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.
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.
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