As the biopharma industry faces the challenge of increasing cost of drug development, increasing emphasis is placed on strategies to accelerate clinical development, reduce late-stage attrition and pursue innovation through collaboration. Cambridge Healthtech Institute’s Tenth Annual Clinical and Translational Science conference at the 2014 Molecular Med Tri-Con will bring together thought leaders from academia, industry and government to share strategies to accelerate and de-risk clinical development through better and earlier safety and POC models, the use of translational biomarkers and imaging, novel clinical trial design and patient selection, and collaboration.
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Monday, February 10
10:30 am Conference Program Registration
11:50 Chairperson’s Opening Remarks
12:00 pm Reinventing Drug Development: Acceleration in the Information Age
Jamie Freedman, M.D., Ph.D., Senior Vice President and Global Head, Clinical Development, MedImmune/AstraZeneca
Time is crucial! The information age provides access to patient-level genomic data; are your development plans keeping pace? Small, targeted studies with strong science are driving development. New thinking, informed patients and strong relationships between academic sites and industry will drive the next generation of blockbusters. Are you in?
12:30 Informing Early Development Decisions
Richard Scheyer, M.D., President and CSO, in vivo veritas, LLC
PoC studies are often used to determine go/no-go. Alternatively, early development may be viewed as the accumulation of knowledge informing probability of successful development, until sufficient to either transition to late phase or to terminate development. For maximal efficiency, early phase should focus on activities having greatest impact on PoS estimation.
1:00 Session Break
1:15 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
2:15 Session Break
2:30 Chairperson’s Remarks
Lynn Zieske, Ph.D., Vice President, Commercial Solutions, Life Sciences Business Development, Singulex, Inc.
2:35 Prevention of Alzheimer’s: What Would It Take? An ISTY-2 Pre-Competitive Proof-of-Concept Clinical Trial Process
Michael Krams, M.D., Ph.D., Vice President and Head, Neurology, Johnson & Johnson
3:05 Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (SCCA)
Vassiliki Papadimitrakopoulou, M.D., Professor, Thoracic/Head & Neck Medical Oncology, University of Texas MD Anderson Cancer Center
There are few effective therapeutic options for patients with advanced, lung SCCA. The TCGA project and similar studies have detected a large number of somatic gene mutations/amplifications in patients with this disease; frequency is low (5-20%), making recruitment and treatment very challenging in the traditional single-agent trial setting. Our strategy is to use next-generation DNA sequencing to enable a single “umbrella screening protocol” to efficiently find patients with varied, uncommon molecular changes.
3:35 Speaker to be Announced
4:05 Multiplex Protein Biomarkers in Clinical Studies: A Strategy for Pharmacodynamic and Companion Diagnostic Discovery
Dominic Eisinger, Ph.D., Director, Strategic Development, Myriad RBM
The “RBM Approach” to biomarker discovery and validation is one of the most successful means of clinical biomarker analysis for multiple therapeutic areas. Myriad RBM’s multiplexed immunoassays are validated to clinical laboratory standards and can quantify hundreds of biomarkers.
4:20 Quantitative Measurement of Low-Abundance Biomarkers Using Digital Single Molecule Counting
Lynn R. Zieske, Ph.D., Vice President, Commercial Solutions, Life Sciences Business Development, Singulex, Inc.
Several considerations must be taken into account to establish a clinical biomarker, including the ability to measure normal states. Singulex’s proprietary single molecule counting technology helps overcome challenges in biomarker translation from discovery to clinic. This presentation reviews cardiac troponin I (cTnI) development as a clinically relevant biomarker.
4:35 Refreshment Break and Transition to Plenary Keynote
6:15 Grand Opening Reception in the Exhibit Hall with Poster Viewing
7:45 Close of Day
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