Our Team
The team at the BioMedical Strategy group applies their deep and diverse experience to develop creative, efficient, and cost-effective regulatory pathways to introduce your product to new global markets.
Orna Oz, Ph.D.
Founder & CEO
Dr. Orna Oz is a Clinical and Regulatory Affairs specialist with more than thirty years of experience in the Regulatory, Pre-Clinical, and Clinical research fields. In academia (as a senior researcher), as well as in the medical industry, Orna has led multidisciplinary research projects and teams, gaining vast experience in project Strategic Planning, Pre-Clinical Testing (bench and animal), Clinical Studies, and Regulatory submissions.
She holds a M.Sc., in Mathematics and Natural Sciences from The University of Rome, and a Ph.D. in Physics (Medical Physics) from Tel Aviv University, where she published her pioneering research in the field of linear and non-linear, time and frequency domain, signal analysis of hemodynamic parameters for the analysis of the cardiovascular control mechanisms.
After her long academic experience, as a senior researcher, Dr. Oz joined in 1996 the biomedical industry.
Rina Lev, Ph.D.
Executive Manager,
Clinical, Regulatory & Quality Expert
Dr. Lev is a Scientific Regulatory and Clinical Affairs consultant with over twenty five years of experience in the Medical Device industry. During this time, Rina has led multidisciplinary projects in the Clinical, Regulatory, and QA fields that included among others, the preparation of Clinical and Regulatory Strategies (IL, EU, US, China), Clinical Evaluation Reports (EU), management of Clinical Trials activities worldwide and Quality System management (Quality planning, CAPA, Risk management). Rina has a broad scientific background, she holds a M.Sc., in Clinical Biochemistry from Tel Aviv University and a Ph.D. in Clinical Neurophysiology from the Faculty of Medicine from the Technion, where she published her scientific work.
Batya Barkan, Ph.D.
Clinical & Regulatory Affairs Expert
Dr. Barkan is a Scientific Regulatory and Clinical affairs consultant with over 15 years of experience in the Regulation of Medical Devices in the U.S. and Europe. Batya has vast gained experience preparing and supporting Regulatory submissions, Clinical Studies, Clinical Evaluation Reports, and other scientific reports supporting the scientific, technological, and clinical demonstration of developing products as well, as Post-Market Surveillance information. Batya holds a M.Sc. in Neurobiochemistry and a Ph.D. from the Department of Neurobiology, Life Science Faculty of Tel Aviv University.
Elena Boim
Regulatory Affairs & Quality Control Expert
Elena has over thirty years of experience in strategic planning, developing and implementing Quality controls (QMS) in numerous and various Medical Device companies. She has a proven comprehensive knowledge and understanding in the field of Medical Device Standards and Regulations, critical when establishing QMS and successfully completing worldwide leading Regulatory Authorities audits. She has proven experience in QMS establishment and compliance maintenance, OBL process, Design Control and Risk management, outsourced production processes, QMS software validation as well as statistical methods implementation. Elena holds a Master’s Degree in Physics from the Saratov State University (Russia), CQT Certificate (Certified Quality Technician) from the American Society for Quality, ICQT Certificate (Israeli Certified Quality Technician) from Israeli Society for Quality, Six Sigma and Lead Auditor Certificates.
Anna Sterkin, Ph.D.
Scientific Expert
Dr. Sterkin has extensive experience in clinical research & medical device development of more than 20 years. Anna has conducted academic research in the field of clinical neuroscience, yielding methodological developments in neurophysiology and behavior in healthy subjects and patients, including newborn VEP, Event-Related Potentials (ERP), Functional Magnetic Resonance Imaging (fMRI) and eye tracking. Her research focused on neuro-physiological substrates, development, and rehabilitation of the visual perception under normal conditions and following pharmacological manipulation. Anna has also led preclinical and clinical stages of medical device development in the industry and served as a regulatory clinical reviewer and scientific expert. Anna holds a Ph.D. in Brain Research from the Weizmann Institute of Science.
Tilda Barliya, Ph.D.
AI & Translational Research Expert
Dr. Barliya is a scientist with over fifteen years of experience in life sciences and biomedical innovation. Her career spans academic and clinical research, including projects in tumor biology, CAR-T immunotherapy, and the application of advanced imaging technologies for cancer detection. In recent years, she has specialized in artificial intelligence, developing models for histological image analysis and mutation detection, as well as founding an AI-focused initiative that brings practical technological solutions to biomedical research and product development. She holds a Ph.D. in Tumor Cell Biology from Tel Aviv University and completed postdoctoral fellowships at Cornell University in New York and the University of North Carolina, Chapel Hill.