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

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 Photography in Dermatology Trials: Leveraging Virtual Solutions during the Pandemic

  • Nicolas Dapis Chief Business Officer (CBO), Clinical Services, QuantifiCare

Synopsis

  • Explore Clinical Trial Photography
  • Examine Mobile Photography in Virtual Trials
  • Case Study: Phase 3 Acne Clinical Trial

Morning Refreshments & Networking

11:00 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

11:30 am FireSide Chat: Orphan & Rare Dermatology Diseases – What is the Current Landscape?

  • Bernat Vidal External Research & Innovation Manager , Almirall
  • Dogan Fidan Head of Global Strategic Franchise, Immunology & Inflammation, 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?

Lunch & Networking

1:00 pm Customized High-end Research for Dermatological Drug Development

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

Synopsis

• Presenting in-vitro and ex-vivo models
• Showcasing in-vivo humanised mouse model and clinical trials unit
• Collaborating opportunities and understanding the advantage of customised approaches

1:20 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

1:50 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?

Afternoon Refreshments & Networking

2:50 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

Advancing the Clinical Development of Dermatological Therapeutics

3:20 pm How to accelerate the development of your topical products?

Synopsis

  • Identify key chemical and formulation development steps and strategies that enable creative, innovative and pragmatic project progression
  • API characterization strategies: solid form characterization, impurity profiling, incompatibility assessments
  • Target product profile and formulation strategy
  • Criticality of raw material selection
  • Preformulation: Solubility and compatibility (API – excipient interaction)
  • Trouble shooting: Identification of degradation pathways and recommendation of preventative approaches

3:50 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

4:20 pm Chair’s Closing Remarks

4:30 pm End of Day 1