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Register
by August 4th and SAVE up to $350!
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Day Two:
Thursday, November 2, 2006
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7:45 AM Morning Coffee
(Breakfast Workshop Sponsorship Available)
8:00
Day One Synopsis and Opening Remarks
Mark Uehling, Senior Science Editor, BioIT World
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PRESENTATION |
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8:15 IT Frameworks for Biomarker Discovery Data Management and Integration
Gary K. Mallow, Ph.D., Director, Research Information Services, Merck & Co., Inc.
Manual or semi-automated approaches to capturing, processing, analyzing, integrating and publishing biomarker discovery data are not viable, given the ever increasing number data points and relevant modalities, quality control demands, complex pre-analysis processing workflows, and robust, across modality, query and reporting needs. Standards-based systems, maximizing the use of
commercial-off-the-shelf products, provide the opportunity to automate handling of data from proteomics, imaging, etc. When custom components are required to fill the gap between commercial solutions and full automation, careful use of object-oriented approaches to software development and frameworks for supplying application services can and do provide complete, tightly integrated, automated solutions.
- Learn how to apply process modeling and agile development to create usable and supportable systems
- Understand the characteristics of a successful framework for data integration in a global corporate setting
- Get practical guidance on setting expectations for the degree of automation feasible in today's
environmen
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Building an Effective and Compliant
Network for Data Sharing
Chairperson: Charles Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel Americas, Inc.
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8:45 Interoperability of Clinical Trials Systems in the Cancer Biomedical Informatics Grid (caBIG)
Peter A. Covitz, Ph.D., Chief Operating Officer, National Cancer Institute Center for
Bioinformatics
The National Cancer Institute has undertaken a nationwide effort to develop, distribute, and support adoption of information technologies and systems for the management, conduct and reporting of clinical trials. This effort is part of the larger caBIG program that seeks to create a world wide web of cancer research information.
- Governance and organizational structure of the national program
- Approach to development and adoption of data and technology standards
- Implementation of standards in clinical trials systems
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9:15 The BRIDG Project: A Shared Model of the Semantics of Clinical Trials Research
Douglas B. Fridsma, M.D., Ph.D., F.A.C.P., Center for Biomedical Informatics, University of Pittsburgh Cancer Institute
In this session, we will describe the BRIDG project, a collaborative effort of pharmaceutical, academic, and standards organizations to define the common semantics of concepts and activities that support clinical trials research. The BRIDG model is a formal representation of the semantics of clinical trials research, a means of bridging existing interoperability standards, a community of stakeholders contributing to a common representation, and a framework for constructing interoperable, standards-based applications and interchange specifications. Specifically, this presentation will
- Describe the challenge of "semantic interoperability" in clinical trials research
- Review the history and motivation of the BRIDG project to support semantic interoperability in clinical trials research
- Provide an overview of the current stakeholders, organizational structure, and development initiatives within the"
BRIDG project
- Suggest ways that individuals or organizations can engage in the project to support their need for interoperability
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| 9:45 Networking Coffee Break (Sponsorship Available)
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10:15 Clinical Trial Registries: Informing Stakeholders and Increasing Transparency
Charles Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel Americas, Inc.
All stakeholders in clinical research are seeking better solutions to enhance information sharing and improve transparency of clinical trials. Globally, efforts are underway from sponsors, journal publishers, trade organizations, regulatory authorities and standards development bodies. Many are calling for a single solution that supports the needs and interests of these disparate parties. Improvement in research quality and safety can be realized if these ends are met.
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Understand the regulatory requirements for trial registries and how a single standard may overcome the inherent conflicts and challenges
- Learn the objectives and potential solutions developed under
the auspices of the World Health Organization
- Recognize the opportunities provided by bringing the global
requirements under and single, open-standards organization
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10:45 CDISC: A Case for Standards in Research and Healthcare
Rebecca D. Kush, Ph.D., Founder and President, Clinical Data Interchange Standards Consortium (CDISC)
The value of rapid, accurate and seamless exchange of information is increasing dramatically as we rely more and more on computer applications. Standards to enable such exchanges among stakeholders in biomedical research have been established through the work of the global, non-profit organization, Clinical Data Interchange Standards Consortium (CDISC). There is also interest in exchanging information between healthcare and research systems. Those involved in biomedical research will:
- Understand the business case for data interchange standards from protocol design through reporting results or regulatory
submission
- Build awareness of the production standards that are now available and those that are in progress
- Comprehend various means of implementation of the standards in different areas of the drug development and protocol-driven
research processes
- Learn about CDISC collaborative work with other organizations,
including Health Level Seven (HL7), the World Health
Organization (WHO), regulatory authorities and more.
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11:15 Integration and Management of
Diverse Clinical Trials and Mechanistic Data, Through an Ontology-Driven
Knowledge Management Approach
Dave Parrish, Executive Director of Informatics, Immune Tolerance
Network
The Immune Tolerance Network (ITN) was established to design,
implement and evaluate clinical trials focused on the induction and
maintaining the state of immune tolerance in a variety of clinical areas,
with the additional mandate of elucidating the pathways and mechanisms
involved. To that end, we have established a knowledge management system
that creates a machine readable representation of each study from a
controlled and curated ontology. This representation configures and is
instantiated by both the transactional workflow and process automation
approach for specimen and patient tracking and the data warehouse strategy
for dynamic reporting and integration of clinical observations with
mechanistic assay results. Components to be discussed:
- Ontology design and creation of a study representation using Protégé as an ontology editor
- Configuration of a patient and specimen tracking
workflow engine based on the study representation
- Web-based trial and assay core management tool
- Visualization engine
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11:45 Networking Luncheon
Strategic Opportunities in Cancer Research
Thomas J. Hudson, M.D., President and Scientific Director, Ontario Institute for Cancer Research
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Sponsored by
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Designing Trials of the Future
Chairperson: David S. Lester, Ph.D., New York Site Head, WorldWide Clinical
Technology, Pfizer Inc.
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1:00 Adapting to Adaptive Trial Designs: Responding to the Call in Oncology
Peter F. Lebowitz, MD, Ph.D., Director, Discovery Medicine -
Oncology, GlaxoSmithKline
Adaptive study designs are increasingly employed in early clinical development to: interrogate novel compounds with less bias; explore a wider breadth of questions within single trials; and accelerate clinical development. Examples where novel adaptive study designs have been employed to facilitate the development of oncologic therapeutics will be presented. We will discuss both successes and less-than-successes of this evolving approach. |
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1:30 Accelerating Innovation in Medical Product Development to Improve Clinical Outcomes: C-Path’s Programs Addressing the FDA Critical Path Initiative
Ellen G. Feigal, M.D., Director, Medical Devices and Imaging, The Critical Path Institute
Modernizing the medical product development toolkit to take advantage of recent scientific and technological advances must occur to accelerate the development of more effective and safer medical products. The FDA Critical Path Initiative points out that the research and development costs for medical products continues to rise; however, the number of new molecular entities submitted to the FDA has markedly declined, success rates for moving from the first in human studies to regulatory approval and clinical application has declined, and post-market safety remains a concern. The reasons are complex, and there is not a single solution; there will be multiple ways to change and optimize the system. Technologies including molecular imaging, gene expression profiling, and genetic tests are emerging as critical tools to change this landscape. In this presentation, examples will be given of unique public-private partnerships utilizing these technologies to inform drug development, patient selection, dosing and evaluation of efficacy and safety. |
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2:00 Reducing the Exposure of Patients in Trials to Ineffective Therapy Using the Bayesian Approach
Donald Berry, Ph.D., Professor and Chair of the Department of Biostatistics and Applied Mathematics, University of Texas M. D. Anderson Cancer Center
I will describe recent Bayesian innovations in the design and analysis of clinical trials. The goals are (i) more efficient clinical trials and clinical development programs, and (ii) treating patients more effectively, both those in and those outside of trials. Recent innovations in clinical trial designs have been effected at the University of Texas M. D. Anderson Cancer Center, in national oncology studies and in pharmaceutical and medical device industry-sponsored trials. I will provide background on Bayesian designs for clinical trials and give case studies of the Bayesian adaptive approach used in actual designs and analyses presented to the FDA. Examples include the possibility of early stopping, seamless phases II and III trials with sequential sampling, using early endpoints to guide sample size and early stopping, and dose finding. The cost savings of such an approach are usually substantial. The treatment benefits can also be great.
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| 2:30 Refreshment Break (Sponsorship Available)
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3:00 Imaging CRO Services for Drug Development: Get the Picture!
Douglas L. Arnold, M.D., Professor, Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, and NeuroRx
Advances in imaging the CNS, particularly using magnetic resonance imaging (MRI), now make it possible to measure structural changes, for example in the size of the brain, to “within a hair’s breadth”, to detect subtle foci of inflammation or cellular infiltration, and to obtain pathologically specific information on the integrity of individual cellular components, such as neurons and myelin. Thus, imaging offers a wealth of markers for assessing drug efficacy that are only just beginning to be exploited. An imaging CRO must be familiar with the strengths and limitations of the imaging being performed, as well as the pathophysiology of the disease under study in order to properly advise on how images should be acquired, what outcome measurements should be made, and when images should be acquired. The CRO should then be able to supervise the implementation of standardized imaging sequences at clinical sites, and collect the original, digital image data for central analysis. Not all measurements are created equal! Manual intervention introduces subjectivity and variability that can be substantially reduced with the proper use of advanced image processing techniques. An imaging CRO should be able to provide image processing that maximizes objectivity, accuracy and precision, while at the same time providing appropriate project management, client focus, and regulatory compliance.
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3:30 Drug Development Decisions: Maximize Value through Decision
Analysis Methods
Vish Viswanathan, Ph.D., Director, Decision Analysis, Johnson & Johnson Pharmaceutical R&D
Drug development involves a series of phased investments and decisions involving multiple alternatives. Phase 2a or proof-of-concept phase is critical in making the decision regarding full development. Learning from imperfect information through Bayesian analysis is an important part of good decision making. Early trials should be designed to maximize the value of information. Using examples drawn from experience, this presentation will frame the basic model and draw some useful insights on managing risk through good clinical trial strategies and the trade-offs involved in decision-making. |
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4:00 INTERACTIVE PANEL
- Increasing efficiency through innovative clinical trial design
- Understanding the latest regulatory requirements of adaptive design
- Evaluating emerging eClinical Technologies
- Leveraging registries, results databases and outcomes research
- Utilizing interim trial data and responding to market developments outside the trial
- Logistical and practical requirements for implementing and running flexible trials
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4:30 PM Close of Executive Forum
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