Valentin Fulga, MD

A seasoned life sciences executive with experience in biologics, small molecules and medical devices, Valentin is a medical doctor who has established and led companies from inception to major value inflection, including taking public one of the companies that he founded.

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During his career, Valentin has climbed all the steps of the biopharmaceutical career, starting as a research scientist and up to the President and CEO level. Implementing lessons learned at each stage and combining them with his medical education, he has led the development of several technologies from scientific concept to advanced human clinical trials. As Senior VP of Development at one of the first cell therapy companies in the world, and then as CEO of a stem cell company, he has been intimately involved in the development of cell therapy products, their manufacturing and analytical processes, while working hand in hand with the FDA and Health Canada. In addition to cell therapies, Valentin has also worked in drug and medical device development.  He has managed clinical trials, has developed clinical and pre-clinical protocols and many other regulatory documents.

Recently, Valentin advised two Fortune 500 companies along with several startups and he also participated in an international think tank debating the future of the healthcare regulatory landscape.

The combination of regulatory, product and clinical development expertise with hands-on business experience allows Valentin to find creative solutions to overcome the diverse challenges that are part of our industry’s day-to-day life.

Valentin was recognized as a Technology Pioneer by the World Economic Forum for the development of a stem cell technology for cardiovascular diseases. He is the inventor of over 50 issued and pending patents and is the author of 15 scientific and medical articles in the areas of neuroscience, cardiovascular diseases and blood. Valentin has been an invited speaker at many prestigious scientific and business meetings.

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Netta Fulga, MSc, CQA

An accomplished Quality Management and Regulatory professional and a Biochemist, with over 20 years of experience in a leadership capacity within the bio-pharmaceutical and clinical labs sectors. Netta has assisted life sciences and medical devices companies in achieving their goals.

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Netta earned her B.Sc. and M.Sc. degrees from the Hebrew University of Jerusalem. She obtained her Quality Auditor Certificate from the American Society for Quality (ASQ), of which she is an active senior member. She was certified by the Canadian Academy of Applied Pharmaceutical Sciences (AAPS) in Regulatory Affairs for Medical Devices. Netta is also a specialist in process improvement and holds a Six Sigma Yellow Belt certificate.

Netta established the Quality Management System (QMS) from inception in one of the large laboratories at the Hospital for Sick Children (Toronto, Canada), where she also served as Quality Manager. Within 2.5 years, she implemented the ISO standards, trained the staff on the QMS and led the lab to successful accreditation.

Earlier in her career, Netta was a laboratory manager in the Development Department at Bio-Technology General and then Ferring Pharmaceuticals, both large pharmaceutical companies strictly complying with the highest regulatory standards (USA, Europe and Japan).

Netta has extensive experience with all aspects of Quality Management, starting with the development of the Quality Manual, designing the entire Quality Assurance and Quality Control systems, establishing the Corrective and Preventive Action program, authorship of analytical method SOPs, designing and implementing validation protocols and reports, planning and performing internal audits, planning and execution of management review.

As an industrial research scientist, she has led and has hands-on experience with projects involving cloning and gene expression of recombinant DNA in bacterial and mammalian cell cultures, protein purification and characterization of active drug substance and drug formulation, all conducted in compliance with GLP, GMP and ICH guidelines. She is the inventor of one patent and an author of six scientific articles.

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Les Szendrovits, MSc, PhD (can)

Les has more than 25 years’ experience in all phases of healthcare, both as an executive and as a consultant.  He is responsible for the approval of over 20 products, including drugs, biologics and medical devices.

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Les worked at Organon, a multinational pharmaceutical organization later acquired by Schering Plough, as Director of Scientific Affairs, where he was in charge with managing all scientific, clinical, medical functions, and QA/QC.  He has also held the position of General Manager and senior scientific officer for a Canadian contract manufacturing organization approved by both Health Canada and the FDA.

His primary areas of interest and expertise cover North America and Europe and include regulatory, clinical, QA/QC, and product development. Other related experience includes manufacturing, toxicology, statistics, epidemiology, as well as report writing.

Les has also been involved in GMP inspections of Canadian manufacturing and clinical sites for Health Canada, FDA, and the Canadian Ministry of Research and Innovation. He has conducted foreign inspections and audits, both corporately and in conjunction with Health Canada’s Bureau of Biologics. He is also registered with Health Canada as responsible person for control and release of narcotic and controlled substances.

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