Director, Regulatory Strategy and Policy , Hoffmann-La Roche Limited, Canada
Lisa Chartrand began her career in the industry with Apotex as a quality assurance chemist and found her passion in Regulatory Affairs when she joined EMD Serono in 1999. At Roche Canada since 2003, she has enjoyed many growth opportunities in Regulatory Affairs and Medical Affairs and was appointed Director, Regulatory Affairs in 2014. Lisa is co-chair and an active member of Innovative Medicines Canada's Regulatory Operations Team and a member of BioteCanada's Biologics Regulatory Affairs Group (BRAG). Lisa earned her Bachelors of Science in Microbiology and Immunology from McGill University in Montreal, Quebec and holds a certificate from TIPT in Quality Assurance.
Loretta Del Bosco
Director, Regulatory Affairs Quality Assurance Operations, AbbVie Corporation, Canada
Loretta has spent several decades in the Canadian pharmaceutical industry and is the current Director, Regulatory Affairs, Quality Assurance and Operations, AbbVie Canada, the Vice-Chair of Canada’s Innovative Medicines Canada Regulatory Affairs Committee and member of BIOTECanada’s Subsequent Entry Biologics Committee and Biologics Regulatory Affairs Group. A member of the McGill University Faculty of Science Advisory Board and Microbiology and Immunology McGill graduate.
Fiona M Frappier, PhD
Senior Policy Analyst, Health Canada, Canada
Fiona Frappier is a Manager in the Office of Policy and International Collaboration at the Biologics and Radiopharmaceutical Drugs Directorate of the Health Products Food Branch at Health Canada. She has a PhD in HIV Immunology and 10 years of experience on multi-jurisdictional policy issues including COVID-19, rare diseases, genomics and antimicrobial resistance.
Melissa Hunt, MSc
Director, Health Canada, Canada
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.
Manager, Digital Health Division, Medical Devices Directorate, Health Canada, Canada
Marc has worked for Health Canada’s Medical Devices Directorate since 2011 specializing in the regulation of medical software, diagnostic imaging devices, and radiotherapy equipment. He is vice-chair of Canada’s Subcommittees for IEC TC62B and TC62C (Diagnostic Imaging and Radiotherapy) and is a co-chair of the International Medical Device Regulators Forum’s Cybersecurity Working Group. He is currently the lead for Health Canada’s Building Better Access to Digital Health Technologies initiative and is now the manager of the Digital Health Division within the Medical Devices Directorate at Health Canada.
Rania Mouchantaf, PhD
Acting Executive Director, Marketed Pharmaceuticals Bureau, Marketed Health Prod, Health Canada, Canada
Dr. Rania Mouchantaf has over 15 years of experience in the area of pharmacovigilance and drug safety. Her career at Health Canada has spanned a number of roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety, efficacy and quality throughout the drug lifecycle. She has also led on policy development and implementation of risk management planning in Canada. Her education includes a Bachelor degree in Microbiology and Immunology and a doctorate degree in Pharmacology and Therapeutics from McGill University.
Manager, Health Canada, Canada
Lissa Murseli is a manager at Health Canada's Health Products and Food Branch, within the Policy, Planning and International Affairs Directorate. Prior to this, Lissa was a senior advisor to Health Canada’s Deputy Minister, where she helped to coordinate a range of regulatory and policy files. Lissa's previous experience includes regulatory and operational roles within the office of Health Canada that regulates tobacco products. Lissa completed a Master of Public Health and Bachelor of Science at the University of British Columbia.
Marc Poitras, PhD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
Dr. Poitras has worked at Health Canada in different capacities in Pharmacovigilance and drug safety for the last 13 years. His undergraduate and graduate training includes a BSc in Biotechnology and MSc/PhD degrees in Pharmacology from the University of Sherbrooke. He also completed post-doctoral training programs in cellular biology and neuroscience at Johns Hopkins University and New York University. He then completed a MBA at the University of Ottawa. Dr. Poitras is currently working as a Scientific Manager at the Marketed Health Products Directorate.
Kristin Willemsen, MS
Vice President, Scientific & Regulatory Affairs, Food, Health & Consumer Products of Canada, Canada
Kristin Willemsen is the Vice President of Scientific and Regulatory Affairs at Food, Health & Consumer Products Canada. Since 2008, she has been working with members to influence the regulation, policy and administration of over-the-counter drugs and natural health products. Kristin earned a Masters of Science from the University of Ottawa and is a Certified Association Executive.
Manager, Emerging Sciences Policy, Health Canada, Canada
Andrew Atkinson has been the Manager of Emerging Science Policy, Strategic Policy Branch, Health Canada since 2011. His group provides science and policy coordination across Health Canada’s regulatory and research groups, addressing nanotechnology, genomics, synthetic biology and precision medicine sectors. Prior to joining Health Canada, Andrew managed ecological new chemical and nanomaterial risk assessment programs at Environment Canada.
Marilena Bassi, MA
Senior Executive Director, Therapeutic Products Directorate, Health Canada, Canada
Marilena Bassi has been with Health Canada since 2004 where she has held various policy, evaluation and performance management related positions. Currently she is the Senior Executive Director of the Therapeutic Products Directorate at Health Canada.
President, Redstone Health Group, Inc., Canada
Karen Feltmate is the President of Redstone Health Group Inc., a consulting firm providing regulatory strategy and guidance to the innovative Pharmaceutical industry. Karen has over 20 years of corporate executive experience primarily in the area of Canadian Federal registration and also manufacturing, packaging, quality and distribution. Karen holds a B.Sc. in Biology from McMaster University. She is a past Board member of both the Canadian Pharmaceutical Distribution Network (CPDN) and the University of Toronto Biotechnology Bridging Program. She is a member of the Drug Information Association, and was a founding member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA).
Patient Engagement Officer, CADTH, Canada
Sarah Berglas works with 160 patient groups to contribute to the CADTH Common Drug Review and pan-Canadian Oncology Review and with teams and committees to integrate patient perspectives into assessments. Sarah supports individual patients to contribute to CADTH early Scientific Advice and leads initiatives to further the practice of patient engagement in health technology assessment. Prior to joining CADTH in 2010, Sarah worked for ten years in the private sector in healthcare public relations in the UK. She holds a BA and a BSc from Monash University, Australia, and Diploma in Public Policy and Program Evaluation from Carleton University, Canada.
Senior Policy Advisor, Natural and Non-Prescription Products Directorate, Canada
Matthew has been working at Health Canada for the last 15 years. During this time he has specialized in the areas of compliance and enforcement of natural health products, quality requirements for active pharmaceutical ingredients, risk management and the development of regulatory reform for non-prescription drugs and natural health products. Presently, Matthew Bown is the policy lead for the development of the Self-Care Framework and its three phases. Along with a small team at NNHPD, Matthew is responsible for the development of Departmental positions on a variety of issues, including the oversight of the development of regulatory proposals.
Mugdha Chopra, DDS
Co-Founder and Director, AWINSA Life Sciences, United States
Dr. Mugdha Chopra, Co-founder and Director of AWINSA Life Sciences, is a dental Surgeon by qualification with post-graduation in Clinical Research. She has an overall experience of 16 years, with extensive and deep-rooted knowledge of various Pharmacovigilance data bases, systems and processes. Her vast experience in the implementation of large Pharmacovigilance projects is another feather in her cap. She has been a speaker at various national and international conferences. She began her journey with a successful stint in Ranbaxy where she achieved excellence in management of Pharmacovigilance compliance. Later, she worked as Associate Vice President of Pharmacovigilance and Clinical Safety at APCER.
Jason DiMuzio, MS
Label Review Coordinator, Non-Prescription Drugs Evaluation Division, Health Canada, Canada
Jason DiMuzio serves as the Label Review Coordinator in the Natural and Non-prescription Health Products Directorate. Jason brings expertise in plain language labelling in support of label reviews. Previously, he worked as an NHP Coordinator and as a Scientific Evaluator. Jason holds a Master of Science in Health: Science, Technology and Policy (Carleton University) and an Honours Bachelor’s Degree with Specialization in Chemistry (University of Ottawa).
Zsuzsanna Gesztesi, MD
Director, Patient Safety and Medical Information, AstraZeneca Canada Inc., Canada
Zsuzsanna Gesztesi, MD is the Director Patient Safety and Medical Information at AstraZeneca Canada since 2015. Prior to joining AstraZeneca, Zsuzsanna worked for a major Patient Support Program provider where she established and lead the Pharmacovigilance group, as well as Clinical Research Organizations.
Manager, International Unit, Health Canada, Canada
Mary Hill has over 20 years’ experience in both the regulatory and scientific area of health products. Ms. Hill’s career has also included working in the healthcare field. She currently leads the International Unit and activities in the Office of Policy and International Collaboration within Health Canada’s Biologics and Genetic Therapies Directorate. Ms. Hill was Health Canada’s lead for the Secretariat of the International Coalition of Regulatory Authorities. Ms. Hill has a BSc. in Physical Therapy from the University of Toronto and a Bachelor of Industrial Design from Carleton University.
Manager, Policy Development, Office of Drug Policy and Science, Health Canada, Canada
Ian Hodges is a policy manager in the Office of Controlled Substances at Health Canada. He is responsible for substance use policy development and managing the federal approach to substance use, the Canadian Drugs and Substances Strategy. He also has experience as senior policy advisor to the Deputy Minister of Health on substance use issues in Canada.
Executive Director, Canadian Treatment Action Council, Canada
Shelina has extensive leadership experience in the not-for-profit sector. She is a seasoned senior executive with national and international experience in leading and growing organizations. As a patient advocate, Shelina champions the voice of lived experience in policy making. A natural relationship builder, Shelina believes that all stakeholders need to be involved in developing innovative and integrative approaches to resolving persistent social injustices.
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer, NoNO Inc, Canada
Dr. Yatika Kohli is an accomplished Senior Regulatory Professional with strong leadership skills, strategic foresight and business acumen. At NoNO Inc, Dr. Kohli is leading all strategic and global regulatory initiatives for NoNO’s products. With more than 20 years of experience in Biotech/Pharmaceutical industry, Dr. Kohli has expertise in developing global regulatory and clinical strategy with project and product management across multiple modalities and jurisdictions. She led the regulatory activities for the registration and launch of two blockbuster vaccines for Sanofi Pasteur in the USA and Apotex’s first biosimilar product in Europe.
Director, Innovation Solutions Group, Jones Packaging, Canada
James is the Director, Innovation Solutions Group with Jones Packaging based in London Ontario, a leader in folding carton, labelling and contract filling. James focuses on new packaging technologies for tomorrow and their potential outcomes for consumers, patients and brandowners. He has over 20 years of experience in prepress and print production with global packaging organizations. He also serves as co-chair of the IntelliPack leadership council, a joint initiative between PAC and Intelliflex to promote adoption of smart packaging by brands, retailers and consumers.
Michelle Limoli, PharmD, RPh
Senior International Health Science Advisor, Office of the Director, CBER, FDA, United States
Michelle Limoli is the Senior International Health Science Advisor in FDA’s CBER. She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at FDA, she has coordinated activities in various harmonization and multilateral initiatives such as ICH, VICH, ICCR, GHTF, IMDRF, APEC RHSC, OECD, and WHO. Michelle joined CBER after having worked in the Center for Drug’s international programs, and the Office of the Commissioner, where Michelle served as the Director of FDA’s Europe Office. Michelle is a clinical pharmacist with both hospital and community pharmacy experience.
Celia Lourenco, PhD
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.
Sanjeev Miglani, MD
Founder and Director, AWINSA Life Sciences, United States
Dr. Sanjeev Miglani is the founder and Director at AWINSA Life Sciences. Sanjeev is an MD in Internal Medicine and has more than 18 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities for Pharmacovigilance, medical writing, medical affairs and Clinical research. Sanjeev was also Senior Resident in the Cardiology and Medicine Departments in renowned hospitals of New Delhi. Sanjeev is also a fellow of IACM.
Associate Director, Regulatory Affairs, Eisai Limited, Canada
Tammy Mitchell-Moore has over 16 years of experience in Regulatory Affairs starting at GSK in 2002, moving to Nycomed in 2007, UCB Canada in 2010 and to Eisai Limited in 2017. Prior to Regulatory Affairs, Tammy worked as an analytical chemist for 8 years, with two years in the environmental sector and 6 years in pharmaceutical development. Tammy’s regulatory knowledge expands across numerous therapy areas, most extensively in neurology, respiratory and oncology. Since 2017, Tammy has become involved with BIOTECanada’s Biologics Regulatory Affairs Group (BRAG). She earned her BS degree at the University of Guelph in 1996 specializing in environmental protection and attended Seneca College’s Regulatory Affairs program in 2001.
Director, Product Security & Services, Johnson & Johnson, United States
Colin Morgan, Director of Product Security & Services at Johnson & Johnson, is responsible for leading the company’s Global Product Security & Services Program. The Product Security Team’s mission is to ensure all products of the Johnson & Johnson Family of Companies are built on Cybersecurity best practices and Cybersecurity Risks in marketed products are properly managed to support customer’s safety and security. Colin has worked in the Cybersecurity field for a number of organizations including the Central Intelligence Agency and as a contractor for the National Oceanic & Atmospheric Administration. He is a featured speaker on Cybersecurity and is passionate about the integration of the competency across all industries.
Yola Moride, PhD, FISPE
President, YolaRX Consultants, Canada
Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral Fellowship in Pharmacovigilance from the University of Bordeaux (France). She was President of the International Society for Pharmacoepidemiology (ISPE) and Vice-President of the International Society of Pharmacovigilance (ISoP). She also served on the Steering Group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicines Agency, and was a member of CIOMS Working Group IX on risk min.
CEO, Accelera Pharma Canada, Canada
Joe O’Neill has 20+ years of commercial experience at various levels in the healthcare industry. Joe is the CEO of Accelera Pharma, a solutions focused provider of Pharmaceutical and Biotech products to the Canadian Healthcare Community. Joe is also a co-founder of Liffey Biotech and KinaRx. Prior roles include President Americas / Chief Commercial Officer, at ADIENNE SA, a Swiss biotech company and Sanofi Genzyme (Boston) in various senior commercial positions, most recently as Sr. Director Marketing, US Hematology & Oncology Business. Joe resides in Toronto, ON.
Jeannine Ritchot, MA
Executive Director of the Regulatory Policy and Cooperation Directorate, Treasury Board of Canada Secretariat, Canada
Ms. Jeannine Ritchot has over 15 years of experience working for the Government of Canada. In June 2016, she joined the Regulatory Affairs Sector of the Treasury Board of Canada Secretariat as Executive Director, Regulatory Policy and Cooperation Directorate. She exercises a central oversight role in the implementation of Canada’s federal regulatory policy framework, the Cabinet Directive on Regulation, by ensuring that regulators comply with the good regulatory practices set out therein. Ms. Ritchot also leads the Government of Canada’s domestic and international efforts at regulatory alignment with key trading partners. She advises and supports Global Affairs Canada in the negotiation of regulatory measures in trade agreements.
Craig Simon, PhD
Acting Director, Bureau of Pharmaceutical Sciences, TPD, Health Canada, Canada
Craig Simon has worked for Health Canada in the field of drug regulation since 1996, becoming Manager of the Division of Biopharmaceutics Evaluation 1 in 2002. He also worked as Associate Director of the Office of Clinical Trials from 2008 to 2010 and of the Bureau of Pharmaceutical Sciences from 2013 to 2018. Dr. Simon is currently Associate Director in the Bureau of Metabolism, Oncology and Reproductive Sciences. He has also served as an expert resource for the WHO and the USP and as Co-Chair of the IGDRP Bioequivalence Working Group.
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.
Rachel E Sobel, DrPH, MPH, FISPE
Executive Director, Head of Pharmacoepidemiology, Regeneron , United States
Dr. Sobel has over 24 years of experience in epidemiology, risk management, and registries. She is currently Head of Pharmacoepidemiology at Regeneron in Global Patient Safety and has held roles of increasing responsibility at Pfizer Inc and UBC, a CRO. She has extensive experience in the use of RWE for regulatory decision making and using epidemiology to support multiple aspects of drug safety, such as post-authorization safety studies and Risk Evaluation and Mitigation Strategy (REMS) for FDA, EMA, and others. Her work has been published in multiple peer review journals, and she is also an active member of the International Society of Pharmacoepidemiology (ISPE), where she has held a number of leadership positions.
Katherine M. Soltys, MD
Director, Office of Clinical Trials, Pharmaceutical Drug Directorate, Health Canada, Canada
Dr. Soltys received her MD degree and completed her post-graduate training at the University of Saskatchewan. In addition to her regulatory work, Dr. Soltys maintains part time clinical practice at The Ottawa Hospital Cancer Centre where she is involved in the care of patients with lung cancer.
Wendy Ungar, PhD, MSc
Senior Scientist, The Hospital for Sick Children Research Institute, Canada
Wendy Ungar is a Senior Scientist at The Hospital for Sick Children, Professor in Health Policy, Management & Evaluation, University of Toronto and Director of Technology Assessment at SickKids (TASK). Dr. Ungar conducts economic evaluation in child health with a current focus on genomics and autism. In 2017 Dr. Ungar was appointed Chair of the Ontario Genetics Advisory Committee with a mandate to make funding recommendations on emerging genetic testing technologies for Ontario. In 2010 Dr. Ungar’s book Economic Evaluation in Child Health was published by Oxford University Press.
, Health Canada, Canada
Alicia Li holds a Master of Biotechnology from the University of Toronto and a Bachelor of Science from McGill University. Prior to starting her 10-year career at Health Canada, she completed internships at sanofi Pasteur, AstraZeneca Canada and GlaxoSmithKline in various roles including regulatory affairs and international clinical study management. She is currently a Senior Policy Analyst in the Office of Legislative and Regulatory Modernisation. She has led the implementation of several key legislative and regulatory proposals within the Health Products and Food Branch. She also worked as a Regulatory Project Manager at the Therapeutic Products Directorate and a Senior Policy Advisor in the Biologics and Genetic Therapies Directorate.
President and CEO, Canadian Wireless Telecommunications Association, Canada
Robert Ghiz is President and CEO of the Canadian Wireless Telecommunications Association (CWTA) and Chair of the Mobile Giving Foundation Canada. Twice elected Premier of Prince Edward Island, Robert’s accomplishments included his successful stewardship of PEI’s economy through the 2008 global financial collapse, overseeing its record-setting economic growth following the recession, implementing full-day kindergarten for the first time in the province’s history, and leading successful trade missions in Europe, Asia, South America and the United States. Robert is a proud champion of Canada’s wireless industry and its ability to enhance the lives of people across the country.
Pierre Sabourin, MBA
Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory authority for health products and food in Canada and internationally. Mr. Sabourin was the Senior Vice-President, at Canada Mortgage and Housing Corporation (CMHC) from 2013 – 2014. From 2010 to 2013, he held the position of Vice-President, Operations at Canada Border Services Agency. He also filled senior management positions up to Assistant Deputy Minister at the former Department of Foreign Affairs and International Trade.
Marcin Boruk, MBA, MSc
Manager RMOD, HFPB, Health Canada, Canada
Marcin Boruk has been with Health Canada since 2005 and has worked in the areas review, legislation and business transformation. Currently he is a manager in the Information Sciences and Openness Division, Health Canada supporting the branch in projects related to data governance, stewardships and standards.
Director, Evidence Generation, Medical Affairs, Hoffmann-La Roche Limited, Canada
Michael is the Director for Personalized Healthcare and Evidence Generation for Hoffmann-La Roche Limited. Michael is responsible for Roche’s strategy to advance the personalization of healthcare, as well as, managing the medical research portfolio in Canada. Michael received his undergraduate degree in Biology and Pharmacology and a Ph.D. in Medical Sciences with a specialization in Neuroscience, both from McMaster University.
Sarah Lussier Hoskyn, MA
Senior Analyst, Regulatory Affairs and Market Access, Innovative Medicines Canada, Canada
Sarah Lussier is passionate about sound economic analysis to support policy development in the area of health care. She came to Innovative Medicines Canada in 2015 to support the organization and its members with economic analysis and research. She has produced research on regulatory performance, public reimbursement timelines, private market forecasts and cost drivers, international pricing comparisons, and the drug insurance coverage landscape. Prior to working at IMC, Sarah spent 9 years at IQVIA doing health economics and pricing strategy consulting. Sarah graduated from the University of Waterloo with a Master’s in Economics, and from McGill University with a Bachelor’s in Economics.
Siofradh McMahon, MSc
Senior Manager, Clinical Translation and Regulatory affairs, CCRM, Canada
Global Director of Client Solutions, Welocalize Life Sciences, United States
With more than a decade experience in the life sciences industry, Marta Motta has worked with several leading global pharmaceutical companies and CROs. She has played a key role in helping them with business process automation, change management and workflow standards, allowing them to achieve their business goals through a range of solutions from pre-clinical to post-marketing support. Ms. Motta has extensive expertise within multiple areas of the life sciences industry and regularly advises customers on language and translation solutions for global clinical studies, regulatory submissions, patient recruitment, ePRO and mobile apps.
Kelly Robinson, MSc
Director General, Marketed Health Products Directorate, Health Canada, Canada
Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly has been involved in initiatives such as international work sharing, HTA alignment and policy related to submissions relying on third party data. Kelly has recently rejoined the Marketed Health Products Directorate as the Director General.
Director, Office of Legislation and Regulatory Modernization, Health Canada, Canada
Daniel Zikovitz, PhD
Principal Digital Solutions Architect, GE Healthcare Canada, Canada
Dr. Dan Zikovitz is currently the Principal Digital Solutions Architect at GE Healthcare Canada. He has 20 + years healthcare and technology industry experience, coupled with significant domain expertise in areas of Analytics, Artificial Intelligence, Cloud Computing and Simulation used to solve pragmatic clinical, operational and health system challenges. Dr. Zikovitz is a Digital Ambassador for GE Healthcare, with focus on GE’s next generation of data, analytics and digital health platforms to promote innovation, constructive disruption and empower health systems, hospitals and care providers to impact patient outcomes. He is an Advisory Board Member for the Ontario Brain Institute.
Manager, Economic Analysis, Office of Legislative and Regulatory Modernization, Health Canada, Canada
Kristen Beausoleil graduated with a Bachelor of Arts in English from Bishop’s University in 1998 and a Bachelor of Laws from Dalhousie University in 2001. She was called to the bar in 2002 and started her public service career that same year. She has almost two decades worth of experience working in various departments on regulatory and legislative reform; she is currently a manager in the Office of Legislative and Regulatory Modernization at Health Canada.
Megan Bettle, PhD
, Health Canada, Canada
Megan Bettle joined Health Canada in 2005 as a drug safety reviewer, after a PhD and research in molecular biology and the genetics of rare diseases. Since then, she has taken on a number of roles in pre- and post-market drug review, cannabis policy, and tobacco and illicit drugs surveillance. She is currently the director of the Centre for Regulatory Excellence, Statistics and Trials in the Biologics and Genetic Therapies Directorate, a horizontal science team including regulatory intelligence, drug submissions management, regulation of clinical trials for biologics, pediatric strategies, and ongoing work on Health Canada’s Regulatory Review of Drugs and Devices.
David K. Lee
Chief Regulatory Officer for Health Product and Food Branch, Health Canada, Canada
David K. Lee is the Chief Regulatory Officer for the Health Products and Food Branch, Health Canada.He was previously the Director of the Office of Legislative and Regulatory Modernization. In this capacity, he led modernization initiatives for the Food and Drugs Act and Regulations. Prior to that he was the Director of the Office of Patented Medicines and Liaison. David received his law degree at Queen’s University and articled at the Federal Court of Canada. He has lectured extensively on intellectual property law and food and drug law both nationally and internationally.
Maxwell Morgan, JD, LLM
Lead Legal & Policy Advisor, Structural Genomics Consortium (SGC), Canada
Max leads open science policy development and outreach, as well as translational initiatives for open innovation, at the Structural Genomics Consortium (SGC). Prior to joining SGC, he worked as an intellectual property litigator and pharmaceutical regulatory lawyer, and more recently served as in-house counsel with Grand Challenges Canada. Max holds a B.Sc. from McGill University, a J.D. from the University of Toronto, and an LL.M. from Harvard Law School. He is a member of the Law Society of Ontario and the New York State Bar.
Alain G. Musende, PhD
Manager, Section for Transparency and Advertising Regulatory Surveillance, Marketed Health Products Directorate, Health Canada, Canada
Doctor Musende is a Manager at the Marketed Health Products Directorate (MHPD), which oversees regulatory advertising activities of regulated marketed health products. Additionally, as a commitment to transparency, Health Canada is publishing summaries of its Safety Reviews and Alain’s section leads this publication. Doctor Musende possesses a Bachelor of Science degree in chemistry (Université du Québec à Montréal), a Master’s degree in pharmaceutical sciences (University of British Columbia), and a Ph.D. in pathology and laboratory medicine (University of British Columbia). Dr. Musende is as well a part-time professor at the University of Ottawa, where he teaches biopharmaceutical sciences courses.
Lauren Neighbours, PhD, RAC
Sr. Director and Head, Regulatory Affairs, Istari Oncology, United States
Lauren Neighbours, PhD, RAC oversees the regulatory strategy, compliance, and program management for the Optum Digital Research Network. Lauren has over 15 years of research experience within industry, government, and academia. Lauren led multidisciplinary development programs from the pre-clinical stage through marketing. Lauren has managed regulatory submissions and clinical studies, facilitated FDA meetings, and authored corporate SOPs.
Janice Parente, PhD
President and CEO, Orion Human Research Accreditation, Canada
Janice completed her PhD and Post-Doctoral Fellowship in Molecular Pharmacology, and worked at the Director level within global pharma. In 1992, Janice established her credentials as a successful and respected business leader and entrepreneur by founding the ethica Group of Companies. Janice’s commitment to the protection of human research participants was exemplified when her company’s HRPP was accredited in 2006, becoming the first in Canada and first CRO accredited worldwide. To emphasize Canadian research participant protection and Canadian human research excellence, in 2017, Janice founded Canada’s first human research accrediting body, Orion HRA. Janice currently serves as the President and CEO of Orion HRA.
Policy Analyst, Health Canada, Canada
Ruth Hansson has worked at Health Canada for over 15 years in the policy office at the Biologics and Genetic Therapies Directorate. In her role as Policy Analyst, she specializes in the guidance development process from concept to publication.
Léo Bouthillier, PhD
Director, Bureau of Cardiology, Allergy and Neurological Sciences, Therapeutic P, Health Canada, Canada
Julie Chateauvert, MS
Senior Scientific Project Coordination Biologist, Health Canada, Canada
I completed my master’s degree at the University of Ottawa where I studied mercury accumulation in foodwebs. During my studies I developed an interest in the management of species at risk which I pursued as a Species at Risk Biologist with Fisheries and Oceans Canada. In 2015 I joined Health Canada where I currently lead a team that is developing environmental assessment regulations and industry guidance for new active ingredients in human and veterinary drugs. I am particularly interested in creating and validating regulatory tools for the environmental assessment of pharmaceuticals and international harmonization of technical requirements.
Associate Professor of Medicine, Memorial University, Canada
Dr. Kathleen Hodgkinson is an associate professor of clinical epidemiology and genetics in the Faculty of Medicine at Memorial University. She holds a Doctor of Philosophy (with distinction) in Medicine. Dr. Hodgkinson was the recipient in 2017 of the Marilyn Harvey Memorial University award for excellence in human research ethics, and alongside her colleagues, Dr's. Young, Pullman and Connors received the 2018 Governor General's Innovation Award. Her input was central to the identification of the ARVC TMEM43 gene and mutation (p. S358L) in 2008, and her recent work has shown that genetic testing and subsequent treatment has resulted in an increased lifespan in ARVC males with the TMEM43 p.S358L mutation of 31yrs.
Senior Policy Analyst , Health Canada, Canada
Nadine is the policy lead for advanced cell therapies in Health Canada’s Biologics and Genetic Therapies Directorate. She received her PhD in molecular genetics from Albert Einstein College of Medicine in New York City, and conducted post-doctoral work at the Lunenfeld-Tanenbaum Research Institute in Toronto. With expertise including reproductive biology and early mechanisms of cancer development using mouse models and genomics approaches, her work has been published in journals including Science and Cell. Nadine has held fellowships from CIHR, The Terry Fox Research Institute, EIRR21, and won the 2008 Polanyi Award for medicine/physiology from the Ontario government.
Vice-President, Pharmaceutical Reviews , Canadian Agency for Drugs and Technologies in Health, Canada
Heather Logan, CADTH Vice-President, Pharmaceutical Reviews (Acting), with responsibility for the CADTH Common Drug Review, the pan-Canadian Oncology Drug Review, therapeutic class reviews, and optimal use projects, also drug-related Environmental Scans, Horizon Scans, and Rapid Response. Heather and her team deliver high-quality, relevant, and timely assessments of drugs using the best available science, tools, and methodologies. Heather has over 20 years’ experience working with local and national decision-makers, and has a background as a Nursing Officer in the Canadian Armed Forces, health care administrator and systems leader.
Susan Marlin, MSc
President & CEO, Clinical Trials Ontario, Canada
Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established in 2012 to improve the environment for conducting clinical trials. Prior to joining CTO she was the Associate Vice-Principal of Research at Queen’s University and worked for many years with the National Cancer Institute of Canada Clinical Trials Group. Susan has engaged in research ethics over the years serving on research ethics boards. She was President of the Canadian Association of Research Ethics Boards and is currently a member of several boards and committees supporting clinical research and innovation in health care.
Executive Director, Scientific & Regulatory Affairs, Innovative Medicines Canada, Canada
Keith McIntosh is Executive Director, Scientific & Regulatory Affairs at Innovative Medicines Canada, and joined the organization in 2012. Previously, Keith spent 12 years in progressively senior policy and regulatory roles at another trade association. He has successfully advocated industry positions to federal, provincial and municipal departments and agencies covering a diversity of issues and topics. Keith has primary responsibility for the association’s interactions with Health Canada’s drug review bureaus, and developing the association’s positions on regulatory proposals and amendments. He also supports the work of the Regulatory Affairs and PMPRB committees, among others.
Setu Purohit, JD
Co-Founder, President, Chief Legal Officer, Avicanna Inc., Canada
Setu is a lawyer and entrepreneur with experience in complex corporate and legal strategy, contract negotiations, and litigation. He has been involved in the cannabis industry for several years as an advocate for patients’ rights and advising healthcare professionals, licensed cannabis producers, and other corporate and regulatory stakeholders in Canada and abroad. Setu has received a Bachelor of Commerce degree from the University of Ottawa and Juris Doctorate (JD) degree from the University of Western Ontario. Prior to co-founding Avicanna, Setu operated his own private practice for several years.
Senior Policy Analyst, Health Canada, Canada
Nadia Giancaspro has been with Health Canada since 2001. She is a Senior Policy Analyst within the Therapeutics Directorate of the Health Products and Food Branch. Her latest work has been focused on the development of regulations, policies and guidance on issues related to special access to drugs in Canada, the opioid crisis, H1N1, and other emergency-related issues.
Brian O'Rourke, PharmD
President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health, Canada
Dr. Brian O’Rourke is the President and Chief Executive Officer of CADTH. He joined CADTH in January of 2009 following a distinguished career as a Pharmacist and Health Service Executive with the Canadian military. With over 30 years of experience in health care, Brian actively positions CADTH as the leading Canadian source of evidence-informed advice on managing pharmaceuticals and health technologies. He has a Bachelor of Science in Pharmacy from Dalhousie University and a Doctor of Pharmacy from the University of Toronto.
General Manager, AKCEA Therapeutics Canada Inc, Canada
Jared Rhines is General Manager of Akcea Therapeutics Canada and serves as the Chair of IMC's Regulatory Affairs Committee. He is an experienced pharmaceutical executive with multi-faceted, international, orphan drug experience, including country management, developing global markets, and managing end-to-end drug and device development in Canada, Asia, Latin America, and the United States. In addition, he has extensive clinical, regulatory, and commercialization experience in both pharmaceuticals and medical devices, specifically in rare diseases. Mr. Rhines completed his undergraduate education at the University of Pennsylvania and received his MBA at Duke University’s Fuqua School of Business.
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