Agenda EBF 2011 Open Symposium

		Day 0 - 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
11.20	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?
12.10	12.20	Morten Rohde (Lundbeck)
		Topic 4 from EMA Guidance – topic tbd
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	Surendra Bansal (on behalf of GBC HT-A1)
		Harmonization team A1 (scope and regulations) update
14.45	15.00	Nico van de Merbel (on behalf of GBC HT-A6)
		Harmonization team A6 (stability) update
15.00	15.15	Michaela Golob (on behalf of GBC HT-L6)
		Harmonization team L6 (immunogenicity) update
15.15	15.30	Ben Gordon (on behalf of GBC HT-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
16.30	18.00	Technology Session I
		Chair: Margarete Brudny-Kloeppel (Bayer)
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
		Discover Catalunyan cava: enjoy a few drinks and savor 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 SC)
		Introduction
10.05	10.20	Award winner
		Presentation
10.20	11.00	Coffee Break
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 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 Plenary Session With Focus On AMS
		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	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
		AFTERNOON BREAKOUT SESSIONS
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)
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)
18.30	20.00	Conference Reception II
		Discover Catalunyan red: enjoy a few drinks and savor traditional food during this great networking opportunity
		Day 3 – 18 November 2011
		MORNING BREAKOUT SESSIONS
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)
8.30	10.45	IV.  Challenge Of "Free" And "Total" Macromolecule Quantification
		Chair & Moderator: Michaela Golob
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
10.45	11.15	Coffee Break
		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)
		Title to be announced: “GCP in the BA lab”
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 TT-16)
		Feedback from topic team 16: formulation analysis
13.30	13.40	Philip Timmerman (on behalf of EBF TT-09)
		Feedback from topic team 9: alternative techniques
13.40	14.00	Silke Luedtke (representing EBF SC)
		<< EBF Special Event >>
14.00		Adjourn

EBF 2011 Symposium site active again

Friday late afternoon Google enabled the site again.

Note: older EBF symposia sites (2010 open symposium and 2011 focus meeting) and GBC site are still disabled. To be resolved by Google.

EBF 2011 Symposium site down

EBF 2011 4th Open Symposium conference site http://bcn2011.europeanbioanalysisforum.eu is momentarely down. We hope to be able to resolve the issue soon.

Downloads:
Conference Program
Delegate Registration

EBF publications list updated

>> DBS - Dried Blood Spots

Philip Timmerman, Steve White, Susanne Globig, Silke Lüdtke, Leonarda Brunet, Christopher Smith, John Smeraglia
EBF and dried blood spots: from recommendations to potential resolution
Bioanalysis, Aug 2011, Vol. 3, No. 16, Pages 1787-1789.

Philip Timmerman, Steve White, Susanne Globig, Silke Lüdtke, Leonarda Brunet, John Smeraglia
EBF recommendation on the validation of bioanalytical methods for dried blood spots
Bioanalysis, Jul 2011, Vol. 3, No. 14, Pages 1567-1575.

Richard Abbott, John Smeraglia, Stephen White, Silke Luedtke, Leonarda Brunet, Elizabeth Thomas, Suzanne Globig, Philip Timmerman
Conference Report EBF 1st Focus Meeting: Connecting strategies on dried blood spots
Bioanalysis, Nov 2010, Vol. 2, No. 11, Pages 1809-1816

>> EBF Conference Reports

Richard W Abbott, Ben Gordon, Peter van Amsterdam, Berthold Lausecker, Margarete Brudny-Kloeppel, John Smeraglia, Fernando Romero, Susanne Globig, Michaela Golob, Magnus Knutsson, Christian Herling, Eva Vieser, Philip Timmerman
Conference Report 3rd Open EBF Symposium: From challenges to solutions
Bioanalysis, April 2011, Vol. 3, No. 8, Pages 833-838

Richard Abbott, John Smeraglia, Stephen White, Silke Luedtke, Leonarda Brunet, Elizabeth Thomas, Suzanne Globig, Philip Timmerman
Conference Report EBF 1st Focus Meeting: Connecting strategies on dried blood spots
Bioanalysis, Nov 2010, Vol. 2, No. 11, Pages 1809-1816

Richard W. Abbott
Conference Report 2nd Open EBF Symposium: The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis
Bioanalysis 2010, 1:4, 703-708

Richard W Abbott, Margarete Brudny-Kloeppel
Conference Report 1st Open EBF Symposium: European Bioanalysis Forum
Bioanalysis 2009 1:2, 273-276

Peter van Amsterdam
Succesvol eerste EBF symposium
Laboratorium Magazine Nr 2, 2009

Richard W. Abbott and Margarete Brudny-Kloeppel
Konferenz Report: European Bioanalysis Forum 1st Open Symposium "Burning Issues in Bioanalysis", 01-02 December 2008, Hilton Hotel, Barcelona
Nachrichten aus der Chemie (DE)

>> Immunogenicity

EBF-IGM consolidated comments on FDA Draft Guidance: Assay Development for Immunogenicity Testing of Therapeutic Proteins

>> ISR - Incurred Sample Repeatability

Philip Timmerman, Silke Luedtke, Peter van Amsterdam, Margarete Brudny-Kloeppel, Berthold Lausecker
Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum
Bioanalysis 2009 1:6, 1049-1056

>> MIST - Metabolites in Safety Testing

Philip Timmerman, Morten Anders Kall, Ben Gordon, Sirpa Laakso, Achim Freisleben, Richard Hucker
Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum
Bioanalysis, July 2010, Vol. 2, No. 7, Pages 1185-1194

>> Regulations

Henning Blume, Erich Brendel, Margarete Brudny-Klöppel, Sylvia Grebe, Berthold Lausecker, Gabriele Rohde, Christoph Siethoff
Workshop/Conference Report on EMA Draft Guideline on Validation of Bioanalytical Methods
European J. of Pharmaceutical Sciences 42(2011) 300-305

Peter van Amsterdam, Mark Arnold, Surendra Bansal, Douglas Fast, Fabio Garofolo, Philip Timmerman, Eric Woolf
Global Bioanalysis Consortium - Working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation
Bioanalysis 2(11), 1801-1803 (2010)

Peter van Amsterdam, Berthold Lausecker, Silke Luedtke, Philip Timmerman, Margarete Brudny-Kloeppel
Towards harmonized regulations for bioanalysis: moving forward!
Bioanalysis 2010 2:4, 689-691

Philip Timmerman, Steve Lowes, Douglas M Fast, Fabio Garofolo
Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis
Bioanalysis 2010 2:4, 683-683

Berthold Lausecker, Peter van Amsterdam, Margarete Brudny-Kloeppel, Silke Luedtke, Philip Timmerman
European Bioanalysis Forum and the way forward towards harmonized regulations
Bioanalysis 2009 1:5, 873-875

>> Stability

Achim Freisleben, Margarete Brudny-Klöppel, Hans Mulder, Ronald de Vries, Marcel de Zwart, Philip Timmerman
Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis
Bioanalysis, Jun 2011, Vol. 3, No. 12, Pages 1333-1336

Source: http://www.europeanbioanalysisforum.eu/publications.php

EBF 4th Open Symposium - Last Call for Speakers

The deadline for submitting oral presentations for 2011 EBF Open Symposium of this year, 15 September, is rapidly approaching and the Open Symposium Organizing Committee (OSOC) would kindly like to remind you not to forget to submit your abstract in time. We still have a few open slots!

Submitted oral presentations will be reviewed by the OSOC on September 16 on scientific content and its fit with the conference theme and session topics. Acceptance your talk will be communicated shortly after that date.

Timelines:

·         Oral presentations: deadline for abstracts 15 September 2011
  EBF OSOC review: 16 September

·         Poster presentations: deadline for abstracts 15 October 2011
  No EBF OSOC review

·         Meeting registration: deadline 1 November 2011
  After that date only on-site registration (in cash)

·         4^th Open Symposium: 16-18 November June 2011

Conference website: http://bcn2011.europeanbioanalysisforum.eu/

Conference email address: bcn2011@europeanbioanalysisforum.eu

Forms:

·         Oral presentation submission

·         Poster submission

·         Conference registration

·         Hotel room booking

Oral presentation 2011 Focus Meeting available

Slide decks of the of the oral presentations of the 2011 EBF Focus Meeting "Large meets Small" have been made available for public viewing and or download at the conference site:

http://bru2011.europeanbioanalysisforum.eu/slides

Photos of the 2011 EBF Focus Meeting "Large meets Small"

The second Focus Meeting organised by the European Bioanalysis Forum attracted a good international fearless*) crowd of a bit over 180 scientists from academia, industry and contract service organisations.

A conference report is being prepared by the Organising Committee (to be published in Bioanalysis) and soon the slide decks will be made available on the meeting website.

In the mean time you can already view and/or download the pictures by visiting either the EBF Facebook page or our Picasa album.

*) see: http://ebfnewsletter.blogspot.com/2011/05/are-bioanalysts-afraid-of-grimsvotn.html

EBF membership open to CROs

As presented during the 3rd Open Symposium in Barcelona in 2010, EBF has changed its structure and has slightly adapted her groundrules to facilitate CROs becoming a member of the European Bioanalysis Forum. CROs being interested to become a member of EBF are advised to view the attached slide deck:

Donwload the EBF-CRO integration slide deck (pdf)

and submit an EBF member company application form.