BrainStorm Appoints Pharmaceutical Veteran Anthony Waclawski as Executive Vice President, Global Head of Regulatory Affairs Company plans to further strengthen its regulatory expertise and capabilities as ALS phase 3 clinical trial nears completion in Q4
NEW YORK, Sept. 02, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the appointment of Anthony P. Waclawski, Ph.D. as Executive Vice President, Global Head of Regulatory Affairs. Dr. Waclawski is an industry veteran and a recognized leader in regulatory affairs with over 35 years of multinational experience in the FDA regulatory approval process, including Biologics License Applications (BLAs), New Drug Applications (NDAs), and FDA Advisory Committees.
"Tony’s unique regulatory experience within one of the largest global pharmaceuticals, makes him exceptionally well qualified to join the BrainStorm leadership team,” commented Chaim Lebovits, BrainStorm’s Chief Executive Officer. “He has held leadership roles in many of the key functions of regulatory, including regulatory strategy and operations, establishing a track record of success for many development stage and marketed products. Dr. Waclawski will enhance our global regulatory strategy, as we work to bring better treatment options to patients afflicted with ALS and other neurodegenerative diseases. We look forward to the strategic contributions and key insights he will bring to BrainStorm.”
Anthony Waclawski commented, “I’m very excited to join the team at BrainStorm and do all I can to help bring new therapies to patients with ALS and other neurodegenerative diseases. This is a challenging area for drug development and there is a critical need for effective and safe therapies.“
Prior to his appointment at BrainStorm, Dr. Waclawski spent 35 years of increasing responsibility at Bristol-Myers Squibb, most recently as Vice President and Head, Regulatory and Pharmaceutical Sciences, Cardiovascular, Immunosciences, Fibrosis, and Genetically-defined diseases. In this role, he was responsible for the strategic and operational deliverables of regulatory, biostatistics, clinical pharmacology, and pharmacometrics for the development assets in these areas. Dr. Waclawski’s experience spans a broad range of regulatory capabilities across multiple therapeutic areas and geographies, guiding successful FDA interactions and establishing and executing successful global regulatory strategies.
Dr. Waclawski holds a Ph.D. in Pharmaceutical Sciences, a Master of Pharmaceutical Science, and a Bachelor of Science in Pharmacy from Rutgers University.
The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. https://finance.yahoo.com/news/brainstorm-appoints-pharmaceutical-veteran-anthony-123000324.html