Real World Drug Safety and Effectiveness

Profiles of co-chairs, presenters, and panelists

Dr. Penny Ballem

On August 27, 2001, Dr. Penny Ballem was appointed Deputy Minister of Health Services for British Columbia. In June 2005, Dr. Ballem was reappointed as Deputy Minister of Health. In this role, she is a member of the Canadian Council for Donation and Transplantation and Canada Health Infoway. She holds an appointment on the Board of Directors for the Canadian Institute for Health Information (CIHI).

Over the last 22 years, Dr. Ballem has been a health administrator, an advisor to health policy-makers, both provincially and nationally, and a practicing academic physician.

She was previously the Vice-President of the Children's and Women's Health Centre of British Columbia, having responsibility for the largest maternity hospital in the country, and held a position of Clinical Professor in the Faculty of Medicine at the University of British Columbia (UBC). Previously, she held the position of Deputy Medical Director of the Canadian Red Cross, Blood Transfusion Service in British Columbia.

Dr. Ballem received her medical degree in 1978, and her specialist fellowship in 1983, both from UBC. She is sought after as a speaker on health systems, health policy, and women's health. She has published widely in her area of clinical expertise and she is the recipient of several awards for her work in education, research and advocacy in women's health.

Dr. Bruce Carleton

Dr. Carleton earned his Bachelor degree in pharmacy in 1986 from Washington State University. He continued his academic preparation at the University of Utah, earning a Doctor of Pharmacy degree in 1989. After completing a residency in clinical therapeutics at the University of Utah Medical Center and a research fellowship in experimental pharmacotherapeutics at the University of Minnesota, he joined the faculty at the University of British Columbia.

Dr. Carleton is also cross-appointed to the Children's and Women's Health Centre of British Columbia where he has served as director of the Pharmaceutical Outcomes Research Programme since 1994. He currently serves as a drug policy advisor for the British Columbia Ministry of Health, and is a member of CEDAC - the federal government's expert drug advisory committee. In addition, he is Clinical Lead for the BC Ministry of Health - PharmaCare.

The central theme of Dr. Carleton's research program is the study of drug therapy with the goal of improving human health and quality of life. He is particularly interested in the development of models for the evaluation of the effects of drugs on health outcomes, medication use models designed to improve patient health, and the development of effective surveillance systems to improve the safe use of medication. Dr. Carleton has a particular clinical interest in paediatric asthma and the clinical use of drugs in children. Another key area of interest is in the epidemiology and clinical management of pediatric adverse drug events.

Dr. Carleton is a member of the Association of Faculties of Pharmacy of Canada, the American College of Clinical Pharmacy, the Canadian Paediatric Society, the Pediatric Pharmacy Advocacy Group for which he served on the Board of Directors from 1997-2003 and the International Society for Pharmacoeconomics and Outcomes Research.

Dr. David Clapin, conference co-chair

David Clapin is a graduate of the University of Ottawa in biochemistry (BSc, PhD) and of Carleton University, where he studied public administration (MPA). His post-doctoral studies included work in the field of neuroscience at the Marine Biological Laboratory, Woods Hole, Massachusetts. He is certified by the American Board of Toxicology and is also a Eurotox Registered Toxicologist. Over the past seventeen years, he has held a variety of positions in the federal public service related to risk management programs for human health and safety.

Dr. Clapin became the Associate Director General of the Marketed Health Products Directorate (MHPD) at Health Canada on May 1, 2004. The Marketed Health Products Directorate contributes significantly to the health and safety of Canadians through the coordinated surveillance of marketed health products. By monitoring health product safety data, such as adverse drug reaction reports, evaluating product effectiveness, conducting risk/benefit assessments and recommending appropriate regulatory action, MHPD ensures that the marketed health products that Canadians access are safe and effective. In addition to promoting partnerships in the reporting of adverse reactions and the study of product effectiveness, MHPD communicates about product safety with health professionals and the public, provides policies to effectively regulate marketed health products, and oversees industry regulated advertising activities.

Pierre Gerlier Forest, PhD

Pierre Gerlier Forest, PhD, is Health Canada's Chief Scientist. As such, he advises the Minister of Health and the Deputy Minister on science and research issues of interest to the Department. He also identifies and monitors scientific priorities. In addition, his office supports other Health Canada branches in the planning and evaluation of their scientific activities.

Before being appointed Chief Scientist, Pierre Gerlier Forest was the G.D.W. Cameron Visiting Chair, a position he held from 2003 to 2005. This Chair, which is associated with Health Canada, gives a renowned Canadian researcher the opportunity to actively participate in the development of health policies. During his term as the Cameron Visiting Chair, Pierre Gerlier Forest worked specifically to develop exchanges between the Department and the scientific community, by promoting meetings and the sharing of knowledge between policy makers and researchers.

A researcher recognized in Canada and abroad for his publications and his work in the areas of health policy and the governance of health care organizations and systems, Pierre Gerlier Forest held the position of Director of Research, Commission on the Future of Health Care in Canada (Romanow Commission). From 2001 to 2003, he was also the regional officer (Quebec) of the Canadian Health Services Research Foundation. He spent most of his academic career at Université Laval, where he is a full professor in policy analysis and public management with the Department of Political Science.

Pierre Gerlier Forest obtained his Master's degree in Political Science at Université Laval (1984) and his PhD in history and socio politics of science at Université de Montréal (1989). In the years following his post-doctoral studies (Manchester Business School), several governments and numerous organizations from the health sector have called on his expertise, particularly in the areas of primary care and knowledge management. In addition, he has actively contributed to science in Canada by regularly participating in the research assessment committees of major funding agencies.

Dr. Richard Hill

Dr. Hill graduated in medicine from Melbourne University, Australia, in 1990, and has also obtained a Graduate Diploma in Clinical Epidemiology from the University of Newcastle, Australia. Over the following 7 years, he worked at a number of posts in hospital-based general medicine, and in 1998 served as an Editor at Australian Medicines Handbook, an independent source of evidence-based drug information. In 1998, he joined the Therapeutic Goods Administration, Australia's medicines and medical devices regulator, as a pre-market clinical evaluator in the cardiovascular, arthritis and analgesia fields. Since September 2001, he has been the Deputy Director of the Adverse Drug Reactions Unit at TGA, and served as Director of the ADRU from 2002-2004. The ADRU is responsible for monitoring the post-market safety of medicines in Australia, and for providing the secretariat for the Australian Adverse Drug Reactions Advisory Committee (ADRAC).

Dr. Hill is currently completing a 12-month secondment to the Marketed Health Products Directorate, Health Canada. His interests include drug utilization studies, formal risk-benefit assessments of medicines, and risk communication. He is a member of the International Society for Pharmacoepidemiology and of the Editorial Advisory Board of the Australian Medicines Handbook.

Abby Hoffman

Abby Hoffman is the Executive Coordinator, Pharmaceuticals Management Strategies, Health Policy Branch, Health Canada. In this capacity, she oversees the development and implementation of Health Canada's Therapeutics Access Strategy (TAS). The objective of the strategy is to improve the health of Canadians by enhancing access to effective, safe and affordable therapeutic products. The strategy supports initiatives aimed at: improving the transparency and timeliness of regulatory decision-making, strengthening assessment of safety and therapeutic effectiveness, and, better management and use of therapeutic products in the Canadian health system.

Abby Hoffman has held a number of senior executive positions in Health Canada, including the first Director General of the Women's Health Bureau, and, Director General, Health Care Strategies and Policy. Before joining Health Canada, for ten years she was the Director General of the federal government sport agency, Sport Canada.

Dr. Ed Hunt

A native of Bragg's Island, Bonavista Bay, Newfoundland, Dr. Hunt is a graduate of Memorial University of Newfoundland (MUN), having completed a B.A.(Ed.) and a B.Sc. in 1971, a B.Med.Sci. in 1974, and his M.D. in 1976. He practised family medicine in the Clarenville area for 19 years and was active in that community through organizations such as Rotary and the Chamber of Commerce. He served as President of the Newfoundland and Labrador Medical Association for the 1994/95 term. Prior to medicine, Dr. Hunt taught school for 8 years.

Dr. Hunt joined the Newfoundland Department of Health and Community Services in January 1997 as a Medical Consultant, and is currently the Assistant Deputy Minister for the Medical Services Branch.

Dr. Hunt is currently the Chair of the Board of Directors for the Canadian Agency for Drugs and Technologies in Health (CADTH).

Katharina (Kathy) Kovacs Burns

Kathy Kovacs Burns obtained her PhD in Policy Studies at the University of Alberta in the fall of 2000, with a focus on public participation in decision making processes for program and policy development. In addition, she has Masters degrees in Health Services Administration and Community Medicine from the University of Alberta and in Kinesiology from Simon Fraser University.

Kathy Kovacs Burns has spent over 28 years as a volunteer in community and advocacy work, in areas such as heart and stroke, HIV/AIDS, diabetes and neurodegenerative disorders. She is currently Chairperson of Best Medicines Coalition, which is an alliance of non-profit health and consumer groups representing millions of Canadians living with chronic illness or disease. She is also a member of the Canadian Diabetes Association National Advocacy Council, as well as a volunteer and member of both the Canadian Public Health Association and Alberta Public Health Association.

She is currently the Director of Research Planning and Development, as well as a faculty member, for the Faculty of Nursing at the University of Alberta. Her additional roles include committee work such as the International Patient Alliance Organizations Congress Steering Committee, research review panels for Canadian Institutes of Health Research and Capital Health Authority (Alberta), and the University of Alberta Health Ethics Advisory Board. Prior to her work with the university, she held senior management positions within the Alberta government and community health organizations.

Dr. Rav Kumar

Dr. Rav Kumar graduated from the Welsh School of Pharmacy and was awarded a PhD in Pharmaceutical Sciences from the University of Bath, UK for research into controlled delivery of drugs such as Insulin. After working for several pharmaceutical companies in the UK, he re-located to Canada in 1991 and helped to establish and grow GlaxoSmithKline's Canadian R&D operations. In 1998, he accepted an assignment with the company in France leading an R&D department developing asthma, influenza and cardiovascular medicines.

In 2000, Dr. Kumar returned to Canada and was appointed Vice-President and a member of GlaxoSmithKline's Canadian Executive Team, which oversees the company's $1billion business in Canada. He leads the Regulatory Affairs and Pharmaceutical R&D Division, which comprises over 150 scientists and staff. The Canadian Pharmaceutical R&D team develops new drugs, including diabetes, HIV, anti-malarial and cardiovascular medicines for worldwide markets and also collaborates with Canadian Universities to increase R&D activity in the pharmaceutical sciences. His responsibilities include working with Health Canada for ongoing regulatory compliance of GSK medicines to ensure patient safety as well as approvals of new medicines and vaccines and Canadian clinical trials.

Dr. Kumar is a member of the executive council of the Canadian Society of Pharmaceutical Scientists and vice-chair of the Regulatory Affairs Committee of the Canadian Research Pharmaceutical Industry Association - "Rx&D". He was a member of the University of Toronto Advancement Board for the new Pharmacy building and is Board Governor at Hillfield Strathallan College in Hamilton.

Dr. Steve Morgan

Dr. Steve Morgan is a health economist from the University of British Columbia. He is Assistant Professor at the Centre for Health Services and Policy Research (CHSPR), and Research Lead for the Program in Pharmaceutical Policy. Dr. Morgan holds career awards from the Canadian Institutes of Health Research and the Michael Smith Foundation for Health Research. He specializes in a range of topics, including the populations' use of medicines, the determinants of drug expenditures, and the design of coverage policies. The overarching theme of Dr. Morgan's work is the investigation of how public policies may balance equitable access to medically necessary technologies with the needs to control costs and provide incentive for valued innovation.

Dr. Morgan has published over 50 papers and reports to government on health care economics and policy and holds over $1 million in grants from research foundations in Canada and the United States. He is a consultant to federal and provincial governments, and has been commissioned to write reports on pharmaceutical policy by the National Forum on Health, the Commission on the Future of Health Care in Canada, and others.

Dr. Morgan obtained a BA (Hons) in economics at the University of Western Ontario, an MA in economics at Queen's University at Kingston, and a PhD in economics at the University of British Columbia. He conducted post-doctoral training at CHSPR and at the Centre for Health Economics and Policy Analysis (CHEPA) at McMaster University.

Susan Paetkau, conference co-chair

Susan is currently the Director of Drug Programs Branch, Ontario Ministry of Health and Long-Term Care. She has worked with the ministries of Health, Education, Training, College and Universities, and Cabinet Office. Prior to joining the provincial government, Susan worked as a community and hospital pharmacist.

Over the past couple of years, Susan has been developing new initiatives for the Ontario Drug Benefit program, building relationships with various stakeholders and managing the day to day business. Susan was also the provincial co-chair of the national Pharmaceutical Issues Committee in 2003 and 2004.

Susan has a Master of Business Administration degree from York University and a Bachelor of Science in Pharmacy from the University of Toronto.

Michael Paterson

Michael Paterson completed a Bachelors degree in Human Biology at the University of Guelph in 1987 and a Masters degree in Physiology at the University of Toronto in 1989. After a brief stint as a clinical trials coordinator for a pharmaceutical company, he joined the newly formed Institute for Clinical Evaluative Sciences (ICES) as a Research Coordinator in 1992. Between 1998 and 2004, he worked half-time as a Research Officer for the Department of Family Medicine at St. Joseph's Healthcare in Hamilton.

Michael is currently a Senior Research Coordinator at ICES, a member of St. Joseph's Healthcare's Centre for Evaluation of Medicines, and holds a part-time appointment with the Department of Family Medicine at McMaster University in Hamilton.

Dr. Supriya Sharma

Dr. Sharma joined Health Canada three years ago as the Director of the Marketed Biologicals and Biotechnology Products Division of the Marketed Health Products Directorate. She recently joined the Health Policy Branch as Senior Policy Advisor in the Quality Care, Technology and Pharmaceuticals Division. She is trained as a pediatrician, having completed her medical school at the University of Ottawa, and her residency training at the University of Calgary, including a year on exchange in Australia.

Following her certification in Pediatrics, Dr. Sharma spent two years in clinical research in hematology at the University of Toronto, conducting research in thalassemia and sickle cell disease under the direction of Dr. Nancy Olivieri. She was involved in several Canadian and international studies, including one in Sri Lanka in collaboration with researchers from the University of Oxford.

Dr. Sharma completed a Masters of Public Health degree from the Harvard School of Public Health, with a focus in International Health and Health Policy. Following completion of her degree, she was involved in health policy research in patient safety and medical errors for the Kennedy School of Government at Harvard.

Ian Shugart

Ian Shugart is currently the Senior Assistant Deputy Minister of Health Policy Branch for Health Canada. Within his current responsibilities, Mr. Shugart co-chairs two advisory committees that support Ministers of Health: Health Delivery and Human Resources, and Governance and Accountability. He is also a member of the Executive Board of the World Health Organization. Previously, he was the Visiting Assistant Deputy Minister in the Health Protection Branch of Health Canada, responsible for the coordination of the HPB Transition project. This project was created to position the Health Protection Branch to meet the needs of Canadians for health risk management in the next century.

Mr. Shugart was the Executive Director of the former Medical Research Council for four years. He previously served as Assistant Secretary to the Cabinet for Social Policy and Programs in the Federal Provincial Relations Office of the Privy Council Office. He was Chief of Staff to the Minister of Energy, Mines and Resources. He also spent four years in the Department of National Health and Welfare as the senior advisor on policy matters to the Minister. He studied Political Economy at Trinity College, University of Toronto.

Dr. Jeffrey Tyberg

Dr. Jeffrey Tyberg earned his medical degree from McGill University in Montreal. He completed his emergency medicine residency at Long Island Jewish Medical Center in New York, and a fellowship in Clinical Pharmacology and Toxicology at the Hospital for Sick Children in Toronto.

Dr. Tyberg is currently the Chief of the Department of Emergency Medicine, as well as Program Medical Director of Emergency Services for the Toronto East General Hospital. In addition, he holds the position of Assistant Professor at the University of Toronto in the Division of Emergency Medicine, part of the Department of Medicine.

Dr. Tyberg is the Chair of the Ontario Medical Association's Patient Safety Working Group. He is also a member of the OMA's Committee on Drugs and Pharmacotherapy.

Dr. Stephanie Young

Dr. Stephanie Young earned a Bachelors degree in pharmacy from the Memorial University School of Pharmacy, and completed a 1-year Hospital Pharmacy Residency in Halifax, Nova Scotia. In 2003, she completed a Doctor of Pharmacy degree from Idaho State University. She is currently enrolled (part time) in the Diploma Program in Clinical Epidemiology Research at the Memorial University of Newfoundland.

Dr. Young is currently a Clinical Pharmacy Specialist in the Cardiac Care Program, and Chair of the Drug Utilization Evaluation Committee, both at the Health Care Corporation of St. John's / Eastern Health. In addition, she is a Clinical Assistant Professor at the Memorial University School of Pharmacy.

Dr. Young previously worked as a clinical pharmacist in several different hospitals in St. John's (NL), Halifax (NS) and Saudi Arabia, in clinical areas such as general medicine, palliative care, critical care, and pediatric oncology. Her research interests include the use of evidence based medicine for cardiac patients in Newfoundland, and patient safety as it relates to the medication reconciliation process.