Companion Diagnostics (CDX) Forum

Demonstrating the Value of Companion Diagnostics for Precision Biologics and Drugs


December 6-7, 2017


New Jersey Hospital Association
Princeton, NJ


Demonstrating the Value of Companion Diagnostics
for Precision Biologics and Drugs

Companion diagnostics (CDx) have been on the market and used to treat diseases for several years. Notable examples include Xalkori and Ventana ALK (D5F3) CDx Assay; Gleevec and Dako C-KIT PharmDx; Keytruda and Dako PD-L1 IHC 22C3 pharmDx; Tarceva and cobas® EGFR Mutation Test v2; and Herceptin and Pathvysion HER-2 DNA Probe Kit. However, not only must CDx-drug pairs demonstrate therapeutic utility, drug companies and their business partners must realize net financial benefits.In this symposium, examples and strategies to pair drugs and assays to improve safety, efficacy, outcomes, and economic value will be presented and discussed.

What is a Companion Diagnostic? The FDA’s definition:

A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.

Companion diagnostics can:

  • identify patients who are most likely to benefit from a particular therapeutic product;

  • identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or

  • monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

Benefits Of Attending & Who Should Attend

Attendees will hear speakers address topics covering the following areas:

  • Tools and techniques to validate CDx-drug pairs
  • Examples of business cases as models for future offerings
  • Growth potential of complementary diagnostics
  • Trade-offs between LDTs and CDx pathways
  • Competitive advantages for drugs with a companion assays
  • Strategies for successful partnerships enabling development through marketing
  • Alliance management among pharma, diagnostic, and CRO partners
  • Tactics for drafting and closing deals for CDx-drug pairs

We welcome researchers in biotechnology organizations ranging from start-up companies to leading-edge suppliers to non-profit institutions. Functions of attendees range from development to post-marketing surveillance with biomarkers (development) and diagnostics (market offerings).

Professionals in biopharma, biotech, academics, government, diagnostics, and CROs are all invited to register:

  • VPs in Translational Medicine and related functions
  • Executive/Senior Directors
  • Laboratory and Technology Directors
  • Project Managers (technical, logistical, and transitioning projects to partners)
  • Technology leaders and researchers (assays, platforms, informatics)
  • Researchers in assays, diagnostics (basic, development, validation, execution)
  • Allied VP, Executive/Senior Directors, Directors, and Associates in licensing and regulatory


We are accepting Abstracts for this Forum.  The Abstract Submission page includes Abstract guidelines and Topics.

2016 Companion diagnostic highlights

Sign-up to watch the 2016 Companion Diagnostics highlights

First Name*
Last Name*
Job Title*