Fremont, Calif., May 23, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that Dr. Maurizio Fava and Dr. Thomas Laughren have agreed to to provide consulting services in connection with clinical studies of its central nervous system drugs designed to relieve symptoms of major depressive disorder (MDD) and adult hyperactive depressive disorder (ADHD). The Company’s MDD drug successfully completed Phase II clinical studies which were accepted by the U.S. Food & Drug Administration in October 2020. Its ADHD drug successfully completed Phase II Part 1 and begins Part 2 at the University of California, San Francisco Medical Center as well as five clinical study sites in Taiwan.
Dr. Fava is Chief Psychiatrist of Massachusetts General Hospital (MGH), Executive Director of the Clinical Trials Network and Institute (MGH), Associate Dean for Clinical and Translational Research, and Slater Family Professor of Psychiatry at Harvard Medical School. He is a world leader in the field of depression, has edited eight books, and authored or co-authored more than 900 original articles published in medical journals with international circulation, articles that have been cited more than 95,000 times. in the literature and with an h index of more than 150. Dr. Fava obtained his medical degree from the Medical School of the University of Padua and completed his residency in endocrinology at the same university. He then moved to the United States and completed his residency in psychiatry at the MGH. He founded and directed the hospital’s Depression Clinical and Research Program from 1990 to 2014. Under Dr. Fava’s leadership, the Depression Clinical and Research Program has become one of the most recognized in the country, a model for university programs that link, in a bidirectional way, clinical and research work. In 2007, he also founded and is now the Executive Director of the Network and Institute for Clinical Trials in Psychiatry at the MGH, the first academic CRO specializing in the coordination of multicenter clinical trials in psychiatry.
Dr. Thomas Laughren is Regulatory Director for the MGH’s Psychiatry Clinical Trials Network and Institute, providing consultation on psychiatric and neurological drug development. He retired as Division Director of the Psychiatric Products Division of the FDA Center for Drug Evaluation and Research in December 2012. As Division Director, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. Prior to coming to the FDA in September 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, RI, and on the faculty of Brown University’s medical program. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and completed his residency in psychiatry at the University of Wisconsin. He has authored and co-authored numerous articles and book chapters on regulatory and methodological issues in psychiatric drug development and is a frequent speaker at professional meetings on these same topics. Dr. Laughren has received numerous awards for his regulatory achievements.
“We are delighted that Drs. Fava and Laughren have agreed to provide valuable guidance as we move our MDD and ADHD drugs through the regulatory process for clinical trials,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “Their experience of psychiatric medicine and the regulatory process is unmatched in the United States today.”
About ABVC BioPharma
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) in development. For its pharmaceuticals, it focuses on using its licensed technology to conduct proof-of-concept trials throughout the Phase II clinical development process at world-renowned research institutes (such as the Stanford University, University of California San Francisco and Cedars-Sinai Medical Center). For Vitargus®, the company intends to conduct clinical trials through phase III in various locations around the world.
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