11th GCC Closed Forum for Bioanalysis

Apr 3, 2017,

Sheraton Universal Hotel – 4min Walk from Hilton

Grand Ballroom

Applications of Fit-for-Purpose (FFP) Validation
Topic Leaders: Chad Briscoe, Patrick Bennett, Joseph Bower

  • GCC issued White Paper as guideline for all CROs for Biomarkers screening, qualified and fully validated methods in 2012 (link: http://www.future-science.com/doi/pdf/10.4155/bio.12.197). However, it seems that CROs increasingly continue to be asked for full validation of biomarker assays vs. screening or qualified. This is very time consuming and challenging and very likely not needed based on the intended use of the data (e.g. exploratory biomarkers)

    • What can we do more as CRO community to convince clients to use the screening, qualified and fully validated approach?

    • How can we further apply/standardize our 2012 GCC White Paper to help all the CROs better manage these requests?

    • What about turning this White Paper in SOPs to better define the use of screening, qualified and fully validated methods?

  • Fit-for-purpose validations - What to do when was asked for full validation even when it doesn't seem necessary based on the intended use of the data.

    • What is our regulatory risk of not doing a full validation and then not having control of the data that is generated?

    • When do CROs really see value for ourselves in doing FFP validation approaches?

  • What are the issues, limitations, risks and benefits of performing early phase (or discovery) biomarker project at a CRO. This would include how best to manage method development and qualifications for discovery, FFP studies and how best to manage these as they progress towards use in GLP and GCP studies. It could be focused on LC/MS and or LBA, or can (and should) include flow cytometry.

  • LBA support for ocular or tissue methods: Full Validation or FFP Validation?

    • Historically LCMS team would consider these all non-GLP and on rare occasion try to fully validate a method. For large molecules, most clients are tending to request LBA methods to be fully validated. However, this is very challenging and often not possible. Therefore, a topic to raise discussion on what other CRO are doing for ocular studies and tissue work in general may be of value to all.

2016 immunogenicity guidance and Recent and unexpected 483s on Immunogenicity Assays - Topic Leaders: Joseph Bower, Bruce Stouffer

  • FDA 2016 draft guidance on ADA, Trends?

  • CRO Experiences

  • Recent and unexpected 483s on Immunogenicity Assays. It is very important to understand the reasoning behind this kind of 483s

Hybrid LBA/LCMS assays - Topic Leaders: Stephanie Cape, Mark Arnold

  • How CROs are managing this?

  • Has everyone decided to use ligand binding acceptance criteria?

  • Are critical reagents being managed similarly to the processes in the ligand binding space?

Biosimilar - regulatory Feedback - Topic Leaders: Rafiq Islam, Yi Qun Xiao, Barry van der Strate, Dan Sikkema

  • CROs'experiences and interactions with FDA

  • Lessons Learned from CROs' perspectives

Bioanalytical laboratory's role in writing PK sample collection instructions - Topic Leaders: Roger Hayes, Shane Karnik, Mark Warren

  • What parameters are BioA labs testing to provide these instructions?

  • Are BioA labs training the clinics on how to collect the samples?

Cumulative Stability - Topic Leaders: Stephanie Cape, Mark Arnold

  • Is benchtop stability for samples considered and managed cumulatively (e.g. if you have established 6 hours of wet ice stability, does this cover a situation where a sample is exposed to wet ice for 3 hours, frozen, then exposed to wet ice for 4 hours)?

  • Tracking of stocks and intermediates to ensure cumulative time exposed to room temperature conditions (or wet ice as it may be) are covered by stability (this came up in a recent EMA audit);

  • Tracking of blank matrix freeze/thaw cycles and time at room temperature (this also came up in a recent EMA audit)

Health Canada Oct. 8th Notice - compiling data from all CROs and put together a position paper/ white paper - Topic Leaders: Rafiq Islam

  • Almost all CROs have implemented Health Canada Oct. 8th Notice on how to perform sample stability even if other Regulatory Agencies are not asking to follow Health Canada procedure for now. There have been numerous discussions on the fact that this procedure is not "scientific based". Protocols have been already written to demonstrate the equivalence of multiple aliquots vs. single aliquot for stability testing.

  • Other Regulatory Agencies have not decided yet on what procedure to enforce. From a CRO point of view this procedure implies unjustified extra cost without increasing quality. We should compile data from all CROs and put together a position paper/ white paper on trying to:

    • Influence other Regulatory Agencies and mainly the upcoming ICH M10 on BMV

    • Minimize unjustified extra cost for all the studies that are not submitted to Health Canada

CRO perspective on use of Chiral vs Achiral methods - Topic Leaders: Chad Briscoe

  • EMA is requiring chiral method more often that FDA for BE studies. What's the CRO impact? Chiral methods are much more complicated to be developed and more expensive than achiral ones. Moreover, Regulatory Agencies issue deficiency letters more often for chiral methods for reproducibility and poor integration.

  • Can CROs provide feedback and clarification on this topic and avoid regulatory findings by writing a paper/recommendation?

  • Sometime Agencies ask for R, S and sum of them. Is the sum of R and S enantiomers equivalent to the results obtained with an achiral method?

  • Can data of the Achiral method be provided to agencies rather than the sum of R and S?

  • Is there any ion suppression with co-eluting enantiomers in the achiral method vs. sum of R and S? Please note that in incurred samples it is possible to have a large excess of an enantiomer vs. the other.

  • Did any CRO find any ionization differences between R and S enantiomers?

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

08:00am-08:15am : Opening Remarks, Admonition Statement, and Participants’ introduction – Natasha Savoie

08:15am-09:00am : “Cumulative Stability” Topic Leader: Stephanie Cape, Mark Arnold

09:00am-09:30am : “Health Canada Oct. 8th Notice - Compiling Data From All Cros And Put Together A Position Paper/ White Paper” Topic Leaders: Rafiq Islam

09:30am-10:00am : Morning Coffee and Refreshment Break

10:00am-10:30am : “2016 Immunogenicity Guidance And Recent And Unexpected 483s On Immunogenicity Assays” Topic Leader: Joe Bower, Bruce Stouffer

10:30am-11:30am : “Bioanalytical Laboratory's Role In Writing Pk Sample Collection Instructions” Topic Leader: Roger Hayes, Mark Warren, Shane Karnik

11:30am-12:15pm : “Biosimilar - Regulatory Feedback” Topic Leader: Rafiq Islam, Yi Qun Xiao, Barry Van Der Strate, Dan Sikkema

12:15pm-01:15pm : Buffet Lunch outdoor at Ballroom Circle

01:15pm-02:00pm : “Cro Perspective On Use Of Chiral Vs Achiral Methods” – Topic Leaders: Chad Briscoe

02:00pm-02:45pm : “Hybrid Lba/Lcms Assays” Topic Leader: Stephanie Cape, Mark Arnold

02:45pm-03:30pm : Wine and Cheese, and Ice Cream Break (of course also coffee and sweets)

03:30pm-05:00pm : “Applications Of Fit-For-Purpose (Ffp) Validation” Topic Leaders: Chad Briscoe, Joe Bower, Pat Bennett

05:00pm-05:20pm : “Status and Trend of Current Regulated Bioanalytical Practice in China under CFDA’s New BMV Policy” Topic Leader: XinPing Fang

05:20pm Meeting Adjourn and Welcome Reception of WRIB starts at 5:30pm at Hilton

Inclusion Criteria :

  • Presently working in the bioanalytical lab of a CRO;
  • Holding a decision making position in bioanalytical sciences and regulations within the CRO (Executives, lab directors, lab managers or equivalent positions) to be able to represent your bioanalytical lab;
  • Max 2 representatives from each CRO, one representing LCMS, and the other LBA;
  • 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.

Registration Fee:

  • Before Feb. 1, 2017: US $650
  • Before Mar. 1, 2017: US $750
  • After Mar. 1, 2017: US $850

Breakfast, Hot Buffet Lunch, Morning and Afternoon Drinks and Refreshments, and Cocktail Reception will be Provided during the Closed Forum.

Cancellation Policy:

You may cancel with refund minus an administrative fee of US$100 if written cancellation requests are received by e-mail before March 1, 2017. Due to financial obligations incurred, No refunds or credits will be issued on cancellation requests received after March 1, 2017.

Time and Location:

The 11th GCC Closed Forum will take place on Apr 3, 2017, the day before the 11th WRIB Main Workshop. It will be a Whole Day Closed Form starting at 8am and finishing at 5pm.

11th GCC will be held at the same venue of the 11th WRIB at the Sheraton Universal Hotel – 4min Walk from Hilton (Los Angeles/Universal City, CA, USA).

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

WRIB Hotel Reservation Link