Explore the Agenda
7:30 am Check In, Coffee & Light Breakfast
8:25 am Chair’s Opening Remarks
EUROPEAN REGULATORY & ACCESS STRATEGY: FROM APPROVAL TO PATIENT IMPACT
8:30 am Navigating Europe’s Post-Approval Maze: Shortening the ‘500-Day’ Gap Between EMA Approval & Patient Access
- Decoding country-by-country HTA differences and their impact on launch timelines
- Preparing comparative data packages aligned with EU national requirements
- Strategizing launch sequencing to avoid reimbursement bottlenecks
9:00 am Session Reserved for SCARLETRED
9:30 am Session Reserved for Simmi Wiggins, Senior Global Market Development Director, Dermatology, Sanofi
10:00 am Speed Networking, Morning Break & Refreshments
A prime chance to make the most of in-person networking and forge new connections as new companies enter and existing ones broaden their presence within the dermatology space. This is designed to maximize your exposure to a wide range of new individuals and serve as a catalyst for ongoing discussions throughout the summit.
DE-RISKING EARLY CLINICAL STRATEGY IN DERMATOLOGY: FROM FIRST INDICATION SELECTION TO ROBUST CONFIRMATORY EVIDENCE
11:00 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
11:30 am Roundtable Discussion: Strategic Selection of the First Validation Indication for Novel Biologic Formats
- How emerging biologic formats (nanobodies, bispecifics, multi-pathway antibodies) change the logic of indication selection
- When crowded indications like psoriasis or AD make sense as platform-validation settings rather than commercial endpoints
- Trade-offs between rare diseases and common diseases as first-in-human or first-proof-of-concept opportunities
- What level and type of early data regulators and pharma partners actually need to believe in a platform
- Balancing scientific elegance, capital efficiency, CMC risk, and partnering attractiveness in early development decisions
12:30 pm Lunch & Networking Break
ADVANCING NOVEL DERMATOLOGY MODALITIES: FROM UNCONVENTIONAL MECHANISMS TO REGULATORY ACCEPTANCE & MARKET DIFFERENTIATION
1:30 pm Transforming Atopic Dermatitis Treatment with Biodiversity-Based Topicals: Leveraging Microbial Ecosystems to Address the Root Cause of Immune-Mediated Skin Disease
- Demonstrating how a biodiversity-based topical with 13,000+ microbial species can modulate immune function and target the root cause of atopic dermatitis, supported by 142-patient clinical data
- Exploring regulatory and manufacturing challenges of advancing a microbiomederived topical into phase 2 under Europe’s emerging multi-country licensing coordination model
- Addressing market differentiation and commercial strategy when a drug asset already exists in cosmetic form across 12 countries, and designing evidence to clearly separate drug vs cosmetic claims
2:00 pm Advancing Oral Lipid-Based Therapies in Psoriasis: Overcoming Placebo Barriers & Unlocking Durable Efficacy
- Advancing a first-in-class oral phospholipid therapy (HRO350) targeting inflammatory resolution pathways in mild-to-moderate psoriasis, offering a non-immunosuppressive alternative with a favourable long-term safety profile
- Demonstrating durable clinical and biological effects through extended follow-up data, highlighting sustained skin improvement and disease control beyond short-term symptom suppression
- Addressing high placebo response as a trial-design consideration by refining endpoint selection, population enrichment, and longitudinal outcome measures to strengthen signal detection in oral psoriasis programs
2:30 pm Afternoon Break & Scientific Poster Session
This is an informal session to help you connect with your peers in a relaxed atmosphere to
continue forging new and beneficial relationships. With an audience of immunology experts
eager to hear the latest discoveries in dermatology therapeutic research, you will have the
opportunity to display a poster presenting your own work and innovations. Don’t miss out
on the chance to connect, learn, and present.
3:00 pm Afternoon Break & Refreshments
ACCELERATING DIGITAL INNOVATION IN DERMATOLOGY R&D: BIOMARKERS, IMAGING & PATIENT-CENTRED TECHNOLOGIES TRANSFORMING TRIAL EXECUTION
3:30 pm Biomarker-Driven Trials to Accelerate Early Phase Clinical Drug Development
- Deep phenotyping of inflammatory skin diseases
- Case studies of atopic dermatitis, psoriasis, urticaria and cutaneous T-cell lymphoma
- Novel imaging applications in dermatology trials and application of AI
4:00 pm Leveraging Innovative Imaging & Biophysical Techniques: Strengthening Claims and Differentiation for Topical Dermatology Products
- Interrogating how innovative imaging and biophysical techniques (e.g. digital imaging, 3D, AI-based assessment) can robustly support efficacy and cosmetic/dermatology claims for topical products in real regulatory dossiers rather than just in marketing decks
- Debating what level of validation, standardisation, and reproducibility regulators and internal governance teams actually require before they will accept novel techniques as part of the evidence package for label or claim support
- Comparing real-world case examples where innovative techniques have (or have not) helped to differentiate topical dermatology products, and exploring how pharma, dermocosmetic companies and imaging providers can collaborate to generate decision-changing data rather than technology showcases
4:30 pm Roundtable Discussion: Digital Patient Engagement: Enhancing Retention & Monitoring Across Europe’s Fragmented Healthcare Systems
- How can digital tools overcome geographic and behavioural variability in patient follow-up?
- What technologies best support remote visits validated during COVID?
- How do we manage cultural differences in digital adoption across Europe?