8:45 am Chair’s Opening Remarks

  • Paul Lizzul Chief Medical Officer , Sienna Biopharmaceuticals

9:00 am Opening Keynote Panel Discussion: What’s Next in Dermatology Drug Development?

Synopsis

• Establishing the current landscape and state-of-the art in dermatology drug development – latest advances and challenges
• Lessons learned for rational and effective drug development in dermatology – discussing a ‘blueprint’ of what success looks like in dermatology drug development
• Analysing the end-to-end pain points that accompany dermatology programs – from improving preclinical translation, to tackling late regulatory and commercial challenges
• Where’s dermatology going? – new indication, new targets, the next antibodies
• Identifying and addressing unmet needs – defining the strategic driver for companies involved in drug development for rare and orphan dermatological diseases or moderate skin conditions (vs. standard of care)
• Driving precision medicine approaches in dermatology

9:45 am Topical Formulation Development: Boosting Your Success

  • Charles Evans Vice President of Pharmaceutical Development, MedPharm

Synopsis

  • How is topical drug product development different?
  • Discussing API design and selection
  • Analysing the importance of preformulation and baseline understanding in topical development
  • Formulation selection: the drug, the patient, the disease and the market
  • Exploring innovative disease models to de-risk development and expand marketing claims

10:15 am Speed Networking Session

10:45 am Morning Refreshments

Enhancing Discovery, Preclinical Development & Translational Research in Dermatology

11:15 am Translational Data to Guide Clinical Development & Target Discovery

  • Ernst Kriehuber Vice President - Translational Sciences, Glenmark Pharmaceuticals

Synopsis

• Human disease derived data are discussed vis a vis in-vitro model systems and animal models
• Examples are provided from GBR 830 program, an OX40/OX40L pathway blocking antibody in Ph2b development in Atopic Dermatitis

11:45 am Application of a Translational in Vitro Assay Platform for Selection of a Highly Selective JAK1 Inhibitor

Synopsis

• Establishing the importance of JAK1 selectivity in drug candidates for oral administration versus topical administration
• Exploring in vitro screening platform to address the JAK kinase selectivity
• Supporting the identification of a clinical candidate by pre-clinical profiling of a highly selective JAK1 inhibitor

12:15 pm OX40L: A New Target in the Treatment of Dermatological Diseases?

Synopsis

· Giving background on OX40L in autoimmune diseases
· Introducing KY1005, a novel fully human anti-OX40L blocking antibody and preclinical data supporting the MOA
· Exploring the scientific rationale for targeting OX40L in atopic dermatitis

12:45 pm Preclinical Toxicology for Wound Healing Therapies: Animal Models & Analysis

Synopsis

  • Overviewing the FDA’s guideline on wound repair therapies that indicate to use an in vivo model, which mimics the clinical setting
  • Among the accepted animal models we, at RTC, propose the minipigs for its similarities to humans in terms of skin structure and wound repair process
  • Presenting wound induction techniques, analysis to be included in the tox study and reviewing of pros and cons

12:55 pm Lunch & Networking

1:55 pm Advancing Bioprinting to the Level of Individual Cells

Synopsis

  • Introducing Biopixlar – a single-cell resolution bioprinter based on microfluidics technology
    Building complex tissue-like structures via controlled positioning of individual cells
    Presenting formation of multi-cell tissue models for the field of dermatology

2:05 pm Addressing The Medical Need for Pemphigus: A New Biologic

  • Carlo Pincelli Professor of Dermatology & CEO, University of Modena and Reggio Emilia, PinCell

Synopsis

• Overviewing the need for reliable models of complex diseases
• Exploring challenges in translating pathway targets to precise human efficacy
• Defining a better translatability approach for accelerating the drug development process and adding value to the project
• Providing regulatory agents and investors with more appealing approaches

2:35 pm TEM1657 – A Novel Small Molecule Approach Targeting Psoriasis

Synopsis

• Describing TEM1657, a novel small molecule asset showing unrivalled efficacy to reduce psoriasis symptoms in IMQ animal model
• Analysing TEM1657’s MOA – regulation of a key player in the IL-17 signalling pathway in keratinocytes
• Exploring next steps into clinical trials

Advancing the Clinical Development of Dermatological Therapeutics

3:05 pm Treating Epidermolysis Bullosa by Removing Mutations from The RNA

  • Deborah Ramsdell Head of Regulatory & Clinical Operations , Wings Therapeutics

Synopsis

• Developing a treatment for recessive dystrophic epidermolysis bullosa (RDEB)
• Translating in vitro data to an easy to use therapy
• Harnessing exon skipping AONs to treat skin diseases

Remote presentation & discussion

3:35 pm Bridging the Innovation Gap in the Treatment of Mild to Moderate Dermatological Diseases

  • Paul Lizzul Chief Medical Officer , Sienna Biopharmaceuticals

Synopsis

• Addressing the unmet need in topical drug development towards a large patient population with mild to moderate dermatological diseases, still primarily using topical steroids
• Updating on SNA-120 (TrkA inhibitor) – SNA-120, a novel approach to the treatment of psoriasis, targeting NGF/TrkA and neurogenic inflammation
– The important role of nerves & neuropeptides in psoriasis
– Itch as a proxy clinical biomarker for high NGF/TrkA expression in psoriasis
– A novel non-steroidal approach in the treatment of psoriasis and associated itch targeting the NGF/TrkA pathway

4:05 pm Afternoon Refreshments & Networking

4:35 pm Product Development in Dermatology

  • Kendall Marcus Director of the Division of Dermatology and Dental Products , FDA

Synopsis

  • Demonstrating efficacy in atopic dermatitis and alopecia areata
  • Addressing Patient Reported Outcomes
  • Exploring the size of safety databases needed to support marketing applications
  • Overviewing perspectives on product development in dermatological rare conditions
  • 15 min of dedicated Q&A time
Remote presentation & discussion

5:20 pm Innovative Trial Design to Determine Early Efficacy of Drugs in Translational Medicine at Novartis

  • Felicitas Thom Director, Project Management in Autoimmunity,
    Transplantation & Inflammation , NIBR

Synopsis

• Innovative Trial Design to Determine Early Efficacy of Drugs in Translational Medicine at Novartis
• Exploring different study designs for proof of concept studies in Dermatology (examples from clinical studies in Acne, Atopic Dermatitis, Hidradenitis suppurativa)
• Addressing considerations of scientific aspects in drug development under various operational models
• Identifying factors influencing operational setup and recruitment

5:50 pm Digitisation of Dermatology – Is It Happening?

Synopsis

  • Digital patient tools in dermatology
  • Exploring telemedicine and the fit in dermatology
  • Digitalisation of Clinical Trials in dermatology
  • Real-world data in Clinical trials gathered from digital tools

6:20 pm Chair’s Closing Remarks

  • Paul Lizzul Chief Medical Officer , Sienna Biopharmaceuticals