3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

1. CHALLENGES IN GLOBAL
`
CLINICAL DEVELOPMENT
Presented
January 28, 2010
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET

2. Meeting Agenda
– Tough times demand good decision making and efficient clinical
development
– Leveraging biometrics to optimize clinical development
• EDC systems and risk mitigation
• Overcoming Current Medical Practice Challenges by Leveraging Statistics
• Experience can salvage a clinical program jeopardized by poor planning
– Strategic Paradigm for Global Clinical Development by Emerging
and Mid-Size Companies
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET

3. • Case Studies
TOUGH TIMES DEMAND GOOD
DECISION MAKING AND EFFICIENT
CLINICAL DEVELOPMENT
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET

4. Tough Times > Smart Development
– Decrease in Venture Capital investment
“Venture
– Patent expirations and potential loss of revenues Capital
investment
– Shorter development cycles are critical and
fundraising
– Strategic solutions to study challenges
slowed
– Successful study results considerably
in 2009 and
– Identify and harness market potential, capture the
interest of Large Pharma and Venture Capital will continue
in 2010.”
– Respond to higher demands in risk management
NVCA
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET

5. • Case Studies
LEVERAGING BIOMETRICS TO
OPTIMIZE CLINICAL DEVELOPMENT
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET

6. EDC Systems and Risk Mitigation
• EDC is generally seen as a tool which:
– Collects data in ‘real time’
– Provides cleaner data
– Enables faster database locking
– More expensive option compared to paper
• Paper-based systems are problematic due to:
– Meeting eligibility criteria ensure uniformity of subjects across
study sites
– Paper based systems cannot ensure that criteria have been met
– Paper based systems allow for more protocol deviations
– Allow for shipment of drug – IVRS or not – if entry criteria not met
– Violation of an entry criterion could lead to unnecessary safety
concerns
ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET

7. ATTENTION!
The entire presentation is available to registered
attendees only!
To view the rest of this exciting presentation and many
more!
Please Register for the
3rd Annual Challenges in Global Clinical Trials Conference
at
www.gtcbio.com
If you are already registered, please contact
GTCbio for the full version.