2013 Archived Content

Companion Diagnostics

Strategies and Solutions to Streamline Development


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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 PerspectivesThis 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 

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Biocartis  Elsevier  Luminex  RemedyMD  Scientia Advisors  Singulex 

9:40 Refreshment Break in the Exhibit Hall with Poster Viewing 


Ctcs In Companion Diagnostics 

10:40 Chairperson’s Remarks

Thomas Krahn, Ph.D., Head, Global Biomarker Research, Bayer HealthCare Pharmaceuticals, Bayer Pharma AG

10:45 Capturing and Molecular Analysis of Circulating Tumor Cells to Support Early Clinical Studies

Thomas Krahn, Ph.D., Head, Global Biomarker Research, Bayer HealthCare Pharmaceuticals, Bayer Pharma AG

We will present the capturing efficiency of different technologies for CTC isolation and the subsequent molecular analysis of captured cells. The path forward from assay development to a validated biomarker assay will be discussed and first results from molecular CTC analysis in clinical studies will be shown.

11:15 Implementation of CTC Assaysin Oncology Clinical Trials

Iman Jilani, Ph.D., Associate Director, Clinical Assay Group, Global Clinical Pharmacology, Pfizer, Inc.

This presentation will discuss the incorporation of CTC assays in Oncology clinical trials. Content will include choosing a platform, method development, validation, and clinical trial implementation.

11:45 Analysis and Characterization of Subpopulations of Circulating Tumor Cells in Breast Cancer Patients

Haifeng Bao, Ph.D., Principal Scientist, Research & Development Translational Sciences, MedImmune

Silicon Biosystems12:15 pm Assessment of Single Cell Mutational Status Reveals Breast Cancer CTC Heterogeneityon

Nicolo Manaresi, Ph.D., CTO, Silicon Biosystems
Circulating Tumor Cells can be viewed as a "fluid biopsy" and have the potential to be used as an aid in cancer diagnosis and the monitoring of patient response to therapy.  Results of genetic analysis of individual CTCs from breast cancer patient samples show significant heterogeneity amongst the cells and supports the position that it is possible to obtain a clear picture of mutational heterogeneity at the single cell level.

OriGene12:30 Luncheon Presentation
 High Density Protein Microarray and its Application in Developing Ultra-Specific mAbsWeiwu He, Ph.D., CEO & President, OriGene Technologies, IncAntibody specificity is of pivotal importance for its use, especially in diagnostic and therapeutic applications.Currently no technologies have been established for antibody specificity validation. Here we will showcase OriGene’s novel platform of high density protein microarray technology to test antibody specificity. Using such platform, OriGene has successfully created a new line of ultra-specific mAbs, UltraMAB®, for multiple diagnostic targets, including HER2 and ERCC1. Sample cases will be discussed.   

1:15 Refreshment Break in the Exhibit Hall with Poster Viewing





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


Randox Pharma Services3:15 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.

almac3:30 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.

Personalized Medicine Coalition3:45 Valentine’s Day Celebration and Poster Competition Winner Announced in the Exhibit Hall

(Last Chance for Poster Viewing)


How Academic Medical Centers are Leading Personalized Medicine Research 

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.

Boston Healthcare6:05 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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