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Thursday, February 4
8:25 AM Chairperson’s Remarks
Jingsong Wang, M.D., Director, Immunology, Discovery Medicine & Clinical Pharmacology, Bristol-Myers Squibb, Co.
8:30 Assessing Mechanism of Action of Anticancer Agents using Functional Imaging in Oncology Drug Development
Dana Hu-Lowe, Ph.D., Group Leader, Associate Research Fellow, Cancer Biology, Pfizer, Inc., PGRD-La Jolla
Multiple imaging modalities have helped us to gain a deeper understanding of the mechanism of action of drug candidates beyond conventional pharmacological end points used in nonclinical and clinical settings. More importantly, functional imaging modalities are providing in-depth information on the modes of action of various anti-angiogenesis agents. These learnings are vital for improving efficiency in drug development.
9:00 Animal Imaging for Translational Approaches to CNS Drug Discovery
Rudy Schreiber, Ph.D., Senior Director, Pharmacology, Discovery and Early Clinical Research
In this presentation, I demonstrate how Sepracor’s translational medicine approach for CNS drug discovery using emerging imaging methods and collaborative approaches such as cooperative technology development within a pain consortium. I’ll present animal SPECT data for our inhibitors of monoamine neurotransmitter transporters (serotonin, noradrenaline and dopamine) in rodents and non human primates (with one example of human PET): I will include also brain microdialysis data in rodents where we measured all 3 neurotransmitters, and share human data generated in a fMRI pain imaging consortium.
9:30 Image Analysis Considerations for Pre-clinical, in vivo Medical Imaging
Matthew Silva, Ph.D., Head, Imaging Sciences, Millennium, The Takeda Oncology Company
10:00 Sponsored Presentation
Standardized Solutions for Non-Invasive Imaging of Cell Trafficking
Eric T. Ahrens, Ph.D., Founder and Chief Scientific Officer, Celsense, Inc.
A limiting factor in the development of new therapies is an inability to non-invasively assay cell trafficking in vivo preclinically and in humans. In this talk Dr. Eric Ahrens will describe a unique non-invasive imaging platform for visualizing and quantifying cells in vivo using magnetic resonance techniques. This technology utilizes novel fluorine-based MRI tracer agents used to track specific cell populations or sites of inflammation in vivo. Applications include visualization and quantification of transplanted cells in immunotherapy and regenerative medicine and monitoring of inflammatory processes. Additionally, the cell labeling platform can be used as a powerful high-throughput cytometry method to rapidly assay transferred cells or inflammation within panels of intact tissue. Exemplary data using this technology as a quantitative biomarker in rodent models will be presented.
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10:30 Poster Competition Refreshment Break & Raffles in the Exhibit Hall
11:30 Biomarkers for Proof of Concept and Patient Selection
Hans Winkler, Ph.D., Senior Director, Global Head Oncology Biomarkers, Johnson & Johnson
The talk will comprise a discussion about the value of pharmacodynamic markers for proof of principle and decision making in PhaseI/II. Furthermore, the necessity and utility of predictive markers that can be applied for patient selection will be discussed.
12:00 PM Patient Selection Biomarker Approaches in Oncology
Daniel S. Johnston, Ph.D., Principal Research Scientist II, Pfizer Research and Development
This presentation will focus on the current strategies to identify patient selection biomakers in oncology. Both clinical and preclinical approaches will be discussed.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:45 Ice Cream Refreshment Break in the Exhibit Hall
2:15 Plenary Keynote Introduction
2:25 Chips, Clones and Living Beyond 100
Paul J.H. Schoemaker, Ph.D., M.B.A., Chairman and Chief Executive Officer, Decision Strategies International, Inc.; Research Director, Mack Center for Technological Innovation, The Wharton School; Adjunct Professor of Marketing, The Wharton School Adjunct Professor, Wharton School of Business
As information technologies and life sciences continue to converge, new business opportunities and challenges will arise for the field of diagnostics and beyond. This keynote reviews the deeper forces shaping the future of the biosciences, from social and economic to technological and political, including the stresses they will introduce for existing business models and healthcare. Not only will bioconvergence introduce new products, services and competitors, it may create entirely new industries on a scale larger than the computer revolution has to date. Several broad scenarios will be painted for the state of the biosciences in 2025 and the forces that might take us there, summarizing a multi-year strategy study conducted and supervised by the speaker at the Wharton school.
3:05 Refreshment Break in the Exhibit Hall
3:45 Chairperson’s Remarks
Alain Stricker-Krongrad, Ph.D., Senior Scientific Adviser, Global Business Development, Charles River
3:50 An Animal Model of Parkinson’s Disease Psychosis: Assessing Potential Therapeutic Efficacy of 5-HT2A Inverse Agonists
Krista McFarland, Ph.D., Team Leader, In Vivo Pharmacology, ACADIA Pharmaceuticals, Inc.
Available antipsychotic drugs do not provide an ideal treatment for psychosis in Parkinson’s disease (PDP) because their blockade of dopamine receptors counteracts the dopamine replacement therapy used to alleviate the motor symptoms of PD. Development of alternate pharmacotherapies is limited by the lack of an animal model. Recent efforts to develop such a model and assess the potential therapeutic efficacy of 5-HT2A inverse agonists for the treatment of PDP will be discussed.
4:20 Engineered Human-In-Mouse Tumors for Population Based in vivo Biomarker Discovery
Min Wu, Ph.D., Principal Scientist, Translational Research, AVEO Pharmaceuticals, Inc.
I will present a NEW population-based tumor model system using Human-in-Mouse tissue transgenic human tumors that feature naturally occurring tumor variation akin to that observed in human tumor populations. The goal is to identify and validate biomarkers that ultimately predict responsive versus non-responsive patient populations to guide clinical development.
4:50 Appropriate animals models for safety assessment of biologics
Timothy MacLachlan, Ph.D., Associate Director of Nonclinical Safety Assessment, Genzyme Corporation
The proper safety assessment of biopharmaceuticals has been an evolving process. While the paradigm set for small molecules was applied early, and some aspects have remained the same, other areas have required modification. The specificity of some biologics like monoclonal antibodies has necessitated study in higher order species. However, alternatives such as mice transgenic for the human target have proved useful, and at times, more accurate in risk assessment. Examples of these approaches will be discussed.
5:20 Comparative Oncology Drug Development
Melissa C. Paoloni, DVM, DACVIM, Director, Comparative Oncology Program, National Institutes of Health, National Cancer Institute
Comparative oncology is a model system to evaluate novel drugs, devices, biologics and imaging strategies in pet dogs with cancer to help inform their development for human cancer patients. Although much of this effort is preclinical, it also applies to agents that are already “first in man.” The goal behind it is to garner information to help make informed go and no-go decisions to drive human oncology clinical trial design by answering questions about PK, PD, schedule, regime, dose, toxicity and clinical outcome (to just name a few). It has been well recognized and utilized by many within the pharmaceutical industry. It also has the ability to pilot personalized medicine approaches-a key to the future of oncology drug development.
5:50 Close of Day
Short Courses | Day 1 | Day 2 | Day 3 | Download Brochure