Resume

• 2008

  Osgoode Hall Law School

  Institute for Advanced Study

  KVAB - Royal Flemish Academy of Belgium for Science and the Arts

  CENTER FOR TRANSNATIONAL LEGAL STUDIES

  Toronto

  Canada

  Adjunct Professor

  Osgoode Hall Law School

  French

  Dutch

  German

  English

  Spanish

  DCL

  Doctor of Civil Law

  Law

  McGill University

  Kandidaat Rechten (Bachelors)

  Candidate in Law

  KULeuven

  Campus Kortrijk

  Katholieke Universiteit Leuven

  LLM (Specialization bioethics)

  Master of Laws (LLM)

  LL.Lic.

  Licentiate of Laws

• 1997

  Faculty of Law

  University of Toronto

  KU Leuven

  Faculty of Law

  University of Otago

  Pontificia Universidad Javeriana

  University of Oxford

  Princeton

  USA

  Member

  School of Social Science

  Member

  Institute for Advanced Study

  Brussels Area

  Belgium

  Fellow

  Vlaams Academisch Centrum

  Fellow

  KVAB - Royal Flemish Academy of Belgium for Science and the Arts

  CENTER FOR TRANSNATIONAL LEGAL STUDIES

  Faculty of Law

  University of Otago

  Dunedin

  New Zealand

  Visiting Professor

  Faculty of Law

  University of Toronto

  Pontificia Universidad Javeriana

  Bogotá D.C. Area

  Colombia

  Visiting Professor

  Greater Buenos Aires

  Argentina

  Visiting Professor

  Universidad Torcuato Di Tella

  Oxford

  United Kingdom

  Academic Visitor

  HeLEX Centre and Faculty of Law & Plumer Visiting Fellow

  St. Anne's College

  University of Oxford

  Academic Visitor

  University of Oxford

  Leuven

  Belgium

  Visiting Professor

  Faculty of Law and Faculty of Medicine

  Visiting Professor

  KU Leuven

• Distance Learning

  Theory

  Public Health

  Program Evaluation

  Health Services Research

  Qualitative Research

  Science

  Policy

  Legal Research

  Medical Education

  University Teaching

  Bioethics

  Teaching

  Lecturing

  Research

  Nonprofits

  Higher Education

  Grant Writing

  Curriculum Development

  Editing

  The Promise and Peril of Adapting the Regulatory System to the Pharmacogenomic Context

  Pharmacogenomics—the study of the influence that genetic factors have on drug response—presents significant regulatory challenges. Pharmacogenomics products require the approval of both a pharmaceutical drug and a companion diagnostic

  a situation which is further complicated by the fact that authority to regulate these two different types of products is fragmented between different levels of government

  different provinces

  and even different agencies within the same level of government. Although Health Canada reports that they are ramping up efforts to determine the most appropriate means of incorporating pharmacogenomics information into drug evaluation and regulatory decision-making throughout the stages of drug development

  Canada continues to lag behind other jurisdictions in adopting substantial reforms. This is in marked contrast to the significant efforts made by the Food and Drug Administration in the US

  which has taken a leadership role in proposing new draft guidance on reforms to improve the evaluation and regulation of pharmacogenomic products—documents that provide useful insight into how Canada may more effectively adapt existing regulatory practices to the pharmacogenomic context. Informed by both the literature and interviews with key Canadian stakeholders

  we explore how pharmacogenomic drugs and tests are evaluated and approved within the current Canadian regulatory system and what reforms may be necessary to more effectively evaluate and regulate these emerging health technologies. We begin by looking at

  first

  the split regulation of companion diagnostics by federal and provincial authorities and

  second

  how pharmacogenomic products are currently integrated into the drug regulatory system at the federal level. Subsequently

  we consider possible reform efforts to better coordinate the review of drug and test components

  to offer more flexible approaches to market authorization and to expand regulatory oversight during the post-market phase.

  The Promise and Peril of Adapting the Regulatory System to the Pharmacogenomic Context

  Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine

  Pharmaceutical research and development is increasingly focused on niche markets

  most notably treatments for rare diseases and “personalized” medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators

  funders

  scientists

  policy experts

  pharmaceutical industry representatives

  and patient advocates)

  we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in niche markets. Informed by both these key informant interviews and a review of the relevant literature

  our paper provides a critical analysis of the many different—and sometimes conflicting—views on the reasons for and extent of the shift toward niche markets. We consider some of the potential advantages to industry

  as well the important implications and risks that arise from the increasing pursuit of niche markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases

  niche market therapies also present evidentiary challenges (e.g.

  smaller clinical trials and enrichment strategies) that can make approval decisions difficult

  and uncertainties remain around the true benefits of many therapies.

  Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine

  Lemmens

  Universidad Torcuato Di Tella