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WEDNESDAY, FEBRUARY 25

7:15am Registration Open and Morning Coffee

8:45 Plenary Keynote Introduction 
Kathryn Lowell, Deputy Secretary, Life Sciences, California Business Transportation & Housing Agency

8:55 PLENARY KEYNOTE 
Using Molecular Medicine to do Therapeutic Development in the Network Age
Jay M. Tenenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.
A new paradigm for translational research will be described that combines the integrative and collaborative power of the Internet with personalized molecular analysis to slash the time and cost of therapy development. A key element is the creation of Health Commons, an open web-based ecosystem of researchers, clinicians, patients, pharma/biotechs, and service/technology providers that can be rapidly mobilized to develop targeted therapies for disease subclasses. This ecosystem will stimulate the same radical increase in efficiency for therapy development that ecommerce brought to business in the 1990s, ushering in a new age of collaborative, personalized medicine where every patient can afford custom therapies and discovery is driven by collectively interpreting the outcomes across all patients.

9:40 Grand Opening Refreshment Break in the Exhibit Hall

TRANSLATIONAL MEDICINE INITIATIVES AT BIG PHARMA

11:00 Chairperson’s Remarks
Chairperson: Christopher-Paul Milne, D.V.M., M.P.H., J.D., Tufts University 

11:10 Translational Medicine: Where Are We Going? How Will We Get There?
Christopher-Paul Milne, D.V.M., M.P.H., J.D., Associate Director, Tufts Center for the Study of Drug Development, Tufts University
Translational Medicine is the communication channel that flows from researcher goals upstream in the R&D continuum to patient needs at the other end, covering territory popu-lated by a varied and complex set of interactions and interdependency. The achievements of translational medicine depend on the perception and purpose of those who have set it in motion as an essential vehicle for moving the R&D paradigm toward a more patient-centered focus. This presentation examines several TM initiatives to look at who’s doing what and how it’ll change the process and products of R&D. 

11:40 Questions, Answers, Decisions: A Systematic Translational Research Approach
Erik D. Sprengers, Ph.D., M.D., M.B.A., Site Head, SPRI Singapore; Head, Translational Medicine Research Centre Singapore, Schering-Plough
Translational Research in the pharmaceutical industry is an approach to reduce pipeline attrition. At Schering-Plough we implemented a simple tool that is used from early Lead Optimization to guide the R&D teams and management in their translational approaches. Basic questions about target engagement, target modulation, downstream pharmacol-ogy, clinical effects, and patient stratification, need to be addressed. Case by case, R&D teams need to find and apply the right biomarker approaches to get reliable answers to these questions, which will result in reliable go/no-go decisions.

Sponsored by

12:10  Biomarker Validation in Translational Medicine: in vitro Model to Human
Michael Ford, Senior Scientist, NextGen Sciences 
An in vitro model system of metastatic cancer was employed for the discovery of biomarkers for new compounds efficacy as well as putative biomarkers for various stages of cancer in humans. A pMRM multiplexed assay was developed for the quantitation of 20 proteins as biomarker candidates for metastatic disease. The assay was utilized to validate these biomarkers in the cell model system for testing compounds and was applied to human plasma samples obtained from normal volunteers and patients with various stages of lung cancer.

12:40 Expert Panel: Translational Medicine Best Practices
Panel Moderator: Christopher-Paul Milne, Tufts University

Panelists:
Christopher-Paul Milne, Tufts University
Erik Sprengers, Schering-Plough
Gerhard Wolff, Roche

1:10 Walk & Talk Luncheon in the Exhibit Hall

EVALUATING AND IMPROVING PRE-CLINICAL MODELS: ARE THEY PREDICTIVE OF HUMAN RESPONSE?
(Shared with Preclinical Drug Safety Track)

2:15 Chairperson’s Remarks 
Chairperson: Vivek Kadambi, Ph.D., Senior Director, Millennium Pharmaceuticals

2:20 Can Studies of Animal Idiosyncratic Drug Toxicity Break the Unpredictability Log Jam for Human Serious Adverse Reactions?
John R. Senior, M.D., Associate Director for Science, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration
It’s believed that serious idiosyncratic adverse drug reactions in patients aren’t discovered in preclinical animal studies because they’re very rare, not predictable or dose-related and occur only in humans who are genetically extremely diverse. However, an increasing number of findings challenge these beliefs. This presentation uses drug-induced liver injury (DILI) as a model to elucidate why certain individual animals differ in response to the same dose-duration of drugs, which may allow earlier detection of rare human adverse drug toxicity. 

3:00 How Well do Animal Models Predict Adverse Effects in Humans?
Vivek Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, Millennium Pharmaceuticals

3:40 Predictive Preclinical Cardiosafety Assays
Martin Traebert, Ph.D., Head, Safety Pharmacology EU, Translational Sciences, Novartis Institutes for BioMedical Research
Drug-induced long QT syndrome and potential cardiac arrhythmia are a major concern for patients, regulators and the pharmaceutical industry. Thus the preclinical identification of a potential cardiosafety liability needs to be addressed very carefully by a variety of in vitro and in vivo assays with increasing complexity. The most important assays (receptor binding studies, hERG electrophysiology, isolated cardiac tissue/organs and in vivo ECG recording) will be presented and discussed. 

4:20 Reception in the Exhibit Hall

5:00 Breakout Discussions in the Exhibit Hall 
Evaluating and Improving Pre-Clinical Models 
Moderator: Vivek Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, Millennium Pharmaceuticals

• How predictive are animal models of human response?

• What are the “validation” criteria for animal models?

• What assays can be done in in vitro models?

• How can human adverse reactions be predicted?

• How to address variability in animal models?

Optimizing Translation to FIH Studies 
Moderator: Kailash Swarna, Ph.D., Executive Director, Research & Development, Amgen, Inc.

• How predictive are pre-clinical models of human response?

• What are the effective dose selection strategies?

• What are the roles of biomarkers in FIH studies?

• What technologies are most useful in optimizing translation to FIH studies?

Biomarkers for Go/No-Go Decision Making 
Moderator: Hans Winkler, Ph.D., Senior Director, Global Head, Oncology Biomarkers, Ortho Biotech Oncology R&D, a Division of Janssen Pharmaceutical, Johnson & Johnson

• 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? 

• Where is the value of using biomarkers in decision making?

6:00 Close of Day One

Overview | Day 1 | Day 2 | Day 3 | Download Brochure| Breakout Discussions

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