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DIA Annual Canadian Meeting

Transformation with Collaboration


Speakers

  • Lisa  Chartrand

    Lisa Chartrand

    • Director, Regulatory Affairs and Quality Management
    • Hoffmann-La Roche Limited, Canada

    Lisa Chartrand began her 20 year 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 and Quality Management in 2014. Lisa is an active member of both Innovative Medicines Canada's Regulatory Affairs Committee and 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 the Toronto Institute of Pharmaceutical Technology in Quality Assurance.

  • Loretta  Del Bosco

    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  Frappier, PhD

    Fiona Frappier, PhD

    • Senior Policy Analyst
    • Health Canada, Canada

    Fiona Frappier is a Senior Policy Analyst at the Biologics and Genetic Therapies Directorate of the Health Products Food Branch. Fiona supports Branch work in applying the Canadian Food and Drug Act and Regulations by developing Guidance to Sponsors regarding submission requirements for clinical trial applications and new drug submissions. Previous work experience includes policy development and coordination, public health system design and transformation, fostering research and stakeholder engagement. Prior to joining BGTD Fiona has worked with Health Canada and the Public Health Agency of Canada on multi-jurisdictional policy issues such as climate change, antimicrobial resistance and genomics.

  • Melissa  Hunt, MSc

    Melissa Hunt, MSc

    • Acting 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 to working at Health Canada, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has worked as a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within MHPD, as well as on the core team Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Most recently she has taken a position as the Interim Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Therapeutic Products Directorate.

  • Marc  Lamoureux

    Marc Lamoureux

    • Manager, Digital Health Division, Medical Devices Bureau
    • Health Canada, Canada

  • Rania  Mouchantaf, PhD

    Rania Mouchantaf, PhD

    • Manager
    • Marketed Health Product Directorate, Health Canada, Canada

    Dr. Rania Mouchantaf has over 10 years of experience in the area of pharmacovigilance and drug safety. In addition to her role as manager, Dr. Mouchantaf has led the standardization of the risk management planning process in Canada and is actively involved in the regulatory modernization of other various pre and post-market processes. Before entering the government Dr. Mouchantaf worked in the area of business development at Paladin labs in Montreal. Her education includes a Bachelor degree in Microbiology and Immunology and a doctorate degree in Pharmacology and Therapeutics from McGill University. She also completed a post-doctoral fellowship at the University of Montreal in the area of oncology and breast cancer-research.

  • Lissa  Murseli

    Lissa Murseli

    • 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 F. Poitras, PhD, MBA

    Marc F. 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 10 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

    Kristin Willemsen, MS

    • Director of Scientific & Regulatory Affairs
    • Consumer Health Products Canada, Canada

    Kristin Willemsen is the Director of Scientific and Regulatory Affairs for Consumer Health Products Canada. Since 2008, she has been working with members to influence the regulation 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.

  • Andrew  Atkinson

    Andrew Atkinson

    • 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

    Marilena Bassi, MA

    • 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 Director of the Bureau of Policy, Science and International Programs with the Therapeutic Products Directorate at Health Canada.

  • Karen  Feltmate

    Karen Feltmate

    • 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).

  • Sarah  Berglas

    Sarah Berglas

    • 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.

  • Matthew  Bown

    Matthew Bown

    • Senior Policy Advisor
    • Natural and Non-Prescription Products Directorate, Canada

  • Mugdha  Chopra, DDS

    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  DiMuzo

    Jason DiMuzo

    • Label Review Coordinator, Non-Prescription Drugs Evaluation Division, BLSS
    • 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

    Zsuzsanna Gesztesi, MD

    • Director, Patient Safety and Medical Information
    • AstraZeneca Canada Inc., Canada

  • Mary  Hill

    Mary Hill

    • 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.

  • Ian   Hodges

    Ian Hodges

    • 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.

  • Shelina  Karmali

    Shelina Karmali

    • 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

    Yatika Kohli, PhD, MBA

    • Vice-President, Regulatory Affairs and Project Office
    • Medicago Inc, Canada

    Dr. Yatika Kohli is a candid professional of strategic foresight & business acumen with over 15 years of experience in leading Research to Launch activities in a fast-paced, high growth environment at global bio-pharma companies. She has expertise in developing global regulatory & clinical strategy of biologics and biosimilar products with project management experience across several therapeutic areas and technical initiatives. She has registered 2 US vaccines at Sanofi Pasteur and 1 EU biosimilar at Apotex. Currently as VP of Regulatory Affairs and Project Office at Medicago, she is working on development and registration of plant-derived influenza vaccine.

  • James  Lee

    James Lee

    • 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.

  • C. Michelle  Limoli, PharmD

    C. Michelle Limoli, PharmD

    • Senior International Health Sciences Advisor, Office of the Director, CBER
    • FDA, United States

    Dr. Limoli is currently with FDA's Center for Biologics' International Team serving as the Senior International Health Science Advisor.

  • Celia  Lourenco, PhD

    Celia Lourenco, PhD

    • Interim Senior Executive Director, Therapeutic Products Directorate
    • Health Canada, Canada

    Dr. Celia Lourenco has been with Health Canada for over 17 years and has been the Senior Executive Director of the Therapeutic Products Directorate since July 2017. She previously held the position of Director of the Bureau of Gastroenterology, Infection, and Viral Diseases from 2014 to 2017. Dr. Lourenco represents Health Canada at the International Council on Harmonization (ICH) and is currently the vice-chair of the International Pharmaceutical Regulators Programme (IPRP).

  • Sanjeev  Miglani, MD

    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.

  • Tammy  Mitchell-Moore

    Tammy Mitchell-Moore

    • 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.

  • Yola  Moride, PhD, FISPE

    Yola Moride, PhD, FISPE

    • Professor, Faculty of Pharmacy
    • University of Montreal, Canada

    Yola Moride PhD FISPE, Pharmacoepidemiology and risk management. Full Professor at Université de Montréal, Research Professor at Rutgers University, President of YOLARX Consultants (Montreal, Paris); Past-President of the International Society for Pharmacoepidemiology (ISPE), Past Vice-President of the International Society of Pharmacovigilance (ISoP) and currently on the Steering Group of ENCePP (EMA). She was a member of CIOMS Working Group IX on Practical Approaches to Risk Minimisation.

  • Joe  O’Neill

    Joe O’Neill

    • 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

    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

    Craig Simon, PhD

    • Associate Director, Bureau of Metabolism, Oncology and Reproductive Sciences
    • 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 Y. Smith, PhD, MPA

    Meredith Y. Smith, PhD, MPA

    • Global Risk Management Officer, Global Patient Safety
    • Amgen Inc., United States

    Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience in the pharmaceutical industry. She has served on numerous FDA expert panels and on CIOMS WGs VIII, IX and XI. Currently, she is the Pharmacovigilance Track Chair for the 2019 DIA Annual Meeting Planning Committee. Recently, she led the effort to develop the RIMES Statement, a set of quality reporting guidelines for risk minimization evaluation studies.

  • Rachel E. Sobel, DrPH, MPH, FISPE

    Rachel E. Sobel, DrPH, MPH, FISPE

    • Senior Director, Epidemiology - Group Lead
    • Pfizer Inc, United States

    Dr. Sobel is a Group Lead, Epidemiology, Worldwide Safety and Regulatory group at Pfizer. In her >18 year career, her responsibilities have included general epidemiology support and contributing to the design, implementation, and evaluation of risk management strategies for medicines in a number of therapeutic areas.

  • Katherine M. Soltys, MD

    Katherine M. Soltys, MD

    • Director
    • 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

    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.

  • Alicia  Li

    Alicia Li

    • 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.

  • Robert  Ghiz

    Robert Ghiz

    • 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.

  • Shanti  Gidwani, MHA, MSN, RN

    Shanti Gidwani, MHA, MSN, RN

    • National Director, Healthcare
    • Cisco Systems Canada, Canada

  • Pierre  Sabourin, MBA

    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

    Marcin Boruk, MBA, MSc

    • Senior Policy Analyst
    • Health Canada, Canada

  • Michael  Duong

    Michael Duong

    • 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

    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

    Siofradh McMahon, MSc

    • Senior Manager, Clinical Translation and Regulatory affairs
    • CCRM, Canada

  • Marta  Motta

    Marta Motta

    • 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

    Kelly Robinson, MSc

    • Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
    • 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 is the Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics in the Biologics and Genetic Therapies Directorate where she leads a team of multi-disciplinary scientists and clinicians who are responsible for reviewing biotherapeutic and radiopharmaceutical drug submissions. Kelly is also involved in initiatives such as international work sharing, HTA alignment and policy related to submissions relying on third party data. Kelly has an MSc from the University of Aberdeen in Scotland and a BSc from Queen’s University in Kingston.

  • Bruno  Rodrigue

    Bruno Rodrigue

    • Director, Office of Legislation and Regulatory Modernization
    • Health Canada, Canada

  • Daniel  Zikovitz, PhD

    Daniel Zikovitz, PhD

    • Principal Digital Solutions Architect
    • GE Healthcare Canada, Canada

  • Kristen  Beausoleil

    Kristen Beausoleil

    • 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

    Megan Bettle, PhD

    • Director, Regulatory Review of Drugs and Devices
    • Health Canada, Canada

    Megan Bettle joined Health Canada as a drug safety reviewer for biologics and blood products. A graduate of the Health Canada Science Management Development Program, she has broad regulatory experience in pre-and post-market drug regulation, developed the rules for the first commercial medical marijuana program, and conducted surveillance of tobacco and illicit drug use. She is now Director of the Regulatory Review of Drugs and Devices (R2D2) initiative; a multi-year project aimed at improving access to medicines for Canadian patients. Megan has a PhD from the Department of Pathology at Queen’s University, followed by post-doc work on the genetics of a rare developmental disease and on developing novel molecules to treat hemophilia.

  • David K. Lee

    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

    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

    Alain G. Musende, PhD

    • Manager, Regulatory Advertising Section
    • Marketed Health Products Directorate, 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

    Lauren Neighbours, PhD, RAC

    • Head of Regulatory Affairs
    • PSI CRO, United States

    Lauren Neighbours, PhD, RAC is Head of Regulatory Affairs at PSI where she leads regulatory strategy and operations in North America. Lauren has over 10 years of research experience within industry, government, and academic settings. She has led multidisciplinary product development programs from the pre-IND/CTA stage through marketing, partnering with companies to develop and refine strategic development plans, design and execute Phase 1-4 clinical studies, lead regulatory submissions, and provide support for regulatory authority meetings and consulting needs. Lauren has authored a variety of clinical and regulatory documents, and has contributed to over a dozen IND/CTA and marketing application dossiers.

  • Janice  Parente, PhD

    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.

  • Ruth  Hansson

    Ruth Hansson

    • 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

    Léo Bouthillier, PhD

    • Director, Bureau of Cardiology, Allergy and Neurological Sciences
    • Health Canada, Canada

    Dr. Léo Bouthillier is currently the Director of the Bureau of Cardiology, Allergy and Neurological Sciences, in the Therapeutic products Directorate. Previous to that he was a manager in the Office of Clinical Trials in TPD and also worked over the years in other programs such as the Pest Management Regulatory Agency and the Marketed Health Products Directorate. He obtained is Ph.D. in the field of toxicology from Université de Montréal.

  • Julie  Chateauvert, MS

    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.

  • Kathleen  Hodgkinson

    Kathleen Hodgkinson

    • 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.

  • Nadine  Kolas

    Nadine Kolas

    • 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.

  • Heather  Logan

    Heather Logan

    • 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

    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.

  • Keith  McIntosh

    Keith McIntosh

    • 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

    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.

  • Nadia  Giancaspro

    Nadia Giancaspro

    • Senior Policy Analyst
    • Health Canada(Hpfb), 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

    Brian O'Rourke

    • President and Chief Executive Officer
    • Canadian Agency for Drugs and Technologies in Health, Canada

  • Jared  Rhines

    Jared Rhines

    • General Manager
    • AKCEA Therapeutics Canada Inc, United States

    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.