Aurélie Schwarzbach has over 15 years of experience in the clinical research field. She is currently a senior project manager at Gamida Cell, a Jerusalem-based company, that she joined 7 years ago. She has been managing several clinical activities in studies of different phases, mainly Phase I-II and Phase III studies. More recently, she has orchestrated the clinical activities and documents preparation for the submission of a Biologics License Application (BLA) for omidubicel, an advanced cell therapy of Gamida Cell advanced cell therapies (www.gamida-cell.com).
VP Clinical & Regulatory Affairs
A Doctor of Veterinary Medicine from the Hebrew University of Jerusalem, Dr. Shalev Stein has nine years of experience as a clinical trials and regulatory affairs leader at innovative medical device companies.
Dr. Shalev has led clinical trials at several medical device companies, including Nuvo Group, CarboFix Orthopedics, and Oridion Medical, managing trials from concept to execution, with clinically significant results for FDA and CE approvals (510K and de novo).
Mrs. Erlich is a senior regulatory, clinical trials, and compliance expert for the health-care and medical device industry. She has served as a senior management member and held VP positions in national startups and international health-care companies since 2003. As part of her job, she managed large company teams, delineated the regulatory and compliance strategy and led its implementation, leading to multinational market clearance, including the EU, USA, South America and the Japanese market. She also designed and managed multinational multisets clinical trials and submissions. In addition, since 2001, she also served as a senior consultant in the PushMed group and N.G.I.T, for more than 70 medical device companies in miscellanies clinical fields. As a consultant she established quality systems, lead the design control process to support successful regulatory submissions, supported the company during CE audits and FDA inspections, and tailored regulatory and clinical strategy. She also held meetings with regulatory bodies, including notified bodies and FDA, and managed clearance file submissions, such as a Technical File, 510(k) notices and post market activities.
Tsvia Erlich joined ConTIPI Medical, as Regulatory and Clinical Affairs officer in 2007.
She holds a BSc. degree (cum laude) in Biochemistry and Food Engineering from the Hebrew University in Jerusalem. Later, she graduated the Technion Institute of Technology, Haifa and received her M.Sc. degree (cum laude) in Biotechnology and Food Engineering, in 1993. During that time she completed her research in the field of protein engineering at the laboratory of Professor Yuval Shoham, at Technion Institute.
She holds CQE and CQM certificates since 1999 and is an active member of RAPS and she lectures at national and international conferences.
Aida Bibliowicz has wide-ranging experience in drug development and clinical development international programs. Prior to joining RedHill Ms. Bibliowicz worked as Director, Project Management and Regulatory Affairs at Cato Research Israel, overseeing large multinational clinical studies in various indications. Ms. Bibliowicz holds a M.Sc. in Quality Assurance and Reliability from the Israel Institute of Technology, Technion, and an MBA from the Tel Aviv University.
Dina Kofler has been with Medinol since 2013. As VP Clinical Affairs, she leads the clinical department and manages all clinical trial activities including the pivotal trials that constituted the clinical basis for the EluNIR DES’ approval in the United States, Europe and Israel. Before joining Medinol, Dina worked at MediWound Ltd. and prior to that she worked for 14 years at Teva Pharmaceutical Industries Ltd and held various clinical-trial management positions. She holds B.Sc. in Biology from the Tel Aviv University and an MBA from the Herriot-Watt University’s Edinburgh Business School.
Irit is the current VP of clinical operations for Gamida Cell. Her tasks include Management of Clinical Department (clinical trial managers) and clinical activities with Clinical Investigators, CRO’s and other vendors. Irit and her team design and update the clinical operational strategy Plan.
Prior to Gamida, irit was the head of clinical development and Cartiheal
