Day 1 – Wednesday 16 nov 2016
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08:40
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Towards Utopia
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Keynote Speaker: Norberto A. Guzman, Princeton Biochemicals |
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A Rapid, Sensitive and High-Throughput Affinity-Capture-Separation Technique for |
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Bioanalytical Applications – Monitoring Wellness, Disease, and Treatment Effectiveness |
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Scott Summerfield, GlaxoSmithKline |
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LC-MS Bioanalysis: From minutes to seconds |
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Renuka Pillutla, Bristol Myers Squibb |
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Managing the challenges of technology changes in regulated bioanalysis of biotherapeutics |
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Ann-Christin Niehoff, Shimadzu (not released for publication) |
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Mass Spectrometry Imaging of Human Brain Tumors Resected by Fluorescence-Guided Surgery |
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| 10:10 |
Coffee break |
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10:50
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Regulatory Interpretation
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Paul Morgan, AstraZeneca |
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Tailoring bioanalytical science strategies to support PKPD understanding at |
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different stages of project lifecycle |
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Ian Waterson, MHRA |
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Bioanalysis and GLP: A Regulatory Perspective |
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Yoshiaki Ohtsu, on behalf of the Japan Bioanalysis Forum |
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Scientific Validation: Feedback from JBF Discussion Group |
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Marianne Scheel Fjording, on behalf of the EBF |
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Feedback from the EBF Focus Workshop on Biomarker Assay validation and analysis |
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Philip Timmerman, on behalf of the EBF |
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What does GLP mean in regulated Bioanalysis or Biomarker Bioanalysis” |
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panel discussion |
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| 12:50 |
Lunch break |
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14:00
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Coping with Rare Matrices
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Hans Stieltjes, Janssen R&D |
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Evaluation of adsorption of various analytes in cerebrospinal fluid |
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Michael Gröschl, Celerion |
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Saliva – a reliable sample matrix in bioanalytics |
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Jamil Hantash, Intertek |
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Method Development and Validation of Biologics and Small Molecules in Ocular Tissues – |
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Focusing on Bioanalytical Challenges and Foreseeing Regulatory Concerns |
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Enric Bertran, F. Hoffmann La Roche |
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Challenges in Ocular Bioanalysis |
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| 15:20 |
Tea break |
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16:00
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Exploring the Challenges of ADCs
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Rand Jenkins, PPD |
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ADCs Bioanalysis—LBA and LC-MS methods, a changing paradigm? |
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Astrid Leegte, PRA Health Sciences |
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Total and conjugated PK LBA assays and ADA assay for Antibody-Drug Conjugates (ADC) |
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Ranbir Mannu, Covance |
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LC-MS/MS based strategies for quantification of therapeutic antibody drug conjugates in |
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clinical and preclinical studies. |
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John Gebler, Waters |
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LC/MS Quantification of Critical Components of Antibody Drug Conjugates (ADCs) |
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Corinna Krinos-Fiorotti, BioAgilytix |
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Considerations for the development and validation of cell based neutralization assays for antibody-drug conjugates |
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| 18:00 |
Cocktail reception |
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PARALLEL SESSION —-Day-1 |
14:00
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Discussion Forum: OECD17
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David Van Bedaf & Eva Lindqvist, for EBF |
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Introduction and Feedback from EBF team discussing harmonized implementation of OECD-17 |
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Moderators: David Van Bedaf & Eva Lindqvist, for EBF |
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Forum discussion: towards harmonized implementation of OECD-17 |
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| 15:20 |
Teabreak |
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SHOW AND TELL : Feedback from EBF Topic Teams
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(pre-registration required when picking up your badge at the registraion desk) |
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16:00
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Show and tell 1: Towards a harmonized Data Transfer Agreement (DTA),
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Feedback and recommendation from EBF Topic Team 12
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Moderators from TT-12 |
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Sharing the EBF team recommendation and discussion |
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16:00
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Show and tell 2: A harmonized Certificate of Analysis (CoA): Utopia?
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Feedback and recommendation from EBF Topic Team 40
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moderators: topic team leaders |
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Sharing the EBF team recommendation and discussion |
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Day 2 – Thursday 17 nov 2016
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08:30
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Spotlight on Microsampling
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Urs Duthaler, UH Basel (not released for publication) |
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A fully automated extraction method to overcome methodological drawbacks of |
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antiretroviral drug analysis in dried blood spots |
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Karien Bloem, Sanquin (not released for publication) |
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Dried blood spots obtained by finger prick facilitates therapeutic drug monitoring in |
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adalimumab treated patients |
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Sheelan Ahmad, GlaxoSmithKline |
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Will Zero Blood Withdrawal Make SPME a Microsampling Hero? |
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Glen Hawthorne, on behalf of the EBF LMS Consortium |
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Update from the EBF Liquid Microsampling Consortium |
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Panel discussion |
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| 10:10 |
Coffee break |
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11:00
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The e-environment
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Andreas Henrichs, Sanofi |
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Current practice of archiving e-data in the GLP environment at SANOFI |
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David Van Bedaf, Janssen R&D (in collaboration with BSSN-Sciex) |
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Strategies for long-term preservation of analytical e-data using the AnIML format |
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Anne Kruse Lykkeberg, Lundbeck |
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Study Master: Management of clinical samples in phase III studies using advances Excel. |
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Nicola Stacey, LGC |
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A risk-based approach to validation of Commercial off the Shelf (COTS) Computerised Systems |
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in a GxP environment – The challenge of balancing efficiency with integrity. |
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Louise Radzikowski, Novo Nordisk |
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SEND implementation in NN – story, status and challenges from a Bioanalytical point of view |
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| 12:40 |
Lunch break |
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14:00
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What makes Bioanalysis Fun – 1
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Teresa Heslop, GlaxoSmithKline (not released for publication) |
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“Old Dogs, New Tricks!”: HILIC Chromatography with Deuterium Exchange for the Quantification |
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of Ribarvirin from Human Plasma and Bronchoalveolar Lavage Fluid |
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Morten Funch Carlsen, Leo Pharma |
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Biosynthesis, structural identification and quantification of low pg/mL levels of a major human |
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metabolite of a dermal drug candidate – a multidisciplinary challenge! |
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Amedeo De Nicolò, Università degli Studi di Torino in collaboration with Shimadzu |
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Evaluation of Internal Standard Normalized Matrix Effects (IS-nME) for mass spectrometry method |
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validation: examples of clinical application. |
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Lieve Dillen, Janssen R&D |
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Standardized approach to assess light stability of drugs in blood and plasma and subsequent impact |
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on pharmacokinetic sampling procedures. |
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Sara Stensson, Ferring |
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Bioanalysis of potent small cyclic peptides – Ways to reach the LLQ Utopia |
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| 15:40 |
Tea break |
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16:15
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Large Molecule LC-MS
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Leo Kirkovsky, Pfizer |
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Dual “Hybrid” and Regular LC-MS/MS Assay for the Quantitation of Unconjugated and Conjugated |
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Calicheamicin in Support of Mylotarg (gemtuzumab ozogamicin) Pediatric Study |
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Szabolcs Szarka, LGC |
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Glu-C – an orthogonal and alternative enzyme for protein quantitation by LC-MS/MS |
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Daniel Wilffert, QPS |
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Antibody-free LC-MS/MS protein analysis of TRAIL |
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Nikunj Tanna, Waters |
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Large Molecule Bioanalysis – Tools and workflows to simplify method development for targeted MRM methods |
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Kevin Ray, MilliporeSigma / Merck KGaA |
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Quantitation of Proteins and Monoclonal Antibodies In Serum by LC-MS/MS Using Full-Length |
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Stable Isotope Labeled Internal Standards |
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| 18:00 |
Cocktail reception |
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PARALLEL SESSION —-Day-2 |
08:30
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Biomarker Parallelism
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Robert Nelson, on behalf of EBF TT-61 |
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Non-parallelism in biomarker assays |
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Afshin Safavi, BioAgilytix |
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Considerations for Evaluation of Parallelism in Biomarker Ligand-Binding Assays: |
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Case Studies of Failed Biomarker Assay Parallelism |
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Julie De Gagné, Novartis |
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The use of parallelism to define biomarker assay parameters: a case study |
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Jing Tu, PPD |
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A Soluble Receptor (sBCMA) Biomarker Parallelism Case Study – Using Parallelism Experiments to |
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Effectively Evaluate Matrix Effects and Selectivity in the Early Stage of LBA Method Development |
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Panel discussion |
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| 10:10 |
Coffee break |
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11:00
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Pushing the boundaries of Large Molecule Analysis
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Gregor Jordan, F. Hoffmann La Roche (not released for publication) |
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Improved ELISA performance by simple switching from a colorimetric to fluorimetric HRP substrate |
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Christian Pieper, Chimera Biotec |
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Biologics – Biomarker – Bioanalysis. Challenges followed by solution – What to do when new drug |
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programs reach technical limitations in target quantification |
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Craig Stovold, AstraZeneca |
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Amplification Challenge: Comparison of bDNA and PCR-based analytical methods for the |
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determination of nucleotide-based therapeutics |
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Bert Rutten, LGC |
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Comparison of Critical Method Validation Parameters on the Quanterix Simoa and the Singulex Erenna. |
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Bioanalysis Zone New Investigator Award Winner |
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| 12:40 |
Lunch break |
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14:00
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What makes Bioanalysis fun – 2
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Roland Staack, F. Hoffmann La Roche |
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Importance of fully characterized bioanalytical methods – the bioanalytical challenges to |
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support the develpment of a lipidated fusion protein |
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Hanna Ritzen, Mercodia |
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Life cycle management of biomarker assays a route to improved patient outcome. |
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Martine Broekema, PRA Health Sciences |
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Challenges in receptor occupancy determination assays by flow cytometry in drug development |
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Christele Gonneau, Covance CLS |
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Paving the road to Utopia through instrument standardization |
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Anne Incamps, Thermo Fisher Scientific |
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Biomarkers Validation : an Orthogonal approach using Mass Spectrometry and Immunoassays |
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| 15:40 |
Tea break |
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16:15
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Immunogenicity
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Jo Goodman, on behalf of the EBF |
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Feedback from the EBF Focus Workshop (September 2016, Lisbon) on Current Analysis of Immunogenicity |
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James Munday, Covance |
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Pre-clinical Immunogenicity assessment – Scientific validation versus Regulatory |
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validation approach. What is the appropriate tiered analysis? |
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Robert Nelson, Novimmune |
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The best-laid schemes o’ mice an’ men: when clinical assumptions go awry |
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Viswanath Devanarayan, Abbvie |
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Clinical Interpretation of ADA |
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Panel discussion |
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Day 3 – Friday 18 nov 2016
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09:00
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The Broad Utility of HRMS
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Esther van Duijn, TNO |
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The combined use of HRMS and AMS for simultaneous metabolite quantification and identification |
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Nico van de Merbel, PRA Health Sciences |
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A practical comparison of triple-quadrupole and high-resolution mass spectrometry for peptide and protein quantification |
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Barry Jones, Q2 Solutions |
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LC-HRMS for Quantitative Bioanalysis in the Regulated Contract Research Laboratory: |
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Small, Medium, and Large Molecule Applications |
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Keeley Murphy, Thermo Fisher Scientific |
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Comprehensive workflows for high performance quantitation utilizing high resolution accurate mass |
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PARALLEL SESSION —-Day-3 |
09:00
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Abnormal PK
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Daniela Stoellner, on behalf of EBF TT-63 |
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TT-63: Handling of PK data from ADA positive animals |
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Nick White, MedImmune |
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Abnormal PK; Even With Informed Predictions it Happens to the Best of Us! |
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Sherri Dudal, UCB BioPharma (not released for publication) |
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Challenge of PKPD of biologics in preclinical disease models: PK and BA perspectives |
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Anne Larvor, Amatsigroup |
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Management of abnormal PK profiles:s BA and PK point of view through several examples. |
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Panel discussion |
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| 10:40 |
Coffee break |
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11:25
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UTOPIA: THE SCIENCE OF A MODERN GUIDELINE
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Interactive session (Each sub-session consists of a short introduction followed |
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by an interactive discussion involving all conference delegates) |
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General Introduction – aim of the session |
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The science of a modern guidance – focus on The common themes |
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moderated panel session |
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The science of a modern guidance – focus on Ligand binding assays |
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moderated panel session |
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The science of a modern guidance – focus on Chromatography based assays |
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moderated panel session |
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Closing comments and next steps |
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| 12:55 |
Plans for 2017 / Close Out |
