Tuesday, February 25, 2014

EBF Publications in 2013

The fruit of the hard work within the EBF community is shared and presented at our Open Symposia, Focus workshops, at several international meetings world wide and in peer reviewed journals.

In 2013 seven papers were published in the Bioanalysis journal:

1 on Innovation
1 on Implementation of the EMA BMV Guideline
1 on LC-MS of macromolecules
4 on DBS / DBS-Microsampling

Managing scientific, technical and regulatory innovation in regulated bioanalysis: a discussion paper from the European Bioanalysis Forum
Philip Timmerman, Neil Henderson, John Smeraglia, Hans Mulder, Benno Ingelse, Margarete Brudny-Kloeppel, Arjen Companjen
Bioanalysis, Jan 2013, Vol. 5, No. 2, Pages 139-145.

The European Bioanalysis Forum community’s evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation
Peter van Amsterdam, Arjen Companjen, Margarete Brudny-Kloeppel, Michaela Golob, Silke Luedtke, Philip Timmerman
Bioanalysis, Mar 2013, Vol. 5, No. 6, Pages 645-659.

Update of the EBF recommendation for the use of DBS in regulated bioanalysis integrating the conclusions from the EBF DBS-microsampling consortium
Philip Timmerman, Steve White, Zoe Cobb, Ronald de Vries, Elizabeth Thomas, Ben van Baar
Bioanalysis, Sep 2013, Vol. 5, No. 17, Pages 2129-2136.

IS addition in bioanalysis of DBS: results from the EBF DBS-microsampling consortium
Ben LM van Baar, Tom Verhaeghe, Olivier Heudi, Morten Rohde, Simon Wood, Jaap Wieling, Ronald de Vries, Steve White, Zoe Cobb, Philip Timmerman
Bioanalysis, Sep 2013, Vol. 5, No. 17, Pages 2137-2145.

The effect of hematocrit on bioanalysis of DBS: results from the EBF DBS-microsampling consortium
Ronald de Vries, Matthew Barfield, Nico van de Merbel, Bernhard Schmid, Christoph Siethoff, Jordi Ortiz, Elwin Verheij, Ben van Baar, Zoe Cobb, Steve White, Philip Timmerman
Bioanalysis, Sep 2013, Vol. 5, No. 17, Pages 2147-2160.

In-depth study of homogeneity in DBS using two different techniques: results from the EBF DBS-microsampling consortium
Zoe Cobb, Ronald de Vries, Neil Spooner, Stephen Williams, Ludovicus Staelens, Mira Doig, Rebecca Broadhurst, Matthew Barfield, Nico van de Merbel, Bernhard Schmid, Christoph Siethoff, Jordi Ortiz, Elwin Verheij, Ben van Baar, Steve White, Philip Timmerman
Bioanalysis, Sep 2013, Vol. 5, No. 17, Pages 2161-2169.

LC–MS/MS of large molecules in a regulated bioanalytical environment – which acceptance criteria to apply?
Magnus Knutsson, Ronald Schmidt, Philip Timmerman
Bioanalysis, Sep 2013, Vol. 5, No. 18, Pages 2211-2214.

Monday, February 24, 2014

EBF Focus Workshop - Taking tiered approach to the next level

Call for Speakers and Registration 

17-18 June 2014,NH Sablon hotel, Brussels, Belgium.


Tiered approach, fit-for-purpose, qualified or validated methods,….it has become part of the bioanalysts vocabulary over the last years. However, as an industry, we didn’t come together yet to ensure harmonized thinking on how to apply this in our day to day work. Following up on the sustained discussions in EBF, considering the discussions in the GBC and capitalizing on the discussions at the recent Crystal City –V meeting in Baltimore, EBF is now ready to organize a dedicated non-sponsored workshop to discuss and define tangible processes for methods other than validated methods and take tiered approach to the next level.
This Focus Workshop is organized in NH Sablon, Brussels (in the historic center of Brussels, with good connection to Zaventem airport, Brussels South international train station). The meeting starts 17 June 2014 at 9.00h and ends 18 June2014 at 16.00h

Aim of the meeting

The aim of the meeting is twofold. On the one hand, we will try to get industry agreement on which studies require validation as per Guidance or which can be supported using the principles scientific qualification (i.e. screening or qualified assays). Second, we will try to work out more practical details on method performance tests to be included and acceptance criteria to be applied for assays for different study types or stages of development. The outcome will be published and allow the industry to use a robust and consolidated scientific approach when applying method qualification.
The meeting will be held in a true workshop format, with limited number of presentations and a lot of time for interactive breakouts as well as plenary workshop discussions to ensure we have captured everybody’s input.

Who should attend?

The meeting is open for industry, academia and health authority professionals with vested interest on how to balance regulated bioanalytical validation requirements with increased scientific freedom in a tiered approach scheme for method qualification. Essential to make this meeting a success is a strong representation from Pharma/CRO scientist with experience in small and large molecule bioanalysis and quality assurance, able to influence internal bioanalytical validation strategies.


For this workshop we look for your contribution as a presenter. As mentioned above, to allow time for discussion and round table workshop activities, the number of presentations is limited to five (20 minutes each). Also your presentation should focus on the key aspects of the problem statement and provide a good overview of the issues for our industry or solutions applicable for all. Please send your title and abstract to focus@europeanbioanalysisforum.eu prior to 15 May 2014


Participation to the meeting is 320 Euro (After 10 June, we only accept on-site registration at an increased fee of € 400 (cash only, no credit cards)). The fee includes entrance to the workshop, food and beverages during lunch, coffee breaks and a cocktail reception on the first evening. Dinner and lodging is not included. In order to allow a multi-company multi-angle discussion, a maximum of 5 delegates per company is suggested and the meeting is capped at 120 delegates.
Register for the meeting: fill out attached registration form and send to admin@europeanbioanalysisforum.eu
Book your hotel: fill out attached hotel reservation form and send to c.devos@nh-hotels.com (prior to 17 May 2014 at special conference rate)


John Smeraglia, UCB - Stuart McDougall, Covance - Philip Timmerman, Janssen R&D - Magnus Knutsson, Ferring - Steve White, GlaxoSmithKline - Morten Anders Kall, Lundbeck - Margarete Brudny Kloeppel, Bayer Pharma AG

Tuesday, February 18, 2014

Focus Workshop Labmanual - Slide decks available for download

EBF is happy to inform you that the EBF Lab Manual Workshop was a great success. We succeeded in reaching out to the majority of the stakeholders involved in preparing or using the lab manual for PK samples for clinical volunteer and multi centre (MCT) patient trials.
Our multi-stakeholder document got great input on 5 and 6 Februaru in Brussels. Industry representative from clin ops, clin Pk, central labs, phase I clinics, couriers… and RQA (legacy BARQA) gave support and provided input into the lab manual.

In true EBF style, the meeting was very interactive and there was full support by all – with the desire to use the final document as the point of reference. During the meeting, enhancements to the document were proposed, which we will now integrate in the next and final version of the manual. For this, our current BA team will be supplemented with representatives from above mentioned stakeholders  (Quintiles, Covance, LKF, PRA, QPS, CRS) to make the document a bullet proof template for Phase-I healthy volunteer trials and CL coordinated MCT. Similarly, the audience expressed the desire to bring the EBF principles of harmonizing  also for other areas to ensure more quality for biomarker samples and other samples taken in clinical trials.

Go to: http://labman.europeanbioanalysisforum.eu/Slides/ for a free download of the presentations.

Wednesday, February 12, 2014

EBF 7th Open Symposium - First Call for Speakers

In the program outline we identified 5 major themes where we want to travel with you beyond the horizon. For each of the 5 themes we suggest session topics. Again, in the spirit of a true Forum, we will build the final agenda reflecting your interest, contributions and engagement. Your submission will define how some session topics will make it into a plenary or a breakout session, or may qualify for an integrated small workshop.

1. Technology improvements
o Miniaturisation in sampling and analysis: updates on micro sampling technologies and
o Bioanalysis below the pg/mL: The next level of sensitivity for potent drugs or micro dosing
o Immunoassays for biomarkers
o New Technologies in large molecule analysis
o Automated sample analysis in a regulated environment

2. Enhancements in Bioanalytical Processes
o Pre-GLP bioanalysis: a breeding pond for new bioanalytical applications?
o Ensuring “end to end robustness” of bioanalytical assays
o Ensuring Data integrity and smart e-(raw)data management
o Validation and implementation clinical analyzers in support of drug development
o Bioanalysis of biosimilars - a follow up
o Consult the Doctor: dealing with the unexpected, Large and Small

3. Building bridges within Bioanalysis: connecting the dots for peptide and protein bioanalysis
o Protein bioanalysis using immunoextraction and HRMS, multiplexing
o Hybrid Bioanalysis of biologics, bringing LBA and LC-MS/MS together – focus on new technology opportunities
o Combined use LBA + LC-MS/MS in drug development of peptide/proteins: 1+1=3
or where complementary data made a difference

4. Building bridges outside bioanalysis
o What lies beyond the horizon? (e.g. novel study design, bedside monitoring, Integrated PK-PD-IG (bio)analysis)

5. The regulatory landscape
o Moving beyond a “one size fits all” approach, incl. feedback from EBF Focus workshop
“Taking Tiered Approach to the next level”
o Harmonization of BMV: how can we help to paint a new landscape?


You are invited to submit your contribution to open@europeanbioanalysisforum.eu before May 26th, 2014, providing title of the presentation, a recent bio (max 150 words) and an abstract (max 350 words). As last year, we intend to publish the agenda before summer.
You can find detailed instructions on http://bcn2014.europeanbioanalysisforum.eu/Speakers/


We would also like to invite you to register your posters. Please submit your poster contribution (before October 16th, 2014) to open@europeanbioanalysisforum.eu. You can find detailed instructions on http://bcn2014.europeanbioanalysisforum.eu/Posters/