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Recommended Pre-Conference Short Courses *
(SC3) Best Practices in Translational & Personal Medicine
* Separate Registration Required.
7:00 am Registration and Morning Coffee
8:00 Plenary Keynotes - Details
9:40 Grand Opening Refreshment Break in the Exhibit Hall
KEYNOTE SESSION: TRANSLATIONAL SCIENCE
11:00 Chairperson’s Opening Remarks
11:10 The Role & Promise of the Translational Scientist in Current Drug Development
Michael Cooreman, M.D., Vice President, Translational Medicine, Biological Sciences, Takeda Global Research & Development Center, Inc.
The Translational Scientist in Drug Research and Development brings together understanding of the biology of human disease, interaction of the investigational compound with target pathways and corresponding relevant animal models of disease into an integrated TM strategy, applying state-of-the art technology and study design, resulting in a mechanism-of-action guided R&D program up to clinical proof on concept, the demonstration of biologically meaningful therapeutic efficacy. In this cross-functional activity, Translational Science/Medicine has the promise to increase confidence in data and information based decision making for discontinuation or investment in full development.
11:40 Translatability Assessment and Proof-of-Concept Planning: Understanding Risks & Opportunities
Martin Wehling, M.D., Managing Director, Institute for Experimental and Clinical Pharmacology and Toxicology, Director, Clinical Pharmacology Mannheim Medical Faculty, Mannheim Ruprecht-Karls-University Heidelberg
‘Translational medicine’ has the negative connotation of a fashionable phrase. To realize its valuable claims, translational processes need to be based on robust methods regarding biomarker development and predictivity assessment, biostatistical methods, smart and accelerated early human study designs, integration of clinical data and decision algorithms. Systematic translatability assessment increases the reliability of portfolio risk estimates.
12:10 pm How Can We Succeed at Translational Science? A Consideration of Various Strategies
Lucienne Ronco, Ph.D., Global Director, Discovery Medicine/Translational Sciences, Oncology, AstraZeneca
Successful integration of translational science (TS) into drug discovery requires iterative and intimate alignment of drug hunters, clinical disease experts, biomarker and molecular technical experts, and alliance and regulatory partners. Numerous organizational models exist; what works and why? Oncology case studies will be presented illustrating successful incorporation of TS from target selection through to Phase II.
Sponsored by12:40 Luncheon Presentation I
Tumor Segregation Panels: FFPE RT-PCR Assays for Molecular Sub-Typing and Rapid Companion Diagnostic DevelopmentDaniel R. Rhodes, Ph.D., CEO and Co-Founder, Compendia Bioscience
Derived from a meta-analysis of more than 25,000 clinical tumor samples and optimized to perform with formalin-fixed specimens, Tumor Segregation Panels™ measure the key molecular variables of 14 major cancer types. This measurement enables correlation with drug response data to identify highly specific companion diagnostics on an existing go-to-market validated platform. During this presentation, case examples from breast cancer and colon cancer will be presented.
1:10 Luncheon Presentation Sponsored by
IIStrategic Partnering to Increase the Speed and Efficiency of Drug Discovery and DevelopmentThomas Turi Ph.D., Vice President Science & Technology, Covance Discovery & Translational Services, Head Biomarker Center of ExcellenceEffective discovery and translational medicine strategies require significant investment ranging from experienced staff to appropriate adoption of emerging technologies. Strategic partnering can offer efficiencies in: reduced administrative handling, access to experienced scientists and emerging technologies. This talk will explore the changing landscape and pressures of translational medicine and suggest ways to address the pressures of increased speed and efficiency in drug discovery and development through strategic partnering.
1:45 Dessert in the Exhibit Hall
2:15 Chairperson’s Remarks: Theresa LaVallee, MedImmune
2:20 Found in Translation – What and How to Establish Effective Science Driven Drug Development
Theresa LaVallee, Ph.D., Director, Research & Development, MedImmune
2:50 An Academic Model of Translational Science
Michael Kalos, Ph.D., Director, Translational and Correlative Studies Laboratory, University of Pennsylvania School of Medicine
It is becoming increasingly apparent that biomarkers drive in a fundamental manner translational and clinical research. Accordingly, the appropriate development of biomarkers is fundamental to the success of the translational studies. In this presentation we will discuss approaches to support the appropriate development of biomarkers, focusing on three elements; 1) quality, 2) comprehensiveness, 3) and integratability of data sets.
3:20 Creating a Translational Science Program: Lessons Learned
Doina Roman, M.D., Senior Medical Director, Translational Medicine,Takeda Global Research & Development Center, Inc.
This talk will describe the journey of Takeda Global Research & Development Center to implement a translational science program into their drug discovery and development. Examples of methodologies & strategies that do and do not work will be presented, as well as the role of the translational science team within an organization.
3:50 Enterprise Translational Medicine: It’s a Kind of MagicPaul Denny-Gouldson, Ph.D., VP Translational Research, IDBSThe convergence of life science research and medicine is leading to more personalised healthcare. This means organisations need to implement advanced clinical research information systems (ACRIS) that are able to bring together clinical, molecular and imaging data to support translational research. ACRIS architectures typically have a research data repository (RDR) that is separate from medical record systems and is designed to answer scientific questions and assess patient outcomes. Collaborative Web based access to RDR’s enable clinical data to be browsed and patient cohorts to be easily created by clinicians and researchers. Critically, sample, molecular and research results also stored in the RDR can be used to stratify the patient cohorts. This presentation will detail key lessons learned in designing and developing ACRIS-type systems for oncology, cardiovascular and neuroscience disease areas; it will also look at technical challenges of clinical data ETL and terminology mapping, pseudonymisation, coping with large data sets such as Next Gen Sequencing (NGS) and cloud based deployment.
4:20 Reception in the Exhibit Hall
5:20 Breakout Discussions in the Exhibit Hall
The Role of Correlative Studies in Translational Medicine
Moderator: Michael Kalos, Ph.D. Director, Translational and Correlative Studies Laboratory, University of Pennsylvania School of Medicine
Keys to Creating a Win-Win Collaboration
Moderator: Christopher Milne, Ph.D., Associate Director, CSDDR; Assistant Professor, Public Health & Community Medicine, Tufts University Medical School
•Hear about ways to identify partner opportunities and how to promote your own partnering potential
•Discuss the “wish list” for an ideal academic-industry collaboration and the initial “must-have” list for go/no-go
•Consider how to foster the right environment within your research unit as well as broader organizational support necessary for collaboration
•Learn how to both protect and share what you bring to a collaboration (IP, expertise, etc.)
Imaging as a Co-Developed Diagnostic to Meet FDA Standards
Moderator: Rikki N. Waterhouse, Ph.D., Senior Group Leader, Cancer Imaging and Radiochemistry, Advanced Technology, Global Pharmaceutical Discovery, Abbott
Overcoming Roadblocks to Personalized Medicine
Moderator: Bruce H. Littman, M.D., President, Translational Medicine Associates, LLC
How can advances in molecular definition of disease, biomarker technologies and known targeted drug mechanisms be more rapidly translated into individualized treatment paradigms for existing marketed drugs?
• Academia and non-industry sponsored research, e.g. N.I.H.
• Industry-sponsored research
• Regulatory agencies such as F.D.A.
• Patient advocacy groups
• Diagnostics companies
• Case control studies
• Prospective outcome studies
• Health economics
• Comparative effectiveness
• Retrospective analyses of completed studies
• Biorepositories and database informatics
• Commercial opportunities
• Intellectual property
Concurrent Problem Solving Break-Out Sessions are interactive, problem solving discussions hosted by a moderator to discuss a topic in depth. The discussions are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners. Please click on Break-Out Discussions box to pick a topic of your choice and join in.
6:20 Close of Day
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