8:30 - 12:00 Pre-Conference
Tutorial*
Biomarker Assay Development and Validation - Principles and Practices
Instructors:
• Dr. Pauline Lau, President, Suntec Corporation
• Dr. Robert T. Dworschack, Director, Clinical Trials, Roche Diagnostics
•
Ms. Olive Wolfe, President, Clinical
Consultants, Inc
After biomarkers are identified, the development and validation of assays useful for clinical trials are often difficult tasks for pharmaceutical companies to handle without prior diagnostic development experience. This workshop will present the critical requirements and procedures of assay development and validation, sample requirements, stability studies, and assay performance documentation. It will also address quality assurance (e.g.
GLP) requirements to ensure the consistency in producing the biomarker assays and enabling the assays to be used for clinical trials and down-stream commercialization. For commercialization, the FDA approval process and requirements will be reviewed.
About the instructors:
Dr. Pauline Lau is the founder and president of Suntec Corporation, USA. She also serves on the advisory board and consultants for several major medical companies and research institutes including Roche Diagnostics and ITRI (Industrial Technology Research Institute). Prior to founding Suntec Corporation, Dr. Lau was head of Integrated Health Care Department at Hoffman La Roche Pharmaceutical Research Center in California, responsible for biomarker development and validation. She is a globally recognized expert in personalized medicine and biomarkers. Dr. Lau also has over 15 years of experience in medical diagnostic research and product development. Dr. Lau has extensive experiences in managing FDA approval process of medical devices. She has successfully launched devices for physician’s office and other hospital-based products. Dr. Lau also has many years of successful records in new biomarker market/business development. In 1996-2002, she successfully managed the cardiac and tumor markers with over 30% market growth each year.
Dr. Robert T. Dworschack has been responsible for biomarker clinical evaluations for over 10 years. He is currently Director of Clinical Trials at Roche Diagnostics, responsible for external product evaluation and generation of clinical data for regulatory submission for 510k and
PMA. He also has over 10 years biomarker research and development experiences including internal validation process. Prior to Roche, he worked at Abbott Diagnostics R/D developing many immunoassays products.
Dr. Omar Laterza is a Research Fellow at Merck Research Laboratories in Rahway, New Jersey. He is the co-director of the Clinical Development Laboratory, which provides support for Phase I and II human clinical trials. He has been at Merck since 2003. Dr. Laterza obtained his Ph.D. in Biochemistry at Colorado State University and a post-doctoral fellowship in Clinical Chemistry at Washington University, School of Medicine, in St. Louis, Missouri. He is a diplomat of the American Board of Clinical Chemistry
(DABCC) and a Fellow of the American Academy of Clinical Biochemistry
(FACB). Prior to working at Merck, Dr. Laterza was a instructor of Pathology at Johns Hopkins School of Medicine. He has a number of publications on cardiac markers and is the co-inventor in a patent on biomarkers of brain injury.
* Separate registration is required.
