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FRIDAY, FEBRUARY 27

ROI ON BIOMARKERS AND ENABLING 
TECHNOLOGIES IN TRANSLATIONAL MEDICINE

8:30am Chairperson’s Remarks
Chairperson: Stephen H. Friend, M.D., Ph.D., Senior Vice President, Franchise Head, Oncology, Merck Research Laboratories, Merck & Co., Inc. 

8:35 Examining the Scale and Scope of Tools and Programs to Navigate in Translational Oncology Space: Lessons Learned
Stephen H. Friend, M.D., Ph.D., Senior Vice President, Franchise Head, Oncology, Merck Research Laboratories, Merck & Co., Inc. 

9:05 Integration of Predictive Biomarker Strategies in Oncology Drug Development
Mitch Raponi, Ph.D., Principal Research Scientist, Biomarkers, Centocor Research & Development, Inc., Johnson & Johnson
All currently approved companion diagnostics directly test the status of the drug target. However, the emergence of advanced technical platforms such as genome wide expression profiling is enabling the generation of genomic-based signatures that reflect the activity of signaling pathways down-stream of the targeted molecule. Identification of a molecular predictor of response to a farnesyltransefrase inhibitor will be presented to highlight the challenges and opportunities of integrating genome-wide approaches for the development of predictive biomarkers in oncology drug development.

9:35 To be Announced

10:05 Coffee Break

11:00 Expert Panel: Biomarkers for Go/No-Go Decision Making
Panel Moderator: Stephen H. Friend, M.D., Ph.D., Senior Vice President, Franchise Head, Oncology, Merck Research Laboratories, Merck & Co., Inc. 

Panelists: 
Mitch Raponi, 
Stephen Friend, Merck & Co. 
Lin Wu, Roche

• Has there been sufficient ROI on biomarkers and enabling technologies in drug development? How is ROI estimated and measured?
• Which types of biomarkers should be developed at various stages in the drug pipeline?
• What strategies help translate biomarkers from preclinical to clinical development?
• What type of biomarker data should lead to terminating a target or a compound? What type of data should lead to increased investment in a compound?
• How should biomarker data be weighed against “traditional” safety and efficacy data? Can “general” toxicity biomarkers be re-used across programs?
• What level of validation is required for which types of decisions?
• What regulatory guidance is needed?
• How to manage risk in biomarker development? What validation and monitoring practices should be in place?
• Where is the value of using biomarkers in decision making? What is the cost of mistakes? Which biomarkers are the highest-value or highest-risk?
• What are the current obstacles in biomarker implementation?
• What translational strategies enable more efficient implementation of personalized medicine?

12:00pm Luncheon Presentation (Opportunity available) or Lunch on your own

ROLE OF SYSTEMS BIOLOGY IN TRANSLATIONAL MEDICINE: IS IT FEASIBLE AT BIG PHARMA?

1:00 Chairperson’s Remarks
Chairperson: Stephen Naylor, Ph.D., Chief Executive Officer, Predictive Physiology & Medicine, Inc.

1:05 Translational Medicine and Pharma: More Measurement or Knowledge Management?
Stephen Naylor, Ph.D., Chief Executive Officer, Chairman, Predictive Physiology & Medicine, Inc.
It might be argued that the bench-to-bedside description often applied to Translational Medicine is also applicable to current pharmaceutical industry practice. Clearly this is not the case, particularly in light of Lean’s definition that Translational Medicine is “the process which leads from evidence based medicine to sustainable solutions for public health problems.” Translational medicine requires basic research tools, individual and population measurements as well as sophisticated knowledge management capabilities. We’ll discuss how systems biology tools address these issues and their application in the pharmaceutical sector. 

1:35 How Systems Biology Can Enable Translational and Individualized Medicine 
Keith Elliston, Ph.D., President & Chief Executive Officer, Genstruct, Inc.
The development of novel therapeutics increasingly relies upon the ability of pharmaceutical companies to leverage preclinical models for clinical applications. The identification of biomarkers for clinical trials is one key application. This talk will focus on the translation of preclinical models to develop mechanistic biomarkers for clinical applications.

2:05 Systems Biology in Translational Medicine: Parallel or Orthogonal to Pharma’s Needs?
Michael N. Liebman, Ph.D., Managing Director, Strategic Medicine, Inc.
Although much progress continues to support the development and implementation of new technologies in systems biology, its role in translational medicine has not yet evolved to maturity. This is further complicated by the conventional association of translational medicine with the movement of academic research into clinical application. The critical missing link is a focus on the needs of the patient and clinician as the principal drivers for the research. Pharma remains caught in the middle, needing to improve the transla-tion of therapeutics (and diagnostics) into clinical utilization while maintaining patient safety and efficacy. 

2:35 Translational Systems Biology: Bridging Gaps for Genome Medicine 
Jake Chen, Ph.D., Assistant Professor, Informatics, Indiana University; Computer Science, Purdue University; Director, Indiana Center for Systems Biology and Personalized Medicine; Chief Executive Officer, MedeoLinx, LLC 
In translational systems biology, there is an emerging demand for building multi-scale disease-relevant molecular network and pathway models to shorten the gap between drug discovery research and biomedical applications. We demonstrate how computational systems biology techniques and tools could be developed to address translational medicine problems. C-maps is a new application software tool that integrates network data mining and literature data mining. 

3:05 Close of Conference

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