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Subject Helixmith Builds BLA Prep Team
Writer ViroMed
Date 2019/07/02

 

Jun 28, 2019, Seoul, Korea – Helixmith Co., Ltd. has newly established a "BLA Prep Team” to ready itself for the Biologics License Application of flagship product, VM202. Dr. Cindy Fisher, former Regulatory Lead at Vical and Astellas, has come on board as the team's Head. With a BS from UCLA and PhD from UC Irvine, Dr. Fisher has gained over 10 years of experience in regulatory affairs, overseeing clinical trial approvals and BLA procedures of various products, including plasmid DNA-based gene therapy and Fast Track and Orphan Drug medicines.

Contrary to popular belief, a successful clinical trial does not always guarantee successful market approval. For a biologics treatment to gain market approval, experts from a wide variety of areas need to be involved to prepare a vast amount of data for the regulatory agency’s review: in addition to clinical study results, required data include safety data, preclinical studies, (e.g., the drug’s mechanism of action), manufacturing (CMC), quality control and quality assurance, regulatory procedures, and pharmacovigilance. Even when clinical trial results are positive, approval may be delayed or possibly rejected altogether if the other data are poorly organized and prepared. Helixmith is confident that Dr. Fisher has the expertise and capability to carry out the BLA procedures of VM202 swiftly and accurately.

Executive Director Jehee Suh of Helixmith's Global Business commented, "By recruiting Dr. Fisher, we have now completed building our BLA Prep Team. She will lead eight experts from different sectors, including the clinical team supervised by Vice President Dr. William Schmidt. Given her outstanding career, Dr. Fisher is surely the perfect person to drive the company’s VM202 marketing approval efforts. We have very high expectations for her and the team."

Translated by English Editor

Original Korean text from The Seoul Economic Daily

https://www.sedaily.com/NewsView/1VKLE88KNT