10th GCC Closed Forum for Bioanalysis

10th GCC Closed Forum at the WRIB
April 18, 2016, Downtown Disney Orlando, FL, USA

Hilton Orlando Lake Buena Vista
Chair: Dr. Steve Lowes

Global Harmonization of Biomarker Validations – Topic Leaders: John Allinson, Afshin Safavi, Patrick Bennett, James Hulse

  • Revisit 2013 GCC White Paper on Biomarker Validations
  • New Developments and Progress, and New Challenges
  • Reaching Consensus in the Global CRO community to provide harmonized inputs and recommendations from GCC on biomarker validation to the Global Regulators as well as the larger bioanlytical community

Health Canada Oct. 8 Notice – Topic Leaders: Bob Nicholson, Shane Karnik, Stephanie Cape

  • GCC Survey sent to Global CRO Community
  • Preliminary Evaluations on GCC Survey Results

FDA 483/Observation for not tabling data from failed runs in Validation – Topic Leader: Stephanie Cape

  • Recently issued form 483 citations for "Failure to report all data from runs during method validation" even when these runs failed to meet SOP defined acceptance criteria.
  • CRO feedback on current practices with regard to reporting of data (calibration, run QC, P&A, and other validation tests) from failed runs.

Electronic data management and integrity– Topic Leader: Rafiq Islam

  • What's the "actual & unbiased" status in CRO?
  • What about e-notebooks?
  • What are the best practices?
  • What's CRO experience with Regulators on this topic?

Extract stability– Topic Leader: Stephanie Cape

  • Follow up from 9th WRIB FDA talk and 2015 White Paper recommendation
  • CRO feedback on current procedures for extract stability vs. what reported in White Paper
  • Alternative acceptable methods beyond FDA presentation

Processed batch acceptance– Topic Leader: Corey Nehls

  • In addition to whole run acceptance criteria. EMA guideline and FDA Draft Guidance (BMV) touch on this topic, although criteria are not defined currently
  • What's CRO's approach and perspective?
  • Practical limitations in some cases – CRO experience

GCP Clinical Samples Bioanalysis– Topic Leader: Stephanie Cape

  • What's the status of Compliance of USA-based bioanalytical labs to the 2012 EU EMA GCP "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples"?
  • How to handle the need to unblinding clinical sample during bioanalysis due to, Carryover Issues, Analytical Repeat, and ISR and ISS failures and investigations
  • Is the Role & responsibilities of the Bioanalytical Principal Investigator (BPI) for Clinical Studies well established in all CROs?
  • EU CROs vs. RoW CROs' experience with EU Agencies audit on GCP training and compliance in a bioanalytical lab, GCP inspections of bioanalytical lab

Characterization of critical reagents– Topic Leaders: Chris Beaver, Rafiq Islam, Masood Khan

  • What is needed?
  • What are current best practice?

Measures being considered by Authorities after recent CRO fraudulent behaviors– Topic Leader: María Cruz Caturla

  • Overview of measures being proposed and impact on quality improvement.
  • Impact and necessary changes on CROs daily work.
  • GCP certification as alternative?

07:00am-08:00am : Breakfast and Registration

08:00am-08:10am : Opening Remarks, Admonition Statement, and Participants' introduction

08:10am-08:40am : "FDA 483/Observation for not tabling data from failed runs in Validation" Topic Leader: Stephanie Cape

08:40am-09:40am : "GCP Clinical Samples Bioanalysis" Topic Leader : Stephanie Cape

09:40am-10:00am : Morning Coffee Break

10:00am-10:30am : "Extract stability" Topic Leader: Stephanie Cape

10:30am-12:00pm : "Global Harmonization of Biomarker Assay Validations" Topic Leader : John Allinson, Afshin Safavi, James Hulse

12:00pm-01:00pm Buffet Lunch at Hotel Pool Deck

01:00pm-01:45pm : "Electronic data management and integrity" Topic Leader : Rafiq Islam

01:45pm-02:30pm : "Processed batch acceptance" Topic Leader : Corey Nehls

02:30pm-03:00pm : "Health Canada Oct. 8 Notice and March 9 Addendum" Topic Leader : Corey Nehls, Shane Karnik, Stephanie Cape

03:00pm-03:45pm : Wine and Cheese, and Ice Cream Break (of course also coffee and sweets)

03:45pm-04:45pm : "Characterization of critical reagents" Topic Leader : Chris Beaver, Rafiq Islam, Masood Khan

04:45pm-05:15pm : "Measures being considered by Authorities after recent CRO fraudulent behaviors" Topic Leader : María Cruz Caturla

05:30pm Meeting Adjourn and Welcome Reception of WRIB starts at 5:30pm At Hotel Pool Deck

Inclusion Criteria :

  • Presently working in the bioanalysis field for a CRO;
  • Holding a decision making position within the company (Executives, directors and laboratory managers or equivalent positions);
  • Max 2 representatives for each CRO;
  • More than 2 representatives could be accepted only if the CRO has multiple bioanalytical sites.

Notes :

  • All the participants will be invited to participate in the authorship of an influential document based on the conclusion of the closed forum.
  • All the participants will be invited to contribute to the agenda of the closed forum.
  • We keep the right to refuse multiple registrations from the same company if the closed forum reaches a too large size to guarantee adequate discussion.

How to become a member of the GCC?

If you meet the following criteria, you can then simply register to attend the next GCC Closed Forum representing your CRO company and contribute to the discussions during the GCC Closed Forum, as well as providing your inputs representing your company to the Paper (either White Paper or Conference Report) that concludes the discussions of the GCC Closed Forum.

Registration Fees:

  • Until Jan. 20, 2016 : US $490
  • Until Mar. 20, 2016 : US $590
  • After Mar. 20, 2016 : US $690

Breakfast, Morning/Afternoon Refreshments, Cheese & Wine Break will be provided.

Cancellation Policy:

You may cancel with refund minus an administrative fee of Can $100 if written cancellation requests are received by e-mail before March 15, 2016. Due to financial obligations incurred, No refunds or credits will be issued on cancellation requests received after March 15, 2016.

Time and Location:

The 10th GCC Closed Forum will take place on Monday April 18, 2016, the day before the 10th WRIB (10th Workshop on Recent Issues in Bioanalysis) Main Workshop. It will be a Whole Day Closed Form starting at 8am and finishing at 5pm.

10th GCC will be held at the same venue of the 10th WRIB at the Hilton Orlando Lake Buena Vista (1751 Hotel Plaza Blvd, Lake Buena Vista, FL 32830).

For hotel reservations, please use the WRIB hotel reservation link below:

WRIB Hotel Information