The Academy of Translational Medicine (ATM) is launching a new micro-credential in regulatory affairs featuring a outstanding team of instructors and guest lecturers from across the regulatory landscape, academia and industry.
We’re excited to announce the world-class team of instructors below, whose wealth of knowledge and real-world experience will help learners gain a foundational understanding of Canadian and global regulatory systems, processes and stakeholders.
The micro-certificate consists of two courses, which can be taken individually or in sequence. Learn more about the micro-credential and register here.
This fall’s instructors are:
Dr. Tania Bubela
Dr. Bubela is the Dean of the Faculty of Health Sciences at Simon Fraser University. Prior to this, she was Professor and Associate Dean (Research) in the School of Public Health and Adjunct Professor in Alberta Business at the University of Alberta (UofA), Canada. She joined the faculty of the UofA in 2004 after clerking for The Honourable Louise Arbour at the Supreme Court of Canada, articling at Field Law LLP in Edmonton, and being called to the bar (Law Society of Alberta) in 2005. Her research program in intellectual property and health law, focused on translational biomedical research, brings together her legal training and a PhD in biology and expertise in genetics and molecular biology. Her research program focuses on large collaborative science networks in genomics, gene therapy, and stem cell biology.
Fenton Fong
Fenton Fong will be teaching Biomanufacturing and Quality Control, including federal legislation, regulations and guidance documents set out the requirements for good manufacturing practices (GMP).
Fenton has nearly 30 years of corporate and consulting experience in Biotechnology, Pharmaceutical, and related industries. Fenton’s expertise spans CMC manufacturing, Quality & Regulatory, with a deep understanding of the application of GMP’s in different environments.
He has participated in and managed a variety of multi-faceted GMP projects and project teams:
- CMC team member for blockbuster parenteral product NDA
- design, construction and commissioning of pharma manufacturing facilities and sterile product manufacturing
- review and evaluations of Cell & Gene Therapy manufacturing processes
- kilo-lab and pilot plant scale manufacturing
- QA Manager for OTC Contract Manufacturer
- QA Manager for biopharmaceutical (sterile product) manufacturer
- numerous domestic & international GMP and QMS remediation projects
Fenton is a ISO9001:2015 certified Lead Auditor and a PDA Editorial Board member (JPST).
Isabelle Gerges
Isabelle Gerges is the Senior Director of Quality and Regulatory Affairs at Medtronic Canada.
Isabelle joined Medtronic in November 2003 and since that time, has held various roles with increasing responsibilities and experience in medical devices, pharmaceuticals, radiopharmaceuticals, narcotics and controlled substances, natural health products and human cells, tissues and organs. Isabelle is currently on the Canadian Leadership Team at Medtronic Canada and leads a team of professionals in the strategic direction and execution of regulatory and quality compliance activities extending from importation, distribution, post-market vigilance and advocacy.
With 22 years of experience in a rapidly evolving healthcare industry, a recent graduate of the University of Toronto Rotman School of Management Initiative for Women in Business, Isabelle values the benefits of growing through learning. A strong thought leader, skilled in building teams to accelerate growth, foster collaborative approach to decision making and shape organizational efficiencies.
Outside of Medtronic, Isabelle strives to maintain a balanced approach to life, where health, family, career, and altruism can live in harmony.
Trina Graham
Trina Graham graduated with a B.Sc. in Biology from Simon Fraser University and started her career in the pharmaceutical industry in 2000. She has been employed by industry leaders Johnson & Johnson, Roche and Sanofi. Ms. Graham has been employed in both commercial roles and medical education where she developed accredited programs targeted to the learning needs of physicians. Since 2013 she has been working in oncology, where she developed her interest in precision medicine and companion diagnostics. In 2020, she completed her Master’s in Biomedical Diagnostics, through the College of Health Solutions at Arizona State University.
Melanie McPhail
Melanie McPhail is the Education Coordinator for the Regulatory Affairs in the Life Sciences Micro-Credential Courses. In addition, Melanie is a Research Associate at Simon Fraser University in the Faculty of Health Sciences and a Doctoral Student at the University of British Columbia in the Faculty of Law. Melanie’s research interests include pharmaceutical and health product regulation, health law and policy, ethics, and regulatory theory. The focus of her doctoral research is novel regulatory authorization and reimbursement approaches for innovative health products. Melanie also serves as an Alternate Member with Expertise in Law on the Health Canada- Public Health Agency of Canada Research Ethics Board.
Dr. Jay Park
Dr. Jay Park is an Assistant Professor in the Department of Health Research Methods, Evidence and Impact at McMaster University’s Faculty of Health Sciences. Jay has previously acted as the Director of Trials Research for Cytel Inc and as an Associate Director of Trials Research at MTEK Sciences. He has provided consulting services to the Bill and Melinda Gates Foundation related to trial simulation and planning in clinical trial investments made by the Foundation. Jay was part of the Master Protocol resources development by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University. He recently wrote a book with the Cambridge University Press titled “Introduction to Adaptive Trial Designs and Master Protocols” that will be published in March 2023.
Dr. Samantha Pollard
Samantha Pollard will be teaching Health Products Evaluation, including clinical epidemiology and biostatistics study the effects of healthcare decisions.
Dr. Pollard is a Senior Methodologist within the Department of Cancer Control Research at BC Cancer. She holds a BA in Philosophy from the University of British Columbia, an MSc in Health Research Methodology from McMaster University, and a PhD in Population and Public Health from the University of British Columbia. Dr. Pollard uses mixed methods approaches to evaluate precision oncology innovations from the perspectives of publicly funded health system payers, clinicians, patients, and members of the public.
Dr. Dean Regier
Dr. Regier is Associate Director of the UBC Faculty of Medicine Academy of Translational Medicine, a Senior Scientist at the BC Cancer Research Institute, and an Associate Professor at UBC’s School of Population and Public Health. Over the past 15 years Dr. Regier’s research has examined translational medicine and the economics of precision medicine, focusing on generating patient-oriented and real-world evidence for sustainable learning healthcare systems. Dr. Regier has been a successful applicant in research grants nationally (Genome Canada, Genome British Columbia, the Canadian Institutes of Health Research) and internationally (US National Institutes of Health, National Institute for Health and Care Research), raising over $15 million in funding as principle investigator and $50million as co-investigator. He has presented this work at leading international academic institutions, with invitations from the US National Academies of Sciences, Australian Genomics, Harvard University, and the University of Oxford. Embedded as part of the BC Cancer Research Institute, Dr. Regier’s research lab employs 15 early career researchers, research staff, and graduate-level trainees. Dr. Regier is Deputy Editor at the International Journal of Technology Assessment in Health Care and currently serves on BC’s Drug Benefit Council, which makes evidence-informed recommendations to the Ministry of Health about the listing of drugs on the provincial PharmaCare program formulary.
Nancy Shadeed
Nancy spent most of 30 years working as a regulator with Health Canada, along with 6 years in regulatory affairs in the pharmaceutical industry.
Nancy worked in many different roles in Health Canada, starting out as a medical device evaluator. In 1994, she was part of a working group that was responsible for developing the revised medical device regulations and later would lead the finalization and publication of the regulations in 1998.
Nancy helped develop the division responsible for the licensing of medical devices and led a team that provided the classification of medical devices, and interpretation of the licensing requirements for medical devices in Canada.
She has been involved in medical device harmonization activities since 1999, first on the Global Harmonization Task Force. Nancy chaired a sub group related to In Vitro Diagnostic Devices, in which this group published many guidance documents on the principles of classification rules and technical requirements for conformity assessment.
Since 2013, Nancy was involved with the International Medical Devices Forum (IMDRF) as a management committee member, working group chair of the Regulated Product Submission, and member of the working groups Software as a Medical Device, and the Unique Device Identification System. She was also a key player in the development and operationalization of the Medical Devices Single Audit Program (MDSAP).
Jean Smart
Jean Smart is the Regulatory Affairs and Quality Officer (Clinical Trials BC) and Privacy Officer with Michael Smith Health Research BC. She has participated in numerous provincial and global regulatory initiatives and is currently active on national and international project committees, teams and boards. Her education and specializations are in global health (research), and development studies in research policy and governance. She has with an interest in research program development, training and growing a research culture.
Jean will be teaching Clinical Trial Regulations: Overview and Processes, including key concepts in clinical trial regulations.
Nicole Taylor Smith
Nicole is a recognized expert in U.S. and international medical device/medtech/pharma and digital health regulatory law and policy. With deep experience as a former U.S. Food and Drug Administration official, and now as a senior executive in the private sector, she effectively builds consensus-driven bridges and public/private partnerships that lead to successful, measurable outcomes. From 2008-2016 Nicole served in various roles at FDA, including Associate Chief Counsel in the Office of the General Counsel and Health and Human Services at FDA headquarters and Acting Deputy Country Director and Assistant Country Director in FDA’s office in Beijing, China. Her roles in the private sector include Vice President, Global Regulatory Policy, Medtronic, and Senior Director, Global Policy & Intelligence, Johnson & Johnson.
Deirdre Weymann
Deirdre Weymann is a Senior Health Economist within Cancer Control Research at BC Cancer and the Canadian Centre for Applied Research in Cancer Control (ARCC). She is a co-investigator in the Canadian Network for Learning Healthcare Systems and Cost-Effective ‘Omics Innovations (CLEO), the Precision Oncology Evidence Development in Cancer Treatment (PREDiCT) program, and a member of the Terry Fox Research Institute Marathon of Hope Cancer Centres Network’s (TFRI MOHCCN) Health Technology Assessment Working Group. Deirdre holds a Master’s degree in Economics from the University of Victoria and her research centres on economic analyses of precision medicine. Her recent work uses quasi-experimental study designs to evaluate genomic technologies and considers machine learning to facilitate real-world data analysis.