October 17 – 19 2017 | Boston, MA

Hilton Boston/Woburn

Pre-Conference AM Workshop
Tuesday, October 17, 2017

09.00 - 12.00
Precision Medicine & Companion Dx – The Evolving Role of In Vitro Diagnostics Guiding Patient Management from Risk Stratification to Outcome

Precision Medicine holds the promise of therapeutics driving improved patient outcomes through targeted molecular approaches that transform historically fatal diseases into chronic, manageable ones. Oncology has spearheaded many of the advances in the recent Precision Medicine but with ever changing healthcare needs and investment we are now also observing an expanding focus into other disease spaces including autoimmune, neurodevelopmental and neurodegenerative diseases.
Join Asuragen Inc. and their panel of cross-healthcare experts in this workshop to do a deep dive into how the 4 key stakeholders – Payer, Pharma, Provider and IVD Companies – can come together for the vision of Precision Medicine to become reality. The workshop will examine themes including the roles of decentralizing testing and evolving CDx offerings to support testing across the entire risk stratification to outcome assessment continuum.

The format for the workshop will be four 40 minute tracks followed by a 30 minute interactive panel discussion.

  • Topic One: The IVD Role in Driving Precision Medicine

*With a broadening of the needs from Dx in therapy selection and management the testing technologies and test characteristics required are evolving. What is required in the IVD space to ensure maximal reach, effectiveness and performance for a complementary or companion diagnostic?

Matthew McManus, President & CEO, Asuragen

  • Topic Two: A Healthcare System Perspective

*New Molecular Dx technologies have created data sets of unprecedented complexity which are not always immediately conducive to aiding clinical decisions. What are the attributes of Complementary and Companion Dx tests that make them effective and usable by healthcare professionals?


John Longshore, Director, Molecular Pathology, Carolinas Pathology Group, Carolinas HealthCare System

  • Topic Three: The Evolving Payer Landscape

*As risk-sharing & outcome-based payment models become increasingly present around the world, how will the Payers change the Complementary and Companion Dx model for all the other stakeholders?

Hannah Mamuszka, CEO, ALVA 10

  • Topic Four: Evolving Pharma Needs from CDx

*With increasing regulatory requirements for Companion Diagnostics and evolving reimbursement landscapes now including “pay for performance” type approaches, the critical nature of selecting biomarkers and the appropriate testing strategies has increased. What characteristics define the optimal CDx partner and test for Pharma success?

Peter Hoehn, Co Diagnostics Commercial Strategy Leader, Janssen Pharmaceuticals


How to Apply

If you are interested in joining the pre-conference workshop hosted by Asuragen, please email ben.carrington@hansonwade.com.
If accepted, the workshop will be free to attend as part of your conference registration. Confirmation of attendance will be given via email.

Pre-Conference PM Workshop
Tuesday, October 17, 2017

13.00 - 17.00
Navigating the Companion Diagnostics Co-Development Process

Join Covance and their panel of industry expert speakers before the start of World CDx in this workshop to take a deeper dive into the strategy behind drug and companion diagnostic co-development. Benefit from multi-stakeholder perspectives, granular discussion and extended networking with the brightest biomarker, precision medicine and diagnostic minds in the field. This workshop will address the following aims:

      1. Understanding the different pathways, cost structures and risks to drive better decision making
      2. Asking the right questions and choosing the best pathway for clinical development and commercial success

 

Agenda

  • Topic One: Regulatory and Operational framework

*Understand and address the necessary the global regulatory requirements.
*When is an IVD partnership the best path? What are the appropriate applications for the lab-developed test model?

Bill Pignato, Principal, W.J. Pignato & Associates

Tom Turi, PhD, Vice President, Companion Diagnostics, Covance, Inc.

 

  • Topic Two: Technical Platforms

*Recognize the role of emerging technologies, with an appreciation for factors such as access / scale / application of a given technology. How do you assess fit?

Sarah Hersey, Companion Diagnostics and Precision Medicine Head, Celgene Corp.

Melissa Reuter, Associate Director, Business Development, QIAGEN

 

  • Topic Three: Commercialization

*Launching a diagnostic is different from launching a drug. With that understanding, how do you ensure adequate access to both the drug and the CDx on Day 1?

Keith Hanigan, Vice President, Integrated Oncology (LabCorp)

 

  • Panel Discussion – Moderated by Steve Anderson, Chief Scientific Officer, Covance, Inc.

How to Apply

 

If you are interested in joining the pre-conference workshop hosted by Covance, please email ben.carrington@hansonwade.com.

 

If accepted, the workshop will be free to attend as part of your conference registration. Confirmation of attendance will be given via email.