*Please note that all agenda timings are Central European Time.

8:50 am Chair’s Opening Remarks

Advancing the Clinical Development of Dermatological Therapeutics

9:00 am Hidradenitis suppurativa (HS): Current & Emerging Treatments

Synopsis

• A deep dive into HS
• Examine how to dissect the Mechanism of Action (MoA)
• Learn how to investigate different MoA in a clinical trial

9:30 am Panel Discussion: Promoting Patient-Centricity in Dermatology

  • Bernat Vidal External Research & Innovation Manager , Almirall
  • Jasmina Jankicevic Dermatologist, Clinical Development & Medical Affairs, JJ Consulting
  • Ofer Toledano Vice President, Research & Development, Sol-Gel Technologies

Synopsis

• Establishing patient-facing protocol development and design of development programmes
• Discussing the evolution of Patient Reported Outcomes in dermatology
• Promoting digital patient tools in dermatology clinical trials (engagement, recruitment, data collection)

10:15 am How to Really “Put Patients in the Centre”?

  • Dogan Fidan Head of Global Strategic Franchise, Immunology & Inflammation, Galderma

Synopsis

  • Examining the holistic approach to patient centricity from clinical development to commercialization
  • Discussing how patients help in clinical development
  • Evaluating patient support programs

Morning Refreshments & Networking

11:15 am Translational Medicine in Dermatology: Setting the Course for Successful & Accelerated Clinical Development

  • Ernst Kriehuber Vice President, Head of Translational, Medicine- Immunology, UCB

Synopsis

• Exploring accelerated clinical development and successful indication expansion by inclusion of biomarker and mechanistic test settings in early clinical studies
• Discussing human disease derived data and presenting examples from full development programs

11:45 am Spotlight Session: An Academic Prospective on Atopic Dermatitis

Synopsis

• Examining the AD pipeline of new targeted treatments and how it’s currently expanding
• A look at development of treatments for AD, which is largely based on the increasing understanding of disease mechanisms
• Reviewing immunological changes very early in life that predispose to the development of AD

12:15 pm Case Study by TWi Biotechnology: Use of Tofacitinib Citrate Gel in the Treatment of Atopic Dermatitis and Vitiligo

  • Yiumo Chan Senior Director, TWi Biotechnology, Inc

Synopsis

• What is the role of tofacitinib, a JAK1/3 inhibitor, in pro-inflammatory cytokine pathways in immunological skin diseases?
• Investigating the clinical development of topical tofacitinib using drug repurposing strategy
• Reviewing tofacitinib efficacy results in recent clinical studies in atopic dermatitis and vitiligo

Lunch

1:45 pm Cannabinoids as A New Class of Antimicrobials

Synopsis

• Exploring how cannabinoids kill bacteria via newly identified mechanism
• Myth busting: Are cannabinoids gram positive and gram negative acting?
• Evaluating challenges of bioavailability and addressing difficulties with protein binding

2:15 pm Non-coding RNAs in Chronic Inflammatory Skin Diseases

  • Enikö Sonkoly Senior Lecturer, Dermatologist, Karolinska institutet

Synopsis

• Examining how non-coding RNAs, including miRNAs and long non.coding RNAs, are potent regulators of gene expression and are involved in virtually all biological processes
• Evaluating how chronic inflammatory skin diseases such as psoriasis and atopic dermatitis have altered miRNA expression patterns in the skin
• Showcasing how MiRNA modulation has been shown to be beneficial in preclinical models of chronic inflammatory skin diseases

2:45 pm Case Study by RAPT Therapeutics: Optimise RPT193; A Potent, Selective Oral CCR4 Antagonist for the Treatment of Atopic Dermatitis (AD)

Synopsis

• Exploring the function of Th2 cells in AD and the influence of CCR4-mediated Th2 migration to the disease
• Showcasing the innovative oral CCR4 antagonist: RPT193
• Illustrating the preclinical efficacy of RPT193 in numerous Th2 driven allergic disease mouse models
• Optimising and evaluating the clinical development strategy for RPT193

Afternoon Refreshments & Networking

3:45 pm Connecting Inflammation to Loss of Melanocytes in Vitiligo: Looking at New Mechanisms

Synopsis

• Assessing the current knowledge in vitiligo immune mechanisms
• How can pro-inflammatory cytokines lead to melanocyte loss in vitiligo?
• Evaluating future targeted therapies to promote and/or to prevent depigmentation

4:15 pm Regulatory Perspectives: Emerging Approaches in Dermatology Drug Development

  • Kendall Marcus Director, Division of Dermatology & Dental Products, FDA

Synopsis

• Addressing the utilisation of digital tools in dermatology clinical trials
• Demonstrating efficacy in Hidradenitis suppurativa: Exploring clinical endpoints, new scoring systems and clinical trial design considerations in HS

4:45 pm Evolving Role of Market Access Strategy in Drug Development

  • David Bower Global Value & Access Lead for Dupixent - Dermatology , Sanofi Genzyme

Synopsis

• Overview of market access engagement in strategic clinical development considerations
• Nucleating strategy for products that have multiple therapeutic areas
• Understanding market access role in advancing cross-functional perspectives
• Examining opportunity for early HTA consultation

5:15 pm Chair’s Closing Remarks

5:30 pm End of Summit