36 April 2014 � PharmaVOICE

C-Suite: CROsBy Taren Grom

Contract Research

Organizationswe asked c-suite executives throughout the cRo arena to provide their insights on what the

biggest opportunities and barriers for innovation are for improving the drug development process,

as well as identify a recent innovation that is improving the process.

STUART ABELSONPresident and CEO Ora Inc.

Opportunities: Theshort answer is that thegreatest opportunity liesin true scientific and op-eration contribution.Contributing to a spon-

sor’s development program in a non-linear fashionthat transcends the value typically placed on out-sourcing is the ultimate opportunity. A CRO canprovide a greater opportunity for the developmentpartner when it demonstrates an unparalleled, un-equivocal ability to enhance the likelihood of thesuccess of its program by mitigating significantrisks and enhancing the value of the product. Bysurrounding the customer with all of the resourcesnecessary, whether regulatory, financial, opera-tional, strategic consulting, or otherwise, the CRO isenabling the ultimate goal, which is getting theproduct to market. Barriers: The greatest barriers to innovation are at-tracting innovative people, creating a regulatoryenvironment that is open to innovation, and find-ing clients that are willing to consider new ways ofdoing things.

Clinician-scientist teams with disease-specificexperience, tactile operational knowledge, and aclear understanding of the study’s drug pharma-cology, pharmacokinetics, and toxicology cou-pled with an understanding of the regulatorypathway are essential in the development of asuccessful protocol that includes the correct pop-ulation, time course, and end points. The barrierto entry into the generic CRO space is quite low,and so it’s easy to set up shop without the properknowledge, staff, training, quality systems, and un-derstanding of the true need for innovation in theindustry.

The ability to overcome these barriers are whatwill identify and differentiate high-quality CROsfrom their generic counterparts.

JIM ESINHARTCEO Chiltern

Opportunities: Withthe eClinical revolutionof the past decade, clini-cal research is moving ata much greater speed.There has been nearly

universal uptake of electronic data capture andmanagement through EDC, IVRS, ePRO, and othertechnologies that were only a blip on the radar five,or certainly, 10 years ago. But now we’re seeingtechnological advancement literally explode. Forexample, this revolution has led Chiltern to suc-cessfully implement a wide range of programsusing innovative adaptive trial features and risk-based monitoring techniques that are helping ourclients work smarter, more efficiently, and yet at thesame time, yield even higher levels of quality.

Looking further down the road from outsidethe industry, the growing wearables market is inits infancy as a consumer novelty today, but imag-ine how real-time, all-the-time data collectionfrom wearable devicescould transform theclinical research indus-try. These technologiesare going to allow us tocapture data never be-fore thought possible,potentially eliminatingthe need for study sub-jects to ever enter aclinic after their enroll-ment. Barriers: Perhaps thegreatest barrier is theever-expanding expec-tations that eClinical so-lutions bring. As withany technological ad-vancement, once the

bar has been raised, there is a huge appetite — aperception — that we must do more. This creates ahealthy tension and our ability to manage that ten-sion becomes key. With implementation of new in-novations, particularly something that causes aparadigm shift, there is a huge investment requiredfor training and interoperability. We have to chan-nel that in a positive way to move with the changes,but in a controlled way with respect for our regula-tory environment and trial subject safety.

RAYMOND HILLPresidentinVentiv Health Clinical

Opportunities: It is es-timated that about $10billion a year is wasteddue to poor investiga-tive site selection. Trial

planners simply don’t have adequate analyticsabout research centers and locations where cen-ters operate. Information is often inaccurate andoutdated — or simply does not exist. To find the

2014 CRO Analysis

In 2014, the CRO market is expected to comprise 9.6% of the total worldwide

R&D market.

Note: Dollars are in billionsSource: ISR Reports

$0 $50 $100 $150 $200 $250 $300

R&D market

Development market

Phase I-V development market

CRO market size

$245.7

$100.1

$71.3

$23.6

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C-Suite: CROs

right trial site, across more than 400,000 researchcenters worldwide, trial planners send out lengthyfeasibility questionnaires, often on paper, that arefrequently never filled out or returned. inVentiv hasapplied both advanced technology and process in-novation to revamp the entire feasibility process. Forinstance, through its partnership with ViS, inVentivbrings a sophisticated database and interactivenavigation to the clinical research universe, so thattrial planners can swiftly match their needs with thedisease-specific capabilities of individual researchcenters worldwide. They can quickly and efficientlyevaluate all the relevant analytics, such as local pa-tient population, research activity, infrastructure,personnel, timelines, at the country level as well asdown through state, city, postal code, all the way towhat is inside the research center facilities.

MIKE JAGIELSKICEO KCR

Opportunities: Inno-vation is a multifacetedconcept, the more so, ifdiscussed in terms ofinnovation-intensiveindustries. What di-

rectly enters my mind is huge innovative potentialfor the CRO industry, as well as the clinical opera-

tions field, which lies in direct patient engagementprocesses and technologies. As clinical trials arebecoming more and more complex, so are the re-quirements for patients to be included into trials.In today’s world, CROs compete mainly via patientfees to attract sites and subjects. With an increasedpressure to reduce research costs, this trend can nolonger remain in place. Direct patient engagementmight be a path forward to cost-effective subjectenrollment.

Although I believe investigators will continue toplay a crucial role in clinical research, I assume theirimpact on recruitment and patient retention islikely to diminish. This shift of responsibilities mightultimately decrease costs and urge CROs andpharma companies to seek more creative and trulyinnovative ways to directly attract patients to trials,with no straight financial incentive.Barriers: The current CRO business model, whichboils down to CROs charging per hour, seems tohamper innovation. Surely, there might be dozensof CROs that charge unit fees or apply other alter-native models, for example, deliverable-based. Nev-ertheless, the general tendency shows breakingdown unit prices to compare them against thehourly model. In my opinion, the model used in thesoftware industry would be more effective. The so-lution I’m referring to involves license fees for cer-tain key performance indicator or functionality andsolution delivery in addition to actual service hours.

By employing this kind of business model, CROsmight receive considerably more effective ways ofproject execution, even if it results in fewer servicehours sold. The “license” fee might or even should godirectly into innovations, such as tools to enhancepatient compliance, better remote monitoring con-cepts, and technology to easily integrate electronicmedical records from more diverse sources into trialdata sets. These solutions are vital if CROs are to re-main competitive with their services.

MARIA LARSONCEOExecuPharm

Opportunities: Thegreatest innovationthat could occur withinthe CRO industrywould be a true “part-nership” between a

CRO and a client where transparency in everymove is expected and realized. When this truepartnership is achieved the teams work togetheras one cohesive unit avoiding unnecessarychange orders and delays in timelines. When thismodel is put in place there are fewer surprises,which increase the budget and fewer crises acrossboth organizations. This also decreases any re-sponsibility gaps across organizations and opens

In the big world of clinical trials, it’s the small stuff that counts.

© PRA 2014. All Rights Reserved. 4.14

about our

clearlypra.com

In the big world of clinical trials, it’s the small stuff that counts.

In the big world of clinical trials, it’s the small stuff that counts.

In the big world of clinical trials, it’s the small stuff that counts.

In the big world of clinical trials, it’s the small stuff that counts.

In the big world of clinical trials, it’s the small stuff that counts.

In the big world of clinical trials, it’s the small stuff that counts.

clear

about our

© PRA 2014. All Righ

d. 4.14eveserts R© PRA 2014. All Righ

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38 April 2014 � PharmaVOICE

C-Suite: CROs

the lines of communications, in turn creating amore productive working environment and betterproduct in the end, usually in the approved time-lines and budgetary guidelines.Barriers: I believe that the greatest barrier for in-novation is ego. The fact that more C-level individ-uals on both sides are more concerned with beingright than being open to innovation is an issue thatprevents companies from change. To believe youhave all the answers and that your way is the onlyway to do things could actually halt innovation. Asa CRO we are lucky to have the ability to see whatis working and what is not for a multitude of com-panies and able to observe different strategies thatare tried within the industry. One of the toughestsituations to work through is when a C-level indi-vidual insists on a specific strategy that you haveseen fail with other organizations time and timeagain. As a vendor we obviously need to do what-ever the client wants, however not putting ego’saside puts everyone on the defense and hence abarrier.

ALISTAIR MACDONALDChief Operating OfficerINC Research

Opportunities. I seethree areas that areprimed for innovation.

First is innovationaround technology

and the use of data. CROs are getting better andmore efficient at gathering and analyzing data forfaster decision making. This involves the use ofleading indicators rather than lagging indicators.By using metadata, we can identify risks and de-veloping issues as they are happening, rather thanwaiting for final data. It’s an important innovationwith a myriad of implications and benefits for theindustry.

The second area of innovation is in how part-nerships are designed and delivered betweenCROs and sponsors. Being in a partnership is noth-ing new, but the approach to the relationship andthe commitment that each side makes is where theinnovation takes place. Our industry has held itselfback in the past in some ways, because each side ofthese partnerships seemed to have a need forleverage over the other. But as good partnership re-lationships have matured I think we’ve learned tohave each other’s best interests at heart. This leadsto great efficiencies as we roll forward with lessonslearned, better processes, etc.

Third is a willingness and ability to embracenew directives coming from regulators and to de-sign and deliver trials around these guidances. Risk-based monitoring would fall into this category. It’sreally up to us to identify where the areas of great-est opportunity and efficiency lie within the guid-ance and be able to act.Barriers:We work in a heavily regulated industry

and — rightly so — you never want to trade inno-vation for safety. But the greatest barrier comesfrom not being willing to risk innovation for fearthat regulatory authorities will reject a new ap-proach. Clear guidance from regulators that we canuse to build solutions is critical to innovation in thedrug development industry.

JOHN POTTHOFF,PH.D.President and CEO Theorem Clinical Research

Opportunities: Clinicaltrials today generatevast quantities of datathat must be under-

stood before they can be acted upon. The greatestopportunity for innovation in clinical developmentof biopharmaceuticals and medical devices lies inadvanced software tools and techniques that allowreal-time visualization of information in ways thatspeed understanding. In an era of risk-based moni-toring and continual fine-tuning of trial design,connecting data streams with data visualizationtechniques provides a way for scientists to “see”multiple levels of data as they are generated, re-vealing new insights that can lead to better choicesand decisions.

As more and more data sources become avail-able, this ability to visualize data will lead to an evendeeper understanding of patients, products, andprocesses.

JULIE ROSSExecutive VP, CROAdvanced Clinical

Opportunities: Busi-ness process automa-tion (BPA) is an innova-tive opportunity toprovide a cost-effective

and efficient solution to the overall drug develop-ment process.

The advantage of BPA is the timely and accuratereporting of data that are pulled from one place,one source of truth, rather than multiple databaseswith possible data variations. Another benefit ofBPA is it allows companies to be system agnostic.Should a company desire to change a related sys-tem or database, BPA software will point to the newsystem or database as a singular place to pull orpush data, with the added benefit that data can beaggregated across multiple systems from any-where in the world. Finally, one of the best featuresof BPA is the deployment of timelines and costs area fraction of buying and deploying name brandsystems. Processes can be automated one at a timeor by function such that ROI can be demonstratedquickly.

KENT THOELKEExecutive VP, Scientific& Medical AffairsPRA

Opportunities: The es-calation of trial com-plexity and expansionof collected data pointscontinues to increase

the burden on both participants and investigators.One opportunity for innovation for CROs is to findways to streamline this data collection. Key to aCRO’s ability to affect change is people supportedby a culture of innovation. As the use of EHRs in-creases at trials sites, the potential to integrate andtranslate this data directly into data collection toolswill become essential to maximize efficiency.

Additionally, the use of mobile and wearabledevice technologies to collect biometric data di-rectly from patients will decrease the burden onpatients and increase the real-time capture of datapoints. While all of these technologies are doable inthe foreseeable future, companies need to them todrive these breakthroughs.

GLYN WILLIAMSVP, ProductDeliveryIDBS

Opportunities: CROshave two main optionsto achieve success. Thefirst is to be more cost-effective and efficient

than large pharma companies or biotechs. The sec-ond is to provide a service or niche specialty thatlarger organizations do not have or are cost pro-hibitive. There are some options that can be con-sidered in the areas of automation and qualityguarantees. There is great opportunity for CROs toinnovate by devising new techniques or fosteringspecialist expertise in specific domains. Customersthen pay for leading-edge services at a premiumrather than spending money on developing un-proven technology. This gives CROs an opportu-nity to innovate and share the risk across multiplecustomers.Barriers: The cost of developing new products andtaking them to market is the greatest barrier to in-novation. Large companies with the money to in-novate tend to focus on economies of scale. Inno-vations tend to come from smaller companies thatcannot compete in terms of scale. These innova-tions then compete with larger companies or reacha point where bigger players are willing to invest. Inthese terms the greatest barrier is the perceivedrisk of innovating. PV

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We asked experts in the clinical field to provide the innovations that they believe are having the biggest impact.

April 2014 � PharmaVOICE

DIGITAL EDITION — BONUS CONTENT

STUART ABELSONPresident and CEO Ora Inc.

Imaging Modality IntegrationThe integration of imaging modalities into clinicaltrials such as positron emission tomography (PET)scans of metabolic activity and magnetic reso-nance imaging (MRI) of bones, joints, and tissueshas transformed the way we collect and analyzedata and study disease. In the ophthalmic industryin particular, recent imaging developments such asultra wide-angle fluorescein angiography, adaptiveoptics scanning laser ophthalmoscopy, and spec-tral domain optical coherence tomography pro-vide a more precise assessment of ocular struc-tures. This continued innovation in imagingaccelerates the pace of drug development and im-proves patient care for vision-related illnesses. Aswe embrace these technologies, however, stan-dardization becomes a key component in ensuringthat we are collecting, processing, and tracking im-ages in a consistent manner.

JIM ESINHARTCEO Chiltern

Big DataLike in all industries, the attention to big data couldimpact the clinical trial landscape dramatically. Thisis coming at a time of precipitous pharmaceuticalrevenue from patent expirations and generic com-petition, combined with accelerating R&D costsdue to the rising price tag for healthcare overall,and the increasing needs for large scale and longterm safety monitoring.

Though NHS has recently delayed its release ofmedical records data, we know this will likely come,possibly with other sources to follow. We need tobe stringent in our protection of these data sothere is not even a single instance of patient identi-fication, but as a whole, they offer huge value thatcannot be ignored. Central repositories will pro-mote a better understanding of diseases and the

related effects of pharmaceutical use, help to iden-tify population effects, and reduce the burden ofcollecting safety and rare events. As a result, clinicaltrial design may become much more targeted andcost-effective.

MARIA LARSONCEOExecuPharm

Flexibility and FunctionalityA notable innovation within the CRO industry is theuse of FSPs (flexible/functional service providers),which allows for a more cost-effective solutioncompared with full-service CROs.

FSPs manage, train, and staff a particular func-tion and this benefits the sponsor by acting morelike a true partnership while the sponsor still ownsthe study. The FSP manages the study, which allowsboth sides to share in responsibility.

This model, where there is a mutual interest forsuccess from both sides, presents more care andpride is taken within a project. In the end it allowsa sponsor company to be more open to new ideasand becomes cost-effective in many ways be-cause the usual expenses are not incurred as theywould with a full- service CRO. This allows the FSPto hire more experienced individuals, whichequates to speedier timelines being met andfewer turnovers.

ALISTAIR MACDONALDChief Operating OfficerINC Research

Metadata ActionThe area of greatest recent innovation in our indus-try is the ability to quickly turn data into actionableinformation. Innovative systems and technologyare producing metadata — that is data about thedata itself — that helps us identify trends and is-sues in nearly real time as collection occurs. This al-lows us to see developing risks and issues from theprogram level all the way down to individual siteswithout waiting until the end of a trial.

KENT THOELKEExecutive VP, Scientific & Medical AffairsPRA

Virtual TrialsThe attempt at a “virtual trial” by Pfizer was quiteinnovative and represented a true paradigm shiftin how clinical trials can be run. While this first at-tempt at a fully virtual trial did not accrue patientsat the desired rate, the attempt and idea wasclearly innovative.

True innovation is an iterative process, and Ifully expect in this case that a virtual trial, or clinicaltrials with virtual components, will become muchmore common in clinical development. There is aneed to increase participation in clinical researchby the general public, and models such as the vir-tual trial make participation in trials much moremanageable for patients. The lessons learned fromthis virtual trial will clearly help build a foundationfor future innovation in clinical trial execution thattakes advantage of technology to fuel efficiency ofdelivery. And while the methods of a particular trialcan help efficiency, innovative environments withforward-looking people will be the engine thatdrives innovative breakthroughs.

GLYN WILLIAMSVP, Product DeliveryIDBS

Portable PlatformsI consider the iPad a notable innovation, althoughbeing involved in informatics means I might be alittle biased. The hardware and software is aesthet-ically pleasing, which helps acceptance. Its innova-tion lies in how it has changed the way we usetechnology and, more specifically, consume andshare information. The mobility of these devicesmeans they can be used anywhere, which changesbehavior in a fundamental way. Perhaps more im-portantly, it’s providing a platform on which indi-viduals and companies are innovating. It’s excitingto see how these subsequent innovations now faroutweigh the initial base technology. PV

Clinical

Innovations

C-Suite: CROs

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7TH 8TH MAY 2014, BRUSSELS

The 14th Annual European Clinical Data Forum is back and due to take place on

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