Explore the Agenda
8:00 am Check In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
9:00 am Scaling Innovation: Regulatory, Clinical & System-Level Transformation in Healthcare
9:30 am Mastering Single-Confirmatory-Study Expectations: Meeting Stricter P-Value & Validation Requirements in Rare Dermatology
- Interpreting agency expectations for statistical robustness in single-study approvals
- Designing confirmatory studies with realistic assumptions for small populations
- Approaches to building evidence in diseases without accepted measurement tools
10:00 am Case Study & Fireside Chat: 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- Redesigning dermatology endpoints by addressing outdated scales, high placebo response, and the need for validated assessments in understudied diseases where current tools fail to capture meaningful patient change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 dermatologyspecific 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
10:45 am Morning Break & Refreshments
FROM PRECLINICAL TARGET VALIDATION TO TRANSLATIONAL PROOF-OF-MECHANISM: DE-RISKING EARLY DERMATOLOGY PIPELINES
11:30 am Strengthening Early Confidence in Dermatology Drug Development: Using Translational Pharmacology Models to Validate Targets Before Patient Trials
- Validating inflammatory pathways through translational human pharmacology models, including inducible skin challenge systems that allow early proof-of-mechanism testing before committing to full patient trials
- Benchmarking multi-pathway modulation against known therapeutic mechanisms to differentiate biological effects and prioritize the most promising targets for further development
- Using early translational pharmacology and experimental therapeutic studies to inform clinical strategy, generating mechanistic evidence that strengthens regulatory discussions and supports progression toward Phase II trials in indications such as HS
12:00 pm Roundtable Disucussion: Advancing Translational Confidence in Dermatology Drug Development: Leveraging Predictive Skin Models, Precision Biomarkers & Smarter Preclinical Design to De-Risk Early Programs
- How can we improve the predictive value of preclinical dermatology models, such as humanized mouse skin models or ex vivo human skin systems, to better replicate human disease biology and generate stronger proof-of-concept before entering costly clinical trials?
- What strategies can help developers overcome key formulation and delivery challenges in topical drug development, ensuring sufficient drug penetration into the skin while avoiding systemic exposure and reducing variability in early efficacy data?
- Where should the field focus next to identify more precise biomarkers and mechanisms that allow earlier validation of therapeutic targets, particularly in underserved indications such as HS, vitiligo and alopecia where translational signals remain unclear?
1:00 pm Lunch & Networking Break
2:00 pm Salt Inducible Kinase Inhibitors: A Novel Approach for Next-Generation Topical Therapies
- Explore the potential of proprietary topical SIK inhibitors supported by in vitro, ex vivo, and early human data to deliver differentiated Topical Therapies
- Discover how bioassays and skin penetration studies are enabling targeted topical delivery with favorable safety and pharmacologic properties to profile potential therapeutic indications
- Learn how integrated pharmacology, toxicology, and transcriptomic approaches are being used to de-risk next-generation therapeutics before full development
2:30 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?