8:50 am Chair’s Opening Remarks

Regulatory Perspective of the Dermatology Drug Development Landscape

9:00 am Keynote Session by BfArM: Equivalence Assessment of Topical Products: Justification of the Current Regulatory Approach by EMA

  • Janet König Head, Unit on Anesthesiology/ Algesiology/Rheumatology/ Pulmonology/ENT, BfArM

Synopsis

• Updating the CHMP/QWP draft guideline on quality and equivalence of topical products since December 2018
• Evaluating changes in formulation, dosage form, method of administration and manufacturing processes that significantly influence efficacy and safety
• Assessing why clinical therapeutic equivalence studies are necessary, but also how other models can be used and developed
• Uncovering scope, limitations and acceptance criteria of models and studies used to independently determine equivalence

9:30 am Panel Discussion: Developing Conversations Among Regulators & Industry Experts

  • Janet König Head, Unit on Anesthesiology/ Algesiology/Rheumatology/ Pulmonology/ENT, BfArM

Synopsis

• Exploring the regulators current expectations
• Evaluating common challenges faced by all industry leaders with regards to regulatory guidelines
• How will regulatory guidance change in response to AI and digitalisation of dermatology drug development?
• Looking ahead: Predicting the future of dermatology drug development

Enhancing Discovery, Preclinical Development & Translational Research in Dermatology

10:15 am The Changing Landscape of Topical Dermal Delivery

  • Charles Evans Vice President, Pharmaceutical Development, MedPharm

Synopsis

• Exploring the current state of drug development
• Assessing techniques to break the boundaries on formulation development
• Understanding topical product development, process development, and testing of topical dermatologic products
• Where is the advancing state for dermatology heading?

10:45 am

Morning Refreshments & Networking

11:15 am Case Study by LEO Pharma: IL22R a new target for treatment of Atopic Dermatitis (AD)

Synopsis

• Studying the mechanisms being trialled for systemic treatment of AD
• What is the pharmacological relevance of inhibiting IL22R for treatment of AD?
• Examining the preclinical skin models used to evaluate IL22R as a new target

11:45 am Understanding Immunology Through Translational Research in Inflammatory Skin Diseases

Synopsis

• Studying skin as the ideal tissue to do translational studies
• How can clinical observation guide us to identify new treatment targets?
• Evaluating non-invasive approaches to access human skin interstitium for multiomics studies

12:15 pm Panel Discussion: Orphan & Rare Dermatology Diseases: What is the current landscape?

  • Bernat Vidal External Research & Innovation Manager , Almirall
  • Ofer Toledano Vice President, Research & Development, Sol-Gel Technologies
  • Sylvie Gabriel Head of Market Access, Pricing & HEOR, Galderma

Synopsis

• What is the current landscape for drug developments for orphan and rare dermatology conditions?
• Spotlight on Hidradenitis Suppurativa: Explore the advancements and challenges with drug development
• Spotlight on Epidermolysis Bullosa: Examine success and setbacks with dermatology drug developments
• How can we convince the FDA that some rarer diseases are to be taken seriously?

1:00 pm

Lunch & Networking

2:00 pm Connecting Inflammation to Loss of Melanocytes in Vitiligo: Looking at New Mechanisms

Synopsis

• Assessing the current knowledge in vitiligo immune mechanisms
• How can pro-inflammatory cytokines lead to melanocyte loss in vitiligo?
• Evaluating future targeted therapies to promote and/or to prevent depigmentation

2:30 pm Small Pharma/Biotech Spotlight: Evaluate Overarching Challenges & Opportunities within the Dermatology Drug Development Landscape

Synopsis

• Overcoming challenges and understanding opportunities of a small biotech in the field of dermatology
• How can topical development help you accelerate your drug development strategy and gain value?
• Optimising the development stage of your topical and oral assets towards clinicals trials
• How does regulating the target NFKBIZ/IκBζ result in very high efficacy in alleviating psoriasis symptoms?

Advancing the Clinical Development of Dermatological Therapeutics

3:00 pm Breakthrough Therapy Designation for nemolizumab in Prurigo Nodularis

Synopsis

• Understanding Prurigo Nodularis: Background, pathophysiology and prognosis
• Evaluating the unmet need in Prurigo Nodularis
• A deep dive into the etiology and epidemiology of Prurigo Nodularis
• Understanding the significant inpatient burden of disease

3:30 pm

Afternoon Refreshments & Networking

4:00 pm Case Study by Sol-Gel: Positive Phase III Clinical Results for Two Trials of Twyneo for the Treatment of Acne Vulgaris

  • Ofer Toledano Vice President, Research & Development, Sol-Gel Technologies

Synopsis

• Overviewing Sol-gel’s proprietary, silica-based microencapsulation technology platform: Designed to enhance the tolerability, efficacy and stability of topical drugs
• Enabling the production of novel fixed-dose active ingredient combinations
• Discussing Sol-Gel’s lead product candidate, Twyneo, 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, compared to vehicle – overviewing the recently completed two double-blind, placebo-controlled, phase III clinical studies

4:30 pm Panel Discussion: Advancements & Challenges with Clinical Trial Design within Dermatology Drug Development

Synopsis

• Exploring true innovation within clinical trials design
• Evaluating challenges to clinical trials design
• How can we improve patient recruitment and retention by leveraging clinical trial designs?
• Measuring clinical trial efficacy end point data

5:15 pm Leo Innovation Lab Spotlight: Digitalising Dermatology; What’s New?

Synopsis

• Exploring digital patient tools in dermatology
• Understanding telemedicine and how it ultimately the fits within the dermatology drug development space
• How can we truly digitalise of clinical trials in dermatology?

5:45 pm Chair’s Closing Remarks