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please join us for

short courses Presented by Our Sponsors


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



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


September 17-19, 2012

Baltimore Sheration City Center Baltimore, MD

SHORT COURSE 2 Advancement in Met-ID (Full Day)

Introduction to the course Ramaswamy Iyer, BMS Mass Spectrometry Fundamentals Jonathan Josephs, BMS Break NMR Fundamentals Gregory Walker & Kathleen Farley, Pfizer


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

Organized by:

Gregory Walker & Kathleen Farley, Pfizer

NMR in DMPK in Drug Development

Gregory Walker & Kathleen Farley, Pfizer

welcome to apa 2012!

Monday, September 17
REGISTRATION Conference Introduction SESSION III: Bioanalysis of Biotherapeutics LC-MS Bioanalytical Method Validations: What Should Be Different for Large Molecules? Rand Jenkins, PPD LC-MS of Proteins in the Regulated Lab Jianing Zeng, BMS Peptides? Sarah Walter, KAI Pharmaceuticals A Decade of Isis Experience with Hybridization Based ELISA Methods for Quantitation of Antisense Oligonucleotides in Biological Matrices Rosie Yu, Isis Pharmaceuticals Evening Reception SESSION V: ADC - Biotrans/Biologics The Clinical Pharmacology of Brentuximab Vedotin: Metabolism and Drug-Drug Interactions Tae Han, Seattle Genetics Antibody Drug Conjugate Assay Challenges Pamela Chan, Genentech The ADME of ADCs: In Vitro to In Vivo Dan Rock, Amgen Lunch SESSION VI: Immunogenicity Characterization of Soluble Target Interference in PK and Immunogenicity Immunoassays Montserrat Carrasco-Triguero, Genentech Improved Drug Tolerance of Immunogenicity Assay Using Solution ELISA Alvydas Mikulskis, Biogen-Idec Recommendations on Sampling Considerations and Reporting of Immunogenicity Data for Appropriate Parameters Robert Hendricks, Genentec SESSION VII: Emerging Technologies for Tissue Analysis Tissue Imaging, MALDI: Introduction and Discovery Applications Walter Korfmacher, Medpace Bioanalytical Laboratories Tissue Imaging, MALDI: Quantitation and Sample Prep Tim Garrett, U. of Florida MALDI Imaging MS: Integrating Molecular Structure and Histology in Drug Development Steve Castallino, GlaxoSmithKline Panel Discussion All Session Speakers Evening Reception

wednesday, September 19
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

SESSION I: Latest issues cited in regulated BA 483s

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
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


Before 5/18/12 5/19/12-6/30/12 7/1/12-8/10/12 8/11/12-9/14/11 On-site Registration

550 800 900 1000 1100

950 1200 1300 1400 1500

550 800 900 1000 1100

275 400 450 500 500

500 50 500 500 500

* 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