BCN2011-Slides
Program of EBF 4th Open Conference “Less is More” November 16-18, 2011
PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here
Opening
Biomarker Validation Recommendation
- 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
How To Implement The EMA Guideline On Bioanalytical Method Validation
- 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.
Updates From The Globe
- 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)
Global Harmonization – Updates And Feedback From GBC Harmonization Teams
- 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
Technology Session I
- 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
Technology Session II
- 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
Bioanalysis Young Investigator Award
- Peter van Amsterdam (representing EBF Steering Committee) – Introduction
- Michelle Yoo (University of Nebraska) – Development of affinity microcolumns for high-throughput biointeraction analysis
Relationship Between Incurred Sample Reproducibility (ISR) And Incurred Sample Stability (ISS)
- 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.
Plenary Microdosing /Microtracer
Microdosing /Microtracer Plenary Session With Focus On AMS (Plenary)
- 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?
Breakout I: Microdosing /Microtracer Plenary Session With Focus On High Sensitivity LC-MS/MS
- 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
Breakout II: Stability Issues In Ligand Binding Assays
- 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
Breakout III. Updates On Dried Blood Spots, Blood Analysis And Microsampling
Feedback and status of EBF Dried Blood Spot Consortium: EBF June 2011 DBS workshop – where are we today?
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- 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
Breakout IV. Challenge Of “Free” And “Total” Macromolecule Quantification
- 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
Anomalous Results
- 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
2011-2012 EBF Feedback on planned and ongoing activities
- 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
