DIGITAL EVENT
Thursday, June 9, 2022 | 8.55 AM - 3.15 PM (EST)
8:55 am Chair’s Opening Remarks
Weighing the Benefit-Risk: Reviewing How We Measure Safety Against Practicality
9:00 am Spotlighting Real-World Experience of Safety & Long-Term Patient Welfare
Synopsis
- Discussing the overall safety of prolonged use of JAK inhibitors
- Highlighting the major side effects noted acutely and chronically treated patients with JAK inhibitors
- Managing the side effects of JAK inhibitors
- Evaluating the safety of vaccinations while on JAK inhibitors
9:30 am Long-Term Dosing with an Oral JAK Inhibitor for Moderate to Severe Alopecia Areata: Safety & Efficacy Update for CTP-543
Synopsis
- Examining how JAK inhibitors represent a potentially-important mechanism for the treatment of alopecia areata (AA), a serious autoimmune hair-loss disorder with unmet need.
- Exploring CTP-543 a selective JAK1 and JAK2 inhibitor currently in Phase 3 trials, which has successfully regrown hair in multiple Phase 2 trials and most eligible trial patients have rolled over into open-label, long-term extension studies.
- Reviewing phase 2 results: hair regrowth was maintained or improved and CTP543 continues to be generally well tolerated in the vast majority of patients participating in the ongoing, long- term extension studies to date
10:00 am PANEL DISCUSSION: The JAK Class Black Box Warning: The Implications for the JAK Inhibitor Drug Development Landscape for Dermatology & Beyond
Synopsis
- Cataloguing the implications across numerous disciplines the FDA issued JAK black box warning will have just as pharma was beginning to realise the potential the JAK/STAT pathway holds.
- Evaluating where the community sees the market potential for JAK inhibitors within the pharmaceutical industry despite the warning.
- Discussing ways in which companies may begin marketing their JAK inhibitors whilst also debating the demand for novel therapeutic options in underserved indications, where benefit-risk calculations must take place.
10:45 am
Morning Break & Structured Networking
Weighing the Benefit-Risk: Reviewing How We Measure Safety Against Practicality
11:15 am Balancing Benefit/Risk in the Dermatology Disease Space
Synopsis
- Considering whether the black box warning will stifle innovation across the JAK inhibitor class
- Correlating disease severity and quality of life with off-target effects of JAK inhibitors
- Rethinking how we define the black box warning to patients
11:45 am Shedding Light on the Patient Perspective in the Clinic
Synopsis
- Unearthing unique considerations for JAK inhibitor use in pediatrics
- Comparing and contrasting the deployment of JAK inhibitors in rheumatology vs dermatology
- Moving forward: what conditions stand to benefit most from JAK inhibitor
development
12:15 pm
Lunch Break
Future Horizons: Looking Ahead to Best Prepare Your JAK Inhibitor Pipelines
1:15 pm Revolutionizing Translational Modeling with 3D Technology
Synopsis
- Introducing the capabilities of the Tissue Bioprinting Lab at NCATS
- Championing 3D vascularized barrier tissue models with relevant disease models
- Relaying the multitude of translational applications with JAK inhibitors
1:45 pm Novel Strategies of Localized Drug Delivery to Re-Think the Application of JAK inhibitors
Synopsis
- Developing a biocompatible lipid nanoformulation that encapsulate JAK inhibitors to achieve preferential targeting of the gut immune system following oral administration.
- Exploring a novel potential for JAK inhibitors as immunotherapeutics, rather than immunosuppressive drugs, in the treatment of autoimmunity and transplant rejection.
- Developing injectable hydrogels for localized and controlled release of JAK inhibitors and future advances.
2:15 pm
Afternoon Break & Networking
2:45 pm FDA Perspective on JAK Inhibitor Development & Dermatologic Disorders
Synopsis
- Considering what clinical endpoints the FDA will accept across multiple disciplines within JAK inhibitor drug development to accelerate delivery to market
- Q&A Time: An extended 15 minute session post presentation to alleviate all JAK inhibitor pipeline queries and save labor downstream