Consolidated feedback by GBC on the draft FDA guidance on Bioanalytical Method Validation

The draft FDA Guidance on Bioanalytical Method Validation (BMV) was released 2 weeks ago  (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf).
Following up on earlier communications from the GBC last year, the Steering Committee came together this week to agree on our next action items:

  1. GBC is preparing to give consolidated feedback at the “AAPS Workshop -Quantitative BMV and Implementation_2013 Revised FDA Guidance (http://www.aaps.org/bmv/ ). More info on what this looks like will follow in the next days or weeks.
  2. GBC SC is still evaluating if and how we can provide consolidated written feedback to FDA. Our evaluation takes into account the logistics of getting written feedback from all of you and the fact that most of you are connected to regional organizations which are planning group feedback.
  3. GBC will not be organizing a pre- or post- BMV meeting in Baltimore.
    Keep an eye on the GBC LinkedIn page for further updates.

GBC SC

(Nieuwe Nieuws Item)

Webinars!

Outcomes of the GBC Harmonization Teams on

Bioanalytical Method Validation

The GBC announces two Webinars presenting key recommendations from the Harmonization Teams.  The Harmonization teams were grouped under broad categories of topics related to 1) all therapeutics, 2) chromatographic-based assays and 3) ligand-binding assays.  To minimize the number of webinars most attendees are interested in, the topics for all therapeutics have been grouped with the chromatographic assays and ligand-binding assay content producing just two sessions.  Each Webinar session will be presented twice to accommodate all regions and each session will take 2 hours.

Details and links to the meetings are available at:

http://www.globalbioanalysisconsortium.org/site/gbc/assets/documents/Webinar/Global%20Bioanalysis%20Consortium%20Webinar%20Announcement%20Final5.pdf

Note: Some sessions require advanced registration.

The Webinars will be moderated so that questions can be submitted by the web meeting functions or to specific e-mail accounts. Details will be provided before the meeting.  MONITOR THIS PAGE FOR UPDATES!

Common Topics & those specifically for Chromatographic Assays

(link to slide deck) 

Common Topics & those specifically for Ligand Binding Assays

(link to slide deck) 

Speaker:   Stuart McDougall

Date:   08-May-2013

Time:  08:00 AM British Summer Time

9:00 AM CET/GMT/UCT

New York  3:00 AM

Rio de Janeiro  4:00 AM

Mumbai  12:30

Shanghai  15:00

Tokyo  16:00

Web access link:  https://www4.gotomeeting.com/register/351298207

Please register in advance

Speaker:  Sherri Dudal

Date: 07-May-2013

Time: 08:00 AM British Summer Time

9:00 AM CET/GMT/UCT

New York  3:00 AM

Rio de Janeiro  4:00 AM

Mumbai  12:30

Shanghai  15:00

Tokyo  16:00

Web access link:   http://engage.vevent.com/rt/roche~20130507

Please register in advance.

Speaker:  Eric Fluhler

Date:   03-May-2013

Time:  11:00 AM EDT (15:00 GMT/UCT)

Rio de Janeiro  12:00 Noon

London 16:00

Brussels  17:00

Mumbai  20:30

Shanghai  23:00

Tokyo  Midnight (3-May to 4-May)

Web access link: 

Link to Webinar

Password: GBCwebinar

Speaker:  Binodh DeSilva

Date: 06-May-2013

Time: 10:00 AM EDT (14:00 pm GMT/UCT)

Rio de Janeiro  11:00 Noon

London 15:00

Brussels  16:00

Mumbai  19:30

Shanghai  22:00

Tokyo  23:00

This event uses Microsoft Live Meeting

Install Live Meeting

Teleconference information for Domestic & Int'l:  Audio Conferencing Dial-In Numbers

Conf Code: 9469554 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

What concerns you about the Harmonization team recommendation: Provide input to the GBC Roundtable at AAPS in Chicago

A Roundtable discussion of the most important and controversial recommendations from the Global Bioanalysis Consortium’s (GBC) 20 Harmonization Teams will be held Monday morning 8:00-10:00 AM on 15-Oct-2012 at this year’s AAPS Annual Meeting in Chicago. Drs. Binodh DeSilva and Eric Fluhler will highlight those topics that the Harmonization Teams feel need to be discussed with the scientific, quality and regulatory communities. Dr. Brian Booth (FDA) is scheduled to provide feedback. Additionally, GBC Harmonization Team Leaders and Team members, as well as Steering Committee members attending the meeting will be present and asked to present insights into the concepts and thinking that went into the proposals. 

In preparation for the discussion, we’re reaching out in advance of the meeting seeking your input on the Harmonization Team recommendations and particularly those you would like to have discussed at the Roundtable. Please go to the GBC website (http://www.globalbioanalysisconsortium.org) to review the proposals, and then come back here to post and let us know what interests or concerns you!

GBC group formed on LinkedIn

The Global Bioanalysis Consortium has created a group in the LinkedIn environment to enable the bioanalytical scientists - world wide - to interact with the GBC Harmonization Teams. Membership is open to all bioanalysts, regulators and QA specialists. To join go to: GBC - Global Bioanalysis Consortium | LinkedIn

AAPS/FDA Fifth Bioanalytical Workshop; Quantitative Bioanalytical Methods Validation and Implementation: The 2012 Revised FDA Guidance

Bringing Together Small and Large Molecules

When: Summer 2012

Where: Washington D.C.

Download flyer: front & back

Website: www.aaps.org/BMV

Updated Harmonization Team Pages

The Harmonization Team pages were recently updated by adding the presentations given by the Japanese and Latin American team members during the 2nd JBF symposium (Tokyo, March 2012) and Acbio 1st Bioanalytical meeting (Sao Paulo, May 2012) respectively.

17-May-2012

Moving the GBC Conference!

Adaptation and Impact. These two words represent key concepts that the Global Bioanalysis Consortium (GBC) has embodied during the past two years. As the GBC’s message of harmonized science-based bioanalytical guidelines has spread and become accepted, the GBC Steering Committee and Harmonization Teams have recognized that the environment in which we work continues to change.

Recent presentations by US, EU, Canadian, Japanese, Brazilian and Chinese regulatory authorities have noted that the message for harmonized practices has been heard and is being taken into account as each revises or writes its regulations. It was gratifying to see that the work of the GBC is having Impact. 

While the Steering committee has been promoting the harmonization message, 20 Harmonization Teams have been diligently working to develop  specific science-based recommendations that cover all aspects of bioanalysis using nearly any technology (LC-MS/MS, ligand-binding, AMS, ICP-MS, etc.). Last week the Steering Committee and Harmonization Team leaders met and reviewed the progress made to date in generating recommendations.   In addition to the well-thought out and scientific recommendations presented, the in-depth review also clearly demonstrated the commitment and impact that collaborating scientists from around the globe can have when working together. The Teams left the meeting with clear expectations on what is needed to complete their recommendations and release them in June to the global bioanalytical scientific, quality assurance and regulatory communities.

After a period of open global review, the GBC plan had been to have a conference in September where the bioanalytical scientific, quality assurance and regulatory communities could discuss the recommendations and generally agree on them.  However, the US FDA has indicated that a draft revision of its Bioanalytical Method Validation Guidance would be released for comment this summer and that a joint FDA-AAPS Crystal City Workshop would be held on the revisions has caused the GBC to reconsider its plans and adapt to the new reality. The GBC Steering Committee and Harmonization Team Leaders recognize that their efforts to date must be released, debated and finalized in time for them to be used and have impact in responding to the revised FDA Guidance. To achieve that, the Harmonization teams have been asked to ensure their efforts deliver workable recommendations by June, a clear agreement that regional meetings need to whenever possible leverage more in-depth discussions on the HT recommendations, and the Steering Committee has evaluated its options with regard to the planned meeting in The Netherlands.

Many factors went into the assessment on the place and timing of a GBC global meeting, including timing relative to the revised guidance, timing relative to other regional meetings, travel costs for participants for both the Crystal City meeting and GBC conference, and the need for the Harmonization Team recommendations to be included in the discussions.  After deliberations, our plan has changed to having the GBC conference in the Washington DC area the two days prior to the FDA-AAPS Crystal City Conference.  Because there is not now, nor expected to be any warning on the release of the FDA’s draft revised guidance, planning the dates for these two meetings by their respective organizations cannot be made.  However, the GBC is committed to ensuring the global bioanalytical community can complete its deliberations in time to influence the FDA and will as quickly as possible after the Guidance is released announce the dates and location of the GBC meeting.

We recognize that these changes will make it difficult for some to attend, but by minimizing the travel costs, we feel the greatest number of scientists will be able to meet in consideration of the HT recommendations.  For those not able to attend, we hope that the regional meetings provide an opportunity to debate the recommendations such that the regional representatives may carry your message to the global conference. 

In closing, we wish to assure the community that it is not our intent to use the GBC conference as a platform for discussing the FDA revised Guidance, but to maintain a focus on the science-based recommendations that can be agreed upon as a global platform for bioanalysis, and thereby use that consensus to carry the message into the Crystal City meeting. 

Sincerely,

The Global Bioanalysis Steering Committee

Binodh DeSilva, Daniel Tang, Fabio Garofolo, Mark Arnold, Michaela Golob, Peter van Amsterdam, Philip Timmerman, Rafael Barrientos, Shinobu Kudoh, Shrinivas Savale

5-Apr-2012

GBC global conference - Mark your calendars

September 25-27, 2012

the GBC will organize the first global bioanalysis conference on the international harmonization of bioanalytical guidance

“Science-based Proposals for Global Consensus on Bioanalysis”

 at the NH Conference Center Leeuwenhorst, Noordwijkerhout, The Netherlands. 

The conference will bring together leaders in industry (pharma and CRO), academia, quality assurance and regulatory authorities to discuss recent thinking on regulations impacting bioanalysis. The scientific program is currently under development and will comprise of presentations by and discussions with each of the following 20 harmonization teams: 

•All Molecules / All Techniques: A1 - Scope and Regulations, A2 - Tiered approaches for method validation, A3 - Method transfer, partial/cross validations, A4 - Reference standards and reagents, A5 - Sample Management, A6 – Stability, A7 - Repeat analysis and ISR, A8 – Documentation, A9 - Analytical instrument qualification, A10 - New Frontiers, A11 – Biomarkers

•Large Molecules / Ligand Binding: L1 - Large molecule specific run acceptance, L2 - Large molecule specific assay operation, L3 - Assay formats, L4 - Reagents and their stability, L5 - Automation practices in LM bioanalysis, L6 – Immunogenicity: Effect on PK

•Small Molecules / Chromatographic Assays: S1 - Small molecule specific run acceptance, S2 -: Small molecule specific assay operation, S3 - Chromatographic run quality assessment

26-Jan-2012: GBC Global Conference

Dates: 25 - 27 September 2012
Where: Leeuwenhorst Conference Center
Registration fee: not set yet
Delegate Registration: not available yet
Room Registratrion: not opened yet