On May 1, 2022, CorrectSequence Therapeutics (Correctseq), a pioneer gene editing biotechnology company, announced that Dr. Guang Gao was invited to serve as a long-term special consultant for global quality standards, to guide the global application of Correctseq R&D pipeline and the establishment of global quality systems in line with China, USA and European standards.
Correctseq CEO Dr. Xiaodun Mou said, "for Correctseq, who has the world-leading and proprietary precision base editing system, transforming innovations into finished medicines that meet Chinese and global regulatory standards needs rich pharmaceutical experience and strong quality system assurance, especially for innovative gene editing therapy. Correctseq is pushing forward the first IND pipeline decisively and orderly, while developing multiple pipelines for genetic diseases, metabolic diseases, tumor immunotherapy, and infectious diseases. We very much welcome Dr. Gao to join us in this important stage, whose experience in evaluating clinical research projects of blood cell therapy and vaccine products in drug regulatory authorities of multiple countries and regions and international listed drug audit supervision will help order Correctseq quickly establish an efficient declaration system and a quality standard system that meets global quality standards. Dr. Gao will be fully involved in the design, construction, verification and pass of CMC and cGMP laboratories and production workshops. Recently, Dr. Gao and several executives with more than 10 years of industrial process develop, clinical research and management experience will accelerate the progress of IND pipeline and engineering construction.”
Dr. Guang Gao
Dr. Gao has more than 20 years regulatory experience in US FDA overseeing the development and approval strategies of a broad range of drug and medical device products. After that, Dr. Gao worked as an independent consultant for 4 years providing advice on GMP inspection, quality system establishment, and IND filing strategies. Given her great experience with FDA’s regulatory requirements for drugs and medical devices, Dr. Gao helped many with technical and strategic advice on improving their GMP compliance to meet WHO certification requirements.
As a senior technical officer at PATH China Office, Dr. Gao is responsible for providing strategic and technical advice to the Center for Vaccine Innovation and Access (CVIA/PATH) and obtaining the WHO certification for Chinese COVID-19 vaccine. Before joining PATH, Dr. Gao worked at US FDA (CBER) where she held various positions since 1999. She served as chief review scientist by providing technical guidance and suggestions for regulatory agency’s review and approval processes. Her advisory scope included many areas such as clinical studies, GLP and cGMP compliance, and particularly the safety and effectiveness of in process testing during manufacturing process. Dr. Gao also worked at US FDA China Office stationed in Beijing as an inspector. She conducted many inspections of drug and medical device on Chinese manufacturers who export their products to US. During that time, she also provided a series of trainings to Chinese regulators and manufacturers on regulatory and compliance guidance and practice.
Dr. Gao received a bachelor's degree and doctor’s degree in biochemistry from Nanjing University and was a postdoctoral fellow at Dartmouth Medical School and the National Institutes of Health (NIH) of USA. She has received many honors issued by FDA and published nearly 30 articles in peer-reviewed professional journals.
Correctseq Co-founders said, "we believe Dr. Gao is professional and has fluence experience in quality control/assurance of drug development and production, which will help Correctseq with technical and strategic advice on compliance in the fields of R&D, CMC, clinical application, etc., and insure Correctseq gene editing therapy meets the global quality standards, which will benefit patients around the world. We are also glad to see that Dr. Gao will further strengthen Correctseq operation team. We hope that under the leadership of the management team with Dr. Xiaodun Mou as the core, our cutting-edge scientific research achievements related to base editing will be quickly transformed into efficient, safe and reliable gene editing treatment drugs, helping people living with serious diseases.”
About CorrectSequence Therapeutics
CorrectSequence Therapeutics (Correctseq) is a pioneer gene editing biotechnology company committed to creating a precision genetic therapy based on our word-leading and proprietary base editing system for people living with serious diseases around the world. We have created a base editing system with independent intellectual property rights. Multiple pipelines are under development based on our proprietary technology. Since its establishment in August 2020, Correctseq has been promoting the translation of the advanced scientific research achievements of our scientific founder team and always at the forefront in the field of gene editing-based therapeutics and innovative biotechnology research. Our independent R&D platform and process development laboratory have world-class R&D capabilities, which enable us to promote the application of the cutting-edge technologies related to the base editing system in disease treatment. We strive to realize the vision of benefiting all mankind with innovative gene editing technologies.