Friday, May 31, 2013

EBF Newsletter Vol. 2, No. 2


The second newsletter of 2013 is out. In this issue:
  • Conference News: 
    • 6th Open Symposium 
    • Focus workshops 
  • Presentations & Publications 
    • NC3R Forum 
    • JPAG-DMDG meeting 
    • EMA guideline on BMV 
    • Reid Bioanalytical Forum 
    • AMS validation 
    • GBC webinars 
  • Guidelines 
  • Calendar of Events 

Friday, May 3, 2013

EBF 6th Open Symposium - Call for Speakers - Deadline 26 May


EBF 6th Open Symposium

Moving Forward Together
Science, Technology and Regulations Embracing New Paradigms
20th – 22nd November 2013, Hesperia Tower, Barcelona, Spain

2nd CALL FOR SPEAKERS
In comparison to previous years, the deadlines for submission have changed significantly. Speakers are requested to submit their contribution to open@europeanbioanalysisforum.eu, before May 26th 2013, providing the title of the presentation, a recent bio (max 150 words) and an abstract (max 350 words). You can find detailed instructions on: http://bcn2013.europeanbioanalysisforum.eu/Speakers/. It is our intention to publish the detailed conference agenda before the summer.
Planned sessions for the 2013 EBF Open Symposium are:
  • ·       Assay transfer - Expectations & Practicalities
  • ·       Interpretation and implementation of Guidance
  • ·       From biomarker to diagnostics or personalized medicine: is there a role for regulated bioanalysis?
  • ·       Consult the doctor: lessons learned session from where we failed… or not.
  • ·       Is validation really needed for all assays: taking tiered approach outside the world of MIST
  • ·       Interpretation and implementation of Guidance expectations:  Internal Standard variability, carry-over
  • ·       Emerging Technologies in sampling & extraction: microsampling and development in sample preparation
  • ·       Emerging Technologies in separation & quantification: miniaturization in LC and MS
  • ·       Challenges in the analysis of antibody-drug conjugates (ADCs)
  • ·       Challenges for Flow Cytometry in regulated Bioanalysis
  • ·       Surprises in Ligand Binding Assay method development
  • ·       Analysis of parallelism for biomarkers and therapeutic proteins
  • ·       Promises of new technology: sense and nonsense of HR-MS
  • ·       Challenges and solutions of sample logistics
  • ·       Interferences in LBA

Please check our website to see a full list of program topics: http://bcn2013.europeanbioanalysisforum.eu/Program/.
We anticipate bringing an exciting program and candid discussions and in the spirit of a true Forum, we will build the agenda reflecting your interest, contributions and engagement.

POSTERS

We would also like to invite you to register your posters. Please submit your poster contribution (before September 15th 2013) to open@europeanbioanalysisforum.eu using the poster registration form at: http://bcn2013.europeanbioanalysisforum.eu/Posters/

Wednesday, May 1, 2013

Global Bioanalysis Consortium Webinars


Outcomes of the GBC Harmonization Teams on
Bioanalytical Method Validation
The GBC announces two Webinars presenting key recommendations from the Harmonization Teams.  The Harmonization teams were grouped under broad categories of topics related to 1) all chemotypes, 2) chromatographic-based assays and 3) Ligand-binding assays.  To minimize the number of webinars most attendees are interested in, the topics for all chemotypes have been grouped with both the chromatographic assays and ligand-binding assay content producing just two sessions.  Each Webinar session will be presented twice to accommodate all regions

Full details in Global Bioanalysis Consortium Webinars: Outcomes of the GBC Harmonization Teams on Bioanalytical Method Validation

Wednesday, January 30, 2013

Moving Forward Together: First Call for Speakers



6th Open Symposium

Moving Forward Together


Science, Technology and Regulations Embracing New Paradigms

Date: 20th – 22nd November 2013
Hesperia Tower, Barcelona, Spain


With already five great Barcelona Symposia behind us, the EBF Organizing Committee is ready to share the program outline of the 6th Open Symposium: MOVING FORWARD TOGETHER. Hence, we announce our

1st CALL FOR SPEAKERS
This year we identified 4 major themes where we want to move forward together:
  • ·       Regulations
  • ·       Technology and process improvement
  • ·        Increasing the added value of connectivity outside Bioanalysis
  • ·       The impact of new technologies, strategies and requirements on our day-to-day executing of bioanalysis.

For each of these themes we identified a number of program topics from which we will build the sessions. Please check our website to see a full list of program topics: http://bcn2013.europeanbioanalysisforum.eu/Program/.
We anticipate bringing an exciting program and candid discussions. Depending on your submissions, some program topics will become stand-alone sessions, others will be integrated into dedicated theme sessions or workshops. In the spirit of a true Forum, we plan to build the agenda reflecting your interest, contributions and engagement.

ORAL PRESENTATIONS

In comparison to previous years, the deadlines for submission have changed significantly. Speakers are requested to submit their contribution to open@europeanbioanalysisforum.eu, before May 26th 2013, providing the title of the presentation, a recent bio (max 150 words) and an abstract (max 350 words). You can find detailed instructions on: http://bcn2013.europeanbioanalysisforum.eu/Speakers/. We intend to publish the agenda before summer.

POSTERS

We would also like to invite you to register your posters. Please submit your poster contribution (before September 15th 2013) to open@europeanbioanalysisforum.eu using the poster registration form at: http://bcn2013.europeanbioanalysisforum.eu/Posters/
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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), Benno Ingelse (MSD) and 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.

Thursday, October 4, 2012

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:
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



Monday, September 24, 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!



Monday, September 17, 2012

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.

Tuesday, September 11, 2012

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.

Sunday, September 9, 2012

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“.

Monday, August 20, 2012

EBF 5th Open Symposium - Last Call for Speakers



European Bioanalysis Forum
5th 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 5th 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 10th  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 15th 2012) or apply for the ‘Best Poster‘ content (in which case you poster + abstract needs to be submitted before September 10th2012  (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.