Clinical Trial Optimization - A Global View

Nikos Kostaras

General Manager, IMS Hellas

Athens, 10/11/2014

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Clinical R&D Process Average of 6- 7 Years in Clinical Trials to Bring a New Drug to Market.

7-9% of R&D budget is invested in Clinical Trials.

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Critical Industry Trends

Growth Drivers

FDA Safety and Efficacy Focus

Payer Reimbursement and ROI Scrutiny

Industry Cost Efficiency and Speed Priorities

Patent expiries have slowed but not stopped growth, esp. in outsourced solutions. $20bn+ are invested in Clinical trials every year.

11/12/2014

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Industry Challenges in Clinical Trials

Lack of evidence -

based decision making

Costly mid-trial rescues

Unrealistic protocol criteria

Disparate, homegrown solutions

Enrollment plans based on guesswork

Can’t find relevant patients

Low performing investigators

No real-time access to global information

No historical evidence

Manual processes

WHY?

• Wasted $$$$$$$

• Lost revenue potential

• Fewer drugs in market

• 89% drugs fail in the clinic

• 80% trials run behind schedule

• 30% investigators don’t enroll patients

• 7% annual grant payment increases

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IMS Health Clinical Trial Optimization Portfolio

● Tracking and monitoring

● Rescue scenario modeling

● Patient identification

● Supply optimization

● StudyOptimizer

● Pharmacy outreach

● Protocol design

● Country allocation

● Enrollment planning

● Budgeting

● Real World Evidence

● StudyOptimizer

● Enrollment Benchmarks

● GrantPlan and SOC

● Site planning and selection

● Site budgeting

● Supply planning

● Real World Evidence

● SiteOptimizer

● GrantPlan and SOC

IMS Health Clinical Trial Optimization Solutions

Technology, Data, Analytics

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Trial Execution Trial Planning Trial Initiation

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Customer Impact

RESULTS:

• 100% increase in studies recruiting to plan

• 1/3 decrease in non-performing sites

• Estimated savings of $38M

RESULTS:

• 30-40 day decrease in patient recruitment

• 20% reduction in rescue studies

• 30% decrease in variance to plan

• Used to manage partner accountability

Enterprise implementation of

StudyOptimizer and SiteOptimizer

Best Practice implementation of StudyOptimizer,

extended to manage CROs

Enterprise implementation of

GrantPlan and Standard of Care

RESULTS:

• 20% savings across Studies in the U.S. by passing those costs to 3rd party insurers

• Used as a template for countries that recognize Standard of Care

11/12/2014

UK pharma giant

US pharma giant

Top US biologic pharma

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