EBF 5th Open Symposium

Old Battles, New Horizons

Hesperia Tower Conference Center

Barcelona, Spain

November 14-16, 2012

The final agenda is now available on our conference website:

http://bcn2012.europeanbioanalysisforum.eu/

Again, we are proud to bring together expert speakers on topics which connect with our day to day challenges. So join us for the last big appointment on bioanalysis in 2012

What concerns you about the Harmonization team recommendation: Provide input to the GBC Roundtable at AAPS in Chicago

A Roundtable discussion of the most important and controversial recommendations from the Global Bioanalysis Consortium’s (GBC) 20 Harmonization Teams will be held Monday morning 8:00-10:00 AM on 15-Oct-2012 at this year’s AAPS Annual Meeting in Chicago. Drs. Binodh DeSilva and Eric Fluhler will highlight those topics that the Harmonization Teams feel need to be discussed with the scientific, quality and regulatory communities. Dr. Brian Booth (FDA) is scheduled to provide feedback. Additionally, GBC Harmonization Team Leaders and Team members, as well as Steering Committee members attending the meeting will be present and asked to present insights into the concepts and thinking that went into the proposals.

In preparation for the discussion, we’re reaching out in advance of the meeting seeking your input on the Harmonization Team recommendations and particularly those you would like to have discussed at the Roundtable. Please go to the GBC website (http://www.globalbioanalysisconsortium.org) to review the proposals, and then come back here to post and let us know what interests or concerns you!

Agenda 5th EBF Open Symposium

The EBF organising committee has completed the agenda for this year's Open Symposium in Barcelona. There are however a few aspects which still need to confirmed before we can publish it. You may anticipate the detailed conference program to be available on the bcn2012.europeanbioanalysisforum.eu website within about one week.

New EBF papers on Biomarkers and DBS-microsampling

Philip Timmerman, Christian Herling, Daniela Stoellner, Birgit Jaitner, Susanne Pihl, Karen Elsby, Neil Henderson, Begona Barroso, Stephanie Fischmann, Arjen Companjen, Amanda Versteilen, Stewart Bates, Clare Kingsley, Ulrich Kunz
European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development
Bioanalysis, Aug 2012, Vol. 4, No. 15, Pages 1883-1894.

Philip Timmerman, Steve White, Zoe Cobb, Ronald de Vries, Elisabeth Thomas, Ben van Baar, Christopher Smith, Dieter Zimmer, Pascal Delrat, John Smeraglia, Silke Lüdtke
Updates from the EBF DBS–microsampling consortium
Bioanalysis, Aug 2012, Vol. 4, No. 16, Pages 1969-1970.

EBF Newsletter number 1 is out!

We have our the first issue of the EBF Newsletter! We will release the newsletter on a regular base to stay in touch with you and inform you about EBF activities like our conferences, publications and topic team activities in particular as well as bioanalytical news „from the globe“.

Click here to read/download the newsletter

EBF 5th Open Symposium - Last Call for Speakers

European Bioanalysis Forum

5^th Open Symposium

Old Battles - New Horizons

November 14-16, 2012 • Hesperia Tower Hotel • Barcelona • Spain

LAST CALL FOR SPEAKERS/POSTERS

Only 3 weeks until the submission deadline for oral presentations and competing posters!

The theme of the 5^th Open Symposium is "Old Battles – New Horizons", where we intend to discuss ongoing ambiguities in areas like the tiered approach, micro sampling and tissue analysis as well as new and cutting edge applications in LBA and LC-MS/MS.  We anticipate to bring an exciting program which combines above with regulated bioanalysis themes, including updates from the globe (i.e. GBC and emerging regulations).  The draft program can be found on our website at: http://bcn2012.europeanbioanalysisforum.eu/Program/

LASTEST PROGRAM UPDATE:

Following up on the recent announcements on an upcoming Crystal City (CC-V) meeting on the (to be released) draft FDA BMV guidance (http://www.aaps.org/BMV), the Organizing Committee (OSOC) has decided to adapt the program of the Open Symposium and host a 1-day discussion on Friday Nov. 16th on the draft Guideline in front of this planned CC-V meeting (in continuation of this mail called ‘EBF FDA-BMV guidelines session’). We anticipate to create minimal impact on the original content of our 5th Symposium. The sessions that were originally scheduled for Friday will be included in the program of Nov. 14th and 15th, either by shortening some other sessions or by creating additional breakouts. The OSOC will work out a detailed agenda in the coming weeks.

In the EBF FDA-BMV guidelines session, it is our goal to include speakers who are closely involved in the preparation of the CC-V meeting, provide feedback from speakers around the globe and discuss the EBF consolidated feedback. Breakouts will be arranged for small molecules/chromatography and large molecules/LBA discussions.

We are aware of the current vagueness of the AAPS announcement. Of course, if no draft FDA Guideline is available at the time of the EBF Open Symposium, we will re-adapt the program accordingly, with focus of the Friday remaining on emerging guidelines as originally planned.

ORAL PRESENTATIONS

Speakers are requested to submit their contribution to open@europeanbioanalysisforum.eu, before September 10^th  2012, providing title of the presentation, a recent bio (max 150 words) and an abstract (max 350 words). The registration fee is waived for accepted speakers. As the summer breaks are approaching rapidly, do not hesitate to submit your talk soon. And preferably identify the session you plan to contribute to. See also: http://bcn2012.europeanbioanalysisforum.eu/Speakers/.

POSTERS

The EBF would also like to invite registrations for posters. This year, there will be a different approach to the poster sessions. You can either submit a regular poster (before October 15^th 2012) or apply for the ‘Best Poster‘ content (in which case you poster + abstract needs to be submitted before September 10^th2012  (see more details on the poster registration form at: http://bcn2012.europeanbioanalysisforum.eu/Posters/). All posters, need to be submitted to:  open@europeanbioanalysisforum.eu

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Meeting Organisation

Richard Abbott (Shire), Begona Barroso (Astellas), Magnus Knutsson (Ferring), Steve White (GSK), Peter van Amsterdam (Abbott), Margarete Brudny-Kloeppel (Bayer Healthcare), Arjen Companjen (Crucell), Michaela Golob (Merck-Serono), Silke Luedtke (Boehringer Ingelheim), Philip Timmerman (Janssen R&D),

Sponsor relations, marketing and logistics: Christina Smith, Bavalan Bioconference  SARL

The conference is organised as a non-profit event on behalf of the EBF vzw
The organisation of the conference is independent of all EBF member companies and conference sponsors.

GBC discussion group on LinkedIn

The Global Bioanalysis Consortium (GBC) is using a LinkedIn (www.linkedin.com) Group to provide a discussion forum for the recommendations that are coming from the 20 Harmonization Teams. Membership in LinkedIn is free and you must request access to the Global Bioanalysis Consortium Group. To not duplicate the exact recommendations, they will be maintained and updated at the GBC web site http://www.globalbioanalysisconsortium.org/Harmonizationteams/, but discussed under the Global Bioanalysis Consortium Linked Group.

We encourage all bioanalytical scientists to review the GBC recommendations and engage in the dialogue at the LinkedIn group.

AAPS/FDA Fifth Bioanalytical Workshop; Quantitative Bioanalytical Methods Validation and Implementation: The 2012 Revised FDA Guidance

Bringing Together Small and Large Molecules

When: Summer 2012

Where: Washington D.C.

Download flyer: front & back

Website: www.aaps.org/BMV

EBF 2012 Focus Meeting - Last Call to Register!

EBF - European Bioanalysis Forum

3^rd Focus Meeting

“Hatching”

Emerging Technologies Approaching the Regulated Bioanalysis Laboratory

12-13 June 2012

Sheraton, Brussels, Belgium

Last Call to Register

For this year’s Focus Meeting we again managed to attract excellent scientists and industry leaders to present and discuss at our meeting. The agenda of the is available on the conference website and can be viewed at:

http://bru2012.europeanbioanalysisforum.eu/Program/

Please move forward to register using below link

http://bru2012.europeanbioanalysisforum.eu/Registration/

On-line registration fee is 250 euro (150 for academia). On-site registration is also possible will be 350 euro and can only be payed in cash. The deadline for on-line registration is 1 June 2012. For registration forms received after that date, swift processing and a personal conference badge can not be guarenteed.

Looking forward to see you in Brussels

Meeting Organising Committee

Benno Ingelse, MSD # Margarete Brudny-Kloeppel, Bayer Healthcare # Arjen Companjen, Crucell # Peter van Amsterdam, Abbott Healthcare Products # John Smeraglia, HLS #  Neil Henderson, AstraZeneca # Hans Mulder, Astellas # Philip Timmerman, Janssen Research & Development

Program of EBF 5th Open Symposium 2012

The EBF Organizing Committee of the 5th Open Symposium (Barcelona 14-16 November 2012) proudly presents the program of this years meeting.

NOTE: EBF recognizes the importance of the anouncement of AAPS/FDA and their plans to hold a Crystal City V conference within 90 days of the release of the draft FDA BMV draft guidance (planned to occur summer 2012). and the decision of the GBC to move their Global Conference from the Netherlands to Washington DC area to provide optimal alignment in time and location for the scientific community. Depending on the   timing of those meetings, EBF intends to adapt it's Open Symposium program accordingly to either report back on the Crystal City V and/or GBC meeting or hold extensive discussions to prepare for those meetings.

	EBF 5th Open Symposium "Old Battles and New horizons"
Day 0 - 13 NOVEMBER 2012
	Registration and Information Desk Open
Day 1 - 14 NOVEMBER 2012
	Morning PLENARY SESSIONS
0	Welcome and introduction
1	Tiered approach in practice - are our minds ready for it?
	Goal: session aims at providing succes stories, hurdels and showing advantages or disadvantages on applying the tiered approach in early late development, in order to stimulate the scientist to use this approach when appropriate
	Break
2	Morning session: Bioanalysis and Toxicokinetics, or how to marry GLP and science
	Goal: Provide workable solutions to ensure our scientific brain doesn't dry our because of overinterpreting the GLP regulations (e.g. metabolites, tissues,….)
3	Posters going Oral
	Goal: In this session, 5 poster authors get a 5 minute opportunity to present their work plenary. The organising committee will select the 5 posters before 15 Oct 2012. In order to qualify to be eligible for selection, the poster abstract needs be be availabe before 15 September and you will need to indicate if you whish to be included in the selection. From these 5 posters, all delegates at the conference can select who wins the first EBF Best Poster Award, which will be communcated during a short ceremony at the end of the symposium as part of the closing session.
	Lunch
	Afternoon PLENARY SESSIONS
4	A progress update since Large meets Small
	Goal: in follow up of the 2011 Focus Meeting, ensure LBA and Chromatography scientist meet and connect around new approaches and developments on peptide and protein quantification.
	Break
5	Technology updates
	Goal: The goal of this session is to discuss new technologies and approaches for solving problems connected with  the peptide and protein quantification topic discussed in Session 4. Pt sponsors will be encouraged to focus on case examples which demonstrate innovative solutions for complex scientific problems.
	Conference Reception I
Day 2 - 15 NOVEMBER 2012
	Morning BREAKOUT SESSIONS
6a	Micro sampling I -  updates on DBS
	Goal: in this session, EBF will report back on the results from the DBS micro sampling/DBS consortium. A lot of results have been generated as well as intensive discussions continued within EBF. At the same time, this session will welcome other scientists to report back or give insights in the progress of DBS technology and applicationstions
6b	Biosimilars
	Goal : the session will mainly focus on the new draft FDA guidelines on biosimilar product development. The EBF topic team "Biosimilar" will host this session, present the consolidated repsonse provided to the Agency and discuss the implications on future analytical strategies.
	Break
7a	Micro sampling II - recent developments
	Goal: with EBF also anticipated to take BA-leadership in the microsampling discussion (as per our editorial), room is given to microsampling beyond DBS Goal: in this session, we will focus on micro sampling technologies on top of or in replacement of DBS. Over the recent years, capillary micro sampling has made great progress, but other technologies can be discussed in this session as well.
7b	Emerging Technologies applied for PK/PD assays
	Goal : to follow up on the EBF Focus Meeting (12-13 June 2012 , Brussels) and with a special focus on further developments and possible applications for PK/PD assays
	Lunch and poster session
	Afternoon BREAKOUT SESSIONS
WS1	Electronic raw data and ELN
	Goal: the EBF ELN Topic Team will host a workshop on introduction of ELN into the regulated bioanalytical lab. Further details to be communicated following meetings of the Topic Team.
8a	Is quantitative bioanalysis ready for HR/MS
	Goal : The goal of this session is to provide a platform for the discussion of the use of HR/MS in quantitative, regulated bioanalysis. We now have the capability to acquire both quantitative and qualitative ADME/PK data routinely from a single analysis. The associated efficiencies are obvious. However, are there remaining issues of concern for the use of HR/MS within the regulated environment? Case examples will be sought from the potential speakers.
8b	Wanted and unwanted immunogenicity
	Goal : The EBF topic team "Vaccines" will host the discussions on analytical challenges of wanted and unwanted immunogenicity. As no regulations are published yet the scientists are invited to reflect on recommendations and practical procedures.
	Break
	Afternoon PLENAIRY SESSIONS
9	Young Scientist Award
10	Technology updates
	Goal: The goal of this session is to discuss new technologies and approaches for solving problems connected with the type of intractable issues discussed in Sections 10a/b. Pt sponsors will be encouraged to focus on case examples which demonstrate innovative solutions for complex scientific problems.
	Conference Reception II
Day 3 - 16 NOVEMBER 2012
	Morning BREAKOUT SESSIONS
11a	SMOL session: BA clinic - consult the doctor (Breakout)
	Goal: lessons learned session from where we failed…a few brave experts to give an example of a tricky problem and an open discussion on how others would have approached it. Scientist wil be asked to present a poster at the session on day 1, after which it is discussed plenary (i.e. in this breakout session) for input and resolution or compassion e.g.: - Provide pragmatic scientific insight & solutions to addressing contentious elements of regulatory validation guidance documents - Haemolysed & lipemic samples, matrix effects & stability testing in the presence of co-meds, OTCs and (potentially unknown) metabolites.
11b	IGM session: BA clinic - consult the doctor (Breakout)
	Goal: lessons learned session from where we failed…a few brave experts to give an example of a tricky problem and an open discussion on how others would have approached it. Scientist wil be asked to present a poster at the session on day 1, after which it is discussed plenary (i.e. in this breakout session) for input and resolution or compassion e.g.: - Provide pragmatic scientific insight & solutions to addressing contentious elements of regulatory validation guidance documents - Haemolysed & lipemic samples, matrix effects & stability testing in the presence of co-meds, critical reagents, robustness
	Break
	Morning PLENARY SESSIONS
12	Global Harmonization: has the dust settled? And "updates from the globe"
	The goal of this session is to reflect on the outcome of the activities of the GBC and it's harmonization teams and to inform about activities within the various bioanalytical communities and regulatory bodies around the world. A forum should be provided for the audience to ask questions but also to give feedback on the impact of these global activities on their daily business. See also important notice at the top of the agenda on potential enhancements or enlargement of this session
13	Increasing challenges in clinical studies
	The aim of the session is to discuss the challenges of a bioanalytical laboratory involved in global clinical trials. The hurdles in these kind of trials vary from regulatory aspects such as country specific design/approval of the informed consent or problems with sample identification, to logistic aspects such as availability of certain equipment at the clinical site or the sample shipment from the clinical site to the bioanalytical laboratory.
14	Close out discussion, ideas for 2013
	Adjourn

Agenda EBF 3rd Focus Meeting

The agenda of the Brussels EBF Focus Meeting 2012 has been put online:

http://bru2012.europeanbioanalysisforum.eu/Program/

We are looking forward to meet you in Brussels!

EBF 2012 Focus Meeting "HATCHING" 12-13 June, Brussels

Two new EBF publications

The conference reports of both 2011 EBF meetings have been published in the most recent issue of Bioanalysis: http://www.future-science.com/toc/bio/4/6. The EBF Steering Committee would like to thank all contributers: authors, sponsors, speakers, poster presenters and organisers.

Philip Timmerman, Berthold Lausecker, Begona Barossa, Peter van Amsterdam, Silke Luedtke and Jessica Dijksman
Conference report from the European Bioanalysis Forum Open Meeting – ‘Large meets Small’ on connecting the bioanalytical community around peptide and protein bioanalysis with LC-MS(/MS)
Bioanalysis (2012) 4(6) 627-631
http://www.future-science.com/doi/pdfplus/10.4155/bio.12.37

Jessica Dijksman, Philip Timmerman, Richard Abbott, Begona Barroso, Margarete Brudny Kloeppel, Arjen Companjen, Michaela Golob, Ben Gordon, Christian Herling, Magnus Knutsson, Silke Luedtke, Birgitte Buur Rasmussen, Daniela Stoellner, Eva Vieser, Graeme Young, Peter van Amsterdam
Conference report from the European Bioanalysis Forum Open Meeting: Less is More – Defining modern Bioanalysis
Bioanalysis (2012) 4(6) 633-642
http://www.future-science.com/doi/pdfplus/10.4155/bio.12.36

GBC Conference: Science-based Proposals for Global Consensus on Bioanalysis

GBC Global Conference moved to Washington DC area

Based upon the announcement that the FDA will release their draft update guidance on bioanalytical method validation this summar and subsequnetly that an AAPS-FDA Crystal City V conference is planned to be held within 90 days after release of the guidance document, the GBC SC has decided to move the GBC global conference from the Netherlands to the Washington DC area. A date can not be set yet, but the conference is planned to be held 2 days prior to the AAPS-FDA meeting.

See also: Adaptation and Impact

Crystal City V is being planned!

We’re pleased to announce that the AAPS and FDA have agreed to hold a Crystal City Workshop on the upcoming draft revision to the Bioanalytical Method Validation Guidance. While no release date has been set, the AAPS plans to hold the 2.5 day meeting during the 90 day review period. Like its predecessors, this meeting will provide a forum for direct discussion by the scientific community with FDA representatives on the details of the draft guidance.

From: Bioanalytical Focus Group - AAPS - Spring Message - 21-Mar-2012

EBF 5th Open: Mark your Calendars!

European Bioanalysis Forum

5^th Open Symposium

Mark your Calendars!

November 14-16, 2012

EBF will organize its 5^th Open Symposium on regulated bioanalysis

“Old Battles and New Horizons”

at the Hesperia Tower Conference Center, Barcelona, Spain.

The conference will bring together leaders in industry (Pharma and CRO), academia, quality assurance and regulatory authorities to discuss established concepts and recent thinking on regulated bioanalysis. The scientific program is currently under development and will comprise of presentations by and discussions with experts from around the globe. The conference program will include topics as:

Tiered approach in practice - are our minds ready for it? # Bioanalysis and Toxicokinetics, or how to marry GLP and science # "Oral Posters session" # A progress update since Large meets Small # Technology updates # Micro sampling - updates on DBS & recent developments # Large molecule/LBA dedicated sessions # Electronic raw data and Electronic Lab Notebook (ELN) # Is quantitative bioanalysis ready for HR/MS  # Young Scientist Award # BA clinics - consult the doctor (Breakout) # Global Harmonization: has the dust settled? And "updates from the globe" # Challenges in global clinical studies

EBF invites scientist who are considering to present their work at our meeting to submit their oral presentation and/or poster to the conference email account: bcn2012@europeanbioanalysisforum.eu

The dedicated conference site: http://bcn2012.europeanbioanalysisforum.eu will go live this month. Visit the site for further announcements and details on the meeting, venue and registration. 

EBF Focus Meeting - Second Call for Speakers & Posters

Second Call for Speakers & Posters

European Bioanalysis Forum

3^rd Focus Meeting – “Hatching”

Emerging Technologies Approaching the
Regulated Bioanalysis Laboratory

With scientific developments and regulatory expectations not always in concert, our 3^rd Focus Meeting aims to connect on the potential of a broad array of new technologies. We will provide a scientific hub for the development of strategies, which may enable the application of these emerging technologies to their full potential in regulated bioanalysis.

Each session intends to have 4 speakers (1 keynote of 30 minutes and 3 contributions of 20 minutes). For details on the goals and objectives of each session, please visit the conference website at http://bru2012.europeanbioanalysisforum.eu/program

CALL FOR SPEAKERS

Potential speakers, please submit the title and abstract of your presentation before 31 March 2012 to conference address: BRU2012@europeanbioanalysisforum.eu, attaching a filled out oral presentation submission form available on the conference website. Acceptance of your presentation will be communicated before 15 April 2011.

CALL FOR POSTERS

There will be room for approx. 30 posters and in principle all submitted posters will be accepted. Please submit the title and abstract of your poster before 15 May 2012 to conference address: BRU2012@europeanbioanalysisforum.eu, attaching a filled out poster presentation submission form available on the conference website. Supported poster format is portrait (size A0).

CONFERENCE PROGRAM

Day 1 - 12 June 2012

Morning plenary sessions: What's new in Sample Enrichment Technology

Session 1 - Miniaturization and/or automation of sample preparation techniques
This session will focus on recent progress made in automation and/or miniaturization in support of (regulated) bioanalytical sample preparation. This includes but is not limited to liquid handling technologies, micro extraction and chip technologies. The goal of this session is to share and discuss techniques and processes that will facilitate the sample preparation workflow.

Session 2 - How can antibody technology help with sample enrichment for NCE or peptides quantification?
This session will focus the use of antibody capture techniques used to optimise sample enrichment for Pharmocokinetic and Pharmacodynamic endpoint technologies.

Afternoon plenary sessions: Recent developments in tissue analysis

Session 3 - Tissue analysis (including micro sampling) and PK/PD
Over the last years, the analytical potential offered by modern MS technology or  immunological approaches opened new avenues in the analysis of non standard matrices for PK, TK or PK/PD reasons. In this session we invite scientist to share their experience or observed scientific, analytical or regulatory hurdles when applying these new technologies. Both MS and LBA scientist will be welcomed.

Session 4 - Is Tissue Imaging approaching quantitative bioanalysis expectations
The goal of this session is to highlight & discuss the advances and current/potential future use of Tissue Imaging approaches as quantitative bioanalytical tools in a regulated environment.

Day 2 - 13 June 2012

Morning breakout sessions: Miniaturization and diversification in LC – MS interfacing

Session 5 - Miniaturization of LC using ‘conventional’ MS Ionization techniques
Advances made in LC miniaturization, such as microbore and capillary LC, CE, and chip techniques, is opening new possibilities for the bioanalytical scientist. Together with these new possibilities come new challenges. In this session, thoughts and experiences with these techniques will be shared with the aim to enhance the toolset in the (regulated) bioanalytical laboratory and improve problem solving capability.

Session 6 - Alternative MS-interfaces for quantitative bioanalysis
The last 5 years may have been one of the most exciting periods for the bioanalytical scientist with (historically less robust) alternative MS-interfaces  (to the commonly used ESI and APCI) coming available to their fullest potential for quantitative bioanalysis. In this session, we aim at providing examples of these alternative MS-interfaces and want to stimulate discussions to enhance their application in (regulated) quantitative bioanalysis.

Morning Breakout Sessions: Emerging platforms in support of LBA

Session 7 - Recent new technologies – Methodologies
As the industry looks at options beyond traditional single-plate ELISAs  to achieve greater dynamic ranges, analyze multiple analytes or exploit new reporting systems; what are the technology options available (e.g. Flow Cytometry, multiplex analysers etc)? The goal of this session is to showcase & discuss the emerging new LBA technologies & novel LBA methodologies for use in a regulated bioanalysis setting.

Session 8 - Recent new technologies – Applications and validation approaches
How are methods being validated on new technology platforms? This session aims to identify and discuss best practices for the validation package requirements of novel LBA applications - are these bespoke or can traditional ELISA method validation packages be used?

Afternoon plenary session: Global Bioanalysis Consortium Updates

Session 9 - GBC feedback session
Discuss and provide feedback on the progress made in global harmonization of the bioanalysis guidelines (GBC). The intention is to invite 4-5 Harmonization team leads (or a regional representative from those teams) to present the progress of their teams and to engage with delegates for input and feedback.