October 18 – 19 2017

Boston, MA

Day 1
Wednesday October 19th, 2016

Day 2
Thursday October 20th, 2016

Day 3
Friday October 21st, 2016

Workshops
Tuesday October 18th, 2016

Synopsis

We’re busy building the agenda for 2017

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08.00
Registration & Breakfast

09.00
Chairman’s Opening Remarks

Targeted Immunotherapies, Complementary & Companion Diagnostics

09.05
Predictive Biomarkers for Pembrolizumab

  • Eric Rubin Vice President & Therapeutic Area Head, Oncology Early Development, Merck

Synopsis

  • Clinical utility of PD-L1 immunohistochemistry in identifying responders to pembrolizumab
  • Beyond PD-L1 immunohistochemistry – potential of RNA- and DNAbased assays to identify responders to pembrolizumab

09.30
Decentralized Multiplexed Companion Diagnostics on the NanoString nCounter Analysis System

  • Sean Ferree Vice President, Diagnostic Development, NanoString Technologies

Synopsis

  • The NanoString nCounter Dx Analysis System is a novel technology that digitally counts single nucleic acid molecules using fluorescent single-molecule barcodes
  • Several companion diagnostic tests are in development including a cell-of-origin subtyping test for diffuse large B-cell lymphoma to select patients for targeted therapies and an immune response signature to predict response to anti-PD1 blockade in multiple solid tumor types

10.00
Diagnostics for Cancer Immunotherapies: Present and Future Outlook in Healthcare and Precision Medicine

Synopsis

  • Understand the challenge of companion diagnostics approaches for cancer immunotherapies
  • Discussion will be lead around the interplay of molecular information and diagnostics in a precision medicine strategy accompanying development and adoption of immuno-oncology drugs

10.25
Immuno-Oncology Targeting Therapies: Developing Diagnostics to Meet Patient Needs

Synopsis

  • Understand the strategy behind developing diagnostics for different patient populations
  • Evidence Based Diagnostic Utility: Evolution of PD-L1 from a complementary to a companion diagnostic
  • The Bristol-Myers Squibb pipeline and diagnostics to address continued unmet needs in ImmunoOncology

10.50
Speed Networking & Morning Refreshments

11.40
The Art of Oncology: How to Utilize Biomarker Tests for Immuno-Oncology Treatments in the Real-World

  • Zhen Su Vice President & Head, Global Medical Affairs, Oncology, EMD Serono

Synopsis

  • Understand the strategic and practical implications of how to select the right test at the right time for the right patient
  • Discussion will be led around what is the next wave of biomarkers for immuno-oncology therapies

12.05
Fast to Pivotal: An Approach to Cut-Off Determination to go Directly to Pivotal Trial

  • Jay Foust CDx Partnering, Roche Tissue Diagnostics (Ventana)

Synopsis

  • Understand how clinical trial design should have a strategic impact on targeted therapy development
  • Case studies of opportunities where this strategic impact is experienced when developing companion diagnostics

12.35
How to Maximise the Value of Biomarkers in Immuno-Oncology: A Role for Companion and Complementary Diagnostics

Synopsis

  • Appreciate the key role that biomarker of immune function will play in the development of next generation immunotherapies
  • Gain an overview of the various biomarkers that are being evaluated in immuno-oncology
  • Define and better understand the value provided by companion and complementary diagnostics for immuno-oncology therapies
  • Learn the key steps to be considered for the successful development and commercialization of a companion or complementary diagnostic

13.05
Networking Lunch

14.15
Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

  • Eric Rubin Vice President & Therapeutic Area Head, Oncology Early Development, Merck
  • Miro Venturi Global Head, Diagnostics, Biomarkers, Roche
  • Steven Anderson CSO , Covance
  • Zhen Su Vice President & Head, Global Medical Affairs, Oncology, EMD Serono
  • Bruce Jordan Vice President, International Business Leader, Companion Diagnostics, Roche Diagnostics
  • Steven D. Averbuch, M.D. Vice President, Development, Oncology & Pharmacodiagnostics, Bristol-Myers Squibb

Synopsis

  • What does a clear definition of a “complementary diagnostic” look like?
  • How do we maximize the impact of diagnostics in immuno-oncology therapeutic development?
  • Do we need complete standardization between different diagnostic assays targeting the same biomarker?
  • Are we in a position to utilize combination therapies with diagnostics?
  • How are we making decisions on how to develop complementary diagnostics without much guidance?
  • Was the first approval of a complementary diagnostic what the FDA have actually labelled it as?
  • Are the FDA struggling to keep up with the science in the field at large?

Liquid Biopsies in Precision Medicine

15.00
Liquid Biopsies: Changing Treatment Paradigms for Patients

  • Stefan Scherer Vice President, Global Head, Correlative Sciences, Novartis

Synopsis

  • Understand the importance and the added value of liquid biopsies in precision medicine and drug development
  • Discussion will be led around how liquid biopsies are shifting us to more real-time treatment decisions for patients in need

15.30
Epitope-Indpendent Capture and Harvest of CTCs from Blood

  • Claudia Hille PhD Student, University Medical Center Hamburg - Eppendorf (UKE)

Synopsis

  • Introduction to the operation and performance of the Parsortix CTC capture and harvest system
  • Illustration of the workflows for protein and genomic analysis of CTCs
  • Case studies from collaborations exploring the use of CTCs as companion diagnostics

16.00
Afternoon Refreshments

Targeted Therapy, Diagnostic & Technology Regulation & Policy

17.00
The Regulatory & Policy Landscape of Precision Medicine’s and Diagnostics: What have we Accomplished?

Synopsis

  • Understand the recent history and important milestones along the timeline for precision therapies, diagnostics and associated technologies
  • Discussion around what is likely to change in the future with regards to drug and device regulation and policy impacting precision medicine
  • An look at key drug-companion diagnostic approvals and what lessons have been taken forward

17.30
Panel Session: Achieving Drug, Diagnostic and Tech Regulatory Approval in the U.S. and Other Leading Geographies

Synopsis

  • What can we expect to see from the finalized guidance of LDT’s by the FDA?
  • What can be done to get FDA and the Clinical Lab’s speaking the same regulatory language?
  • What are the key success factors when aligning drug-CDx co-development for regulatory approval and launch?
  • How do you define a biomarker and what is the criteria for a “validated” assay?
  • How do we make the most of breakthrough designations and adaptive licensing?
  • How are we dealing with The EU, China, Japan and beyond with precision medicine regulation?

18.10
Close of Day 1

Boston Tea Party Evening Reception, Hosted by Abbott Molecular