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Distributed by

THE DRUG DEVELOPMENT JOURNEY

A special publication brought to you by

The mission is to getnew and innovative

drug treatments into

the hands of those

who need them most

by simplifying the

journey to market.


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DRUG DEVELOPMENT JOURNEY

SPECIAL PUBLICATION | JUNE 20152

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 ar-

ray 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 of-

ten lasting more than a decade to bring a new prescrip-

tion 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 treat-

ment 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 estimat-

ed that PhRMA member companies invested $51.2 billion in

R&D in 2014; since 2000, more than $600 billion has been

The Journey: More than a Goal

Copyright 2015 by PAREXEL International

All rights reserved.

Published in the United States by PharmaLinx LLC, Titusville, NJ.CUSTOM PUBLISHING

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 prod-

ucts 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 ef-

fectiveness 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 dy-

namics that can breathe new vitality into commercial

success. This reinvention entails an integrated approach

that combines global clinical services infused with stra-

tegic insights and enabled by technologiesall focused

on accelerating time-to-market and maximizing the po-

tential to unlock greater value in products. n

TRENDS IN CLINICAL TRIALS

PROTOCOL COMPLEXITY

Increase in2000-2003 2008-2011 complexity

Total procedures

per trial protocol

(e.g., bloodwork, routine

exams, x-rays, etc.) 105.9 166.6 57%

Total investigative

site work burden

(median units) 28.9 47.5 64%

Total eligibility

criteria 31 46 58%

Clinical trial

treatment period

(median days)* 140 175 25%

Number of case report

form pages per protocol 55 171 227%

* These numbers reflect only the treatment durationof the protocol.

O

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

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 dataprovided through correspondence with Tufts Center for theStudy of Drug Development.


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JUNE 2015 | SPECIAL PUBLICATION 3

ecause drug development is multifaceted and

complex, and requires the successful comple-

tion 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 inte-

grated team of experts.

According to PhRMA, more than 7,000 medicines

are in development globally. A 2012 analysis of the bio-

pharmaceutical 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 $250,000loss, 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 un-

lock the value in biopharma development. To make clini-

cal development more effective, PAREXEL formulated a

multidisciplinary and systems-oriented approach to out-

sourced clinical development, bringing efficiencies, scal-ability, and standardization to the process.

Our customers have told us that our ability to partner

strategically has resulted in increased efficiencies, opti-

mized performance, and continued innovation through-

out the drug development cycle, Dr. Pretorius says.

Over the last few years, we have witnessed a trans-

formation in the way industry sponsors work with

CROs, says Paul Evans, VP, Global Head, Feasibility

and Enrollment Solutions at PAREXEL. This trend is in-

creasing, 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.

A Multifaceted Journey

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 out-

source more of their work to fewer suppliers based on a

model that is designed to save money, reduce complex-

ity, and limit the number of clinical suppliers needed in

the clinical development space.

In recent years, the strategic partnerships mod-

el 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 inter-

est by pharmaceutical, biotechnology, and drug device

sponsors to outsource the development of an entire as-

set 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 proj-

ect proceeds according to the jointly developed plan.

B


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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 cy-

cle 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 Clini-cal Research Services. Sponsors will then come to de-

pend more and more on their CRO partner for the rela-

tionships 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 pre-

scribe 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 partici-

pants in the Tufts CSDD Executive Forum, which noted

that soliciting input from clinical research sites on pro-

tocol design, providing payments directly to study pa-

tients, 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.

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 re-

cruitment. 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 tech-

nology solution, we will integrate it into what we do, if itserves 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, clin-

ical 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 in-

cludes 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

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

There is now a

genuine partnership

between CROs and

sponsors. Theserelationships 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


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rom feasibility analysis, site selection, and patient

recruitment to clinical monitoring, data collection,

and management on through NDA preparation, sub-

mission, and post-approval studies, sponsors are look-

ing 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 im-

provement. 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 spon-

sors to employ large global workforces.

In this day and age, CROs, especially those with an

array of integrated services, including technology solu-

tions, 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 ap-

proach, we can help sponsors be much more cost-ef-ficient, 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-sav-

ing 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 op-

erational resource model allows the staff to become

well-versed in the clients processes. In many instanc-

es, 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 en-

sure 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

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 de-

sign, 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, opera-

tional, regulatory, ethical, etc.) to ensure everything in

the protocol makes sense from an operational perspec-

tive, 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 ex-

pertise and enables its experts to generate alternative

scenarios to the current proposed design. The impact

that these different scenarios have on the data gath-

ered, 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 exe-

cution of adaptive trials, which are becoming increas-

ingly 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

Enhancing the Clinical Journey

In five years, not only

will there be a lot ofinvestment 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

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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 commer-

cialization.

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 au-

thorities and payers. This input is used to effectively de-

sign 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 il-

lustrate what happens when companies spend 10-plus

years developing a product, which may receive approv-

al in the United States but doesnt receive reimburse-

ment 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 get-

ting products to patients.

One of the global markets that is growing exponen-

tially is the Asia-Pacific pharmaceutical market, which

is second to all of the European countries now.

Chu says to penetrate this market efficiently for cli-

ents, PAREXEL has created an integrated pathway in-

clusive 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

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 invest-

ment 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 develop-

ment 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 ex-

pertise to facilitate clinical development for all types of

companies.

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 $26.0

2001 $29.8

2002 $31.0

2003 $34.5

2004 $37.0

2005 $39.9

2006 $43.4

2007 $47.9

2008 $47.4

2009 $46.4

2010 $50.7

2011 $48.6

2012 $49.6

2013 $51.1

Source: Pharmaceutical Research and Manufacturers of America.

PhRMA Annual Membership Survey, 19962014.


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CROs will need very advanced global and diversi-

fied groups of people who can work with sponsor com-

panies, Chu says.

SITES AND INVESTIGATORS

Two of the key linchpins to the success of any clini-

cal development program are sites and physician inves-

tigators, which are facing increased demands based on

the growing complexities of trials.

According to Evans, the average protocol today in-

cludes more procedures than ever before, putting in-

creased burdens on a site, although in many cases in-

vestigators 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

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

The company assigns a relationship manager to as-

sist 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 spon-

sor or CRO and sites is a build-and-break relationship

that often precludes any long-term strategic relation-

ship and is based on a short-term, tactical model.

Were trying to change this paradigm by building

long-term relationships through our Site Alliance Net-

work, Evans says. This relationship is critically important

because it takes a long time to get a site to that advancedlevel 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 Web-

based tool for patient consent, and a reminder app to

keep a study protocol top of mind.

One of the benefits of having an integrated infra-

structure 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 num-

ber of sites and/or countries involved.

PATIENT RECRUITMENT AND RETENTION

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 ad-

dress the challenge has as much to do with their inher-

ent limitations as it does with the lack of a comprehen-

sive 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 small-

er 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 stud-

ies, while 28% are pushed. Researchers suggest in the

near term, more patients will likely be pushed into tri-

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 29%

To help improve my condition 15%To earn extra money 5%

To receive free medical care 3%

Source: CISCRP

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 21%

Family/friends 13%

Source: CISCRP


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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 increas-

ing 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 signif-

icant spending on clinical R&D by pharmaceutical and

biopharmaceutical industries.

eClinical technologies are increasing in sophistica-

tion every year. At every junction of the development

journey, technology is having an impact, from patient

recruitment that can be accelerated by mining consum-

er data to the integration and standardization of data

through EMR/EHR systems.

Big data is providing opportunities for improving

efficiency in all aspects of clinical trials from protocol

planning to drug innovation to development to com-

mercialization.

But the sheer volume of data also comes with the

challenge of managing terabytes of information. Criti-

cal to this process are data analytic tools and process-

es 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 belooking 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 apply-

ing big data strategies to better inform decision-mak-

ing could generate up to $100 billion in value annually

across the U.S. healthcare system, by optimizing inno-

vation; 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 ex-

pertise, processes, and technology to power clinical tri-

als: from voice randomization systems, to medical im-

Bridging the Journey Through Technology

A

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

THE CHALLENGES OF A BIG DATATRANSFORMATION

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.


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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 innova-

tions that make the process faster, more precise, more

trackable, and more productive. The CRO has integrat-

ed platforms and applications that are specifically de-

signed 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 exter-

nal 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 jour-

ney, 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 man-agement, 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 re-

mote patient monitoring market will grow in part be-

cause these devices appeal to the baby boomer gen-

eration, 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 wear-

able device and the adoption rate is quickly expected

to rise, according to PwCs Consumer Intelligence Se-

ries. 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 sug-

gests 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, althoughslowing; 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 hos-

pitals are using some kind of electronic medical re-

cord 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 de-

velopment is going to be leveraging the use of elec-

tronic medical records in the data collection and anal-

ysis 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


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s pharmaceutical, biotechnology, and medical de-

vice industries continue to evolve to meet grow-

ing pressures to bring life-enhancing pharmaceuticals,

biologics, and devices to market in a timely, cost-effi-

cient, 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 objec-

tives as well as the technologies to maximize a prod-

ucts 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 accel-

erates product acceptance, formulary adoption, and

recommendation by health professionals.

Through an integrated suite of services and areas of

expertiseconsulting, clinical research, and informat-icsPAREXEL can act as an astute guide to simplify

the journey in the development of safe new products

that can reach patients more quickly. n

The Journey Taken Together

CONTRIBUTING PAREXEL EXPERTS

Joe Avellone, M.D., Executive VP,

PAREXEL

Karen Chu, Corporate VP, PAREXEL Clinical

Research Services

Paul Evans, VP, Global Head, Feasibility and

Enrollment Solutions, PAREXEL

Ken Faulkner, Corporate VP, Medical Imaging,

PAREXEL Informatics

Ron Kraus, Corporate VP, Worldwide Head,

PAREXEL Consulting

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

PAREXEL

POTENTIAL FIRST-IN-CLASS MEDICINES

IN THE PIPELINE

An average of 70% of drugs across the pipeline are

potential first-in-class medicines.

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

Neurology 84%

Cardiovascular 81%

Cancer 80%

Psychiatry 79%

Immunology 72%

Diabetes 71%

HIV/AIDS 69%

Infections 57%

Source: Pharmaceutical Research and Manufacturers of America.

PhRMA Annual Membership Survey, 19962014.

A

MORE 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

Diabetes/Related Conditions 28

Digestive Disorders 26

Eye Conditions 25

Genetic Disorders 30

Infectious Diseases 176

Musculoskeletal Disorders 34

Neurologic Disorders 39

Respiratory Disorders 38

Skin Diseases 30

Transplantation 13

Other 58

*Some medicines are being explored in more than one therapeuticcategorySource Pharmaceutical Research and Manufacturers ofAmerica Medicines in Development BiologicsOverviewWashington DC PhRMA

parexel_drugdevelopment_june2015

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