September 12-14, 2018 Holmdel, NJ

Companion Diagnostics Forum

Next Forum: 4Q 2019

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COMPANION DIAGNOSTICS FORUM 2019

4Q 2019 – The Auditorium at Bell Works in Holmdel, NJ

Thank you for attending the 3rd Annual Companion Diagnostics Forum at the historic Bell Works building in Holmdel, NJ. This targeted forum of over 110 attendees focused on key issues related to the growth of Companion Diagnostics. Information about the 2019 event will be available shortly.

Brochure is Available

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 covered in 2018 included:

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 previous Companion Diagnostics Forums 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

Featured 2018 Speakers

Alberto Gutierrez

Former Director, FDA Office of In Vitro Diagnostic Device Evaluation and Safety

Consultant

John Wagner

Senior Vice President, Head of Translational Research and Early Clinical

Takeda Pharmaceuticals

John Wagner

Senior Vice President, Head of Translational Research and Early Clinical

John A. Wagner, MD, PhD, FCP, FAAPS is currently Senior Vice President and Head of Clinical and Translational Sciences at Takeda Pharmaceuticals International Co. He is also currently Immediate Past-President, the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Wagner has over 20 years of experience in pharmaceuticals, drug research and development, translational medicine, experimental medicine, clinical pharmacology, biomarkers and surrogate endpoints, modeling and simulation, precompetitive collaboration, project leadership and management, portfolio management and prioritization, and scientific strategy. Dr. Wagner received his M.D. from Stanford University School of Medicine and Ph.D. from the Johns Hopkins University School of Medicine. Postgraduate training included Internal Medicine Internship and Residency, as well as Molecular and Clinical Pharmacology Postdoctoral Fellowships at Stanford. He began his professional career in academic research on Cystic Fibrosis and has continued in the pharmaceutical industry, largely in the context of drug development as well as biomarkers. Previously, Dr. Wagner’s professional positions included Senior Consultant to the Institute of Medicine, Vice President and Head, Early Development Pipeline and Projects and Head, Global Project Management at Merck & Co., Inc., Vice President and Head, Clinical Pharmacology, at Merck & Co., Inc and Acting Modeling and Simulation Integrator, Strategically Integrated Modeling and Simulation at Merck & Co., Inc. He is the past chair of the PhRMA Clinical Pharmacology Technical Group, past chair of the adiponectin work group for the Biomarkers Consortium, past committee member of the National Academies Institute of Medicine Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, and past member of the National Academies Institute of Medicine National Cancer Policy Forum. Over 200 peer-reviewed publications detail work across a variety of therapeutic areas and disciplines.

Laurie Howard

Vice President, Policy and Payer Relations

LabCorp

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