Streamlining Companion Diagnostics
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Thursday, February 14
7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 - 9:40 Plenary Keynote Panel: Emerging Technologies & Industry Perspectives
This session features a series of presentations on emerging and hot technologies in diagnostics, drug discovery & development, informatics, and oncology. Interactive Q&A discussion with the audience will be included. - Read more
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing
10:40 Chairperson's Remarks
Alan Carter, Chief Business Officer, PanGenX
10:45 The Clinical Utility of T2DM and Other Genetic Risk Testing in Primary Care?
Alex Cho, M.D., MBA, Assistant Professor, Department of Medicine, General Internal Medicine, DUHS Center for Personalized Medicine, Duke University
Primary care spans the full spectrum of healthcare: preventive care for those who are currently healthy; risk management for those who have preclinical disease; and diagnosis, prognosis, and treatment for those with active disease. Genomics can be employed by providers at each step in the progression from health to advanced disease, providing information regarding disease risk or susceptibility; as well as response to pharmacotherapy, including side effects. The mechanisms by which such information can aid providers can be sorted into four categories: tailoring prevention strategies; raising provider awareness (for certain disease possibilities); selecting optimal therapy; and encouraging patient engagement. Through specific use cases relevant to primary care, the potential utility, limitations, and practical challenges to employing genomics in this manner will be explored.
11:15 Decision Support for Personalized Genomic Medicine
Mark S. Boguski, Ph.D., Associate Professor, Center for Biomedical Informatics, Harvard Medical School
11:45 Turn-Key and Precise Clinical Genome Interpretation
Dietrich Stephan, Ph.D., Founder & CEO, Silicon Valley Biosystems (SVBio)
Genomes are beginning to make their way into the practice of medicine. Clinical diagnostics requires a level of accuracy and simplicity that is far different from the research uses of genomic data. We provide a turn-key service to interpret the human genome to improve patient outcomes in several clinical areas.
12:15 pm Luncheon Presentation I: Multiplexed Molecular Testing for Rapid Diagnosis of Gastrointestinal Infections
Kimberle C. Chapin, M.D., Lifespan Academic Medical Centers and Brown Medical SchoolA discussion on the evaluation of a multiplex molecular test to rapidly identify the top pathogens involved in gastroenteritis and its potential impacts across the various hospital care continuum.
12:45 Luncheon Presentation II: Inspection Ready - Regulatory Compliance of LDTs in Accredited Clinical Laboratories Can Be Eased By Utilizing the LISMegan Schmidt, Product Manager, Sunquest Information SystemsClinical laboratories are subject to robust oversight by federal, state and professional entities. LDTs are subject to special scrutiny. Attendees will learn how the LIS can support a quality system with protocol adherence, checklist activities and quality assurance for confident inspection readiness.
1:15 Refreshment Break in the Exhibit Hall with Poster Viewing
1:45 PANEL DISCUSSION
Moderator: Hakan Sakul, Ph.D., Executive Director & Head, Diagnostics, Worldwide Research & Development, Clinical Research and Precision Medicine, Pfizer, Inc.
• How does throughput affect clinical use?
• How does cost influence use?
• How does regulation impact development?
• Sample collection and sample prep considerations
• Informed consent issues
• How will reimbursement dictate implementation?
• How do we ensure clinical validation?
Jeremy Bridge-Cook, Ph.D., Senior Vice President, Research & Development, Luminex Corporation
David A. Flockhart, M.D., Ph.D., Harry and Edith Gladstein Chair in Cancer Genomics, Professor of Medicine, Genetics and Pharmacology; Director, Division of Clinical Pharmacology, Indiana Institute for Personalized Medicine
Brian Kelly, Lead, Clinical & Applied Market Development, Ion Torrent Systems
3:15 Randox Biochip Array Technology (BAT) - A Revolutionary Multiplex PCR Platform for Infectious Disease Molecular Diagnostics (MDx)
Scott McKeown, Ph.D., R&D Consultant, Export Sales, Randox Pharmaceutical Services, Randox Labs Ltd.Nucleic acid amplification tests (NAATs) have become integral to the modern microbiology lab. Randox has utilized award winning biochip array technology to develop comprehensive ease-of-use multiplex PCR arrays with unparalleled assay sensitivity and specificity for sexually transmitted and respiratory infections.
3:30 Partnering in Biomarker Driven Clinical Trials
Austin Tanney, Ph.D., Scientific Liaison Manager, Almac Group
Almac has significant experience in the discovery, development and delivery of biomarkers. This presentation will incorporate Almac's experiences in translating pre-clinical biomarkers into clinical tests for the application in early phase clinical trials.
3:45 Valentine's Day Celebration and Poster Competition Winner Announced in the Exhibit Hall
(Last Chance for Poster Viewing)
Co-Organized by the Personalized Medicine Coalition
4:30 Chairperson's Remarks
Edward Abrahams, President, Personalized Medicine Coalition
4:35 Clinical Implementation of Pharmacogenomic Testing on a Large Scale
David A. Flockhart, M.D., Ph.D.,Harry and Edith Gladstein Chair in Cancer Genomics, Professor of Medicine, Genetics and Pharmacology; Director, Division of Clinical Pharmacology, Indiana Institute for Personalized Medicine
Increasing evidence supports the use of pharmacogenetic testing in conditions where the adverse effects of medications can be preemptively avoided or effective therapy can be more reliably delivered.The rationale for using this approach and the practical realities of large scale implementation on a system wide scale be discussed.
5:05 Genetic Findings in Predicting Treatment Response in 1,000 Patients with Depression
Evian Gordon, M.D., CEO, Brain Resource Company Limited
Psychiatry remains the only medical specialty that has no objective test to predict treatment response in the organ that it treats. Genetics (600 SNPs) results are presented from the largest international study to predict treatment response in 1,000 patients with depression (20 sites; 10 in the U.S including Academic Centers at Stanford, Cornell and Miami Universities). The initial SNP findings are discussed primarily in their own right, but also in conjunction with other complementary clinically relevant objective measures of cognition and MRIs.
5:35 Pathways to Implementing Personalized Cardiovascular Medicine
Dan Roden, M.D., Assistant Vice Chancellor of Personalized Medicine, Vanderbilt University
There is strong evidence that genomic variation can contribute to variable susceptibility to cardiovascular disease and response to drug treatment. There are important challenges in implementing this new knowledge; examples include levels of evidence needed and informatics infrastructure requirements. These will be discussed in the context of implementation efforts underway at Vanderbilt and other medical centers.
6:05 Global Commercialization of Companion Diagnostics: Value Capture in Personalized MedicineJoseph V. Ferrara, President, Boston HealthcareGiven the significant changes in global health care funding and innovation environment, how can pharmaceutical/diagnostic companies deliver increased value demanded by providers, payers, and patients? A better targeting of therapy through companion diagnostics is one potential method, but the question of value capture and ROI for personalized medicine innovators remains.
6:35 Close of Day
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