8:45 am Chair’s Opening Remarks
9:00 am Opening Keynote Panel Discussion: What’s Next in Dermatology Drug Development?
Synopsis
• Establishing the current landscape and state-of-the art in dermatology drug development – latest advances and challenges
• Lessons learned for rational and effective drug development in dermatology – discussing a ‘blueprint’ of what success looks like in dermatology drug development
• Analysing the end-to-end pain points that accompany dermatology programs – from improving preclinical translation, to tackling late regulatory and commercial challenges
• Where’s dermatology going? – new indication, new targets, the next antibodies
• Identifying and addressing unmet needs – defining the strategic driver for companies involved in drug development for rare and orphan dermatological diseases or moderate skin conditions (vs. standard of care)
• Driving precision medicine approaches in dermatology
9:45 am Topical Formulation Development: Boosting Your Success
Synopsis
- How is topical drug product development different?
- Discussing API design and selection
- Analysing the importance of preformulation and baseline understanding in topical development
- Formulation selection: the drug, the patient, the disease and the market
- Exploring innovative disease models to de-risk development and expand marketing claims
10:15 am Speed Networking Session
10:45 am Morning Refreshments
Enhancing Discovery, Preclinical Development & Translational Research in Dermatology
11:15 am Translational Data to Guide Clinical Development & Target Discovery
Synopsis
• Human disease derived data are discussed vis a vis in-vitro model systems and animal models
• Examples are provided from GBR 830 program, an OX40/OX40L pathway blocking antibody in Ph2b development in Atopic Dermatitis
11:45 am Application of a Translational in Vitro Assay Platform for Selection of a Highly Selective JAK1 Inhibitor
Synopsis
• Establishing the importance of JAK1 selectivity in drug candidates for oral administration versus topical administration
• Exploring in vitro screening platform to address the JAK kinase selectivity
• Supporting the identification of a clinical candidate by pre-clinical profiling of a highly selective JAK1 inhibitor
12:15 pm OX40L: A New Target in the Treatment of Dermatological Diseases?
Synopsis
· Giving background on OX40L in autoimmune diseases
· Introducing KY1005, a novel fully human anti-OX40L blocking antibody and preclinical data supporting the MOA
· Exploring the scientific rationale for targeting OX40L in atopic dermatitis
12:45 pm Preclinical Toxicology for Wound Healing Therapies: Animal Models & Analysis
Synopsis
- Overviewing the FDA’s guideline on wound repair therapies that indicate to use an in vivo model, which mimics the clinical setting
- Among the accepted animal models we, at RTC, propose the minipigs for its similarities to humans in terms of skin structure and wound repair process
- Presenting wound induction techniques, analysis to be included in the tox study and reviewing of pros and cons
12:55 pm Lunch & Networking
1:55 pm Advancing Bioprinting to the Level of Individual Cells
Synopsis
- Introducing Biopixlar – a single-cell resolution bioprinter based on microfluidics technology
Building complex tissue-like structures via controlled positioning of individual cells
Presenting formation of multi-cell tissue models for the field of dermatology
2:05 pm Addressing The Medical Need for Pemphigus: A New Biologic
Synopsis
• Overviewing the need for reliable models of complex diseases
• Exploring challenges in translating pathway targets to precise human efficacy
• Defining a better translatability approach for accelerating the drug development process and adding value to the project
• Providing regulatory agents and investors with more appealing approaches
2:35 pm TEM1657 – A Novel Small Molecule Approach Targeting Psoriasis
Synopsis
• Describing TEM1657, a novel small molecule asset showing unrivalled efficacy to reduce psoriasis symptoms in IMQ animal model
• Analysing TEM1657’s MOA – regulation of a key player in the IL-17 signalling pathway in keratinocytes
• Exploring next steps into clinical trials
Advancing the Clinical Development of Dermatological Therapeutics
3:05 pm Treating Epidermolysis Bullosa by Removing Mutations from The RNA
Synopsis
• Developing a treatment for recessive dystrophic epidermolysis bullosa (RDEB)
• Translating in vitro data to an easy to use therapy
• Harnessing exon skipping AONs to treat skin diseases
Remote presentation & discussion
3:35 pm Bridging the Innovation Gap in the Treatment of Mild to Moderate Dermatological Diseases
Synopsis
• Addressing the unmet need in topical drug development towards a large patient population with mild to moderate dermatological diseases, still primarily using topical steroids
• Updating on SNA-120 (TrkA inhibitor) – SNA-120, a novel approach to the treatment of psoriasis, targeting NGF/TrkA and neurogenic inflammation
– The important role of nerves & neuropeptides in psoriasis
– Itch as a proxy clinical biomarker for high NGF/TrkA expression in psoriasis
– A novel non-steroidal approach in the treatment of psoriasis and associated itch targeting the NGF/TrkA pathway
4:05 pm Afternoon Refreshments & Networking
4:35 pm Product Development in Dermatology
Synopsis
- Demonstrating efficacy in atopic dermatitis and alopecia areata
- Addressing Patient Reported Outcomes
- Exploring the size of safety databases needed to support marketing applications
- Overviewing perspectives on product development in dermatological rare conditions
- 15 min of dedicated Q&A time
Remote presentation & discussion
5:20 pm Innovative Trial Design to Determine Early Efficacy of Drugs in Translational Medicine at Novartis
Synopsis
• Innovative Trial Design to Determine Early Efficacy of Drugs in Translational Medicine at Novartis
• Exploring different study designs for proof of concept studies in Dermatology (examples from clinical studies in Acne, Atopic Dermatitis, Hidradenitis suppurativa)
• Addressing considerations of scientific aspects in drug development under various operational models
• Identifying factors influencing operational setup and recruitment
5:50 pm Digitisation of Dermatology – Is It Happening?
Synopsis
- Digital patient tools in dermatology
- Exploring telemedicine and the fit in dermatology
- Digitalisation of Clinical Trials in dermatology
- Real-world data in Clinical trials gathered from digital tools