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DIA Annual Canadian Meeting


Speakers

  • Fiona  Frappier, PhD

    Fiona Frappier, PhD

    • Senior Policy Analyst
    • Health Canada, Canada

  • Melissa  Hunt, MSc

    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 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 Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Therapeutic Products Directorate.

  • Yatika  Kohli, PhD, MBA

    Yatika Kohli, PhD, MBA

    • Executive Director - Global Regulatory Affairs
    • NoNO 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.

  • Rania  Mouchantaf, PhD

    Rania Mouchantaf, PhD

    • Associate Director, Bureau of Pharmaceutical Sciences
    • Therapeutic Products 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.

  • 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.

  • Jennifer  Chan, MSc

    Jennifer Chan, MSc

    • Vice President, Policy and External Affairs
    • Merck Canada Inc., Canada

  • Lisa  Chartrand

    Lisa Chartrand

    • Director, Regulatory Strategy and Policy
    • 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.

  • Robin  Churchill, PhD, MSc

    Robin Churchill, PhD, MSc

    • Director
    • Health Canada, Canada

    Dr. Robin Churchill is the director of the Bureau of Policy, Risk Management and Stakeholder Engagement in the Natural and Non-prescription Health Products Directorate of Health Canada. She has held several positions in the health and agriculture portfolios focusing on chemical safety across a number of product lines. Robin holds a PhD in environmental Biology (antibody engineering) from the University of Guelph, an MSc in biochemistry from Memorial University of Newfoundland and a BSc (Hon) from the University of Calgary.

  • 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.

  • Lorella  Garofalo, PhD

    Lorella Garofalo, PhD

    • Director, Regulatory Affairs; Worldwide Safety and Regulatory-Innovative
    • Pfizer Canada Inc, Canada

    Lorella has been with Pfizer Canada since 2001 assuming roles of increasing responsibility in clinical research as well as medical affairs and is currently head of regulatory affairs for Pfizer’s Innovative business. She obtained a BSc (Honours) in Biochemistry and a PhD in Pharmacology & Therapeutics from McGill University. Prior to joining Pfizer, Lorella was a drug assessment officer at TPD, Health Canada and since 1999 has maintained an academic appointment with the department of Pharmacology & Therapeutics at McGill. She has served as a member of the board of directors/advisory councils for various research organizations and is a member of the regulatory affairs committees of Innovative Medicines Canada and BIOTECanada.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

  • David K.  Lee

    David K. Lee

    • Chief Regulatory Officer
    • 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.

  • Kyle  Burns

    Kyle Burns

    • Senior Director
    • Treasury Board of Canada Secretariat, Shared Services Canada, Canada

  • Rong  Sun, PhD

    Rong Sun, PhD

    • Policy Advisor with the Office of Policy and International Affairs
    • Health Canada, Canada

    Dr. Rong Sun is Health Canada’s Senior Policy Advisor with the Office of Policy and International Affairs, Health Canada. In this capacity, Rong is leading the international working group studying novel approaches to drug licensing, a part of the Strategic Priority for Innovation of the International Coalition of Medicines Regulatory Authorities. Rong held various positions in healthcare organizations, academia and the Government of Canada. Rong has a PhD from the University of Ottawa specializing in innovation and uptake.

  • Stephanie  Jack, MSc

    Stephanie Jack, MSc

    • Scientific Advisor
    • Health Canada, Canada

  • Mohammed Toseef Ansari, MD, MSc

    Mohammed Toseef Ansari, MD, MSc

    • Senior Scientific Evaluator
    • Health Canada/Marketed Health Products Directorate, Canada

    Mohammed Ansari is a Senior Scientific Evaluator at the Marketed Pharmaceutical and Medical Devices Bureau, Health Canada, and holds faculty appointments at the University of Ottawa and the University of Nottingham-Ningbo. With experience in Evidence-based Medicine, Clinical Epidemiology and Meta-research, he is also a member of the Cochrane and the GRADE working group. Mohammed's research interests include evaluation of the validity of evidence and evidence-based decision-making.

  • Marcin  Boruk, MBA, MSc

    Marcin Boruk, MBA, MSc

    • Manager
    • Health Canada, Canada

    Marcin Boruk is a manager in the Information Sciences and Openness Division, Health Canada working on the projects related to clinical data transparency.

  • David  Boudreau

    David Boudreau

    • Director of Medical Devices Bureau
    • Health Canada, Canada

    David Boudreau has a biochemistry and a chemical engineering degree with honours, both from the University of Ottawa. While at university, he did lab work at the National Research Council (NRC). He worked for three years at i-STAT, as a Process Engineer in the manufacturing of medical devices for blood tests. In March 2010, he joined the Office of the Commissioner of Official Languages (OCOL), as Special Advisor. In January 2014, he was promoted to the Assistant Director position, and was in charge of external audits and evaluations. In November 2014, he returned to the Patent Office as Director, where he was responsible for 145 employees. In January 2018, he joined Health Canada, as Executive Director of the Medical Devices Bureau.

  • Kelly  De Cecco, MBA

    Kelly De Cecco, MBA

    • A/Senior Manager, Epidemiology and Evidence Evaluation for Safety and Effectiven
    • Health Canada, Canada

    Kelly De Cecco is currently the A/Senior Manager, Epidemiology and Evidence Evaluation for Safety and Effectiveness Section of the Marketed Health Products Directorate, Health Products and Food Branch of Health Canada, which is responsible for the oversight of the vigilance of marketed health products in Canada, including ensuring Canadians and health professionals are informed of important issues impacting the safety and effectiveness of health products in a timely fashion. Kelly has a BSc in Psychology and a Masters in Business Administration. Working in the federal government since 2002, Kelly has a significant background in program evaluation, program management, and policy.

  • Jason  DiMuzio, MS

    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).

  • Oxana  Iliach, PhD

    Oxana Iliach, PhD

    • Senior Director, Regulatory Affairs
    • IQVIA, Canada

    Oxana Iliach, PhD is a Sr. Director Regulatory Affairs at Pediatric and Rare Diseases Center of Excellence, IQVIA. She works with the team of dedicated professionals to develop and implement practical and creative strategies for development drug for rare diseases, which often involves pediatric indications. She provided regulatory support for development of new orphan drugs as well as biosimilars of orphan drugs. She is also professor at Seneca College of Applied Arts and Technology and a member of CORD Board of Directors, CAPRA and RAPS.

  • Speaker  Invited

    Speaker Invited

    • United States

  • Talia  Lacroix, MPA

    Talia Lacroix, MPA

    • Senior Policy Analyst
    • Health Canada, Canada

    Talia Lacroix is a Senior Policy Analyst in Health Canada’s Health Products and Food Branch, the area that regulates the safety, quality, and efficacy of drugs and devices in Canada. Talia has spent the last 15 years contributing to regulatory frameworks, guidance, and policy; including capacity building and reform initiatives. She has served as an International Liaison and been an Advisor within her Branch. Talia recently began working in Health Canada’s new Office of Paediatrics and Patient Involvement where she is exploring opportunities to enhance and integrate patient expertise throughout product lifecycles. Talia is a Member of the CIOMS Working Group examining Patient Involvement in the Development and Safe Use of Medicines.

  • 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.

  • Olaf  Schoepke, PhD

    Olaf Schoepke, PhD

    • VP Regulatory Solutions, Samarind
    • Instem, United Kingdom

    Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

  • Louise  Blythe, MSc

    Louise Blythe, MSc

    • Head of Regulatory & Scientific Affairs
    • EMD Serono Canada, Canada

    Louise Blythe is the Head of Regulatory and Scientific Affairs at EMD Serono Canada, a business of Merck KGaA Darmstadt, Germany. Louise has over 20 years of experience in the pharmaceutical industry and has been involved in pharmaceutical and medical device development, registration and post-marketing activities. Prior to joining EMD Serono, Louise held various positions in Regulatory Affairs at several large multinational pharmaceutical companies. Louise holds an Honours Bachelor of Life Sciences degree from Queen’s University and a Master of Science, Pharmacology degree from the University of Toronto.

  • Meghana  Chalasani, MHA

    Meghana Chalasani, MHA

    • Senior Research Analyst, Office of the Center Director, CDER
    • FDA, United States

    Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and policy assistance to facilitate the incorporation of patient input into decision-making. Prior to joining the FDA in July 2015, Meghana worked on Capitol Hill and for FasterCures. She also has a strong biomedical research and clinical experience background in genomic medicine and infectious diseases. Meghana holds a master’s degree in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

  • Tharany  Ganesh

    Tharany Ganesh

    • Director, Regulatory Affairs & Quality Assurance
    • AstraZeneca Canada Inc., Canada

    Tharany Ganesh has been with AstraZeneca since 2006, holding progressive roles in Regulatory Affairs and Quality Assurance. She has worked in several different therapy areas including Oncology, Cardiovascular, Respiratory, Gastrointestinal and Neuroscience during her career at AstraZeneca and is the current Director of Regulatory Affairs and Quality Assurance. Tharany holds a Master of Biotechnology degree from the University of Toronto, and an Honours Bachelor of Science degree from the University of Waterloo.

  • Diana  Johnson

    Diana Johnson

    • Manager, Regulatory Affairs
    • Alcon Canada, Inc., Canada

  • Marc  Lamoureux, MSc

    Marc Lamoureux, MSc

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

    Marc has worked for Health Canada’s Medical Devices Bureau 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 newly created Digital Health Division at the Medical Devices Bureau of Health Canada.

  • Michelle  Leroux

    Michelle Leroux

    • Senior Clinical Project Leader
    • NoNO Inc., Canada

    Michelle Leroux is a clinical researcher with over 13 years experience in both academic and industry phase I through IV clinical trials. She has worked across a range of therapeutic areas, including stroke, acute coronary syndromes and oncology. Having held roles at clinical sites as a Research Coordinator and at sponsors as a Clinical Research Associate and Project Manager, she has worked on trials throughout their life cycle and has been responsible for various operational tasks, including conducting subject consent discussions and study visits, site monitoring, and overall trial management. Michelle joined NoNO Inc. in 2016 and is exclusively working on the development of pre-hospital and in-hospital treatments for acute stoke.

  • Mary  Morgan

    Mary Morgan

    • Associate Director of Health Product Compliance and Risk Management Division
    • Health Canada, Canada

    Mary Morgan is the Associate Director of Health Product Compliance and Risk Management in the Regulatory Operations and Regions Branch (RORB) in Health Canada. Prior to this, Mary was a senior advisor to Assistant Deputy Minister and the Director General of the former Inspectorate, where she helped to coordinate a range of regulatory and policy files. Mary's previous experience includes regulatory and operational roles within Health Canada in both pre-market and post-market environments. Mary completed a Master of Public Health from the University of Massachusetts and Bachelor of Science at the University of Ottawa.

  • Holger J. Schunemann, MD, PhD

    Holger J. Schunemann, MD, PhD

    • Associate Professor of Medicine
    • University at Buffalo State University of NY, United States

  • David  Sealey, PhD

    David Sealey, PhD

    • Associate Director, Regulatory Affairs
    • Janssen Inc., Canada

    Dr. David Sealey is Associate Director of Regulatory Affairs at the Janssen Pharmaceutical Companies of Johnson & Johnson. His current focus is the use of Real World Evidence for regulatory decision making. David has guided drug development programs at various stages from pre-clinical to marketing authorization to post-marketing. David trained as a cancer biologist at the Campbell Family Institute for Breast Cancer Research/Ontario Cancer Institute. He holds a Ph.D. (Medical Biophysics) and Hon.B.Sc. (Pharmacology) from the University of Toronto.

  • Meggan  Davis

    Meggan Davis

    • Director, Policy, Regulatory and International Affairs Division
    • Health Products and Food Branch, Health Canada, Canada

  • Ugbaad  Elmi

    Ugbaad Elmi

    • Regulatory Affairs Leader
    • GE Healthcare, Canada

    Ugbaad is a Regulatory Affairs Leader at GE Healthcare and is currently a co-chair of the eHealth Initiatives subcommittee at Medtech Canada, where she has led/supported engagements with Health Canada regarding Software as a Medical Device (SaMD), cybersecurity, and artificial intelligence. Ugbaad earned her Honours Bachelors of Science in Neuroscience from the University of Toronto and holds a certificate from Humber College in Regulatory Affairs.

  • Brent  Fraser, MBA

    Brent Fraser, MBA

    • Vice President, Pharmaceutical Reviews
    • CADTH, Canada

  • Kimberley  Hanson, MBA

    Kimberley Hanson, MBA

    • Executive Director, Federal Affairs
    • Diabetes Canada, Canada

    Kimberley Hanson is Executive Director of Federal Affairs at Diabetes Canada, responsible for advocacy with the federal government and on national issues. She also leads the Diabetes 360° initiative to implement a nation-wide strategy to address the diabetes epidemic. Having lived with diabetes for nearly 25 years, Kim is passionate about helping others live well with the disease while also working towards a cure. Over the past 15 years, Kim and her family have raised more than $1 million for research into a cure for diabetes and for supports for adults living with type 1 diabetes.

  • Jeremy  Jokinen, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Senior Director, Decision Sciences
    • AbbVie, Inc., United States

    Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel analytical approaches and methodologies to improve patient safety. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, and medical device research. He holds MS and PhD degrees in quantitative psychology from Ohio University.

  • Jovana  Kapor, MD, MSc

    Jovana Kapor, MD, MSc

    • Senior Medical Director, Medical Strategy Lead, Endocrinology
    • Endocrinology Center of Excellence, IQVIA, Canada

    Dr. Kapor is an endocrinologist with 10 years’ experience as a practicing clinician and over 18 years of Pharmaceutical industry experience in roles ranging from Clinical Project Manager within R&D to executive leadership for Canadian Medical Affairs, overseeing multiple therapeutic areas. Her graduate training includes a MSc degree in Medical Sciences from the University of Toronto. She joined IQVIA in 2017 as a Senior Medical Director and Medical Strategy Lead for the Endocrinology Center of Excellence for Americas. She works with cross-functional professionals to develop efficient, medically and scientifically sound clinical research strategies for the development of products for diabetes and other endocrinopathies.

  • Sabrina  Moers, MSc

    Sabrina Moers, MSc

    • Associate Director, Regulatory Afffairs
    • Merck Canada Inc., Canada

  • Kaylene  Raynes

    Kaylene Raynes

    • Director- Applications and Advisory Management
    • Therapeutic Goods Administration, Australia

  • Dawn P. Richards, PhD

    Dawn P. Richards, PhD

    • Vice President
    • Canadian Arthritis Patient Alliance, Canada

    Dawn Richards, PhD, lives with rheumatoid arthritis and is a volunteer Vice President of the Canadian Arthritis Patient Alliance. She advocates for arthritis awareness, access to treatments, patient participation in decision-making and as research collaborators, and the importance of research. Professionally, her firm, Five02 Labs Inc., intertwines her formal training as an analytical chemist with her passion for the patient perspective to inform research and healthcare. Clients include the Network of Networks, Clinical Trials Ontario (where she is the Director of Patient and Public Engagement), the SPOR Chronic Pain Network, and the CIHR Institute of Musculoskeletal Health and Arthritis.

  • Tanya  Ramsamy

    Tanya Ramsamy

    • Assessment Officer
    • Health Canada, Canada