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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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REGISTRATION
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7:00 - 8:00
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Conference Introduction
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Russ Weiner
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Merck
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Workshop Introduction
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Andy Vick
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7th Wave Labs
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Session I: Regulated Bioanalytical
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FDA UPDATE
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Sam Haidar
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FDA
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A Critical Review of FDA Form 483 Findings for
Inspections of Bioanalytical Laboratories
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David Scharberg
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Pharmaceutical Outsourced Solutions
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Lessons Learned and Best Practices Gleaned in
The Auditing of Contract Research Organization Bioanalytical Labs
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Jeff Sialstad
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Caught in the middle: A bioanalytical CRO perspective on sponsor requests vs. regulatory expectations
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Bob Nicholson
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PPD
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Session II: Biomarker Regulations: What exactly are they?
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Pfizer perspective on biomarker mass spectrometry
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Beth Groeber
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Pfizer
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Ligand Binding Assay Applications
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Lakshmi Amaravadi
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Biogen Idec
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Flow Cytometry
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Dianna Wu
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Merck
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Pharmacogenomics
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Session III: Bioanalysis of Biotherapeutics
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Bioanalysis of oligonucleotides
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Rosie Yu
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Isis Pharmaceuticals
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Protein LC-MS analysis
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Rand Jenkins
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PPD |
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TBD |
Sarah Walter |
KAI Pharmaceuticals |
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LC-MS of proteins in the regulated lab
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Jianing Zeng
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Bristol-Myers Squibb |
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EVENING RECEPTION
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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FDA UPDATE
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Brian Booth
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FDA
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Session IV: Tissue Bioanalysis: Best Practices – Validation vs. Qualification
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Qualification Drug Metabolites in Tissues,
Challenges and Case Studies
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Rick Edom
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Janssen
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Tissue recovery and stability, general approach
in industry and work in Celgene
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Yongjun Xue
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Celgene
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Drug in tissue - Only for evaluation of toxic side effects
or critical for treatment development & design?
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Daniel Schulv-Jander
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Medtronic
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Session V: ADC - Biotrans/Biologics
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Antibody Drug Conjugate Assay Challenges
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Pamela Chan
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Genentech |
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The clinical pharmacology of brentuximab vedotin: Metabolism and drug-drug interactions
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Tae Han
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Seattle Genetics
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The ADME of ADCs: In vitro to In vivo
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Dan Rock
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Amgen
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Session VI: Immunogenicity
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How to test for target interference in PK and Immunogenicity method development
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Monserrat Carrasco-Trigero
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Genentech |
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How to improve drug tolerance
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Alvydas Mikulskis
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Biogen idec |
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Recommendations on sampling considerations and reporting of Immunogenicity data for appropriate parameters
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Robert Hendricks
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Genentech |
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Session VII: Emerging Technologies for Tissue Analysis
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Tissue Imaging, MALDI: Introduction and
Discovery Applications
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Walter Korfmacher
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Medpace Bioanalytical Laboratories
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Tissue Imaging, MALDI: Quantitation and Sample Prep |
Tim Garrett |
University of Florida |
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MALDI Imaging: Bridging Biology and Chemistry in
Drug Development
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Steve Castallino
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GlaxoSmithKline
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Panel Discussion
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Session Speakers
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Wednesday, September 19
(Biotransformation and Discovery Workshops run Concurrently)
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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Workshop Introduction |
Deepak Dalvie
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Pfizer
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PLENARY
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Professor Yuichi Sugiyama
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University of Tokyo
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Session VIII: Pharmacogenomics
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Pharmacogenetics of drug transporter |
Professor Mikko Niemi |
University of Helsinki |
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Understanding variability in pharmacokinetics and efficacy for anti-angiogenic therapies: utility of 'omic approaches |
Andy Williams |
Pfizer |
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Session IX: New in-vivo/in-vitro Tools looking into ADME properties
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Mice Studies |
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Knock Out Mice |
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Session X: AMS
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Fundamentals of AMS quantitation, evolving technology,
and future perspectives |
Stephen R. Dueker |
Vitalea Science, Inc |
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Novel exploratory approaches to define clinical PK and ADME – microdoses and microtracers |
Swapan Chowdhury |
Millennium |
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Use of AMS to facilitate collection of ADME data:
practical considerations from an industry perspective |
Lisa Christopher |
Bristol-Myers Squibb |
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Session XI:In-Silico Applications
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P450 Models
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Ken Korzekwa
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Temple University
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Modeling and Simulation
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Towards predictive ADME/Tox: Opportunities and Challenges
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Peter Swan
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University of Maryland
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Wednesday, September 19
(Biotransformation and Discovery Workshops run Concurrently)
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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Workshop Introduction
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Ragu Ramanathan
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Bristol-Myers Squibb
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PLENARY
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Biomarkers in Discovery
and Development Overview
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Meena Subramanyam
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Biogen Idec
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Session XII: Large Molecule in Discovery
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Comparing ELISA with Mass Spec Quantitation
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Keyang Xu
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Genentech
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Development of novel assays and platforms for
dynamic biomarker and cell monitoring
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Tania Konry
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MGH Harvard Medical School
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Session XIII: Flow Cytometry
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TBD
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Virginia Litwin
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Covance
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TBD
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David Wunderlich
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Pfizer
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| Session XIV: Qual/Quan |
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MIST Requirements
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Mark Powley |
FDA |
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New Directions
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Qual/Quan
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Jonathan Josephs
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Bristol-Myers Squibb |
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Session XV: Software for Med-ID
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Software for Metabolite ID in discovery
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Angela Wehr
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Biogen idec
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HT metabolite identification in Drug Discovery: understanding metabolic properties
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Ismael Zamora
|
Lead Molecular Design, S.L.
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Software and Automation Technologies for High Throughput in vitro Half Life Determination
|
Wilson Shou |
Bristol-Myers Squibb |
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