NEW YORK, Oct. 26, 2017 (GLOBE NEWSWIRE) -- AIT Therapeutics Inc. (AITB), a clinical-stage biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with serious lung infections, today announced it has made three key new hires to support its clinical development and regulatory progress. Joining the Company are Giora Davidai, M.D. as Chief Medical Officer, Rhona Shanker as Director of Regulatory Affairs, and Professor Asher Tal, M.D. as Senior Vice President of Clinical Research.
“I am delighted to welcome these extraordinarily talented industry veterans to our growing team. As we move toward initiating two pivotal clinical studies in 2018 with our inhaled NO therapy, their knowledge and experience will be invaluable for AIT,” said Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “Giora provides us with critical expertise in executing advanced clinical and post-marketing studies. Rhona’s vast knowledge of the many facets of the regulatory process gives the AIT team the structure it needs to succeed. Asher has helped AIT since the early days, so to have him come on board in this role is quite special for us.”
Giora Davidai, M.D., joins AIT from Boehringer Ingelheim (BI), where he oversaw clinical development, most recently as Executive Director and Department Head of Established Products in Clinical Development and Medical Affairs. Dr. Davidai also served as the head of Cardiovascular, Metabolic, CNS, and Respiratory, Clinical and Medical Affairs. Prior to BI, Dr. Davidai held various management roles at Glaxo Wellcome (GW), establishing the Global Bone Research team within GW R&D, in addition to leading clinical development as Global Medical head for Migraine, Headache, Epilepsy, and Smoking Cessation. Dr. Davidai is a Board-Certified physician in Pediatrics and Pediatric Nephrology and received his medical degrees from Tel Aviv Sackler School of Medicine, Haifa Medical Center and Duke University School of Medicine.
Rhona Shanker joins AIT as a seasoned regulatory affairs expert having reviewed thousands of medical device applications during her 35-year career as an FDA/CDRH/ODE expert regulatory reviewer and FDA regulatory consultant. Throughout her distinguished career, Ms. Shanker focused on developing strategies for complying with FDA pre- and post-market regulatory requirements, including: developing regulatory strategies for pre-market submissions, planning IDE, 510(k), PMA, HUD, HDE, and CE projects; preparing 510(k), IDE, PMA, Design Dossiers, and Clinical Evaluation Reports for submission. Ms. Shanker has been an invited speaker at multiple medical and regulatory affair conferences, expositions and webinars. She graduated from Emory University with a degree in Biology and has co-authored several professional publications.
Asher Tal, M.D., Professor of Pediatrics and Founder of the Pediatric Pulmonary Unit at Soroka Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel, joins AIT as Senior Vice President of Clinical Research. During his 25 years as head of the Department of Pediatrics at Soroka, Professor Tal authored or co-authored over 100 publications. His research interests include childhood asthma, bronchiolitis and wheezing in infancy, sleep-disordered breathing, pediatric and adult obstructive sleep apnea syndrome and insomnia. During his esteemed career, Dr. Tal was responsible for developing the Tal score for assessing the severity of bronchiolitis in infants, which is now the accepted clinical measure of severity of respiratory infections in clinical and research settings.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care. AIT Therapeutics is advancing its revolutionary NO respiratory targeted system in clinical trials for the treatment of bronchiolitis and nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
AIT Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care. AIT Therapeutics is advancing its revolutionary NO respiratory targeted system in clinical trials for the treatment of bronchiolitis and nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
