Explore the Agenda
FROM CLINICAL SIGNAL TO INVESTMENT CONFIDENCE IN DERMATOLOGY DEVELOPMENT
8:00 am Check In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
CLINICAL PHARMACOLOGY–LED PROOF-OF-MECHANISM STRATEGIES TO DE-RISK EARLY DERMATOLOGY PIPELINES
9:00 am De-Risking Early Dermatology Development Through Clinical Pharmacology Models
- Validating inflammatory pathways in vivo using inducible skin challenge models, enabling direct proof-of-mechanism in healthy participants where baseline disease activity is absent, building early confidence that targets are biologically active before committing to patient trials
- Benchmarking multi-pathway modulation against approved single-target therapies to allow mechanistic differentiation and strengthen scientific rationale and prioritisation
- Leveraging phase 0–1 experimental therapeutics data to engage regulators and investigators, translating mechanistic evidence into credible narratives for Phase II readiness, reducing downstream development risk and accelerating progression into patient populations such as HS
9:30 am Session Reserved
10:00 am Morning Break & Refreshments
REIMAGINING CLINICAL STRATEGY & TRIAL DESIGN FOR THE NEXT ERA OF DERMATOLOGY
10:30 am Designing Trials for Type-2 Inflammation as a Systemic Construct: Rethinking Single-Organ Drug Development
- Re-engineering development programmes to demonstrate efficacy across interconnected type-2–driven diseases (dermatology, pulmonology, allergy, GI), avoiding siloed organ-by-organ strategies that dilute evidence and delay approval
- Determining the regulatory bar for cross-disease indications, including lessons from countries like Spain that have granted Type-2 inflammation approvals and what constitutes sufficient evidence of systemic immune normalisation
- Redefining recruitment and endpoint strategy by identifying shared mechanistic markers, designing trans-organ inclusion criteria, and crafting commercial and medical narratives that communicate a unified systemic mechanism
11:00 am Designing Prevention Trials for Dermatology Conditions Such as Acne & BCC Syndromes
- Structuring prevention-focused clinical trials where event onset is unpredictable
- Managing long timelines and high placebo variability
- Identifying disease-modifying vs disease-preventing mechanisms early in development
11:30 am Panel Discussion: Modernising Dermatology Trial Design: Reducing Placebo Noise, Updating Endpoints & Strengthening Site Execution
- Redesigning dermatology endpoints by addressing outdated scales, high placebo response, and the need for validated assessments in understudied diseases where current tools fail to capture meaningful patient change
- Improving trial integrity through stronger site strategy by prioritising dermatology-specific expertise, rigorous site preparation, and high-quality CRO oversight to minimise variability, reduce placebo inflation, and ensure reliable clinical evaluation
- Designing studies that reflect real-world dermatology by incorporating combination therapy considerations, cultural and behavioural adaptations, patient-centred outcomes, and feasible protocols that account for Europe’s fragmented healthcare pathways
12:30 pm Lunch & Networking Break
1:30 pm Cracking the Placebo Problem in Dermatology: Understanding, Measuring & Mitigating Signal Dilution in Clinical Trials
- Interrogating why placebo responses are uniquely high in dermatology, examining biological, neurological, behavioural, and trial-design drivers to distinguish true treatment effect from contextual and care-related responses
- Evaluating methodological levers to reduce placebo inflation, including endpoint selection, clinician vs patient-reported outcomes, sample size strategy, mode of administration, and site-level operational practices
- Navigating regulatory expectations in high-placebo indications, exploring how agencies interpret placebo-heavy datasets and what design adaptations are acceptable to preserve statistical and clinical relevance
2:00 pm Panel Discussion: Leveraging Cross-Sector Partnerships: How Small Biotechs Navigate Big Pharma Interest in Dermatology
- What data packages de-risk acquisition or licensing for large pharma?
- How do biotechs time interactions with BD teams and investment banks?
- What distinguishes “interesting science” from investable clinical programs?