Short Courses:

Bioanalytical Large Molecule Short Course, Organizer: Russ Weiner, BMS

• Introduction to Immunochemistry and LBA Method Development, Ron Bowsher, Millipore/B2S Consulting
• Pre-Study and In-Study Validation of Large Molecules, Binodh DeSilva , Amgen
• Introduction to Pharmacokinetic Analysis of Biologics, Andy Vick, 7th Wave Labs
• Important Considerations in the Evaluation of Macromolecule Bioanalytical Assays, Viswanath Devanarayan, Abbott

Biotransformation - Fundamentals, Techniques and Applications, Organizers: James Mangold, Novartis & Kaushik Mitra, Merck

• Fundamentals of Biotransformation:  Metabolic Enzymes, Reactions and Biological Matrixes, Deepak Dalvie, Pfizer
• Metabolite Identification:  Mass Spectrometric Approaches , Donglu Zhang, BMS
• Metabolite Identification:  NMR Technologies and Metabolite Generation , Raju Subramanian, Amgen
• Drug-Drug Interactions:  Enzyme Phenotyping and Inhibition, James Mangold, Novartis
• Metabolite Identification as a Tool to Address Bioactivation and Pharmacokinetic Liabilities, Kaushik Mitra, Merck

Short Course:

Preclinical Pharmacokinetic-Pharmacodynamic Relationships, Organizers: Anup Zutshi & Alison Betts, Pfizer

• Small Molecule Preclinical PK/PD, Anup Zutshi, Pfizer
• Large Molecule Preclinical PK/PD, Allison Betts, Pfizer
• Large Molecule Clinical PK/PD, Michael Xu, Johnson & Johnson
  

Regulated Bioanalysis Workshop

Conference Introductory Comments, Steve Unger, Conference Chair, CEDRA

Session I: Regulatory Issues: A Global Perspective, Organizer: Doug Fast, Covance

• FDA Overview, CT Viswanathan, FDA
• Global Harmonization Process, Steve Lowes, Advion
• Q&A / Discussion

Session II: Dried Blood Spots and Blood Assays, Organizer: Chris Evans, GSK

• Applications for Biomarkers and Biologics (tentative title), Kelly Chen, Sanofi Aventis
• Considerations Associated With Implementation of Dry Blood Spot Technology, Yang Xu, Merck
• Applications for Mice Studies (tentative title), Graeme Clark, Pfizer
• How to Run a Clinical Study (tentative title), (speaker tba), GSK
• Q&A / Discussion

Session III: Large Molecules, Organizer: Russ Weiner, BMS

• Quantitative Analysis of Biologics by LC/MS: Current Status and Future Prospects, Guodong Chen , BMS
• Strategies for Measuring Free vs. Total Biologic Therapeutics (tentative title), John Kamerud, Covance
• Bioanalytical Challenges of Non-Antibody Protein Therapeutics
• Bioanalytical Challenges of Antibody Drug Conjugates (tentative title), (speaker tba), Genentech
• Biologics Metabolism: Is it Just Another Small Molecule Box-Checking Exercise? (tentative title), (speaker tba), Merck
  

Evening Reception  

Combined Track Workshop: Regulated, Biotrans, Discovery

Session IV: Metabolites in Safety Testing, Organizer: Eric Woolf, Merck

• FDA Perspective, Mark Powley, FDA
• Industry Perspective, Scott Obach , Pfizer
• ICH M3 and metabolite quantification: Views and Recommendations of EBF, Philip Timmerman, Johnson & Johnson
• How Do We Meet the MIST Requirements in Detecting, Identifying, and Quantifying Metabolites?, Swapan Chowdhury, Merck
• Q/A Session  

   
Session V: Regulated Bioanalytical Aspects of MIST Implementation, Organizer: Naidong Weng, Johnson & Johnson

• Pitfalls in Metabolite Measurement Strategy, Wenying Jian, Johnson & Johnson
• Quantitation Of Drug Metabolites, Duxi Zhang, BMS
• Biomarkers of Exposure To Reactive Metabolites, Professor Ian Blair, University of Pennsylvania

   
Session VI: New Technological Aspects of Metabolite Identification and Quantification, Organizer: Brad Ackermann, Eli Lilly

• AMS (tentative title), John Vogel, Lawrence Livermore
• Beyond AMS- Laboratory Based High Sensitivity 14C Analysis, Dan Murnick, Rutgers
• NanoSpary and CaptiveSpray Ionization for Metabolite Identification and Quantification, Ragu Ramanathan, BMS

Session VII: Role of Metabolites in Drug Development, Organizer: Gondi Kumar, Celgene

• Importance of Metabolites in Drug Development: Challenges and Opportunities, Deepak Dalvie, Pfizer
• Investigation of Metabolism-Mediated Toxicity in Early Drug Development, Griff Humphries, BMS
• Pharmacokinetics of Antiviral Nucleotide Prodrugs: Achieving Target Tissue Enrichment, Adrian Ray, Gilead

   
Evening Poster Reception  

Biotransformation Workshop

Session VIII: Modeling Tools for DDI and PK Prediction, Organizer: Sharon Ripp, Pfizer

• Using Simcyp for DDI Trial Design, Kirk Bertelsen, Johnson & Johnson
• Prediction of Systemic Exposure and PK Performance in Preclinical Species and Humans: Practical Strategies and Learnings Using GastroPlus and Other Tools, Tycho Heimbach, Novartis

   
Session IX: Biologics DDI, Organizer: Rao Mamidi, Johnson & Johnson

• Preclinical Models for Biologic DDI Prediction, Eugenia A. Kraynov, Pfizer
• Strategies to Assess Therapeutic Protein Drug Interactions During Clinical Development, Sandhya Girish, Genentech
• Strategies for Assessing Drug-Drug Interactions for Therapeutic Proteins - An Industry Perspective, Honghui Zhou, Johnson & Johnson

   
Session X: Exploratory IND, Organizer: Cindy Xia, Millennium/Takeda

• FDA Perspective, Adebayo Laniyonu , FDA
• Exploratory IND - An Industry Perspective and Experience, Vijay Tammara, Merck
• Exploratory Clinical Trials: Drivers and Lessons Learned, Rao Mamidi, Johnson & Johnson

   
Session XI: Predicting Metabolism, Organizer: Raju Subramanian, Amgen

• Predictive Met ID to Complement Efforts to Removing Metabolic Liability at Discovery Stage, Cyrus Khojasteh, Genentech
• Qualitative Prediction of Drug Metabolism: Putting it into Practice, Michelle Dennehy , Novartis
• Linking Metabolite Prediction to Rational Drug Design, Mike Wester, Pfizer

Discovery Workshop

Approaches to Multiplex Protein, MS vs. Ligand Binding, Organizer: Rick Steenwyk, Pfizer

• High-Sensitivity Multiplex Protein Quantitation Using MRM Mass Spectrometry, Leigh Anderson, Plasma Proteome Institute
• Multiplexed Ligand Binding Assays for the Analysis of Clinical Protein Biomarkers, Paul Rhyne, BMS
• Verification of Biomarkers via Hypothesis Driven Targeted Proteomics, Chris Coangelo, Yale University

   
Middle Molecular Weight Bioanalysis, Organizer: Ragu Ramanathan, BMS

• Relevance of the Measurement of Free and Total Protein Therapeutic and Target Ligand in PK Studies, Martin Ullmann, Amgen
• ELISA and LC/MS Methods for the Measurement of Plasma Calcitonin Gene Related Peptide; Endogenous, Free and Total, Lindsay King, Pfizer
• Strategies and Methods for the LC/MS Analysis of siRNA, Mark Cancilla, Sima Therapeutics

   
Metabolite Quantitation Strategies, Organizer: Chris Holliman, Pfizer

• Biocatalysis: A Rapid Direct Approach to Preparative Synthesis of Drug Metabolites, Robert Vail
• Advances in Quantitative NMR: A new Tool for the Drug Metabolism Scientist, Greg Walker, Pfizer
• Quantitation using Full Scan High Resolution Mass Spectrometry, Kevin Bateman, Merck

   
Way Cool Technologies; One's I Wish I Invented, Organizer: Kevin Bateman, Merck

• Ion/Ion Reaction Techniques for Pharmaceutical Analysis, Scott McLuckey, Purdue
• Beyond 30 Parameters in Single Cells with Mass Cytometry, Scott Tanner, U Toronto & DVS Sciences