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2013 Archived Content
Ninth Annual

Clinical and Translational Science

Strategies to Accelerate and De-Risk Clinical Development


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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 Ninth Annual Clinical and Translational Science conference at the 2013 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.

Wednesday, February 13

7:00 am Registration and Morning Coffee


Plenary Keynote Session 

8:00 – 9:40 am Plenary Keynote Presentation - Personalized Oncology – Fulfilling the Promise for Today's Patients

In honor of the 20th anniversary of the Molecular Medicine Tri-Conference, CHI and Cancer Commons will present a plenary panel on Personalized Oncology. Innovations such as NGS and The Cancer Genome Atlas have revealed that cancer comprises hundreds of distinct molecular diseases. Early clinical successes with targeted therapies suggest that cancer might one day be managed as a chronic disease using an evolving cocktail of drugs. Representing all five conference channels, Diagnostics, Therapeutics, Clinical, Informatics, and Cancer, a panel of experts will lead a highly interactive exploration of what it will take to realize this vision in the near future.

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9:40 Refreshment Break in the Exhibit Hall with Poster Viewing


Strategies to De-Risk Clinical Development 

11:00 Chairperson’s Opening Remarks

Scott Kennedy, Ph.D., Global Head, Biomarker Development, Novartis Institutes for BioMedical Research

11:10 Leveraging the Intersection of Mechanism and Disease Biology to De-Risk Early Clinical Development

Scott Kennedy, Ph.D., Global Head, Biomarker Development, Novartis Institutes for BioMedical Research

This presentation will discuss challenges and opportunities for leveraging stratification biomarkers which inform a biological understanding of targeted and disease pathways to enable increased success of early clinical development and the identification of additional treatable disease populations.

11:40 Safety of Targeted Immunotherapy in Cancer: Early Toxicity Risk Mitigation Strategies

Rakesh Dixit, Ph.D., Vice President, Research & Development; Global Head, Biologics Safety Assessment, MedImmune

Biologics immunotherapies have revolutionized cancer treatment but there is increasing concern that certain toxicities may limit their long-term benefits. We will discuss the early risk mitigation approaches to reduce toxicities and better manage safety of these therapies in clinical trials.

12:10 pm Translating Therapeutic Index into Probability of Success for Clinical Drug Candidates

Patrick Y. Mueller, Ph.D., Director, Novartis Institutes for BioMedical Research

A balanced safety/efficacy profile is key for the clinical success of drug candidates. The therapeutic index is an important parameter in efforts to achieve this goal in a translational drug development setting.

Elsevier12:40 Luncheon Presentation I: A New Method to Rapidly Access “Specificity” of Selected Proteins

Thomas Van Himbergen, Ph.D., Content Researcher & Manager, Elsevier

Tremendous amount of energy is spent on researching disease specific proteins with the hope that they are useful drug targets or disease biomarkers.  Literature searches must be precise and comprehensive to support these research efforts and are time intensive.  A new approach has been developed that can quickly glean relevant information on proteins and access specificity of these across multiple diseases and or tissues, providing a rapid way to verify or create new hypotheses and research avenues.

1:10 Luncheon Presentation II: (Sponsorship Opportunity Available) or Lunch on Your Own

1:45 20th Anniversary Cake in the Exhibit Hall with Poster Viewing


Innovation in Clinical Development 

2:15 Chairperson’s Remarks

Harsukh Parmar, M.D., Vice President and Head, Translational and Experimental Medicine, F. Hoffmann La Roche

2:20 Human Target Validation and Patient-Centric, Novel Therapeutic Strategies to Improve Clinical Outcomes in R&D

Harsukh Parmar, M.D., Vice President and Head, Translational and Experimental Medicine, F. Hoffmann La Roche

R&D productivity has continued to decline despite the readout of the human genome project. We need a change in the quality and rigor of experimental methods using human clinical studies as a paradigm shift in improving the success rate of R&D.

2:50 Innovation in Clinical Trials: Theory vs. Practice

Jorge DiMartino, M.D., Ph.D., Executive Director, Translational Development, Celgene Corporation

The biomarker approach is now being fully implemented in most of the clinical development plans for oncology compounds in Celgene. We will show examples and will focus on the various methodological issues.

RemedyMD3:20 The Difference Between Generating and Understanding Research Data: Ontology-Driven Approaches to Advancing Research

Mike Cummens, M.D., CMO, Remedy Informatics

Remedy’s CMO, Dr. Michael Cummens, will demonstrate why an ontology-based registry is essential to advance your research by accelerating pattern discovery. Employing an ontology will allow you to aggregate, map, and harmonize data from disparate sources and enable intelligent queries.

Soma Logic 3:50 Never Send a Gene to do a Protein’s Job: Dissecting Biological Complexity to Impact Drug Development

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

The well-documented failures across the drug development pipeline are almost all a result of our current technological inability to understand complex biology. We present here a powerful new proteomics “scalpel” for dissecting complex and real-time biology and pharmacology in drug discovery and development. We also demonstrate multiple successful applications of this technology to understanding disease biology, validating targets, uncovering the pharmacology of new compounds, and accelerating the development pipeline. 

Singulex4:05 Establishing Clinically Relevant Biomarkers through Advanced Single Molecule Counting

Cleland C. Landolt, M.D., CMO, Singulex, Inc.

  • Singulex’s proprietary digital immunoassay technology helps to overcome challenges in the translation of biomarkers to the clinic, due to improved assay precision and sensitivity which has enabled the measurement of endogenous biomarker levels and the precise monitoring over time.
  • Review the recent development of ultra-sensitive cardiac troponin I (cTnI) as a clinically relevant biomarker for CVD risk characterization and chronic disease management.
  • Present a case study demonstrating the clinical application of ultra-sensitive cTnI.

4:20 Networking Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunities Available)

5:20 Breakout Discussions in the Exhibit Hall

6:20 Close of Day


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