*Please note that all agenda timings are Central European Time.

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
  • Jasmina Jankicevic Dermatologist, Clinical Development & Medical Affairs, JJ Consulting

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?

Morning Refreshments & Networking

11:15 am Examine the Effect of Tralokinumab on Staph Aureus Skin Colonization & Clinical Aspects of Assessing the Skin Microbiome in Atopic Dermatitis (AD)

Synopsis

• Understand how the skin microbiome, and especially S. aureus, plays an important role in atopic dermatitis
• Evaluate Tralokinumab, a first-in-class, fully human, monoclonal antibody that binds with high affinity to and specifically neutralises IL-13, which demonstrates efficacy in AD
• Summarize key data on the effect of tralokinumab on skin colonization and discuss technical details of these assessments

11:45 am Panel Discussion: Orphan & Rare Dermatology Diseases: What is the current landscape?

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

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?

Lunch & Networking

1:30 pm Examining in-vitro, ex-vivo & in-vivo testing

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

Synopsis

• Evaluating in-vitro and ex-vivo models
• Optimising in-vivo humanised mouse model and clinical trials unit
• Exploring collaborating opportunities and understanding the advantage of customised approaches

2:00 pm Filling Unmet Needs with Physician Administered Treatments in Dermatology

Synopsis

• Assessing VP-102 in the treatment of Molluscum Contagiosum
• Discussing VP-102 in the treatment of HPV-induced skin diseases
• Examining the potential application of LTX-315 in Non-Melanoma Skin Cancer

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?

3:00 pm Session TBC

Afternoon Refreshments & Networking

Advancing the Clinical Development of Dermatological Therapeutics

4:00 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

4:30 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

5:00 pm Reviewing the Global Burden of Acne

  • Alison Layton Consultant Dermatologist & Associate Medical Director, Harrogate & District NHS Foundation Trust

Synopsis

• Examining why acne remains the most common inflammatory dermatosis treated worldwide?
• How can we improve care to reduce the burden?
• Understanding the challenges with tackling acne

5:30 pm Chair’s Closing Remarks

5:45 pm End of Day 1