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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

  • Melissa  Hunt, MSc

    Melissa Hunt, MSc

    • Scientific Manager
    • 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.

  • 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.

  • Rania  Mouchantaf, PhD

    Rania Mouchantaf, PhD

    • Proactive Pharmacovigilance-Risk Management Planning
    • 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.

  • Polina  Ostrovsky, MPH

    Polina Ostrovsky, MPH

    • Policy Analyst
    • Health Canada, Canada

  • 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.

  • Ashley  Zakhem

    Ashley Zakhem

    • Policy Analyst
    • Health Canada, Canada

    Ashley Zakhem is a Policy Analyst at Health Canada who works on strategic horizontal policy files related to health products, food and the opioid crisis including: marketing to kids and financial transparency.

  • Andrew  Atkinson

    Andrew Atkinson

    • USAMMDA, United States

  • 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).

  • Megan  Bettle, PhD

    Megan Bettle, PhD

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

    Megan Bettle has a PhD from the Department of Pathology at Queen’s University, followed by post-doctoral work on the genetics of a rare developmental disease, and on developing novel molecules for treatment of hemophilia. She joined Health Canada in 2005 as a drug safety reviewer. Since then, she has developed broader regulatory experience across the department, working in the areas of pre- and post-market drug regulation, developing the rules for the first commercial medical marijuana program, and conducting surveillance of tobacco and illicit drug use. She is currently the director of the Regulatory Review of Drugs and Devices (R2D2) initiative, a multi-year project aimed at improving access to medicines for Canadian patients.

  • 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, 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.

  • 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.

  • 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.

  • Celia  Lourenco, PhD

    Celia Lourenco, PhD

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

    Dr. Celia Lourenco is the Interim Senior Executive Director for the Therapeutic Products Directorate. She has been in management roles at Health Canada since 2007 and was until recently the director of the Bureau of Gastroenterology, Infection and Viral Diseases. She currently also represents Health Canada on the Management Committee of the International Council for Harmonization.

  • Siofradh  McMahon, MSc

    Siofradh McMahon, MSc

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

  • 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.

  • Maxwell  Morgan

    Maxwell Morgan

    • 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.

  • 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.

  • Lauren  Neighbours

    Lauren Neighbours

    • 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.

  • Joe  O’Neill

    Joe O’Neill

    • General Manager
    • 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.

  • 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.

  • 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.

  • Wendy  Ungar, PhD, MSc

    Wendy Ungar, PhD, MSc

    • Senior Scientist
    • The Hospital for Sick Children Research Institute, Canada

  • 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.

  • 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 at Health Canada in 2016. 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 where he led all Canadian customs and immigration border operations. 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

  • 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.

  • Léo  Bouthillier, PhD

    Léo Bouthillier, PhD

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

  • 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.

  • Brian  O'Rourke

    Brian O'Rourke

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