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Track 6 explores how to leverage technology to optimize speed, quality and cost of clinical trials. Themes covered include best practices in data collection and analysis, systems integration, recruiting and engaging patient communities using Web 2.0 technologies, pharmacovigilance and utilization of EHR data for drug development.
TUESDAY, APRIL 20
2:00 - 6:00 pm Main Conference Registration
4:00 Event Chairperson’s Opening Remarks
Cindy Crowninshield, Conference Director, Cambridge Healthtech Institute
Presented by
4:05 Keynote Introduction: Ronald Ranauro, Chief Executive Officer, GenomeQuest, Inc.
 4:15 PLENARY KEYNOTE: Drug Discovery Opportunities and Challenges -- VC, Biotech and Pharma Perspectives
Christoph Westphal, M.D., Ph.D., CEO, Sitris Pharmaceuticals; Senior Vice President, Center of Excellence for External Drug Discovery, GlaxoSmithKline
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5:00 - 7:00 pm Welcome Reception in the Exhibit Hall
***Drop off your business card at the CHI Sales Booth for a chance to win an Apple® - iPod nano®! 2 Winners will be announced at 6:45pm in the Exhibit Hall
WEDNESDAY, APRIL 21
7:30 am Registration and Morning Coffee
Sponsored by
8:15 Event Chairperson’s Opening Remarks
Phillips Kuhl, Co-founder and President, Cambridge Healthtech Institute
Keynote Introduction: Jamie Wyatt, Vice President and General Manager Health and Life Sciences, Netezza
 8:20 PLENARY KEYNOTE: Impact of HIT Stimulus on Novel Sources of Data for Research
John Halamka, M.D., M.S., CIO, Harvard Medical School
9:00 Keynote Presentation & 2010 Benjamin Franklin Award
Alex Bateman, Ph.D., Senior Investigator, Pfam Database Project, Wellcome Trust Sanger Institute
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Sponsored by
9:30 Coffee Break, Poster and Exhibit Viewing
***Drop off your business card at the CHI Sales Booth for a chance to win 1 of 2 Prizes! (Nintendo® Wii™ System or Apple® - iPod touch®)
10:50 Track Chairperson’s Remarks 
Mohammad Afshar, M.D., Ph.D., CEO, Ariana Pharmaceuticals
11:00 Patient-Centered Clinical Trials – Engaging Patients Through On-line Communities and Novel Trial Data Capture
Craig H. Lipset, Director/Commercial Lead (Molecular Medicine) and eHealth Team Member, Pfizer, Inc.
Web 2.0 technologies enable unprecedented engagement of patients in managing their health and wellness. In the emerging age of participatory medicine, the active role of the e-patient as an informed participant is encouraged. Patient communities expand beyond discussion forums into vehicles for patient-generated research. Clinical trials are often characterized by their extensive regulation and legacy processes. Can we shift from our current “site-centric” model to more actively engage the patient in clinical research? Can telemedicine and mobile technology enable a less burdensome and more accessible trial? The session will present a novel integration of mobile and internet-based technologies, along with principles of telemedicine and tools of health information technology, to demonstrate the potential for a disruptive new model, a patient-centered clinical trial. Tools to enable this model will be presented in the context of an ongoing pilot designed to demonstrate the value of patient-centered trials in improving patient engagement while reducing the time, cost, and complexity of clinical research.
11:30 eCollaboration: A Case Study on the Challenges in Building an Internet Collaborative Platform for Study Teams and Investigators
Laszlo Vasko, Director, Business Relationship Management, Global Drug Development IS, AstraZeneca
This presentation will provide an overview of AstraZeneca’s Clinical Partners Portal - an internet platform to support collaboration both within AZ and externally with investigators. The case study will present the challenges with technology and project management that were encountered. The presentation will educate on the complexity of the technologies, advise on pitfalls to avoid, and help anyone looking to either build or buy such capabilities.
Presented by
12:00 pm Powering Collaborations in Clinical Research
John Speakman, Clinical Science Program Manager/Associate Director, National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT)
William T. Dyer, Jr., Clinical Trials Management Systems Representative, NCI CBIIT
Umit Topaloglu, Ph.D., IT Bioinformatics Manager, University of Arkansas for Medical Sciences
Large-scale, multi-site collaborations are a growing trend in clinical research, creating a need for the means to seamlessly exchange and integrate data between various departments and institutions. This approach is powered by the use of a standards-based infrastructure and interoperable tools that simplify data exchange and facilitate collaborative research. This session will provide an overview of caBIG® capabilities in support of clinical research as well as real-world examples of how standards and tools are being deployed and integrated with existing systems to streamline and enhance clinical trial activation and conduct.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
Sponsored by
1:40 Chairperson’s Remarks
Ken Buetow, Ph.D., Associate Director for Bioinformatics and Information Technology, National Cancer Institute
1:45 How Patients Are Transforming Clinical Trials
Paul Wicks, Ph.D., R&D Director, Research & Development, PatientsLikeMe
Today, patients are playing the central role in defining what aspects of their disease need to be modified, the risks and benefits that shape their decisions, and in some cases even the design of trials. PatientsLikeMe is an online community for patients with life-changing conditions that is bringing the patient voice into the center of the pharmaceutical industry to improve outcomes.
2:15 Addressing the Challenges of Implementing New Tools and Processes that Enable Transparency and Accountability in the Enrollment Planning Process
Munther Baara, Director, R&D Clinical Business Systems & Processes, Wyeth
We are executing on our global strategic vision to make measurable industry leading changes in the management of Trial Operations. We implemented a SaaS application that uses predictive analytics to help model and adjust plans on the fly and collaborate across global teams. It allowed us to plan, forecast, track, model, analyze, and adjust clinical trial enrollment. This project utilizes our operational data warehouse as a common database layer to serve (transmit) data from several source systems (multiple enrollment systems, EDC tools and CTMS application) to the planning tool in a near real-time basis. Governed by the information domain stewards and guided by 2 principles: 1) One version of the truth 2) Collect data as close as possible to the source and fix data issues where we collect them.
Presented by
2:45 Featured Presentation
The BIG Idea: Strategies to Achieve a Rapid-Learning Health System
(Joint Talk with Tracks 2, 3, 4, 6, and 7)
Ken Buetow, Ph.D., Associate Director, Bioinformatics and Information Technology, National Cancer Institute
Considerable momentum has been building in government, academe and the commercial sector towards implementation of a “rapid-learning health system”. In this approach to biomedicine, research and clinical care are seamlessly linked in a virtuous circle that enables the collection and analysis of information on clinical outcomes of large populations. This talk will outline the requisite components of such a system—including a mega-community called the BIG Health Consortium™ encompassing the various sectors of biomedicine and electronic interoperability that enables the liquidity of information—and will showcase this new model in action.
3:15 Refreshment Break, Poster and Exhibit Viewing
***Drop off your business card at the CHI Sales Booth for a chance to win 1 of 2 Prizes! (Nintendo® Wii™ System or Apple® - iPod touch®) Winners will be announced at 3:30pm in the Exhibit Hall
3:45 Optimizing Serious Adverse Event Collection via Technology
Adrian Hsing, Senior Director, Clinical Data Management, Gilead Sciences, Inc.
Wolfgang Summa, Ph.D., Executive Vice President Europe & Asia/Pacific, OmniComm Europe GmbH
Reconciliation of safety and clinical database is not just labor intensive but often becomes a rate limiting factor for clinical trials. We have developed a software module and the corresponding process to link EDC front end to a safety system.
4:15 Integration, Not Reconciliation, Boehringer Ingelheim’s Plan to Integrate SAE Collection with EDC
Tricia Gregory, Senior Associate Director, Global BDM Process & Technology Improvement , Boehringer Ingelheim Pharmaceuticals, Inc.
Lesia Tontisakis, SAE Business Lead, Boehringer Ingelheim Pharmaceuticals, Inc.
We will describe the international project within BI to integrate our Drug Safety serious adverse event reporting with collection of trial data through our EDC system and the subsequent transfer of these data to our safety database. The project was started in late 2008 and is well on its way to the goal of having a pilot underway in early 2010. We will discuss the challenges faced and resolved, as well as those still outstanding. These challenges are both technical and process-based. Issues include consistent definitions of fields to be mapped, designing the ‘perfect’ data collection form, easy printing for sites, prioritized thesaurus coding and investigator approval. We will describe the high-level processes that have been defined by the project team to date.
4:45 Leveraging Semantics for Effective and Accurate Sharing of Clinical Observations
Vipul Kashyap, Director, Applied Informatics, CIGNA
The imperative to control rising healthcare costs and yet achieve optimum outcomes suggests the need for holistic services to deliver optimum therapy and care for patients. Those services embrace biomedical research, clinical research and practice. Re-use of clinical data is also beneficial to healthcare providers, e.g., evaluating clinical care quality; payors, e.g., monitoring patient risk profile, and pharma, e.g., determining patient eligibility for clinical trials, monitoring adverse events during and after trials. We propose an extensible framework and architecture for sharing and exchange of clinical data. This is illustrated via a demonstration utilizing eligibility specifications from several clinical research protocols (using the CDISC-based standards) and (structured) patient data from a real world EHR (using HL7-based standards) to screen the EHR data for potential candidates.
5:15 – 6:15 2010 Best of Show Awards in the Exhibit Hall
6:15 Exhibit Hall Closes
Sponsored by
6:30 – 10:00 2010 Best Practices Awards Reception & Dinner
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THURSDAY, APRIL 22
8:00 am Registration and Morning Coffee
Sponsored by
8:45 Event Chairperson’s Opening Remarks
Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World
Keynote Introduction: Eric Blatte, Vice President of Sales, Commercial & Public Sector, Imprivata
 8:50 PLENARY KEYNOTE: There is No Magic, There is Only Awesome: Scientific Computing with Amazon Web Services
Deepak Singh, Ph.D., Business Development Manager, Amazon Web Services
Presentation delivered via a live, interactive videoconferencing platform.
9:30 KEYNOTE PANEL
The Future of Personal Genomics
A special plenary panel discussion featuring:
James Heywood, Co-founder and Chairman, PatientsLikeMe
Dan Vorhaus, J.D., Attorney, Robinson, Bradshaw & Hinson; Editor, Genomics Law Report
Dietrich Stephan, Ph.D., President & CEO, IGNITE Institute
Kári Stefánsson, MD, Dr Med, Executive Chairman and President of Research, deCODE genetics
Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World
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10:30 Coffee Break, Poster Competition, Vendor Theater Presentations and Exhibit Viewing
***Drop off your business card at the CHI Sales Booth for a chance to win 1 of 2 Prizes! (Nintendo® Wii™ System or Apple® - iPod touch®)
10:55 Track Chairperson’s Remarks
Laszlo Vasko, Director, Business Relationship Management, Global Drug Development IS, AstraZeneca
11:00 Making Clinical Data Integration Work in a Heterogeneous Environment
John Walker, Associate Director of Clinical Informatics, Infinity Pharmaceuticals
Infinity Pharmaceuticals' clinical infrastructure has evolved over the past 5 years to accommodate trials of varying phase, indication and breadth. Execution of the trials involves a hybrid of internal and external resources leading the team to create an architecture that supports information sharing across organizations. The integrated architecture, comprised of the following systems: CTMS, Pharmacovigilance, EDC and a CDISC-compliant data warehouse, contains validated and commercial off the shelf components interspersed with not validated and custom software. Automated reporting and a progressive approach to data visualization and analysis have led to broad use of the platform throughout the company. This adoption has improved communication between groups and facilitated more efficient strategic and tactical decision-making.
11:30 Connecting Healthcare and Clinical Research
Catherine Celingant, Senior Director, Medical Informatics Operations & Innovative Technologies, Millennium: The Takeda Oncology Company
The term Electronic Healthcare Record (EHR) is commonly used to refer to a system which stores individual patient health and healthcare histories in an electronic format. EHR systems are thought to be beneficial in providing an instantly accessible, patient-centric view across medical practitioners, thereby improving the quality of medical care and reducing healthcare costs. The use of EHRs in healthcare institutions is currently on the rise, in many cases encouraged by government initiatives to accelerate adoption. A secondary benefit of such systems is the potential to access to unprecedented amounts of clinical data which can support and promote evidence based medicine and medical practices. This is viewed by government agencies, epidemiologists and the wider clinical research community as a quantum step forward in delivery of their respective needs.
12:00 pm A Primer: Opportunities and Challenges with EHR and EDC System Integration
Frances Nolan, VP, Quality Assurance, Medidata Solutions
It has long been a desire to effectively and efficiently leverage Electronic Health/Medical Record (EHR/EMR) systems in clinical research, most recently with a focus on integration with clinical Electronic Data Capture (EDC) systems. This presentation provides a “back to basics” foundation, outlining the opportunities associated with EHR/EDC integration, as well as a discussion of the various challenges and how some of these challenges are being addressed. Topics addressed include those related to regulatory requirements, privacy and security, standards (e.g., HL7 and CDISC CDASH), and dictionary usage (SNOMED, ICD-9/ICD-10 and MedDRA).
12:30 Luncheon in the Exhibit Hall
***Drop off your business card at the CHI Sales Booth for a chance to win 1 of 2 Prizes! (Nintendo® Wii™ System or Apple® - iPod touch®) Winners will be announced at 1:45pm in the Exhibit Hall
2:00 Exhibit Hall Closes
1:55 Track Chairperson’s Remarks
Tricia Gregory, Senior Associate Director, Global BDM Process & Technology Improvement , Boehringer Ingelheim Pharmaceuticals, Inc.
2:00 Interoperability of Analyses and Data within Clinical Trials from a Biotechnology Perspective
Lynn DiFinizio, Director, Statistical Programming and Operations, Biometrics, Biogen Idec
A summary of how one Biotech company supports interoperability/reusable data exchange using industry standards (CDISC), internal standards (Analysis Output), EHR (RDC technology), along with a strong IT foundation (Software Development Lifecycle & Validation best practices) to ensure efficiency, compliance and productivity in a Biotech environment.
2:30 Best Practices in Lab Data Collection and Analysis
Julia Zhang, Ph.D., Associate Director, Biomedical Data Sciences and Informatics, Genzyme
Interoperability is a key standard goal in data management. Genzyme has implemented the CDISC lab standard in the lab data collection and analysis. We have coordinated with central lab vendors, such as Covance and Quintiles, EDC vendors and CROs. We experienced many different situations in collaborating with in-house data management and different vendors and gained best practices from our experiences. We also explored technology in data validation tools.
3:00 Integrated Signal Detection Tools: An Innovative Suite of Tools Developed by and for Pharmacovigilance Physicians
Steven Bailey, M.D., Senior Director & Lead, Medical Pharmacovigilance, Vaccines and Technology, Pfizer
Robert Maroko, M.D., Medical Pharmacovigilance-Vaccines and Technology, Pfizer
A presentation of the development of new signal detection tools for use in pre-marketing and post-marketing environments. These tools have been developed by physicians with an IT background, used to build efficiencies within a safety/pharmacovigilance department. We will review the development and use of this unique set of tools for early detection of safety signals and how they both improve process and greatly reduce resource requirements. We will also discuss the role of users in developing the most useful and efficient signal detection tools.
3:30 Why an Interoperable Digital Identity and Signature Standard is Fundamental to Improved Efficiencies and Costs in Global eClinical Trials
Mollie Shields Uehling, CEO, Executive, SAFE-BioPharma Association
The research community is under enormous pressure to improve R&D productivity, reduce costs and cycle times, and to raise the quality of regulatory submissions. Moving to eClinical Trials holds the promise to deliver against these goals. One of the key challenges in going electronic is the need to link our many disparate healthcare IT islands with interoperable and standardized identities that are recognized by leading regulatory authorities and meet the requirements of many different legal jurisdictions. The proposed presentation will explain the challenge and present how the SAFE-BioPharma digital identity and signature standard (developed as a pan-biopharmaceutical industry initiative) will accelerate a new phase in drug development.
4:00 Conference Adjourns
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