Cambridge Healthtech Institute’s Third Annual

Companion Diagnostics

Strategies for Guiding Treatment and Improving Health

February 16-18, 2015 | Moscone North Convention Center | San Francisco, CA
Part of the 22nd Annual Molecular Medicine Tri-Conference

 

The field of companion diagnostics is undergoing radical changes with the battery of sequencing tests available and adoption of new clinical trial protocols. The reality is becoming apparent that a new strategy is needed for implementing and commercializing molecularly guided therapies. More personalized therapies are available but significant questions remain as to how to get patients the treatments best suited to their disease. Multi-gene panels are becoming the standard of care in oncology but the practice is far from commonplace. Practical aspects of reimbursement, regulation, patient payment responsibility, commercial launch and drug development will be covered in this comprehensive program detailing the state-of-the-art process for implementing companion diagnostics.

Scientific Advisory Board

Glenn A. Miller, Ph.D., CTO & Executive Vice President, Molecular MD

Jonathan Pan, Ph.D, MBA, Director, Oncology Companion Diagnostic and Disease Strategy, GlaxoSmithKline

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

Hakan Sakul, Ph.D., Executive Director and Head, Diagnostics, Worldwide R&D, Development Operations, Pfizer, Inc.


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Monday, February 16

10:30 am Conference Program Registration


KEYNOTE FORUM

11:50 Moderator’s Opening Remarks

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP (AMP 2014 President and Member, AMP Professional Relations Committee)

 

12:00 pm PANEL DISCUSSION: The Value of Molecular Diagnostics: A Discussion on Clinical Utility 

The number and complexity of clinical molecular diagnostic tests (MDx) are increasing at a rapid rate. The health care professional asks: When does MDx make sense for my patient? What scientific evidence is needed to establish the clinical utility of a particular MDx? This keynote session will focus on the clinical utility of MDx in cancer and inherited disease. It is an outgrowth of ongoing discussions on this issue among members of the Association for Molecular Pathology. We will address the contribution of MDx to the care of patients at the present time, and anticipated progress in the near future.

  • Defining and measuring clinical utility from the point of view of both the clinician and the patient
  • MDx of malignancies to offer prognostic and predictive information useful for selecting the optimal therapy
  • Halting the “diagnostic odyssey” by selecting the appropriate genomic MDx for people, often children, with diseases that are difficult or sometimes seemingly impossible to diagnose
  • Establishing the value of MDx as a modality that will not only improve health-care, but do so in a way that will lower costs in the long run

Panelists:

Loren Joseph, M.D., Medical Director, Molecular Diagnostics & Cancer Genetics, Pathology, Laboratory Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School (2014 Chair, AMP Clinical Practice Committee)

Paul G. Rothberg, Ph.D., Professor, Pathology & Lab Medicine, University of Rochester Medical Center (AMP Clinical Practice Committee, Genetics Subdivision Representative)


1:00 Session Break

1:15 Luncheon Presentation I: Rising to the Challenge of Liquid Biopsies using PointMan DNA Enrichment

Andrew Webb, CEO, EKF Molecular Diagnostics

1:45 Luncheon Presentation ll (Sponsorship Opportunity Available)

2:15 Session Break


PANEL DISCUSSION: COMMERCIALIZATION DYNAMICS OF COMPANION DIAGNOSTICS: ONE SIZE DOES NOT FIT ALL

2:30 Moderator’s Remarks

Jonathan Pan, Ph.D, MBA, Director, Oncology Companion Diagnostic and Disease Strategy, GlaxoSmithKline

  • Perspective on Global Market
  • Companion Diagnostics Assessment and Approval in Ontario; Insights from a Publicly Funded System
  • Defining Commercialization Requirements Lead by Engineering

Panelists:

Kenneth J. Bloom, M.D., Chief Medical Officer, Clarient, Inc.

Suzanne Kamel-Reid, Ph.D., DABMG, FACMG, Head, Clinical Laboratory Genetics; Director, Molecular Diagnostics, Pathology, The University Health Network; The University of Toronto

Omar D. Perez, Ph.D., Diagnostics Lead, Oncology, Biotechnology Clinical Development, Development Operations, Pfizer, Inc.

4:10 Sponsored Presentation

Speaker to be Announced

 

 Myriad RBM large logo4:25 Partnerships to Develop and Commercialize Complex Diagnostic and Companion Diagnostic Tests  

Sam LaBrie, Ph.D., Vice President, Corporate Development, Myriad RBM

4:40 Break and Transition to Plenary Session

5:00 Plenary Session

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day


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Tuesday, February 17

7:00 am Registration and Morning Coffee

8:00 Plenary Session

9:00 Refreshment Break in the Exhibit Hall with Poster Viewing


RNA SEQ FOR PATIENT STRATIFICATIOn

10:05 Chairperson’s Remarks

Michael C. Little,  Ph.D., Senior Advisor, Popper & Co

10:15 Genetic Profiling of Hematologic Malignancies

Ross L. Levine, M.D., Associate Member, HOPP; Associate Attending, Leukemia Service; Memorial Sloan-Kettering Cancer Center .

Clinical, cytogenetic, and gene-based studies have been used to inform biology and improve prognostication for acute myeloid leukemia (AML) patients. We and others have shown somatic mutations can be used to improve risk stratification in AML. We have more recently worked to develop assays for genomic profiling of leukemia, lymphoma and myeloma patients and demonstrated how these assays can be used to inform clinical care.

10:45 Sequencing Approaches for Personalized Cancer Therapy Selection and Monitoring

Daniela Starcevic, Ph.D., Director, Diagnostic Sequencing; Assistant Professor, Genomics and Multiscale Biology; Assistant Professor, Pathology; Icahn School of Medicine at Mount Sinai

The Personalized Cancer Therapy program is aimed at developing molecular diagnostics for better disease management: therapy selection and monitoring. Patients’ samples undergo state of the art sequencing and bioinformatics towards molecular level understanding of disease and a comprehensive/integrated approach for finding alternate, innovative and more effective treatment options. The opportunities and challenges of sequencing and analyzing tumor samples will be addressed and illustrated with examples.

11:15 Precision Oncology through Genomic Testing Strategies and Clinical Trials

Sameek Roychowdhury, M.D., Ph.D., Assistant Professor, Internal Medicine, Ohio State University Comprehensive Cancer Center

Dr. Roychowdhury will present on evolving use of genomic testing strategies for clinical decision making and eligibility, followed by challenges and approaches for application in clinical trials.

11:45 Presentation to be Announced

12:15 pm Session Break

12:25 Luncheon Presentation l (Sponsorship Opportunity Available)

Xagenic12:55 Luncheon Presentation ll : CLIA Waived Molecular Diagnostics: A Ripe Opportunity in the Age of Affordable Health Care

Ihor Boszko, Vice President, Business Development, Xagenic Inc.

1:25 Refreshment Break in the Exhibit Hall with Poster Viewing


Panel Discussion: PRACTICAL ASPECTS OF IMPLEMENTING THE MASTER PROTOCOL

2:00 Moderator’s Remarks

Glenn A. Miller, Ph.D., CTO & Executive Vice President, MolecularMD

  • Predictive biomarkers and translational medicine in the S1400 lung-mAP trial
  • Implementing the MATCH protocol
  • Opportunities and challenges in designing and conducting basket trials

Panelists:

Philip C. Mack, Ph.D., Associate Adjunct Professor, Internal Medicine, Hematology and Oncology, University of California Davis Medical Center

Jason Lih, Ph.D., Principal Scientist, Molecular Characterization Group, Leidos Biomedical Research, Inc./Frederick National Laboratory for Cancer Research

J. Carl Barrett, Ph.D., Vice President, Translational Sciences, Onc iMed, AstraZeneca

3:40 Enabling Advances in Cancer Genomics with NGS 

Frank S. Ong, M.D., Associate Director, Medical Affairs, Illumina, Inc.

4:10 Mardi Gras Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

This interactive session provides attendees an opportunity to choose a specific discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

How to Overcome the Hurdles towards More Efficient Pharma – Academia Collaborations

Daniela Starcevic, Ph.D., Director, Diagnostic Sequencing; Assistant Professor, Genomics and Multiscale Biology; Assistant Professor, Pathology; Icahn School of Medicine at Mount Sinai


• Overcoming the hurdles towards a more expedient translation of research findings from the bench to the clinic
• Understanding cultural and operational differences in pharma and academia
• Types of collaborations that maximize chances of success for both sides
• Structuring agreements towards successful outcomes

Implementation Strategies for NGS-Based Companion Diagnostics

John D. Pfeifer, M.D., Ph.D., Vice Chairman for Clinical Affairs and Professor, Pathology and Immunology; Professor, Obstetrics and Gynecology, Washington University School of Medicine


• Issues related to the fact that different genes have targeted therapies from different Pharma companies
• Issues related to the fact that different NGS platforms have different test metrics
• Issues related to the fact that different NGS test designs identify different classes of mutations

 

6:00 Close of Day


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Wednesday, February 18

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 Plenary Session Panel

9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall


Panel Discussion: HOW THE BUSINESS MODEL IS CHANGING FOR ONE DRUG, ONE DIAGNOSTIC

10:35 Moderator’s Remarks

Hakan Sakul, Ph.D., Executive Director and Head, Diagnostics, Worldwide R&D, Development Operations, Pfizer, Inc.

  • How the paradigm for companion diagnostics is changing with the development of multi-gene panels and NGS coming into commonplace use
  • How regulators view companion diagnostic tests
  • Assessment of companion diagnostic technologies at NICE

Panelists:

Sarah Byron, Ph.D., Diagnostics Assessment Program, National Institute for Health and Care Excellence

Mara Aspinall, MBA, former CEO, Ventana Medical Systems

Garret Hampton, Ph.D., Senior Director, Oncology Biomarker Development, Genentech, Inc.

12:15 pm Session Break

12:25 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing


IMPLEMENTATION STRATEGIES FOR NGS-BASED COMPANION DIAGNOSTICS

1:40 Chairperson’s Remarks

John Pfeifer, M.D., Ph.D., Washington University School of Medicine

1:50 The Devil is in the Details: Clinical Realities of NGS-based Tests as Companion Diagnostics

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

NGS-based approaches make it possible to evaluate several thousand genes in a single assay, which provides the opportunity to stratify patients with many different diseases into many different treatments based on the results of a single lab test.  However, the utility of an NGS-based Companion Diagnostic model will depend on several factors, including the scope of testing (genes and range of variants), test metrics, and medical evidence of better patient outcomes. 

2:20 Companion Dx, LDTs, NGS and the MolDx Perspective – How Can We Get from Here to There?

Dane J. Dickson, M.D., Director, Clinical Science, MolDx, Palmetto GBA

Technology often outpaces clinical application. Yet, in some cases, waiting for clinical medicine to catch up before payer coverage may deprive patients of new and promising therapeutics. Finding an appropriate balance of “faith” and “science” is necessary to bridge the scientific gaps. This presentation discusses the MolDX approach to this complex balancing act, including a well-defined process of moving promising technology forward.

2:50 PANEL DISCUSSION: IMPLEMENTATION STRATEGIES FOR NGS-BASED COMPANION DIAGNOSTICS

Panelists:

Edgar Braendle, M.D., Ph.D., Senior Vice President & Global Head, Companion Diagnostics, Novartis

Dane J. Dickson, M.D., Director, Clinical Science, MolDx, Palmetto GBA

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

3:20 Sponsored Presentations (Opportunities Available)

3:50 Refreshment Break


CTCs FOR COMPANION DX

4:00 Chairperson’s Remarks

Steven A. Soper, Ph.D.

4:10 CTCs in Mouse Models

Jen Jen Yeh, M.D., Associate Professor, Surgery and Pharmacology, UNC Chapel Hill Lineberger Comprehensive Cancer Center

This presentation will provide an overview of the data on CTCs in mouse models and their possible uses as biomarkers.

4:40 Challenges and Opportunities in the Use of CTCs for Companion Diagnostic Development

Elizabeth Punnoose, Ph.D., Senior Scientist, Oncology Biomarker Development, Genentech, Inc.

Circulating tumor cells offer promise as a surrogate source of cancer cells that can be obtained in real time and may provide opportunities to evaluate predictive biomarkers that can guide treatment decisions. In this review, we consider some of the technical hurdles around CTC numbers and suitability of various CTC capture and analysis platforms for biomarker evaluation. In addition, we consider the potential regulatory hurdles to development of CTC-based diagnostics. Finally, we suggest a path for co-development of anticancer therapeutics with CTC-based diagnostics that could enable clinical validation and qualification of CTC-based assays as companion diagnostics.

5:10 Circulating Tumor Cells: What Is in It for the Patient? A Vision Towards the Future

Paul A. van de Wiel, Ph.D., Senior Director, Precision and Decentralized Diagnostics, Philips Research

Knowledge on signal transduction pathways as drivers of cancer growth has fuelled development of targeted therapy. However, good companion diagnostic tests to determine the tumor driving pathways are still lacking. We will discuss novel approaches of assessing active tumor pathways based on advanced staining of CTCs in combination with automated image interpretation on a digital pathology platform, and by PCR-based analysis of isolated CTCs.

5:40 Close of Conference Program



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2015 MMTC Final Agenda 

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