Vice President, Late Clinical Development in Dermatology
This management consulting opportunity brought together experiences from Pfizer Immunology programs, trial design and execution for skin and skin structure infections and advancing novel therapies (including gene therapy) for Epidermolysis Bullosa.
- Advance IgG1 anti-OX40 inhibitory monoclonal antibody with YTE modification demonstrating increased affinity binding to FcRn and prolong half-life for atopic dermatitis and atopic diseases
- Lead medical Advisory boards to acquire clinical development strategy through NDA submission
- Build atopic dermatitis (AD) clinical foundation leveraging OX-40 pathway and associated MOA and align KOLs to potential for achieving disease modification in AD
- Identified and advanced multiple indications leveraging the OX40-OX40L axis to achieve disease modification in major autoimmune diseases.
- Developed accelerated clinical development program including PK/PD study designs leveraging YTE modified monoclonal antibody designs to enable disease modification and/or remission.
- Design clinical protocols including endpoint strategies for optimal dosing strategy to generate early-stage evidence for disease modification in atopic dermatitis vs Dupilumab, amlitelimab and rocatinlimab
- Constructed Target Product Profile and clinical development strategies to assure synchronization with Loss of Exclusivity (LoE) of current Standard of Care mAbs