8:15 am Chair’s Opening Remarks

  • Mandeep Kaur VP & Head of North America Medical Affairs for Immunology, Sanofi

8:30 am Regulatory Perspectives – Emerging Approaches in Dermatology Drug Development

  • Kendall Marcus Director - Division of Dermatology & Dental Products, FDA

Synopsis

  • Addressing the utilization of digital tools in dermatology clinical trials
  • Demonstrating efficacy in Hidradenitis suppurativa – exploring clinical endpoints, new scoring systems and clinical trial design considerations in HS

9:00 am Dedicated Q&A Session

  • Kendall Marcus Director - Division of Dermatology & Dental Products, FDA

9:45 am Fail Early, But Try Not to Fail Often

Synopsis

  • Going from product concept to approval – avoiding CMC, nonclinical, clinical, regulatory and other failure potholes
  • Understanding how success vs. failure is a team responsibility
  • Sharing the risk – partnering of an asset as a failure mitigation strategy

10:15 am Morning Refreshments & Networking

10:20 am

PRECLINICAL & TRANSLATIONAL
Chair: Jasmina Jankicevic, Dermatologist, Clinical
Development & Medical Affairs Consulting

CLINICAL
Chair: Jasmina Jankicevic, Dermatologist, Clinical
Development & Medical Affairs Consulting

Advancing Early Stage Development in
Dermatology – Part 2

Building a Robust Path to Clinic
Dermatology – Part 2

11.15 Precision Dermatology Through the Optics of Omics
• Using Omics approaches to understand disease heterogeneity and pathogenesis
• Integrating precision medicine approaches in clinical trials
• Defining innovative approaches to predictive medicine

Michael Howell, Senior Director - Translational Research,
Incyte Corporation

11.15 The Intersection of Translational Medicine &Technology Development
• Understanding the need for target identification with a
temporal and spatial context within dermatology
• Exploring the unique opportunity for technology
development in dermatology
• Discussing how translational medicine can facilitate
technology integration into the drug development value
chain

Adam Raff, Director, Translational Medicine, LEO Pharma

11.45 Tapinarof & the Aryl Hydrocarbon Receptor (Ahr) in Psoriasis & Atopic Dermatitis: Case Study in Novel Target Validation
• Aryl Hydrocarbon Receptor: structure, function and biology
• Therapeutic versus pathologic AhR ligands
• Tapinarof, a novel AhR agonist being developed as a
differentiated therapeutic aryl hydrocarbon receptor
modulating agent (TAMA) topical cream for the treatment of psoriasis and atopic dermatitis

David Rubenstein, CSO, Dermavant Sciences

11.45 The Potential & Challenges of Patient
Stratification in Immune-Mediated Inflammatory Skin Disease
• Providing a brief background on atopic dermatitis and psoriasis
• Overviewing recent achievements with novel treatments and the challenges that remain
• Exploring the potential of personalized medicine
approaches to the challenges that remain

John Armstrong, Head of Global Strategic Opportunities, Galderma

12.15 RPT193 – A potent, selective oral CCR4 Antagonist for the treatment of Atopic Dermatitis
• Exploring the role of Th2 cells in atopic dermatitis and
the contribution of CCR4-mediated Th2 migration to the
disease
• Introducing the RPT193, a novel oral CCR4 antagonist
• Describing preclinical efficacy of RPT193 in various Th2
driven allergic disease mouse models
• Description of the clinical development plan for RPT193

Dirk Brockstedt, Senior VP of Biology, RAPT Therapeutics

12.15 Advancing Clinical Endpoints in Dermatology
• Exploring primary and secondary endpoints used in
clinical trials for key dermatological indications
• Discussing the role of endpoints in regulatory approval
• Analyzing the role of endpoints in defining and
communicating clinically meaningful benefits to different
stakeholders (prescribing physician, patient, payer or
marketing)

Gurpreet Ahluwalia, Executive Director, Clinical
Development, Sienna Biopharmaceuticals

12:45 pm Lunch & Networking

Patient-Facing Dermatology Drug Development

1:45 pm Patient Engagement: Turning Buzzwords into Action

Synopsis

  • Establishing patients as partners in drug development
  • Exploring opportunities for meaningful engagement and follow-through
  • Translating patient insights from clinical trials to clinical practice

2:15 pm Panel Discussion: Promoting Patient-Centricity in Dermatology

Synopsis

  • Establishing patient-facing protocol development and design of development programs
  • Discussing the evolution of Patient Reported Outcomes in dermatology
  • Promoting digital patient tools in dermatology clinical trials (engagement, recruitment, data collection)

2:45 pm Chair’s Closing Remarks

  • Mandeep Kaur VP & Head of North America Medical Affairs for Immunology, Sanofi

3:00 pm End of Dermatology Drug Development Summit 2019