Companion Diagnostics is a rapidly growing market segment within the in vitro diagnostics/ molecular diagnostics area. CHI's Companion Diagnostics conference is a unique program that presents diagnostics perspectives on personalized medicine and companion tests development from industry and academia. Join us for a plenary keynote session on FDA guidelines for laboratory developed tests.
The conference will cover some of the most important issues, including:
* Solutions for successful partnership with pharmaceutical companies
* Scientific advances in companion testing
* Reimbursement of companion testing
* Business models for pharma-diagnostics partnership
* Internal diagnostics and pharmaceutical partnership
AGENDA AT-A-GLANCE:
Wednesday, August 22
PLENARY KEYNOTE DISCUSSION:
Regulation of LDTs and RUOs
Alberto Gutierrez, Ph.D., Deputy Director, Office of in vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
Moderated by: Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology & Medicine; Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine; President and CEO, Mayo Medical Laboratories and Mayo Collaborative Services, Inc.
PLENARY KEYNOTE:
Position of IVDs on Regulatory Issues
Alan Mertz, President, American Clinical Laboratory Association (ACLA)
Diagnostic Manufacturers: Key Regulatory Issues
Andrew C. Fish, Executive Director, AdvaMedDx
TECHNOLOGY IN THE SERVICE OF COMPANION DIAGNOSTICS
What Will it Take to Realize the True Potential of Companion Dx?
Michael Nohaile, Ph.D., Global Head, Novartis Molecular Diagnostics
Companion Diagnostics of the Future: LDTs and Complex Gene Signatures Using Next Generation Sequencing
Premal Shah, Ph.D., Director, Business Development, Genomic Health, Inc.
Fully Automated Platform for Companion Diagnostics
Richard A. Montagna, Ph.D., Senior Vice President, Scientific Affairs, RHEONIX, Inc. Sponsored by RHEONIX, Inc.
Single Molecule Arrays (SiMoA) for Ultrasensitive Protein Detection in Companion Diagnostics
David C. Duffy, Ph.D., Vice President, Research, Quanterix Corporation
Sponsored by Quanterix Corporation
New Paradigm for Advancing Personalized Medicine: The Contract Diagnostics Organization
Philip D. Cotter, Ph.D., F.A.C.M.G., Co-Founder, ResearchDx, LLC
Sponsored by ResearrchDx, LLC
Companion Diagnostic using Multiparameter Flow Cytometry for Nucleoside Transporter hENT1 in Acute Myeloid Leukemia
Bruce H. Davis, M.D., President & Founder, Trillium Diagnostics, LLC
Sponsored by Trillium Diagnostics, LLC
Finding the Right Tool: Tailoring the Assay to the Clinical Need
Charles (Buck) Strom, M.D., Ph.D., Senior Medical Director, Genetics, Quest Diagnostics Nichols Institute
Sponsored Presentation
Sponsored by 20/20 Gene Systems, Inc.
Speaker to be Announced
6:30- 8:30 pm Dinner Short Courses*
Thursday, August 23
PHARMA-IVD PARTNERSHIPS: STRIVING FOR FAIR AND EFFECTIVE MODELS
Co-Development of Zelboraf and the Cobas BRAF V600 Test, and Beyond
Walter Koch, Ph.D., Vice President & Head, Global Research, Roche Molecular Systems
How to Partner with Pharma and Enable Value Capture for Both Parties
Peter Collins, Ph.D., Vice President & Head, Diagnostics, GlaxoSmithKline Biologicals
Diagnostic Partnerships in Biomarker Identification, Development, and Commercialization
Matthew J. Hawryluk, Ph.D., Director, Business Development , Foundation Medicine, Inc.
Funding for Companion Diagnostics in the US Market: Stakeholders and Trends
Gavin Erickson, Principal Consultant, GfK Bridgehead
Sponsored by GfK Bridgehead
Towards Effective Drug-Diagnostic Co-Development and Commercialization - How Do We Get There?
Rainer Metzger, Ph.D., Vice President, Pharma Partnerships, Leica Biosytems
Delivering Value from Diagnostic/Pharma Partering
Cecilia Schott, Ph.D., M.B.A., Business Development Director, Personalized Healthcare,
AstraZeneca
Challenges Posed to Dx Business Models by Companion Diagnostics and Personalized Medicine
Joseph V. Ferrara, President, Boston Healthcare
Sponsored by Boston Healthcare
PANEL DISCUSSION: Increasing Partnership Value for Diagnostics Partners
Luncheon Presentation I
Sponsored by Myriad RBM
Speaker to be Announced
Luncheon Presentation II
Hire Right the First Time; Interview Techniques That Work
Tara Kochis, President, Slone Partners
Sponsored by Slone Partners
EVIDENCE GENERATION FOR REIMBURSEMENT DECISIONS
Roadmap for Demonstrating Clinical Utility of Molecular Diagnostics: Experience with the 92-Gene Assay for Cancer Classification, Cancer type ID
Catherine A. Schnabel, Ph.D., Senior Director, Medical & Scientific Affairs, bioTheranostics, Inc.
A Payer's Perspective: Reimbursement of Companion Diagnostics
Richard K. Schatzberg, President and CEO, Generation Health
PANEL DISCUSSION
Moderator: Patrick F. Terry, Principal, Pricing & Market Access Practice, Scientia Advisors Additional Panelists:
Elaine K. Jeter, M.D., Medical Director, Palmetto GBA
Sheila D. Walcoff, Esq., Founding Principal, Goldbug Strategies LLC and Counsel for the Coalition for 21st Century Medicine