Our board of directors
P.Eng, B.Sc., I.E.
Director of Business Development, Stantec
Ben Lee brings over 25 years of experience in all aspects of Project Management. He has successfully delivered over $1B in major projects in the biotechnology, pharmaceutical, hospital and manufacturing sectors from concept to completion.
Mr. Lee has comprehensive knowledge and practice of current GMP, GLP, FDA and CFR 21 Part 11. He possesses direct and extensive experience in project planning such as benefit-cost analysis, life cycle costing, feasibility studies, change control, operational/technical requirements, analysis & optimization, functional/space programming, land use and environmental approvals. Mr. Lee has been invited to speak at several associations, including the ISPE conference as a keynote speaker.
President, QIE Consulting
David has over 20 years of experience in the pharmaceutical industry in various roles from Research, Vaccine Production, CSV Compliance and Project Management. Areas of specialization pertain specifically to computer system implementations for all types of CSV systems from simple Lab systems to Global Custom CRM / ERP systems. He is a mentor and collaborative leader, who leads by example, experience and a thorough knowledge of current IT / manufacturing practices. In addition, Mr. McSweeney is an instructor at NSU and AAPS for CSV. David is recognized for his high personal standards for performance and ensuring that all aspects of compliance and data integrity are captured during implementations.
CPA, CA, FP&A
Senior Accountant, Taro Pharmaceuticals Inc.
Faraz is a Chartered Professional Accountant with extensive experience across functional areas of financial accounting and reporting under IFRS and ASPE, management reporting, analysis and forecasting, system designing, audit, taxation and general accounting. He is currently working as Senior Accountant at Taro Pharmaceuticals Inc., a research-based, international, specialty pharmaceutical company listed on NYSE that develops, manufactures and markets prescription and over-the-counter pharmaceutical products. Faraz started his career with PricewaterhouseCoopers and has worked at various organizations across the service and manufacturing sectors.
MBA Business, B.Sc. and M.Sc. Microbiology
AvP, Global Head R&D Product CMC Portfolio and Clinical Supply Chain, Sanofi Pasteur
Joan Bevilacqua has more than 30 years of experience in the pharmaceutical industry, specifically in Vaccine development and licensure. Currently she is the Global Head of R&D Product CMC Portfolio and Clinical Supply Chain, Sanofi Pasteur. Her career has spanned across several vaccine areas, and has included roles in analytical strategy and development of new analytical methods in Quality Control and in R&D as Head of Analytical Research & Development North America, in Clinical Development, and as Global R&D Project Leader. As Global Project Leader, she has successfully led seven new vaccine license submissions in Canada, US , and Europe. Over the years, she has had direct experience in cGMP, cGLP, cGRP, and in strategic lifecycle management of the vaccines globally. As a seasoned leader at Sanofi Pasteur, Joan has had the opportunity to be involved in the design and delivery of a number of strategic corporate business simplification and efficiency programs as well in a several employee development initiatives, in addition to being an employee mentor/coach and a member of the Joint Labour Management Committee.
B.Sc. Chemistry, B.S.P. Pharmacy, M.Sc.Phm. Pharmacy, Ph.D. Health Economics
Health Outcomes Scientific Leader, Latin America, Eli Lilly Canada Inc.
Manny Papadimitropoulos graduated in Pharmacy from the University of Saskatchewan and has worked in retail pharmacy, the pharmaceutical industry, and academia over the last 25 years. His pharmacy experience has been primarily in health economics, and clinical research. He has a master's in Pharmacy and a Ph.D. in Health Economic Evaluation from the University of Toronto in Canada. Manny is currently the Health Outcomes Scientific Leader, Latin America at Eli Lilly and Company. He is also an adjunct assistant professor at the University of Toronto, Faculty of Pharmacy, in the Administrative/Social Pharmacy area. Manny’s areas of research are in HTA and decision analysis, and is a supervisor of three graduate students.
Charles M. Chee
B.Sc., Honours Co-op Biology, Biology
Co-Founder, Qing Bile Therapeutics Inc.
Charles Chee is a Regulatory Compliance veteran with over 35 years in the Pharmaceutical and Biotech industry. Charles is Co-Founder of Qing Bile Therapeutics Inc., a research and development pharmaceutical company engaged in finding cures to clinical disorders associated with Bile Acid imbalance. Most recently, Charles served as Vice President of Quality Assurance at LifeLabs, Corporate Vice President of Quality at Biovail Pharmaceuticals Corporation, and Vice President of Quality at Torpharm (Apotex). Charles holds a Bachelor's degree in Honours Biology from the University of Waterloo, a Certificate in Business Administration from Ryerson University and a Graduate Diploma in Christian Studies from Tyndale University College and Seminary. In the community, Charles continues to serve on several non-profit organizations.
Ph.D. MBA P.Eng RAC
Director of Regulatory Affairs, Hologic Inc.
Yuan currently serves as the Director of Regulatory Affairs at Hologic Inc. and serves as a member of the Board of Directors of several private medical device companies. Yuan worked at the U.S. Food and Drug Administration for 8+ years and as the acting Branch Chief and team lead, he led multidisciplinary review teams for 150+ medical device premarket submissions (including PMA, IDE, 510(k) and 513(g)) and 100+ compliance assignments (inspections, warning letter resolutions, recalls, ARO and trade complaints). Yuan received the prestigious FDA Outstanding Service Award for his contributions and expertise in Total Product Life Cycle (TPLC) management and the lead author on the FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. Yuan received his PhD majoring in Electrical Engineering from the University of Waterloo, MBA from Ivey Business School - Western University and is a licensed Professional Engineer (P.Eng) in the province of Ontario.
J.D., Ph.D. Chemistry, M.Sc. Chemistry, B.A. Chemistry
Partner, Blaney McMurtry LLP
Junyi practices intellectual property law with an emphasis on patent litigation and general IP matters in the areas of pharmaceuticals and other health sciences. She has appeared frequently before the Federal Court and the Federal Court of Appeal. Junyi is a Registered Patent Agent and Registered Trademark Agent in Canada, and has extensive experience in patent and trademark prosecution matters and licensing. Junyi is fluent in Mandarin and has frequently represented Chinese clients in patent and trademark litigation and in procuring their IP rights in Canada.
B.A. Commerce and Economics
President, North America Operations, Bora Pharmaceuticals
In his current role as President, North American Operations at Contract Development and Manufacturing Organization (CDMO), Bora Pharmaceuticals, Sam Ricchezza is responsible for advancing the North American growth of the company and any North American acquisition plans.
Sam has more than 25 years’ CDMO experience, and prior to joining Bora, he was President of WellSpring Pharma Services and led the company through a sale of the business. Before that, he previously held progressively responsible Business Development and Marketing roles at companies such as Patheon, DPT Labs, AAIPharma (Alcami) and Diteba Research Laboratories.
Sam has also held Board positions with the Pharma & Biopharma Outsourcing Association, where he served as Secretary of the Board of Trustees and Board Member for the Niagara Escarpment Biosphere Fund.
Vice President of People and Corporate Culture, BioVectra
Lester brings over 20 years of Human Resources experience to the Pharmaceutical Science Group with a diverse career spent in professional services, healthcare, oil and gas, government, and Contract Manufacturing. As Vice President of People and Corporate Culture at BioVectra, Lester is responsible for delivering a modern and inclusive corporate culture where employees are valued, heard, and engaged.
As a Certified Human Resources Specialist (CHRP) with a BBA from the University of Fredericton, Lester also serves as a Board Member of the Greater Charlottetown Area Chamber of Commerce.
Senior Manager International Regulatory Affairs, Bracco Imaging Canada ∕ E-Z-EM Canada Inc.
Accomplished regulatory professional with more than 20 years of in-depth experience in international regulatory affairs. A biochemist by training with a postgraduate Master’s degree in Analytical Biochemistry from the University of Quebec In Montreal. Various management positions in the biotechnology and pharmaceutical industry as a global Regulatory Affairs with various responsibilities. Led regulatory teams for submissions and approvals of various Pharmaceuticals and diverse regulatory procedures from initial marketing authorization applications to life-cycle management. Therapeutic area experience includes Cardiovascular, Obesity, diabetes, Alzheimer's and contrast, and imaging products. Extensive practical work experience in international regulations including Canada. Served on Board of directors for medical devices. currently active in industry organizations and Internship programs with the University of Montreal, Department of Pharmacy for both undergrads and postgraduate programs.
Head of Quality and Regulatory Affairs, the Conconi Family Immunotherapy Laboratory and the Genome Sciences Centre, BC Cancer
Miruna Bala is currently the Head of Quality and Regulatory Affairs at the Conconi Family Immunotherapy Laboratory and the Genome Sciences Centre, BC Cancer. She is a qualified Professional Engineer and certified project management professional. Miruna is a certified College of American Pathologists (CAP) and ISO lead auditor (BSI).
At CFIL, Miruna provides quality and regulatory affairs leadership for the development of clinical trial applications. She is experienced in CTA and NSN regulatory submissions to Health Canada.
At the GSC, Miruna is responsible for bringing key quality programs, Change Control, Audit, Validation, Document Control, and CAPA programs into compliance with various accreditation standards. She has successfully led the GSC through CAP and ISO accreditation inspections since 2011.
Miruna brings over 20 years of QMS expertise in the genomics, biotechnology, cell therapy, and nutritional supplement industries with extensive knowledge in CAP, DAP, GMP, ISO 9001, ISO 27001 and CLIA standards. She holds a Bachelor of Applied Science Degree in Biological and Process Engineering from the University of British Columbia and a Masters Certificate in Project Management from the Gustavson School of Business, University of Victoria.
Senior Corporate Regulatory Compliance and Enforcement Adviser, Health Canada
Paul Gustafson brings over 26 years of experience taking on various roles within the pharmaceutical sector. Paul is currently a Senior Corporate Regulatory Compliance and Enforcement Advisor at Health Canada with 16 years of experience as a regulator in the field of good manufacturing practices (GMP).
Paul also holds Executive Bureau positions with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) where he is currently the Deputy Chairperson and Chairperson for the Sub-committee on Harmonisation of Good Manufacturing and Distribution Practices (GMDP). PIC/S is a non-profit association registered under Swiss law that leads the international development, implementation, and maintenance of harmonized good manufacturing practices (GMP) standards and quality systems of Inspectorates in the field of medicinal products.
Within the pharmaceutical private sector, Paul’s 10 years of experience included positions in analytical chemistry, quality assurance, and senior management.
Ex-Officio, Advisory Board Representative
B.Sc. Pharm. D.T.M.
President, Zipharm International Inc.
Max is a board member, former Chairman of PSG Annual Conference Committee, and past Acting Executive Director of the PSG. As a pharmacist and entrepreneur, he is president and founder of Genpharm Inc., a major Toronto generic pharmaceutical company; part of an international group of pharma companies located in England, Ireland, Australia, New Zealand and Europe.
Max has been involved in substantial humanitarian activities, providing medicines and related humanitarian donations to third-world countries in Africa, Europe and Asia, valued at approximately $60 million. These included sizable contributions to Red Cross in North and South Vietnam for four consecutive years. Furthermore, Max visited/inspected Red Cross clinics, hospitals and humanitarian organizations in Vietnam. Max is also president and founder of Zipharm International Inc. Toronto, which provides specialized consulting services to the pharma industry relating to regulatory, government, and business affairs.
Amanda is a highly motivated and outgoing professional with over 10 years of experience in both the Pharmaceutical and Event Coordinating Industries. In addition to being a Principal Planner for a successful business, she also has an extensive background in Microbiology and Quality Control. Her career highlights include starting her own event coordinating business as well as working her way up from a Microbiology Analyst to the Department Head of Microbiology for a large contract laboratory in Toronto. She is always looking for ways to develop her skills and has been involved in many committees along her career including being an active member of the Pharmaceutical Sciences Group as well as the Hiring Committee at Seneca College School of Biological Sciences and Applied Chemistry.
Shirley completed her Masters of Health Science at Ryerson University and has experience in nutrition-related research and knowledge translation methods. She is committed to professional learning and growth and is excited to be part of the professional development initiatives at the PSG.
Lynn completed her Bachelor of Mathematics/Business Administration at University of Waterloo and has a wealth of experience in both customer service and administrative support. She is highly organized and able to work on several projects simultaneously and meet the deadlines with deliverable results. She is always striving to work hard for our members and is proud to be part of PSG team.