CONTROLLING THE KNOWN VARIABLESStrategies for solving the operational challenges of oncology clinical trials

EXECUTIVE BRIEF

The Promise of Personalized Medicine

• Reduce drug failure

• Reduce time/cost

• Enhance patient participation

• Increase number of approvals

• Reimbursement of effective drugs

Tufts CSDD

At the 2011 ASCO Meeting we got a glimpse of what the future holds for patients and drug developers.

A deeper understanding of the pathways governing cancer are showing significant results in deadly diseases that previously had limited options…

Glimpse Into The Future

Vemurafenib – A BRAF Inhibitor (ASCO 2011)

Targeted: A mutated form of a gene called BRAF found in more than half of patients with advanced melanoma

Tailored: 63% less likely to die over a six-month period compared to those taking chemotherapy

Where Are We Today?

Over 9,000 oncology drugs under evaluation

~16 targets actively studied

Source: TCSDD

Where Are We Today?

Impact of Personalized Medicine on Clinical Trials

• 94% of companies investing in personalized medicine

• 50% of compounds in development qualify as personalized

• 75%* increase in funding for targeted therapies

Tufts CSDD

*Over the last 5 years

As an industry, we continue to focus on the traditional barriers to oncology clinical research here in North America…

Traditional barriers to oncology clinical research

Applied Clinical Trials Live Webcast June 14, 2011

New issues as a result of personalized medicine

1. Regulatory oversight (implications for R&D)

2. Reimbursement (testing & costly treatment)

3. Privacy, confidentiality and patient rights

Most important issue is the impact Personalized Medicine will have on your clinical operations.

The goal is to find new ways of reducing costs by finding the “Right Sites” more quickly.

• Impact on Clinical Operations

Cost

Site/PI selection

Administrative burden

A Challenge Often Overlooked

• Average cost of R&D is now $2.3 Billion USD

R&D Spending On The Rise

Low Approval Rate in Oncology

The declining number of North American investigators means that your ability to find the right sites that are motivated to work on your trials is more critical than ever.

Declining Number of Investigators

Source: FDA’s Bioresearch Monitoring Information System File (BMIS)

Increased Administrative Burden

Source: TCSDD

Source: Getz et al. Assessing the Impact of Protocol Design Change on Clinical Trial Performance. American Journal of Therapeutics. 2008 15(5); 450 - 457

Increased Workloads

Personalized medicine adds to the recruitment problem.

Need for smaller patient populations means you need to screen more patients to find enough that are eligible for your trial.

POSSIBLE SOLUTIONS

CONTROLLING THE KNOWN VARIABLES

Challenges

• Cost

• Site/PI Selection

• Administrative Burden

Solutions

Strategic Relationships

Identifying Right Sites

Optimizing Output

Keys to Success

• FDA & EMA have created programs to

tackle questions surrounding biomarkers

& defining endpoints

Collaboration with Regulatory Agencies

• Networks to address “unmet clinical trial

needs”

• Match investigators with trials of interest

Reducing Costs by Enriching Site Selection

Personalized Medicine

Applied Clinical Trials Live Webcast June 14, 2011

Keys To Success

Scimega Research maintains an ongoing dialogue with a network of oncology investigators to identify their study needs.

This allows us to match studies to sites that are motivated to recruit patients and get trials up and running.

SCIMEGA RESEARCH – REVERSE FEASIBILITYTM

A new approach to site selection & patient recruitment

Investigative Network Information Gathered

• Experience

• Interest

• Facilities

• Recruitment openings over next 6 months

• IRB requirements/schedule

• SOC – availability and reimbursement

• Catchment area

The Value of Privileged Relationships

Benefits To You

+ Accelerated communication with the right investigators + Protocol synopsis, recruitment target and timelines & budget + Access to pre-approved CDA templates

= Immediate, accurate assessment

CONCLUSION

Are you controlling your known variables ?

SPEAK TO US TODAY ABOUT YOUR SITUATION

Contact Roberto Lara at (450) 629-2200 ext. 226 or rlara@scimega.com

About Scimega Research

Scimega Research was founded as a specialty Oncology CRO in 1997 to meet the demand for

superior clinical trial management services in the complex field of oncology clinical research. The

company’s depth of oncology expertise and ability to offer full North American coverage brings

tremendous value to its clients. But it’s our privileged relationships with North American

investigative sites that allow us to fulfill our mission of accelerating strategic drug development

decisions.

To learn more visit us at www.scimega.com LinkedIn Group: Optimizing Oncology Clinical Research