• Philip Timmerman (for EBF) - Welcome to the conference

• Philip Timmerman (on behalf of EBF) - Introduction to biomarker validation recommendation session
• Christian Herling (on behalf of EBF) - EBF reflections on biomarker validation
• Alexandre Avrameas (Novartis) - Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation
• Barry Jones (Advion) - LC/MS biomarker assay validation strategies using surrogate matrix and surrogate analyte approaches
• Richard Houghton (Quotient Bioresearch) - Challenges of validating small molecule LC-MS/MS biomarker methods
• John Chappell (ICON Development Solutions) - Biomarker Measurement- maximum information from limited volume

• Peter van Amsterdam (on behalf of EBF) - Introduction
• Olivier Le Blaye (afssaps) - The EMA Guideline on bioanalytical method validation
• Timothy Sangster (Charles River Laboratories) - EMA – have our prayers been answered!
• Daniela Stoellner (Novartis) - New EMA guideline on method validation and how it translates into best practice for Ligand Binding Assays
• Graeme Smith (Huntingdon Life Sciences) - Partial Validation when is enough, enough?
• Morten Rohde (Lundbeck) - Matrix Effects in Bioanalysis, when established procedures become obsolete.

• Rafael Barrientos (Magabi for ACBio) - ANVISA guideline on bioanalytical method validation updates
• Shinobu Kudoh (Shimadzu for Japan Bioanalysis Forum) - Introducing the Japan Bioanalysis Forum (JBF)

• Philip Timmerman (on behalf of GBC) - Global Bioanalysis Consortium status update
• John Smeraglia (on behalf of GBC Harmonisation Team A1) - Harmonization team A1 (scope and regulations) update
• Nico van de Merbel (on behalf of GBC Harmonisation Team A6) - Harmonization team A6 (stability) update
• Michaela Golob (on behalf of GBC Harmonisation Team L6) - Harmonization team L6 (immunogenicity effect on PK) update
• Ben Gordon (on behalf of GBC Harmonisation Team S1) - Harmonization team S1 (run acceptance) update

• Patrick Bennett (Thermo Scientific) - Applying proven proteomics workflows and tools for quantitative bioanalysis of large molecules
• Barry van der Strate (PRA International) - Flow cytometry for determination of efficacy in phase I
• Andrew Roberts (Quotient Bioresearch) - Challenges in developing anti-drug antibody ligand binding assays

• Mauro Aiello (AB Sciex) - Differential ion mobility spectrometry, creating a new dimension of selectivity for LC/MS/MS analysis
• Diego Rodriguez Calabeiro (Waters Corporation) - Beyond sensitivity: improving the performance, productivity and compliance of the bioanalytical assay process
• Lester Taylor (Agilent Technologies) - Automation and optimization of an on-line extraction system for dried blood spot analysis

• Peter van Amsterdam (representing EBF Steering Committee) - Introduction
• Michelle Yoo (University of Nebraska) - Development of affinity microcolumns for high-throughput biointeraction analysis

• Morten Anders Kall (on behalf of EBF) - Feedback on EBF survey on Incurred Sample Stability (ISS)
• Theo de Boer (QPS) - Incurred sample accuracy assessment: design of experiments based on standard addition
• Ronald de Vries (Janssen Research & Development) - Assessment of ISS using an efficient standardized stepwise “black box’’ process.

• Malcolm Rowland (School of Pharmacy and Pharmaceutical Sciences, University of Manchester) - Microdosing: a simple idea with big results

• Graeme Young (GSK) - “LC+AMS” in support of microdose/microtracer clinical studies at GSK – an evolving science
• David Higton (on behalf of EBF) - Towards a recommendation of bioanalytical qualification or validation of microdosing and microtracer studies – part 1 – LC+AMS
• Stuart Best (Xceleron) - What are the critical factors determining the performance of an LC+AMS assay?

• David Higton (on behalf of EBF) - Towards a recommendation of bioanalytical qualification or validation of microdosing and microtracer studies – part 2 – LC-MS/MS
• Richard Abbott (Shire) - Microdosing and cold LC-MS/MS: bioanalysis and its evolving role in strategic drug development
• Alberto Guenzi (Hoffmann-La Roche) - Microdosing with LC-MS analysis: variations on the theme
• Magnus Knutsson (Ferring) - Drug development of highly potent therapeutic peptides - A bioanalytical challenge with micro-dosing plasma levels at therapeutic doses

• Arjen Companjen (on behalf of EBF) - Introduction
• Jenny Hendriks (Crucell) - Binding and activity of anti-vaccine antibodies in short and long term stability studies
• Ulrich Kunz (Boehringer-Ingelheim) - Case studies of issues with stability of antibody reagents
• Susanne Pihl (on behalf of EBF) - Long term stability investigation of macromolecules in an isochronic study design

• Philip Timmerman (on behalf of EBF) - Moving forward from the EBF Recommendation

Feedback and status of EBF Dried Blood Spot Consortium: EBF June 2011 DBS workshop – where are we today?

• Steve White (on behalf of the EBF DBS consortium) - Introduction
• Susanne Globig (on behalf of the EBF DBS consortium) - Sample Dilution
• Zoe Cobb (on behalf of the EBF DBS consortium) - Stability/recovery
• Dieter Zimmer (on behalf of the EBF DBS consortium) - Internal Standard
• Steve White (on behalf of the EBF DBS consortium) - Haematocrit
  
• Eric Fluhler (Pfizer, on behalf of AAPS Bioanalytical Focus Group) - Feedback from the AAPS APQ Open Forum: “DBS and microsampling: moving past the hype to knowledge and implementation” 27-Oct-2011, Washington D.C.
• Ove Jonsson (AstraZeneca) - Capillary micro sampling (CMS): handling and analysis of small volumes of blood, plasma and other biofluids

• Daniela Stoellner (on behalf of EBF) - EBF overview
• Lindsay King (Pfizer) - Risk assessment for the measurement of Free and Total drug and target
• Roland Staack (Hoffmann-La Roche) - Mathematical simulation tools in bioanalytical assay development
• Philip Lowe (Novartis) - Integration of physiological and biochemical concepts into the development of biopharmaceuticals

• Magnus Knutsson (on behalf of EBF) - Updates from EBF survey on unexpected results
• Fabio Garofolo (Algorithm Pharma) - An in-depth bioanalytical investigation to determine the root cause of abnormal results
• Silke Luedtke (Boehringer-Ingelheim) - Unexpected results in a bioanalytical laboratory – a safety and compliance issue?
• Rachel Green (Quotient Bioresearch) - Use of a CAPA system in handling anomalous results – with a focus on maintaining GCP compliance
• Andreas Henrichs (Sanofi-Aventis) - GCP in a bioanalytical laboratory

• Margarete Brudny Kloeppel - Overview of 2011 activities and plans for 2012
• Arjen Companjen (on behalf of EBF Topic Teams) - Overview activities teams 18, 19 & 20)
• Philip Timmerman (on behalf of EBF Topic Team -09) - Feedback from topic team 9: alternative techniques
• Silke Luedtke & Peter van Amsterdam (representing EBF SC) - Let's have a birthday party