National Biotechnology Conference 2009 Preliminary Program - (Page 19) INFORMATION - WORKSHOPS, SHORT COURSES and TRAINING COURSE 1:30 pm – 3:30 pm QT Analysis for Biotherapeutic Proteins Megan Gibbs, Ph.D. Amgen, Inc Module 3: Technology, Overview of Assay Design Considerations and Mire-Sluis 3:30 pm – 3:45 pm Coffee Break Fixed Dose or Body Weight Dosing: When to Switch Diane Wang, Ph.D. Pfizer 3:45 pm – 5:45 pm MODULE 4: Breakout Sessions 5:45 pm Comparability Approaches for Therapeutic Proteins During Development and Post Marketing Angela Men, Ph.D. (Invited) U.S. Food and Drug Administration Adjournment SHORT COURSE #2 SHORT COURSE #1 Thursday, June 25 8:30 am – 5:00 pm Thursday, June 25 8:30 am – 5:00 pm Clinical Pharmacology of Biotherapeutic Proteins This is a one day short course. An additional fee is required to attend this course. Lunch will be provided complimentary for all course attendees. Analytical and Bioanalytical Assay Development for Biological Therapeutics This is a one day short course. An additional fee is required to attend this course. Lunch will be provided complimentary for all course attendees. This course will be co-chaired with the U.S Food and Drug Administration. This short course is divided into three related topics: The objectives of early clinical development of therapeutic proteins are the same as for small molecules, (i.e., to investigate the molecule in a manner that will gain necessary knowledge about its tolerability, safety, PK and if possible, PD effects in the most appropriate human populations while simultaneously protecting their safety). However, there are specific features of proteins that must be considered when designing clinical pharmacology studies. This short course provides a general overview and current thinking of the range of factors that are relevant when designing clinical studies for therapeutic proteins. Note that each therapeutic protein under consideration will present its own set of unique characteristics, which should be reflected in study design and safety precautions. Moderator Amita Joshi, Ph.D. Genentech TOPIC 1: Strategies for Applying Molecular Interaction Information to Aid Drug Discovery & Development Background and Challenge Information on biomolecular interactions (e.g., binding affinities and kinetics) has been widely used to aid drug discovery and development. However, due to the intrinsic complexity of protein-based biotherapeutics and the lack of simple correlations between in vivo efficacy and in vitro binding affinities, challenges are frequently encountered in generating and interpreting data on molecular. Discussion to Provide • Best practices for obtaining physically and biologically meaningful data on biomolecular interactions • Guidance on applying affinities/kinetics to aid molecule selection based on MOA (case studies) • Alternative strategies for affinity/kinetics measurements Review of Clinical Pharmacology Packages for Recently Approved Biologics Mark Peterson, Ph.D. Biogen Idec TOPIC 2: Current PK Assay Strategies Background and Challenge Although there are guidance papers describing best practices for Ligand Binding Assay development and validation for the measurement of protein therapeutics in serum or plasma, it is not clear whether methods are needed to quantitate and/or differentiate between unbound (free) and target-bound therapeutic (total), nor is it widely understood what these differences mean from a pharmacokinetic, safety toxicology or clinical viewpoint. Predicting PK in Humans and First Dose Selection Anne Heatherington, Ph.D. Pfizer Immunogenicity Risk Assessment and Monitoring/Impact on PK Safety Efficacy Valerie Quarmby, Ph.D. Genentech Discussion to Provide • Current PK assay strategies • Case examples where (a) different strategies were used for non-clinical versus clinical studies, (b) methods were developed and implemented to separately measure “total” drug as well as unbound therapeutic and (c) impact of unanticipated circulating target methods on PK assay strategy • Pharmacokinetics and safety perspective Immunogenicity Impact on PK Safety Efficacy Hong Zhao, Ph.D. U.S. Food and Drug Administration Drug-drug Interactions for Biologics Sandhya Girish, Ph.D. Genentech 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 19 PRELIMINARY PROGRAM
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