BCN 2010 - Call for Speakers

Again this year, EBF welcomes stimulating speakers to the symposium.

Potential speakers, please submit your contribution to BCN2010@europeanbioanalysisforum.eu

• title of your presentation (before September 30th 2010)
• abstract (250 words) (before October 30th 2009)

Please identify the session in which you plan to contribute. See also the conference program. Depending on the topic, your presentation may be assigned to the plenary lectures or to a breakout session.

BCN 2010 - Call for Posters

EBF will welcome scientific poster presentations at her third open conference "From Challenges to Solutions" and researchers are encouraged to present their work at our meeting.

Poster submissions should make use of the attached form and be sent to contact@bioanalysis-forum.com.

Key information to be provided: Title, Author(s), Company/organisation, Email of contact person, Category and an Abstract (250 words)

Prelimenary Program EBF 3rd Open Barcelona Meeting

The draft program for this years EBF open meeting "From Challenges to Solutions" 1-3 December 2010, Barcelona, Spain has been published on the dedicated conference site and may also be downloaded following this link. In short the conference program has sessions on the following topics:

· Bioanalysis – thinking outside the ”commodity” box
· Practical Solutions to Bioanalytical Challenges
· Towards Global harmonization
· Platinum Sponsors session
· Conference dinner - evening speaker
· Technologies and comparison of assay platforms
· Breakout sessions
  o Breakout Small molecules
  o Guideline on "Assay Development for Immunogenicity Testing of Therapeutic Proteins" and related topics
  o Practical Solutions to Bioanalytical Challenges: Matrix Effects
· EBF feedback on internal discussions
· Finding the right level
· Biomarkers

Download EBF DBS workshop presentations

PDF renditions of all the 21 the powerpoint presentations given at EBF's workshop on Connecting Strategies on Dried Blood Spots have been uploaded to the dedicated workshop site and can be viewed and downloaded from this page.


Plenary Session

• P. Timmerman (J&J, EBF) - The Use of Dried Blood Spots in Drug Discovery and Development: Overview and EBF’s Perspectives on Hurdles and Opportunities

DBS in the Non Regulated Environment

• K. Beaumont (Pfizer) - Who Decided We Should Measure Plasma?
• F. Picard (Novartis) - An Overview of the Implementation of DBS At Novartis: Results and Next Step
• P. Wright (Pfizer) - DBS for Metabolite Identification: Can We ? Should We?
• C. Smith (AstraZeneca) - Metabonomic Analysis of Dried Biofluid (Blood, Plasma, Urine) Spots

Combined Toxicology/Regulatory/QA

• F. McClure (GSK) - Spot the Difference: Effect of TK Blood Sampling on Clinical Pathology Parameters
• L. Patrone (BMS) - Direct Comparison of DBS Analysis to Plasma and Whole Blood Analysis in Toxicokinetic Studies of Rats
• J. Burnett (Covance) - Practical Application of Dried Blood Spot Techniques in Toxicology
• M. Benton (Fulcrum Pharma) - QA Perspective on Dried Blood Spot Analysis

Bioanalytical and DBS: Applications

• P. Abu-Rabie (GSK) - Direct Quantitative Bioanalysis of Drugs in Dried Blood Spot Samples
• H. Ghobarah (AB Sciex) - High Sensitivity LC-MS/MS Quantification of Corticosteroids in Dried Blood Spots and Evaluation of Software Saturation Correction for Extending Dynamic Range
• M. Barfield (GSK) - the Use of Dried Plasma Spots (DPS) and Dried Urine Spots (DUS) for LC-MS/MS Assays
• A. Gajate Perez (Roche) - Can DBS Stabilize Ester Pro-Drugs and Glucuronide Metabolites?
• M. Hemsley (Covance) - Logistical Considerations and Experiences in Utilising Dried Blood Spots in Quantitative Bioanalysis

Clinical Environment

• A. Van Peer (J&J) - Blood and Plasma: A Magic Twin or Single in Human Pharmacokinetics?
• H. Pandya (Univ. of Leicester) - PK Studies in Infants and Children: Are Dried Blood Spots the Answer?
• L. Stolk (Univ. Maastricht) - Dried Blood Spot Methods in Therapeutic Drug Monitoring: Methods, Assays and Pitfalls
• T. de Boer (Xendo) - Extensive Utilisation of Dried Blood Spot Sampling in Early Clinical Development Studies: Pharmacokinetics, Pharmacogenomics and Safety Assessments

Bioanalytical and DBS: Tools

• B. Ooms (Spark Holland) - On-Line DBS-SPE-MS/MS. Feasibility of a Concept for Rapid DBS Analysis Without Punching
• G. Harland (Waters) - the Use of An Integrated Micro Fluidic LC-MS/MS Device for DBS Assays An Approach to Increased Sensitivity
• J. Dinan (BSD Robotics) - Bringing the DBS Advantage into the Laboratory

Harmonization of Bioanalytical Method Validation guidances

When the EMA (formerly known as EMEA) presented it's concept paper on the need of a bioanalytical method validation guideline, the bioanalytical community was worried about the consequences of having multiple, potentially contradicting, guidelines from major economies. This lead to the strong feeling to move towards the direction of harmonization of BMV guidelines, basically to come to one guideline. This wish was clearly expressed by the hundreds of attendees at the EBF 2nd open conference in Barcelona last year.

In December the EMA presented their draft Guideline on Validation of Bioanalytical Methods and already early spring 2010, two important workshops were held discussing this guideline in particular (joint EBF / EUFEPS workshop) but also global harmonization (CVG / Canadian LC-MS Group). Again, as in Barcelona in 2009, there was a clear consensus among the many participants at this latter meeting in Montreal to strive towards a harmonized guideline or white paper. EBF presented their views on the draft EMA guideline and a harmonization process at the Montreal meeting in: EBF Perspective on the New EMA Guidelines on Bioanalytical Method Validation (BMV) and input on global BMV harmonization

Next to these meetings there are also a number of relevant publications in the April issue of Bioanalysis dealing with this topic:

• Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis
  Philip Timmerman, Steve Lowes, Douglas M Fast, Fabio Garofolo
• International harmonization of bioanalytical guidance
  Surendra K Bansal, Mark Arnold, Fabio Garofolo
• Towards harmonized regulations for bioanalysis: moving forward!
  Peter van Amsterdam, Berthold Lausecker, Silke Luedtke, Philip Timmerman, Margarete Brudny-Kloeppel

An idea that was seeded at the Barcelona 2009 meeting: set-up an international group to foster and manage processes towards harmonization of BMV guidances, was extensively discussed and further developed at the Montreal CVG meeting. A group named 'Global BMV Consortium (GBC)' with representatives of AAPS, APA, CVG and EBF is being set-up for this purpose. The GBC would like to get a number of representatives from international BA organisations from other continents then North America and Europe on board and is reaching out to identify key organizations that represent the bioanalytical community in their region/continent in accordance with the current 4 founding members. It is the intention to publish the activities of this group at one or a few websites.

Dried Blood Spots

Bioanalysis and Dried Blood Spots (DBS) first entered the agenda of EBF in June 2008 and has been repeatedly discussed ever since that first presentation in Basel. There was a full conference session dedicated to DBS during the 2009 open EBF conference in Barcelona and a one and a 3/4 day workshop is currently in preparation. For more information on this workshop in Brussels check out EBF's dedicated DBS conference webpages.

Final Draft Program DBS Workshop

The program of this two day EBF workshop in Brussels on the value and use of Dried Blood Spots is approaching its completion. The meeting will start at 8:30 on Thursday 17 June and will close at 14:30 on Friday 18 June.

Sessions:
- DBS in the non regulated environment
- Combined poster & tutorial
- Combined toxicology & regulatory/QA aspects
- Bioanalytical & DBS: applications
- Clinical environment
- Bioanalytical & DBS: tools

The detailed final draft can be downloaded from the conference site.

EBF DBS workshop: Call for Posters

There is still room for a good number of posters at the June "Connecting Strategies on Dried Blood Spots" workshop and EBF welcomes bioanalists, clinicans, toxicologists, pharmacokineticists, regulators, instrument developers and vendors, blood spot collection paper developers and vendors to present their work.

Posters will have to be registered prior to the conference using the attached form to be submitted via email to contact@bioanalysis-forum.com. The preferred abstract length is about 250 words. The workshop organisation may enforce trunkating of to extensive abstracts.
The supported poster format is Portrait.

For further information: DBS workshop website

Slide decks of EBF/EUFEPS workshop made available

The presentations of last week's EBF / EUFEPS workshop on the EMA bioanalytical method validation guideline are available for download at: http://www.eufeps.org/spring10041516.html

Conference report of 2nd open meeting

The conference report on EBF's second open meeting "The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis" has been published in this month's issue of Bioanalysis and is available for a free download.

Comments, suggestions, with respect to our 2nd open meeting can be entered either here on LinkedIn