Quebec LNG In Person Event: BIO Québec Breakfast Panel Discussion: Overcoming Regulatory Challenges in Biologics Development Through Proactive Planning

Marcel Bassil M.Sc, Ph.D, C.C.R.P., LSSGBC

Marcel is a Biochemist with a Master’s and PhD in Medical Physiology and over 19 years of experience in biomanufacturing and GMP operations. A seasoned leader in GMP compliance, regulatory strategy, and technology transfer, he has spearheaded transformative projects across Africa, Europe, and North America. He has proven expertise in GMP implementation of biologics, including biosimilars, monoclonal antibodies, recombinant proteins, vaccines, and cell therapies across multiple expression systems.  Previously, Marcel served as MSAT Director at the Institut de Pasteur a Dakar, strengthening Africa’s biomanufacturing capacity.  He also led in design, engineering and operationalization of Canada's first Canadian owned biological and gene therapy manufacturing facility, a landmark achievement in North American biotech.

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Ibtissem Helal

Clinical Compliance & Licensing Specialist, Sandoz Canada

Ibtissem Helal is a Quality Assurance and Regulatory professional with over eight years of experience supporting pharmaceutical products from early development through regulatory submission and market launch. She holds two Master’s degrees in Genetic Engineering & Molecular Biology and Industrial Microbiology. Ibtissem has contributed to Canadian submissions for innovative products, injectables, and biosimilars and currently specializes in clinical compliance.  

She is recognized for her proactive, submission-focused approach and is passionate about mentoring students, academic innovators, and biotech start-ups in building strong regulatory foundations early.

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Esther Tremblay

Quality Assurance and Regulatory Affairs Consultant, GMP Consultants Inc

A strategic professional with over 25 years of experience in compliance and regulatory affairs, including more than 6 years with biologic drugs, particularly the drug products coming from plasma fractionation. Esther led the regulatory compliance activities of several organizations, ensuring the timely approval and maintenance of their portfolios of drug products. Her various roles include managing regulatory submissions, providing strategic compliance advice, qualifying suppliers, conducting internal and external audits, and collaborating with cross-functional teams to support business objectives. She coordinated due diligence and identified potential compliance and regulatory risks for product development and licensing projects.  

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Tunde Golemar PhD

Associate Director of Project Management, Ability Biotherapeutics

Tunde Golenar, PhD is currently Associate Director of Project Management at Ability Biotherapeutics. Previously she was at Congruence Therapeutics as Principal Scientist. Tunde holds a Phd from McGill University in oncology. Since starting her industry career she has been working on various early and pre-clinical phases of small molecule drug and antibody therapeutics development

Richard Vaillancourt Ph. D.

Director of Quality Assurance, C3i Center

Currently Director of Quality Assurance at the C3i Center in Montreal, Richard oversees the quality management system, ensures GMP compliance across the organization, and prepares the team for regulatory inspections. He was also part of the inspection team that secured Health Canada’s establishment license and the EMA’s GMP certification for C3i for the manufacturing of cell therapy products.

Previously, he supported several clinical manufacturing programs at the Center of Excellence in Cell Therapy (Maisonneuve-Rosemont Hospital), where he managed GMP documentation, batch release, deviation and CAPA systems, as well as qualification activities for cleanrooms, equipment, and computerized systems.

Richard holds a Ph.D. in biochemistry from McGill University. He is recognized for his strong communication skills, collaborative approach, and deep expertise in managing regulatory expectations for advanced therapies.

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