Followers | 144 |
Posts | 27709 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Wednesday, September 02, 2020 9:42:54 AM
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.
About NurOwn®
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
Recent BCLI News
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/24/2024 08:30:50 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 09/17/2024 07:32:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 08:36:41 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/09/2024 04:15:04 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 08/28/2024 09:01:02 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/16/2024 11:00:19 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 12:01:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 11:15:21 AM
- Form PRER14A - Preliminary Proxy Soliciting materials • Edgar (US Regulatory) • 08/06/2024 08:59:18 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 08/05/2024 09:11:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 08:05:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/24/2024 08:05:18 PM
- BCLI Update - Progress Supports Our 10x Plus Value Range Potential • PR Newswire (Canada) • 07/24/2024 12:30:00 PM
- BCLI Update - Progress Supports Our 10x Plus Value Range Potential • PR Newswire (US) • 07/24/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/19/2024 08:05:57 PM
- Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation • PR Newswire (US) • 06/14/2024 04:01:00 PM
- Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation • PR Newswire (Canada) • 06/14/2024 04:01:00 PM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM