Thursday, December 8, 2011

Tuesday, November 22, 2011

4th Open Symposium Survey - EBF is asking your opinion!


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.
EBF 4th Open Symposium Survey: http://www.surveymonkey.com/s/WXS5F2V

Thank you for your input.

Friday, November 11, 2011

Monday, November 7, 2011

EBF 4th Open Symposium - Update EMA BMV session


Day 1 – 16 November 2011
MORNING PLENARY SESSIONS
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

To download the full program, follow this link.

Thursday, October 27, 2011

Exhibition Hall setup EBF 4th Open, Barcelona 2011

The 4th EBF Open Symposium will have a good sized exposition with 40 sponsor booths. An excellent oppertunity and environment to meet and discuss with your peers, clients and vendors. Submitted posters will be presented in the exhibition area.
The floor plan is shown below and a PDFed copy can be downloaded.


Friday, October 14, 2011

Updated Agenda EBF 4th Open Symposoum - 2011 Barcelona




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