BCN Slides 2010
Program of EBF 3rd Open Conference “From Challenges to Solutions” December 1-3, 2010
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
Bioanalysis – Thinking out of the commodity box
- Ian Wilson (AstraZeneca) – What You Can’t See Can Hurt You: Looking at Bioanalysis by LC-MS From the Outside
- John Pugh (University of Sheffield) – Elemental imaging via LA-ICP-MS – New oppertunities in the life sciences
- Robert Plumb (Waters) – High Sensitivity Analysis of Biotherapeutics Using Capillary LC
- Martyn Hemsley (Covance) – Considerations and Experiences in Developing Bioanalytical Assays for the Quantitative Determination of Oligonucleotides
Practical Solutions to Bioanalytical Challenges: Blood – the original bioanalytical matrix?
- Albert Wolthuis (KCL) – The Blood Matrix: A Dynamic Mirror
- Achiel Van Peer (Janssen Research and Development) – Blood and Plasma: “A Magic Twin or Single in Human Pharmacokinetics ?”
- John Perkins (Advion BioServices) – Long Term Stability Issues Observed during Validation of an LC-MS/MS assay for Clopidogrel and Metabolites
- Ronald de Vries (Janssen Research and Development) – Analyte Instability Issues in Blood
- Achim Freisleben (Merck-Serono for EBF) – EBF Current Thinking on the Conduct of Whole Blood Stability
Towards Global Harmonization
- Philip Timmerman (Janssen Research and Development for EBF and GBC) – GBC-Harmonization Initiative and EBF Perspective
- Jérôme Barré (afssaps) – EMA Perspective on Global Harmonization
- Rafael Barrientos (Magabi for ACBio) – South America perspective
- Daniel Tang (Frontage for BBDS and SBDS) – APAC Perspective on Global Harmonization
- Mark Arnold (Bristol Meyers Squibb for AAPS) – AAPS Perspective on Global Harmonization
- T. Viswanthan (FDA/CDER) – FDA Perspective on Global Harmonization – Not released for publication
Platinum Sponsor sessions
- Gary Harland (Waters) – Addressing The Challenge of Sensitivity and Metabolite Detection in Bioanalytical Studies
- Mauro Aiello (AB SCIEX) – Overcoming the Data Analysis Bottleneck with Next Generation Quantitative Software
- Pat Bennett (Thermo Scientific) – Future of the Triple Quadrupole: What is Possible and what is Practical?
- Lester Taylor (Agilent) – Use of an Ion Funnel Triple Quadrupole LC/MS Instrument for HighSensitivity Quantitation
- Martin Nemansky (PRA International) – Comparison of various platforms for large molecule analysis – Introduction of the Imperacer® technology
- Iain Shaw (Quotient Bioresearch) – C14 enabled drug development
Technologies and Comparison of Assay Platforms
- Stefanie Fischmann (Abbott) – Comparison of Data from ECL and Hyphenated LC-MS Platforms on Quantitation of mAb from Serum Samples
- Fritz Poulsen (NovoNordisk) – Wash AlphaLISA – An Extension of the AlphaLISA/LOCI Technology
- Ronald Schmidt (Sanofi-Aventis) – Quantitative LC-MS/MS Analysis of Synthetic Insulins – Withdrawn
- Craig Stovold (Quotient Bioresearch) – Appliation of the Gyrolab to bioanalytical, pharmacodynamic and immunogenicity analysis in a regulated laboratory
- Birgit Jaitner (Novartis) – An approach to measure total drug levels in human serum samples while overcoming target interference
Reconnect on Dried Blood Spots
- Philip Timmerman (Janssen Research and Development for EBF) – EBF recommendation on Method Validation for Dried Blood Spots
- Julian Haynes (Pfizer) – Application of a Simple 2D-LC-MS/MS System to Control Ion Suppression Effects from DBS Samples
- Rohan Takur (Taylor Technology) – DBS and HRMS for in vivo Fast PK studies – The Value and Advantage for Pre-Clinical Studies
Practical Solutions to Bioanalytical Challenges: Matrix Effects
- Vincenzo Pucci (Merck & Co Inc) – Strategies for Reducing Phospholipid-based Matrix Effects in LC-ESI-MS Bioanalysis
- Curtis Sheldon (Celerion) – Haemolysed Sample Evaluation : A Variety of Issues for a Variety of Situations
- Carl-Johan Sennbro (Active Biotech for EBF) – Choice of Anticoagulant and Comparison of Counter-Ions – Results from Two EBF Surveys
- Tom Verhaeghe (Janssen Research and Development) – Matrix Effects in Practice : Sense and Nonsense of Internal Standard Response Acceptance Criteria
- Magnus Knutsson (Ferring) – Experiences of Assessing Matrix Effects by Monitoring Internal Standard Response in Study Samples
FDA Draft Guideline on “Assay Development for Immunogenicity Testing of Therapeutic Proteins” and Related Topics
- Susan Kirshner (FDA) – US FDA Draft Guidance on Immunogenicity Testing
- Arjen Companjen (Crucell for EBF) – The EBF Perspective on the FDA draft guidance on Assay Development for Immunogenicity Testing of Therapeutic Proteins
- Robin Thorpe (NIBSC) – European Guidance on Unwanted Immunogenicity of Biologicals
- Geoff Hale (Merck/Millipore) – The untility and futility of cut points for assessing unwanted immunogenicity – Not released for publication
- Janka Ryding (Ferring) – Case Study: Neutralization Assay Design and Qualification
- Andrea Kiessling (Novartis) – Integrated Approach of PK/PD/Immunogenicity Analysis
Finding the Right Level
- Fabio Garofolo (Algorithme Pharma Inc.) – When and How Much do Anomalous Results Need to be Investigated?
- Silke Lüdtke (Boehringer-Ingelheim for EBF) – Handling of Anomalous Results in Europe – Feedback from EBF Survey
- Margarete Brudny-Kloeppel (Bayer Schering Pharma AG for EBF) – Case studies from EBF member companies
EBF Feedback
- Peter van Amsterdam (Abbott for EBF) – Update on New Organization
- Margarete Brudny-Kloeppel (Bayer Schering Pharma AG for EBF) – Feedback from EBF 2010 Surveys and Activities
Biomarkers
- Liesbeth Vereyken (Janssen Research and Development) – Challenges with Nucleoside Triphospate Method Development and Analysis during the Life Cycle of a HCV Program
- Mark Spengler (Chimera) – Using Ligang-Binding Assay Sensitivity for Improved Matrix Tolerance and Related Parameters by Tailored Sample Dilution.
- Anna Valeri (MHRA) – Biomarker Development: A Regulatory Perspective – Not released for publication
- Jan Moack (Slovak University of Technology, Bratislava) – Effective use of Combination of Lung Malignity Marker
