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

 

Day 1 | Day 2 | Day 3 |  Download Brochure 

Wednesday, February 12

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


8:00 Plenary Keynote Session (Click Here For More Details)  


9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall


CLINICAL AND TRANSLATIONAL BIOMARKERS 

10:35 Chairperson’s Remarks

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

10:40 Making Use of “Big Data”: Identification and Modelling of Critical States in Disease Progression on the Example of Chronic Myeloid Leukemia

Andreas Schuppert, Ph.D., Vice President, Technology Development, Bayer Technology Services GmbH; Professor, AICES, RWTH Aachen University

Biomarker identification for prediction of benign to malignant disease states from multivariate data leads to a high ambiguity. We demonstrate on the example of CML that a combination of appropriate Systems Biology disease models and pattern recognition enables a significant improvement. It enables classification of risk of patients in the benign phase for crossover to the malignant accelerated phase. Extension to other diseases showing benign-malignant state transitions will be discussed.

11:10 Translational Science and Predictive Biomarkers for Multiple Receptor Tyrosine Kinase Inhibitor

Yasuhiro Funahashi, Ph.D., Senior Director, Biomarkers and Personalized Medicine, Eisai

Success of molecular targeted agents like crizotinib in lung cancer accelerated development of novel anticancer agents to specific cancer driver genes. Next-generation sequencing promotes rapid progress of molecular profiling and continuously identifies novel gene alterations to be targeted. However, molecular profiling simultaneously reveals that many cancers are not caused by single driver mutation and accumulated alterations in selected signaling pathways may be more responsible to tumorigenesis in subgroups of cancers. There are increasing needs to identify biomarkers to predict antitumor activity especially for anticancer agents targeting tumor microenvironments as are the angiogenesis inhibitors. A systematic approach utilizing pharmacologic and pharmacogenomics data are keys to make important advances. In this presentation, we will introduce our research to identify predictive biomarkers for an investigational inhibitor of multiple receptor tyrosine kinase in preclinical and clinical settings based on a systems biology approach.

11:40 Translating Biomarkers into Companion Diagnostics

Philip Brohawn, Manager, Research & Development, Translational Science, MedImmune

Utilizing current regulatory guidance as a framework, this talk will navigate the process of development of a companion diagnostic. Covering a full breadth of topics from proper implementation of markers in clinical design to proper execution of assay validation, case examples will be utilized to provide a practical frame of reference for translating clinical biomarkers into companion diagnostic tests.

12:10 Enjoy Lunch on Your Own

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

1:40 Chairperson’s Remarks

1:45 From Molecular Snapshots to Molecular Symptoms: Towards Precision Medicine with Integrative Personal Omics Profiles

Rui Chen, Ph.D., Postdoctoral Scholar, Genetics, Stanford University

2:15 NOTCH Gene Rearrangement as a Biomarker for Response to GSI Therapy in Breast Cancer

Serguei Lejnine, Ph.D., Associate Director, Merck Research Labs

NOTCH gene translocation resulted in copy number variation between the exons encoding the N-terminal and C-terminal regions of NOTCH. NOTCH translocations were prevalent in the triple negative sub-type (TNBC) of breast cancer (6/66). TNBC cell lines and xenografts with NOTCH translocations are remarkably sensitive to treatment with the gamma-secretase inhibitor (GSI) MRK-003.

2:45 Panel Discussion: Biomarker Utility in Accelerating and De-Risking Drug Development

Moderator:

Serguei Lejnine, Ph.D., Associate Director, Merck Research Labs

Panelists:

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

Philip Brohawn, Manager, Research & Development, Translational Science, MedImmune

Andreas Schuppert, Ph.D., Vice President, Technology Development, Bayer Technology Services GmbH; Professor, AICES, RWTH Aachen University

3:45 Refreshment Break


FROM BIG DATA TO TRANSLATIONAL INFORMATICS 

4:00 Chairperson’s Remarks

Shoibal Datta, Ph.D., Director, Data Sciences, Biogen Idec

4:05 Designing and Building a Data Sciences Capability to Support R&D and Corporate Big
Data Needs

Shoibal Datta, Ph.D., Director, Data Sciences, Biogen Idec

To achieve Biogen Idec’s strategic goals, we have built a cross-disciplinary team to focus on key areas of interest and the required capabilities. To provide a reusable set of IT services we have broken down our platform to focus on the Ingestion, Digestion, Extraction and Analysis of data. In this presentation, we will outline how we brought focus and prioritization to our data sciences needs, our data sciences architecture, lessons learned and our future direction.

4:35 Translational Informatics: Decomposing to Singularity

John Shon, M.D., Head, Translational Informatics IT, Johnson & Johnson

There has been an explosion of data across discovery, development, and beyond and all informatics groups are struggling with major challenges in computation, storage and analysis. In a large pharmaceutical environment, the value propositions of informatics lie primarily in three dimensions which I describe. In the larger hyperdynamic environments of research technologies, information technologies, and modern science, interdisciplinary and collaborative approaches become imperative to execute translational strategies effectively.

5:05 Integrating Translational Research Tools

Erik Bierwagen, Ph.D., Principal Programmer Analyst, Department of Bioinformatics, Genentech, Inc.

This talk will cover our efforts at creating an integrated informatics system for animal studies from birth to death and beyond. Our efforts span many different disciplines and groups, but share the common effort of integrating data seamlessly.

5:35 Close of Conference Program



Day 1 | Day 2 | Day 3 |  Download Brochure 

 

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2015 MMTC Final Agenda 

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