Ian Bayles
Analytical Assay Development Manager & Head of Quality Control Expression Therapeutics LLC
Seminars
Wednesday 2nd December 2026
When Comparable Does Not Mean Equivalent: Designing Analytical Comparability Studies That Withstand Regulatory Scrutiny in ex vivo Lentiviral Gene Therapy
10:00 am
- Framing comparability as characterization, not equivalence, when a process change is expected to improve the product
- Anchoring acceptance criteria to the clinical therapeutic window rather than assay variability alone
- Separating dose-finding from formal assessment to keep pre-specification auditable under regulatory scrutiny; using Type C meetings to align before executing
Thursday 3rd December 2026
Roundtable Discussion: Adopting AI Effectively in Analytical Development to Reduce Unnecessary Cost & Complexity
9:30 am
- Exploring where AI genuinely reduces workload versus adding validation burden, cost, or review time
- Using historical data responsibly to support credible AI-assisted decisions, including where the GxP boundary sits and what documentation is required either side of it
- Comparing how large and small organizations are adopting AI differently, and what each can learn from the other’s constraints
