8:50 am Chair’s Opening Remarks

  • Paul Lizzul Chief Medical Officer , Sienna Biopharmaceuticals

Developments in Topical Drug Development & Formulation Approaches

9:00 am New Topical Drugs Having a Novel Silica-Based Delivery System

Synopsis

• Overviewing Sol-gel’s proprietary, silica-based microencapsulation technology platform, which is designed to enhance the tolerability and stability of topical drugs while maintaining their efficacy
• Exploring how the technology platform entraps active ingredients in an inert, inorganic silica shell, which creates an unnoticeable barrier between the active ingredient and the skin
• Enabling the production of novel fixed-dose active ingredient combinations that otherwise would not be stable.
• Discussing Sol-Gel’s lead product candidate, TWIN, a novel, once-daily, topical cream containing encapsulated benzoyl peroxide and encapsulated tretinoin, for the treatment of acne vulgaris.
• Demonstrating statistically significant improvements in all pre-defined co-primary and secondary efficacy endpoints, as compared to vehicle – overviewing the recently completed 726 subject, double-blind, placebo controlled, six-arm, multi-center Phase II clinical trial designed to assess the safety and efficacy of TWIN in subjects with facial acne

9:30 am The Topical-by-Design Technology – Defying Conventional Wisdom

Synopsis

• Does size really matter?
• Exploring an innovative way of using polymers
• Bringing potent drugs to derm fruition, minimizing systemic exposure

10:00 am Topical Formulations of Cannabidiol for the Treatment of Acne, Atopic Dermatitis, & Psoriasis

  • Bill Bosch Executive Director & CSO, Botanix Pharmaceuticals

Synopsis

• Novel formulation approaches to maximize delivery of the active ingredient
• Discussion of multiple mechanisms of action for treating skin diseases
• Update on clinical development

10:30 am Morning Refreshments & Networking

The Current Landscape in Dermatology Drug Development

11:15 am Begin with the End in Mind

  • Lee Heeson President - Worldwide Markets, Inflammation & Immunology, Celgene Corporation
  • Volker Koscielny Vice President, Global Medical Affairs, Inflammation & Immunology, Celgene Corporation

Synopsis

• Making choices – assessing the unmet needs across dermatology
• Understanding the future dermatology pricing and reimbursement dynamics in Europe
• Demonstrating clinical value against outdated regulatory endpoints – growing utility of Real World Evidence (Payers & Clinicians)

11:45 am Mastermind Session: Supporting the Successful Development & Commercialisation of Dermatology Medicines

Synopsis

This session facilitates in-depth discussions among participants in an informal environment. After splitting into groups, participants will discuss key issues and common challenges regarding the current landscape of dermatology drug development.

12:30 pm Lunch & Networking

1:30 pm Panel Discussion: The Evolving Clinical, Regulatory & Commercial Paradigm in Dermatology

  • Dogan Fidan Head of Global Strategic Franchise, Immunology & Inflammation, Galderma
  • Lee Heeson President - Worldwide Markets, Inflammation & Immunology, Celgene Corporation

Synopsis

• Exploring how to overcome key challenges in dermatology clinical development
• Assessing the need for cooperation between regulators, payers and drug developers in the definition of appropriate endpoints in the development of therapies targeting rare diseases
• 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

2:15 pm Overviewing The Latest Advances in Biologic Therapies in Dermatology

  • Elena Rizova Vice President & Head of Medical Affairs Immuno Inflammation, Sanofi

Synopsis

• Biologics in dermatology – when did it start?
• Exploring lessons learnt on the introduction of these therapeutics in the treatment paradigm of psoriasis and atopic dermatitis
• What is the path forward? – considerations on what the next generation of biologics look like and exploring further indications

Remote presentation & discussion

2:45 pm Chair’s Closing Remarks

  • Paul Lizzul Chief Medical Officer , Sienna Biopharmaceuticals