, Optimism 2 7
Investors | What are the implications of risk-sharing
agreements between biopharma and managed care
for firms like yours?
DI S A GR E E A GR E E NE I T HE R
These agreements
will generally mean
less return on our
investment.
We will invest less in
this sector if these
agreements become
more common.
These agreements
will mean more access
to the market for
new drugs.
49%
14%
37%
22%
53%
46%
45%
9%
25%
i nv e s t Or s a r e r at He r i ndi f f e r e nt wi t H r e ga r ds t O
r i s k- a nd cOs t- s Ha r i ng a gr e e me nt s b e t we e n b i Op Ha r -
ma c e u t i c a l cOmp a ni e s a nd p ay i ng Or ga ni z at i Ons .
Although biopharmaceutical executives and payers from the U.S. and the U.K. expect
more risk-sharing ahead, such agreements could come in many forms. The form itself,
however, will determine the likelihood of success from such arrangements. Despite that
fact, biopharmaceutical executives and payers express diferent views on the most likely
risk-sharing plans.
Among the biopharmaceutical executives, nearly three-quarters of them support
agreements in which patient adherence determines future discounts to the manufacturer.
They also show similar support of agreements in which some aspect of patient outcome
serves as the goal. The biopharma execs show less enthusiasm for some other possible
forms of risk-sharing, including population-based performance guarantees. As the
numbers show, however, this group spreads its interests across a collection of approaches
to risk-sharing.
Mitigating Risk: The Need for
New Metrics
A Need for New Metrics 2 9
in comparison, the payers display equally
widespread opinions. both groups of payers prefer
agreements based on coverage with evidence
development (ced), which depends on how well
a drug performs against a specifc outcome, and
the population-based performance approach, in
which in drug must meet some long-term beneft
to merit coverage. more than biopharmaceutical
executives or u.s. payers, u.k. payers provide the
most aligned opinion, with 95 percent of them
supporting the ced-based option. notably, this
option ties for frst among u.s. payers and ranks
second with the biopharmaceutical executives.
so despite the support of a variety of options in
risk-sharing agreements, these data indicate that
these three groups of stakeholders could possibly
agree on how to get started with this transition.
if the biopharmaceutical industry and payer
organizations could agree on a way forward,
that might generate a variety of risk-sharing
agreements. two key interests, especially from the
patient perspective, involve getting new therapies
to the market faster and making those therapies
more efective. with regard to speed-to-market,
half of biopharmaceutical executives feel that risk-
sharing agreements will decrease that time, but
that expectation drops to 43 and 32 percent for
u.s. and u.k. payers, respectively. in terms of risk-
sharing agreements increasing the innovative and
efective aspects of new therapies, nearly three-
quarters of u.k. payers show optimism there, and
a majority of the respondents from u.s. payers
and biopharma agree.
when considering a range of other ways to
decrease the time-to-market for new therapies,
none generates a strong consensus among the
stakeholders. even with the most agreed-upon
conceptpre-competitive collaborations among
biopharma companiesit only gains favor from
about half of most of the groups, and even less
from u.k. payers. Overall, the options generate
widely disparate responses and the lack of
majority support.
to enhance the innovation of new drugs, however,
the stakeholders display some level of agreement.
Biopharma, Payers | Percent who support specific types of risk-sharing plans
US PA F R S UI PA F R S B I OP HA R MA
Adherence-
based deals
Coverage with
Fvidence
Development {CFD)
Individual perFormace
guarantees
Discounts to managed
care plans For better
Formulary placement
Contracting to provide
copay osets
Population-
based perFormance
guarantee
0 %
2 0 %
4 0 %
6 0 %
8 0 %
J 0 0 %
73%
77%
66%
69%
84%
95%
67%
59%
69%
60%
68%
61%
59%
64%
30%
56%
84%
89%
upwards of three-quarters of biopharmaceutical
executives and payers, plus 61 percent of
investors, hold hope for pre-competitive
collaborations among biopharmaceutical
companies. nonetheless, other responses (data
not shown) in this survey indicate that 69 percent
of biopharmaceutical executives support pre-
competitive alliances, but only 37 percent of them
claim that their company currently participates
in them. Overall, the responses suggest that
some biopharma executives believe that pre-
competitive alliances might extendor at least
not shortenthe time that it takes to bring a new
drug to market, but the alliances could increase
the innovative aspects of new drugs. although
that could create a more precise approach than
todays often scattershot strategy, a majority of
these executives also indicate that creating such
alliances must overcome a series of problems,
including defning the boundary between
pre-competitive and proprietary data and
protecting intellectual property. so these alliances
might appeal to the executives more in theory
than in practice.
to manage risk efectively, stakeholders need
reliable ways to measure it. that is, the healthcare
industry needs powerful tools to estimate
the risk/beneft tradeofs generated by a new
drug. the results from this survey show that
the biopharmaceutical industry and payers in
the u.k. and the u.s. apply a variety of tools
to address this problem. for example, most of
them look at patient-reported outcome measures
and minimum clinical efcacy, and about half
use quality-adjusted life years. for each of these
metrics, though, the stakeholders only rate these
tools as more or less mediocre in assessing the
risk-beneft profle of a new drug. for example,
nearly three-quarters of u.k. payers rely on
52%
43%
32%
50%
57%
41%
31%
28%
32%
72%
25%
41%
43%
41%
41%
Biopharma, Payers | Percent who feel the
following will decrease time-to-market
for new therapies
US PAY E R S UK PAY E R S B I OP HA R MA
Risk-sharing agreements between biopharma and
payers/managed care
Pre-competitive collaborations among biopharma companies
Direct government participation in drug development
Outcomes research from quasi-governmental bodies governing
real-world research practices such as PCORI/NICE
Managed care / payer input in drug development
55%
63%
73%
75%
72%
73%
27%
44%
55%
31%
60%
57%
32%
29%
36%
Biopharma, Payers | Percent who feel the
following will mean getting more innovative
and effective therapies to market
US PAY E R S UK PAY E R S B I OP HA R MA
Risk-sharing agreements between
biopharma and payers/managed care
Pre-competitive collaborations among biopharma companies
Direct government participation in drug development
Outcomes research from quasi-governmental bodies governing
real-world research practices such as PCORI/NICE
Managed care / payer input in drug development
A Need for New Metrics 3 1
patient-reported outcome measures, but only
a bit more than half of them judge this as an
excellent or good tool for measuring risk. in other
cases, the stakeholders give high marks to some
tools that they use infrequently. for instance,
nearly three-quarters of u.s. payers believe
that minimum clinical efcacy measures risk
efectively, but only 44 percent of them use this
tool. to some extent, these responses indicate
that stakeholders use some of their least
favorite methods and forego some of the more
efective ones.
these data illustrate one of the problems with
most risk-based tools: that they fail to recognize
the underlying predispositions toward value and
therefore make it extremely difcult to understand
the tradeofs involved in such equations.
without considering the values attached to the
riskwhich can sway the perception of the risk/
beneft propositionstakeholders are unable to
assign the proper weight to diferent values that
infuence perception of risk.
Patient Reported Outcome {PROs)
Minimum Clinical Fcacy {MCF)
Quality Adjusted LiFe ears {QALs)
Number Needed to 1reat {NN1)
Clinical Utility Index {CUI)
Number Needed to Harm {NNH)
Disability Adjusted LiFe ears {DALs)
Proprietary instruments
Biopharma, Payers | How well do the following types of data do in accurately assessing a
biopharmaceutical products risk/benefit profile?
0% J0% 20% 30% 40% 50% 60% /0% 80% 90% J00%
Fxcellent
Good
B I OP HA R MA
Fxcellent
Good
US PA F R S
Fxcellent
Good
UI PA F R S
N]A
Patient Reported
Outcome (PROs)
Minimum Clinical
Ecacy (MCE)
Quality Adjusted Life
Years (QALYs)
Number Needed to
Treat (NNT)
Clinical Utility
Index (CUI)
Number Needed
to Harm (NNH)
Disability Adjusted
Life Years (DALYs)
Proprietary
instruments
56% 60% 71%
53% 44% NA
47% 44% 66%
41% 31% 46%
29% 24% 21%
17% 20% 21%
12% 19% 16%
22% 31% 11%
Biopharma, Payers | Do you currently use
the following types of data?
B I OP HA R MA
PAY E R S
% answering yes
in the context of assessing risk and beneft,
one area that warrants further examination is
comparative efectiveness research (cer). as
payers and quasi-governmental agencies in the
u.s. rush to embrace cer, some clarity as to the
utility and construct of cer can be gleaned by
looking at the perception among u.k payers as
to the benefts produced by health technology
assessments (Hta)a diferent yet related form
of product appraisal.
u.k. payers seem unimpressed by the overall
performance of Hta on a number of diferent
measures. less than a third of them feel that
Hta initiatives perform very or extremely well
on improving patient outcomes, and less than a
quarter feel that Hta does a good job of ensuring
that the right patient population receives the right
medication. these fndings contrast sharply with
the perception of cer among u.s. payers, the
majority of whom say that cer performs well on
both measures.
given that the u.k. has more than 10 years
experience in putting Hta into practice, u.k.
payer skepticism as to their utility should be
seen as a learning opportunity for u.s.-based
organizations looking to conduct cer initiatives.
critical to the future application of cer is the
data and methodology employed in the research.
cer methods should not only address technical
aspects of study design, subject selection,
analytic techniques, and process and outcome
measurement, but also address such weighty
issues as ethical, humanistic and feasibility
considerations related to real-world research.
Payers | Percent who believe current
CER / HTA initiatives are doing
extremely / very well on...
Improving patient outcomes / improving eectiveness
56%
32%
Ensuring the right patient population receives the right medication
51%
23%
43%
Improving patient safety
44%
Controlling cost for members in your plan
40%
5%
3 3
Given risks fundamental place in healthcarefrom patients well-being to
biopharmaceutical companies fnancial securitythe interconnected stakeholders
know surprisingly little about how to measure and manage it. Overall, each group of
stakeholders desires more control over the risks that they face and prefers to reduce their
own risk by transferring it to others whenever possible. These perceptions may arise from
a law of nature of sortsprotect yourself. But risk in healthcare involves us all. As such,
the risks must be balanced so that each stakeholder accepts a fair share, and the members
of the healthcare system must fnd ways to accurately measure and communicate risk and
beneft to each other.
Conclusion
much of the data analyzed in this report reveals
the need for deeper knowledge of the inherent
risks in healthcare and medicine. for example,
some of the patient responses indicate a lack
of understanding of how the drug development
process actually works. likewise, the comparison
of patients from the u.k. and the u.s. shows a
need for better education about balancing risk
and beneft. at the same time, biopharmaceutical
executives report little confdence in many of the
tools that they use to evaluate the risk/beneft
balance of a drug in development.
in todays world of data and informatics,
computation should improve risk assessment
and management, but access to robust sources
of data to feed the model is severely lacking.
instead, no one stands behind a confdent
consensus regarding how to measure risk, how
to reduce it, how to manage it or how to weigh
the tradeofs. without that confdence in the data
which underpins assessments, a more efective
system to enhance health around the world cannot
be built.
to address this challenge, the biopharmaceutical
industry must develop new approachesand do
that as soon as possible. the results of this survey
indicate that the biopharmaceutical industry
can act now in several ways: collaborating
early with payers on new compounds under
development; striking pre-competitive alliances
among industry competitors to enhance the
innovative characteristics of new compounds; and
developing risk-sharing agreements to enhance
patient-population targeting.
if the biopharmaceutical industry fails to adapt to
the changing landscape of risk in healthcare, other
stakeholdersperhaps the paying organizations,
well-versed as they are in measuring and working
with riskwill move ahead on their own, and
the responses from both u.k. and u.s. payers
about their interests in earlier involvement in drug
development presages that possibility.
the ultimate goal revolves around reducing risk
for everyone. to enhance the health of patients
while keeping the biopharmaceutical industry and
investors fnancially healthy and payers balancing
their inputs and outlayshealthcare must
accurately assess the value of and risks behind
a promising compound as soon as possible and
then track that balance across the entire drug
development cycle. Only then can the world make
the most of modern medical capabilities.
3 5
about the new health report
The New Health Report is based on surveys of biopharmaceutical executives, managed care executives
in the u.s., national Health service executives in the u.k., patients living with chronic disease in both
the u.s. and the u.k., and investors who focus on the healthcare sectors. each survey was conducted
by richard day research of evanston, illinois, u.s.a., a market probe company, on behalf of Quintiles.
richard day research was responsible for all survey design, data analysis and data reporting.
data for this survey were collected between January 8 and march 14, 2012. screened and included in
the sample were 102 biopharmaceutical executives at the director level or above, 75 managed care
executives in the united states at the director level or above, 72 national Health service executives
(director or above) in the u.k., 509 u.s. and 500 u.k. adults ages 18+ diagnosed with a chronic
health condition who are receiving treatment, and 100 investment professionals (vice president and
above) employed in private equity frms, investment banks, or venture capital frms that focus on the
healthcare/biopharma sector.
professionals were recruited via postal mail, telephone, fax and e-mail and completed the survey
in a self-administered online questionnaire. patient interviews were conducted via landline and
cellular telephone.
with pure probability samples of these sizes, one could say with 95 percent probability that the results
have a sampling error of +/ 10 percentage points for biopharmaceutical executives and investors, +/ 11
percentage points for managed care executives, +/ 4 percentage points for u.s. and u.k. patients.
about quintiles
Quintiles is the only fully integrated
biopharmaceutical services company ofering
clinical, commercial, consulting and capital
solutions worldwide. Our network of more than
25,000 professionals in 60 countries has an eye
on the future while delivering results today with
an unwavering commitment to patients, safety
and ethics. Quintiles helps biopharmaceutical
companies develop and commercialize products
to improve and lengthen patients lives while
demonstrating value to stakeholders. visit
www.quintiles.com for more information and
www.quintiles.com/news for additional
company news.
contact info
for media inquiries:
mari mansfeld, Media Relations, Quintiles
+1 919 998 2639
mari.mansfeld@quintiles.com
for all other inquiries:
adam istas, Corporate Communications, Quintiles
+1 708 948 7070
adam.istas@quintiles.com
cl i nical | commercial | consulti ng | capital
copyright 2012 Quintiles. 01.15.14-052012

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