National Biotechnology Conference 2009 Preliminary Program - (Page 18) INFORMATION - WORKSHOPS, SHORT COURSES and TRAINING COURSE PRE-CONFERENCE Saturday, June 20 8:30 am – 5:00 pm POST-CONFERENCE Thursday, June 25 8:00 am – 5:45 pm AAPS Workshop on the 21st Century Co-sponsored with the Association for Labroratory Automation Bioanalytical Laboratory: Maximizing Quality and Efficiency Through Innovation 2009 LBABFG Immunogenicity Training Course (New Course) 2 Day Event An additional fee is required to attend this course. Goals and Objectives The unpredictability of the immunogenicity of biotherapeutics has been widely publicized. The focus of this course is on the development and validation of analytical methods required for the detection and characterization of the anti-drug antibodies present in pre-clinical and clinical samples. The participants should gain familiarity with the following areas: • the basic principles of the immune response as it is involved in the development of antibodies to biotherapeutic agents • the analytical methods used in the detection, measurement and characterization of the anti-drug antibody response • regulatory perspective: – recent case studies that illustrate unexpected immunogenicity – performance expectations of analytical methods used for evaluation of immunogenicity of biotherapeutics • development of analytical methods for the detection and characterization of the antibody response, including the following aspects: – meeting regulatory performance expectations – quantitative vs. detection – approaches and platforms (ELISA, ECL, RIA) – challenges: sensitivity, background, specificity, positive controls, detection reagents, normal serum pools, tittering strategies, effect of circulating drug and how to manage – cut-off models, statistical analysis • case studies to illustrate: – safety issues – methods development – interpretation of study data – examples of statistical models for cut-off and assay design 2 Day Event An additional fee is required to attend this workshop. Lunch will be provided complimentary for all workshop attendees. Goals and Objectives A common theme throughout drug development is to “do more with less” and reduce the cost of drug development. One way to obtain more results with fewer resources and reduced costs is to be more efficient. The 21st century ligand binding assay laboratories must harness potential synergies between technology platforms, innovative optimization approaches, robotics, software programs, LIMS and electronic lab notebooks. The current consensus is that most ligand binding assay laboratories have not achieved the level of efficiency that is possible. Some of the reasons for this lack of efficiency include dependence on manual processes, lack of instrument and system integration, reliance on paper, and lack of functionality by the LIMS. Many companies are building efficiencies and integrated systems within their own bioanalytical laboratories using similar but individualized approaches. Yet the commonality of the challenges and approaches to addressing issues of inefficiency in individual ligand binding labs suggests opportunities to develop more widely accessible technologies. The purpose of this workshop will be to provide a vision of the ideal 21st century laboratory. In order to build the vision, we will outline the challenges and unique aspects of LBA laboratory processes and workflow and provide examples of successful components that, if combined, would create the ideal laboratory. • Provide a forum for discussing the challenges that have limited lig and binding assay labs from achieving full efficiency; • provide a forum for illustrating state-of-the-art practices; • provide bioanalytical scientists from industry and contract research organizations a forum to describe their vision of the ideal bioanalytical laboratory; • provide vendors an opportunity to share aspects of their current products that will allow the labs to achieve this level of efficiency and quality; and • provide a venue for bioanalytical scientists and vendors to discuss future trends, needs and opportunities. 7:30 am Coffee Break 8:00 am – 10:00 am Module 1: Introduction to Immune Response, Immunogenicity of Biotherapeutics, Clinical Manifestations of Immunogenicity and Nature of Anti-drug Antibody Responses 10:00 am – 10:15 am Coffee Break Sunday, June 21 8:30 am – 5:00 pm 10:15 am – 12:15 pm AAPS Workshop on the 21st Century Bioanalytical Laboratory: Maximizing Quality and Efficiency Through Innovation Co-sponsored with the Association for Labroratory Automation Module 2: Study and Regulatory Considerations (Nonclinical/Clinical) and Risk-based Assessments 12:15 pm – 1:30 pm Lunch Complimentary to all Course Attendees Day 2: Workshop Conclusion An additional fee is required to attend this course. Lunch will be provided complimentary for all workshop attendees. 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 18 PRELIMINARY PROGRAM
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