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

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08.00
Breakfast & Networking

Impact of Precision Medicine on the Healthcare System

09.00
Chairman’s Opening Remarks

09.15
How Can we Improve Patient Access to Testing for Earlier Diagnosis?

  • Jack Whelan From Research Analyst to Research Advocate, Patient Advocate

Synopsis

  • Understand the current shortfalls of the healthcare system when it comes to patient access for cancer testing
  • A look at the current culture of patients and physicians when it comes to access to earlier testing
  • Discussion will be led around what needs to change for us to improve the standard of healthcare in the U.S. and abroad

09.35
Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

  • Jack Whelan From Research Analyst to Research Advocate, Patient Advocate
  • Edmund Pezalla Vice President, National Medical Director, Pharma Policy & Strategy, Aetna
  • David Roth Director, Penn Center for Precision Medicine, University of Pennsylvania
  • Kenna Mills Shaw Executive Director, Institute for Personalized Cancer Therapy, MD Anderson Cancer Center
  • Louis Fiore Executive Director, MAVERIC US Department of Veterans Affairs
  • Eric Faulkner Vice President, Precision and Transformative Technology Solutions, Evidera

Synopsis

With patient advocates, payers and leading physicians, this panel session will discuss and debate the following:

  • What strategies are currently being used by drug developers to manage patient disease progression when looking at archival samples and fresh quality samples?
  • How are liquid biopsies improving the access to quality samples for drug developers?
  • How do we improve physician and patient education to increase the reach and impact of precision medicine?
  • How can drug developers, diagnostic developers, hospitals, patients and consortia work together to identify and treat more patients with unmet medical needs?
  • Patients with multiple mutations: do we look to target all mutations at once?
  • How do we improve the standards of testing sites to ensure the right patients are enrolled onto the right clinical trials?
  • What are the different country acceptances towards clinical trial design on a global scale?
  • How do we feed data from clinical trials and real world evidence into shared databases?
  • How do we balance the urgency of getting a patient tested vs. the validation of the test?

10.15
A Pragmatic Approach for the Successful Co-Development of Drugs and Diagnostics: Case Studies with Focus on Mitigating Risk in Oncology Drug Development

Synopsis

  • Managing design changes and transitioning from CTA to IVD
  • Timing and frequency with FDA meetings
  • Management of reagent supply risks
  • Planning software development and validation
  • Timing of commercialization and reimbursement plans

 

10.45
Morning Refreshments & Networking

Chair: Daniel O’Shannessy, Translational Diagnostics
Emerging Biomarkers & Approaches

11.05 Automated, Sensitive Microfluidic Device for CTC Capturing and Characterization

  • Validated and easy-to-use label-free technology to capture, characterize, and enrich CTCs with 85% reproducible capturing efficiency
  • This technology enables downstream characterization by immunohistochemistry, DNA and mRNA FISH
  • A look at how captured CTCs can be retrieved for use in PCR, NGS and culture
Kalyan Handique, President & Chief Executive Officer, Celsee Diagnostics

12.05 Next-Generation Biomarkers for the Era of Combination Cancer Immunotherapy

  • Understand the thought process of the biomarker and companion diagnostic development in the pembrolizumab program
  • Discussion will be led around translational research and biomarker approaches to address combination approaches in immuno-oncology
David Kaufman, Executive Director, Translational Immuno-Oncology Lead, Oncology Clinical Research, Merck

Chair: Mark Oldroyd, Senior Director, Regional Payer Relations & Reimbursement, Foundation Medicine
Late Phase Clinical Case Studies

11.05 Diagnostic Test to Support PML Risk Stratification in Multiple Sclerosis Patients

  • Case study will describe the science and experience in the development of a 510K cleared clinical diagnostic test
  • Develop to stratify the risk of progressive multifocal leukoencephalopathy (PML) in Multiple Sclerosis patients considering treatment with or treated with natalizumab
Meena Subramanyam, Vice President, Translational Sciences & Technology, Biogen

11.35 Parameters and Models when Efficiently Managing CDx-Rx Programs to Sustain Successful Partnerships

  • More information to follow.
Karina Kulangara, Scientific Manager, Companion Diagnostics, R&D, Agilent Technologies

12.05 Presentation and Speaker to be confirmed

Chair: Sangeetha Ramsagar, Director, Strategic Business Improvement, Johnson & Johnson

11.05 Companion Diagnostics Roundtables

With three days full of the leading case study-driven presentations, the CDx roundtables will allow you to have more intimate discussions with precision medicine leaders around some of the hottest topics in the field. Discover multiple perspectives on these key issues, so that you can learn from your fellow experts in the audience. Drive your own learning, crowd-source ideas and get inspired:

  • Demonstrating Clinical Utility with Liquid Biopsies
  • Is NGS the Future of Precision Medicine?
  • How to evolve the pharma-diagnostic partnering paradigm to ensure continued CDx & precision medicine development?

12.35
Networking Lunch

Securing Evidence-Based Drug, Diagnostics & Test Reimbursement in Precision Medicine

13.35
Deciphering Drug and Diagnostic Reimbursement: Who’s Paying for What?

  • Edmund Pezalla Vice President, National Medical Director, Pharma Policy & Strategy, Aetna

Synopsis

  • Understand what are the general expectations are from both a diagnostic developer and a pharma partner when preparing a drug-companion diagnostic combination
  • An in-depth look as to where in the development process should pharma and diagnostic developers start preparing a market access strategy
  • Understand how to effectively and robustly co-develop value-based evidence and a value proposition for market access and reimbursement

14.05
Evidence Street™: Where the Market Meets Evidence

  • Suzanne Belinson Executive Director, Center for Clinical Effectiveness, BlueCross and BlueShield Association

Synopsis

  • Reducing uncertainty for precision medicine will require collaboration for the collection and synthesis of data
  • The BlueCross BlueShield Association has a long history for leadership in evidence review
  • The Evidence Street™ is a web-based platform providing the opportunity for healthcare stakeholders to submit materials for consideration, track evidence reviews, and collectively receive evidence opinions

14.35
Panel Session: Securing Evidence-Based Drug, Diagnostics & Tech Reimbursement in Precision Medicine

  • Girish Putcha Director, Laboratory Science, Palmetto GBA
  • Edmund Pezalla Vice President, National Medical Director, Pharma Policy & Strategy, Aetna
  • Suzanne Belinson Executive Director, Center for Clinical Effectiveness, BlueCross and BlueShield Association

Synopsis

  • How are we looking to deal with differential pricing indications in molecular testing?
  • With the price of oncology drugs constantly increasing, how do we manage the CDx price vs. value discussion?
  • What’s driving reimbursement? Are payers waiting for tests to drop in price?
  • How do we make molecular testing the standard of healthcare? Will payers reimburse this?
  • If standardization of testing was to occur, would this improve test reimbursement?
  • Should pharma figure out who to support diagnostic partners more with commercialization?
  • What is the expected impact of modifying the Protecting Access to Medicare Act proposed rule?
  • What are we anticipating the impact of bundled pricing to be on new diagnostic entries?

15.05
Close of World CDx Boston 2016