DAY TWO - WEDNESDAY 28th MAY, 2025

8:00 am Registration & Welcome Coffee

8:50 am Chair’s Opening Remarks

  • Ana Rossi Global Senior Medical Director, Immunology, Sanofi

Clinical Endpoints to Align with Global Regulatory Authorities

9:00 am Rethinking 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 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

10:15 am Morning Networking Break

Synopsis

Meet and connect with your peers in this dedicated networking session

Enhancing Clinical Programs: Strategic Insights for Recruitment & Retention Strategies

11:00 am Taking on Trial Timelines in Atopic Dermatitis: Overcoming Obstacles to Site Selection & Patient Recruitment

Synopsis

  • Whilst an exciting time for novel drug development in Atopic Dermatitis, as understanding into unmet medical need through patient heterogeneity becomes clearer – as an increased number of trials take place, and patients naive to treatment more difficult to find in order to measure the efficacy of new treatments, challenges are posed to developers in operationally planning new trials
  • With timelines being impacted, uncover how biopharma are approaching this challenge and regaining control of trial timelines to conserve resources and speed novel therapies towards regulatory

11:30 am Session Reserved for ScareletRed

12:00 pm Lunch Break

Synopsis

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

1:00 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

1:30 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 

2:00 pm Afternoon Break

3:00 pm Developing Bespoke Therapeutics Through AI: Speeding DiscoverThrough Identifying Predictors of Success

Synopsis

  • Employ AI to analyse large-scale molecular data to predict the therapeutic potential of novel compounds, prioritising those with the highest likelihood of success 
  • Utilise AI-powered techniques to design molecules with enhanced potency and selectivity, whilst also leading to safer therapies

3:30 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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