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
Registration for Workshop A & Coffee

09.00
Workshop A – Addressing the Challenges to Commercial Success for your CDx

Synopsis

Hosted by ANGLE plc in collaboration with the DxMA

Time: 9.00am-1.00pm

Purpose – Understanding the challenges in building a successful commercialization strategy will be explored in this workshop:

  • Gain a deep understanding of the U.S. and key global market access and reimbursement landscapes to inform robust strategic decision making
  • Detailed insight into how organizations have successfully developed partnerships enabling smooth commercialization and market adoption
  • In-depth discussion around how to continue to secure regulatory approvals

Workshop Agenda

9:00 Workshop Overview – Peggy Robinson

9:10 Overview of Global Market Access and Reimbursement Landscape with a Focus on US

9:40 The Global Regulatory Horizon & Partnership Components – “How to build a good marriage?”

10:10 Short Break

10:30 The Health Economics of CDx

11:00 Dx Stakeholder Perspective

11:30 CRO/Lab Stakeholder Perspective

12:00 Panel Discussion – An interactive discussion with a multistakeholder panellists experienced in enabling smooth commercialization and market adoption

Workshop Led by ANGLE plc in collaboration with DxMA:

  • Peggy Robinson, US Vice President, ANGLE plc
  • Lawrence J. Worden, President, DxMA and Managing Partner, MDxI
  • Bill Pignato, Founder and Principal at W.J. Pignato & Associates, LLC
  • Steven Anderson, CSO, Covance
  • Kathryn Becker, Franchise Director, Oncology and Companion Diagnostics, Abbott Molecular
  • Paul Keeling, CEO Diaceutics
  • Charles Matthews, VP, Boston Healthcare

13:00
Registration for Workshop B & Networking Lunch

14.00
Workshop B – Comprehensive Understanding of the CDx Development Process From Biomarker Discovery to Approved & Marketed CDx Product

Synopsis

Hosted by Hologic

Time: 2.00pm-6.00pm

Purpose – In depth insight into the needs of both pharmaceutical and diagnostic companies as well as global regulatory agencies and reimbursement

  • A comprehensive understanding of the CDx development process from biomarker discovery to approved and marketed CDx product
  • Understanding the Rx-Dx Dynamic
  • Embarking Down the CDx Road: When, Where & How?
  • Clinical & Regulatory Challenges

14.00 Welcome Introduction and Ice Breaker

14.10 CDx Development From the Rx and Dx Perspective

14.50 Interactive Solution Finding – Better Understanding the Evolving Rx-Dx Dynamic

15.05 Refreshment & Coffee Break

15.30 How does Pharma choose projects for CDx development and how to partner with a Dx company to enable success?

15.50 Where and how does regulatory and its route affect CDx development?

16.20 Interactive Solution Finding – Embarking Down the CDx Road: When, Where & How?

16.40 Short Comfort Break

16.50 Understanding Interactions with the FDA

17.20 Reimbursement challenges for a Dx Company in a CDx Area

17.40 Interactive Solution Finding – Overcoming Clinical and Regulatory Challenges

18.00 Closing Remarks of Workshop

Workshop Led by Hologic:

  • Dr Bob Holt, Companion Diagnostic Development Manager, Hologic
  • Paul Docherty, Regional Sales Manager, Hologic
  • Jane Kelly, Biomarker Services Operations Manager, Hologic
  • anice Hogan, Partner, Hogan Lovells US LLP
  • Martin Armstrong, Senior Director of Molecular Genetics, UCB Pharma
  • Paul Radensky, Partner, McDermott, Will & Emery

18:30
Evening Drinks Reception Co-Hosted by ANGLE & Hologic