FAST Congress
2013 Archived Content


Clinical Biomarker
Assay Development

November 4-5, 2013 | Boston Marriott Cambridge | Cambridge, MA

Day 1 | Day 2 | Download Brochure 

Tuesday, November 5

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

Companion Diagnostic Assay Development 

8:30-8:35 Chairperson’s Opening Remarks

8:35-9:00 Assay and Platform Considerations in Companion Diagnostic Development

Ron Mazumder, Ph.D., MBA, Global Head, Research and Product Development, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

A number of considerations dictate the choice of which diagnostic platform to use. These include time required for development, commercial access, regulatory considerations, and cost/reimbursement. In addition, flexibility in development and implementation of a validated diagnostic is required for many clinical studies. I will highlight some of these issues in this talk.

9:00-9:25 How Is Early Biomarker Assay Analytical Verification Linked into Companion Diagnostic Clinical Validation: Is It Upstream or Is It in Parallel?

Shane Weber, Ph.D., Director, Diagnostics, Clinical Research and Precision Medicine, Pfizer

Both the pharmaceutical and diagnostic industries are moving towards proactive precision medicine patient stratification approaches. Early implementation of patient stratification biomarker strategies into precision medicine development programs are much more likely to lead to Phase III registration trials that successfully validate a companion diagnostic. The biomarker assay analytical verification process must have appropriately prepared the assay in the US for readiness as an Investigational Use Only (IUO) assay under the FDA’s Investigational Device Exemption (IDE) process into clinical trial use.

9:25-9:50 Choosing the Right Assay for a Companion Diagnostic Development Program

Hans Christian Pedersen, MSc, Principal Scientist, Research & Development, PharmDx, Dako

Many choices exist for choosing methods and platforms for companion diagnostics (CDx) development as a result of the revolution in sequencing technology and the continuous development of technology for measuring DNA, RNA and protein in tissues. This session will go through the strengths and weaknesses of the various technologies, giving specific examples within immunohistochemistry (IHC) and FISH of successful CDx assays and discussing the future development of IHC and FISH CDx from an IVD company perspective.

9:50-10:45 Coffee Break in the Exhibit Hall with Poster Viewing

Laboratory-Developed Tests 

10:45-11:10 Regulatory Issues Facing Laboratory-Developed Tests

Andrea Ferreira-Gonzalez, Ph.D., Professor and Chair, Division of Molecular Diagnostics; Director, Molecular Diagnostics Laboratory, Department of Pathology, Virginia Commonwealth University

Franklin Cockerill11:10-11:35 The Value of LDTs as Companion Diagnostics: Utility and Compliance Requirements

Franklin Cockerill, M.D., Chair, Laboratory Medicine and Pathology, Mayo Clinic

Laboratory-developed tests (LDTs) provide important value for patient care outside of FDA-approved kits. LDTs can be developed quickly to address acute needs for therapeutic decisions, including de novo discoveries of drug-target interactions. LDTs can provide important updating and improvements for current companion diagnostic IVD assays, and serve as pre-market diagnostic tests for clinical drug trials. LDTs also fill an important niche in cases of low burden of disease (“orphan” diseases) where commercialization by IVD manufacturers is not economical. The focus of this talk will not only include the utility of LDTs in patient care, but describe the regulatory requirements for CLIA, FDA and other agencies, including New York State.

11:35 Close of Clinical Biomarker Assay Development Meeting

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