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

EBF 2009 Open Meeting "The Broadening Scope of Validation"

Draft Program outline

December 2nd 2009

10:00 Registration desk opens

14:00 Welcome and introduction

14:10 – 16:30 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.

16:30 – 17:00 Break

17:00 – 18:30 Poster session 1, including short plenary presentations

18:30 – 20:00 Cocktail reception

20:00 – 20:30 Evening speaker

20:30 – 22:00 Conference dinner



December 3rd 2009

08:00 – 09:30 Plenary session Biomarkers: Validation and Analytical Challenges

08:00 – 08:30 Keynote speaker
08:30 – 08:50 Oral presentation
08:50 – 09:10 Oral presentation
09:10 – 09:30 Oral presentation

09:30 – 09:50 Coffee break

09:50 – 11:00 Plenary session: Novel approaches for the Analysis of proteins and peptides MS technology

09:50 – 10:20 Keynote speaker
10:20 – 10:40 Oral presentation
10:40 – 11:00 Oral presentation

11:00 – 13:00 Plenary Pt Sponsors session

Scientific update from our Platinum Sponsors

13:00 - 14:00 Lunch

14:00 – 15:30 Plenary session: Challenges in metabolite quantification

14:00 – 14:30 Keynote speaker from EBF
14:30 – 14:50 Oral presentation
14:50 – 15:10 Oral presentation
15:10 – 15:30 Oral presentation

15:30 – 15:50 Coffee break

15:50 – 17:30 Breakout sessions

Breakout session 1: Dried Blood Spots
· Invited speaker from GSK
· Application in discovery
· Reflections on spot size
· Application in clinical studies

Breakout session 2: focus on LBAs
· Topic : EBF-IGM to identify topic for discussion

Breakout session 3: Analytical challenges of non-standard matrices
· Tissues
· CSF
· Others

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

10:30 – 10:50 keynote speaker from EBF
10:50 – 11:10 Oral presentation
11:10 – 11:30 Oral presentation

11:30 – 12:30 Coffee break

12:30 - 13:30 Plenary session: Latest Developments and Current Hot Topics in LBAs

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

EBF Bioanalytical Conference - The Broadening Scope of Validation

02/dec/ 2009 to 04/dec/ 2009 - Barcelona.

After a successful first open symposium in December 2008, EBF is organising their second Open Symposium. Pharma and Biotech companies, CRO’s, academia 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. This year the symposium will include sessions on the EMEA draft Guidance on Bioanalysis, Validation and Analytical Challenges of non-standard Matrices and/or biomarkers, Unresolved Issues in Method Validations, Analysis of Proteins/Peptides with MS Techniques, Dried Blood Spots, Feedback from internal EBF Discussions (including Recommendations) and Latest Developments and Current Hot Topics in LBAs Assay in a programme which covers the spectrum from Small to Large Molecules. Experts and world opinion leaders will be invited as keynote speakers.

The European Bioanalysis Forum (EBF) is an organisation comprised of (both Global and EU-based) Pharmaceutical companies with operational activities in 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.

E-mail: contact@bioanalysis-forum.com
Link: http://www.bioanalysis-forum.com/

18th International Reid Bioanalytical Forum

First Announcement. 6 - 9 July 2009, University of Surrey, UK

Sessions will cover the usual eclectic mix of new technologies, method development and validation together with regulatory aspects (e.g. metabolites in safety testing) and emerging trends in bioanalysis (e.g. bloodspot analysis). There will be a single stream of oral presentations given by lecturers from the industry, instrument manufacturers and academics, supported by poster presentations and exhibitions from contract research organisations and instrument vendors.

Canadian LC-MS group: Bioanalysis Conference

In continuation of 2007 and 2008 workshops, the 3rd Workshop on Recent Issues in Regulated Bioanalysis (Montreal April 16-17, 2009) will address both new issues and follow-ups on the progress of the resolutions that are agreed upon last year in the field of GLP Bioanalysis.

Detailed information of this must attend event for those in Bioanalysis and Pharmacokinetics can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php.

What is New and Why Your Attendance is Important?

Updates on ISR:

• Dr. Brian Booth from FDA will update us on FDA's Experience after 1 year of ISR data, and current status of FDA guidance.
• Dr. Stephen Lowes from Advion will explain you how to perform a scientific Investigations in the event of ISR failure. What kind of action is required if ISR values do not agree with the original assay result?
• We will verify if what discussed and agreed upon last year on Incurred Sample Reanalysis (ISR) has been put in place.
• We will evaluate how the industry is dealing with the new FDA recommendations of using more than 20 samples for ISR.
• We will assess the data and experience that the industry has acquired after one year of performing ISR data by considering regulatory requirement vs. good science.

New EMEA Guidance and Guidelines:

• Based on last year's feedbacks, Louise Mawer from MHRA has been invited this year to update us on new EMEA Bioequivalence Guidance.
• You will also receive an update on the 'Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods' that the EMEA has recently published.

Challenges in Bioanalysis:

• Dr. Patrick Vallano from Mylan will talk about the assessment of processed sample stability.
• Dr. Mario Rocci from Prevalere will present the challenges with bioanalytical method development, qualification & transfer.
• Dr. Rupinder Phull from Barr Laboratories will explain you the multiple difficulties and challenges involved in the bioanalysis of endogenous drugs.
• Dr. Douglas M. Fast from Pfizer will update the latest news, perspectives and suggestions for performing a modernizations on USA GLP .
• Dr. Saleh Hussain will update you about the most recent data on how unstable metabolites can impact bianalytical assay performance.
• Michael Lindsay from Apotex will lecture about the impact of concomitant medications on method specificity (To be confirmed).
• You will gain practical advice from opinion leaders on how to cope with Acetonitrile (ACN) Worldwide shortage.

Foreign Submissions to Canadian Authorities:

• With a growing number of submissions from foreign companies to Canadian authority, Eric Ormsby from Health Canada TPD will talk about the most common issues found in foreign submissions and TPD recommendations.

Instruments/Techniques that Can Improve Quality in Regulated Bioanalysis:

• Myth or Reality? Industry experience on the latest bioanalytical technique available will be discussed.
• You will Increase your knowledge on UPLC, FAIMS, MS3, HRES, etc. and you will find out what will be available for the future.

When and How Much 'Anomalous Results' Need to be Investigated?

• We will hear from authorities in the field and we will share opinions and experiences about acceptation vs. rejection of evaluations/batches that meet acceptance criteria but scientifically disputable.
• How regulatory agencies 'feel' about the rejection of data that meet acceptance criteria borderline?

New or Emerging Guidelines on Method Development and Validation:

• You will hear about the most recent industry standards and regulatory agencies perspective on which extra tests performed during method development should be re-performed during the validation.
  - Hemolysis testing
  - Metabolite testing
  - OTC metabolites
  -Variable injection volumes
  - Cross-validation between different anticoagulant salt forms.

A 2-level 2-half-day Pre-Workshop short course on “Issues in Regulated Bioanalysis: Challenges Solutions and Applications in Bioanalytical Method Validation and Sample Analysis” has been specifically designed to be offered on April 15th to prepare the attendees to fully benefit from this workshop.

For Event Details including Registration Details and Online Registration, please visit http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php .

PharmSciFair

Nice 8-12 June, 2009

A great event in Pharmaceutical Sciences is coming up: the second PharmSciFair. The PharmSciFair is the premier European Platform for Advancing Pharmaceutical Sciences, initiated by EUFEPS. This became absolutely clear during the first PharmSciFair in 2005, where 26 national and international organizations in Pharmaceutical Sciences joined together. More than 700 scientists coming from all pharmaceutical disciplines contributed and set up a truly interdisciplinary meeting (1200 participants) of the highest standard. The meeting was accompanied by a comprehensive exhibition. An even greater number of organizations have committed to the 2009 PharmSciFair. An exciting program has been set up, which promises up-to-date presentations of front line pharmaceutical research and development. All information, including the current partners, is on the PharmSciFair homepage (http://www.pharmscifair.org/).

NVMS - Anniversary meeting

March 26-27, 2009 in Rolduc.

Deadline for registration extened to January 23th 2009.
www.denvms.nl
Already over 100 subscriptions!!! Please make sure to register as soon as possible due to the limited number of rooms available in Rolduc.

The NVMS will celebrate its 45th anniversary in 2009. This will be celebrated during a meeting that will be organised in collaboration with the Belgian society for mass spectrometry.
What to expect?;
- A number of well-known mass spectrometrists will present their work including Graham Cooks, Richard Caprioli, Andrej Schevchenko, Joel VandeKerckhove and Jane Thomas-Oates.
- You will get the opportunity to present your work in an oral or poster. You can submit your abstract for one of the 4 sessions (See website). Abstracts will be judged by an abstract committee who will make a representative selection.
- PhD students will get the opportunity to present their poster in a 5-minute flash presentation (oral). PhD students can off-course also submit their abstract for an oral.
- Staying up-to-date on the latest developments in the field of mass spectrometry and related subjects.
- A good atmosphere with good drinks and diner during the evening of the first day.
- A good opportunity to network.
- A night in the abbey. Rooms are not included in the conference fee.

Registration is possible from now on. The deadline for pre-registration is January 23th. The conference fee will increase after this date.

See you at the spring meeting!

Sander Koster
Secretary NVMS