I had to go back and review - I was not following AVXL closely at this time....
It's difficult to believe that Dr. Jin didn't do his DD before joining AVXL....
It's even more difficult to believe that he would permit an underpowered study of schizophrenia.
Mar 9, 2023 Anavex Life Sciences Appoints Former FDA Lead Neurology Statistician as VP Head of Biostatistics
NEW YORK – March 9, 2023 Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the appointment of Kun Jin, Ph.D., as Vice President, Head of Biostatistics.
Dr. Jin will draw on his extensive experience, including recently as the Statistical Team Leader at the U.S. Food and Drug Administration (FDA). Dr. Jin provided statistical review coverage and expertise for neurological drug products for the Center for Drug Evaluation and Research (CDER), and performed timely and quality reviews of marketing applications, including New Drug Applications (NDA), Biologic License Applications (BLA), and Investigational New Drug (IND) applications. Under the leadership of Dr. Jin, the neuropharmacological statistical team has completed several hundred statistical reviews of NDAs, BLAs, and efficacy supplements.
"I'm excited to welcome Dr. Jin to Anavex at this pivotal time. Dr. Jin has significant experience that will be instrumental as we continue our efforts to maximize value for patients and shareholders," said Christopher U Missling, Ph.D., President and Chief Executive Officer of Anavex. "Dr. Jin's deep and extensive biostatistics experience within clinical development and regulatory process will be invaluable as we advance key mid- and late-stage programs, to provide clinical and regulatory biostatistics leadership in support of Anavex’s goal to bring transformational medicines to the market."
“I’m honored to be joining Anavex and I am very much looking forward to helping guide the Company to secure access to better healthcare outcomes for families around the world,” said Dr. Jin. “There is such a significant unmet medical need around the globe caused by Alzheimer’s disease, Parkinson’s disease, and neurodevelopmental diseases like Rett syndrome and Fragile X syndrome. Anavex has a cutting-edge technology that can make a great deal of difference to those patients. I believe I can make a substantial contribution at this very important time in the Company’s transition towards commercialization.”
Prior to joining Anavex, Dr. Jin had a distinguished career of more than 27 years at the FDA. During his tenure at the agency, Dr. Jin has contributed extensively to statistical review issues and trial designs surrounding the regulatory approval of drugs for the treatment of neurological diseases including Alzheimer’s disease, Parkinson’s disease, migraine, epilepsy, and multiple sclerosis, as well as rare diseases, such as ALS and DMD. Dr. Jin was the lead author in top theoretical statistics, biostatistics, and molecular genetics journals. He was also a winner in a worldwide innovation competition on clinical cardiology data processing (Predicting Acute Hypotensive Episodes).
Dr. Jin has extensive research experience in Alzheimer’s clinical trials. He has been an invited speaker and has authored publications on topics in Alzheimer’s disease endpoints and trial designs. He conducted FDA/CDER The Oak Ridge Institute for Science and Education (ORISE) Summer Fellowship projects, built the Integrative Alzheimer’s Trial Database, FDA/CDER Regulatory Science and Review (RSR) Project and the results have been communicated at Accelerate Cures/Treatments for All Dementias (ACT-AD), Drug Information Association (DIA), and Joint Statistical Meetings (JSM). Before joining the FDA, Dr. Jin was Assistant Professor at the Division of Biostatistics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Dr. Jin received his Ph.D. in Statistics from the University of California at Berkeley, California.
