Welcome to the EBF 2nd Annual Open Symposium
We are pleased to announce the start of the plans for the EBF open symposium in 2009. After the success of the 1st Open Symposium in 2008 we have selected dates and topics for the 2nd Annual Open Symposium, again in Barcelona :
The Broadening Scope of Validation
2nd to 4th of December 2009
Hesperia Towers, Barcelona, Spain
After a successful first open symposium in December 2008 with 250 delegates, the EBF is organising its 2nd Open Symposium. Pharma and Biotech companies, CRO’s, academia, regulatory agencies and instrument vendors are invited to attend this open symposium to exchange ideas and information on topical issues of mutual concern in an atmosphere which facilitates the interactive participation of the attendees.
___________________________________________________________________________________________
Final Program
To download the program for the 2009 2nd EBF Open conference, click the link below
http://www.bioanalysis-forum.com/medias/download/programme[1].pdf
DECEMBER 2nd, 2009
PLENARY SESSION 1: TOWARDS EMEA GUIDELINES FOR BIOANALYSIS
In this session, key speakers will be invited to bring a broader/global perspective on the emerging EMEA guidelines. EBF anticipates and is actively contacting speakers from EBF, EMEA, FDA, AAPS , PEI and CRO to give a contribution to this session. The presentations will be followed by a panel discussion.
DECEMBER 3rd 2009
08:00 – 09:30 PLENARY SESSION BIOMARKERS: VALIDATION AND ANALYTICAL CHALLENGES
The increasing complexity and demand for biomarker analysis urges the broad bioanalytical community continue the discussion on processes and sharing of science on biomarker analysis. The current session intents to focus on how quality and validation should align with the scientific complexity, or in other words: towards sharing of best practices in biomarker validation.
09:30 – 09:50 Coffee break
08:00 – 09:30 PLENARY SESSION: NOVEL APPROACHES FOR THE ANALYSIS OF PROTEINS AND PEPTIDES BY MS TECHNOLOGY
This session is dedicated to new and improved methods and methodologies for the quantification of peptides and proteins using LC-MS and LC-MS/MS technology. This could cover the quantification of an active bio-drug or even the quantification of an endogenous or novel biomarker. As it is known by the practitioner and more and more recognized LC-MS type concentration data are often complementary to ligand-binding data and could be used together for a better understanding of the biological mode of action of a bio-drug, so this section will gain its value from the technical and from pharmacological point of view.
11:00 – 13:00 PLENARY PLATINUM SPONSOR SECTION
Scientific update from our Platinum Sponsors
In this session EBF will give the Platinum sponsors the opportunity to present on how they are supporting bioanalysis in the drug R&D by either recent development is the area of soft and hardware or by providing extraordinary service in supporting early PK/PD and biomarker correlation. In essence, instrument providers will give an update on their recent developments in mass spectrometry with associated front end instrumentation and how they could improve speed and quality of data the same time. CRO’s will give in-life examples how they are using and combining existing and newly developed techniques in order to create more value out of the same sample during analysis. Both, news on instrumentation and application will give the audience a good overview and will trigger thinking what could be done differently in the filed of bioanalysis in order to make the drug R&D more solid with respect to data provision.
13:00 - 14:00 Lunch
14:00 – 15:30 PLENARY SESSION: CHALLENGES IN METABOLITE QUANTIFICATION
Since the publication of the FDA MIST guidance, metabolite quantification is getting a lot of attention within Bioanalysis. This session aims at sharing scientific, technical and procedural experience with respect to quantification of metabolites at different stages of development, including recommendations from EBF on the topic.
15:30 – 15:50 Coffee break
15:50 – 17:30 BREAKOUT SESSIONS
Breakout session 1: Dried Blood Spots
Featuring an invited speaker from GSK, this breakout session will bring together the current experience within the bioanalytical community on the novel approaches offered by the dried blood spot approach. This technique, recently revived by Tox, BA and PK scientist at GSK, is getting a lot of attention in the bioanalytical and in the clinical and nonclinical community. The contributions in this session will provide a good oversight of the applications of this technique from discovery all the way to clinical support.
Breakout session 2: focus on LBAs
Topic : EBF-IGM to identify topic for discussion
Breakout session 3: Analytical challenges of non-standard matrices
This breakout session will be a platform for bioanalysts dealing with non-standard matrices such as tissues, CSF and others. The method validation for these matrices is often more challenging and not as straight forward as the one for a plasma assay. In addition, recommendations given in the FDA guidance on bioanalytical method validation may often be difficult to fulfil for these types of matrices. The aim of the session is therefore to share experiences covering both the scientific as well as the regulatory aspect of non-standard matrices.
17:30 – 18.30 Poster session 2, including short plenary presentations
DECEMBER 4th 2009
08:00 – 10:00 PLENARY SESSION
08:00 – 09:00 Feedback on EBF closed meetings and recommendations
09:00 – 10:00 Feedback from breakout sessions
10:00 – 10:30 Coffee break
10:30 – 12:30 PLENARY SESSION: UNRESOLVED ISSUES IN METHOD VALIDATION
Despite well established guidances and procedures on bionalytical method validation there are still a lot of ongoing discussions within the bioanalytical community on various aspects of method validation. These topics may not only deal with the sample analysis within the bioanalytical laboratory but may also relate to processes performed within the context of a study but not under supervision of the bioanalysts such as sample collection/shipment.
11:30 – 12:30 Coffee break
12:30 - 13:30 PLENARY SESSION: LATEST DEVELOPMENTS AND CURRENT HOT TOPICS IN LBA
12:30 – 12:50 keynote speaker from EBF
12:50 – 13:10 Oral presentation
13:10 – 13:30 Oral presentation
13:30 – 14:00 Final comments and adjourn
14:00 End of the meeting
________________________________________________________________________________
Call for speakers and sponsorship
All speaker slots and sponsorships are now filled. Poster registration is now closed. To submit a poster please contact: contact@bioanalysis-forum.com
Registration
Registration for this years EBF conference will be 250 euros (150 euros for academia).To register go to the inscription tab at the top of the webpage.
Accomodation
Rooms at the Hesperia conference hotel are available at the conference rate of 140 euros excluding tax and can be booked directly with the hotel using the form and booking code attached: http://www.bioanalysis-forum.com/medias/download/hotel_reservation.pdf/
2 alternative hotel options with good connection to airport and metrolines towards the Hesperia:
BARCELO SANTS: 70.00€ + 7% IVA (breakfast included), on top of Barcelona Central Train Station Sants Estació (every 30 min direct connection to Airport). Metro line to city center (direct line) and conference venue (1 stopover). http://www.barcelosants.com/, sants@barcelo.com
AC VILAMARI: 80.00€ + 7% IVA (breakfast not included), please quote 64J21351-M587 for guaranteed rate, connects well with airport and metro line to city center and conference venue. http://www.ac-hotels.com/, acvilamari@ac-hotels.com
The European Bioanalysis Forum
The European Bioanalysis Forum (EBF) is an organisation comprised of (Global and EU-based) pharmaceutical companies with operational activities in the EU, 27 member companies to date. The membership shares a common vision to advance our understanding of topical concerns through discussion of scientific, technological and regulatory issues of bioanalytical interest. To learn more about the EBF: Website: http://www.europeanbioanalysisforum.eu/
EBF member companies:
- Abbott ,
- Actelion Ltd,
- Active Biotech
- Almirall
- Astellas
- AstraZeneca
- Bayer Schering Pharma AG
- Boehringer-Ingelheim
- Ferring Pharmaceuticals A/S
- Grünenthal GmbH
- GSK
- F. Hoffmann-La Roche
- Johnson & Johnson
- H. Lundbeck A/S
- Merck&Co
- Merck Serono
- Novartis Pharma AG
- Novo Nordisk
- Nycomed
- Schering-Plough
- Orion Corp. Orion Pharma
- Pfizer
- Sanofi-Aventis
- Servier
- Shire Pharmaceuticals
- Solvay Pharmaceuticals
- UCB Pharma
MEETING ORGANISATION
SCIENTIFIC CONTENT OF MEETING AND EBF STEERING COMMITTEE Philip Timmerman, Johnson&Johnson, Berthold Lausecker, F Hoffmann-La Roche Ltd, Margarete Brudny-Kloeppel, Bayer Schering Pharma AG, Silke Luedtke, Boehringer Ingelheim, Peter van Amsterdam, Solvay Pharmaceuticals
SPONSOR RELATIONS, MARKETING AND LOGISTICS Christina Smith, Bavalan Bioconference & MDS Pharma Services
The conference is organised as a non-profit event on behalf of the EBF by the EURL Bavalan Bioconference, director: Christina Smith. The organisation of the conference is independent of all EBF member companies and conference sponsors



























