1:20 Current Concerns in GLP Compliance 
Dr. Alex D. Kanarek, President, Bio-Development Consulting Services
This paper will review the difference between “qualification” and “validation” as these terms are applied to GLP study test procedures, especially bioassays. The need to apply either of these analyses during test and product development will be examined. In addition, the current reasons for FDA Form 483 or warning letter citations following inspection of GLP facilities will be analyzed and solutions to the most common problems will be proposed.

1:55 Setting Up and Maintaining the GLP Bioanalytical Lab in the Biotech Non-GLP R&D Environment
Dr. Jinzi J. Wu, Vice President, Preclinical, Ambrilia Biopharma Inc.
This presentation will discuss challenges and strategies to set up a GLP bioanalytical lab at a non-GLP R&D biotech. The presentation will describe the importance of mindset shifting of R&D scientists from non-GLP to GLP, drafting essential SOPs for the first GLP lab, IQ, OQ and PQ for LC/MS, validation of your first GLP bioanalytical method as well as data analysis.

2:30 Requirements of the European Directives for Test Facilities during Pharmaceutical Development
Dr. Cledwyn Davies, Manager, Product Quality & Regulatory Affairs, Health Protection Agency, Centre for Emergency Preparedness & Response, UK
Laboratory testing during the life cycle development of new biotherapeutic agents is governed through regulation defined in four key European Directives, GLP, GCP, The Clinical Trial Directive and GMP. In many laboratories this is regarded as a ‘conflict’, however, the standards may co-exist alongside each other if basic principles are recognised. In this presentation, the application of this approach during the development of biological products is discussed and how ‘research’ based laboratories should respond to meet the challenge.

3:05 Networking Refreshment Break, Poster Viewing

3:45 Method Validation for Bioanalytical Labs
Dr. Michael Zhou, Director, ADMET/PK/Bioanalysis, SCYNEXIS
Method validation for GLP programs is a vital process for Bioanalytical laboratories prior to sample analyses in support of preclinical and clinical studies. In our laboratories, there have been several strategic and systematic approaches in successfully validating method(s) in accordance with current GLP regulations and FDA Guidelines in Bioanalytical Method Validation issued May 2001. Technical and regulatory perspectives will be shared and discussed to meet acceptance criteria specified within FDA Guidelines and laboratory SOPs. Laboratory automation has demonstrated a great success in not only increasing the throughput of validation process, but also enhancing the accuracy and reliability of data and report generation. Typical validation results will be presented and elaborated. As a whole, technical competency along with effective SOPs will yield smooth and successful validations.

4:20 A GLP Approach to Automated Protein Microarray Analysis
Dr. Roisin Molloy, Department of Research, Randox Laboratories LTD
A multipanel approach to biomarker analysis is increasingly important in many areas of research but many methods are not GLP compliant. A new biochip array system has been developed to enable rapid analysis of multiple biomarkers in every patient sample on a high - throughput basis. The system is FDA approved and offers many QC checks throughout the analysis.

4:55 Panel Discussion 

5:45 End of Day One