Registration partneringONE Program & Speakers

Programme

09-11 s8 Sigalit Ariely-Portnoy

Sigalit Ariely-Portnoy, Dr.

|

Sigalit Ariely-Portnoy has a BSc and PhD in Chemical Engineering and MSc in Bio-Medical Engineering, all graduated in the Technion – Israel Institute of Technology, Haifa, Israel.

Dr. Ariely-Portnoy has many years of experience in the pharmaceutical industry (15 years at Taro and Teva and 5 years at Gsap) and is very well acquaintances with pharmaceutical processes, procedures of organizational changes, projects achieving operational excellence and building of production plants and warehouses. As part of her vast experience, she has successfully led tens of regulatory audits of the Israeli MoH, the FDA, the EMA and other regulatory authorities. Dr. Ariely-Portnoy served as President of the Israeli Chapter of Parenteral Drug Association (PDA) between 2003 to 2006.

Gsap was founded by Sigalit Ariely-Portnoy, PhD, on 2009. It provides development, regulatory, quality and validation services to the pharmaceutical, biotechnology and medical industry, with a unique expertise in Cell therapy. Gsap is the biggest consulting company in these fields that leads complex large projects, which require integration of different professions, e.g. development, regulatory affairs, quality, laboratory, production, engineering and validation. Over the years, Gsap has developed methodologies to combine many departments and disciplines in the implementation process of quality setting while creating significant cooperation experience for all participants in the process: employees and managers in production plants, sub-suppliers and consultants.

Gsap staff has broad education and many years of experience in the relevant industries, which enable it to take extensive responsibility for the services provided to clients and their outcomes, to create cooperative work and achieve integrative impact. In each of the projects, the staff members lead complex decisions and bring their personal experience and the benchmark customary in the industry, as well as the most advanced methodologies, to enhance the achievement of the company goals. Gsap leads companies to significant effective re-organization and progress in every step of the process (from development to marketing) in an extent and scope of involvement suitable to their leading personnel. 25 experts are currently working in Gsap.

The cell-therapy industry has progresses in Israel during the recent years and over 20 start-ups were established and operate tirelessly to prove safety and efficacy of products in pre-clinical and clinical trials, while establishing production suits meeting authorities' requirements. Gsap operates in these challenges and their integration. The team implements extensive management skills that complement those of the small start-ups, and helps in providing a wide range of professional solutions in development, regulatory affairs, quality and validations. All of these shorten (sometimes to half) the duration of the development of the company from pre-IND to marketing. Among our clients who have used or are using our services in this field are: Pluristem, CellCure, Bonus Biogoup, Kadinmastem, Brainstorm, Cellect, Sheltagen, CellSource and Accellta.