Dried Blood Spots in Drug Development

A DBS sub team of the European Bioanalysis Forum is organising a meeting focused on the use of Dried Blood Spots in pre-clinical and clinical drug development. In this meeting EBF intends to bring together experts from all areas involved in this technique (Bioanalysis, Toxicology, Pharmacokinetics, Central labs, Regulatory authorities and Vendors) to connect and discuss the potential application of Dried Blood Spots in drug development.

Location: Brussels, Belgium
Date: 16 - 17 June 2010

For future updates follow http://sites.google.com/site/ebfdbs/

EBF-EUFEPS meeting on draft EMEA guidance on BMV

EBF and EUFEPS are jointly setting up a conference to present and discuss the recently released draft guideline on Bionalytical Method Validation by the EMEA.

The meeting is scheduled for 13 - 14 April 2010 and will be held Brussels, Belgium.

More information on: http://sites.google.com/site/emeabmv/home

4th Workshop on Recent Issues in Regulated Bioanalysis

In continuation of 2007 - 2009 workshops, the 4th Workshop on Recent Issues in Regulated Bioanalysis (Montreal April 21-23 2010) will address both new issues and follow-ups on the progress of the resolutions that were agreed upon last year in the field of GLP/Regulated Bioanalysis.

Preliminary 2010 Lectures:

• Updates from Regulatory Agencies: AFSSAPS (France); ANVISA (Brazil); FDA (USA); Health Canada-TPD; MHRA (UK)
• Use of Dried Blood Spots (DBS) in Regulated Bioanalysis: Practical considerations, applicability and progresses.
• Updates in biostatistycal analysis in Bioequivalence/PK studies
• Ligand-Binding Assay (LBA): Recent and old Challenges and Solutions
• Regulatory indications on Follow-on Biologics/Biosimilars: the latest developments on the regulatory pathway
• Evaluation of internal standard (IS) criteria in bioanalysis.
• Is calibration curve slope still important in LC-MS/MS bioanalysis?
• How to investigate an Incurred Samples Reanalysis (ISR) failure: Real case studies & lessons learnt
• Metabolites quantification: what’s new?
• Updates from 2009 Bioanalytical conferences/groups
• Follow up on unresolved 2009 Regulated Bioanalysis Workshop discussion topics (described in the 2009 White Paper – in press – Bioanalysis Journal, January 2010)

2 Pre-Workshop short courses have been specifically designed to be offered prior to the workshop to prepare the attendees to fully benefit from this workshop.

• Short Course 1 (half day): Fundamental of Bioanalysis: Bioanalytical Method Validation (BMV) and Sample Analysis for Chromatographic and Ligand Binding Assays.
• Short Course 2 (full day): Regulated Bioanalysis: Challenges Solutions and Applications.

Detailed information can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php

EBF - European Bioanalysis Forum - Online

The European Bioanalysis Forum has launched its website on 22 October.
Check it out at: http://www.europeanbioanalysisforum.eu/

Program Update EBF 2nd Open Symposium

The updated agenda is now available as PDF (http://www.bioanalysis-forum.com/medias/download/program%20October%202009.pdf) on EBF's conference website http://www.bioanalysis-forum.com/

Free AAPS Webinar will Discuss Design of Experiments

Powerful Statistical Tool is Focus of Event

WHO:
The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of approximately 12,000 members employed in industry, academia, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers timely scientific programs, on-going education, information resources, opportunities for networking, and professional development.

WHAT:
AAPS is pleased to present the complimentary eLearning Webinar on Application of Multifactorial DOE for the Ligand Binding Lab. This module is sponsored by the Ligand Binding Assay (LBA) Bioanalytical Focus Group and AAPS’ BIOTEC Section.

This Webinar will be conducted by Franklin Spriggs and Chad Ray, Ph.D., and moderated by William Nowatzke, Ph.D.

WHY:
This Webinar will explore how DOE is being utilized to develop and optimize LBAs for quantifying therapeutics to support studies. This module will be of interest to bioanalytical lab scientists who are involved in LBA development, design, and validation; it will provide an introduction to DOE applications to support these bioanalytical challenges using case studies.

WHEN:
October 8, 2009
12:30 PM to 2:00 PM EST

CONTACT:
For additional information about the workshop, and to register, visit http://mediaserver.aapspharmaceutica.com/meetings/webinars/lbab/lbab-info.pdf. To set up an interview with a Webinar speaker please contact Joe Catapano at 703-248-4772 or CatapanoJ@aaps.org.

Draft Program - FABIAN 2009

The 9th FABIAN symposium will be held on Tuesday 10 November 2009. Solvay Pharmaceuticals, C.J. van Houtenlaan 36, Weesp, will host the meeting.
The theme of the symposium is ‘Socially Responsible bioanalysis’.

• Date : 10 November 2009
• Venue : Solvay Pharmaceuticals, Weesp, The Netherlands
• Admittance : € 25.-, to be paid upon presentation (students have free entry)
• Registration : by email, attn. Jaap Wieling, jaap.wieling@xendo.com
• Call for posters!: the organizers encourage scientist to present their work on a poster. Please send title and abstract to Jaap Wieling, jaap.wieling@xendo.com
• More information : published soon on http://www.bioanalyse.org/ (programme, abstracts, itinerary, hotels, etc.)

Preliminary programme:

Registration, coffee
09:30 Registration & coffee
Opening
10:00 FABIAN, Welcome & opening symposium
10:05 Bram van Rossum, Solvay Pharmaceuticals, Weesp, Sustainable development / Science Park
10:20 Bas Blaauboer, Uni Utrecht, A paradigm shift in toxicological risk assessment: more science, less animal testing
Session 1: Biological Innovation
10:50 Bas-Jan Van der Leede, J&J, Beerse (B), HET CAM (Hen’s egg test chorioallontoic membrane), Zebra fish, integration of miconucleus test
11:20 Peter Olinga, Solvay Pharmaceuticals, Weesp / Uni Groningen, In vitro liver toxicity predicts in vivo hepatoxicity using the microarray technique
11:50 Jessica Dijksman, Solvay, Weesp, Optimal kinetic screening (in-vivo and in-vitro) and evaluation
12:10 Discussion
Lunch break
12:20 Lunch & Posters
Session 2, Technological innovations
13:30 Pat Sandra, RIC Kortrijk (B), Recent Developments Towards Green Chromatography
14:05 Paul Abu-Rabie, GlaxoSmithKline (UK), The Use of Dried Blood Spot Samples and Direct Analysis for the Quantitative Bioanalysis of Drugs
14:30 Ben Westerink, Uni Groningen, Microdialysis
15:00 Jaap Verweij, Schering-Plough, Oss, werktitel: Full pharmacokinetic profile from one laboratory animal
15:25 Paul Rainville, Waters (UK), Addressing the Challenges of Limited Sample Volumes in Bioanalysis with Microscale LC/MS/MS
Closure
15:50 FABIAN, Closing Remarks
16:00 Farewell drink & snack

EBF 2009: 2nd Call for Speakers

EBF - European Bioanalysis Forum
2nd Open Symposium

“The Broadening Scope of Validation”

Date: 2 - 4 December 2009

Hesperia Tower Conference Center

Barcelona, Spain

After a successful symposium in December 2008, EBF is organising their second Open Symposium. Pharma and Biotech companies, CRO’s, academia, regulatory agencies and instrument vendors are again invited to attend this open symposium. Again this year, the symposium intends to bring together scientists and key opinion leaders around a variety of important subjects in the world of bioanalysis, both small and large molecules. The identified topics for this year’s symposium will provide an excellent opportunity for stimulating discussions and work towards recommendations for industry. In addition, both the scientific and the professional networking opportunities will be comparable, if not enhanced, comparing to last year’s meeting.

Downloads: EBF - call for speakers, Poster presentation - submission form, Oral presentation - submission form

More details can be found on http://www.bioanalysis-forum.com/ and http://www.e-b-f.eu/.

FABIAN 2009

The theme of the 2009 annual FABIAN symposium will be on sustainable life sciences and bioanalysis, or as we like to call it: "Socially Responsible Bioanalysis"

Aspects are:

• animal friendly (e.g. smaller sample volumes, less animals per study, non invasive techniques …)
• environmentally friendly (e.g. less organic solvents, no dry ice shipments ...)
• patient/volunteer friendly (e.g. smaller sample volumes, more tests per sample, non-invasive methods …)

For more information go to: http://www.bioanalyse.org/symposia/fabian2009.htm

Sustainable Bioanalysis