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 Dupilumab Development in Dermatology

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 Advancing Medical Photography in Dermatology Clinical Trials

  • Nicolas Dapis Chief Business Officer - Clinical Service, Quantificare

Synopsis

• Examining photography techniques and their applications
• Exploring photography as a tool for patient screening
• Evaluating photography-based Blinded Independent Central Reviews
• A further look at Quantitative Image Analysis

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 How to successfully pre-clinically dissect the potential of a drug or a target for dermatological disorders?

  • Marta Bertolini Principal Scientist & Deputy General Manager, Monasterium Laboratory

Synopsis

• Discussing key aims for pre-clinical research
• Presenting in-vitro, ex-vivo, and in vivo models
• Understanding the advantage of customised approaches

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

12:30 pm Non-Invasively Driven Precision Approaches to Personalized Dermatology

Synopsis

• Evaluating non-invasive skin assessment for personalized dermatology solutions
• Examining multi-omic analyses in non-invasively collected skin samples
• Exploring translational medicine applications in biomarker identification and clinical research

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 Etrasimod: An Investigational Oral, Selective Sphingosine 1-Phosphate (S1P) Receptor Modulator for the Treatment of Atopic Dermatitis

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

Synopsis

• Reviewing atopic dermatitis pathogenesis and current treatment landscape
• Exploring the proposed mechanism of action of S1P receptor modulator and its role in inflammatory diseases including atopic dermatitis
• Introducing etrasimod, an investigational, oral, selective S1P receptor modulator
• Describing preclinical data of etrasimod in Th2 driven allergic contact dermatitis mouse model
• Reviewing current clinical development path for S1P receptor modulators in inflammatory skin diseases

12:30 pm Artificial Intelligence Supported Skin Drug Testing & Applications in Post Marketing

Synopsis

• Discussing mobile skin imaging and analysis
• Evaluating automated data management and machine learning
• Examining Patient reported outcome and real world evidence

12:40 pm Examining Research Divisions of Vial’s Network Clinics to Run Faster Trials with Higher Quality

Synopsis

• Partnering with experienced researchers
• Examining fully integrated and standardized processes
• Exploring continuous centralized training

1:00 pm Lunch & Networking

Innovating Formulation & Delivery Approaches

2:00 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

2:30 pm IVPT: An Invaluable Tool for Topical Formulation Development

Synopsis

• Examining IVPT as a tool – it’s uses for development of topical formulations, particularly those with novel active molecules, and its use in generating information about the rate of drug permeation, its distribution in the various layers of skin as well as the amount entering systemic circulation
• Evaluating IVPT use in the selection of excipients and their ratios, form of the drug product and the dosage amount, as well as decision making on the route of administration of the drug product
• Case study of how IVPT was used to optimize excipient selection and development of a topical formulation which lead to successful drug molecule permeation

2:40 pm MedScreen it from the Rooftops: Performance Testing Methods to Save Time & Money

  • Jon Lenn Chief Scientific Officer, MedPharm

Synopsis

• Examining in silico modeling and physiochemical properties as a pipeline funnel
• Exploring integration of automation, robotics, and phase appropriate methods
• Evaluating in vitro penetration and permeation to screen for delivery
• Determining ex vivo skin disease models to screen intrinsic pharmacology
• Decision matrix to bring it all together

2:50 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

Topical Products in Late-Stage Clinical Development

2:00 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

2:30 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

3:00 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

3:30 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

4:00 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?

4:15 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

4:30 pm Understanding Patient Needs

  • Lotus Mallbris Chief Development Officer, Head of Global Product Development, Immunology, Eli Lilly and Company

Synopsis

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

5:00 pm Chair’s Closing Remarks

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