The Clinical Trials Networkfor European Manufacturers

Sally Schwarz, MS, RPh, BCNPChair, Manufacturer’s Registry Sub-Committee

SNM Clinical Trials Network

Common needs for pharma and the

imaging community

• Prove the clinical utility of BOTH therapeutic and imaging agents – Need more use of imaging

biomarkers in existing therapy trials as surrogate endpoints

– Need funding of multicenter clinical trials for imaging biomarkers

– Need a framework for timely development & approval of each

Clinical Trial Challenges Exist

• Each company is developing (or re-developing) their own biomarkers – no standardization

• Ad hoc application of Molecular Imaging (MI) technologies in drug development

• Lack of consensus on the regulatory process/pathway for biomarker development

• Too much talk, too little action

So specifically, what’s not working…..?

An innovative molecular imaging program to accelerate

clinical trials for investigational therapeutics through

improved availability and performance of investigational

imaging biomarkers.

The Desired Solution

Established A Vision for the Network

• Facilitate the use of investigational imaging biomarkers in multicenter clinical trials of new therapeutics

• Focus on multicenter INDs for imaging biomarkers of interest to the therapeutic pharmaceutical community

• Coordinate standardized imaging protocols across qualified clinical trial sites via phantom utilization

• Maintain active engagement with the FDA • Span drug development, molecular imaging and the

adherence to good manufacturing practices (GMP) of radio-labeled probes

Early 2008

Major Programs Defined• Imaging Site Registry• Imaging Site Qualification

(Phantom Program) • Imaging Site Validation &

Monitoring• Manufacturer’s Registry • Safety and Efficacy Reporting

Database • Multicenter IND Demonstration

Project: FLT • Pathway for Proprietary Biomarkers

Phase I Launch: August 2008

Organization

Committee Chairs:

Mike GrahamSandy McEwanPeter Conti

Ramsey BadawiToni ShieldsGeorge Segall

John SunderlandSally SchwarzPaul ChristianJohn HoffmanDenise Harbora

World wide interest from imagers and manufacturers

Global Engagement

• Consistent Growth

Network Registries (Jun 09)

Thank-you for your attention!