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Role IT solutions, theoretical knowledge and social infrastructure have in allowing for efficient gathering and analysis of clinical data. Monday, April 27 4:00 pm Event Chairperson’s Opening Remarks Cindy Crowninshield, Conference Director, Cambridge Healthtech Institute Keynote Introduction: Microsoft 4:15 Plenary
Keynote
5:00 Welcome Reception in the Exhibit Hall Drop off a business card at the CHI Sales Booth for a chance to win 1 of 2 iPods ®!
7:00 Networking Event hosted by BiotechTuesday
Tuesday, April 28
7:30 am Registration and Morning Coffee 8:15 Event Chairperson’s Opening Remarks Phillips Kuhl, Co-founder and President, Cambridge Healthtech Institute Keynote Introduction: Ken Buetow, Ph.D., Associate Director, Bioinformatics and Information Technology, National Cancer Institute 8:20 Plenary
Keynote
9:00 Keynote Presentation & 2009 Benjamin Franklin Award 9:30 Coffee Break, Exhibit and Poster Viewing in the Exhibit Hall
EDC 10:50 Track Chairperson’s Remarks Joan Chambers, Senior Director of Marketing & Operations, Publications, Cambridge Healthtech Institute (CHI) 11:00 The Journey towards an Integrated Clinical Data Management Platform: Challenges and Potential Jennifer Teta, Director, Clinical Research Information Services, Merck & Co., Inc. A patient data management platform was implemented with 100% of late stage trials using EDC and a Janus-based clinical data warehouse based on external standards. Lessons learned from this work will be discussed including the challenges and potential of a clinical data warehouse for integrating data, thoughts on the advantages of implementing standards early in the patient data flow process, and the implication of various architectures on the ability to effectively partner with others. 11:30 How a New IT Specification Will Help Clinical Investigators Reduce Their Paperwork and Get Back To Their Real Work Rich Furr, Head, Global Regulatory Affairs and Chief Compliance Officer, SAFE-BioPharma Association Use of the IHE Retrieve Form for Data Capture allows creation of electronic case report forms and individual case safety reports by parsing electronic health records to identify and retrieve data directly to EDC systems based on specified values. This presentation will report on the problem faced by clinical investigators and the results of the joint initiative to address it. Understand the technology, procedures and policies that support the use of digital identities and digital signatures across the clinical trial space. 12:00 eSubmissions: What AstraZeneca Learned Richard Ware, Senior Principal Business Partner, Regulatory Affairs, Global Drug Development Information Systems, AstraZeneca Pharmaceuticals On September 18, 2006, AstraZeneca (AZ) U.S. Regulatory Affairs submitted the first electronic original 356h form to the FDA. In the past, paper originals were the only way to comply with regulations. By using SAFE-BioPharma digital signatures and the FDA Electronic Submissions Gateway (ESG), AstraZeneca reached a milestone for the biopharmaceutical industry. No paper original of the 356h exists. AstraZeneca received BIO-IT World magazine's 2008 Best Practices Grand Prize for its pioneering accomplishment. The proposed presentation will explain how AZ implements eSubmissions and the internal process that resulted in achieving this industry milestone.
EDC (continued) 1:40 Chairperson’s Remarks Joan Chambers, Senior Director of Marketing & Operations, Publications, Cambridge Healthtech Institute (CHI) 1:45 Standards-Based Reference Architecture for Advanced Clinical Research Informatics and Patient Care Jomol Mathew, Ph.D., Director, Clinical Research Information Technology, Dana-Farber Cancer Institute We present a standards-based reference architecture for semantic interoperability between Clinical Information Systems (CIS)/Electronic Health Records (EHRs) and Clinical Trial Management Systems (CTMS). This is based upon the HL7 version 3.1 standards architecture using clinical terminologies designed as part of the Federal Health Architecture/Consolidated Health Informatics (FHA/CHI) to provide a ubiquitous and unambiguous framework. This reference architecture leverages existing terminologies (such as SNOMED-CT, NDFRT, LOINC, and RxNorm) used in health care delivery, clinical trials, structured product labeling (SPL), clinical decision support systems, HL7/ASTM Continuity of Care Document (CCD), and health care reimbursement claims attachments. We leverage a joint HL7/ISO 13606/OpenEHR effort at developing detailed Clinical Models which seeks to define the semantics of clinical findings (such as used in patient health histories, clinical notes, case report forms, diagnosis, or end points) which can be implemented using a range of additional transformations (including HL7 version 2.3+ messages, electronic data capture, or clinical documents) and platforms. This architecture is designed to support such diverse use cases as adverse event description and reporting, clinical decision support, translational research, personalized medicine and individual life-time health records. The architecture is also designed as interchangeable and configurable to serve as an underpinning for EHR/Electronic Data Capture system development. We discuss the design process and rationale, requirements for reference implementation, imperatives to HITSP and CCHIT, as well as required additional research and development. Clinical Informatics Applied Session Chair: Ken Buetow, Ph.D. Associate Director for Bioinformatics and Information Technology, National Cancer Institute Featured by
 2:15 The Cancer Biomedical Informatics Grid
(caBIG®) John Speakman, Associate Director, Clinical Products and Programs, Center for Bioinformatics and Information Technology, National Cancer Institute (NCI) William Dyer, CRI, Principal Consultant, Bioinformatics, National Cancer Institute The caBIG® vision is a virtual network of interconnected data, individuals, and organizations whose goal is to redefine how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise. The caBIG® Clinical Trials Suite is a comprehensive set of modular, interoperable and standards-based tools designed to meet the diverse clinical trials management needs across the clinical research community. Learn how caBIG® Clinical Trials Workspace and suite of applications achieves interoperability and data sharing across clinical research and translational medicine. 2:45 Knowledege Based Approach to Design and Visualization of Clinical Trial Operations Dave Parrish, M.S., Director Informatics, Immune Tolerance Network This presentation will
demonstrate a visualization framework based on the Co-Motion visualization
environment integrated with the ontology based trial design application
(Trial-Designer). We will demonstrate how the integration of these two
applications will allow an end user to define and interact with information
generated in diverse trials from a single user interface and drive a common
ontology based framework. Sponsored by
 3:15 Extending Clinical IT to Support Adaptive Clinical Trials Tom Parke, BSc, Head of Clinical Trial Solutions, Tessella Inc Adaptive Clinical trials are a key part of the solution to the problems of drug development in pharmaceutical companies. Particularly when considered at the program level and not simply the trial level, adaptive designs offer a number of ways to significantly improve the science and efficiency of drug development. At the same time, however, they set a number of challenges to the conventional clinical trial operation. This talk will discuss how can clinical IT can help meet these challenges. 3:30 Refreshment Break, Exhibits and Poster Viewing in the Exhibit Hall
Clinical Outcomes and Standards Session Chair: Ken Buetow, Ph.D. Associate Director for Bioinformatics and Information Technology, National Cancer Institute Featured by
3:45 caBIG®: An Interoperable IT
Framework for Personalized
Medicine Ken Buetow, Ph.D. Associate Director for Bioinformatics and Information Technology, National Cancer Institute Personalized approaches to drug discovery, drug development and clinical care promise a new generation of preventive and preemptive health care. But countless data “disconnects” continue to afflict these biomedical “pillars”, resulting in delays, dysfunction, and poor clinical outcomes. The prerequisite to overcome these hurdles is broad IT interoperability within and across institutions. Many of the challenges of linking research with clinical care to achieve “smart” and personalized medicine are already addressed by caBIG® (cancer Biomedical Informatics Grid® ), developed by the National Cancer Institute and now being deployed within and beyond the cancer community. caBIG® — through its interoperable software tools, standards, databases, and grid-enabled computing infrastructure — is accelerating the shift to the personalized medicine paradigm. This session, presented by leaders from across the country, will showcase actual case studies of improved processes in discovery research, biobanking, imaging, and clinical research; new models of connectivity to enhance and accelerate research collaborations; and a new ecosystem to drive continuous learning from bench to bedside and back . 4:45 Do Healthcare IT Standards Hamper the Advance of Science? (Joint with eHealth Solutions Track) Werner Ceusters, M.D., Director, Ontology Research Group, NYS Center of Excellence in Bioinformatics & Life Sciences Standards are an absolute requirement to make semantic interoperability in healthcare informatics a reality. To achieve the goals of translational medicine, a variety of heterogeneous systems containing data at various levels of granularity need to be made interoperable. This talk will present an analysis of a number of adopted standards and highlight a number of problematic issues and propose directions for solutions. 5:15 2009 Best of Show Awards in Exhibit Hall 6:15 Exhibit Hall Closes 6:30 2009 Bio-IT World’s Best Practices Awards/Dinner
Wednesday, April 29
7:30 am Registration and Morning Coffee 8:00 Event Chairperson’s Opening Remarks Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World 8:05 Plenary
Keynote
8:45 Keynote Panel
9:45 Coffee Break, Exhibit Viewing, Vendor Theater Presentations, and Poster Competition in the Exhibit Hall
Clinical Application of Personalized Medicine 10:45 Track Chairperson’s Remarks Joan Chambers, Senior Director of Marketing & Operations, Publications, Cambridge Healthtech Institute (CHI) 11:00 Enabling a Collaborative, Informative, and Compliant Biobanking Environment Kevin L. Swank, Lead Analyst/Programmer – RLIMS, Mayo Clinic Organizations in today’s economy are facing unprecedented pressures to ensure research success, while at the same time, maximizing operational efficiency and achieving the best return on investment (ROI). In addition, the complexity of managing the dramatically increased number of specimens throughout the organization compels them to replace their existing processes and ad-hoc systems with enterprise solutions. This talk will examine the critical biorepository management requirements for biospecimen accessioning laboratories at Mayo and share experiences in deploying a multi-phase, enterprise biorepository management solution that include ad hoc point system vs. enterprise solution, configurability to fulfill local and enterprise requirements, and truly compliant and secured operational environment. 11:30 Operationalizing Research in Clinical Application of Personalized Medicine Moderator: Ronald Waife, MPH, President, Waife &
Associates, Inc. and This session will feature industry observers’ current predictions on issues and solutions for how to design and conduct the first trials with personalized medicines and how to set up in advance an environment for rapid sharing of lessons learned for industry and regulatory authorities. 12:30 Luncheon in the Exhibit Hall 2:00 Exhibit Hall Closes
Clinical Data Management 1:55 Chairperson’s Remarks Joan Chambers, Senior Director of Marketing & Operations, Publications, Cambridge Healthtech Institute (CHI) 2:00 Collaborative Translational Research in the Public Sector Kyle Brown, President, Innolyst The public sector funds as much research as all pharmaceutical companies combined - with no common infrastructure. Learn how foundations and academia use technology to implement translational research programs. Shared target validation, screening, project management, and patient registries enable public organizations to manage research programs across an array of geographically dispersed vendors and researchers. 2:30 Molecular Considerations in Clinical Decisions: Aromatase Inhibitors in Breast Cancer Michael N. Liebman, Ph.D., Managing Director, Strategic Medicine, Inc. Aromatase inhibitors have become a significant treatment option for post-menopausal breast cancer patients because of their efficacy and limited profile of side-effects. Conventional drug development has focused on characterization of the drug, itself. Our analysis has shown that the clinical decision to treat with these drugs significantly benefits from understanding the biological complexity of the drug target, aromatase. This analysis incorporates structure-function analysis at both the gene and protein levels, evaluates the impact of SNP’s on the target and probes the specific molecular characteristics of the enzyme structure-function response as expressed in extended biological pathways and networks. The ultimate goal is better stratification of the patient and of the disease to provide optimal decision support through molecular diagnostics and analysis. 3:00 Scientific Intelligence in R&D - Knowledge Integration across Discovery, Pre-clinical, and Clinical Development (Joint with IT Infrastructure and Operations & Informatics for Genomic Medicine Tracks) John Apathy, Assistant Vice President, Business Systems and Processes - Discovery, PreClinical, and Vaccines, Wyeth Investments in information systems within Pharmaceutical R&D organizations tend to be made by individual departments or functional units and serve the local purpose of those units. Over time these silo-based approaches lead to challenges in enabling the exchange of data, information, and knowledge across the various Discovery, Pre-clinical, and Clinical Development domains. At Wyeth, we are developing solutions that cut across organizational boundaries and have developed a set of Knowledge Integration solutions allowing senior scientists, study directors, and functional management to find, access, and manage disparate R&D data, information, and knowledge assets. This presentation provides an overview of the journey undertaken to ensure the right information is available to researchers and management within Wyeth Preclinical R&D organization at the right time to enable faster decision-making. 3:30 Service Oriented Architecture – A New Data Sharing Architecture for the Feinstein Institute for Medical Research (Joint with IT Infrastructure & Operations and Informatics for Genomic Medicine Tracks) Robert Lundsten, Director of Biorepository, Feinstein Institute for Medical Research The ability to integrate data from multiple independent data repositories across the North Shore Long Island Jewish Health System’s (NSLIJHS) 15 hospitals and many outpatient care centers into a specialized data warehouse environment for analysis and data mining is a daunting process for many reasons. Creating the scaffolding to facilitate data transfers requires many components including a mediating registry and meta data repository, a data warehouse, a federated identity manager, a standards based methods(s), a web-based portal or user interface, and the services management layer. This talk will describe how the North Shore Informatics Group (NSIG) created a pilot framework of a Service Oriented Architecture that integrated and shared data between different data management groups. 4:00 Conference Adjourns |
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Chris Dagdigian, Founding Partner and Director of
Technology, BioTeam, Inc.
Eric E. Schadt, Ph.D., Executive Scientific Director, Genetics, Rosetta Inpharmatics/Merck Research Labs; Vice President and Chief Scientific Officer, Sage
Clifford Reid,
Ph.D., Chief Executive Officer, Complete Genomics, Inc.
