8:50 am Chair’s Opening Remarks

Advancing the Clinical Development of Dermatological Therapeutics

9:00 am Conducting Clinical Trials in Dermatology in a Cost-Effective Manner

  • Angelo Secci Chief Medical Officer , Vyome Therapeutics Inc.

Synopsis

• Evaluating the challenges with phase II trials for small sized pharmaceutical companies
• Balancing the needs of all stakeholders: regulatory agencies, project development, board of directors, investors
• Exploring the iron triangle of clinical research: Speed of execution, budget, and quality
• Discussing partnerships with CROs and other ancillary vendors

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

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 Case Study by RAPT Therapeutics: Optimise RPT193; A Potent, Selective Oral CCR4 Antagonist for the Treatment of Atopic Dermatitis

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

10:45 am

Morning Refreshments & Networking

11:15 am Case Study by Leo Pharma: Explore How Tralokinumab is Under Development for the Treatment of Atopic Dermatitis after failing for Asthma

Synopsis

• Is targeting IL13 different to other methods?
• Studying the results found from phase II studies: What’s next?
• Exploring challenges faced during phase III and how to overcome them?
• Is IGA 0/1 the right primary endpoint for AD?
• Looking back: How you can improve your clinical trial process and program for AD?

FOCUS SPOT: Itch and pruritus

11:45 am Case Study by Menlo Therapeutics: Impacting Mega-Itch: Managing Intense Pruritus in Prurigo Nodularis Through NK1-Substance Neurotransmission Inhibition

Synopsis

• Understanding Prurigo Nodularis
• Taking a step back: What is tachykinin-mediated neurobiology?
• Exploring the development of the orally bioavailable neurokinin-1 receptor antagonist, Serlopitant
• Showcasing phase III topline data from NULARIS-1 and NULARIS-2 studies

Developments in Topical Drug Development & Formulation Approaches

12:15 pm Case Study by Foamix Pharmaceuticals: AMZEEQTM; Topical Minocycline is Now a Reality

  • Iain Stuart Chief Scientific Officer, Foamix Pharmaceuticals

Synopsis

• A deep dive into the historical development of a hydrophobic vehicle system to support dermal delivery of minocycline HCl
• Assessing the roles of administration route, vehicle and antibiotic choice in the mitigation of resistance development potential
• Showcasing topline data from the AMZEEQTM phase III programme

12:45 pm

Lunch

1:45 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

2:15 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

2:45 pm Novel Approaches to Characterise Topical Products

  • Narasimha Murthy Professor Pharmaceutics & Drug Delivery, University of Mississippi

Synopsis

• Studying novel approaches of microstructural characterisation of complex topical products
• Evaluating modified in-vitro release for testing the performance of topical products
• Optimising innovative approaches in in-vitro permeation testing techniques

3:15 pm

Afternoon Refreshments & Networking

Commercialisation

3:45 pm Keynote Session by Galderma: Patient Centricity to Drive Blockbuster Sales in Dermatology Drug Development

Synopsis

• Optimising blockbuster launches: Are these the ‘easy’ years for big biopharma?
• Do better drugs bring higher expectations?
• Evaluating how biomarkers are used for patient segmentation
• Exploring companion verses complementary diagnostics, before verses sales

4:15 pm Panel Discussion: The Evolving Clinical, Regulatory & Commercial Paradigm in Dermatology

  • Iain Stuart Chief Scientific Officer, Foamix Pharmaceuticals

Synopsis

• Assessing the need for cooperation between regulators, payers and drug developers in the definition of appropriate endpoints in the development of dermatological therapies
• Supporting value-based evidence to external stakeholders: Establishing the value of new therapies and effectively demonstrating improved outcomes
• Discussing the different payer requirements between Europe and US
• Navigating the challenges of a crowded development space

5:00 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

5:30 pm Chair’s closing remarks