Healthcare Industry News: FDA
News Release - May 14, 2024
Nanoscope Therapeutics Appoints Khandan Baradaran as Senior Vice President of Regulatory and Quality
DALLAS, May 14, 2024 -- (Healthcare Sales & Marketing Network) -- Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for inherited retinal diseases and age-related macular degenerations (AMD), today announced the appointment of Khandan Baradaran, PhD, as Senior Vice President of Regulatory and Quality. Dr. Baradaran brings nearly two decades of extensive experience in manufacturing and regulatory review of gene therapy products, including regulatory and chemistry, manufacturing, and controls (CMC) experience."Khandan's experience leading quality and compliance for rare genetic disease biopharmaceutical companies will be valuable as we continue to advance our versatile MCO platform, including MCO-010, which is driving our expanding pipeline of programs. This appointment supports the continued advancement of our mutation-agnostic therapies to restore vision in millions of people blinded by retinal diseases and further highlights our continued growth as a company," said Sulagna Bhattacharya, Co-Founder and Chief Executive Officer of Nanoscope.
"I am honored to join the highly motivated team at Nanoscope in the development of its novel approach to treating retinal degenerative diseases," said Dr. Baradaran. "Following the impressive durable efficacy and safety results from the randomized control trial in retinitis pigmentosa, I eagerly anticipate contributing to Nanoscope's advancement as we navigate forthcoming regulatory milestones and prepare for commercial readiness."
Dr. Baradaran was most recently Vice President of Regulatory CMC at Ultragenyx Pharmaceutical Inc., a biopharmaceutical company involved in the research and development of novel products for the treatment of rare and ultra-rare genetic diseases. Previously, Dr. Baradaran was Vice President and Head of Quality at Dimension Therapeutics, a gene therapy company focused on developing novel treatments for rare diseases. Prior to this, she held CMC and Regulatory positions at Biogen, Novartis, and Dyax. She holds a PhD in Virology from Harvard University and a BA in Molecular Biology from Wellesley College.
About Nanoscope Therapeutics Inc.
Nanoscope Therapeutics is developing gene-agnostic, sight-restoring optogenetic therapies for the millions of patients blinded by inherited retinal diseases, for which no cure exists. The company's lead asset, MCO-010, recently announced the 100-week data from the RESTORE Phase 2b/3 multicenter, randomized, double-masked, sham-controlled clinical trial in the U.S. for RP (NCT04945772). The company has also recently completed the Phase 2 STARLIGHT trial of MCO-010 therapy in patients with Stargardt disease (NCT05417126). MCO-010 has received FDA fast-track designations and FDA orphan drug designations for both RP and Stargardt disease. Preclinical assets include non-viral laser-delivered MCO-020 gene therapy for geographic atrophies secondary to AMD.
Source: Nanoscope Therapeutics
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