08:00 | Breakfast and Networking |
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Session Title: Biomarker Classes and the Potential of NGS in Companion Diagnostics Development, Also Who Will Pay for These New Technologies and Approaches? |
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Session Chairman: Robert Wassman, Ph.D. |
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08:30 |  | Keynote Presentation MicroRNAs as Potential Companion Diagnostics
Robert Wassman, Chief Medical Officer, Rosetta Genomics, United States of America
MicroRNAs represent a novel class of biomarkers that are “Master” regulators of post-transcriptional gene expression. They have already been demonstrated to have clinical utility in oncology diagnostics. Beyond oncology, microRNAs have been demonstrated to play a role in numerous other disease processes and the development of specific assays in other clinical areas is imminent. Their unique biological properties make them stable, specific, and robust for clinical diagnostic purposes and amenable to measurement on multiple platforms. Evidence for their utility in prediction of response to therapy suggest the potential for their evolution into Companion Diagnostics in the near future. |
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09:15 |  | Keynote Presentation Discovery & Development of Circulating Biomarkers for Drug Development
Yoshiya Oda, President, Eisai Inc, United States of America
Biomarkers play important roles for drug development, because (1) biomarkers can show target engagement (proof of mechanism) of drug candidates, (2) biomarkers can determine right dosage and dosing schedule (pharmacodynamic biomarkers), (3) biomarkers can identify responders/poor responders for drug candidates (patient stratification), and (4) biomarkers can monitor drug responses (drug monitoring). Disease target tissue analysis is common in oncology area, but we cannot always get archival tissue samples when we need. Especially it may be hard to obtain tissues samples when our drug is used as 3rd line therapy. In addition, we sometimes need clinical samples from both pre- and post-dosing. Body fluid samples such as plasma, serum, urine would be ideal for biomarker analysis, because it is relatively easy to obtain samples during clinical studies, even multiple time points. Proteins, endogenous metabolites and miRNAs are interesting as circulating biomarkers among different disease areas. During the conference, I would like to show some examples from our data, and discuss current challenges such as: How to obtain clinical relevant samples for preclinical studies? How to show scientific rationale about drug efficacy/patient stratification biomarkers? How to determine the cut-off values? When is a good time to start the development of companion diagnostics? |
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10:00 | The Changing Reimbursement Landscape
Andrew Fish, Executive Director, AdvaMedDx, United States of America
This presentation will address recent reimbursement changes, including historic legislative reforms to the Medicare Clinical Laboratory Fee Schedule. The presenter will discuss evidence expectations and the imperatives for developing a strong value case based on clinical and health economic considerations. |
10:30 | Coffee Break, Networking, Exhibit and Poster Viewing |
11:00 | A Unified Approach to NGS-based Oncology Companion Diagnostics Development
Dan Rhodes, Head of Oncology Strategy, Thermo Fisher Scientific, United States of America
There is significant interest from pharmaceutical and regulatory communities, alike, for the development toward a multi-marker companion diagnostic product to support the increasing number of potential targeted therapeutic candidates that may address small cancer sub-populations. Traditionally, pharmaceutical and diagnostic development partners have designed individual companion diagnostic products for each therapeutic candidate, however this has proven costly, time-consuming and is increasingly impractical in the marketplace as the number of targeted therapies and individual companion tests grow. To aid in addressing these challenges, we developed the Oncomine® Cancer Research Panel*, an NGS panel targeting 143 genes, capable of accurately detecting the majority of genetic biomarkers associated with on market therapies and investigational-targeted therapies. Classes of genetic alterations detected include mutations, copy number variants, indels, and gene fusions. Retrospective and prospective research studies demonstrating the value of the panel will be described. In addition, our efforts to partner with the pharmaceutical community to help design clinical trial strategies supporting multiple drug candidates will be discussed.
*For Research Use Only. Not for use in diagnostic procedures. |
11:30 | When Genomics Meets Human Health
Erick Lin, Manager, Illumina Inc, United States of America
The development of next-generation sequencing (NGS) technologies has made sequencing not only rapid and cost-effective, but also highly accurate and reproducible. These advances have increased the utility of NGS in clinical settings, with applications ranging from the identification of rare diseases to the detection of chromosomal abnormalities in maternal-fetal medicine. Deep sequencing and circulating free tumor DNA in the oncology space is also trending toward clinical utility. Regulatory clearance of NGS-based platforms and approval of clinical assays utilizing NGS technologies are also central to the widescale implementation of NGS in personalized medicine. |
12:00 | The Development of Regulated Next Generation Sequencing-based Clinical Trial Assays and Companion Diagnostics
Matthew Marton, Director, Merck Research Laboratories, United States of America
Topics Addressed based on the Following:
Pant, S., Weiner, R. and Marton, MJ. Navigating the Rapids : The Development of Regulated Next Generation Sequencing-based Clinical Trial Assays and Companion Diagnostics. 2014. Frontiers in Oncology. 17 April 2014 | doi: 10.3389/fonc.2014.00078.
Chang, C.N., Kang, J, Qiu, P., Pant, S., Wei, B., Weiner, R and Marton, MJ. Validation of Next Generation Sequencing Cancer Panels for Clinical Mutation Profiling-- Identification of Source of Variations and Artifactual Mutations using FFPE Tissues. 2014. Submitted to Journal of Next Generation Sequencing and Applications.
Chang, C.N. and Marton, MJ. Past, Current and Future Approaches to Querying MAPK Pathway Activation – Status and Clinical Implications. 2014. Submitted to Future Medicine.
Chang, C.N., Galuska, S., Weiner, R. and M.J. Marton. Development and Validation of a Clinical Trial Patient Stratification Assay that Interrogates 27 Mutation Sites in MAPK Pathway Genes. 2013. PLoS One. 2013 Aug 21;8(8):e72239. doi: 10.1371/journal.pone.0072239.
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12:30 | Lunch, Networking, Meet the Exhibitors, and View Posters |
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Session Title: Companion Diagnostics (CDX) Impacting Clinical Development--Case Studies |
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Session Chairman: Dan Rhodes Ph.D. |
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14:00 | Big Data and Small Trials: Translating Biological Data into Clinical Biomarkers
Nicholas Dracopoli, Vice President/Head, Johnson & Johnson, United States of America
All of the companion diagnostic tests approved by the FDA for use in oncology are for “driver mutations” in genes involved in signal transduction pathways. These tests are for single analytes predicting the functional status of the drug target or pathway. There are no approved companion diagnostics for drugs that work through alternative mechanisms such as chemotherapy or immunomodulation. This presentation will discuss why so few biomarkers have been developed, and why we have mostly failed to develop molecular profiles that predict drug response. |
14:30 | Companion Diagnostics: Aligning Development, Commercialization, and Market Access
Charles Mathews, Vice President, Boston Healthcare, United States of America
Ideally pharmaceutical innovators identify a companion diagnostic need early in the development process and identify an in vitro diagnostic partner that is able to not only support the execution of testing during the clinical trial but also launch the test globally when the drug is approved. However, this is often not the case. Variables in immediate testing needs, difficult commercialization pathways, and misaligned incentives lead to disconnects between the promise of CDx and the realities. This presentation will provide an overview of companion diagnostic development and launch/distribution options and market access pathways. It will review the needs and capabilities of various stakeholders (drug, IVD, lab, CRO, etc.) and not only point out where some of the disconnects lie but also provide suggestions for incorporating stage appropriate activities into drug development and CDx commercialization/market access planning and partnering/deal-terms. |
15:00 | Coffee Break, Networking, Exhibit and Poster Viewing |
15:30 | Novel Business Models and Technologies for Driving Successful Companion Partnerships
Christopher Jowett, Global Head, Abbott Molecular, United States of America
• Partnering early to drive biomarker development
• Enabling global patient access to quality diagnostic testing
• Moving multiplex technologies into the clinical setting, The Idylla Advantage |
16:00 | T2MR: Focused on Rapid & Sensitive Detection of Sepsis Pathogens Directly from Whole Blood Without Blood Culture
Frederic Sweeney, Senior Director, T2 Biosystems, United States of America
Rapid diagnostic testing to narrow clinical trial populations and improve therapeutic efficacy has had limited benefit for antimicrobial therapies due to the low titer levels of infection and long diagnostic times required by the standard of care, blood culture. In order to truly make an impact in drug development as companion diagnostics, new technologies are required to deliver dramatically faster and more accurate results. The ideal diagnostics assays (1) would achieve clinically relevant limits of detection directly from patient samples, (2) would not rely on culture or enrichment and (3) would have very high positive and negative predictive values. T2 Magnetic Resonance (T2MR®) technology has the potential to deliver a rapid, sensitive and simple diagnostic platform that can identify specific pathogens directly from an unpurified blood sample as fast as three hours.
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16:30 | At the Intersection of Integrated Care and Technology, An Industry Perspective
Brian Ellerman, Head, Technology Scouting and Information Science Innovation, Sanofi, United States of America
Walt Gall, VP of Healthcare and Strategic Partnerships, Saffron Technology, United States of America
Integrated care is a concept bringing together inputs, delivery, management, and organization of services related to diagnosis, treatment, care, rehabilitation, and health promotion. Increasingly, technology – and in particular cognitive computing – plays a central role in making sense of the myriad, often conflicting, always overwhelming data. In this presentation, the perspective of integrated care within a global healthcare company will be presented along with the challenge of incorporating data of interest into its decision-making. In particular, the challenge of discovery will be called out. One technology innovator, with examples from industry, will describe how cognitive computing has been applied successfully to similar problems, and where wearable device data could provide still more insight. |
17:00 | Close of the Conference. |
