FOCUSING ON CARE FOR THE PATIENT:
PRECISION DIAGNOSTICS OPENS THE WAY TO PRECISION MEDICINE
Join us for the 3rd Annual Companion Diagnostics Forum on September 13-14 at the historic BellWorks building in Holmdel, NJ, with a day of workshops on September 12th. This targeted forum of over 120 attendees focuses on key issues related to the growth of Companion Diagnostics. This year we expect to add more discussion of Regulatory and Reimbursement topics to our agenda.
Precision Diagnostics have played a critical role in the introduction of precision medicine in the clinic. Whereas first generation companion diagnostics have largely been single-analyte tests, researchers are now engaged in converting even more complex biology into novel drug therapies and next generation assays to treat a broader array of diseases. At the same time, biopharma companies are communicating with FDA and the Centers for Medicare & Medicaid Services to facilitate parallel approval and coverage determinations of these novel drugs and assays. A notable next generation example is CMS proposed coverage of the multi-gene F1CDx assay; this test is the second IVD to be approved and covered by the FDA and CMS under the Parallel Review Program. At this Forum, talks and topics will focus on the value of new and existing precision diagnostics from the development stage to reimbursement coverage as well as factors influencing the uptake of these technologies in healthcare.
*For purposes of this event, Precision Diagnostics includes Companion Diagnostics (CDx), Laboratory-Developed Tests (LDT), and Complementary Diagnostics.
Topics expected to be covered include:
Role of Precision Diagnostics in Precision Medicine
Tools for educating Physicians on Companion Diagnostics, Precision Medicine, and related products
Updates on FDA Regulatory topics and related issues
Experiences and expectations of Payers, Patients, and Patient Advocates on Reimbursement
Approaches to incentivize Adoption and Uptake of Companion Diagnostics and Precision Medicine by Physicians.
Representative from Patient Advocacy Groups on educational channels for patients to community Physicians and Clinics
Experiences of Patients who have used Companion Diagnostics
FDA path vs. LDT/CLIA: related issues, pros/cons, trade-offs
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.
Companion Diagnostics (CDx) and Complementary Diagnostics have now been available for several years. Notable examples of Companion Diagnostics 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. Not only must CDx-drug pairs demonstrate therapeutic utility, Pharma/Biotech and their business partners must realize net financial benefits.
Talk Recordings from the Companion Diagnostics Forum 2016 and 2017 are available to view, you will just need to fill in a simple form to view.
“Overall, the conference was fantastic. The quality of talks was outstanding: Michelle, Nick, Steve, Jeff, Bill, Ken, Chris Major, etc, etc Their talks were great. I really like that vendors like nanostring and thermofisher gave great talks explaining the development of their approved CDx and outcome of FDA review, plus tough situations they encountered during this process. Fantastic meeting!”
Oscar Puig Chief Scientific Officer Phosphorus
Discounted Attendee Registration
Register 3 Attendees and get a 4th Attendee Free. Contact us to take advantage of the discount.