Day 1 – Wednesday 19 NOV 2014
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PLENARY SESSIONS |
08.30-08.40 |
Welcome Philip Timmerman, on behalf of the EBF |
08.40-10.20 |
Large molecules – LBA or LC-MS? Why and when |
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Roland Staack (Hoffmann-La Roche) |
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Protein Quantification by LBA or LC-MS: Key Criteria for the Definition of the |
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Bioanalytical Strategy |
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Barry van der Strate & Nico van de Merbel (PRA Health Sciences) |
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Can 1+1 be 3? The combination of LBA and LC-MS to look beyond the horizon of |
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large molecule quantification |
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Rand Jenkins (PPD, Inc.) |
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Immunogenicity assessments, an important aspect of biotherapeutic drug |
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development: Can LC-MS technology be applied to complement traditional |
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LBA-based approaches? |
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Ronald de Vries (Janssen R&D) |
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Combined use LBA + LC-MS/MS in drug development of a 4kDa peptide: |
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1+1=3 or where complementary data made a difference |
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Panel Discussion |
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10.20-11.00 |
Coffee break |
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11.00-12.40 |
Large molecules – LBA and LC-MS! How |
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Matt Barfield (GlaxoSmithKline, on behalf of EBF TT-43)
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How to develop Antibody Drug Conjugates – Recommendations from TT43 and |
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survey results |
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Charlotte Hagman (Novartis) |
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Characterization of Antibody-Drug Conjugates using Affinity Enrichment |
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and High-Resolution Mass Spectrometry |
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Fabio Garofolo (Algorithme Pharma Inc) |
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Recent Trends in Antibody-Drug Conjugate (ADC) Bioanalysis: Total |
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Antibody Quantification by HRMS |
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Ravindra Chaudhari (Thermo Fisher Scientific) |
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Highly Sensitive and Robust Workflow for Therapeutic Monoclonal |
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Antibody Analysis from Complex Matrices |
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Panel Discussion |
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12.40-14.00 |
Lunch break |
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14.00-15.20 |
Looking Beyond the Horizon |
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Philip Timmerman (Janssen R&D) |
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Making the impossible possible |
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EBF YSS |
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We are the future |
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Zsofia Berke (AstraZeneca) |
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Analytical Comparison Between Point-of-Care Uric Acid Testing Meters |
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Daniela Stoellner (Novartis, on behalf of EBF TT-20) |
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How the bioanalytical scientist plays a key role in interdisciplinary project |
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teams in the development of biotherapeutics – a reflection of the |
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European Bioanalysis Forum |
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15.20-16.00 |
Tea break |
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16.00-17.45 |
Scientific or Regulated Validation? AKA Tiered Approach |
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Philip Timmerman (Janssen R&D, on behalf of EBF) |
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EBF proposals on balancing Scientific vs. Regulated Validation |
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David Jones (MHRA) |
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An EU Regulator�s viewpoint as why Regulatory Guidelines should not be |
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followed |
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Hans Stieltjes (Janssen R&D) |
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Tiered Approach for Bioanalysis of Drugs and their Metabolites: Examples |
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of the Use of Qualified Assays at Janssen R&D during the past decade |
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Graeme Smith (Harlan / Huntington Life Sciences) |
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A Tiered Approach to Bioanalysis: From Concept to Practice |
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Panel discussion |
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18.00-19.00 |
Cocktail reception |
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SPOTLIGHT WORKSHOP |
11.00-12.40 |
Spotlight on e-Data: towards a common standard |
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Introduction to the workshop |
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Workshop chairs (Hans Mulder (Astellas) /David Van Bedaf (Janssen R&D)) |
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Jim Brennan (LabWare) |
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A perspective on paperless operations in a modern bioanalytical laboratory |
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Gerhard Noelken (Allotrope) |
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Allotrope: An open ecosystem for seamless data management and exchange for |
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Bioanalysis |
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Peter Esch (Novartis) |
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Electronic Raw Data in a GLP Environment – Swiss AGIT Working Group |
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Guidelines |
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Panel discussion – workshop |
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Gaps and practical steps towards a common e-standard for bioanalysis |
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Day 2 – Thursday 20 NOV 2014
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PARALLEL SESSIONS 1 |
08.30-10.10 |
LC-MS Applications for Large Molecules |
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Kevin Bateman (MSD) |
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Application of LC-MS for characterization and bioanalysis of therapeutic |
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antibodies |
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Ludovicus Staelens (UCB Pharma) |
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Internal standard approaches in quantification of proteins by LC-MS/MS |
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Richard Kay (LGC) |
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Supercharging reagents – revving up peptide LC-MS analyses. |
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Vincent Trinh (inVentiv Health Clinical) |
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Insulin Glargine: From the Immunoassays to the More Specific LC-MS/MS Assay |
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Erin Chambers (Waters Corporation) |
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Getting More with Less: Improving Sensitivity and Reducing Sample |
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Consumption in LC/MS Assays for Endogenous and Injected Glucagon, |
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6 insulins, and Teriparatide |
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10.10-11.00 |
Coffee break |
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11.00-12.40 |
Diversity of the Bioanalytical Landscape |
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Ann Lévesque (inVentiv Health Clinical) |
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Determination of Testosterone in Plasma instead of Serum: |
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When is it needed? Is it accepted? |
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Susan Pang (LGC) |
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The development of robust cortisol assays for sports-based applications |
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Vincenzo Pucci (Merck) |
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Merck global bioanalytical strategy to ensure data quality in the discovery space |
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and successful LC-MS/MS methods transfer to preclinical GLP and clinical |
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bioanalytical groups |
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Jonathan Stauber (ImaBiotech) |
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Applications of Quantitative Mass Spectrometry Imaging in drug development |
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Mohammed Abrar (Unilabs York Bioanalytical Solutions) |
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Vitamin D3 Determination- Automated, Streamlined, Robust and Reliable |
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12.40-14.00 |
Lunch break |
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14.00-15.40 |
Low, Lower, Lowest |
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William van Dongen (TNO Triskelion) |
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Nano-UPLC and Chip-based LC-MS methods for the sensitive determination of |
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therapeutic monoclonal antibodies in serum |
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Mark Wrona (Waters Corporation) |
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Integration of microfluidics with High Resolution Mass Spectrometry (HRMS) |
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for DMPK Studies |
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Tom Verhaeghe (Janssen R&D) |
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LC-MS/MS as an enabler for a broader application of microdose studies in drug |
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development; the Janssen experience |
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Adrian Pereira (GlaxoSmithKline) |
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Validation of a clinical assay with LLoQ of 350 fg/mL by Liquid Chromatography |
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+ Accelerator Mass Spectrometry in support of dermal dosing |
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Stephen English (Xceleron) |
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Tiered validation of LC+AMS Assays: Recommendations for best practices |
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15.40-16.15 |
Tea break |
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16.15-17.55 |
Bioanalytical Assay Robustness |
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Steve White (GlaxoSmithKline) |
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Measuring assay robustness across the life cycle of a bioanalyical method |
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Amanda Wilson (AstraZeneca, on behalf of EBF TT-41) |
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EBF Topic Team-41; Processed Sample Reproducibility and Stability |
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David Bakes (Harlan / Huntington Life Sciences) |
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An industry consensus towards baseline assignment – where do we draw the line? |
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Luc Bouchard (inVentiv Health Clinical) |
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Importance of End-to-End Robustness when dealing with Glucuronide |
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Metabolites |
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Susanne Pihl (Lundbeck, on behalf of EBF TT-47) |
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EBF recommendation on practical management of critical reagents for |
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ligand-binding assays |
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18.00-19.00 |
Cocktail reception |
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PARALLEL SESSIONS 2 |
08.30-10.10 |
Day to Day Challenges and Automation in Bioanalysis |
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Raymond Farmen (Celerion) |
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Integrating automated systems for regulated bioanalysis |
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Christophe Zickler (Novartis) |
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Automated bioanalysis of PK, PD and immunogenicity in a GLP/GCLP |
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regulated environment |
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Craig Stovold (LGC) |
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Assessing Carryover in the Immunoassay Laboratory |
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Matt Bentley (Eurofins Pharma Bioanalysis Services) |
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Practical solutions to the optimisation of drug tolerance in ADA method Development |
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Gert Hendriks (PRA Health Sciences) |
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Matrix effects in lipemic plasma: practical solutions to additional issues in |
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bioanalytical method development and validation |
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10.10-11.00 |
Coffee break |
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11.00-12.40 |
Immunoassays for Biomarkers |
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Dominique Gouty (BioAgilytix) |
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Selecting the right strategy for Biomarkers |
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Karen Elsby (AstraZeneca) |
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The MULTIple trials of generating a SINGLE data set: taking biomarker assays |
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through the clinical phases |
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James Lawrence (Harlan / Huntington Life Sciences) |
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Adapting Commercial Immunoassay Kits for Pre-Clinical Biomarkers: |
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Challenges and Solutions. |
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Jo Goodman (MedImmune) |
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The changing face of the immunoassay landscape for soluble target engagement |
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biomarkers quantification |
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Marianne Scheel Fjording (Novo Nordisk) |
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Gold, Silver, Bronze |
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12.40-14.00 |
Lunch break |
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14.00-15.40 |
New Technologies and Applications in Large Molecule Bioanalysis |
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Michael Przybylski (University of Konstanz) |
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Online SAW-Biosensor-Mass Spectrometry: Simultaneous Detection, Structure |
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Determination and Affinity Quantification of Protein-Ligand Interactions |
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Robert Nelson (NovImmune SA) |
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Evaluating multiple technology platforms in the development of large molecule |
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bioanalytical assays. |
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Clare Kingsley (LGC) |
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Ultrasensitivity immunoassays |
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Nick Pearson (CiToxLAB) |
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Quantifying short RNA molecules in a regulatory environment |
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Ashleigh Wake (Intertek Life Sciences) |
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Alternative Methods to LC-MSMS and Immunochemistry Based Method in |
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Bioanalysis |
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15.40-16.15 |
Tea break |
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16.15-17.55 |
Biosimilars |
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Timo Piironen (Syrinx Bioanalytics) |
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Challenges and strategies of developing and validating immunogenicity assays |
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for biosimilars |
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James Munday (Covance) |
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The use of PK, PD and ADA bioanalysis for evaluation of the overall |
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immunogenicity of biosimilars and the bioanalytical challenges for determining |
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if there are equivalent safety risks. |
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Ricardo Gutierrez-Gallego (Anapharm Biotech) |
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Biosimilarity assessment – impact on safety and efficacy |
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Joseph C. Marini (Janssen R&D, on behalf of AAPS LBABFG) |
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Recommendations from the AAPS LBABFG Biosimilars Action Program |
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Committee on the Development and Validation of PK and ADA assays for |
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Biosimilar Drug Development |
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Birgitte Buur Rasmussen (Ferring Pharmaceuticals, on behalf of EBF) |
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Recommendations from EBF biosimilars evaluation group |
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Panel Discussion |
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18.00-19.00 |
Cocktail reception |
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Day 3 – Friday 21 NOV 2014
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PLENARY SESSIONS |
08.30-09.00 |
Consult the Doctor |
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Martijn Hilhorst (PRA Health Sciences) |
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Selectivity issues during the determination of resolvin E1 in human plasma |
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Matt Barfield (Glaxo SmithKline) |
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Issues with transferring Gyrolab preclinical assays to human |
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09.00-10.40 |
“Honey I Shrunk the Sample” |
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Maryann Ngeny (AstraZeneca) |
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Pushing the Boundaries of Microsampling – Realising and Understanding the |
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Full Potential |
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Jo Goodman (MedImmune) |
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One Mouse, One PK: the Magic of Capillary Microsampling in Combination |
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with the Gyrolab TM Assay Platform |
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Beena Punnamoottil (Chimera Biotec) |
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LBA testing in the fraction of a drop: |
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Case studies for ultra-sensitive assays in 1 to 5 microliter sample volume |
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Vera Hillewaert (Janssen R&D) |
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Assessment of capillary microsampling of blood in a healthy volunteer study |
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Zoe Cobb (LGC, on behalf of the EBF Liquid Microsampling Consortium) |
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Feedback from EBF Liquid Microsampling Consortium |
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10.40-11.15 |
Young Investigator Award |
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Introduction |
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Presentation by the 2014 Young Investigator Award winner |
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11.15-11.55 |
Coffee & Snack break |
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11.55-12.55 |
The Regulatory Landscape |
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Michaela Golob (on behalf of EBF |
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Feedback from AAPS Open Forum |
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Akiko Ishii (National Institute of Health Science) |
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Japan LBA guideline |
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Margarete Brudny-Kloeppel (Bayer Pharma AG, on behalf of EBF) |
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Feedback form China Days knowledge exchange meeting |
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12.55-13.55 |
Diversity of the Bioanalytical Techniques |
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Gérard Hopfgartner (University of Geneva) |
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Quantification of endogenous and exogenous metabolites in small samples |
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using parallel narrow bore to capillary LC with fast polarity switching MRM |
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Jim Settlage (inVentiv Health Clinical) |
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Using Supercritical Fluid Chromatography coupled with Tandem Mass |
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Spectrometry to Provide Easier Solutions to Old Problems and New Solutions |
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to Previously Unsolved Problems |
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Johannes Stanta (Covance) |
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Comparing time-of-flight mass spectrometry with triple quadrapole mass |
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spectrometry for small molecule, peptide and oligonucleotide bioanalysis. |
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13.55-14.00 |
Plans for 2015 / Close Out |