Summit Day One Agenda

8:00 am Registration & Morning Coffee

8:45 am Chair’s Opening Remarks

  • Ana Rossi Senior Medical Director, Global Medical Affairs Dermatology, Sanofi

The Market Perspective An Overview of the Current Treatment Landscape: What Do We Already Know & What is on the Horizon?

9:00 am Update on Dupilumab’s Safety & Efficacy

Synopsis

• Discussing the burden of disease of patients included in the Dupilumab clinical program
• Exploring outcomes measures included in clinical studies
• Presenting an overview of results in adults and paediatrics

9:30 am Reserved for Quantificare

9:45 am Emerging Therapies in Atopic Dermatitis

  • Leon Kircik Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai

Synopsis

• Exploring why Atopic Dermatits has been the main focus of innovation in medical dermatology within the last couple of years
• Examining how unlike psoriasis, we have development not only in biologicals but also in small molecules as well as topicals
• Discussing emerging treatments in Atopic Dermatitis

10:15 am Reserved for Monasterium Laboratory

10:25 am Morning Refreshments & Structured Networking

Preclinical & Translational Development

Novel Drug Development for Dermatology & Various Promising Pathways: What is Next in Human Clinical Drug Candidates?

11:00 am Translational Research in Vitiligo: Launching a New Era of Targeted Treatments

  • John Harris Associate Professor of Dermatology, Vice Chair, Department of Dermatology Director, Vitiligo Clinic & Research Center, Associate Director, MD/PhD Program, University of Massachusetts Medical School

Synopsis

• Understanding vitiligo as an autoimmune disease of the skin with significant unmet medical need
• Examining how Vitiligo is driven by immune signaling through IFNg, and therapies that target this pathway are effective new treatments
• Evaluating relapse and how it occurs in up to 40% of vitiligo patients after stopping therapy and this is due to autoreactive resident memory T cells that can be targeted by blocking IL-15
• Exploring newly discovered pathways in vitiligo skin showing promise as novel therapeutic targets

11:30 am Atopic Dermatitis & Alopecia Areata: Similar Mechanisms, Biomarkers & Therapeutic Implications?

  • Emma Guttman Waldman Professor & System Chair | Director, Center of Excellence in Eczema & Director, Laboratory of Inflammatory Skin Diseases , The Kimberly & Eric J. Waldman Department of Dermatology | Icahn School of Medicine at Mount Sinai

Synopsis

• Examining pathogenic concepts in AD
• Exploring similar and different mechanisms between alopecia areata and atopic dermatitis
• Can we adopt some therapeutics from AD to treat alopecia areata?

12:00 pm Hidradenitis Suppurativa (HS) & Pustular Psoriasis: Pathogenesis & Therapeutic Targets

  • James Krueger Chief Executive Officer, a Co- Director for the Center for Clinical & Translational Science, Senior Attending Physician, D. Martin Carter Professor in Clinical Investigation & Head of the Laboratory of Investigative Dermatology, The Rockefeller University

Synopsis

• Discussing how both HS and Pustular Psoriasis are diseases centered on neutrophilic inflammation, but also related to Type 17 T-cells/IL-17A and IL-17F
• Examining how in both diseases, inflammatory signals are amplified through “feed forward” keratinocyte responses
• Exploring Dermal tunnels or sinus tracts and how they are unique inflammatory drivers in HS regulated by IL-17 family cytokines
• Understanding how HS has distinct endotypes that can help to assemble more homogeneous cohorts for therapeutic trials

Clinical Development

Emerging Systemic Biologics Therapy Make Waves in Atopic Dermatitis

11:00 am Modeling & Simulation Tools to Support the Clinical Drug Development of Nemolizumab

Synopsis

• Understanding the role of M&S in nemolizumab clinical drug development
• Examining how to select the optimal dose and dosing regimen, to support formulation changes
• Evaluating how to address compliance issues amid COVID-19 pandemic
• Optimizing pediatric drug development

11:30 am Spotlight on Imsidolimab (ANB019): An Anti-IL36 Receptor Monoclonal Antibody, in the Treatment of Generalized Pustular Psoriasis & Other Inflammatory Dermatoses

Synopsis

• Examining the IL36 signaling axis and its role in inflammatory skin disease and explore characterization of imsidolimab, a humanized anti-IL36 receptor monoclonal antibody
• Summarizing AnaptysBio imsidolimab clinical development strategy in dermatology
• Discussing the results of a phase 2 clinical trial of imsidolimab in subjects with active generalized pustular psoriasis (GPP)
• Evaluating pivotal Phase 3 clinical trial design for imsidolimab in GPP

12:00 pm Spotlight on Etrasimod: An Oral, Selective Sphingosine 1-Phosphate (S1P) Receptor Modulator for the Treatment of AD

  • Fiona Kuo Director, Clinical Science, Dermatology, Arena Pharmaceuticals

Synopsis

• Exploring the mechanism of action of S1P receptor modulator and its role in atopic dermatitis
• Demonstrating safety and efficacy of etrasimod from a phase 2 atopic dermatitis clinical trail
• Descripting the clinical development plan for etrasimod

12:30 pm Lunch & Networking

Innovating Formulation & Delivery Approaches

1:30 pm Reserved for CPL

2:00 pm Topical Drug Delivery: Too Much or Too Little; Impact of Molecular Properties & Formulation on Delivery

  • Jaymin Shah Research Fellow & Head of Topical & Advanced Drug Delivery, Pharmaceutical Sciences Small Molecules, Pfizer

Synopsis

• Impact of Molecular Properties & Formulation on Delivery
• Discussing how topical drug delivery requires a fine balance between
• local versus systemic delivery for therapeutic index
• Examining molecular properties and formulation factors and how they influence delivery through and across skin
• Understanding how the balance between molecular properties and formulation design for delivery will be exemplified

2:30 pm Developing Dermatology Drug Products with Unmet Clinical Needs in Mind

Synopsis

• Developing a right Target Product Profile (TPP)
• Understanding the molecule’s safety & efficacy and translate them into a drug product
• Navigating through early Proof of Concept (PoC) studies using early formulation(s)
• Selecting the final formulation and clinical derisking

Topical Products in Late-Stage Clinical Development

1:30 pm Delivering on the Non-steroidal Promise, Roflumilast: A Potent Topical PDE-4 inhibitor in Development for the Treatment of Psoriasis, Atopic Dermatitis & Seborrheic Dermatitis

Synopsis

• Examining completed Phase 3 studies in psoriasis with roflumilast cream which demonstrates favorable safety and efficacy with treatment up to 52 weeks
• Exploring Phase 3 studies in Atopic Dermatitis with roflumilast cream ongoing in subjects ages 2 and above
• Discussing successful Phase 2 studies with a foam formulation in subjects with seborrheic dermatitis and scalp psoriasis

2:00 pm Topical Drug Development for Immune Mediated Skin Diseases

  • Jim Lee Group Vice President, Head Inflammation & Autoimmunity, Incyte

Synopsis

• Understanding disease pathogenesis
• Examining formulation development
• Discussing the clinical development pathway
• Evaluating the life cycle strategy

2:30 pm Spotlight on Tapinarof & the Aryl Hydrocarbon Receptor (AhR) in Inflammatory Skin Disease

Synopsis

• Examining Aryl Hydrocarbon Receptor (AhR), it’s structure, function and biology
• Exploring Tapinarof topical cream with psoriasis
• Evaluating Tapinarof topical cream with atopic dermatitis

3:00 pm Afternoon Refreshments, Networking & Poster Session

Synopsis

The Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session scientific posters will be presented on novel targets, drugs with new mechanisms of action, preclinical models, and latest progress in clinical programs.

Strategic/Patient Insights into Dermatology Drug Development – Patient-Centricity: The Power of the Patient

3:30 pm Understanding Patient Needs

  • Anabela Cardoso Global Brand Development Lead, Immunology, Eli Lilly and Company

Synopsis

  • Examining Lilly’s role in patient experience and outcomes
  • Changing the narrative, understanding alopecia areata as an autoimmune disease
  • Looking ahead to truly understand patient needs when developing drugs for autoimmune diseases

4:00 pm Progress in Psoriasis Care is Clear, but More Exciting Advances are Ahead

  • Stacie Bell Chief Scientific & Medical Officer, National Psoriasis Foundation

Synopsis

• Understanding psoriasis as a systemic, immune-mediated disease for better health outcomes
• Examining the importance of timely diagnosis and screening
• What is in a name? Exploring disease severity and burden considerations in the treatment plan
• Optimizing the provider-patient relationship for personalized medicine

4:15 pm Atopic Dermatitis Treatment Landscape: The View from The Patient’s Seat

  • Julie Block President & Chief Executive Officer, National Eczema Association

Synopsis

• What we know, what we don’t know and how to address the gaps
• How will patient needs and expectations change over time?
• What’s next?

4:30 pm Panel Discussion: Challenges of Patient Engagement & Promoting Patient-Centricity in Dermatology

  • Stacie Bell Chief Scientific & Medical Officer, National Psoriasis Foundation
  • Julie Block President & Chief Executive Officer, National Eczema Association
  • Ana Rossi Senior Medical Director, Global Medical Affairs Dermatology, Sanofi
  • Jasmina Jankicevic Dermatologist, Clinical Development & Medical Affairs, JJ Consulting

Synopsis

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

5:00 pm Chair’s Closing Remarks

  • Ana Rossi Senior Medical Director, Global Medical Affairs Dermatology, Sanofi

5:15 pm End of Day One