Archived Content

Track 2: Clinical Assay Development 


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Sunday, May 5


5:00-6:00 pm Conference Pre-Registration


Monday, May 6

7:30-8:30 am Conference Registration and Morning Coffee

8:30-8:40 Welcome Remarks from Conference Director

Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute


From Research Biomarkers to Clinical Assays 

8:40-8:45 Chairperson’s Opening Remarks

8:45-9:10 Biomarkers and the Quest for Clinical Utility—Obstacles, Challenges and Opportunities

Steven Gutman, M.D., MBA, Strategic Advisor, Myraqa

Over the past ten years there has been an explosive increase in the number of biomarker assays available for the study and evaluation of human disease. To ensure stakeholders are able to use this growing menu of tests responsibly, there is a compelling need to understand the clinical utility of these assays. Unfortunately a surprising number of tests are plagued by inadequate information on clinical utility. This talk will focus on obstacles, challenges and opportunities for addressing this problem.

9:10-9:35 Clinical Assay Development—The Process and Considerations

OliveJoy Wolfe, MS, President, Clinical Consultants, Inc.

9:35-10:00 Bridging Research and “Clinical” Assays in Pharmaceutical Research & Development

John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions

Many biomarker assays used in drug development are research assays (i.e., not accredited diagnostic devices). This presentation will look at the following: basic validation experiments across assays in research and diagnostics; differences and assay evolution as methods progress through different uses of results data; the requirements for accreditation of assays to be used in diagnostics; and a brief look at the development of a companion diagnostic and its implications from the laboratory perspective.

10:00-10:30 Networking Coffee Break

10:30-10:55 Key Considerations for Choosing and Transitioning a Research Grade Assay to the Clinical Setting

Tammie C. Yeh, Ph.D., Molecular Biomarkers, Oncology Lead, Merck

Developing a biomarker assay with the clinical perspective in mind is critical to the success of the biomarker. Identifying/choosing a robust biomarker readout is as important as developing a robust analytical assay to ensure clinical utility. It is important to understand the inherent biological variability as well as the clinical feasibility of a biomarker readout, both of which will depend on tissue type, tissue processing and the specific clinical setting. Both patient selection and pharmacodynamic biomarkers will be addressed in this presentation.

10:55-11:20 Clinical Assay Development for Cancer Protein Biomarkers: What Works and What Does Not Work

Samir Hanash, Ph.D., Program Head, Molecular Diagnostics, Fred Hutchinson Cancer Research Center

The breadth and depth of proteomics technologies for the discovery of biomarkers has increased substantially over the past decade, covering a dynamic range of more than 7 logs in protein abundance. As a result, numerous cancer biomarker candidates have emerged from discovery studies. There remains a need for the development of high-throughput technologies that allow testing the utility of these biomarkers for their intended clinical application to meet regulatory requirements. Current opportunities and challenges will be presented.

BioAgilytix Labs11:20-11:50 Assay and Kit Lot Bridging Considerations for Single and Multiplex Biomarker Analysis in Support of Clinical Studies

Afshin Safavi, Ph.D., Senior Vice President, Bioanalytical Operations, BioAgilytix Labs

Biomarker analysis has become a common practice by many pharmaceutical companies to help PK/PD modeling. The reliability of outcomes is heavily influenced by the quality of the reagents. One of the challenges that bioanalytical labs face when running biomarker studies is the control of lot-to-lot variability of critical reagents and commercial immunoassay kits. Case studies will be presented to highlight the key bioanalytical considerations involved in running successful biomarker analyses in support of clinical studies.

11:50-1:20 pm Enjoy Lunch on Your Own


NGS in Clinical Use 

1:20-1:25 Chairperson’s Remarks

1:25-1:50 College of American Pathologists’ Standards and Proficiency Testing for Next-Generation Sequencing for the Clinical Laboratory

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists

The rapid and ongoing advances in the genetic test market, spurred by the opportunities of Next-Generation Sequencing (NGS), necessitate many facets of the health care industry to work cohesively. Adoption of NGS as a clinical test requires the adoption of many processes and procedures, such as the analytic and clinical validation of the test, CLIA certification/CAP accreditation, standards for reference materials, availability for proficiency testing, genetic counseling, and questions regarding reimbursement, informed consent and incidental findings. This talk will focus on the laboratory requirements developed at CAP for CLIA/CAP accreditation and the plans for proficiency testing for NGS.

1:50-2:15 Assuring the Quality of Next-Generation Sequencing in Clinical Laboratory Practice

Ira M. Lubin, Ph.D., FACMG, Team Lead, Genetics, Division of Laboratory Science and Standards, Centers for Disease Control and Prevention

Integration of next-generation sequencing (NGS) into the clinical laboratory requires test validation, establishment of quality control procedures, and the independent assessment of test performance by proficiency testing or alternate approaches. Existing regulatory requirements and professional guidance do not adequately address these quality issues for clinical NGS testing. This talk will describe the outcomes of a national workgroup organized by the Centers for Disease Control and Prevention tasked to identify principles and develop guidance to promote good clinical laboratory practices for NGS and meet regulatory and professional standards.

2:15-2:40 Clinical NGS: Validation, Reporting and Economics

Seth Crosby, M.D., Director, Partnerships & Alliances, Washington University School of Medicine

As NGS enters the clinic, matters of analytic and clinical validation are just the start of the medical director’s worries. How should results be quickly generated and communicated to a physician in a meaningful and actionable manner? What are the new rules for billing and reimbursement?

2:40-3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

3:40-4:05 Exome Sequencing in a Clinical Setting to Guide Patient Care

Madhuri Hegde, Ph.D., Executive Director, Emory Genetics Laboratory; Associate Professor, Human Genetics, Emory University School of Medicine

Advances in genomic medicine have made it necessary for clinical laboratories to rapidly implement new technologies to guide patient care. Exome sequencing is rapidly being implemented across different specialties such as inherited diseases, cancer and infectious diseases. This talk will focus on the clinical utility of exome sequencing in patient care with real case examples.

4:05-4:30 Interpreting Clinical Next-Generation Sequencing Data: Current Challenges and Hope for the Future

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director, Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

With the complexity of genomic scale sequencing (next-generation sequencing or NGS) and the massive amounts of data obtained, informatics is essential. Two challenges in evaluating a variant are 1) is it real and 2) is it clinically significant. Informatics allow alignment and variant calling (differences from a reference sequence), and sifting of probable clinically insignificant variants. More challenging is prioritizing variants that are likely to be associated with the clinical symptoms. In addition to the symptom-guided analysis approach, NGS data can reveal variants in genes related to drug metabolism that may affect efficacy or response. This presentation will discuss approaches to prioritize symptom-related variants as well as the potential of NGS data for companion diagnostics or therapeutics.

4:30-5:00 Panel Discussion

Panelists to be Announced

5:00-6:00 Welcome Reception in the Exhibit Hall with Poster Viewing

6:00-9:00 Dinner Courses

Fit-for-Purpose Biomarker Assay Development and Validation
Next-Generation Sequencing as a Clinical Test

(Separate registration required)



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