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WEDNESDAY, AUGUST 20
7:15 am Registration
7:30 – 8:25 Problem-Solving Breakout Discussions with Continental Breakfast
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Latin American Market Access for Personalized Medicine
Carlos Gil Ferreira, M.D., Executive Director, INOVA-CANCER; Director, Clinical Research, Brazilian National Cancer Institute
- Personalized medicine in LATAM: how aware of the topic are medical oncologists in the region
- The barrier of reimbursement
- Sample quality and molecular pathology in the region
Clinical Perspectives of Next Generation Sequencing
Divyaa Ravishankar, Senior Industry Analyst, North America & Europe, Life Sciences, Frost & Sullivan
- Potential challenges in Developing a NGS based Companion Diagnostic test.
- Are we going to see more NGS platforms getting FDA and CE clearance in the next few years?
- Within Oncology which of the cancer types will see the uptake of NGS based tests at the earliest and why?
- What kind of business models / strategy partnerships we can observe between NGS tool makers and drug companies in future?
New Partnership Paradigms in Companion Diagnostics/Personalized Medicine
Matthew J. Hawryluk, Ph.D., Senior Director, Corporate & Business Development, Foundation Medicine, Inc.
- Increasing the value for the diagnostic partners and maximizing the outcomes for the pharma partners
- Deliverables and the desired outcomes
- Average costs and financial structures
8:25 Chairperson’s Opening Remarks
Catherine Brownstein, M.D., Harvard Medical School and Boston Children’s Hospital
8:30 Regulatory Challenges in Co-Development of CDX and Drugs: A Diagnostics Perspective
Tracy Bush, Ph.D., Director and Global Coordinator, Companion Diagnostics, Regulatory Affairs, Roche Diagnostics
Globally, Pharma and Diagnostics operate under different regulations, with different statutory requirements and timelines. Drug and diagnostic codevelopment timelines are not always optimally aligned to meet the needs of the various regulatory processes. This presentation will explore various regulatory challenges that ensue when the standard diagnostics development pathway is asked to flex to meet the needs of a drug clinical program; and offer possible pathways for their resolution.
9:00 Global Clinical Trial Design Considerations When Incorporating a Companion Diagnostic
Sabah Malek, Associate Director, Global Regulatory Affairs, Eisai, Inc.
A well thought-out clinical trial, especially one that will be the basis for the approval of two products from different divisions within FDA not to mention different governing bodies in the EU, is imperative for a successful launch. Since the recognition of personalized medicine, FDA and other health authorities have been resolute regarding the ideal co-development plan for targeted therapeutics and companion diagnostics. However in practice, this proves to be difficult for numerous reasons. One example of this is the identification of the need for a companion diagnostic in a mature program.
9:30 NGS-Based Companion Diagnostics: Points to Consider
Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration
While there has not yet been a companion diagnostic approval of a Next Gen Sequencing-based assay, there has been considerable interest in using gene panels or single gene sequencing to select the patient population that will benefit from targeted therapy. This talk will highlight points to consider in developing a NGS-based companion diagnostics
10:00 Sponsored Presentation (Opportunity Available)
10:15 Cellular Multiplex™, a Pathway Approach to Companion Diagnostics
Bruce K. Patterson, M. D., CEO, InCellDx, Inc
Cellular Multiplex™, a diagnostic approach that allows multiplexing of proteins using antibodies, mRNA using in situ hybridization, and DNA cell cycle using dyes. Morphologic measurements such as mean corpuscular volume, nuclear area, and nuclear-to-cytoplasmic ratio can be determined. It provides prognostic information, companion diagnostic functions when deployed in our novel bioinformatics algorithms.
10:30 Coffee Break in Exhibit Hall with Poster Viewing
11:00 Chairperson’s Opening Remarks
Harry Glorikian, Healthcare Consultant
11:10 Discussion: Regulatory Review of Clinical Sequencing Assays
Moderator: Harry Glorikian, Healthcare Consultant
Guest Speaker: Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration
In November of 2013, the FDA issued the first clearances of Next Gen Sequencing- (NGS) based assays. There have additionally been a number of clinical trials approved recently that utilize NGS-based assays for patient enrollment or stratification. In light of the expanding roles that new sequencing technologies are playing in clinical decision making, this talk will focus on critical elements that FDA considers when evaluating NGS validation using the recent clearances/approvals as examples. There will also be a discussion of any new communications that FDA has issued in regard to the regulatory review of NGS- based assays. Following the discussion there will be a Q&A with the audience.
11:55 Next-Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement
Moderator: Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP
Andrea Ferreira-Gonzalez, Ph.D., Professor, Pathology; Director, Molecular Diagnostics Lab, Virginia Commonwealth University
Madhuri Hegde, Ph.D., FACMG, Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine
The landscape of next-generation sequencing diagnostics is changing rapidly. Clinical laboratories are offering highly complex tests using new technologies, but face challenges in reimbursement. To be reimbursed for these tests, laboratories will need to address clinical utility as well as clinical validity. Clinical cases that demonstrate the utility of genomic oncological and inherited disease testing will be presented. Experiences with reimbursement of these tests will be discussed.
12:40 pm Close of Conference
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