Tuesday, March 13, 2012
7:30 am Breakfast Presentation (Sponsorship Opportunity Available, please contact Carol Dinerstein: dinerstein@healthtech.com, 781-972-5471) or Morning Coffee
8:00 Roundtable Discussions: Join your fellow delegates for a morning coffee and lively discussion of current topics related to Phase III. Choose a table and join the discussion.
Table 1: Impact of Comparative Effectiveness Research in Phase III
Table 2: Quantitative Decision Making for Improved Drug Development
Table 3: The Challenge of Personalized Medicine in Phase III Trials
8:45 FEATURED SPEAKER:
Moving to Phase III in an Orphan Disease: Lessons from the Vertex Cystic Fibrosis Program
Eric Olson, Ph.D., Vice President, Cystic Fibrosis Franchise Lead, Vertex Pharmaceuticals, Inc.
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9:30 FEATURED SPEAKER:
Phase III Challenges in Neurology Drug Development
Michael Krams, M.D., Vice President, Research & Development; Head, Neurology Franchise, Johnson & Johnson
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10:15 Speed Networking
An exciting way to meet your fellow conference attendees and speakers! Bring extra business cards to exchange. Each "mini networking 1-on-1" will be 3 minutes long.
10:45 Networking Coffee Break in the Exhibit Hall
» 11:15 Session PRESENTATION:
Evidentiary Standards for Surrogate Endpoints, Genetic Testing & CDx
 Stephen A. Williams, M.D., Ph.D., CMO, SomaLogic, Inc.
How can we explain, understand and manage the perceived differences in evidentiary standards viewed as reasonable by Pharma and regulatory authorities? This talk will use examples such as suicidality, cardiovascular risk and K-ras, while providing evidence from recent case studies and standards set by the FDA.
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11:45 Lessons Learned from a Phase 2 Systemic Lupus Erythematosus (SLE) Study with Belimumab Enabled Design of Phase 3 BLISS Trials
William W. Freimuth, M.D., Ph.D., Vice-President of Clinical Research Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.
Belimumab is a human monoclonal antibody which inhibits B-Lymphocyte Stimulator (BLyS) and has been developed as a novel therapeutic for patients with SLE. BLyS is responsible for the survival and differentiation of B-cells to antibody producing plasma cells. Post-hoc analysis of a belimumab dose ranging phase 2 study in active SLE patients receiving standard therapy identified an autoantibody subpopulation responsive to belimumab. Lessons learned led to design of phase 3 BLISS trials and creation of a novel primary endpoint called the SLE responder Index (SRI).
12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:30 FEATURED SPEAKER:
Talk Title to be Announced
Charles Knirsch, M.D., M.P.H., Vice President, Clinical Affairs Head, Specialty Therapeutics, Pfizer, Inc.
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2:15 The Case for Early Failure Studies
Doina Roman, M.D., Senior Medical Director, Translational Medicine Sciences, Takeda Global Research & Development, Inc.
The talk will focus on the practical use of translational medicine/biomarkers in drug development. Compound failure in Phase III is costly, but lessons can be learned from these studies and applied to drugs in development as early as pre-clinical and early clinical stages by utilizing translational medicine principles. Identifying mistakes, patterns, and decision-making criteria can be a successful tool in both establishing a Phase 3 implementation program and a successful NDA submission.
2:45 EXPERT PANEL:
What Does Your Ideal Phase III Package Look Like?
Join experts from the clinical community in discussing what the ideal Phase III-ready package looks like. What proof-of-concept data and confidence will you require and would you include simulation and modeling data? Explore both business and scientific decision making requirements.
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3:30 Phase III Success: the CRO Perspective
Judith Quinlan, M.Sc., Senior Vice President, Trial Design Implementation, Aptiv Solutions’ Innovation Center
4:00 Biomarkers in Phase III Clinical Trials: Potential Applications and Caveats
Abdel Halim, Pharm.D., Ph.D., DABCC-CC, DABCC-TOX, DABCC-MD, FACB, Director, Clinical Biomarkers, Daiichi Sankyo Pharma Development
4:30 End of Conference