

Short Courses | Day 1 | Day 2 | Day 3 | Download Brochure
Friday, February 5
8:30 AM Chairperson’s Opening Remarks
Pearl S. Huang, Ph.D., Integrator, Oncology Franchise, Research & Early Development, Merck & Co.
8:35 Implementing a Translational Biomarker Strategy to Reduce Attrition in Drug Development
Irina Antonijevic, M.D. Ph.D., Director, Translational Research, Biological Research, Lundbeck Research, Inc. USA
Early efforts towards the discovery of molecular biomarkers for CNS disorders are encouraging. However, confirmation, and ultimately validation of such biomarkers is dependent on state-of-the-art bioinformatics analyses as well as assay development. These prerequisites will ensure identification of biomarkers that are reproducible and hence of clinical relevance.
9:05 High Content Mining of Disease Biomarkers
Jake Chen, Ph.D., Assistant Professor, Informatics & Computer Science, Indiana University School of Informatics; Director, Indiana Center for Systems Biology and Personalized Medicine, Indiana University - Purdue University Indianapolis; Founder, MedeoLinx, Inc.
To facilitate the interpretation of raw Omics data into detailed disease-specific knowledge of candidate biomarkers, we developed a “high-content biomarker mining” software system. The system can help manage and correlate molecular functions, molecular connectivity, biological pathways, and literature information. Its application into the current biomarker development process will help improve the success rate and quality of candidate biomarkers.
9:35 Single Molecule Real Time Biology: New technologies Enabling a More Complete Characterization of Disease Biology
Eric Schadt, Ph.D., Chief Scientific Officer, Pacific Biosciencess
While there has been an explosion of technologies that enable more comprehensive characterizations of complex biological processes like common human diseases, we are still unable to glimpse a large enough fraction of the biology of these systems to build models that are predictive enough to achieve clinical utility. However, with a new wave of technologies on the horizon, providing for the capability to examine the activity of single molecules real time, we will soon be capable of generating the right scale and diversity of data (DNA sequence, RNA sequence, real time monitoring of mRNA translation, full characterizations of base modifications in genomes and transcriptomes) at low cost to dramatically enhance the construction of models for common human diseases that achieve clinical utility. I will cover the single molecule real time (SMRT) technologies from Pacific Biosciences and how these technologies will revolutionize our ability to characterize living systems, and then present a number of integrative biology approaches to taking the types of data SMRT technologies will generate to get at predictive models of disease that can be used to drive the identification and validation of drug targets and biomarkers.
10:05 Automating Biomarker Discovery and Qualification; Capturing Hypothesis, Analysis and IP Jonathan Sheldon, Ph.D., Director of Translational Medicine, IDBS
Long lists of un-annotated proteins and genes are not a sufficient end point for ‘omics analysis, they need to be annotated with data from many public and proprietary sources. IDBS provide solutions to not only automate the discovery and subsequent annotation of biomarker results, but to capture each step of the experimental set up, data capture, and analysis in a compliant manner.
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10:20 Coffee Break
11:00 Profiling Patients to Drive Biomarker Development
N. R. Nirmala, Ph.D.,Director, Biomarker Analysis and Informatics Unit, Translational Sciences, Novartis Institutes of Biomedical Research
Gene expression profiling is one of the key ways in which a genome-wide view of a patient’s response to drug treatment can be obtained. Such a molecular level view can provide strategies for customized therapies in many contexts. In this talk, the oppportunities and challenges that this technology presents will be discussed with a couple of case studies. Extension of this approach to other technologies will also be presented in the context of biomarker development.
11:30 Panel: Informatics at R&D Interphases
Moderator: Pearl S. Huang, Ph.D., Integrator, Oncology Franchise, Research & Early Development, Merck & Co.
- Linking clinical outcome with molecular data: filling the gaps
- Capturing uniform clinical language for outcomes
- Compatible and user- friendly data systems—can one size fit all?
- Disease cohorts-how many, how big, what is acceptable quality
12:00 PM Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 Chairperson’s Remarks
William B. Mattes, Ph.D., DABT; Former Executive Director, Predictive Safety Testing Consortium, Critical Path Institute
1:05Taking personalized medicine to the next level- The critical Interface between Translational Medicine and Molecular Diagnostics
Lise Kjems, M.D. Ph.D., Executive Director, Global Program DiagnosticDirector, Molecular Diagnostics Novartis
Translational Medicine has reformed our drug development paradigm. Early clinical profiling of New Molecular Entities can enable identification of subsets of patients with a unique risk/benefit profile. In this talk, the opportunities and challenges related to this identification will be discussed. The role of Molecular Diagnostics is critical in developing and integrating novel patient treatment algorithms.
1:35 Fostering Collaborations between Biotech and Academics to Speed Translational Medicine
Thomas Ichim, Ph.D., CEO, MediStem Labs, Inc.
2:05 Commercial Collaborations and other Approaches to Direct Academic Cancer Research towards Clinical Outcomes
Clive Stanway, Ph.D., CSO, Cancer Research Technology Ltd., Wolfson Institute for Biomedical Research
Cancer Research Technology (CRT) is the development and commercialization arm of Cancer Research UK (CR-UK) which has an annual science spend in excess of $500M.CRT works with CR-UK through multiple tracks to drive translational research including dedicated industry experienced, peer-reviewed funding for managed research in the PI’s laboratory or in collaboration with focused drug discovery research groups around the UK. Specific examples and outcomes of this strategy will be presented with some discussion of CRT’s flexible and creative approach to partnerships.
2:35 Development of Combination Therapies for Multiple Sclerosis Using Systems Level Informatics
Frederic S. Young, Ph.D., Chief Scientist, Vicus Therapeutics
We start with a multilevel systems physiology model that combines metabolomic analysis with integrated physiological analysis. The model is used to define a set of systems informatic features of ontogeny, phylogeny, homeostasis, and repair that distinguishes the disease state from homeostasis. We describe our use of this systems informatic signature as an algorithm for the development of combination therapies for multiple sclerosis.
3:05 Close of Conference
Short Courses | Day 1 | Day 2 | Day 3 | Download Brochure