Sathya Ganesan
Director, Global Regulatory Affairs UCB
Seminars
Thursday 5th February 2026
Roundtable Discussion: Using Real-World Dopamine Add-On Templates to Illuminate Regulatory Paths for Combination Labels & Unlock More Effective Multi- Mechanism Therapies
11:30 am
- Have the modest effect sizes of stand‑alone antibodies accelerated the field’s appetite for multi‑mechanism therapeutic strategies?
- What specific regulatory hurdles must be overcome to secure combination labelling and achieve smoother NDA reviews
- Add-on dopamine replacement examples from early PD studies illustrate feasibility – how can these real-world templates be used as ready-made protocol blueprints?
Wednesday 4th February 2026
Roundtable Discussion: Is Biomarker‑Only “Preclinical Alzheimer’s” a Disease Stage or a Risk Flag
2:00 pm
- Comparing FDA/Alzheimer’s Association staging versus the International Working Group’s “risk‑only” view, unifying language for target‑discovery teams so translational models match the biology regulators will ultimately judge
- Exploring how the ongoing pre‑symptomatic Donanemab and Lecanemab studies will read out time‑to‑symptoms data, supplying hard evidence on early intervention that can recalibrate animal‑model endpoints and biomarker cut‑offs before the next IND
- Weighing the risk‑benefit of treating asymptomatic, amyloid‑positive individuals given ARIA and payer concerns, clarifying safety and economics thresholds that determine which pre‑clinical candidates advance and at what dose
