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个人简介
I have 25 years of executive management, academic leadership and clinical research experience, spanning angiogenesis, drug delivery, gene therapy, rare and autoimmune disease, leading to 3 FDA approvals so far.
As Chief Medical Officer, Chief Development Officer and Executive Vice President at Clearside, I guided preclinical and clinical development, supported an NDA to first FDA approval of a suprachoroidal therapy (XIPERE, a drug-device combo), led an IND submission with development of a new clinical program and successful P1/2a trial (CLS-AX, a TKI), supported corporate partnerships (Regenxbio, Aura, Bausch, Arctic), and interfaced with investors and analysts.
Previously at Spark, I led medical strategy through approval and commercialization of LUXTURNA, the first FDA-approved gene therapy for inherited disease. The launch mandated an innovative ecosystem for this orphan gene therapy: introducing a genetic testing program (“ID Your IRD”), training gene therapy treatment centers on new procedures, educating on novel endpoints (MLMT) and developing new HEOR models (IRD health utilities, CEA and ICER, P4P programs). Roche ultimately acquired Spark for $4.3B.
Previously at Ophthotech (now Iveric), I contributed to protocol and analysis plan for the first successful AMD/Geo Atrophy P3 trial (GATHER1) of an anti-complement, recently FDA-approved IZERVAY. Astellas is acquiring Iveric for $5.9B.
After graduating from Harvard College and UCSF Med School, I completed internal medicine internship, ophthalmology residency and retina fellowship at Harvard and Tufts, training under key early innovators in OCT, PDT and anti-VEGF therapy. I progressed to tenured Associate Professor and Co-Director of the retina service and ocular angiogenesis research lab at Indiana University School of Medicine, the largest US med school with 9 campuses. I published numerous preclinical and clinical papers, built a large research-focused practice and earned an MBA from Indiana University, specializing in business of medicine.
I held numerous leadership roles in clinical research, including PI, medical monitor and member of SAB, DSMB or writing committees in >100 national P1-4 trials. I serve on journal editorial boards, edited textbooks and co-authored >300 papers, including the first published US-based randomized trial of an intravitreal therapy in AMD.
I remain a volunteer Clinical Professor and board member of Midwest Eye Institute, one of the largest subspecialty ophthalmology institutes in the Midwest. I am board-certified, fellow of the American Society of Retina Specialists and member of the American Society of Gene and Cell Therapy, ARVO, AAO, Macula and Retina Societies.
研究兴趣
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Genesno. 6 (2024): 720
Lucas W Rowe,Thomas A Ciulla
Expert opinion on biological therapy (2024)
Journal of vitreoretinal diseasesno. 3 (2024): 270-279
INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCEno. 8 (2023)
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Expert opinion on biological therapyno. 10 (2023): 969-985
Expert opinion on pharmacotherapyno. 17 (2023): 1887-1899
INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCEno. 8 (2023)
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