|
|
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
|
|
|
|
|
|
12.45
|
How To Implement The EMA Guideline On Bioanalytical Method Validation
|
|
|
Chair and Moderator: Silke Luedtke (Boehringer-Ingelheim)
|
|
|
|
11.20
|
11.30
|
Peter van Amsterdam (on behalf of EBF)
|
|
|
Introduction
|
11.30
|
11.40
|
Timothy Sangster (Charles River Laboratories)
|
|
|
EMA – have our prayers been answered!
|
11.40
|
11.50
|
Daniela Stoellner (Novartis)
|
|
|
New EMA guideline on method validation and how it translates into best practice for Ligand Binding Assays
|
11.50
|
12.00
|
Graeme Smith (Huntingdon Life Sciences)
|
|
|
Partial Validation when is enough, enough?
|
12.00
|
12.10
|
Morten Rohde (Lundbeck)
|
|
|
Matrix Effects in Bioanalysis, when established procedures become obsolete.
|
12.10
|
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 Sensitive 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
|
|
|
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
|
The EBF steering committee is interested to learn from the delegates, sponsors and speakers, who visited the 4th Open symposium, how they experienced and valued the meeting. With the aid of your opinion we can maintain the high quality of our meetings and bring you again a better program next year. Filling in the survey is anonymous and will only take a few minutes of your time.
Posts
