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Pre-Conference Workshops
Tuesday 21st May, 2019

Workshop A

Innovative Approaches to Early Clinical Development & Dose-Finding – Integration of PK-PD in Dermatology Drug Development
12:00 – 15:00

One of the biggest challenges in dermatological
research today remains the development of meaningful
methodologies to determine the rate and extent to
which topically or systemically applied drugs reaches its
site of action and engages its target in the skin.

In this workshop, learn how to make the most of early
clinical development by integrating advances in
techniques to quantitate dermal pharmacokinetis (PK)
and pharmacodynamics (PD) measurements in model
and patient settings and their role in dose finding.

Key topics to be discussed include:

• Challenges with dermal PK – did the API reach the
site of action?
• Stratum corneum (tape-stripping)
• Epidermis (raman spectroscopy)
• Dermis (open flow microperfusion)
• Transdermal (systemic absorption)

• Challenge models in healthy volunteers
• Imiquimod
• Wound healing after skin punch biopsies
• Lipopolysaccharide intradermal and
• UVB irradiation
• Histamine
• Capsaicin

• Models in patients
• Psoriasis
• Atopic dermatitis / contact dermatitis
• Wound healing in ulcers, atopic dermatitis
• Hidradenitis suppurativa, vitiligo, acne

• The role of samples
• Biopsy
• Skin surface
• Non-invasive sampling: dry blood spot, swabs

• Dose response relationship: Intended vs.
unintended effects

• Toolbox
• Biochemistry (e.g. biomarkers in biopsy, noninvasive
• Next generation biophysical measurements
• Non-invasive imaging
• Clinical assessments
• Lipidomics
• Patient reported assessments
• Mobile apps

Join us in this interactive session that will bring
practical insights into the inclusion of PK and
PD measurements and clinical models in early
clinical development programs, and how these can
provide value and de-risk clinical development of
dermatological drugs.

Workshop Leaders

Betsy Hughes Formella

Betsy Hughes-Formella
Independent Consultant, Dermatology Drug Development

Robert Rissmann

Robert Rissman
Research Director, Dermatology
Center for Human Drug Research

Workshop B

Looking Ahead – What Will Come Next in Dermatology R&D?
15:30 – 18:30

Within the past 10- 15 years, there has been an enormous progress in the treatment of psoriasis and a topic dermatitis. New, highly effective biologics have
been registered since and new ones including small molecules like JAK inhibitors are coming up, which show promise also for the treatment of other immunemediated skin diseases like alopecia areata and vitiligo.

However, within the next 5 to10 years, the number of registered and highly effective treatments for these diseases will be so high, that investments into new treatments of the same diseases or of the same classes of compounds/targets may not be considered commercially attractive any more.

In view of encouraging forward-looking thinking on this matter, this session will aim at discussing what will come next in dermatology R&D – are there other skin indications with high medical need and commercial attractiveness which deserve investment in future R&D?

Key areas to be discussed include:

• Lessons learned during R&D of new therapies for
treatment of skin diseases, from discovery to launch

• Options and challenges for the future in dermatology
R&D (including insights in skin cancers like SCC and
BCC, or chronic wounds)

• Is there high unmet medical need in dermatology
beyond psoriasis and atopic dermatitis?

• New approaches in wound healing and tissue repair

Join this session and take part in an engaging discussion led by Prof. Anton Stuetz, an industry dermatology veteran and expert, and recipient of the 2011 award for Innovative Therapy of the Skin by the American Academy of Dermatology. You will also be able to hear and learn from esteemed colleagues and experts including:

- Dr. Barbara Wolff-Winiski (CSO and Co-CEO at Akribes Biomedical GmbH)

- Prof. Georg Stingl (Medical University of Vienna)

- Prof. Thomas Luger (Munster University)

You will leave this workshop with information on unmet medical need, future R&D trends and approaches, which will help you support the success of the development work in your own organisation in the near future.

Workshop Leader

Anton Stuetz

Anton Stuetz
Founder & CEO
Pharma R&D Consulting Stuetz GmbH & Akribes Biomedical GmbH