Program‎ > ‎

Agenda

Day 0 - 30 NOVEMBER 2010

14:00

20:00

Registration and Information Desk Open

Day 1 - 1 DECEMBER 2010

07.00

18:00

Registration and Information Desk Open

MORNING PLENARY SESSIONS

 

 

 

08.30

08.40

Welcome and opening remarks

08.40

10.00

Bioanalysis – Thinking Outside the ”Commodity” Box

08.40

09.00

Ian Wilson (AstraZeneca)

What You Can’t See Can Hurt You: Looking at Bioanalysis by LC-MS From the Outside

09.00

09.20

John Pugh (University of Sheffield)

Elemental imaging via LA-ICP-MS - New oppertunities in the life sciences

09.20

09.40

Robert Plumb (Waters)

High Sensitivity Analysis of Biotherapeutics Using Capillary LC

09.40

10.00

Martyn Hemsley (Covance)

Considerations and Experiences in Developing Bioanalytical Assays for the Quantitative Determination of Oligonucleotides

10.00

10.30

Coffee Break

10.30

12.30

Practical Solutions to Bioanalytical Challenges : Blood - the original bioanalytical matrix?

10.30

11.00

Keynote Speaker : Albert Wolthuis (KCL)

The Blood Matrix: A Dynamic Mirror

11.00

11.20

Achiel Van Peer (Janssen Research and Development)

Blood and Plasma: "A Magic Twin or Single in Human Pharmacokinetics ?"

11.20

11.35

John Perkins (Advion BioServices)

Long Term Stability Issues Observed during Validation of an LC-MS/MS assay for Clopidogrel and Metabolites

11.35

11.50

Ronald de Vries (Janssen Research and Development)

Analyte Instability Issues in Blood

11.50

12.10

Achim Freisleben (Merck-Serono for EBF)

EBF Current Thinking on the Conduct of Whole Blood Stability

12.10

12.30

Panel Discussion

12.30

13.30

Lunch and poster session

Day 1 - 1 DECEMBER 2010

AFTERNOON PLENARY SESSIONS

13.30

16.00

Towards Global Harmonization

13.30

13.50

Philip Timmerman (Janssen Research and Development for EBF and GBC)

GBC-Harmonization Initiative and EBF Perspective

13.50

14.10

Jérôme Barré (afssaps)

EMA Perspective on Global Harmonization

14.10

14.30

Rafael Barrientos  (Magabi for ACBio)

South America perspective

14.30

14.50

Daniel Tang (Frontage for BBDS and SBDS)

APAC Perspective on Global Harmonization

14.50

15.10

Mark Arnold (Bristol Meyers Squibb for AAPS)

AAPS Perspective on Global Harmonization

15.10

15.30

C.T. Viswanthan  (FDA/CDER)

FDA Perspective on Global Harmonization

15.30

16.00

Panel Discussion

 

 

 

16.00

16.30

Coffee Break

 

 

 

16.30

18.00

Pt Sponsor session I

16.30

17.00

Gary Harland (Waters)

Addressing The Challenge of Sensitivity and Metabolite Detection in Bioanalytical Studies

17.00

17.30

Mauro Aiello (AB SCIEX)

Overcoming the Data Analysis Bottleneck with Next Generation Quantitative Software

17.30

18.00

Pat Bennett (Thermo Scientific)

Future of the Triple Quadrupole:  What is Possible and what is Practical?

18.30

20.00

Conference Reception I

Discover Catalunyan Reds : Enjoy a Few Drinks and Savor Traditional Food During this Great Networking Opportunity

Day 2 - 2 DECEMBER 2010

07.00

18:00

Registration and Information Desk Open

MORNING PLENARY SESSIONS

08.30

10.00

Pt Sponsor session II

08.30

09.00

Lester Taylor (Agilent)

Use of an Ion Funnel Triple Quadrupole LC/MS Instrument for HighSensitivity Quantitation.

09.00

09.30

Martin Nemansky (PRA International)

Comparison of various platforms for large molecule analysis - Introduction of the Imperacer® technology

09.30

10.00

Iain Shaw (Quotient Bioresearch)

C14 enabled drug development

10.00

10.30

Coffee Break

 

 

 

10.30

12.30

Technologies and Comparison of Assay Platforms

10.30

10.50

Stefanie Fischmann (Abbott)

Comparison of Data from ECL and Hyphenated LC-MS Platforms on Quantitation of mAb from Serum Samples

10.50

11.10

Fritz Poulsen (NovoNordisk)

Wash AlphaLISA - An Extension of the AlphaLISA/LOCI Technology

11.10

11.30

Ronald Schmidt (Sanofi-Aventis)

Quantitative LC-MS/MS Analysis of Synthetic Insulins

11.30

11.50

Craig Stovold (Quotient Bioresearch)

Appliation of the Gyrolab to bioanalytical, pharmacodynamic and immunogenicity analysis in a regulated laboratory

11.50

12.10

Birgit Jaitner (Novartis)

An approach to measure total drug levels in human serum samples while overcoming target interference

12.10

12.30

Panel Discussion

 

 

 

12.30

14.00

Lunch and Poster Session

Day 2 - 2 DECEMBER 2010

AFTERNOON BREAKOUT SESSIONS

14.00

15.30

Ia - Reconnect on Dried Blood Spots

14.00

14.30

Philip Timmerman (Janssen Research and Development for EBF and GBC)

EBF recommendation on Method Validation for Dried Blood Spots

14.30

14.50

Julian Haynes (Pfizer)

Application of a Simple 2D-LC-MS/MS System to Control Ion Suppression Effects from DBS Samples

14.50

15.10

Rohan Takur (Taylor Technology)

DBS and HRMS for in vivo Fast PK studies – The Value and Advantage for Pre-Clinical Studies.

15.10

15.30

Panel Discussion

14.00

15.30

Ib - FDA Draft Guideline on "Assay Development for Immunogenicity Testing of Therapeutic Proteins" and Related Topics

14.00

14.20

Susan Kirshner (FDA)

US FDA Draft Guidance on Immunogenicity Testing

14.20

14.40

Arjen Companjen (Crucell for EBF)

The EBF Perspective on the FDA draft guidance on Assay Development for Immunogenicity Testing of Therapeutic Proteins

14.40

15.00

Robin Thorpe (NIBSC)

European Guidance on Unwanted Immunogenicity of Biologicals

15.00

15.30

Panel Discussion

15.30

16.00

Coffee Break

16.00

18.00

IIa - Continuation from Break Out Session 14.00-15.30 on Immunogenicity Guideline and Related Topics

16.00

16.30

Geoff Hale (Merck/Millipore)

The untility and futility of cut points for assessing unwanted immunogenicity

16.30

17.00

Janka Ryding (Ferring)

Case Study: Neutralization Assay Design and Qualification.

17.00

17.30

Andrea Kiessling (Novartis)

Integrated Approach of PK/PD/Immunogenicity Analysis

17:30

18:00

Panel Discussion

16.00

18.00

IIb - Practical Solutions to Bioanalytical Challenges : Matrix Effects

16.00

16.30

Keynote Speaker : Vincenzo Pucci (Merck & Co Inc)

Strategies for Reducing Phospholipid-based Matrix Effects in LC-ESI-MS Bioanalysis

16.30

16.50

Curtis Sheldon (Celerion)

Haemolysed Sample Evaluation : A Variety of Issues for a Variety of Situations

16.50

17.10

Carl-Johan Sennbro (Active Biotech for EBF)

Choice of Anticoagulant and Comparison of Counter-Ions - Results from Two EBF Surveys

17.10

17.25

Tom Verhaeghe (Janssen Research and Development)

Matrix Effects in Practice : Sense and Nonsense of Internal Standard Response Acceptance Criteria 

17.25

17.40

Magnus Knutsson (Ferring)

Experiences of Assessing Matrix Effects by Monitoring Internal Standard Response in Study Samples

17.40

18.00

Panel Discussion

18.30

20.00

Conference Reception II

The Catalunya Cava Experience: Enjoy a Few Drinks and Savor Traditional Food During this Great Networking Opportunity

Day 3 - 3 DECEMBER 2010

MORNING PLENARY SESSIONS

8.30

10.30

Finding the Right Level 

8.30

8.40

Margarete Brudny-Kloeppel (Bayer Schering Pharma AG for EBF)

Introduction

8.40

9.10

Fabio Garofolo (Algorithme Pharma Inc.)

When and How Much do Anomalous Results Need to be Investigated?

9.10

9.40

Silke Lüdtke (Boehringer-Ingelheim for EBF)

Handling of Anomalous Results in Europe – Feedback from EBF Survey

9.40

10.10

EBF speaker(s) to be announced

Case Studies

10.10

10.30

Panel Discussion

10.30

11.00

Coffee Break

11.00

12.00

EBF Feedback

11.00

11.30

Peter van Amsterdam (Abbott for EBF)

Update on New Organization

11.30

12.00

Margarete Brudny-Kloeppel  (Bayer Schering Pharma AG for EBF)

Feedback from EBF 2010 Surveys and Activities

12.00

13.40

Biomarkers

12.00

12.20

Liesbeth Vereyken (Janssen Research and Development)

Challenges with Nucleoside Triphospate Method Development and Analysis during the Life Cycle of a HCV Program

12.20

12.40

Mark Spengler (Chimera)

Using Ligang-Binding Assay Sensitivity for Improved Matrix Tolerance and Related Parameters by Tailored Sample Dilution.

12.40

13.00

Anna Valeri (MHRA)

Title to be Confirmed

13.00

13.20

Jan Moack (Slovak University of Technology, Bratislava)

Effective use of Combination of Lung Malignity Marker

13.20

13.45

Panel Discussion

13.45

14.00

Close out Discussion, Ideas for 2011

14.00

Adjourn

 

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