Conference Day One
Wednesday, November 13 2024
7:20 am Check In, Morning Coffee & Light Breakfast
8:20 am Chair’s Opening Remarks
Uncovering the Global Medical Dermatology Drug Development Landscape to Identify Unmet Need
8:30 am Putting Patients at the Focus for Drug Innovation in Dermatology
Synopsis
- Precision Medicine approaches in Dermatology: Window to drug and pathological mechanisms learned from bedside
- Relevance of in situ analysis in clinical trials
- Case study: IL-23 pathway blockade in inflammatory pathologies of the skin (PsO/PsA/AD)
9:00 am SCARLETRED AI: Breaking the Boundaries Between Human & Machine in Skin Drug Research
Synopsis
- Standardized high-quality mobile skin imaging
- Smart skin imaging data and objective image analysis
- Machine learning and AI-powered decision support in Psoriasis, Hidradenitis and more disease areas
- New digital skin biomarker and endpoints in clinical R&D and post-marketing
9:30 am Panel Discussion: Monoclonals, Topicals, Orals, Targets, Mild Disease & More – Where Are the Industry’s Priorities to Develop Safe Therapies with Superior Efficacy?
Synopsis
- With a rich pipeline of drugs targeting various inflammatory mechanisms, for different indications and leveraging different approaches, what will be the next blockbuster drug to reach the market?
- How are safety concerns around systemics and efficacy challenges around topicals being addressed, amidst regulatory and reimbursement environments?
- Faced with varying challenges to demonstrating clinical superiority and market acceptance, what does this mean for patients and the direction of pipelines today?
10:15 am Structured Networking Break
Synopsis
Your most important networking session, where you connect with your fellow industry experts in dermatological drug development and form important relationships with like-minded leaders for expediting your research and pipeline development!
Discovery & Translation to the Clinic
Track Chair:
Emerging Targets & Drug Discovery for Heterogenous Inflammatory Disease
11:15 am A Novel Target in Vitiligo: CxCL10
Synopsis
- Vitiligo remains an area with a significant unmet need, in particular for new targeted systemic treatments
- The IFNγ-CXCL10-CXCR3 pathway offers new and exciting opportunities for addressing the condition, with CXCL10 playing an important role in apoptosis of melanocytes, and recruitment and positioning of effector T-cells
- EB06 is a novel anti-CXCL10 monoclonal antibody that is being developed for treatment of vitiligo.
11:45 am Clinically Predictive Assays & Innovative Clinical Solutions for Drug Research & Development in Dermatology
Synopsis
- Case studies across the development cycle
- Clinically predictive preclinical models to increase clinical trial success rate
- Cutting-edge clinical imaging technologies that replace subjective observations
- Customized approach to ensuring optimal success rates and accelerated timelines
12:15 pm STAR-0310: A Monoclonal Antibody OX40 Antagonist
Synopsis
- OX40 inhibition is a clinically validated mechanism for the treatment of AD
- Using half-life extension technology with the aim of durable efficacy with less frequent dosing every 2-3 months, STAR0310 is designed with the potential to be a first-choice treatment that reduces disease and treatment burden to help normalize the lives of people with atopic dermatitis
- STAR-0310 has a potential best-in-class profile with a high potency, potential for favorable safety and tolerability profile with low T-cell depletion from ADCC or possible on-target cellular toxicity, and less frequent dosing
- How this MoA has utility across the spectrum of dermatology diseases
12:45 pm Networking Lunch
Clinical & Commercial Strategy
Track Chair:
Clinical Progress: Creative Design & Durable Responses for In-Human Safety, Efficacy & Long-Term Improvements in QoL
11:15 am Targeting IL-13 with Tralokinumab Normalizes Type 2 Inflammation in Atopic Dermatitis Both Early & at 2 Years
Synopsis
- Evaluation of skin and serum biomarkers from patients enrolled in the Phase 3 ECZTRA 1 trial and long-term extension ECZTEND trials with Tralokinumab (IL-13 neutralizing monoclonal antibody)
- Gene expression assessed by RNA sequencing and protein expression assessed by immunohistochemistry and immunoassay
- Measuring Tralokinumab treatment’s improvement of epidermal pathology, along with reducing systemic markets of Type 2 inflammation and shifting expression of AD biomarkers to nonlesional levels to highlight the key role of IL-13 in AD pathogenesis
11:45 am Novel Imaging Endpoints: Redefining Objectivity in Dermatology Clinical Trials
Synopsis
- Automatic detection and segmentation of vitiligo
- 3D photography as a way to quantify dermatologic conditions
- Artificial Intelligence: automatic scoring of acne severity
11:55 am Recent Trials in AD – Inconsistency Between Outcome Scales
Synopsis
- Decreasing EASI baseline severity in recent years AD trial has led to very high placebo responses – Particularly in the moderate patient segment
- IGA and PGIC remain robust endpoints
- What can we learn, and can Biomarkers help substantiate which scale is the most appropriate
- Going forward – How do we face the EASI “Challenge” – better training, higher baseline severity, better monitoring
12:45 pm Networking Lunch
Emerging Targets & Drug Discovery for Heterogenous Inflammatory Disease
1:45 pm New Therapeutic Targets in Alopecia Areata Revealed by Analysis of Single T-Cells
Synopsis
- Discuss recent findings in the analysis of individual T-cells in alopecia areata and the role of various cytokine and immune signaling pathways
- Characterization of TCRs at the single cell level provides new information into potential autoantigens
- Uncovering new therapeutic opportunities from single T-cell analysis invites novel approaches for T-cell targeting
2:15 pm Unmasking Skin Biology with Metabolomics
Synopsis
- What can metabolomics provide?
- Examining Skin Strip data in detail
- Roadmap to using metabolomics
2:25 pm Personalized Therapy Selection for the Treatment of Inflammatory Skin Disease: Where Do We Stand?
Synopsis
- Review immunologic heterogeneity in common inflammatory skin diseases (atopic dermatitis and psoriasis) and implications for therapy responsiveness
- Outline tools for immunologically phenotyping patients with inflammatory skin diseases and their role in leveraging immunologic heterogeneity in clinical practice and clinical trials
- Discuss the future of personalized medicine in dermatology, biomarker optimization and new opportunities for discovery and drug development
Clinical Progress: Creative Design & Durable Responses for In-Human Safety, Efficacy & Long-Term Improvements in QoL
1:45 pm Complement C5a Drug Development for Immuno-Dermatology Indications
Synopsis
- The role of C5a/C5aR in chronic inflammation has become increasingly clear in recent years, making C5a & C5aR attractive targets for many immune-inflammatory diseases
- InflaRx have two potential therapeutics targeting C5a with the anti-C5a antibody (vilobelimab) and an oral anti-C5aR inhibitor (INF-904); with initial focus on immune-dermatology indications such as hidradenitis suppurativa, pyoderma gangrenosum and chronic spontaneous urticaria
2:15 pm Accelerating Dermatology Drug Development in Atopic Dermatitis: Innovative Clinical Strategies for Expedited Timelines
Synopsis
- Gain insights from a clinical study demonstrating approaches undertaken to speed timelines effectively
- What approaches are seeing results when it comes to speeding timelines and conserving spend whilst demonstrating robust efficacy and safety as pipelines progress
- Uncovering biomarkers to define responders in heterogenous patient populations
Optimizing the Delivery of Dermatological Agents to Increase Targeting Specificity in Inflammatory Environments
2:55 pm Afternoon Networking Break & Poster Session
Synopsis
The learning and networking continues! Join us for our NEW scientific poster session, providing an opportunity to connect with peers, fostering new relationships and a platform for showcasing your work, while also allowing you to explore cutting-edge contributions across research, drug discovery and clinical updates.
3:30 pm JNJ-2113 Long-Term Extension FRONTIER 2 Study: The First & Only Investigational Targeted Oral Peptide Designed to Block the IL-23 Receptor
Synopsis
- IL-23 plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis (PsO) and underpins the inflammatory response in PsO and other IL-23- mediated diseases in dermatology, rheumatology and gastroenterology
- JNJ-2113 is a novel oral peptide modality with a unique MoA of binding and inhibiting the IL-23R
- In the FRONTIER 2 52-week Long-Term Extension Study following the FRONTIER 1 16-week Ph2b Study, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO, and found safety consistent with FRONTIER 1
4:00 pm Next Generation Drug Targeting in Dermatology: Alys Pharmaceuticals’ Pioneering Approach
Synopsis
- Optimal benefit/risk outcomes from state-of-the-art tissue and cell-level targeting strategies
- Molecular targeting to sidestep side effects: antibody vectorization for chronic spontaneous urticaria
- Truly sharp targeting: siRNA-based technology for inflammatory skin disease