Day One

• 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

• 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

•  How do companies price new therapies when topicals are benchmarked against corticosteroids?
• How does biosimilar competition reshape pricing windows for innovators?
• What evidence creates justification for premium pricing in chronic inflammatory diseases? 

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.

•  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 microbiome-derived 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

• 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

• 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