FAST Congress

CONFERENCE SERIES: Biomarkers and Diagnostics

Recorded at: ADAPT Congress


Digital Course: Clinical Assay Development


Clinical Assay Development DVD Cover About this Product: 

Presentations selected from the Clinical Assay Development workshop at the Fourth Annual ADAPT Congress 2012 discuss how discovery and research assays are increasingly being converted into clinically useful assays that are used in clinical trials to improve patient outcome and to support drug development. Regulatory issues and the dedication of resources to develop assays are addressed, as well as strategies to overcome the challenges of using commercial assays on clinical samples; analytical validation studies to determine clinical utility; and the benefits of working with a diagnostics organization with both experienced IVD manufacturing and an extensive CLIA laboratory infrastructure.



About this Product:
4 Presentations
90 Slides
Over 98 Minutes
Individual: $345
Site License: $1380

Formats Available:
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On Demand


Clinical Assay Development: Priorities, Resources and Regulations

J. Milburn JessupJ. Milburn Jessup, M.D., Chief, Diagnostics Evaluation Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health

Discovery and research assays are increasingly being converted into clinically useful assays that then are used in clinical trials to improve patient outcome and to support drug development. This process requires that laboratory directors dedicate resources to develop such assays as well as to prioritize what assays should be developed. As assays become clinically useful and are used in trials, a series of regulations must be met that consume more resources. This presentation will discuss these issues in the context of a new National Cancer Institute Clinical Assay Development Program (CADP) that may assist this process.

Biography:  J. Milburn Jessup, M.D., is a surgical oncologist who joined the Cancer Diagnosis Program and NCI as Chief of the Diagnostics Evaluation Branch.  This branch facilitates the development of discovery-based markers into in vitro diagnostics that are used in clinical research and trials.  In 25 years of practice he focused on the multidisciplinary treatment of GI and breast cancer as well as melanoma and soft tissue and skeletal sarcomas in several different academic settings. He also led a research effort studying the mechanisms that underpin hepatic metastasis by human colorectal carcinoma and identified roles for the marker carcinoembryonic antigen in modulating inflammatory responses and promoting metastasis. He is an Adjunct Investigator in the Laboratory of Experimental Carcinogenesis where his research targets a novel embryonic retrogene that drives cancer stem cells in metastatic human colorectal carcinoma.

Clinical Assay Development: The Process and Considerations

Herbert A. FritscheHerbert A. Fritsche, Ph.D., Senior Vice President and CSO, Health Discovery Corporation

The process for successful development of a clinical laboratory test begins with a strict definition of the test concept and its clinical utility; design of an accurate and robust assay for the analyte; analytical validation followed by clinical validation; and lastly, translation of the new test for routine clinical use, which includes validation of the test outside of the research setting.  Success of development is defined as acceptance of the new test by the medical community as the "standard of care."

Biography:  Dr. Herbert Fritsche is a native of Houston, Texas. He received a B.S. in Chemistry (University of Houston, 1963), and M.S. (1965) and Ph.D. degrees (1968) in Chemistry from Texas A &M University. He has been an active member of the American Association for Clinical Chemistry since 1968, and he has served in all positions of the Texas Section, chaired the National Education Committee, and the Education Committee of the Immunology Division of the AACC. Dr. Fritsche is a Fellow in the National Academy of Clinical Biochemistry (NACB).  He has served on many of the committees of the AACC and the NACB, and numerous review committees for the National Cancer Institute. He served as National President of both the Clinical Ligand Assay Society, and the Texas Medical Center Chapter of Sigma Xi. Currently, he is a member of the editorial board of six journals, a founding member of the Tumor Marker Expert Panel (American Society of Clinical Oncology) and the Tumor Marker Guidelines Committee for (NACB); he has served as a consultant to the Technology Expert Panel for Blue Cross Blue Shield and the FDA. He has lectured at many international meetings and has published more than 180 manuscripts and 30 book chapters in the field of cancer diagnostics. In 2010, after 41 years of service, Dr. Fritsche retired from the University of Texas MD Anderson Cancer Center as Professor, Full Biochemist, Chief of Clinical Chemistry and Member of the Graduate Faculty of the Graduate School of Biomedical Sciences. Currently, Dr. Fritsche is Senior Vice President, Chief Science Officer and Member of the Board of Directors for Health Discovery Corporation.

Assessment of the Analytical and Clinical Performance of Biomarker Assays: When Are Biomarkers Ready for Prime Time?

Gene PennelloGene Pennello, Ph.D., Team Leader, Division of Biostatistics, U.S. Food and Drug Administration

Many biomarkers require an in vitro diagnostic assay for measurement. For example, companion in vitro diagnostic assays measure biomarkers that provide information that is essential for the safe and effective use of a specific therapeutic product. For such biomarkers, clinical utility is only as good as assay quality of measurement. Quality of measurement is characterized by analytical validation studies of accuracy,
reproducibility, and limit of detection, for example. In this presentation, I’ll review the design and statistical evaluation of common analytical validation studies. For companion in vitro diagnostic assays, I’ll link analytical performance with clinical performance in drug trials. To illustrate concepts, I’ll provide many examples.

Biography:  Dr. Gene A. Pennello is an FDA Team Leader and Expert Mathematical Statistician in the Center for Devices and Radiological Health (CDRH), residing in the Diagnostics Devices Branch of the Division of Biostatistics.  He has been with the agency for 14 years. Before joining FDA, Gene was a postdoctoral training fellow at the National Cancer Institute, Division of Cancer Epidemiology and Genetics.  In 1993, he obtained his Ph.D. in statistics from Oregon State University. He also has from the University of California at Davis a Master’s degree in Statistics, a B.S. degree in Statistics, and a B.S. degree in Computer Science and Mathematics. Dr. Pennello has experience in the FDA review of in vitro diagnostic (IVD) tests, in particular IVDs that measure biomarkers for prognostic or predictive claims. He also has experience in the review of diagnostic imaging systems. His current statistical research interests include Bayesian methods, multiple comparisons, and missing data.  

Combined CLIA and IVD Strategy Accelerates Timing and Mitigates Risk for Companion Diagnostics

Andrew GrupeAndrew Grupe, Ph.D., Senior Director, Pharmacogenomics, Celera/Quest Diagnostics

Personalized medicines are heralded as the future of drug development. Bringing a targeted medicine to market requires the concerted efforts of a drug developer and a diagnostics partner. There is no one size fits all approach for these partnerships, and often a tailored relationship is forged between the two partners either before or during a pivotal Phase III trial. Late-stage partnerships increase the drug candidate’s risk profile when it is deemed to need a predictive biomarker for a pivotal Phase III trial. This presentation will provide specific examples that illustrate the benefits of working with a diagnostics organization with both experienced IVD manufacturing and an extensive CLIA laboratory infrastructure. The tangible benefits that mitigate the drug development risk and may be attractive to both partners if relationship starts before Phase II will be described.

Biography:  Andrew Grupe has spent over 17 years working in the diagnostics, biotechnology and pharmaceutical industries. Andrew has been with Celera since 2001, where he serves as the Senior Director for Pharmacogenomics. His team applies next-generation sequencing, genotyping and expression profiling in collaborations with pharma to identify and validate predictive biomarkers. Before taking on the pharmacogenomics responsibilities, he served as Director of Celera’s CNS Research Group and studied genetic variants that contribute to Alzheimer’s disease and Parkinson’s disease. His group described the results of these studies in the scientific literature. Between 1996 and 2001 he was a principal scientist at Roche in Palo Alto where his group identified novel drug targets through genetic and gene expression analyses of murine model systems for human diseases and advanced small molecules to proof of principle in animal models up to early toxicity screening. Prior to Roche, Andrew held a postdoctoral position at Genentech in the Endocrinology Department, where he developed cell and animal models to analyze the contribution of specific proteins to diabetes. Andrew graduated with a Ph.D. in 1991 from the Department of Chemistry at the University of Bochum, Germany, and spent one year at the Center for Molecular Neurobiology at the Universitaetsklinik Hamburg Eppendorf in Hamburg, Germany, to study the molecular function of potassium channels with Professor Olaf Pongs.

About the Conference: 

Cambridge Healthtech Institute’s Fourth Annual ADAPT 2012: Accelerating Development & Advancing Personalized Therapy Congress is being held at the Renaissance Washington, DC Downtown Hotel in Washington, DC, September 19-21, 2012. This year, the coverage has been expanded to seven concurrent tracks, focusing on (1) strategies to accelerate and de-risk drug and diagnostic development through innovative clinical programs and utilizing biomarker data in decision making; (2) implementing personalized medicine though drug-diagnostic co-development; and (3) innovative non-invasive diagnostics for cancer and other diseases. ADAPT 2012 attracts a balanced mix of delegates from pharma and diagnostic companies, clinical organizations, academia, and government, providing a unique opportunity to learn from the thought leaders, network with the decision makers, and discover actionable implementation strategies bridging drug and diagnostic development.