Would you like to improve the reproducibility of your potency assay?
Would you like to have more confidence in your measurements of critical quality attributes?
Do you want work as a team with your colleagues to improve confidence in the assays that are critical to getting your cell therapy products to market?
As the saying goes, "If you can't measure something, you can't improve it." So please join us as we examine approaches for improving confidence in measurements critical for cell therapy products!
Goal: Examine approaches for improving confidence in the measurements that are necessary for bringing cell therapy products to market.
Scope: Challenges in achieving reproducibility, accuracy and comparability in biological assays have been identified as major roadblocks to development, manufacturing and regulatory approval of cell therapy products (CTPs). Improving confidence in measurements for CTPs involves understanding and controlling sources of variability, development of appropriate reference materials to enable traceability and providing objective evidence to validate results. The workshop will focus on strategies to achieve measurement assurance for assays that may contribute to characterizing critical quality attributes and/or potency, and will include breakout sessions focused on specific measurements.
Content: The first morning will cover strategies for achieving confidence in measurements, such as traceability, reference materials, validation, uncertainty analysis & inter-laboratory testing. In the afternoon, we will breakout into sessions focused on specific measurements, such as cell counting, viability and functional tests. On the second morning, report-outs will lead discussion on the key steps that were identified for improving the confidence in the cell measurements that were examined.
Monday, May 11, 2015, 9:00am – 5:30pm
7:30: Coffee & pastries; NIST cafeteria also has a full breakfast bar for purchase
9:00 – 9:10: Anne Plant (Chief, Biosystems & Biomaterials Division), Opening remarks
9:10 – 9:15: Laurie Locascio (Director, Material Measurement Lab), Welcome to NIST
9:15 – 9:45: Marc Salit (NIST), "Systematic Elements of Metrology, & How They Work"
9:45 – 10:15: John Elliott (NIST), "Protocol Design & Inter-Laboratory Testing"
10:15 – 10:45: Chris Wiwi (Celgene), "Analytical Considerations for Cell Therapy Manufacturing"
10:45 – 11:05: Coffee Break
11:05 – 11:35: Mahendra Rao (Q-Therapeutics), "Developing & Using Reference Materials for Stem Cells"
11:35 – 12:05: Ivan Rich (Hemogenix), "Validating a Cell Viability Measurement"
12:05 – 12:30: John Elliott, Charge for breakout sessions: Discuss how to improve confidence in the assigned measurement. Generate a draft summary of challenges and opportunities that may include: sources of variability, cause & effect diagram, flow chart of a robust assay protocol, sensitivity testing, needs for reference materials, positive & negative controls, inter-laboratory testing.
12:30 – 1:30: Lunch (for purchase at NIST cafeteria)
1:30 – 1:45: Continue charge for breakout sessions (Green Auditorium)
1:45 – 4:30: Parallel Breakout Sessions:
4:30 – 5:00: Reconvene: Preliminary reports from breakout sections
5:00: Break for the day
5:30: Shuttle back to Holiday Inn (for those not going to Brasserie Beck)
Tuesday, May 12, 9:00am – 12:15pm
7:30: Coffee & pastries;NIST cafeteria also has a full breakfast bar for purchase
9:00 – 9:10: Sheng Lin-Gibson (Deputy Chief, Biosystems & Biomaterials Division), Welcome back
9:10 – 10:40: Full reports from breakouts showing cause and effects diagrams, flow charts, needs for reference materials, potential for inter-laboratory studies, etc.
10:40 – 11:00: Coffee Break
11:00 – 12:00: Panel Discussion; Moderator: Carl Simon
Michael Mendocino (Mesoblast), Pam Robey (NIH), Chris Wiwi (CelGene), Steven Oh (FDA), Mahendra Rao (Q-Therapeutics), John Elliott (NIST), Jessica Carmen (ARM), Ivan Rich (Hemogenix)12:00 –
12:15: Concluding remarks