Sunday, September 16
SHORT COURSE 1 Immunogenicity Short Course
Introduction to Immune Response Marie Rock, WIL Research Overview of Assay Design Considerations Marie Rock, WIL Research Break ATA Screening Assay: Development, Optimization and Validation Montserrat Carrasco-Triguero, Genentech LUNCH
http://bostonsociety.org/APA/index.html
2012
gold
Analysis, Interpretation and Reporting of Immunogenicity Data from Clinical Studies Susan Paulson, Paulson PK Consulting, LLC Case Study-Based Immunogenicity Risk Assesment and Bioanalytical Strategies Heather Myler, BMS
silver
bronze
LUNCH Application of Mass Spec in Drug Discovery Jonathan Josephs & Silvi Chacko, BMS Application of Mass Spec in Drug Development Ramaswamy Iyer & Silvi Chacko, BMS Break NMR in DMPK in Drug Discovery
pharmaceutical
Organized by: www.bostonsociety.org
wednesday, September 19
Biotransformation
Plenary Talk: Drug Transporters: Clinical Relevance and Prediction From Preclinical Animal Model and In Vitro Model Prof. Hiroyuki Kusuhara, University of Tokyo SESSION VIII: Pharmacogenomics (around drug metabolism enzymes) Pharmacogenetics of Drug Transporters Professor Mikko Niemi, University of Helsinki Personalized Medicine: Hope vs. Hype Margaret Woo, Novartis Understanding Variability in Pharmacokinetics and Efficacy for Anti-angiogenic Therapies: Utility of omic Approaches Andy Williams, Pfizer SESSION IX: New In-Vivo/In-Vitro Tools Looking Into ADME Properties Chimeric Mice with Humanized Livers: Utility within Drug Discovery and Development Matthew Wright, Genentech Using the Abcg2(-/-) Rat to Explore the Role of Bcrp in Drug Clearance and Excretion Brad Wong, Amgen Application of Humanized Animal Models to Study the Role of Transporters in ADME of Drug Candidates Xiaoyan Chu, Merck Lunch SESSION X: AMS Fundamentals of AMS Quantitation, Evolving Technology, and Future Perspectives Stephen R. Dueker, Vitalea Science, Inc
Regulated Bioanalysis
Plenary Talk: FDA Update Sam Haidar, FDA
A Critical Review of FDA Form 483 Findings for Inspections of Bioanalytical Laboratories David Scharberg, Pharmaceutical Outsourced Solutions Lessons Learned and Best Practices Gleaned in The Auditing of Contract Research Organization Bioanalytical Labs Jeff Sailstad, Sailstad and Associates, Inc. Caught in the Middle: A Bioanalytical CRO Perspective on Sponsor Requests vs. Regulatory Expectations Bob Nicholson, PPD Panel Discussion Sam Haidar, David Scharberg, Jeff Sailstad and Bob Nicholson SESSION II: Perspectives on Quality Systems and Regulatory Compliance for Biomarker Research Pfizer Perspective on Biomarker Mass Spectrometry Beth Groeber, Pfizer Regulated Biomarker Analysis, from a Ligand Binding Assay prespective: challenges and solutions Lakshmi Amaravadi, Biogen idec Flow Cytometry Dianna Wu, Merck Pharmacogenomics Lei Li, Novartis Lunch
tuesday, September 18
Combined Track: Regulated Bioanalysis, Biotransformation, Discovery Technologies
Workshop Intro Russ Weiner, Merck
Plenary Talk: FDA Update Brian Booth, FDA SESSION IV: Tissue Bioanalysis: Best Practices Validation vs. Qualification Tissue Recovery and Stability, General Approach in Industry and Work in Celgene Yongjun Xue, Celgene Quantification of Drugs and Metabolites in Tissues: Case Studies to Demonstrate the Value Richard Edom, Janssen Drug in Tissue - Only for Evaluation of Toxic Side Effects or Critical for Treatment Development & Design? Daniel Schulz-Jander, Medtronic
http://bostonsociety.org/APA/registration.html
Recent Advances in Microdose and Microtracer Studies to support Drug Development Swapan Chowdhury, Millennium Use of AMS to Facilitate Collection of ADME Data: Practical Considerations from an Industry Perspective Lisa Christopher, BMS SESSION XI: In-Silico Applications Modeling the CYP Enzymes and Other ADME Processes Ken Korzekwa, Temple University Pilot Validation of an Alternative Platform for the Simulation of Drug Drug Interactions in CPT-1 Stephen Wang, Millennium Predictive ADME Modeling: Fact or Fiction? Peter Swaan, University of Maryland Lunch SESSION XIV: Qual/Quan Qual/Quan Jonathan Josephs, BMS LC-HRMS: Challenges, Opportunities, and Open Questions in Evaluating a Change from Triple Quadrupoles Richard LeLacheur, Agilux Labs MIST Requirements Mark Powley, FDA SESSION XV: Software for Med-ID Software for Metabolite ID in Discovery Angela Wehr, Biogen idec HT Metabolite Identification in Drug Discovery: Understanding Metabolic Properties Ismael Zamora, Lead Molecular Design, S.L. Software and Automation Technologies for High Throughput In Vitro Half Life Determination Wilson Shou, BMS
registration
SOCIETY/ ATTENDEE AFFILIATE/NONSPONSORING VENDOR* PAID SPONSOR DISCOUNTED RATE STUDENT ONLY PRICING SHORT COURSE ONLY (FULL DAY)
* This rate is for software vendors, consultants, CROs, and instrumentation companies who have a commercial interest in the meeting. It does not apply to FDA, pharmaceutical, or academic scientists, who are invited to apply at the Attendee rate.
Discovery Workshop
Organizing Committees
Presiding Chairs Chair: Russell Weiner, Merck Chair-Elect: Andy Vick, 7th Wave Labs Regulated Bioanalysis Chair: Andy Vick, 7th Wave Labs Chair-Elect: Binodh DeSilva, Bristol-Myers Squibb Committee: Chris Evans, GlaxoSmithKline; Eric Woolf, Merck; Anne Aubry, Bristol-Myers Squibb; Johanna Mora, Bristol-Myers Squibb; Rick Steenwyk, Pfizer; Fumin Li, Covance; Farhad Sayyarpour, WIL Research, Yongjun Xue, Celgene Discovery Bioanalysis & New Technologies Chair: Ragu Ramanathan, BMS Chair-Elect: Jing-Tao Wu, Millennium/Takeda Committee: Chris Holliman, Pfizer; Mark Cancilla, Merck; Surinder Kaur, Genentech; Stephanie Pasas Farmer, Galleon; Silvi Chacko, Bristol-Myers Squibb; Pat Bennett, Thermo Scientific; Natasha Penner, Biogen Idec Biotransformation Chair: Deepak Dalvie, Pfizer Chair-Elect: Chandra Prakash, Biogen Idec Committee: Tian Yang, Global Alliance for TB; Mark Milton, Novartis; Greg Walker, Pfizer; Rama Iyer, Bristol-Myers Squibb; Kirk Henne, Amgen; Cindy Xia, Millennium/Takeda, Hongbin Yu, Boehringer-Ingelheim
Plenary Talk: Biomarkers in Discovery and Development Overview Meena Subramanyam (VP Translational Med), Biogen idec SESSION XII: Large Molecule in Discovery Comparing ELISA with Mass Spec Quantitation Surinder Kaur, Genentech Development of Novel Assays and Platforms for Dynamic Biomarker and Cell Monitoring Tania Konroy, MIT SESSION XIII: Flow Cytometry Title TBD Virginia Litwin, Covance Title TBD David Wunderlich, Pfizer Title TBD Speaker