Saturday, April 21, 2012

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of AAPS/FDA and their plans to hold a Crystal City V conference within 90 days of the release of the draft FDA BMV draft guidance (planned to occur summer 2012).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

Thursday, April 19, 2012

Friday, April 6, 2012

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

Thursday, April 5, 2012

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

Tuesday, April 3, 2012

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