Day 1 – Wednesday 20 NOV 2013
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| PLENARY SESSION |
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| 08.30-08.35 |
Welcome |
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| 08.35-10.30 |
Assay transfer – Expectations & Practicalities |
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Cheryl McAlpine (Merck-Millipore) |
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Challenges in assay transfer of complex assay formats |
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Fabienne Deckert-Salva (Novartis) |
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Outsourcing and assay transfer strategies for biologics programs |
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Graeme Smith (Huntingdon Life Sciences) |
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Fit for purpose method transfer |
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Ronald de Vries (Janssen R&D) |
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Janssen strategy for bioanalytical assay transfer |
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Steve White (GlaxoSmithKline) |
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Assay cross validation – Recent experiences in transfering bioanalytical assays from |
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sponsor to CRO partners and between CROs |
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Panel Discussion |
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| 10.30-11.00 |
Coffee break |
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| 11.00-12.15 |
From biomarker to diagnostics or personalized medicine: |
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is there a role for regulated bioanalysis? |
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John Mills (AstraZeneca) |
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Delivering on the Promise of Personalized Healthcare |
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Suntje Sander and Peter van Amsterdam (Abbott) |
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Successful treatment of maldigestion due to pancreatic exocrine insufficiency: |
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diagnosis, clinical picture and the challenges of measurements involved |
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Joan-Carles Arce and Birgitte Buur Rasmussen (Ferring) |
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Individualized dosing regimen for fertility treatment based on a biomarker |
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(Not released for publication) |
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| 12.15-12.45 |
Bioanalysis Young Investigator Award |
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Peter van Amsterdam (on behalf of EBF) |
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Announcing the Young Investigator Award Winner |
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Young Investigator (TBD) |
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Young Investigator Award Winning Presentation |
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| 12.45-14.00 |
Lunch break |
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| 14.00-15.35 |
Interpretation and implementation of guidance on haemolysed / |
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hyperlipedemic plasma and co-administrated drugs |
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Benno Ingelse (on behalf of EBF TT-15) |
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How to deal with haemolysed and hyperlipidaemic samples: an EBF perspective |
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Fabio Garofolo (Algorithme Pharma) |
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Criteria for performing a scientifically meaningful lipemic plasma test during |
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LC-MS/MS bioanalytical method validation (BMV): which type to choose? |
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Martina Wein (Boehringer-Ingelheim) |
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How to investigate in the influence of hyperlipidemic samples on bioanalytical assays |
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Tom Verhaeghe (Janssen R&D) |
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Co-stability assessment for fixed dose combinations: an additional burden to |
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bioanalytical method validation |
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Berthold Lausecker (on behalf of EBF TT-31) |
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Interaction compounds & comedication testing |
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Panel Discussion |
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| 15.35-16.15 |
Coffee break |
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| 16.15-18.00 |
Peptide and protein analysis with LC-MS |
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Nico van de Merbel (RUG) |
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The usefulness of LC-MS as a platform for protein quantification: |
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from theory to practice |
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Rand Jenkins (PPD Inc) |
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Application of LC-MS/MS and LBA methods in concert for bioanalysis of |
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monoclonal antibody oncology drugs and associated soluble target receptors |
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William van Dongen (TNO Triskelion) |
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Low ng/ml bioanalysis of monoclonal antibody therapeutics using immuno |
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extraction and LC-MS |
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Anders Sonesson (Ferring) |
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LC-MS/MS bioanalysis of peptides – How to manage non specific binding? |
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Mireia Fernandez Ocaña (Pfizer) (Not released for publication) |
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Sensitive peptide immunoaffinity LC-MS/MS quantification |
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of a membrane-bound target receptor from clinical biopsies |
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Erin Chambers (Waters) |
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Ultra-sensitive simultaneous LC-MS/MS quantification of human insulin, glargine, lispro, |
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aspart, detemir and glulisine in human plasma using 2D-LC and a novel high efficiency column |
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| 18.00-19.00 |
Cocktail reception |
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Day 2 – Thursday 21 NOV 2013
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| 08.30-10.30 |
SPOTLIGHT WORKSHOP: CONTINUED DEVELOPMENTS IN DBS |
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Philip Timmerman (on behalf of the EBF Consortium) |
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Introduction and recap of EBF Recommendation on DBS |
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Bert Ooms (Spark Holland) |
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Towards unbiased Dried blood spot analysis using temperature-enhanced flow- |
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through desorption coupled online to solid phase extraction and mass spectrometry |
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Kevin Bateman (Merck & Co.) (Not released for publication) |
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Dried blood spot (DBS) sample collection for drug development: recent experience at Merck |
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Jack Henion (Quintiles Bioanalytical and ADME Labs) (Not released for publication) |
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Recent Developments in Dried Plasma Spot Analysis Using a Novel Red Blood Cell Filtration Card |
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Ynze Mengerink (Chemelot) |
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New Ht independent dried blood spot cards |
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Workshop discussion (coffee will be served in workshop room) |
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Moderator: Steve White (on behalf of the EBF Consortium) |
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| 13.30-15.40 |
SPOTLIGHT WORKSHOP: DEFINING RAW DATA IN REGULATED BIOANALYSIS |
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-Introduction to the Workshop: categorizing raw data |
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-Proposed way forward on ‘Organization/system related Data (non-laboratory)’ |
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-Proposed way forward on ‘Non-study related Data (general laboratory equipment/tools)’ |
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-Proposed way forward on ‘Study related Data (non-laboratory)’ |
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-Proposed way forward on ‘Study related Data (laboratory)’ |
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-Discussion |
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-Prerequisites for successful use of e-data (in regulated bioanalysis) |
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| 16.15-18.00 |
SPOTLIGHT WORKSHOP: IS VALIDATION REALLY NEEDED FOR ALL ASSAYS: |
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TAKING TIERED APPROACH OUTSIDE THE WORLD OF MIST |
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Philip Timmerman (on behalf of EBF) |
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The MIST concept taken beyond metabolite quantification: overview of |
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EBF discussions on applying tiered approach |
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Jaap Wieling (QPS) |
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Can we validate an assay for a biomarker that we have not identified ? |
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Vera Hillewaert |
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A complex problem: what (and how) should we quantify? |
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Neil Henderson (AstraZeneca) |
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Characterising the performance of in situ hybridisation (ISH) methodologies in |
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order to demonstrate fit-for-purpose assays for clinical deployment |
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Panel Discussion |
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| BREAKOUT SESSIONS SMALL MOLECULES / CHROMATOGRAPHY BASED |
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| 08.30-10.00 |
Consult the doctor |
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Alex Muntendam (ABL) |
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Positive control group samples in a toxicity study. Now what? |
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Ann Lévesque (inVentiv Health clinical) |
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How problematic situations can become positive ones: case studies of bioanalytical Issues |
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David Neville (Quotient Bio Analytical Sciences) |
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Non-specific binding, Non-linearity or Nonsense? |
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Iain Love (Huntingdon Life Sciences) |
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Viewing the big picture through a keyhole: providing context to Bioanalytical challenges |
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Nico van de Merbel (PRA) |
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Blood is no plasma: failing long-term frozen stability results for cyclosporin A in diluted whole blood |
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First Aid: last minute submitted cases (Panel) |
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| 10.45-12.30 |
Interpretation and implementation of Guidance expectations: |
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Internal Standard variability |
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Olivier Le Blaye (ANSM) |
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Examples of IS variations seen during inspections |
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Aimin Tan (BioPharma Services Inc) |
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Leveraging Successful Troubleshooting Experiences for the Prevention or |
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Reduction of Internal Standard Response Variations during LC-MS Bioanalysis |
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John Allanson (Unilabs York Bioanalytical Solutions) |
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Challenges and solutions in the application IS variability criteria |
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Luc Bouchard (inVentiv Health clinical) |
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Internal standard variation during routine sample analysis: investigation of case studies |
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Steve White (on behalf of EBF TT-07) |
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Dealing with internal standard variability – Towards a recommendation |
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Panel Discussion |
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| 12.45-14.00 |
Lunch break |
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| 14.00-15.40 |
Innovative applications in sampling & extraction |
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Kathryn Chapman (NCR3s) |
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Overcoming the barriers for uptake of microsampling techniques in regulatory toxicology |
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Stephen Williams (Charles River) |
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Small samples, large molecules and bigger benefits |
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Neil Spooner (GlaxoSmithKline) |
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Latest developments in microsampling for regulated quantitative bioanalysis |
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Craig Aurand (Supelco/Sigma-Aldrich) withdrawn |
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Investigation of solid phase micro extraction as an alternative to dried blood spot |
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Ranbir Mannu (Covance) |
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Development of a capillary micro-sample bioanalytical method for quantification of |
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an phosphorothioated 18-mer oligonucleotide in human plasma using LC-MS/MS |
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| 15.40-16.15 |
Coffee break |
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| 16.15-17.55 |
Innovative applications in separation & quantification |
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Gert Hendriks (PRA) |
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Old school derivatization in modern LC-MS analysis |
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Jim Settlage (inVentiv Health clinical) |
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The re-emergence of GC-MS/MS as a tool for the analysis of small molecule biomarkers |
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Paul Rainville (Waters) |
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Critical evaluation of common sample preparation techniques for bioanalysis |
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on microfluidic LC/MS performance |
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Lester Taylor (Agilent Technologies) |
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High-Throughput SPE-MS/MS – A Viable Approach For Validated Bioanalytical Analysis? |
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Sega Ndiaye (Innate Pharma / Proteomic Platform Innovation Technologic |
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Timone PIT2) – Shimadzu
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Free MMAE toxin quantitation by triple quadrupole in Antibody drug Conjugate analysis |
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| BREAKOUT SESSIONS LARGE MOLECULES / LIGAND BINDING BASED |
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| 08.30-10.00 |
Analysis of parallelism for biomarkers and therapeutic proteins |
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Edwin Janssen (on behalf of EBF TT-35) |
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Validation of ligand-binding assays: the Importance parallelism |
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Clare Kingsley (Associate Director) |
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A Global view on paralelism. |
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Ulrich Kunz (Boehringer-Ingelheim) |
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Case studies of non-parallelism in various biomarker assays |
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Bruno Boulanger (Arlenda) (Not released for publication) |
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How to develop and assess the parallelism in a bioassays: a fit-for-purpose strategy |
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Panel Discussion |
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| 10.00-10.45 |
Coffee break |
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| 10.45-12.30 |
Challenges for flow cytometry in regulated bioanalysis |
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Barry van der Strate (on behalf of EBF TT-32) |
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Short introduction the increased use of flow cytometry to support clinical studies |
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Minesh Patel (Merck-Millipore) |
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Challenges for Flow Cytometry in regulated Bioanalysis |
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Nora Bachmayer (Crucell) |
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Encountered challenges during the standardization of the ICS assay |
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Robin Longdin (Quotient Bio Analytical Sciences) |
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Challenges for flow cytometry in regulated Bioanalysis; |
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quality assurance and regulatory considerations |
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Virginia Litwin (Covance) |
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Analytical Method Validation: Perspectives from the Flow Cytometry Action |
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Programming Committee of the AAPS |
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Panel Discussion |
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| 12.30-14.00 |
Lunch break |
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| 14.00-15.30 |
Interferences & surprises ligand binding assay method development |
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Helen Young (Quotient Bio Analytical Sciences) (Not released for publication) |
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Implementation of Critical Reagent Monitoring in a Clinical Laboratory |
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Martin Nemansky (PRA) (Not released for publication) |
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Guidelines at work – Examples of theoretical considerations versus practical |
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solutions in Immunogenicity assays |
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Matthew Bentley (Merck-Millipore) (Not released for publication) |
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Immunogenicity analysis challenges and solutions for PEGylated biopharmaceuticals |
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Roland Staack (F. Hoffmann-La Roche) (Not released for publication) |
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Free analyte QC concept – a novel approach for qualification/validation of free drug assays |
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Open Discussion |
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| 15.40-16.15 |
Coffee break |
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| 16.15-18.00 |
Analytical challenges of antibody-drug conjugates (ADCs) |
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Bernhard Beckermann (Bayer) |
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Introduction to ADC Bioanalysis |
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Steffen Groß (Paul-Ehrlich-Institut) |
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Regulatory expectations for the characterisation of ADCs |
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Stefanie Fischmann (AbbVie) (Not released for publication) |
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Strategy for bioanalysis of ADCs along project development stages |
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Marie-Hélène Pascual (Sanofi) |
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Selective immunoassay of the naked antibody as a new tool for pharmacokinetic |
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interpretation of an antibody drug conjugate |
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Jasja Wolthoorn (TNO Triskelion) |
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Novel Platform Using LC-MS and Ligand Binding Assays for Characterization and |
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PK analysis of ADCs |
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Panel discussion |
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Day 3 – Friday 22 NOV 2013
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| BREAKOUT SESSIONS |
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| 08.30-10.20 |
Promises of new technology: sense and nonsense of HR-MS |
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Suma Ramagiri (AB SCIEX) |
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ADC quantitation using HRMS |
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Lieve Dillen (Janssen R&D) s68 B3-HRMS-2 Lieve Dillen EBF BCN2013 LDIL |
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High resolution mass spectrometry for bioanalysis at Janssen. |
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Current experiences and future perspectives |
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Mark Wrona (Waters) |
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Moving forward on Quan-Qual, perspectives on using TOFs for bioanalytical work |
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Mohammed Abrar (Unilabs York Bioanalytical Solutions) |
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The comparison of high resolution MS with triple quadrupole MS for the analysis of oligonucleotides |
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Hongxia Wang (Thermo Fisher Scientific) (Not released for publication) |
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Quantification of protein biotherapeutics by a universal LC-high resolution/accurate |
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mass based approach: intact protein or proteolytic peptides? |
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| 08.30-10.20 |
Issues & solutions in sample logistics |
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Jose Groenboom (on behalf of EBF TT-12) |
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Sample logistics: problems and solutions in multi-center clinical trials |
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Rebecca Sleigh (on behalf of EBF TT-12) |
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Proposed generic lab manual |
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Scott Vincent (A4P Consulting) |
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Bio-logistical considerations in planning and executing early phase bioanalytical components |
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Jean-Guy de Gruben (World Courier) |
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Issues within the context of Clinical Trials Logistics. Practical examples and solutions |
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Bärbel Wilke (LKF – Laboratorium für Klinische Forschung) |
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Logistics within a Central Laboratory – From Specimen Receipt to Result Reporting |
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Introducing the Focus Workshop |
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| 10.20-11.00 |
Coffee break |
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| PLENARY SESSIONS |
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| 11.00-14.15 |
2013 draft FDA Guidance for Industry on Bioanalytical Method Validation – |
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preparing for Crystal City V |
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-Each session will consist of a short introduction summarizing the EBF consolidated |
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comments on the draft Guidance on the specific chapter, followed by plenary discussion. |
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-Timing of the sessions is indicative and depends on extent of comments. |
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-Introduction and background |
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-Chromatographic methods |
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-Ligand Binding Assays |
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-Incurred Sample Reanalysis |
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-Additional issues: endogenous compounds, biomarkers, diagnostic kits and new technologies |
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-Documentation and glossary |
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-Wrap up |
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| 14.15-14.30 |
Plans for 2014 and adjourn |
