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Biomarker Assay Development
May 11, 2009
1:00 p.m. - 3:00 p.m. EST

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1:00-1:10  Chairperson's Opening Remarks

1:10-1:40  Molecular Diagostics Laboratories (MoDEL): A Program to Support Cancer Biomarker Clinical Assay Development
J. Milburn Jessup, M.D., Chief, Diagnostics Evaluation Branch, Cancer Diagnosis Program, DCTD/National Cancer Institute
Although biomarkers will become increasingly important as targeted and personalized therapies dominate the care of the cancer patient, the development and validation of useful biomarkers is often stopped by inadequate assay development. The Cancer Diagnosis Program (CDP) of NCI issued a Request for Information that defined significant needs for assay development as: specimen acquisition, access to standards and reagents, guidance on assay development for academia to facilitate transfer to industry, and support for improving assay performance, evaluation and validation for clinical use. As a result, CDP will present its plans for developing MoDEL as a suite of services that 1) will assist the utilization of biomarkers in late phase clinical trials in oncology and 2) will be available to both academia and industry.

1:40-1:50  Sponsored Presentation
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com

1:50-2:20  Application of Intra-Assay Calibration Curves to Quantitate Clinical Biomarker Immunoassays
Paul W. Rhyne, Ph.D., Associate Director, Bioanalytical Sciences, Bristol Myers Squibb Co.
The measurement of biomarkers in clinical samples using immunoassays is typically accomplished using calibration curves generated from known concentrations of standards or calibrators.  These standards usually consist of purified protein standards diluted in assay buffer and are run in separate wells.  We have developed a different approach using the multiplexing capabilities of the Luminex bead based xMAP technology, where the calibration standards are incorporated into each well along with a clinical sample.  This allows for the first time, reference standard information to be generated simultaneously with the measurement of the biomarker in the same well.  The benefits of this approach include increased number of clinical samples run on as assay plate, higher replicates of the calibration curve points, and the elimination of buffers dedicated to dilution of reference standards.  The principles of this biomarker assay design will be discussed and examples of its application will be shown.   Additionally, the benefits and risks of using intra-assay calibration based assays will be discussed.

2:20-2:30  Sponsored Presentation 
Opportunity available. Contact Ilana Quigley, Business Development, 781-972-5457 or iquigley@healthtech.com

2:30-3:00  Assessment of Free- and Total- Drug Concentration in the Development of Biotherapeutic Agents – Practical Considerations
Bing Kuang, Ph.D., Principal Scientist, Translational Research, PDM, PGRD, Pfizer, Inc.
Full characterization of exposure/response kinetics of antibody therapeutics, such as PKPD and PBPK modeling, often requires assessment of both the “free” and “total” concentration of the biotherapeutic in circulating and target bound forms.  The knowledge on what the analytical assay measures, is important for quantitative understanding of the pharmacology of biotherapeutic agents.  This presentation will provide perspectives on the requirement for measuring different forms of biotherapeutics and the analytical assessment challenges.  Theoretical consideration for ligand binding assay and practical consideration for pharmacokinetic assays supporting development of biotherapeutic agents will be discussed.  Aspects of “free” assay measuring unbound biotherapeutic agent in biological matrices will be addressed.   Examples will be given to demonstrate the challenges of developing “free” ligand binding assay for soluble circulating target and the practical utility for antigen-specific capture assay in the development of antibody therapeutics. 


About the Speakers:

J. Milburn Jessup, M.D., Chief, Diagnostics Evaluation Branch, Cancer Diagnosis Program, DCTD/National Cancer Institute
J. Milburn Jessup, M.D., is a surgical oncologist and scientist with the Laboratory of Experimental Carcinogenesis as an Adjunct Investigator in CCR. He is also Chief of the Diagnostics Evaluation Branch of the Cancer Diagnosis Program in DCTD. In 25 years of practice he focused on the multidisciplinary treatment of GI and breast cancer, melanoma and soft tissue/skeletal sarcomas in several different academic settings. He has led a research effort to study the mechanisms by which human colorectal carcinomas form hepatic metastasis and identified roles for the marker Carcinoembryonic Antigen in modulating inflammatory responses and promoting metastasis. He is currently Chair of the AJCC Hindgut Task Force that formulates the TNM staging classification in the United States. He has been involved for over a decade with the American College of Surgeons Commission on Cancer and served as Chair of the National Cancer Data Committee that oversees hospital tumor registries throughout the U.S. Dr. Jessup also aids investigators in facilitating the development of biomarkers for clinical use in patients with cancer.  The focus of Dr. Jessup’s research effort currently is on cancer stem cells (CSC) in colorectal carcinoma that give rise to liver metastases. The major interest is in the role of pluripotency transcription factors in regulating quiescence, differentiation and metastasis by putative CSC. An important related scientific interest is in the mechanisms by which metastatic precursor cells survive toxic drugs or host microenvironments and approaches to ablate that resistance.

Bing Kuang, Ph.D., Principal Scientist, Translational Research, PDM, PGRD, Pfizer, Inc.
Bing Kuang is currently a Principal Scientist in the Pharmacokinetics, Dynamics, & Metabolism Department, Pfizer Global Research and Development. He received his B.S. degree in biochemistry from Peking University in China and his Ph.D. degree in 1996 from the University of Iowa in the U.S.  He completed his postdoctoral training at Vanderbilt University in 2000.  Prior to joining Pfizer in 2006, he was a project leader at CuraGen Corporation with responsibility for conducting proteomic studies, biomarker discovery, biotherapeutics agent characterization and target identification.  His primary research interests are pharmacokinetic analysis and bioanalytical support for biotherapeutics agents and translational research for pharmacodynamic markers in supporting pre-clinical discovery portfolios.

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