DAY TWO - WEDNESDAY 28th MAY, 2025

8:00 am Registration & Welcome Coffee

8:50 am Chair’s Opening Remarks

Rethinking Endpoints & Maximizing Clinical Success Across Indications & Regulatory Authorities

9:00 am Understanding HS Disease Assessment: Bridging the Gap Between Inflammatory Mechanisms and Regulatory Endpoints

Synopsis

  • Understanding current clinical endpoint frameworks for Hidradenitis Suppurativa and their limitations in accurately measuring disease activity 
  • Emerging differences in regulatory view? A hot debate: HiSCR vs. IHS4 
  • Future direction: Aligning trial design with treatment goals putting inflammatory burden and PROs in the center

9:30 am Harmonizing Clinical Endpoints in Dermatology: Bridging Science, Industry, and Regulatory Requirements

  • Hyun Kim SVP Clinical Development, AOBiome

Synopsis

  • Navigate the complexities of endpoint selection across global markets, examining the disconnect between US IGA and European EASI scoring systems
  • Evaluate the challenges of subjective measurements like pruritus in clinical trials, and their evolving role as primary vs secondary endpoints
  • Explore strategies for designing trials that balance scientific rigor with pragmatic industry needs while meeting diverse regulatory requirements

10:00 am Phase 3 Development of First-in-Class C5a Inhibitor Vilobelimab: Transforming Treatment for Pyoderma Gangrenosum

Synopsis

  • Understand C5a inhibition how demonstrates a novel mechanism for targeting neutrophil-driven inflammation in PG 
  • Examine Phase 1 and 2a clinical data showcasing safety profile and biological proof of concept across multiple indications 
  • Discover the strategic approach to Phase 3 trial design that builds on demonstrated efficacy while addressing rare disease challenges

10:30 am Morning Networking Break

Synopsis

Meet and connect with your peers in this dedicated networking session

11:30 am Panel Discussion: Strategic Considerations for Clinical Success in Hidradenitis Suppurativa

Synopsis

  • Explore how leading developers are balancing the need for regulatory-aligned endpoints with endpoints that demonstrate value to payers and patients 
  • Debate strategies for designing more efficient trials through novel endpoint combinations and timing of assessments to accelerate development timelines 
  • Understand different approaches to generating compelling evidence packages that support both regulatory approval and market access in an increasingly competitive landscape 
  • Discuss how industry, academia, clinicians, patients, and regulators can cooperate to advance the state of HS treatment and deliver higher quality drugs to patients

12:30 pm Lunch Break

Synopsis

Take this chance to meet the expert speakers, connect with your peers and explore our exhibition booths 

1:30 pm Roundtable Discussion: Improving Patient Assessment in Dermatology: Assessing Scoring Systems & Regulatory Considerations

Synopsis

Join your peers to explore standardisation of patient assessment across dermatological conditions, focusing on scoring system effectiveness, bias reduction, and regulatory alignment. 

Key Discussion Points: 

  • Evaluating scoring system sensitivity across conditions and detecting meaningful clinical changes  
  • Addressing bias and integrating digital tools to standardisation 
  • Meeting regulatory requirements across different regulatory and reimbursement environments

The Road Ahead: Innovation in Discovery, Modality, & Delivery

2:15 pm Gene Silencing: Biologic Development for Greater Selectivity

  • Lars French Chief Medical Officer, Alys Pharmaceuticals

Synopsis

  • As the dermatology pipeline continues to diversity, hear from developers leveraging siRNA as a modality demonstrating great potential in treating skin-related diseases  
  • Learn how pipelines are progressing, in addition to how challenges related to intracellular delivery are being overcome through novel delivery means 

2:45 pm From AI-Based Discovery to the Clinic: Using Millions of Measurements to Speed Discovery, with ENS-002 for Atopic Dermatitis as a Clinical-Stage Example

  • Cheri Ackerman Co-Founder & Chief Executive Officer, Concerto Biosciences

Synopsis

  • Employ AI to analyse large-scale microbial interaction data and predict the performance of novel microbial combinations and by-products, prioritising those with the highest activity
  • Discovery and development of ENS-002, a live biotherapeutic product providing ultrasafe, long-term relief from atopic dermatitis, now in Phase 1b trials

3:15 pm Metabolomic Mining of Bacterial Microbiome Therapeutics to Expand Potential Indications

Synopsis

  • Using metabolomic analysis to understand bacterial metabolite interactions 
  • Identifying shared inflammatory pathways across conditions to enable strategic expansion  
  • Developing an indication expansion strategy for future potential clinical trials and lifecycle extension

4:15 pm Chair’s Closing Remarks & End of Summit

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