Janice Drew has over 30 years of experience in clinical development covering early-stage research, Phase 1 through Phase 3 clinical trials, and development activities through the commercialization and life-cycle–management phase of a product. Janice’s expertise lies in program and project-team management, clinical development and operations, and regulatory interactions. Over the past 20 years, Janice has had direct responsibility for 5 NDAs/BLAs, multiple INDs and EOP2, and pre-NDA/BLA meetings, including oversight for 4 global clinical development programs. Janice’s most recent position was as Senior Vice President, Portfolio Planning and Management at Dermira, Inc. During her 10 years at Dermira, Janice supported clinical strategy, clinical program development, and protocol development for topical and biologic products targeting acne, rosacea, psoriasis, hyperhidrosis, and atopic dermatitis. Janice supported strategic growth at Dermira and helped plan and build the infrastructure and governance for the product development department. Janice had specific oversight for clinical operations, biostatistics, medical writing, and project and alliance management functions at Dermira. Janice was a member of the senior management team and supported due diligence activities for potential product in-licensing opportunities and partnerships. While at Dermira, Janice supported Phase 3 development and the BLA for Cimziane® for plaque psoriasis, the NDA for QBREXZA® for axillary hyperhidrosis, and the global Phase 3 program for lebrikizumab for atopic dermatitis.
Prior to joining Dermira, Janice was at Peplin, where she led the Phase 3 program, NDA, and global regulatory submissions for Picato®, a topical treatment for actinic keratosis. Prior to Peplin, Janice worked at Allergan, building the Phase 3 development team for BOTOX® for the treatment of neurogenic and idiopathic overactive bladder. Janice also spent 8 years at Roche in Palo Alto, California, and Basel, Switzerland, leading the global clinical operations team working on CellCept® and Zenapax®, both indicated for solid organ transplantation. Her work on the CellCept® program covered label extensions for multiple solid organs and a pediatric development program with a pediatric formulation. Janice holds a BS from the University of California, Irvine, and a MPH from California State University, Fullerton.