Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques

Speaker Bios

Speaker biographies for each of the sessions are below:


Pierre Sabourin

Pierre Sabourin a été nommé sous-ministre adjoint de la Direction générale des produits de santé et des aliments à Santé Canada en 2016.

En tant qu’autorité de réglementation des produits de santé et des aliments, Santé Canada :

  • évalue et surveille l’innocuité, la qualité et l’efficacité des produits de santé destinés aux humains et aux animaux, y compris les médicaments, les instruments médicaux, les thérapies biologiques et génétiques, et les produits de santé naturels ;
  • élabore et met en œuvre des politiques et des normes en matière de nutrition et d’alimentation ;
  • aide les Canadiens à prendre des décisions éclairées au sujet de leur bien-être ; et
  • anticipe et répond aux problèmes de santé publique liés aux produits de santé humaine et animale, aux aliments et à la nutrition.
  1. Sabourin a été vice-président principal à la Société canadienne d’hypothèques et de logement (SCHL) de 2013 à 2014. Il a été vice-président des opérations à l’Agence des services frontaliers du Canada de 2010 à 2013. Il a également occupé divers postes de haute direction, dont celui de sous-ministre adjoint à l’ancien ministère des Affaires étrangères et du Commerce international.


Pierre Sabourin was appointed Assistant Deputy Minister of the Health Products and Food Branch at Health Canada in 2016.

As the regulatory authority for health products and food, Health Canada:

  • evaluates and monitors the safety, quality and efficacy of human and animal health products including drugs, medical devices, biologic and genetic therapies, and natural health products;
  • develops and implements nutrition and food policies and standards;
  • helps Canadians make informed decisions about their well-being; and
  • anticipates and responds to public health issues associated with human and animal health products, food and nutrition.

Mr. Sabourin was the Senior Vice-President at Canada Mortgage and Housing Corporation (CMHC) from 2013 – 2014. From 2010 to 2013, he was Vice-President, Operations at Canada Border Services Agency. He also held senior management positions up to Assistant Deputy Minister at the former Department of Foreign Affairs and International Trade.



 Stuart MacLeod 

At present Dr. MacLeod is a retired clinical pharmacologist and emeritus professor in the Department of Pediatrics at the University of British Columbia. Beginning in January 2003, he served as Professor and Associate Dean Research at the University of British Columbia. Between 2003 and 2010 he also led the BC Children’s Hospital Research Institute. From 1987-1992 Dr. MacLeod served as Dean of McMaster University’s Faculty of Health Sciences.

Since 1973 he has been an international leader pursuing optimal drug therapy. His contributions span pediatric and adult medicine, but major impact has been on the basic and clinical investigation of therapies for children and youth with a parallel focus on safe medication use and pharmacogenomics, including minimization of drug risk.

Innovative health professional education and global child health are central interests that have taken Dr. MacLeod to more than 25 countries. He has published seven books and almost 300 scientific papers. Between 2012 and 2014, at the request of Health Canada he chaired an expert panel on improving medicines use by children in Canada for the Council of Canadian Academies. The panel’s final report was published in 2014 and remains widely cited.


Dr. Co Pham is the Interim Executive Director of the Centre for Regulatory Excellence, Statistics and Trials (CREST) in the Biologics and Radiopharmaceutical Drugs Directorate at Health Canada. Previously, he was the Associate Director, Office of Clinical Trials, Special Access Program, Therapeutic Products Directorate, and had served as the Senior Scientific Advisor to the Director General in the Marketed Health Products Directorate.

Dr. Pham is also the Longitudinal Content Lead and Professor for Clinical Pharmacology, Faculty of Medicine, University of Ottawa. He also works directly with the University of Waterloo, Faculty of Pharmacy, providing work training in Drug Information and Research.


 Alysha Croker 

 Dr. Alysha Croker, Manager, Office of Paediatrics and Patient Involvement, Health Canada

 Following her PhD in cell biology studying the molecular mechanisms of breast cancer metastasis and therapy resistance at Western University, Alysha Croker joined the Canadian Institutes of Health Research (CIHR) where she discovered her passion for science policy and led the development of CIHR’s training and equity strategies and was awarded the CIHR Innovation Award. Since then, she has taken on a number of leadership roles managing high profile science files, including managing the Canada Excellence Research Chair (CERC) and the Canada First Research Excellence Fund (CFREF) programs. Alysha joined Health Canada in 2019 as the manager of the Office of Paediatrics and Patient Involvement, a role which involves developing ways to increase access to safe and effective drugs and devices for pediatric populations in Canada, as well as integrating both the patient voice and equity considerations throughout the drug and device lifecycles.

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John Alexander

Dr. Alexander is currently Deputy Director of the Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research at FDA. Dr. Alexander is a pediatrician who joined the US Food and Drug Administration in 1995 as part of a joint fellowship in pediatric infectious diseases with FDA and Children’s National Medical Center.  After completion of his fellowship, he became a full-time medical officer, and subsequently a team leader, in the Division of Anti-Infective Products. Dr. Alexander also obtained a Masters in Public Health degree from the George Washington University School of Public Health in 2001. He has been involved in drug regulation and pediatric drug development for more than 20 years.


Dr Angeliki Siapkara, Paediatric Unit Manager MHRA UK

Dr Siapkara obtained her medical degree from the University of Athens, and completed her postgraduate qualification in Orthopaedic Surgery with a special interest in Paediatrics at hospitals in Athens, Glasgow and at Great Ormond Street Hospital. In 2010 she undertook postgraduate research leading a MSc in International Child Health from University College London. Dr Siapkara joined the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in 2008 and is currently the manager of the Paediatric Unit. The team leads the implementation of regulatory activities for delivery of innovating paediatric medicines and also the collaboration with all key stakeholders to improve paediatric pharmacovigilance. She was the UK delegate at EMA’s Paediatric Committee (PDCO) and was member of the CMDh/EMA Working Party on Paediatric Regulation. Dr Siapkara is an observer at Joint Standing Committee on Medicines of the Royal College of Paediatrics and Child Health.



Michael Rieder 

Dr. Rieder obtained his MD at the University of Saskatchewan in 1980 and his Ph.D. at the University of Toronto in 1992. His paediatric resident training was at the Children’s Hospital of Michigan and he completed fellowships in Paediatric Clinical Pharmacology and Paediatric Emergency Medicine at the Hospital for Sick Children in Toronto.

Dr. Rieder is a Professor with the Department of Paediatrics, Physiology and Pharmacology and Medicine at Western University and a Scientist at the Robarts Research Institute. He is the Past President of the Canadian Society of Pharmacology and Therapeutics and is a member of the Drug Therapy Committee of the Canadian Paediatric Society and has served as a consultant to Health Canada, the NIH, the MRC and the Canadian College of Academies. Dr. Rieder’s research focuses on drug safety, adverse drug reaction, optimal therapeutics in children and steroid biology with a special emphasis on corticosteroids and stress. This includes studying genetic variations and their impact on drug efficacy and safety and mechanistic studies of drug hypersensitivity as well as studies of acute, chronic and long term stress.  He is the author of the CPS Statement on Medical Marijuana in Children and has spoken on this topic as well as Drug Safety in Children in many venues.

Dr. Rieder has been the recipient of many awards including the 1994 and 1996 Young Investigator of the Year for the Canadian and American Societies of Clinical Pharmacology, the Senior Investigator Award of the Canadian Society of Clinical Pharmacology and the Academic Leadership Award in Clinical Investigation from the Paediatric Chairs of Canada as well as Sumner Yaffe Lifetime Achievement Award for Pediatric Pharmacotherapy. Other distinguished awards include the Harvard Macy Scholar Award, the Douglas Bocking Award, several Teacher of the Year Awards, Fellowships from the Royal Colleges of Physicians and Surgeons of Glasgow and Edinburgh and a Distinguished University Professor award at Western. He holds the CIHR-GSK Chair in Paediatric Clinical Pharmacology, the only endowed Chair in Paediatric Clinical Pharmacology in Canada.


Raimar Löbenberg

Dr. Löbenberg holds a BS in pharmacy from the Johannes Gutenberg-University in Mainz, Germany. He received his PhD in pharmaceutics from the Johann Wolfgang Goethe-University in Frankfurt for his work with pharmaceutical nanoparticles.

He joined the University of Alberta in 2000.

His research interests are in Biopharmaceutics to predict the oral performance of drugs and botanicals and inhalable nanoparticles to treat lung diseases like lung cancer and tuberculosis.

He is founder and director of the Drug Development and Innovation Centre at the University of Alberta. He was president of the Canadian Society for Pharmaceutical Sciences 2014-2015.  He is member and vice chair of the United States Pharmacopeia Dietary Supplement Expert Committee. He is vice chair of the Specialty Committee of Traditional Chinese Medicine in Pharmaceutics of the World Foundation of Chinese Medicine Science. He is member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Advisory Committee on Opiate Abuse.


Bruce Carleton 

Dr. Bruce Carleton has been at the BC Children’s Hospital for 30 years.  He is Director of the Pharmaceutical Outcomes Programme and Professor of Pediatrics, Medical Genetics, Pharmaceutical Sciences, Population & Public Health at UBC.  He is the Chief of the Division of Translational Therapeutics, in the Department of Pediatrics and a Senior Clinician Scientist at the BC Children’s Hospital Research Institute.  His work in genomics is more recent, since 2004.  When he isn’t working he can be found boating, hiking, biking and touring around the Sunshine Coast and Hawai’i.  The latter of course pre-pandemic.  Now his exotic destinations include El Patio de Cabana and La Kitchen.



Carole Légaré, BSc, MD, CCFP, Cert PE & PV

Dr Carole Légaré completed her medical training at the University of Ottawa, and her postgraduate pharmacoepidemiology and pharmacovigilance training at the London School of Hygiene and Tropical Medicine in the UK. After gaining in clinical practice and public health, she joined Health Canada in 2002 where she initially worked in pharmacovigilance.  She also worked as a senior medical advisor for the Centre for Biologics Evaluation during the H1N1 influenza pandemic.   In 2013, she joined the Therapeutic Products Directorate as the Director of the Office of Clinical Trials, where she oversees all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals as well as Health Canada’s Special Access Program.  She currently represents Health Canada as a member of the ICH E8 and ICH E6 working groups.


Barbara E. Bierer, MD 

Barbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center,, a collaborative effort to improve standards for the planning and conduct of international clinical trials. In this capacity, she works with regulators around the world, pharmaceutical companies, CROs, academia and patients/patient advocates to harmonize policies for and approaches to clinical trial regulation.  She is a co-founder of COVID-19 Collaboration Platform (, a platform for cooperation in research. In 2017, the MRCT Center launched the non-profit Vivli (, a global clinical research data sharing platform. She is Director of the Regulatory Foundations, Ethics, and Law program at the Harvard Catalyst, and Director of Regulatory Policy for SMART IRB ( She serves as Faculty in the Center for Bioethics, HMS and Affiliate Faculty in the Petrie-Flom Center for Health Law at HLS. From 2003 – 2014, Dr. Bierer served as Senior Vice-President, Research, BWH. During her tenure, Dr. Bierer founded and served as Executive Sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in healthcare.  She has authored over 240 publications.


NOV. 4 – PEDIATRIC DATA EXTRAPOLATION – Chair: Dr. Robert “Skip” Nelson, M.D., Ph.D

Robert “Skip” Nelson, M.D., Ph.D 

Robert “Skip” Nelson, M.D., Ph.D. is Senior Director, Pediatric Drug Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. In addition, Dr. Nelson serves as the Pediatric Development Team Lead in the Immunology Therapeutic Area, Janssen Pharmaceutical Companies of Johnson & Johnson. Previously (2006-2017), Dr. Nelson was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration. Prior to joining FDA, Dr. Nelson spent 20 years in the academic practice of pediatric critical care medicine, most recently as Professor of Anesthesiology, Critical Care and Pediatrics at The Children’s Hospital of Philadelphia (CHOP) and University of Pennsylvania School of Medicine.  Dr. Nelson is a member of the International Council for Harmonisation (ICH) E11A Working Group developing a guideline on the use of extrapolation in pediatric drug development plans. He is a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP).  After receiving his M.D. degree from Yale University, Dr. Nelson trained in pediatrics (Massachusetts General Hospital), neonatology and pediatric critical care (University of California, San Francisco), and remains Board certified in all three areas.  He has a Master of Divinity degree from Yale Divinity School and a Ph.D. in The Study of Religion from Harvard University, specializing in ethics.


Catherine (Cathy) Lau, Ph.D

Currently Strategic Advisor, Catherine was previously VP Regulatory Affairs and Quality at Janssen Canada (a J&J company). Catherine was a graduate of Yale University with a PhD in Molecular Biology and Biochemistry and a post-doctoral fellow of Princess Margaret Hospital focusing on cancer research. Catherine joined Johnson & Johnson to head Discovery Research and was made Director of the research unit in 1988, heading a group of 40 research scientists focusing on oncology, immunology and metabolism in drug discovery. After completing over 50 publications in basic science, Catherine moved to head the Clinical research group and was made Senior Director of Clinical Research 1999. From 2006 onwards, she was made Vice-President of Regulatory Affairs. Catherine has published over 70 papers in reputable scientific journals and was made of member of Who’s Who Canada and International.

Catherine was elected to the role of President Elect of Canadian Society of Pharmaceutical Sciences in 2016 and is the president from 2018 to 2019.


Lynne Yao Bio

Lynne Yao, M.D., is the Director, Division of Pediatric and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. Dr. Yao received a B.S. degree in Biology from Yale University, and an M.D. degree from the George Washington University School of Medicine.  She is board certified in both Pediatrics and Pediatric Nephrology.  Prior to joining FDA, Dr. Yao was the Director of Dialysis and Associate Pediatric Residency Program Director at the Inova Fairfax Hospital for Children in Fairfax, VA.  She has been with the FDA since 2008. The Division of Pediatric and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population; and improve collection of data to support the safe use of drugs and biological products in pregnant and lactating individuals.  She collaborates with numerous stakeholders both inside and outside of FDA to advance development of safe and effective therapies for children, and pregnant and lactating women.


Alex Bliu 

Dr. Alex Bliu is a senior biostatistician with the Office of Biostatistics, Centre for Regulatory Excellence, Statistics and Trials (CREST) at Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Canada. Alex holds a doctorate in Biostatistics from the McGill University. In addition to reviewing and providing statistical expertise in different drug submissions at BRDD, Alex is involved in different policymaking activities both within Health Canada and internationally and contributes to several regulatory guidelines.  Dr. Bliu’s research work and expertise focuses on designs and analysis of clinical and epidemiological studies, biostatistics in general, causal inference, missing data methods, and time to event outcomes.


Janelle Burnham, M.D.

Janelle Burnham is a pediatrician with experience in pediatric drug development and regulatory science. She obtained her medical degree from Ross University School of Medicine and completed her pediatric residency at the State University of New York (Buffalo) through John R. Oishei Children’s Hospital and Roswell Park Cancer Institute. Additionally, Janelle completed a drug development and regulatory science fellowship at the U.S. Food and Drug Administration (FDA), where she conducted research evaluating pediatric clinical trial design elements and prevention of clinical trial failures. Her research focused on stimulating innovation in clinical trials and personalized medicine to improve product development and pediatric patient outcomes. After her fellowship training, Dr. Burnham continued at FDA, Center for Drug Evaluation of Research, Office of Translational Science for many years as a pediatric clinical pharmacologist and labeling specialist. Currently, Janelle is a Pediatric Clinical Director in the Pfizer Pediatric Center of Excellence, where she supports various Pfizer study teams in development of pediatric studies and collaborates with Children’s Hospitals to facilitate maximal efficiency in the process and execution of pediatric clinical trials.

Edress Darsey 

Edress Darsey graduated with her Doctorate of Pharmacy Degree from Mercer University.  She completed a Clinical Pharmacy Practice Residency at the University of Alabama in Birmingham followed by a Specialty Residency in Clinical Pharmacokinetics at Mercer University.  Following her training, Edress spent eight years developing and leading clinical pharmacy services and a pediatric pharmacy residency program at Children’s Healthcare of Atlanta.  During this time, she researched and published studies around pediatric pharmacokinetics, pain management and other areas of need.    In 2000, Edress joined Pfizer Pharmaceuticals where she worked on a variety of medical teams until January 2014 when she was offered an opportunity to help build Pfizer’s Pediatric Center of Excellence in the office of the Chief Medical Officer.  Edress has served as a Global Pediatric Medical Director/Pediatric Clinical Director at Pfizer for the last 6 years.  In this position, Edress works internally across many Pfizer medicine teams to provide end to end support of pediatric studies, including study protocol development, regulation, pediatric pharmacology and formulations.  In addition, Edress works externally with Children’s Hospitals to build and maintain relationships with a network of major children’s hospitals and pediatric research centers in order to facilitate pediatric clinical trial site identification and to optimize clinical trial process execution for investigators and patients.

Edress has served on the Board of Directors for the Pediatric Pharmacy Association (PPAG) and is current chair of the Drug Development Committee.  She is a member of the American College of Clinical Pharmacologists (ACCP) and the American Academy of Pediatrics Section on Advances in Therapeutics and Technology.


Chair: David K. Lee


David K. Lee

David K. Lee is the Chief Regulatory Officer for the Health Products and Food Branch. In this role, he advises on regulatory matters across the Branch; guides the development of legislative and regulatory amendments; leads foresight initiatives for food and health product regulation; and coordinates with the Department of Justice on certain litigation.

David was previously the Director of the Office of Legislative and Regulatory Modernization, Health Canada. Prior to that, he was the Director of the Office of Patented Medicines and Liaison which administered the Patented Medicines (Notice of Compliance) Regulations and provided liaison for health product litigation.

David received his law degree at Queen’s University, and articled at the Federal Court of Canada. He worked in private practice until joining Health Canada in 1999. He has lectured extensively on intellectual property law and food and drug law both nationally and internationally.


Arshia Ghani

Arshia Ghani has over twenty years’ experience in the Pharmaceutical Industry and at Health Canada’s Therapeutic Products Directorate, in various areas of the Canadian regulatory environment. During the past 19 years at Pfizer, she has held positions of increasing responsibilities within Regulatory Affairs across multiple therapeutic areas.

As part of Pfizer’s corporate philanthropy platform, Global Health Fellows Program, Arshia spent 6 months in New Delhi, India working on policy and advocacy initiatives related to maternal and infant health and nutrition with CARE (non-profit organization).

Arshia received her B.Sc. from the University of Ottawa and has completed her regulatory affairs certifications by the Regulatory Affairs Professionals Society.


Karen Walsh BScPhm. ACPR. RPh.

Karen Walsh is a Compounding Resource Pharmacist at The Hospital for Sick Children. She has many years experience in compounding various formulations that are needed in the pediatric population, mainly focusing on extemporaneous oral suspensions. She is involved in conducting stability studies on oral suspensions with Scott Walker at Sunnybrook Health Sciences Centre. She has presented posters and talks at national conferences on compounding. Karen was a recent member of the Pharmacist Scholar Program at the Children’s Oncology Group which promotes Pharmacist initiated research such as the published Temozolomide stability study. She is also a member of the Ontario College of Pharmacists Hospital Practice Advisory Committee.



Andrea Gilpin, Ph.D., MBA 

Andrea Gilpin is the General Manager of the Goodman Pediatric Formulations Centre. Dr. Gilpin began her career as a scientist and completed her Doctorate in Molecular Biology and Biochemistry from the University of Toronto and completed an MBA at the Asper School of Business. Since that time, her career has brought her through several different roles including working 12 years in small biotechnology companies in investor relations and communications. She also worked at two multinational pharmaceutical companies, where for one of these companies she was on the Executive Leadership Team and led the Corporate Communications function. Dr. Gilpin gained commercial experience during her tenure at one of these multinationals, when she worked in marketing for lung and melanoma oncology products. She has been at the Goodman Pediatric Formulations Centre since 2017.




 DURHANE WONG-RIEGER, PHD is Chair of Rare Disease International, Vice-Chair of Asia Pacific Rare Disease International, Treasurer of United Nations Nongovernmental Organization for Rare Diseases. Chair of Patient Advocates Constituency Committee of the International Rare Disease Research Consortium, Patient Advisor to the APEC Rare Disease Network, member of the Editorial Board of The Patient- Patient Centred Outcomes Research, member of the Global Commission to End the Diagnostic Odyssey for Rare Diseases and member of Health Technology Assessment International Patient /Citizen Involvement Interest Group.

In Canada, she is President & CEO of the Canadian Organization for Rare Disorders, Chair of the Consumer Advocare Network, President & CEO of the Institute for Optimizing Health Outcomes and Chair of Canadian Heart Patient Alliance.  She is a certified Health Coach.

Dr. Wong-Rieger has served on numerous health policy advisory committees and panels and is a member of Ontario’s Rare Disease Implementation Working Group and member of Genome Canada Steering Committee for the Rare Disease Precision Health Initiative.

Durhane has a PhD in psychology from McGill University and was professor at the University of Windsor, Canada.  She is a trainer and frequent lecturer and author of three books and many articles.


Dr. Nicole Mittmann

Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. Dr. Mittmann leads CADTH’s shared science groups, including the Health Economics, Research Information Services, and Scientific Affairs teams.

Dr. Nicole Mittmann joins CADTH from Cancer Care Ontario, where she held the position of Chief Research Officer. She holds a faculty position as an assistant professor at the University of Toronto in the Department of Pharmacology & Toxicology, and is an associate scientist at Sunnybrook Health Sciences Centre.

Dr. Mittmann is also the co-chair of the Committee on Economic Analysis (CEA) at the Canadian Cancer Trials Group. Responsibilities include embedding economic parameters into clinical trials, economic evaluations, and guidelines development.

In her academic capacity, Dr. Mittmann has conducted and collaborated on notable research in the areas of economic evaluations, outcomes research, and drug/patient safety. Research methodologies include the examination of large databases, economic methodologies, and decision analysis.

Dr. Mittmann holds an MSc and PhD in pharmacology from the University of Toronto.


Ian MacKay

A biologist by training, Ian MacKay has been living and working in Ottawa since 1990.  He first worked as a research assistant in the human genetics division at the Royal Commission on New Reproductive Technologies from 1990-1992 before joining the Emergency Drug Release Program in 1992.  He has held various positions in the program (now SAP) and has been manager since 2000.  He manages a diverse team of employees from front-line staff to scientists and heath professionals behind the scenes.  He also manages interaction and collaboration with experts across the Health Products and Food Branch as it relates to the review of individual requests for special access drugs and risk issues that arise from first-time requests, safety signals, drug shortages, discontinuations.


Celia Lourenco, PhD 

Celia Lourenco holds a PhD in Pharmacology and 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.  BRDD is the federal regulatory authority responsible for regulating a variety of drug products for the Canadian market, including blood, blood products, vaccines, biotherapeutics, gene therapies, cell therapies, and radioactive drug products.   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 as a regulator, 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 represents Health Canada at the Assembly and Management Committee of the International Council for Harmonization and at the Management Committee of the International Pharmaceutical Regulators Programme.