The introduction of new clinical trial protocols, next-generation sequencing, reimbursement constraints, immunotherapy treatments and changing regulatory guidelines are all impacting the progress of companion diagnostics. Conflicting demands on the system make it difficult to assess the best way to move forward in matching patients with a treatment regimen that is suited to them based on genomic information. The standard of care in oncology demonstrates how powerful this change and adaptation can be to the practice of personalized medicine, but developing a comprehensive and successful plan requires careful consideration of the factors at play. Experts in the field will assemble for the Companion Diagnostics symposium to address these questions and shed light on both the technology development as well as implementation.
Scientific Advisory Board
Scott Marshall, Managing Partner Analytics, Precision for Medicine
Jonathan Pan, Ph.D, MBA, Senior Marketing Director, Worldwide Insulin Delivery, Johnson & Johnson
John Pfeifer, M.D., Ph.D., Vice Chair for Clinical Affairs, Pathology; Professor, Pathology and Immunology; Professor, Obstetrics and Gynecology, Washington University School of Medicine
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Thursday, March 10
7:30 am Registration and Morning Coffee
9:00 Chairperson’s Opening Remarks
Glenn A. Miller, Ph.D., President, CDx Vision, LLC
9:10 Personalized Medicine Risk-Sharing Business Models: What Does It Really Mean?
Cecilia Schott, MBA, Head, Personalized Healthcare, Corporate Development & Ventures, AstraZeneca
The term risk-sharing business models in personalized healthcare (PHC) has been approached in different ways. One simple way of understanding the risk associated with the development of new drugs that incorporate a PHC is by breaking it down in three parts: (1) development, (2) regulatory approval, and (3) commercialization of the companion diagnostic and the drug. This presentation will take a critical look at what it really means to risk share the co-development of a drug and a diagnostic.
9:20 Preventive Diagnostics: The Future of Personalized Healthcare
Rainer Metzger, Ph.D., Vice President, Global Business Development Pharma, Qiagen GmbH
I will review the emerging trends in Personalized Healthcare, which includes companion diagnostics and NGS with lead multi-biomarkers and multiplex testing. Pharma and Diagnostics companies are advancing through formation of consortia to foster the emergence of liquid biopsy and monitoring testing in cancer and chronic diseases. I will discuss how combinatorial & targeted therapy and immunooncology will be established and how diagnostic testing will be a key component. Furthermore, bioinformatics will become an integral part for the analysis, interpretation and reporting of biological and clinical data.
9:30 Seeking the Evidence Base: How Will Personalized Medicine Save Medical Cost?
Mark E. Nunes, M.D., Associate Professor, Pediatrics, Division Chief, Medical Genetics, Kaiser Permanente
By its own definition, the target population for personalized medicine diagnostics and therapeutics is small and highly selected, resulting in greater costs. Would a focus on prevention, rather than therapy, improve the equation? Challenges in establishing the model and evidence from the payor’s perspective will be examined.
9:40 PANEL DISCUSSION
10:40 Coffee Break with Exhibit and Poster Viewing
11:15 Chairperson’s Remarks
Jonathan Pan, Ph.D., MBA, Senior Marketing Director, Worldwide Insulin Delivery, Johnson & Johnson
11:30 Building a Rapid Learning System to Improve Cancer Care
Richard L. Schilsky, M.D., FASCO, CMO, American Society of Clinical Oncology
ASCO is developing CancerLinQ to capture the complete, longitudinal electronic health record of every patient along with practice management data from all participating practices to “learn” from every patient. Over time, the value of the CancerLinQ data will be enhanced by incorporating genomic data, imaging data and patient-reported outcomes. This information will provide the ability to rapidly generate the evidence needed to deliver the best care for each cancer patient.
11:45 Creating an Integrated Multi-Site Cancer Care Program – Electronic Measurement of Impact of Value vs. Volume Algorithms
Derek Raghavan, M.D., Ph.D., FACP, FRACP, FASCO, President, Levine Cancer Institute, Carolinas HealthCare System; Professor of Medicine, University of North Carolina School of Medicine
This brief review of Carolina HealthCare System’s novel, integrated multi-site system of cancer care, incorporating an academic pattern of practice and the use of pathways, apps, video conferencing and telemedicine, illustrates novel approaches to cost reduction, improvement of access to care and scientific progress via clinical trials, and reflects the move from volume-driven to value-driven/high volume adjusted health care practice and tight fiscal planning without loss of patient-driven satisfaction scores.
12:00 pm Technology Providers and Solution Integrators
Christopher Larkin, CTO, GE Software
In this talk, I will describe how we are generating copious amount of data and it will be necessary to ensure real-time data acquisition as well as analytics to begin mining the optimal pathways associated with outcomes. I will review how cloud infrastructure and EMR technologies are paving the way. The current limitation is understanding the analytics and how to optimize those in a fast and expedient way to ensure HCPs and patients go through the right journey.
12:15 Driving to a New Paradigm in Personalized Medicine through Multiplex Protein Biomarkers
Pankaj Oberoi, Scientific Director, Meso Scale Discovery
MESO SCALE DISCOVERY® offers a comprehensive service to screen, select, and validate custom biomarker tests. Examples of different stages of biomarker development and partnerships will be presented.
12:30 Session Break
12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:15 Session Break
1:50 PANEL DISCUSSION: Integrating Information for Better Outcomes
Moderator: Jonathan Pan, Ph.D., MBA, Senior Marketing Director, Worldwide Insulin Delivery, Johnson & Johnson
3:00 Refreshment Break with Exhibit and Poster Viewing
3:30 Fusing Systems Biology and Predictive Analytics for Integration of Multi `Omic Data: Demonstration of the PATHTM Platform for Knowledge Generation
Scott Marshall, Ph.D., Managing Director, Analytics, Precision for Medicine
The future of healthcare will be transformed by flexible frameworks designed to discover complex signals in rich datasets through the merger of predictive genomic analytics and systems biology that are designed to incorporate information about molecular and cellular systems across multi `omic data. PATH™ a secure, scalable, cloud-based solution for predictive genomic analytics serves as a knowledge generation platform for translational and clinical research.
4:00 Application of Pharmacogenomic in Non-Oncology Areas: Why Is It So Hard?
Eric Lai, Ph.D., Senior Vice President and Head, Pharmacogenomics, Companion Diagnostics, Takeda Development Centers of America
Pharmacogenomics has been applied successfully in mainly oncology but not in other therapeutic areas. This presentation will examine some of the factors that are limiting the use of pharmacogenomics in non-oncology areas.
4:30 PANEL DISCUSSION
5:00 Reception with Exhibit and Poster Viewing
6:00 Close of Day
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Friday, March 11
8:00 am Morning Coffee
8:25 Chairperson’s Remarks
John D. Pfeifer, M.D., Ph.D., Vice Chair & Professor, Pathology & Immunology, Washington University
8:45 The Payer’s Need for Standards
Girish Putcha, M.D., Ph.D., Director, Laboratory Science, Palmetto GBA (MolDX)
Palmetto’s MolDX is a pilot program launched in 2011 that attempts to make more transparent, consistent and robust the mechanisms by which molecular tests are coded, covered, and reimbursed. During this presentation, we will briefly review the technical assessment process at MolDX
9:05 Using Plasmid-Based Materials as Multiplex Quality Controls and Calibrators for Clinical Next-Generation Sequencing Assays
Jason Lih, Ph.D., Principal Scientist, Molecular Characterization & Clinical Assay Development Laboratory (MoCha), Frederick National Laboratory for Cancer Research
Though the next-generation sequencing technologies have been widely adapted for clinical diagnostic applications, an urgent need exists for multiple-analyte control materials to evaluate and monitor the assays’ performance. Control materials play a major role in the assessment and improvement for developing assays and serve as standards for cross lab/platform comparison study. A plasmid-based control materials approach will be reported to provide effective multi-analyte controls for clinical NGS assays.
9:25 In silico Datasets as Multiplex Quality Controls and Calibrators for Clinical Next-Generation Sequencing Assays
John D. Pfeifer, M.D., Ph.D., Vice Chair & Professor, Department of Pathology, Washington University
Biologic control specimens challenge both the “wet lab” and “bioinformatic” aspects of NGS tests. However, it is difficult to use biologic specimens to comprehensively evaluate the full spectrum of mutations, range of variant allele frequencies, and multiple genetic loci characteristic of NGS assays. In silico datasets (i.e., NGS sequence files manipulated by computerized algorithms to introduce a spectrum of sequence variants) are ideal standards for the “bioinformatic” aspects of clinical NGS assays from alignment through variant detection, annotation, and interpretation, and thus are complimentary to biologic specimens as multianalyte controls.
9:45 PANEL DISCUSSION
10:00 Sponsored Presentation (Opportunity Available)
10:30 Coffee Break with Exhibit and Poster Viewing
11:00 Moderator’s Remarks
James R. Mansfield, Global Head, Imaging, Quantitative Pathology Solutions, PerkinElmer
11:05 Establishing a PD-L1 Companion Diagnostic for Opdivo, a Novel Immune Checkpoint Inhibitor for the Treatment of Cancer
Steven D. Averbuch, M.D., Vice President, Translational Clinical Development & Pharmacodiagnostics, Bristol-Myers Squibb
PD-L1 expression on the membrane surface of solid tumors may correlate with the efficacy of PD-1 pathway inhibitors. Nivolumab is a fully human IgG4 PD-1 immune checkpoint inhibitor antibody that selectively prevents interaction with PD-L1 and PD-L2 to inhibit the suppression of antitumor T-cell function. A comprehensive analytical and clinical evaluation of PD-L1 expression by IHC to determine the association between expression and clinical outcome for Nivolumab will be described.
11:15 A Critical Appraisal of Biomarkers for Immune Therapy: The Pathologist’s Perspective
Robert A. Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins School of Medicine; Director, Liver Pathology, Division of Gastrointestinal and Liver Pathology, Johns Hopkins Hospital
Dr. Anders will summarize the current understanding of immune checkpoint inhibitors. The mechanism of action of check point inhibitors targeting PD-1/PD-L1 and CTLA will be the focus of the discussion. Particular emphasis will be on gastrointestinal malignancies. He will discuss the challenges in developing prognostic and predictive biomarkers in patient derived tissues.
11:25 CDx Development for PDL1 Therapies and Blueprint Update
Abigail McElhinny, Ph.D., Vice President, Assay and Reagent Development, Ventana
11:35 Developing an Immunohistochemistry Test for “Programmed Cell Death 1 Ligand” (PD-L1) as a Companion Diagnostic for Pembrolizumab
Kenneth Emancipator, M.D., Executive Medical Director, Molecular Biomarkers and Diagnostics, Merck Research Laboratories
Tumors express PD-L1 to contribute to escape from immunosurveillance. Pembrolizumab blocks this escape mechanism and thus effectively treats a number of cancers. The rapid clinical development of pembrolizumab required rapid development of an immunohistochemistry assay for PD-L1. Merck developed the assay initially to determine whether or not PD-L1 is a predictive biomarker, then to enrich clinical trials, and ultimately partnered with a diagnostics company to develop the assay as a companion diagnostic.
11:45 PANEL DISCUSSION
12:30 pm Close of Symposium
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