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MAIN CONFERENCE

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
Therapy Development in a Networked World
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

KEYNOTE PERSPECTIVE

11:00 Chairperson’s Remarks 

11:10 Challenges and Opportunities in 21st Century Safety Testing 
William B. Mattes, Ph.D., D.A.B.T., Director of Toxicology, The Critical Path Institute

• The “-omic” technologies will truly bear fruit as a means for discovering, translating, and confirming novel biomarkers and safety testing approaches 

• 21st Century safety testing will rediscover itself as “Translational Toxicology”, i.e. translating findings in animal studies to measurable risks in humans through the use of novel, translational, non-invasive biomarkers

• Regulatory agencies will play a much more engaged and important role in shaping and approving new safety testing strategies

CARDIOVASCULAR SAFETY EVALUATION 

11:40 Cardiotoxicity Screening: Cardiomyocytes and Engineered Cell Lines
Craig T. January, M.D., Ph.D., Professor, Division of Cardiovascular Medicine, University of Wisconsin-Madison
This presentation focuses on cardiotoxicity approaches that couples engineered cell lines and stem cell derived cardiomyocytes with multiple screening methods. Electrophysiologic, biochemical and immunohistologic modalities will be discussed.

12:10pm What is Acceptable Cardiotoxicity Risk for a Preclinical Small Molecule Drug Candidate
Shayne Gad, Ph.D., Gad Consulting
The range of potential mechanisms of drug cardiotoxicity will be considered with examples - it isn’t just QTc anymore. The components of a cardiovascular risk/therapeutic benefit matrix for a new pharmaceutical as well as more effectively identifying and quantifying cardiovascular risk in the nonclinical phase will be discussed.

1:10 Walk & Talk Luncheon in the Exhibit Hall

EVALUATING AND IMPROVING PRE-CLINICAL MODELS: ARE THEY PREDICTIVE OF HUMAN RESPONSE?
(combined with Translational Medicine Track)

2:15 Chairperson’s Remarks 
Vivek Kadambi, Ph.D., Senior Director, Drug Safety Evaluation, 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 
Accelerating Technology Adoption in Preclinical Drug Safety
Moderator: Jack Reynolds, DVM, Chairman of the Advisory Board, The Drug Safety Executive
Council 

• How much does the 'Not Invented Here' mentality inhibit new technology assessment/implementation in your organization?

• What can be done to lower the barriers for new technology or novel platform adoption? 

• Can we simplify the technology evaluation process?

• Collaborative projects - is this the solution?

Animal Models and Idiosyncratic Toxicity
Co-Moderators: John R. Senior, M.D., Associate Director for Science, Offi ce of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration; and 
Paul B. Watkins, M.D., Director of Hamner/U.N.C. Center for Drug SafetyScience, University of North Carolina at Chapel Hill

• Should current animal testing focus on outliers rather than mean responses (as is the case in assessing toxicity in clinical trials)

• What is the potential of various animal models proposed to mimic idiosyncratic adverse drug reactions (eg. genetically modified mice, panels of inbred but genetically diverse mice)

• Are these efforts just killing more harmless drugs?

Translational Safety Biomarkers
Moderator: William B. Mattes, Ph.D., D.A.B.T., Director of Toxicology, The Critical Path Institute

• Recently the FDA and EMEA have qualified seven new biomarkers for sensitive detection of drug-
  induced kidney injury. How do other safety biomarkers, applicable both in a non-clinical and in a clinical setting, improve the progression of candidates in drug development from discovery through clinical studies?

• What other approaches and technologies may be applied for addressing safety issues at the preclinical-Phase 1 interface?

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?

Cardiotoxicity Assays for Preclinical Screening
Moderated by: Craig T. January, M.D., Ph.D., Professor, Division of Cardiovascular, Medicine, University of Wisconsin-Madison
Blake D. Anson, Ph.D., Director hERG Screening Services, Cellular Dynamics International, Inc

• limitations of current assays

• new technologies on the horizon

• adopting new technologies into your screening programs

6:00 Close of Day

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

For sales information, contact:
Carol Dinerstein
Tel: 781-972-5471 
email: Dinerstein@healthtech.com 
OR
Jon Stroup
Tel: 781-972-5483
email: jstroup@healthtech.com