Raja...quote:
A) 9 months and counting since CTAD (especially after assuring that there would be more data to share, sooner than later. Each of us can interpret this delay to suit our ego/convenience by making assumptions accordingly).
B) If one considers the time since the AD trial was done and dusted, it has been more than a year.
So, what has changed since the CTAD data release 9 months ago?
Anavex Life Sciences Corp. Appoints Dr. Kun Jin as Head of Biostatistics
March 09, 2023
Anavex Life Sciences Corp. announced the appointment of Kun Jin, Ph.D., as 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. 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 Alzheimers disease, Parkinsons 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 Alzheimers clinical trials. He has been an invited speaker and has authored publications on topics in Alzheimers disease endpoints and trial designs. He conducted FDA/CDER The Oak Ridge Institute for Science and Education (ORISE) Summer Fellowship projects, built the Integrative Alzheimers 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.
