2014 Archived Content

Cambridge Healthtech Institute’s Tenth Annual

Clinical and Translational Science

Strategies to Accelerate and De-Risk Clinical Development

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA

 

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.

Day 1 | Day 2 | Day 3 |  Download Brochure 

 

Monday, February 10

10:30 am Conference Program Registration

 

IMPROVING DECISION MAKING IN DRUG DEVELOPMENT 

 

11:50 Chairperson’s Opening Remarks

Lucette Doessegger, M.D., Global Head, Safety Science Licensing & Early Development, F. Hoffmann-La Roche AG


FEATURED PRESENTATION:

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 Presentation: The Big Catch: Unbiased Trawling for Protein Biomarkers

Stephen Williams, M.D., Ph.D., CMO, SomaLogic Inc


1:45 Session Break


INNOVATION IN CLINICAL TRIAL DESIGN: MOVING TOWARD PERSONALIZED MEDICINE 

2:30 Chairperson’s Remarks

Lynn Zieske, Ph.D., Vice President, Commercial Solutions, Life Sciences Business Development, Singulex, Inc.

2:35 Shaping Diagnostic Practice to Drug Development—Moving Beyond Biomarkers

Chris Chamberlain, M.D., Ph.D., Vice President & Head, Experimental Medicine and Diagnostics, UCB Pharma

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

3:35 Concept of Translational Safety Medicine and Integrated Safety Management

Lucette Doessegger, M.D., Global Head, Safety Science Licensing & Early Development, F. Hoffmann-La Roche AG

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


5:00 Plenary Keynote Session (Click Here For More Details)  


6:15 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:45 Close of Day



Day 1 | Day 2 | Day 3 |  Download Brochure 

 

  2015 Plenary Sessions 

2015 MMTC Prelim Agenda 

Premier Sponsors:

Elsevier 


Jackson Laboratory - small logo 

Leica Biosystems 
 

 NanoString2   

 

Singulex 

Thomson Reuters-Large 


Local Partners:

BayBio 


biocube 


Cabs 

City of SSF