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

  • Jim Cassella Chief Development Officer , Concert Pharmaceuticals

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

  • Wilma Bergfeld MD Director of Dermatopathology Fellowship, The Cleveland Clinic
  • David Rosmarin MD Associate Professor, TUFTS Medical Center
  • Raj Chovatiya Assistant Professor Director, Center for Eczema and Itch Department of Dermatology, Northwestern University Feinberg School of Medicine

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

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

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

  • Ruth Ann Vleugels Vice Chair of Academic Affairs, Brigham & Women’s Hospital Department of Dermatology

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

3:15 pm END OF CONFERENCE