THE DRUG DEVELOPMENT JOURNEY

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new and innovative
drug treatments into
the hands of those
who need them most
by simplifying the
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DRUG DEVELOPMENT JOURNEY

The Journey: More than a Goal

ver the past 20 years, advancements in our

knowledge of the molecular and genetic basis
of disease have led to the development of a vast array of scientific tools to target diseases more precisely.
The application of these tools is resulting in a particularly
robust pipeline, as there are more than 7,000 medicines
in development globally, according to the Pharmaceutical
Research and Manufacturers of America (PhRMA).
These advancements in science, however, mean
greater complexity for research and development. The
R&D investment for each new medicine was estimated
to average $1.2 billion, including the cost of failures, in
2014, with more recent studies estimating the costs to
be even higher, upward of $2.6 billion, according to the
Tufts Center for the Study of Drug Development.
And the development journey is long, a process often lasting more than a decade to bring a new prescription medicine from new molecule to new medicine, and
complex, with each stage from Phase I through Phase
IV requiring specialized knowledge and best practices
cultivated from deep experience to navigate clinical,
regulatory, and commercialization hurdles.
Going from a new molecular entity to a drug treatment opportunity is more than a goal for sponsors and
CROsits a journey. Its a complex path that starts with
evidence-based valuations to predict a drugs efficacy,
regulatory acceptance, market potential, licensing impact
and more. But when the journey is carefully mapped to
address the best route and there are decision-support
technologies available to clear obstacles, prospects for
success increase greatly.
And the stakes to achieve success are high. It is estimated that PhRMA member companies invested $51.2 billion in
R&D in 2014; since 2000, more than $600 billion has been
TABLE OF CONTENTS
The Journey: More than a Goal ................................ 2
A Multifaceted Journey ............................................... 3
Enhancing the Clinical Journey ................................ 6
Bridging the Journey Through Technology........ 10
The Journey Taken Together ................................... 12

CUSTOM PUBLISHING

Copyright 2015 by PAREXEL International

All rights reserved.
Published in the United States by PharmaLinx LLC, Titusville, NJ.

SPECIAL PUBLICATION | JUNE 2015

TRENDS IN CLINICAL TRIALS

PROTOCOL COMPLEXITY

Increase in

2000-2003 2008-2011 complexity
Total procedures
per trial protocol
(e.g., bloodwork, routine
exams, x-rays, etc.) 105.9 166.6
Total investigative
site work burden
(median units)
Total eligibility
criteria
Clinical trial
treatment period
(median days)*

57%

28.9 47.5 64%

31 46 58%

140 175 25%

Number of case report

form pages per protocol 55

171

227%

* These numbers reflect only the treatment duration

of the protocol.
Source: K.A. Getz, R.A. Campo, and K.I. Kaitin. Variability in
Protocol Design Complexity by Phase and Therapeutic Area.
Drug Information Journal 2011; 45(4): 413420; updated data
provided through correspondence with Tufts Center for the
Study of Drug Development.

invested in developing new medicines for patients. Despite

the challenges and resources involved, pharmaceutical,
biotechnology, and drug device companies are dedicated
to the mission of advancing science and producing products that improve and save the lives of patients.
With so much money on the line, its no wonder
pressures on biopharmaceutical companies continue to
mount in the quest to bring new, innovative, and safe
treatments to market that demonstrate value and effectiveness amid limited global resources and higher
levels of regulatory scrutiny. As a result, there is a need
for a reinvention of the process and organization dynamics that can breathe new vitality into commercial
success. This reinvention entails an integrated approach
that combines global clinical services infused with strategic insights and enabled by technologiesall focused
on accelerating time-to-market and maximizing the potential to unlock greater value in products. n

DRUG DEVELOPMENT JOURNEY

A Multifaceted Journey

ecause drug development is multifaceted and

complex, and requires the successful completion of many endpoints along the way from planning
through post launch, there is proven value in building
a customized program for each molecule, biologic, or
device for each regulatory environment led by an integrated team of experts.
According to PhRMA, more than 7,000 medicines
are in development globally. A 2012 analysis of the biopharmaceutical pipeline revealed 70% of medicines are
potential first-in-class treatments.
Drug development is complex and its costly, says Sy
Pretorius, M.D., Chief Scientific Officer at PAREXEL. If a
drug does not get approved, its not a $25 or a $250,000
loss, it could potentially be a $2.5 billion issue. The stakes
are incredibly high. When we work with customers, we
leverage the knowledge, experience, and expertise gained
from working on thousands of clinical trials over 30 years
to help simplify this complex and costly journey.
To improve the likelihood of success and reduce costs
and timelines, a close collaboration between sponsors
and CROs is needed to transform the process and unlock the value in biopharma development. To make clinical development more effective, PAREXEL formulated a
multidisciplinary and systems-oriented approach to outsourced clinical development, bringing efficiencies, scalability, and standardization to the process.
Our customers have told us that our ability to partner
strategically has resulted in increased efficiencies, optimized performance, and continued innovation throughout the drug development cycle, Dr. Pretorius says.
Over the last few years, we have witnessed a transformation in the way industry sponsors work with
CROs, says Paul Evans, VP, Global Head, Feasibility
and Enrollment Solutions at PAREXEL. This trend is increasing, not decreasing. The nature of what sponsors
are asking CROs to do is also changing and evolving.
There is now a genuine partnership between CROs and
sponsors. These relationships provide both parties with
opportunities to drive efficiencies and to simplify the
drug development journey.
TRENDS IN OUTSOURCING
Many sponsors are transitioning from traditional
project-by-project and preferred provider outsourcing
methods to a more holistic approach.

Drug development
is complex and its
costly. If a drug does
not get approved,
its not a $25 or a
$250,000 loss, it
could potentially be a
$2.5 billion issue.
Dr. Sy Pretorius, Chief
Scientific Officer, PAREXEL

Year-on-year, we see outsourcing continue to

grow, Dr. Pretorius says. Many sponsors want to outsource more of their work to fewer suppliers based on a
model that is designed to save money, reduce complexity, and limit the number of clinical suppliers needed in
the clinical development space.
In recent years, the strategic partnerships model has played a pivotal role in advancing the overall
CRO-sponsor relationship paradigm.
By deploying this type of delivery model, we have
been able to leverage the staff learning curve and realize
other efficiencies on both the sponsor and CRO side,
Dr. Pretorius says. Ultimately, this improves the level of
staff engagement and overall customer satisfaction.
These highly integrated engagements, which often
span many years, are driven by shared objectives, mutual
investment in aligned processes, and early involvement
in protocol design and operational plan development.
According to Dr. Pretorius, there is increasing interest by pharmaceutical, biotechnology, and drug device
sponsors to outsource the development of an entire asset or a complete phase of development for a compound
with minimal touch points and oversight by sponsors.
The earlier we are engaged in this complex journey,
the more opportunity we have to work with sponsors to
simplify the journey as much as possible, he says.
This means CROs need to be aligned with sponsors in
terms of the vision and the goals for a drug, biologic, or
device and have built-in checkpoints to ensure the project proceeds according to the jointly developed plan.

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DRUG DEVELOPMENT JOURNEY

To serve companies
well, CROs have
to provide all of
the development
servicesintegrated
along the timeline
and with a high level
of transparency.
Dr. Joe Avellone,
Executive VP, PAREXEL

This type of engagement, which is far removed from

the vendor-sponsor relationship of the past, requires
mutual trust and a plan of action that is dependent upon
the insights and knowledge of experts who can execute
along the entire development timelineplanning, Phase
I, Phase IIa, Phase II-III, Phase IIIb-IV, and post launch.
Having a knowledgeable, dedicated team work with
a sponsor throughout the entire drug development cycle drives consistency, improves quality, and minimizes
transitions and hand-offs, Dr. Pretorius says.
Building and getting to that trusted relationship is
critical, says Karen Chu, Corporate VP, PAREXEL Clinical Research Services. Sponsors will then come to depend more and more on their CRO partner for the relationships it has with the other stakeholders involved in
the development process.
Sponsors very much value the relationships CROs
have with the sites, the hospitals, the people who will prescribe the medicines, Chu says. In the next year or two,
sponsor companies will increasingly rely on their CRO
partners to do monitoring as well as build relationships
with the sites and with the investigators on their behalf.
This trend is supported by research from participants in the Tufts CSDD Executive Forum, which noted
that soliciting input from clinical research sites on protocol design, providing payments directly to study patients, sharing their development plans, and providing
feedback via scorecards that use quality metrics can
help sponsors and CROs mitigate challenges.
In addition, having a medical monitor available 24/7
to answer questions when patients are at the site once
a trial is running can help sponsors and CROs ensure
strong site performance.
4

SPECIAL PUBLICATION | JUNE 2015

There is now a
genuine partnership
between CROs and
sponsors. These
relationships provide
both parties with
opportunities to
drive efficiencies and
to simplify the drug
development journey.
Paul Evans, VP, Global
Head, Feasibility and
Enrollment Solutions,
PAREXEL

Our integrated approach helps to identify where

a sponsors greatest needs are, says Ken Faulkner,
Corporate VP, Medical Imaging, PAREXEL Informatics.
For example, it might be data analytics or patient recruitment. At the same time, a sponsor company may
already have a technology or solution that it is using
with good results that needs to be incorporated into
the CROs toolkit.
At PAREXEL, we have a technology division, but the
focus should always be on the bigger picture, Faulkner
adds. If a company is already using a best-in-class technology solution, we will integrate it into what we do, if it
serves the study, the sponsor, and patients best interests.
INTEGRATION OF CONTRACT RESEARCH
SERVICES
For relationships between sponsors and CROs to be
truly effective, CROs have to provide an integrated array
of services. There also needs to be close-knit collaboration
extending across investigator recruitment, feasibility, clinical monitoring, data management, biostatistical analysis,
medical writing, and clinical logistics, among other areas.
We think of ourselves as the guide to our clients
journey, says Ron Kraus, Corporate VP, Worldwide Head,
PAREXEL Consulting. When we are brought in to start
planning, we look at the clients objective for the therapy
and then deploy an expert, multidimensional team that includes regulatory, scientific, and commercial disciplines.
We can bring regulatory and scientific expertise,
which is married with the strength of our operations. This
allows us to generate and evaluate various scenarios for
the broader development program as well as individual

DRUG DEVELOPMENT JOURNEY

study protocols, which can drive savings in time, as well

as cost, Kraus explains.
Dr. Pretorius says while pharmaceutical sponsors are,
in fact, now buying CRO services in an integrated way, its
also important for CROs to have a global footprint. The
right global delivery model, combined with expertise and
harmonized processes, enable CROs to simplify what is a
very complex journey. The journey becomes even more
complex when you include the regulatory and operational
considerations of working across geographies.
In addition to integration across service lines, there
needs to be integration around the globe, he says. Over
time, PAREXEL has invested in operations to establish a
global footprint allowing the CRO to leverage capabilities
in a seamless manner.
Joe Avellone, M.D., Executive VP, PAREXEL, says
bringing together clinical research services, informatics,
and consulting to meet the needs of biopharmaceutical clientslarge and smallis absolutely critical given
the pressures that sponsors are under to become more
cost-efficient in terms of their R&D expenditures.
To serve companies well, CROs have to provide all of

STRATEGIC PARTNERSHIPS DELIVER

GREATEST OUTSOURCING VALUE
Management of capacity gaps
Enabling strategic management of R&D portfolio
Better cost predictability
Reduction in fixed costs
More efficient resolution of issues
Consistency in quality of execution
Reduced complexity

20

30

40

Strategic Partnerships

50

60

70

Perceived effectiveness (%)

Preferred Provider
Project-by-Project

Source: 2014 Strategic Partnerships Report, PAREXEL

When we are brought

in to start planning,
we look at the clients
objective for the
therapy and then
deploy an expert,
multidimensional
team that includes
regulatory, scientific,
and commercial
disciplines.
Ron Kraus, Corporate
VP, Worldwide Head,
PAREXEL Consulting

the development servicesintegrated along the timeline

and with a high level of transparency, Dr. Avellone says.
From a technology standpoint, it is especially important
to have consistency and scalability on a global basis.
To better serve the needs of smaller companies,
PAREXEL launched its BioPharm Unit in 2012 to deliver
innovative solutions to help small to mid-sized companies
expand their in-house expertise, support internal decision-making, and position themselves among the industrys leaders. Recent data indicate that 80% of ongoing
development programs originated outside the top 25
pharmaceutical companies.
We provide a level of transparency and expertise
of a big CRO, and through our BioPharm Unit we can
still focus on their needs under one arrangement, Dr.
Avellone says. We know that no two projects are alike.
Thats why for every drug, treatment, and molecule we
work on, we develop a strategy that reduces complexity,
accelerates timelines, reduces fixed costs, and helps clients reach their goals faster.
The industry shift toward more biologic developmentby both large and smaller pharma companies
requires more sophisticated protocols and trials requiring global development. As a result, there will be a need
for closer collaboration between sponsors and CROs,
and a need for shared technologies to manage more
complex studies for more complex drugs.
The CROs that are going to succeed will be those that
can deliver comprehensive and integrated services anywhere in the world, and leverage technology to make the
process more cost-efficient. There will always be a role
for small CROs that have expertise in specific therapeutic areas in smaller regional studies to support those. nw
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DRUG DEVELOPMENT JOURNEY

Enhancing the Clinical Journey

rom feasibility analysis, site selection, and patient

recruitment to clinical monitoring, data collection,
and management on through NDA preparation, submission, and post-approval studies, sponsors are looking for ways to reduce costs, improve efficiencies, and
increase the commercialization success of the drugs,
biologics, and devices they strive to bring to market.
Along the way, sponsors and their CRO partners
face several challenges. One of the biggest is the need
to drive clinical research efficiencies and process improvement. Sponsors are pressured with either flat or
reduced R&D budgets, but with the imperative to get
more out of their pipelines.
Historically, CROs have presented the opportunity
for variable costs, thus eliminating the need for sponsors to employ large global workforces.
In this day and age, CROs, especially those with an
array of integrated services, including technology solutions, can offer sponsors both large and small a number
of opportunities to enhance their clinical development
programs.
Dr. Avellone notes that PAREXEL brings innovative
thinking and technologies to the table so that sponsors
can focus on the science or commercialization of the
drug, biologic, or device.
With our breadth of experience and integrated approach, we can help sponsors be much more cost-efficient, while providing the requisite expertise to bring
new treatments to the market, Dr. Avellone says. Our
clients tell us that there is a clear opportunity for CROs
to play an important role in bringing new and life-saving drugs to the market if they can simplify the journey
of drug development and become a full development
partner. Thats what we are committed to doing.
Understanding the sponsors needs is imperative to
leveraging efficiencies, which often necessitates having
CRO staff members work exclusively for a sponsor.
Dr. Pretorius says this type of dedicated clinical operational resource model allows the staff to become
well-versed in the clients processes. In many instances, this becomes a seamless integration into the clients
own clinical operations.
To optimize clinical operational execution, there are
some general principles that need to be applied to ensure trial efficiency. One is the need for a high level of
discipline and rigor around not only the protocol, but
the entire development program.
An important service that PAREXEL provides is
6

SPECIAL PUBLICATION | JUNE 2015

In five years, not only

will there be a lot of
investment from East to
West but also West to
East. Asian companies
may not have the
expertise in the West,
and they will be looking
to CROs for their global
development experience.
Karen Chu, Corporate VP,
PAREXEL Clinical Research
Services

around protocol optimization. Experts in this area help

clients to optimize their protocol designs by analyzing
each of the elements in a protocol synopsis such as the
primary objective(s), secondary objective(s), the design, the sample size, inclusion and exclusion criteria,
the study procedures and so forth.
Dr. Pretorius says each element is evaluated from
several different perspectives (e.g., scientific, operational, regulatory, ethical, etc.) to ensure everything in
the protocol makes sense from an operational perspective, that its practical in terms of the patient, that its
ethical, and that it makes an important contribution to
healthcare around the globe.
This rigor, Dr. Pretorius says, leverages the CROs expertise and enables its experts to generate alternative
scenarios to the current proposed design. The impact
that these different scenarios have on the data gathered, as well as cost and time, are quantified to assist
clients in making informed, trade-off decisions.
PAREXEL also assists clients in the design and execution of adaptive trials, which are becoming increasingly more important for pharmaceutical sponsors.
The FDA as part of its Critical Path Initiative in 2006
identified adaptive designs as a key trend regulators
thought could reduce costs associated with developing
drugs. We are seeing increasing traction and demand

DRUG DEVELOPMENT JOURNEY

for these services, and have invested quite heavily in

our abilities to run adaptive trials, Dr. Pretorius says.
In addition to the statistical component of these trials,
specialized procedures and enabling technologies are
critical to execute these studies successfully.
Kraus says over the past five years or so,
PAREXEL has gained valuable and copious insights
from its consultations with large and small pharma
companies, feedback that has helped shape its suite of
offerings, ranging from planning through to commercialization.
We are being brought in early during development
discussions to engage with sponsors and, therefore, we
can have clear conversations about their objectives,
Kraus says. This approach of coming in early resonates
favorably with clients and allows us to determine what
evidence should be generated to satisfy the health authorities and payers. This input is used to effectively design and develop programs that collect the right data
through Phase I, Phase II, and Phase III. As those data
are collected, we are able to assess the data in real time
against the pre-established plan to make sure that we
have evidence required to successfully commercially
launch the product.
This is especially important in global markets where
local issues of payer consideration and patient access
are critical. Having data about the cost-effectiveness of
a new product relative to the standard of care is critical,
and this can be a hurdle in many countries.
Kraus notes there are many cautionary tales that illustrate what happens when companies spend 10-plus
years developing a product, which may receive approval in the United States but doesnt receive reimbursement approval in the EU.
This is a critical show stopper for many companies,
Kraus notes. We can provide a holistic view and bring
tremendous value in terms of the ultimate goal of getting products to patients.
One of the global markets that is growing exponentially is the Asia-Pacific pharmaceutical market, which
is second to all of the European countries now.
Chu says to penetrate this market efficiently for clients, PAREXEL has created an integrated pathway inclusive of regulatory strategy, operational strategy, and
technology.
Crucial to operating in the Asia-Pacific market is
in-depth knowledge of the regulatory environment, as
well as the healthcare culture. Therefore, Chu says its
important to have operational staff members on the
ground who understand the environment, as well as the

PHRMA MEMBER COMPANY R&D EXPENDITURES:

1995-2013

Expenditures (Billions of Dollars)

$10 $20 $30 $40 $50 $60

1995

$15.2

1996

$16.9

1997

$19.0

1998

$21.0

1999

$22.7

2000
2001
2002
2003
2004
2005
2006

$26.0
$29.8
$31.0
$34.5
$37.0
$39.9
$43.4

2007

$47.9

2008

$47.4

2009

$46.4

2010
2011

$50.7
$48.6

2012

$49.6

2013

$51.1

Source: Pharmaceutical Research and Manufacturers of America.

PhRMA Annual Membership Survey, 19962014.

operational infrastructure, including technology, and

the power to execute studies in various local regions.
An emerging trend Chu notes is the movement of
Asian pharmaceutical companies looking to penetrate
the West.
In five years, not only will there be a lot of investment from East to West but also West to East. Asian
companies may not have the expertise in the West, and
they will be looking to CROs for their global development experience, Chu says.
With this cross-global movement, it will be even
more important for CROs to be able to do business
globally and have the services, technologies, and expertise to facilitate clinical development for all types of
companies.

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DRUG DEVELOPMENT JOURNEY

CROs will need very advanced global and diversified groups of people who can work with sponsor companies, Chu says.
SITES AND INVESTIGATORS
Two of the key linchpins to the success of any clinical development program are sites and physician investigators, which are facing increased demands based on
the growing complexities of trials.
According to Evans, the average protocol today includes more procedures than ever before, putting increased burdens on a site, although in many cases investigators fees have not increased.
Most clinical sites around the world operate as
busy clinical facilities as well as research sites. To help
ease some of the burden on sites, PAREXEL in the
last few years has introduced a new program, the Site
Alliance Network. This takes a partnership approach
to working with clinical trial sites. The company has
TOP REASONS PEOPLE CHOOSE TO PARTICIPATE
IN CLINICAL TRIALS

0% 10% 20% 30% 40%

To advance medical science

33%

To help improve the lives of others

To help improve my condition
To earn extra money

29%
15%

5%

To receive free medical care 3%

PATIENT RECRUITMENT AND RETENTION

Source: CISCRP

Despite the development of an impressive array of

recruitment tactics over the last decade, the challenge
of recruiting patients for clinical trials has continued to
grow. The failure of these new tactics to adequately address the challenge has as much to do with their inherent limitations as it does with the lack of a comprehensive strategy for applying them.
Each day a company goes beyond the planned
deadline for a clinical trial, a sponsor company could
lose as much as $600,000 in foregone sales of smaller products and as much as $8 million on blockbuster
drugs, according to ISR Reports. This survey of mid- to
large pharma, biotech, and medical device companies
found that currently 28% of patients in clinical trials
are not active patients at the site. In other words, 72%
of current trial participants are pulled into these studies, while 28% are pushed. Researchers suggest in the
near term, more patients will likely be pushed into tri-

TOP WAYS THAT PEOPLE REPORT FINDING OUT

ABOUT CLINICAL TRIALS

0% 10% 20% 30% 40% 50%

Internet

46%

Media (TV, radio, newspapers)

39%

Email

32%

Research center ads

28%

Physician or nurse

23%

Mail
Family/friends

21%
13%

Source: CISCRP

a dedicated team whose job it is to work with sites.

The company assigns a relationship manager to assist with quality processes and patient recruitment,
as well as provide support systems for the sites. The
alliance managers have no more than a dozen sites to
work with so that they are able to work closely with
those sites. This helps to ensure sites are provided
with the right tools that will make a difference and
help improve performance.
Evans says the classic relationship between a sponsor or CRO and sites is a build-and-break relationship
that often precludes any long-term strategic relationship and is based on a short-term, tactical model.
Were trying to change this paradigm by building
long-term relationships through our Site Alliance Network, Evans says. This relationship is critically important
because it takes a long time to get a site to that advanced
level for sustainable and long-term clinical success.
PAREXEL also provides sites with tools to help with
management of the study, including a tool to screen
the sites database for potential study subjects, a Webbased tool for patient consent, and a reminder app to
keep a study protocol top of mind.
One of the benefits of having an integrated infrastructure is having the technology tools to evaluate a
sites performance based on sophisticated analytics.
Kraus says PAREXELs analytics allow the CRO to
maximize recruiting efforts while minimizing the number of sites and/or countries involved.

SPECIAL PUBLICATION | JUNE 2015

DRUG DEVELOPMENT JOURNEY

als, through patient advocacy organizations and other

push methods.
PAREXEL leverages its experience in populating
clinical trials with an innovative model that integrates
all drivers of effective patient recruitment. The companys Feasibility and Enrollment Solutions group offers
capabilities sponsors need to ensure that their clinical
trials begin on time and are effectively managed from
start to finish. The company offers a set of proprietary
data assets and tools, including a feasibility database;
worldwide site selection database; scenario planning
and recruitment calculator; site tracking and readiness
tools; and site-specific recruitment plans.
Evans points out an important part of site success is
having patient awareness programs in place to educate
potential patients about trials. He says the main reason that patients dont take part in clinical trials is they
dont know clinical trials exist.
Most people dont know what clinical trials are;
they dont know where they are; they dont know that
a trial might be ongoing that could help them, Evans
says. Surveys reporting on patients experience post
trial indicate that the experience in a clinical trial is extremely positive and most patients health outcomes
are better if they take part in a trial than if they dont
take part in a clinical trial, even a placebo-controlled
clinical trial.
In a global CISCRP survey in which people were
asked how they found out about clinical trials, 46% of
the study volunteers reported that the main way they
found out about clinical trials was the Internet.

POSITIVE PERCEPTIONS OF OUTSOURCING

EFFECTIVENESS INCREASE GLOBALLY
% by Geography

Patient satisfaction and continuation in a study is often dependent upon the protocol, which harkens back
to the importance of having a clear line of site to the
endpoint.
Too many clinical trials are designed that do not
take into account the patient and as a result are not
patient-friendly, Evans says. Patient input is rarely
sought. We are now beginning to see more and more
patient involvement in the clinical trial process. And the
influence is being felt. Sponsors are starting to ask for
patients input about practical aspects of a trial that
would dissuade them from taking part in the clinical
process.
Today, through technology, CROs and sponsors can
keep patients engaged through websites and social
groups throughout the clinical trial. Technology solutions in the form of the Internet and social media are
being leveraged more and more for patient recruitment and retention. In the not too recent past, a patient would be scheduled for a site visit every couple of
months and this was the only contact that patient had
with the clinical trial staff.
Dr. Pretorius says social media is playing an increasingly important role in disease awareness and awareness around clinical trials.
Disease foundations and other patient groups are
working with pharma and CROs in terms of creating
awareness about trials and the value that they bring not
only for patients currently suffering from the disease,
but also generations to come, Dr. Pretorius says. n

POSITIVE PERCEPTIONS OF OUTSOURCING

EFFECTIVENESS INCREASE WITH
SPONSORS OF ALL SIZES
% by R&D Spend

80

80

70

70

60

60

50

50

40

40

30

30

20

20

10

10

0
North America

Europe

Source: 2014 Strategic Partnerships

Report, PAREXEL

Asia
3 Years Ago
Today

$1B+ $500M-$999M $250M-$499 <$250M

Source: 2014 Strategic Partnerships

Report, PAREXEL

3 Years Ago
Today

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DRUG DEVELOPMENT JOURNEY

Bridging the Journey Through Technology

s the pharmaceutical industry strives to meet the

ever-increasing complexity of drug development,
new clinical trial technologies are offering tremendous
opportunities for efficiencies, patient safety, and cost
reductions.
The global eClinical solutions market is forecast to
reach $5 billion by 2018, at a CAGR of 13.5% from 2013
to 2018, according to MarketsandMarkets. There are a
number of factors driving the market, such as increasing pressure to reduce costs and time; rising need for
better data standardization in terms of improving and
maintaining the quality of clinical trial procedures to
meet regulatory requirements; government grants and
initiatives to support drug development; increasing
adoption of cloud-based eClinical solutions; and significant spending on clinical R&D by pharmaceutical and
biopharmaceutical industries.
eClinical technologies are increasing in sophistication every year. At every junction of the development
journey, technology is having an impact, from patient
recruitment that can be accelerated by mining consumer data to the integration and standardization of data
through EMR/EHR systems.
Big data is providing opportunities for improving

THE CHALLENGES OF A BIG DATA

TRANSFORMATION
Organization
Adopting a data-centric view, with a clear owner
for each data type across functional silos and
through the data life cycle, will greatly facilitate
the ability to use and share data.
Technology and analytics
Increasing the ability to share data requires
rationalizing and connecting legacy systems
containing disparate data.
Mind-sets
Many pharmaceutical companies fear being
the first mover, since there are few examples
of pharmaceutical companies creating a lot of
value from the improved use of big data.
Source: McKinsey & Co.

10

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Sponsors are looking

for the people,
the processes, the
experience, and
how to apply the
technology to the
drug development
process.
Ken Faulkner, Corporate
VP, Medical Imaging,
PAREXEL Informatics

efficiency in all aspects of clinical trials from protocol

planning to drug innovation to development to commercialization.
But the sheer volume of data also comes with the
challenge of managing terabytes of information. Critical to this process are data analytic tools and processes to create meaningful insights that can lead to real
changes in development.
Brillio, a global technology consulting company,
says 2015 is the year that businesses of all types will be
looking for technology to assist in compiling the droves
of data available and close the gap between data and
actionable insight. On the way are more cloud-based
and mobile analytics and more demand for interactive
and responsive analytics.
The McKinsey Global Institute estimates that applying big data strategies to better inform decision-making could generate up to $100 billion in value annually
across the U.S. healthcare system, by optimizing innovation; improving the efficiency of research and clinical
trials; and building new tools for physicians, consumers,
insurers, and regulators to meet the promise of more
individualized approaches.
Having data that are consistent, reliable, and
well-linked is one of the biggest challenges facing
pharmaceutical R&D. But the right analytics can
help bring clarity to the complex drug development
process.
Several CROs have informatics divisions with the expertise, processes, and technology to power clinical trials: from voice randomization systems, to medical im-

DRUG DEVELOPMENT JOURNEY

aging services, to CTMS, and regulatory management

systems.
Faulkner says recently many sponsors have begun
turning over their technology needs to CROs because
the advantages involve more than just the software and
hardware of the tools.
Sponsors are looking for the people, the processes,
the experience, and how to apply the technology to the
drug development process, Faulkner says.
PAREXEL Informatics has technological innovations that make the process faster, more precise, more
trackable, and more productive. The CRO has integrated platforms and applications that are specifically designed to improve how biopharma companies perform
clinical trials, control and share data, track and report
patient outcomes, and manage regulatory information
worldwide.
PAREXEL also works with data providers and external parties to guide clients on prescription-based data,
data sets of current standards of care, and their use.
We look at technology as a way to become more
efficient and operational to simplify the sponsors journey, Faulkner says.
One way PAREXEL does this is through platforms
and applications specifically designed to improve the
performance of clinical trials. One platform is Perceptive
MyTrials, an integrated suite of eClinical applications
for a single point-of-access. This platform integrates
systems for EDC, randomization and trial supply management, clinical trial management, medical imaging,
and electronic patient-reported outcomes programs to
manage trial data more efficiently and effectively.
PATIENTS AT THE CENTER OF THE JOURNEY
At the heart of every trial is the patient. CROs have
always had a close connection to patients, but as the
overall industry undergoes a shift to patient-centricity,
these clinical specialists can provide valuable insights
into the patient perspective. Technology has been a key
driver of the movement, by providing transparency into
the trial process and more ways to communicate with
patients and physicians. On the horizon are wearables
and other devices that are enabling real-time collection
of patient data in a way never seen before.
Kalorama Information finds that the $29 billion remote patient monitoring market will grow in part because these devices appeal to the baby boomer generation, which will be among the largest user base.
The retirement of baby boomers over the next decade

will lead to the need for a widespread application of

wireless technologies because of the greater need for
tele-homecare, remote patient monitoring, etc.
In fact, 22% of American adults already own a wearable device and the adoption rate is quickly expected
to rise, according to PwCs Consumer Intelligence Series. And 53% of millennials and 54% of early adopters
say they are excited about the future of wearable tech,
according to the PwC survey.
A study by PwCs Health Research Institute suggests that millennials will propel a new health economy
to support a broader market of health and well-being.
Globally, technology adoption has been growing in
terms of identifying patients and hospitals, with greater
technology use at all levels: patient, site, sponsor, and
CRO, Chu says.
EMR/EHR
A recent report from Kalorama Information finds
the market for electronic medical records and health
records (EMR) was valued at $24.9 billion in 2014. The
healthcare market research publisher cites government
incentives, system upgrades, fear of penalties, and
the quest for efficiency in healthcare organizations as
growth factors.
Kalorama analysts expect the market to rise to
$35.2 billion by 2019. Their forecast assumes the trend
of adoption will continue to move forward, although
slowing; hospital EMR adoption will supersede doctors
EMR adoption; and current EMR Stage 3 will move up
in stages.
Dr. Avellone predicts that the use of EMR in the
United States is reaching critical mass driven by both a
push from the federal government and by the evolution
of integrated delivery systems around the country.
About half of all physicians and virtually all hospitals are using some kind of electronic medical record system, Dr. Avellone says. This creates a huge
opportunity for drug development that wasnt there
before.
He says the opportunity lies in the ability to use EMR
data as part of or as a whole data set for some studies.
Clearly, the future of lowering the cost of drug development is going to be leveraging the use of electronic medical records in the data collection and analysis process for clinical trials, Dr. Avellone says. We
have multiple electronic medical record partners and
were actively exploring what type of data to collect in
order to lower the cost of trials. n

JUNE 2015 | SPECIAL PUBLICATION

11

DRUG DEVELOPMENT JOURNEY

The Journey Taken Together

s pharmaceutical, biotechnology, and medical device industries continue to evolve to meet growing pressures to bring life-enhancing pharmaceuticals,
biologics, and devices to market in a timely, cost-efficient, and safe manner, sponsors will need to rely on
the global and integrated services of world-class CROs
that have the experts on staff to align strategic objecMORE THAN 900 BIOLOGIC MEDICINES
IN DEVELOPMENT 2013
Biologic medicineslarge, complex molecules derived
from living cellsfrequently represent novel strategies that
have the potential to transform the clinical treatment of
disease.
Autoimmune Disorders

71

Blood Disorders

43

Cancers/Related Conditions

338

Cardiovascular Disease

58

tives as well as the technologies to maximize a products potential and value.

The first steps of any journey include choosing the
smartest route to the destination and after all the steps
along the wayscience, trials, and paperworkhow far
a new drug will go depends on its use in the real world.
For a drug to reach its intended market after launch,
it takes ongoing data management and multi-pronged
marketing. Safety data from larger populations expand
trust and show regulatory compliance, while tactical
marketing to key players builds recognition as it accelerates product acceptance, formulary adoption, and
recommendation by health professionals.
Through an integrated suite of services and areas of
expertiseconsulting, clinical research, and informaticsPAREXEL can act as an astute guide to simplify
the journey in the development of safe new products
that can reach patients more quickly. n
POTENTIAL FIRST-IN-CLASS MEDICINES
IN THE PIPELINE

Diabetes/Related Conditions

28

Digestive Disorders

26

Eye Conditions

25

Genetic Disorders

Infectious Diseases

Musculoskeletal Disorders

Neurologic Disorders

Respiratory Disorders

38

Psychiatry 79%

Skin Diseases

30

Immunology 72%

An average of 70% of drugs across the pipeline are

potential first-in-class medicines.

30

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

176

34
39

Transplantation 13

Neurology 84%
Cardiovascular 81%
Cancer 80%

Diabetes 71%

Other 58

HIV/AIDS 69%

*Some medicines are being explored in more than one therapeutic

category
Source: Pharmaceutical Research and Manufacturers of
America. "Medicines in Development: BiologicsOverview."
Washington, DC: PhRMA, 2013.

Infections 57%
Source: Pharmaceutical Research and Manufacturers of America.
PhRMA Annual Membership Survey, 19962014.

CONTRIBUTING PAREXEL EXPERTS

Joe Avellone, M.D., Executive VP,
PAREXEL

Ken Faulkner, Corporate VP, Medical Imaging,

PAREXEL Informatics

Karen Chu, Corporate VP, PAREXEL Clinical

Research Services

Ron Kraus, Corporate VP, Worldwide Head,

PAREXEL Consulting

Paul Evans, VP, Global Head, Feasibility and

Enrollment Solutions, PAREXEL

Sy Pretorius, M.D., Chief Scientific Officer,

PAREXEL

12

SPECIAL PUBLICATION | JUNE 2015