April 11, 2011 (Monday)
8:00am - 5:00pm
Registration desk open
Short Course 1a: "High Throughput Drug Analysis by LC-MS"
Short Course 1b: "Bioanalysis of Large Molecule: Ligand Binding Assays (LBA) method development and validation"
Breakfast, Lunch and Morning/afternoon Refreshments are provided during the courses.
April 12, 2011 (Tuesday)
8:00am - 6:30pm
Registration desk open
Short Course 2: "LC-MS/MS Bioanalytical Advanced Method Development"
Breakfast, Lunch and Morning/afternoon Refreshments are provided during the course.
7:00pm - 10:00pm
Speakers/Panelists working dinner for the preparation of the 2011 White Paper
April 13, 2011 (Wednesday)
07:30am-08:30am:
08:30am-09:00am:
Registration & Breakfast
Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma - "Follow up on "unresolved" 2010 White Paper discussion topics - Bioanalysis (2010)2(12) & Need-to-Know from 2010 Major Bioanalytical Conferences: NBC, Land O' Lakes, BSAT-APA, PSWC/AAPS/FIP, EBF"
Method Development Challenges in Bioanalysis: Small Molecules & LC-MS/MS Session
09:00am-09:30am:
09:30am-10:00am:
10:00am-10:30am
10:30am-11:00am:
11:00am-11:30am:
11:30am-12:00am:
12:00pm-01:00pm
Dr. John Dunn, US Bioanalysis Head, GlaxoSmithKline - "The Latest Developments and Insights on DBS"
Dr. Steve Michael, VP and CSO of Global Bioanalytical Services, Covance - "Bioanalytical Validation in Dried Blood Spot (DBS) Analysis"
Coffee & Refreshment Break
Mr. Richard Hucker, Manager Clinical Assay Group, Pfizer - "High Throughput Method Development Approaches & Method Development Strategies to Enhance Sensitivity in LC-MS/MS"
Dr. Stacy Ho, Sr. Scientist, DMPK & Pharmaceutics, Genzyme - "Tissue and Special Matrix Bioanalysis"
Dr. Wenkui Li, Sr. Fellow, Laboratory Head Translational Sciences - DMPK/DMBA, Novartis Institutes for Biomedical Research - "Practical Strategies in Stability Assessment for Quantitative LC-MS/MS Bioanalysis of Small Molecules"
Lunch
Method Development Challenges in Bioanalysis: Large Molecules & LBA Session
01:00pm-01:30pm:
01:30pm-02:00pm:
02:00pm-02:30pm:
02:30pm-03:00pm
03:00pm-03:30pm:
03:30pm-04:00pm:
Dr. Binodh DeSilva (Session Chair), Executive Director Bioanalytical Sciences-Biologics, Bristol-Myers Squibb - "Overview of Macromolecule Bioanalysis - Past, Present and Future"
Dr. Jean Lee, Scientific Director, PKDM, Amgen - "Ligand Binding Assay of Free and/or Total Monoclonal Antibody Drug and Target - Why, What and How?"
Dr. Dominique Gouty, Senior Director Immunochemistry, Intertek - "Curve Fitting Models and Validation Parameters for Ligand Binding Assays"
Coffee & Refreshment Break
Dr. Montse Carrasco, Development Scientist, Bioanalytical Sciences, Genentech - "Strategies to Overcome Interference by a Complex Soluble Target in Immunogenicity and Pharmacokinetic Immunoassay Methods for an Antibody Biotherapeutic"
Dr. Russell Weiner, Executive Director - Clinical Development Lab, Merck Research Laboratories - "When Bioanalytical Worlds Collide - Surviving in a Mixed GLP-CLIA Environment"
Panel Discussion Part One and 2011 WHITE PAPER preparation
04:00pm-05:00pm:
05:00pm-06:00pm:
Panel Discussion - "Method Development Challenges in Bioanalysis: Small & Large Molecules - LC-MS/MS & LBA"
Networking Reception
Innovations in Bioanalysis: From DD to DD (Drug Discovery to Drug Development) Session
06:00pm-06:30pm:
06:30pm-07:00pm:
07:00pm-07:30pm
Dr. Mohammed Jemal, Senior Research Fellow, Bristol-Myers Squibb - "Protein Drug Quantitative Bioanalysis by LC-MS"
Mr. Graeme Young, Manager PTS-DMPK, GlaxoSmithKline - "Accelerator Mass Spectrometry (AMS) in Bioanalysis; Assay Validation and Clinical PK"
Dr. Mohammed Jemal, Senior Research Fellow, Bristol-Myers Squibb - "High Resolution Accurate Mass Spectrometry (HRAMS) for Quantitative Bioanalysis"
April 14, 2011 (Thursday)
Findings from Audits/Inspections - SCIENTIFIC PERSPECTIVE Session
07:30am-08:00am:
08:00am-08:30am:
08:30am-09:00am:
09:00am-09:30am:
09:30am-10:00am:
10:00am-10:30am
10:30am-11:00am:
11:00am-11:30am:
11:30am-12:00am:
12:00pm-01:00pm
01:00pm-01:30pm:
01:30pm-02:00pm:
Breakfast
Dr. Olivier Le Blaye, Inspector - Clinical Trials Inspection Unit - French Health Products Safety Agency - AFSSAPS - "Examples of Scientific Issues Raised During Inspections"
Dr. Surendra Bansal, Research Director Bioanalytical R&D, Non-Clinical Safety, Hoffmann-La Roche - "Considerations on Slope Variations between Runs and on Internal Standard Response Variations within Run in LC-MS/MS Assays"
Dr. Keith Gallicano, Director, Biopharmaceutics Operations, Watson Laboratories - "Setting Specifications for and Monitoring of Variation in Internal Standard Response"
Mr. Corey Nehls, Executive Director Bioanalytical Labs, PPD - "Regulatory Agency Inspections & How to Best Work Together: Industry Perspective"
Coffee & Refreshment Break
Dr. Mario Rocci, Executive Vice President, ICON - "Regulatory/Quality Findings and their Impact in a Regulated Bioanalytical Environment"
Dr. Eric Woolf, Senior Director, Merck Research Laboratories - "Impact of Co-Administered Medications on Regulated Bioanalysis"
Mr. Peter van Amsterdam, Head of Global Bioanalytics, Abbott - "Learning from Issues in Assay Cross-Validation/Method Transfers"
Lunch
Dr. Daniel Tang, Vice President of Bioanalysis and DMPK, Frontage Laboratories - "Technical and Regulatory Challenges for Bioanalysis of Hemolyzed Samples"
Dr. Stephen Lowes, Senior Vice President Scientific, Advion BioServices - "Development of LC-MS/MS Biomarker Assays: Avoiding a World of Chaos"
Findings from Audits/Inspections - REGULATORY PERSPECTIVE Session - Chaired by Dr. Viswanathan (FDA)
View list of questions to be addressed to Regulatory Agencies
02:00pm-02:20pm:
02:20pm-02:40pm:
02:40pm-03:00pm:
03:00pm-03:40pm
03:40pm-04:00pm:
04:00pm-04:20pm:
Mr. Eric Ormsby, Manager, Health Canada Therapeutic Product Directorate - "Regulatory Findings from Audits/Inspections: Questions to be addressed to TPD"
Ms. Ariadna Cristina Gomes Barra, Head Bioequivalence Coordination, Brazil ANVISA - "Regulatory Findings from Audits/Inspections: Questions to be addressed to ANVISA"
Dr. Noriko Katori, Senior Researcher, Japan MHLW-NIHS - "Regulatory Findings from Audits/Inspections: Questions to be addressed to MHLW"
Coffee & Refreshment Break
Dr. CT Viswanathan, Associate Director, Division of Scientific Investigations, US FDA and Dr. Brian Booth, Deputy Director, Office of Clinical Pharmacology, US FDA- "Regulatory Findings from Audits/Inspections: FDA Perspectives & Updates on Harmonisation of Bioanalytical Guidance"
Dr. Olivier Le Blaye, Inspector France AFSSAPS - "Regulatory Findings from Inspections: a European Perspective & Updates on Harmonisation of Bioanalytical Guidance"
Updates from Global Bioanalytical Consortium (GBC)
Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma - "Recent Activities of GBC through International Harmonization Teams (HT): Where We Are and What It Is Left To Do"
Panel Discussion Part Two and 2011 WHITE PAPER preparation
04:40pm-05:55pm:
05:55pm-06:00pm:
Panel Discussion - "Regulatory Findings from Audits/Inspections"
Closing Remarks and Adjournment
2011 Workshop White Paper will be completed and published on Journal "Bioanalysis" from Future Science Group.
