Management of company operations: Strategy, intellectual property, clinical development, process development, company presentations, fund raising, product development

Strategic consultancy for robust company development - eyes on target!Advanced therapies, Gene and cell therapy (CRISPR, gene therapy), GMP manufacturing, product development, preclinical development, effective management.

Expert immunologist for COVID-19 taskforce (IDF and Ministry of Heath) - The Center for Information and Knowledge in the Fight Against COVID-19. Vaccine identification and effectiveness research, Rapid antigen test for home testing, immunity to SARS-CoV-2 in the community.

My team accomplishments:- Design strategy for process and product development to support in-use clinical needs and establish a commercial level manufacturing process.- Receive FDA approval for "Thaw-and-Inject" formulation. An advanced Off-the-Shelf product, uniquely designed by us to replace the expensive-logistic intensive former product required "dose preparation" pre-treatment procedure per every patient.- Design and construction of Lineage's state-of-the-art GMP facility for the manufacturing of its embryonic stem cell derived products- Successful cGMP manufacturing of clinical doses of the new OpRegen version "thaw-and-inject" product to support the clinical trials.- Receive FDA approval for the manufacturing scale up at the new facility and clinical use of the new off-the-shelf product.

My team accomplishments:- Design and oversight the construction of CCN’s new GMP facility for the manufacturing of OpRegen and other cell therapy products at a commercial scale (-50,000 doses annually). The facility includes ISO 5 (grade B) cleanrooms, QC laboratory, controlled warehouse and a fully monitored cryogenic biorepository. - Establish full supply chain to expand OpRegen Phase I/IIa clinical trial in dry AMD to the US, including: trans Atlantic shipping studies, qualification of a dose prep lab at UCSF, development of rapid sterility testing and delivery device studies.

My team accomplishments:- Design and manage preclinical studies for OpRegen, a retinal pigmented epithelium (RPE) cell therapy, enabling an IND approval from FDA for the treatment of dry AMD. - Delivery device development and qualification- Support to clinicians in the development of the surgical procedure and a safe delivery of OpRegen into the eye. - Development of methods for identifying and characterizing OpRegen cells in vivo. - Development and qualification of a unique rapid sterility testing (2 hour long) for OpRegen which is done prior to surgery.

Discovery of the company product for cancer therapy and protection against acute radiation syndrome

Responsible for successful proof-of-concept studies in multiple indications (heart failure, neuropathic pain, limb ischemia, stroke, muscle injury, pulmonary inflammation)Developnent of the company potency assay

Serving as a consultant for an immuno-oncology startup

R&D manager in a start-up company developing a novel bio-sensor for a real time specific detection of pathogens.

My research finding published in the most prestigious journal 'Nature' (see attached pdf) describing how oxidative stress results in specific changes in protein translation that confer protection from reactive oxygen species.Research focus:Immunology, viral immunology, cellular biology, biochemistry, T cell response, antigen processing and presentation

Bacterial fermentation (up to 20,000 liters), downstream, protein purification (UF)