The following concurrent breakout discussion groups will be held on the conclusion of day one between 5:20-6:20 pm:
Forging New Regulatory Pathways for Delivery of Personalized Medicine
Moderator: Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.
- Brainstorm new regulatory pathways to facilitate co-development of drug/diagnostics
- Explore areas where additional FDA guidance is needed for co-development of
- Propose incentives for innovation and risk-based approaches to contemporaneous
development of drug/diagnostics
To Randomize or Not to Randomize in Oncology Phase 2 Clinical Trials
Moderator: Ionel Mitrica, Ph.D., Director, Clinical Development, Oncology, GlaxoSmithKline
- Review experience with/bias toward Phase 2 single-arm trials (SATs) vs randomized
controlled trials (RCTs) in roundtable participants’
- Review some of the pros and cons for SATs vs RCTs, and when one or the other may
make more sense
- Discuss the role of RCTs in early oncology drug development
Genomic Based Approach to Cancer Clinical Trials
Moderator: Apostolia-Maria Tsimberidou, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center
- Optimization of molecular profiling: challenges
- Development of novel targeted agents
- Collaboration and exchange of information regarding molecular profiling and
As part of the Molecular Med TRI-CON 2012, attendees have access to 2 partnering forums, 5 symposia, 18 short courses, and 12 core programs. The event attracts than 3,000 attendees and provides attendees an opportunity to interact with each other in the shared exhibit/poster hall, plenary keynotes and social functions.
Advance registration discounts are available until January 13, 2012. To view the conference agenda and to register, please visit http://www.TriConference.com/
To inquire about sponsoring and/or exhibiting, contact Jon Stroup, 781-972-5483, email@example.com.
Writers and editors are encouraged to attend. To request a press pass, contact Tracey Fielding at firstname.lastname@example.org.
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