Shaping the Futureof Drug Development

ENHANCING CLINICAL DATA QUALITY WITH SPECIALIZED FUNCTIONAL SERVICE PROVIDER MODEL

Jim BakerSenior Vice President Clinical

Research ServicesCytel

JIM BAKER

INTRODUCTIONGlobal development outsourcing spend could reach 36 billion by 2018

1. In this context, selection

of the correct outsourcing model, as well as the right partner to deliver is not only a cornerstone of successful clinical trial delivery but also a strategic commercial necessity. The Functional Service Provider model (FSP) is becoming an increasingly deployed outsourcing approach, not least in the biometrics (statistics, data management, and statistical programming) space, reflecting a requirement for controlling the cost and risk inherent in fluctuating workloads. With effective use of outsourcing, companies are able to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on clinical trial projects. In this paper, we will examine the characteristics, drivers, success factors and outcomes of the FSP approach.

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Senior Vice President ofClinical Research Services

Over his 30 year career, Jim Baker has held leadership positions at some of the world’s top pharmaceutical, biotech and clinical research firms including Amgen, Wyeth and Parexel. Most recently, Baker served as Senior Director of Study Standards Implementation at Millennium.

Mr. Baker is respected not only for his cross-functional experience spanning both product development planning and clinical operations, but for his considerable trial data management knowledge. With a deep familiarity of clinical data handling and regulatory requirements, he specializes in data procurement, security and submission process strategies. For Cytel, Jim oversees global deployment of the Functional Services (FSP) business in support of our clients’ clinical research efforts.

FUNCTIONAL SERVICE PROVIDERCHARACTERISTICS VS STUDY BASED MODELS

What is an FSP? How does it stack up against a study based outsourcing approach? Below we outline some of the key differentiating characteristics.

Provides a single functional service to a sponsor, often operating across multiple sponsor programs for effective use of resources

Tends to be long term relationship, with aim of developing efficiencies over time

CRO will usually work to sponsor SOPs ( Standard Operating Procedures) and systems

Usually contracted on a Full-Time Equivalent (FTE) time and materials basis

Provision of services aligned to the study, or program of studies

Defined by length of the study although relationship may continue into further studies

CRO will usually work to its own SOPs and systems

Usually contracted on a task or milestone basis

CRO staff will handle a variety of projectsCRO personnel usually 100% dedicated to FSP

Functional Service Provider Study based

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DRIVERS FOR USE OF FUNCTIONAL SERVICE PROVISION MODELFunctional service provision can be attractive to sponsors versus full-service outsourcing for a number of reasons. Typical drivers for choosing an FSP model include:

The FSP model tends to be utilized more by large biopharmaceutical companies who have the scale and internal oversight resources available to make this approach worthwhile. However, mid-size and small biopharma companies have the opportunity to experience the same benefits even if on a smaller scale. Smaller companies could choose to retain minimal strategic leadership for a function and outsource the function entirely to reduce the risk assumed in a limited number products or pipeline. A ‘tactical’ FSP approach, using a small number of personnel, can be a viable alternative to a contractor model and overcome some inherent issues such as lack of predictability and control.

...small biopharma companies have the opportunity to experience the same benefits even if on a smaller scale.

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Requirement to consolidate multiple, ad-hoc resourcing

approaches

Drive to lower operational costs

Scarcity of talent in functional area ( i.e.

statistics) and need to access this expertise

Need to have more control and flexibility in the model

than allowed by a full-service model

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TAILORING FSP MODELS While FSP approaches have common characteristics as defined above, they may also be tailored to meet the individual client requirements. For example, for many sponsors, one of the primary drivers for adopting FSP is to lower costs.

This will obviously have an impact on how and where the FSP is resourced and in such cases, the use of low and lower cost regions will be important. With talent at a premium in the biometrics space, it’s critical that the CRO is proactive in developing its candidate base at its global locations, and keeps up to speed with new areas where talent will be accessible for use by its clients. On the other hand, other sponsors are motivated more heavily by factors such as accessibility to talent, oversight, and management of contractors and flexibility than cost. In such cases, the FSP may be resourced locally to the sponsor statisticians and project leads

“The internet has forever changed the competitive

climate for most white-collar knowledge workers. Courtesy

of near-ubiquitous connectivity, the output of the knowledge worker can now be emailed to a desktop anywhere in the world. That brings low-cost,

well-trained, highly-educated workers in Bangalore, Shanghai

and Eastern and Central Europe into the global

knowledge-worker pool.” -Stephen Roach, Chief Economist,

Morgan Stanley

WHY DO SPONSORS ACTUALLY SAY THEY OUTSOURCE?

Avoca: Strategic Partnerships Under Scrutiny:Are They Working and How Long Does It Take?Executive Summary of The Avoca Group’s 2012 Industry Survey Research.

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Reduced Costs

Improved Quality

Improved Efficiency in Use of Internal Staff

Access to Operational Knowledge

Process Improvement

53%

43%

43%

43%

30%

It is critical that the CRO is proactive in developing its candidate base at its

global locations.

SUCCESS FACTORS FOR BIOMETRICS FUNCTIONAL SERVICE PROVISION

Knowledge DevelopmentOne of the advantages of an FSP approach versus ad-hoc models is the ability for the sponsor to benefit from learning and process improvements. Both organizations partner together to share experiences to expand and improve processes that result in efficiency gains. Multiple disciplines can be addressed including technical collaborations, processes and procedures, resource allocation, and organizational structure reviews. As an example, within one FSP collaboration, the Cytel functional leads

presented to the internal client team the tools which had been developed in the partnership. In another example, the Cytel team has access to and is trained in commercially available tools such as EAST- thus freeing the sponsor from taking up advanced training. As part of your evaluation of an FSP vendor, it is important to discuss the measures which have been taken with regard to training and process improvement.

ExperienceSponsors often outsource on an FSP basis where they are looking to access a specific capability or expertise. Business Process Outsourcing (BPO) or Knowledge Process Outsourcing ( KPO) is the contracting of a specific business task, such as payroll, human resources (HR) or accounting, to a third-party service provider.While large BPO organizations may have the advantage of scale, in areas which demand expertise such as statistics and programming, specialist CROs can add value by providing specific functional strength and experience. Valuable insights can be obtained by reviewing the CVs of proposed project leads and members of the wider team. It’s important to remember that the number of years’ experience may not always translate into the same level of expertise from one environment to another- the level of exposure gained in different organizations to a variety of activities can vary significantly. It’s crucial to carefully evaluate your provider’s overall capabilities- does the FSP fall into their core competency? Do they have a track record of delivering the desired services in an FSP model as well as study based models?

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Cultural FitIn order for the endeavor to be a success, the closer your two organizations can be in terms of values the better.

• Will the CRO staff treat the priorities of the sponsor company with the same level of team commitment to timelines and deliverables?

• Will open communication be established between all levels of the two organizations – team, project management, and executive management?

• Is there training in place to ensure that any differences in nationality, language, and national culture are properly managed to ensure strong working relations?

• Is there a commitment between the two companies to resolve issues together versus diverging into unresolvable differences?

One of the differences between an FSP model and other outsourcing arrangements is that it is a longer term partnership. Therefore, the willingness from both sides to invest time and effort up front in establishing strong communication, trust, and mutual objectives is critical to success.

GovernanceAs part of the governance of an FSP clear communication pathways should be established between the various stakeholders from both the sponsor and CRO. An FSP governance structure typically incorporates a governance committee, communication plans, and Key Performance Indicators (KPIs) to ensure that the partnership is kept on track strategically as well as operationally, enabling issues to be identified and corrected early.

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Governance

Go

vern

an

ce

Co

mm

itte

e

Co

mm

un

ica

tion

Pla

ns

Key

Perf

orm

an

ce

Ind

ica

tors

(KP

Is)

ProductivePartnership

-Peter Drucker

DO WHAT YOU DO BEST, & OUTSOURCE

THE REST

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Resourcing/ Ramp Up CapabilityThe ability to resource and retain talent is one of the most important success factors in all CRO delivery, and is particularly critical for FSP. Therefore, it is a key element to explore as part of the evaluation of your FSP provider.

In the statistics and programming space, one of the challenges faced by sponsors and CROs is gaining access to talent which is in short supply.Within clinical data management, it can also be challenging to attract the right talent with the necessary technical ( i.e. EDC), project management and communication skills to ensure success. It is therefore an advantage, if not critical, that the provider has an in-house recruitment team and a strong network within the industry to ensure a track record in ramping up teams.

Remember as well, that career options for biostatisticians, statistical programmers and data managers at CROs are often highly competitive and may offer a greater variety of projects and working styles than a role within a large biopharma. It can be an enriching experience for statisticians and programmers to work in a company whose entire focus is on statistics and biometrics with a foundation of statistical thought leadership.

Key questions to ask your provider include:

How successful have you been attracting personnel for other partnerships? Have you delivered against your ramp-up targets?

What is your retention like in your organization as a whole, and specifically in terms of FSP?

What is your resourcing strategy?

OUTCOMESAn FSP engagement provides an optional approach to a full-service CRO model when a focused level of expertise and strength is required for success. One of the important outcomes of Functional Service Provision is cost saving, which may be derived in a number of ways from a biometrics standpoint: Development of efficiencies • Standard programming approaches • eCRF library development and standards development ( Data Management) • Peer to peer learning and knowledge sharing

Resourcing • More efficient ramp up when managed by a specialist with strong talent mapping capabilities • Recruiting costs can be more easily controlled • Reduced sponsor oversight of contractors or other ad-hoc resources • Flexibility in use of off-shore and lower cost locations • Ability to ramp up and down and reduce risk of resource being under-utilized Oversight • Sponsor oversight reduced by familiarity with CRO teams and streamlined communications • Reduced administrative burden of managing multiple resources Contract Features • Lower rates based on length of contract • Volume discounts by consolidating with a “single” CRO

Other Outcomes The other significant outcomes include:

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Measurable (through KPIs) improvements in quality

and speed of deliverables

Reduction of operational risk (appropriate

resourcing, assurance of quality)

Improved flexibility in responding to regulatory

requests (through familiarity of teams for

rapid response requests)

Access to CRO team insights and recommendations

adding value to the sponsor activity

CASE STUDY 1: ON-SHORE TEAM OF BIOSTATISTICIANS AND STATISTICAL PROGRAMMERS

Challenge:

Our client, a top 20 biopharmaceutical company, requires an outsourcing solution to help reduce their oversight burden over contracted statistics and statistical programming resource by consolidating vendors, as well as manage an increasing workload.

Requirements

• A US East Coast based solution was requested to facilitate strong connections between the Cytel FSP team members and their sponsor counterparts.

• Statistical and statistical programming support was needed for Phases 2 and 3 across a variety of therapeutic areas.

• Assertive ramp-up of 30 statistical programmers and 15 biostatisticians was targeted over 12 months.

• The operational plan proposed that FSP personnel would initially work with sponsor leads and then transition into functional study lead roles.

• Cytel achieved ramp up of statistical programmer requirement ahead of schedule and met an extended ramp-up of biostatisticians inside 12 months. • Due to successful initiation of the relationship, additional resource requirements from the sponsor were shifted to Cytel.

• An excellent collaborative relationship resulting in more efficient planning and utilization of resources has developed.

• KPIs achieved and utilized to ensure the contract and relationship meets and exceeds expectations.

Outcomes

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CASE STUDY 2: A BLENDED US/INDIA TEAM AS A SEAMLESS EXTENSION OF THE SPONSOR TEAM

Challenge:

Our client, a top 10 pharmaceutical company, sought an ‘external arm’ to provide a lower cost approach for later-stage study work.

Requirements

• Lowering cost was a key objective and therefore much of the resource on this project was assigned off-shore.

• Client required a highly expert team of biostatisticians and programmers with advanced degree qualifications and biopharmaceutical industry experience. • An aggressive ramp up schedule was contracted over 3 years.

• The team would work to the client’s own SOPs and quality standards. • The project required support of a robust pipeline portfolio across Phase I-IV of Clinical Development.

Outcomes

• The ramp up schedule was achieved with normal challenges over the 3 year period and met client expectations.

• The client has observed quality and productivity improvements through Cytel familiarization with their products and processes.

• There was an expansion of the biostatistician support beyond the initial plan.

• The client is achieving the cost savings expected in an off-shore engagement.

• The key issue of turnover of staff in the off-shore location has been effectively managed to achieve the expected results.

• The ability to onboard, train, and mentor staff shifted from the client to Cytel.

• The initial collaboration has evolved into a longstanding partnership with Cytel operating as an external arm of the client’s team.

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CASE STUDY 3: A BLENDED ONSHORE/OFFSHORE TEAM TO SUPPORT GLOBAL MEDICAL AFFAIRS IN MID-SIZE BIOTECH

Outcomes

Challenge:

Our client’s medical affairs group needed statistical consulting as well as operational delivery support for preparation of publications/presentations in rare disease indications.

Requirements

• The medical affairs team needed biostatistics and programming support to prepare complex material for publication and conferences.

• The FSP team needed to be led by highly experienced biostatisticians to provide both consulting and oversight of the offshore personnel.

• The turnaround times for assignments would be short, with low visibility over upcoming projects. This meant flexibility and ability to leverage global resources to ‘work around the clock’ was paramount.

• Cytel assigned a multi-disciplinary team combining lead consulting statisticians, with an operational biostatistics and programming team in India.

• The consulting statisticians acted as an extension of sponsor’s own team, regularly providing the statistical input for cross functional meetings.

• The team achieved full productivity and expertise in the client’s processes and niche therapy areas within the first 6 months of the assignment.

• The sponsor benefits from a flexible team with acquired expertise in their niche areas, and capacity to respond to their fast turnaround project requirements.

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HOW CYTEL CAN HELP

As the world’s leading biometrics CRO, all of Cytel’s processes, talent and expertise are applied to maximizing the value of clinical data. A standardized approach to data collection and analysis ensures traceability and delivers operational efficiencies. Our specialist knowledge helps our customers to lower clinical trial risks, accelerate development and improve the probability of success.

We deliver our statistics, statistical programming, and data management expertise through study based and functional outsourcing models. By combining robust, scalable delivery with industry-leading expertise and technology, Cytel offers a unique, high-quality and expert approach. We operate FSPs across our global locations in India, USA, and Europe and have developed a strong reputation for quality within our global client base.

References 1) Parexel Biopharmaceutical R&D Statistical Sourcebook 2015/2016 Global biopharma development spend is predicted to reach $103 billion by 2018. With an addressable CRO market of up to $70 billion by 2018 and predicted market penetration by CROs of 52.1$m Global development outsourcing spend could reach 36 billion in the next 2 years.

FIND OUT MORE ABOUT OURCLINICAL RESEARCH SERVICES:http://www.cytel.com/services

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