​​​​​​​​​Complexities in Personalized Medicine: Harmonizing Companion Diagnostics across a Class of Targeted Therapies

Audio/Slide Recordings Now Available​

On March 24, 2015, The U.S. Food and Drug Administration (FDA), the American Association for Cancer Research (AACR), and the American Society of Clinical Oncology (ASCO) cosponsored a public Workshop titled “Complexities in Personalized Medicine: Harmonizing Companion Diagnostics across a Class of Targeted Therapies” at the Mayflower Renaissance Hotel in Washington, D.C.​

The goal of this workshop is to foster a collaborative examination of challenges related to the development and use of multiple diagnostics and targeted therapies that take advantage of the same or similar biomarkers by: 1) defining the impact of the problem from a multi-stakeholder perspective; 2) drawing attention to the need for harmonization or comparability between companion diagnostics within a class of targeted therapies; and 3) identifying and examining possible solutions. 

Read the​ detailed agenda.

Download the presentation slides.

Read the w​orkshop transcript.

Learn more about the Industry​ Working Group Blueprint Proposal, including public comments and the group's responses.

Listen to recorded audio with accompanying slide presentations.

Numerous sponsors are developing therapeutic products that use similar or identical biomarkers for therapeutic selection requiring a companion diagnostic in vitro diagnostic (IVD) device. Given the current practice of independent IVD development programs for each sponsor, the matrix of drugs and companion diagnostics presents a complex challenge for testing and decision making  in the clinic. The challenge is exacerbated by the need to ensure comparable and/or harmonized analytical and clinical performance characteristics supporting claims that are shared across companion diagnostic devices.

The public workshop brought together patients, clinicians, pathologists, drug and diagnostic manufacturers, regulators and others to discuss potential solutions to these challenges.

Recorded Audio​ with Slides

Below are audio recordings from the workshop with the accompanying slides used during the presentation. Note that not all of the speakers/panels used slides. In these instances, the panelists' names are displayed. 

Session 1: Defining the Problem - Stakeholder Presentations


Session 1: Defining the Problem - Panel Discussion


​Session 2: Comparing the Tests - Industry Working Group Blueprint Proposal​ and Panel Discussion

Session 2: Comparing the Tests - Second Panel Discussion

​​Session 3: Clinical Practice/Education - Panel Discussion, Q&A, and Closing Remarks​