Program

 

 

15 NOVEMBER 2011

 

 

 

14:00

20:00

Registration and Information Desk Open

 

 

 

 

 

 

 

 

Day 1 – 16 November 2011

 

 

 

07.00

18:00

Registration and Information Desk Open

 

 

 

 

 

MORNING PLENARY SESSIONS

 

 

 

08.30

08.45

Welcome And Opening Remarks

 

 

 

08.45

10.40

Biomarker Validation Recommendation

 

 

Chair: Arjen Companjen (Crucell)

 

 

 

08.45

09.00

Philip Timmerman (on behalf of EBF)

 

 

Introduction to biomarker validation recommendation session

09.00

09.20

Christian Herling (on behalf of EBF)

 

 

EBF reflections on biomarker validation

09.20

09.40

Alexandre Avrameas (Novartis)

 

 

Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation

09.40

10.00

Barry Jones (Advion)

 

 

LC/MS biomarker assay validation strategies using surrogate matrix and surrogate analyte approaches

10.00

10.20

Richard Houghton (Quotient Bioresearch)

 

 

Challenges of validating small molecule LC-MS/MS biomarker methods

10.20

10.40

John Chappell (ICON Development Solutions)

 

 

Biomarker Measurement- maximum information from limited volume

 

 

 

10.40

11.20

Coffee Break and Poster Session

 

 

 

11.20

12.45

How To Implement The EMA Guideline On Bioanalytical Method Validation

 

 

Chair and Moderator: Silke Luedtke (Boehringer-Ingelheim)

 

 

 

11.20

11.25

Peter van Amsterdam (on behalf of EBF)

 

 

Introduction

11.25

11.35

Olivier Le Blaye (afssaps)

 

 

< Title to be confirmed >

11.35

11.45

Timothy Sangster (Charles River Laboratories)

 

 

EMA – have our prayers been answered!

11.45

11.55

Daniela Stoellner (Novartis)

 

 

New EMA guideline on method validation and how it translates into best practice for Ligand Binding Assays

11.55

12.05

Graeme Smith (Huntingdon Life Sciences)

 

 

Partial Validation when is enough, enough?

12.05

12.15

Morten Rohde (Lundbeck)

 

 

Matrix Effects in Bioanalysis, when established procedures become obsolete.

12.15

12.45

Panel Discussion

 

 

 

12.45

13:50

Lunch And Poster Session

 

 

 

 

 

 

Day 1 – 16 November 2011

 

 

 

 

 

AFTERNOON PLENARY SESSIONS

 

 

 

13.50

16.00

Updates From The Globe

 

 

Chair: Philip Timmerman (Janssen Research & Development)

 

 

 

13.50

14.05

Rafael Barrientos (Magabi for ACBio)

 

 

ANVISA guideline on bioanalytical method validation updates

14.05

14.20

Shinobu Kudoh (Shimadzu for Japan Bioanalysis Forum)

 

 

Introducing the Japan Bioanalysis Forum (JBF)

 

 

 

 

 

Global Harmonization – Updates And Feedback From GBC Harmonization Teams

 

 

 

14.20

14.30

Philip Timmerman (on behalf of GBC)

 

 

Global Bioanalysis Consortium status update

14.30

14.45

John Smeraglia (on behalf of GBC Harmonisation Team A1)

 

 

Harmonization team A1 (scope and regulations) update

14.45

15.00

Nico van de Merbel (on behalf of GBC Harmonisation Team A6)

 

 

Harmonization team A6 (stability) update

15.00

15.15

Michaela Golob (on behalf of GBC Harmonisation Team L6)

 

 

Harmonization team L6 (immunogenicity effect on PK) update

15.15

15.30

Ben Gordon (on behalf of GBC Harmonisation Team S1)

 

 

Harmonization team S1 (run acceptance) update

15.30

16.00

Panel Discussion

 

 

Moderators: Michaela Golob (EU), Shinobu Kudoh (APAC), Rafael Barrientos (LA) and Fabio Garofolo (NA)

 

 

 

16.00

16.30

Coffee Break and Poster Session

 

 

 

16.30

18.00

Technology Session I

 

 

Chair: Margarete Brudny-Kloeppel (Bayer HealthCare)

 

 

 

16.30

17.00

Patrick Bennett (Thermo Scientific)

 

 

Applying proven proteomics workflows and tools for quantitative bioanalysis of large molecules

17.00

17.30

Barry van der Strate (PRA International)

 

 

Flow cytometry for determination of efficacy in phase I

17.30

18.00

Andrew Roberts (Quotient Bioresearch)

 

 

Challenges in developing anti-drug antibody ligand binding assays

 

 

 

18.30

20.00

Conference Reception I in Exhibition and Poster Hall

Sponsored by Advion

 

 

Discover Catalunyan cava: enjoy a few drinks and savour traditional food during this great networking opportunity

 

 

 

 

 

 

 

 

Day 2 – 17 November 2011

 

 

 

07.00

18:00

Registration and Information Desk Open

 

 

 

 

 

MORNING PLENARY SESSIONS

 

 

 

08.30

10.00

Technology Session II

 

 

Chair: Richard Abbott (Shire)

 

 

 

08.30

09.00

Mauro Aiello (AB Sciex)

 

 

Differential ion mobility spectrometry, creating a new dimension of selectivity for LC/MS/MS analysis

09.00

09.30

Robert S. Plumb (Waters Corporation)

 

 

Beyond sensitivity: improving the performance, productivity and compliance of the bioanalytical assay process

09.30

10.00

Lester Taylor (Agilent Technologies)

 

 

Automation and optimization of an on-line extraction system for dried blood spot analysis

 

 

 

10.00

10.20

Bioanalysis Young Investigator Award

 

 

 

10.00

10.05

Peter van Amsterdam (representing EBF Steering Committee)

 

 

Introduction

10.05

10.20

Award winner

 

 

Presentation

 

 

 

10.20

11.00

Coffee Break and Poster Session

 

 

 

11.00

12.30

Relationship Between Incurred Sample Reproducibility (ISR) And Incurred Sample Stability (ISS)

 

 

Chair & Moderator: Silke Luedtke (Boehringer-Ingelheim)

 

 

 

11.00

11.20

Morten Anders Kall (on behalf of EBF)

 

 

Feedback on EBF survey on Incurred Sample Stability (ISS)

11.20

11.40

Theo de Boer (QPS)

 

 

Incurred sample accuracy assessment: design of experiments based on standard addition

11.40

12.00

Ronald de Vries (Janssen Research & Development)

 

 

Assessment of ISS using an efficient standardized stepwise “black box’’ process.

12.00

12.30

Panel Discussion

 

 

 

12.30

14.00

Lunch and Poster Session

 

 

 

 

 

Day 2 – 17 November  2011

 

 

 

 

 

AFTERNOON PLENARY SESSIONS

 

 

 

14.00

15.40

Plenary Microdosing /Microtracer

 

 

Chair: Philip Timmerman (Janssen Research & Development)

 

 

 

14.00

14.40

Keynote Speaker: Malcolm Rowland (School of Pharmacy and Pharmaceutical Sciences, University of Manchester)

 

 

Microdosing: a simple idea with big results

 

14.40

15.00

Microdosing /Microtracer Plenary Session With Focus On AMS (Plenary)

Graeme Young (GSK)

 

 

“LC+AMS” in support of microdose/microtracer clinical studies at GSK – an evolving science

15.00

15.20

David Higton (on behalf of EBF)

 

 

Towards a recommendation of bioanalytical qualification or validation of microdosing and microtracer studies – part 1 – LC+AMS

15.20

15.40

Stuart Best (Xceleron)

 

 

What are the critical factors determining the performance of an LC+AMS assay?

 

 

 

15.40

16.20

Coffee Break and Poster Session

 

 

 

 

 

AFTERNOON BREAKOUT SESSIONS

 

 

 

 

 

Main Auditorium

16.20

18.00

I:  Microdosing /Microtracer Plenary Session With Focus On High Sensitivity LC-MS/MS

 

 

Chair: Richard Abbott (Shire)

 

 

 

16.20

16.40

David Higton (on behalf of EBF)

 

 

Towards a recommendation of bioanalytical qualification or validation of microdosing and microtracer studies – part 2 – LC-MS/MS

16.40

17.00

Richard Abbott (Shire)

 

 

Microdosing and cold LC-MS/MS: bioanalysis and its evolving role in strategic drug development

17.00

17.20

Alberto Guenzi (Hoffmann-La Roche)

 

 

Microdosing with LC-MS analysis: variations on the theme

17.20

17.40

Magnus Knutsson (Ferring)

 

 

Drug development of highly potent therapeutic peptides - A bioanalytical challenge with micro-dosing plasma levels at therapeutic doses

17.40

18.00

Panel Discussion

 

 

Moderators: Graeme Young (GSK), Richard Abbott (Shire) and David Higton (AstraZeneca)

 

 

 

 

 

Breakout Room

16.20

18.00

II:  Stability Issues In Ligand Binding Assays

 

 

Chair: Arjen Companjen (Crucell)

 

 

 

16.20

16.30

Arjen Companjen (on behalf of EBF)

 

 

Introduction

16.30

16.50

Jenny Hendriks (Crucell)

 

 

Binding and activity of anti-vaccine antibodies in short and long term stability studies

16.50

17.10

Ulrich Kunz (Boehringer-Ingelheim)

 

 

Case studies of issues with stability of antibody reagents

17:10

17:30

Susanne Pihl (on behalf of EBF)

 

 

Long term stability investigation of macromolecules in an isochronic study design

17:30

18.00

Panel Discussion

 

 

Moderator: Margarete Brudny-Kloeppel (Bayer HealthCare)

 

 

 

18.30

20.00

Conference Reception II in Exhibition and Poster Hall

Sponsored by Icon Development Solutions

 

 

Discover Catalunyan red: enjoy a few drinks and savor traditional food during this great networking opportunity

 

 

 

 

 

 

 

 

Day 3 – 18 November 2011

 

 

 

 

 

MORNING BREAKOUT SESSIONS

 

 

 

 

 

Main Auditorium

8.30

10.45

III.  Updates On Dried Blood Spots, Blood Analysis And Microsampling

 

 

Chair: Ben Gordon (for Servier)

 

 

 

8.30

8.45

Philip Timmerman (on behalf of EBF)

 

 

Moving forward from the EBF Recommendation

8.45

9.45

Feedback and status of EBF Dried Blood Spot Consortium

 

 

EBF June 2011 DBS workshop – where are we today?

 

 

All presentations are on behalf of the EBF DBS consortium

 

 

8.40 – 8.45

Steve White

 

 

 

Introduction

 

 

8.45 – 9.00

Liz Thomas

 

 

 

Sample Dilution

 

 

9.00 – 9.15

Zoe Cobb

 

 

 

Stability/recovery

 

 

9.15 – 9.30

Dieter Zimmer

 

 

 

Internal Standard

 

 

9.30 – 9.45

Steve White

 

 

 

Haematocrit

9.45

10.00

Eric Fluhler (Pfizer, on behalf of AAPS Bioanalytical Focus Group)

 

 

Feedback from the AAPS APQ Open Forum: “DBS and microsampling: moving past the hype to knowledge and implementation” 27-Oct-2011, Washington D.C.

10.00

10.20

Ove Jonsson (AstraZeneca)

 

 

Capillary micro sampling (CMS): handling and analysis of small volumes of blood, plasma and other biofluids

10.20

10.45

Panel Discussion

 

 

Moderator: Steve White (GSK)

 

 

 

 

 

Breakout Room

8.30

10.45

IV.  Challenge Of "Free" And "Total" Macromolecule Quantification

 

 

Chair: Daniela Stoellner (Novartis)

 

 

 

8.30

9.00

Daniela Stoellner (on behalf of EBF)

 

 

EBF overview

9.00

9.25

Lindsay King (Pfizer)

 

 

Risk assessment for the measurement of Free and Total drug and target

9.25

9.50

Roland Staack (Hoffmann-La Roche)

 

 

Mathematical simulation tools in bioanalytical assay development

9.50

10.15

Philip Lowe (Novartis)

 

 

Integration of physiological and biochemical concepts into the development of biopharmaceuticals

10.15

10.45

Panel Discussion

 

 

Moderator: Michaela Golob (Merck-Serono)

 

 

 

10.45

11.15

Coffee Break and Poster Session

 

 

 

 

 

 

 

 

Day 3 – 18 November 2011

 

 

 

 

 

PLENARY SESSIONS

 

 

 

11.15

13.00

Anomalous Results

 

 

Chair & Moderator: Peter van Amsterdam (Abbott Healthcare Products)

 

 

 

11.15

11.25

Magnus Knutsson (on behalf of EBF)

 

 

Updates from EBF survey on unexpected results

11.25

11.45

Fabio Garofolo (Algorithm Pharma)

 

 

An in-depth bioanalytical investigation to determine the root cause of abnormal results

11.45

12.00

Silke Luedtke (Boehringer-Ingelheim)

 

 

Unexpected results in a bioanalytical laboratory – a safety and compliance issue?

12:00

12:15

Rachel Green (Quotient Bioresearch)

 

 

Use of a CAPA system in handling anomalous results – with a focus on maintaining GCP compliance

12.15

12.35

Andreas Henrichs (Sanofi-Aventis)

 

 

GCP in a bioanalytical laboratory

12.35

13.00

Panel Discussion

 

 

 

13.00

14.00

2011-2012 EBF Feedback on planned and ongoing activities

 

 

Chair: Peter van Amsterdam (Abbott Healthcare Products)

 

 

 

13.00

13.20

Arjen Companjen (on behalf of EBF)

 

 

Overview of 2011 activities and plans for 2012

13.20

13.30

Speaker to be announced (on behalf of EBF Topic Team-16)

 

 

Feedback from topic team 16: formulation analysis

13.30

13.40

Philip Timmerman (on behalf of EBF Topic Team -09)

 

 

Feedback from topic team 9: alternative techniques

13.40

14.00

Silke Luedtke (representing EBF SC)

 

 

<< EBF Special Event >>

 

 

 

14.00

 

Adjourn