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SELECTBIO Conferences Companion Diagnostics

Companion Diagnostics Agenda

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Biofluid Biopsies | Companion Diagnostics | 

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Monday, 27 October 2014


Conference Registration and Breakfast

Session Title: The Current State of Companion Diagnostics (CDX)

Session Chairman: Scott Patterson, Ph.D.


Scott PattersonKeynote Presentation

Companion Diagnostics: Evolution and Complexities
Scott Patterson, Executive Director, Amgen Inc, United States of America

The model of a single diagnostic used to select patients eligible for a targeted therapy is becoming increasingly challenging within a tumor type given the advent of both multiple biomarkers to define individual patient populations for single therapies and multiple targeted therapies each with their own companion diagnostic. The complexity is further increased with the development of multiple therapies utilizing the same biomarker, but measured with different diagnostics and different selection (cut-off) criteria. Layered on top of that complexity are the differences in implementation diagnostics in various geographies globally. This talk will present some considerations of these topics, both opportunities and challenges.


Crossing the Chasm to Companion Diagnostic Commercialization
Jonathan Pan, Director, GlaxoSmithKline Oncology, United States of America

The development of a companion diagnostic and the evolving regulatory aspects has been of considerable discussion and advancement over the past several years.  An underrepresented area has been the commercialization of the companion diagnostic where several assumptions have proven to be invalid.  In this talk, we shift gears to talk about the commercialization of companion diagnostics, using historical case examples and new insights, looking at the different aspects of access:

•    Commercial Dynamics
•    Reimbursement
•    Sales and Marketing


Coffee Break, Networking, Exhibit and Poster Viewing


An Automated Platform for Enrichment, Detection, and Enumeration of Circulating Tumor Cells (CTCs): Potential Application as a Liquid Biopsy for Development of Companion Diagnostic Tests
Sunil Pandit, Senior Manager, Siemens Healthcare Diagnostics, United States of America

Siemens Healthcare Diagnostics is a global diagnostics company with a CAP accredited CLIA laboratory, the Siemens Clinical Laboratory (SCL) based in Berkeley, California. SCL provides test development and clinical trials testing expertize for pharmaceutical companion diagnostics needs, including enabling access to cutting-edge diagnostic technologies. In this presentation, the speaker will describe a novel Siemens circulating tumor cell (CTC) platform technology that may be used for companion diagnostic assay development at SCL. The ability to isolate and characterize rare circulating tumor cells (CTCs) has the promise of enhancing diagnosis, prognosis, resistance monitoring, and our understanding of cancer progression. Siemens has developed a platform for automated enrichment and characterization of CTCs in whole blood samples. The CTC system utilizes an automated liquid sample handling system to process blood samples and immunostain cellular proteins. CTC enrichment and staining is followed by imaging techniques to scan and analyse fluorescently-labelled cells. This technology is non-commercial and for Research Use Only (RUO).


Insights and Strategies for Companion Diagnostic Commercialization
John Schilling, Director & Advisor of Diagnostics, Eli Lilly & Co., United States of America

The purpose of the talk is to inform and educate the audience about Companion Diagnostic Commercialization strategies from a pharmaceutical business perspective.  The presentation will also discuss key insights that are analyzed in the decision making process.  Also the talk will highlight certain levers that can be used to effectively commercialize a global companion diagnostics.


Partnering for Personalized Medicine – Pharmaceutical and Diagnostic Industry Collaboration
Nicole St Jean, Corporate Business Development, AstraZeneca, United States of America

This presentation will cover a high-level overview of AZ’s current company status, global footprint and core areas of interest (research, investment, commercial, etc). Nicole will present AstraZeneca’s vision and mission in Personalized Healthcare (PHC) and share some of the partnerships AstraZeneca has established to in the Personalized Medicine space to further emphasize AZ’s commitment to PHC. Nicole will highlight challenges in partnering for companion diagnostics and opportunities we see for the future in this space.


Lunch, Networking, Meet the Exhibitors, and View Posters

Session Title: Companion Diagnostics (CDX): EU vs. Asia/Pacific Perspectives

Session Chair: Sylvie Le Gledic, Ph.D.


Current and forthcoming EU Regulations Surrounding in vitro Companion Diagnostics
Sylvie Le Gledic, Director IVD/CDx, Voisin Consulting Life Sciences, France

It is generally recognized that the current European in vitro Diagnostic (IVD) Directive presents a certain number of weaknesses, and more particularly its inadequate classification system (based on positive lists), that leads to an insufficient level of scrutiny for many medium to high risk IVD tests. On September 26th, 2012, the European Commission (EC) released the first draft of the new EU regulation for in vitro diagnostic medical devices (IVDs). Compromised amendments have then been voted in September  2013 by the European Parliament (EP) with an expected date of adoption by mid-2015.  The Companion Diagnostics (CDx) will be classified as high risk devices and specific requirements will be added to get these products CE marked. This presentation will describe the anticipated additional requirements that will apply to CDx in Europe and the practical implications for IVD test and drug developers. A parallel with the current FDA requirements on CDx will also be discussed for integration and provision of both specificities in a more international development.


The Diagnostics Journeys of Companion Dx Product Commercialization: The DxD Hub Perspectives
Thomas Li, Chief Technology Officer, A*STAR Singapore, Singapore

The objective of this presentation is to provide an update on the current status of the Diagnostics Development Hub in Singapore. We will describe the DxD Hub product development process. Within the Hub, we have devised a score card system to allow project entry into the Hub. The presentation will first highlight, the micro RNA technology journey, the biomarker panel development journey with the five levels of evidence for biomarker maturity. For companion diagnostics, another aspect of the diagnostics journey of co-development timeline in conjunction with the phase 1, 2 and 3 of drug clinical development will also be discussed. Finally, the regulatory journey of introducing a new diagnostics test into clinical practice and the oncology and heart failure patient care journey towards a personalized healthcare will also be presented.


Coffee Break, Networking, Exhibit and Poster Viewing


Developing Multi-Gene Biomarker Tests for Drug Therapy: Emphasis on Regulatory Variants and Epistasis
Wolfgang Sadee, Professor, Ohio State University, United States of America

The genetic background of a patient strongly influences response to drugs, affecting both efficacy and adverse drug reactions (ADRs).  Therefore, predictive genetic biomarker test have the potential substantially to improve treatment outcomes; however, known genetic variants account for only a portion of the overall heritability estimated from sibling studies – a gap termed the ‘missing heritability’ of complex phenotypes (mostly applied to common disorders).  Research in our Center focuses on discovery of causative variants that impact pharmacokinetic and pharmacodynamic drug effects, with the hypothesis that a majority of causative variants are regulatory or affect RNA biology.  These can be revealed by measuring allelic RNA ratios in human target tissues, either on a gene-by-gene basis or genome-wide with next generation sequencing (RNAseq).  We have identified such frequent variants in up to 20 key drug target genes.  Since each of these variants alone may not have sufficiently strong effect on outcomes, we propose that epistatic interactions between variants and genes (as a result of co-evolution) have the potential to narrow the gap and yield highly predictive genetic biomarker panels.   Examples will be presented.   Supported by NIH U01 GM092655.


GeneSight Psychotropic, a Combinatorial Pharmacogenomic Test, is Clinically Valid and Provides Clinical Utility for Patients with Treatment-resistant Depression
Anthony Altar, Chief Science Officer and Sr. Vice President, Assurex Health, Inc., United States of America

Pharmacogenomics has been proposed to augment treatment response and decrease healthcare costs by optimizing therapeutic selection for patients.  GeneSight Psychotropic is a combinatorial pharmacogenomic test that creates a composite phenotype based on allelic variations in 8 genes that encode CYP2D6, CYP2C19, CYP2C9, CYP1A2, CYP2B6, CYP3A4, the serotonin transporter, and the 5-HT2A receptor.  The test stratifies 38 psychotropic medications into one of three cautionary categories, based on the metabolic pathways and mechanisms of action for each medication.  Dr. Altar will review the genetic, genotypic, phenotypic, and combinatorial basis of the GeneSight test, and results of 3 prospective, 8-10 week long clinical studies involving 258 depressed subjects who had failed at least one antidepressant medication.  Patients whose clinicians received the test had a 70% greater antidepressant response and more than twice the odds of response compared to unguided clinicians whose patients received the standard of care.  The combinatorial pharamcogenomic apporach of the GeneSight test will also be shown for its superiority over single gene testing in predicting the clinical outcomes of unguided patients.


QIAGENTechnology Spotlight:
Technology platforms for Liquid Biopsy Investigation and Companion Diagnostic Development
Richard Watts, Vice President, QIAGEN

  • Accessing molecular signatures from biofluids presents an extremely useful & patient compliant approach to disease management
  • Overview of evolving technology platforms for signal isolation and detection
  • Case studies of longitudinal monitoring both disease and host response with examples across therapeutic areas including Oncology, Inflammation and CNS

Industry Trajectory Panel Discussion. Hosted by Scott Patterson, PhD, Amgen


Panel Discussion: Emerging Themes in Companion Diagnostics
Scott Patterson, Executive Director, Amgen Inc, United States of America


  • Nicholas Dracopoli, PhD -- Johnson & Johnson
  • Jonathan Pan, PhD -- GlaxoSmithKline
  • Nicole St. Jean, MBA -- AstraZeneca
  • Matthew Marton, PhD -- Merck

Topics for the Panel Discussion:

  • Current Status of the Companion Diagnostics (CDx) Landscape:  Disease Areas and the Types of Companies Participating
  • Types of Deals in this Space and Commercial Strategies:  Collaboration, Partnership, Picture of Deal Considerations/Risks
  • What is Required for Forging a CDx Partnership:  A How-To Guide For New Entrants From the Experts in the Field
  • Areas of Opportunity:  Therapeutic Areas, Technology Platforms, Classes of Biomarkers


Networking Reception: Premium Beers, California Wines, and Dinner for All Speakers, Delegates, and Exhibitors. Enjoy an Awesome Evening and Network with your Fellow Delegates.


Close of Day 1 of the Conference

Tuesday, 28 October 2014


Breakfast and Networking

Session Title: Biomarker Classes and the Potential of NGS in Companion Diagnostics Development, Also Who Will Pay for These New Technologies and Approaches?

Session Chairman: Robert Wassman, Ph.D.


Robert WassmanKeynote 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.


Yoshiya OdaKeynote 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?


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.


Coffee Break, Networking, Exhibit and Poster Viewing


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.


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.


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.


Lunch, Networking, Meet the Exhibitors, and View Posters

Session Title: Companion Diagnostics (CDX) Impacting Clinical Development--Case Studies

Session Chairman: Dan Rhodes Ph.D.


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.


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.


Coffee Break, Networking, Exhibit and Poster Viewing


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


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.


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.


Close of the Conference.

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