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Agenda

8:45 am Chair’s Opening Remarks

  • Elena Rizova VP & Head of Global Medical Affairs, Immuno Inflammation, Sanofi

Industry Leaders’ Perspectives

9:00 am Keynote: Advancing Dermatology Medicines

  • Elena Rizova VP & Head of Global Medical Affairs, Immuno Inflammation, Sanofi

Synopsis

  • What have we learnt from the latest therapeutic breakthroughs in dermatological
    inflammatory diseases?
  • What is the next frontier in dermatology drug development?
  • Bridging the gap between science and patient

9:30 am Industry Leaders Panel: Pioneering in the “Golden Age” in Dermatology

  • Elena Rizova VP & Head of Global Medical Affairs, Immuno Inflammation, Sanofi
  • Paul F. Lizzul CMO, Sienna Biopharmaceuticals
  • Sonya Abraham Head of New Treatment Strategies, Immune-Dermatology, UCB

Synopsis

  • Exploring the “Golden Age” in dermatology drug development – key advances and challenges
  • Discussing what success looks like in derm drug development
  • What’s next? – exploring new indications, new targets, new personalized medicine approaches
  • Addressing unmet need – discussing drug development in rare conditions
  •  Navigating the fiercely competitive topical space

10:15 am Virtual Bioequivalence in Dermal Drug Development is a Reality

  • Sebastian Polak Senior Principal Scientist & Practice Lead for Cardiac Safety, Certara

Synopsis

  • Exploring how modeling and simulation has demonstrated itself to be a game changer by increasing speed and reducing cost of the development process
  • Describing how, encouraged by regulators, this technology is being used to demonstrate bioequivalence, including the ability to waive certain clinical trials
  • Presenting Certara’s technology, including its dermal model is of value to both innovator and complex generics development programs

10:45 am Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the
brightest minds working in the dermatology field and establish meaningful business
relationships.

11:15 am Morning Refreshments

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

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

Advancing Early Stage Development in
Dermatology – Part 1

Next Generation Therapeutic Approaches
– Part 1

11.45 Elucidating Drug Efficacy Via Integrated Preclinical Models - Bridging Molecular, Cellular & Tissue Analysis
• Discussing potential inflammatory in vivo/ex vivo/in vitro
skin models
• Modulating of pruritus associated with allergic dermatitis
• Illustrating the value of an integrated preclinical research
strategy using a clinical stage case study

Paul Smith, Senior Director - Pharmacology Non-Oncology,
Incyte Corporation

11.45 JAK Inhibitors in Alopecia Areata & Other Dermatologic Diseases
• Exploring the genetic and immunological basis of
alopecia areata
• Discussing the rationale for the use of JAK inhibitors in
alopecia areata
• Understanding the broader rationale for the use of JAK
inhibitors in other dermatological diseases

Angela Christiano, Professor & Vice Chair for Research,
Department of Dermatology, Columbia University

12:15 Translational Research in Vitiligo: Launching a New Era of Targeted Treatments
• Exploring vitiligo, an autoimmune disease of the skin with
significant unmet medical need
• Understanding how vitiligo is driven by immune signaling
through IFNg, and therapies that target this pathway
show promise as effective new treatments
• Discussing how relapse occurs in up to 40% of vitiligo
patients after stopping therapy and this is due to
autoreactive resident memory T cells that can be
targeted by blocking IL-15

John Harris, Vice Chair of Dermatology & Director, Vitiligo
Clinic & Research Center, University of Massachusetts Medical School

12:15 Ruxolitinib Cream in The Treatment of Atopic Dermatitis & Vitiligo
• Describing ruxolitinib cream, a JAK1/JAK2 inhibitor
• Exploring phase 2 study outcomes of ruxolitinib cream in
patients with atopic dermatitis and vitiligo
• Analyzing key learnings so far

Michael Kuligowski, Executive Medical Director –
Inflammation & Autoimmunity, Incyte Corporation

12.45 Lunch & Networking

Innovating Formulation & Delivery
Approaches

Next Generation Therapeutic Approaches
– Part 2

2:00 Making a Porsche Out of Your Old Chevy: How SolGel Turned an Old Drug into a Novel Rosacea Treatment
• Exploring the secrets behind Sol-Gel’s topical drug
delivery system
• Delving into the challenges in treating papulopustular
rosacea (PPR)
• EPSOLAY – the most effective treatment for PPR

Ofer Toledano, VP, R&D, Sol-Gel Technologies

2:00 Sarcoidosis & Granuloma Annulare: Emerging Pathways & Treatment
• Detailing on the poor understanding of the pathogenesis
of granulomatous disorders, including sarcoidosis and
granuloma annulare
• Understanding the significant burden of these diseases
– therapies are lacking, and so there is significant unmet
need
• Emerging data using JAK inhibitors for the treatment
of sarcoidosis and granuloma annulare illuminates
pathomechanism and may promise targeted therapy

Brett King, Associate Professor of Dermatology, Yale
University School of Medicine

2.30 Topical Formulations of Cannabidiol for the Treatment of Acne, Atopic Dermatitis, & Psoriasis

• Novel formulation approaches to maximize delivery of the active ingredient
• Discussion of multiple mechanisms of action for treating skin diseases
• Update on clinical development

Bill Bosch, CSO, Botanix Pharmaceuticals

2.30 Krystal’s Engineered HSV-1 Vectors Efficient Vehicles for Local Delivery of Exogenous Genetic Materials to Skin Cells

• Discussing how vector technology can be used to treat
monogenic skin diseases
• Describing how the vector has high payload capacity and is non-integrating with a good safety profile
• Repeating administration with low immunogenicity
• Exploring the scalable manufacturing to process to make this a viable low cost gene therapy drug product

Suma Krishnan, Founder & Chief Operating Officer, Krystal Biotech

3:00 Session Reserved for Groupe Parima
• More information coming soon

3:00 Gene Therapy Company Focused On Developing Personalized Biologics For Rare Skin Diseases With High Unmet Needs

• Leveraging proprietary autologous fibroblast technology and clinical, regulatory, and manufacturing experience in cell therapy to develop novel gene therapies for rare skin diseases
• Recognizing the progress of the DEFI-RDEB Phase 3 clinical trial of FCX-007 gene therapy and the potential therapeutic advantages of autologous fibroblast cells transduced with an integrative lentiviral vector as a treatment for RDEB patients
• Addressing the importance of fostering relationships with FDA, advocacy groups, and industry and academic communities to inform and advance drug development for rare diseases

John Maslowski, President & CEO, Fibrocell

3.15 Innovation in Topical Product Development
• Addressing formulation considerations and novel approaches
• Exploring new options for product packaging formats

Rajiv Mathur, VP, Product Development, CPL

3:30 pm Afternoon Refreshments & Networking

Strategic Insights Into Dermatology Drug Development

4:00 pm Topical Drug Development: Breaking Through Boundaries

Synopsis

  • Understanding the challenges and opportunities within the topical and
    transdermal industry
  •  De-risking the pharmaceutical pipeline to help ensure your chances of success in
    the clinic
  • Influencing key stakeholders to ensure your success

4:30 pm The Role of Medical Affairs in Dermatology as a Strategic Partner

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

Synopsis

  •  More information coming soon

5:00 pm Topical Delivery – The Importance of the Right Formulation in Topical Drug Development

Synopsis

  • Addressing the importance of the right formulation in topical therapies
  • Exploring the influence of formulation components and properties in skin
    absorption and efficacy
  • Discussing good formulation development practices: preformulation studies,
    selection of excipients, early stability studies, cell line/tissue toxicological studies,
    IVRT and skin penetration studies, and formulation development and optimization

5:30 pm Chair’s Closing Remarks

  • Elena Rizova VP & Head of Global Medical Affairs, Immuno Inflammation, Sanofi

5:45 pm Poster Session & Drinks Reception

Synopsis

After the formal presentations have finished, the learning and networking carries
on. The Poster Session is an informal part of the conference agenda, allowing you
to connect with your peers in a relaxed atmosphere and continue to forge new and
existing relationships. During this session scientific posters will be presented on
novel targets, drugs with new mechanisms of action, preclinical models, and latest
progress in clinical programs.