Personalized Medicine

Taking a look at québec’s position in personalized medicine

WITH DR. cLARISSA DeSJARDINS

Biotechnology Focus recently sat down with Dr. Clarissa Desjardins, chief executive offi cer of Cepmed, to discuss personalized medicine.

Cepmed is a non-profit organization dedicated to promoting the science and practice of personalized medicine through research, commercialization and education. It currently participates in several multi-million dollar public-private partnerships in translational medicine that incorporate pharmacogenetic testing into Phase III clinical trials and studies of marketed products. In addition, it funds strategic personalized medicine research projects with high commercialization potential and has embarked on a program to promote the principles of personalized medicine to healthcare practitioners and stakeholders across the country.

Founded by the Montréal Heart Institute and Genome Québec, Cepmed makes use of the Beaulieu-Saucier Pharmacogenomics Centre, the Montréal Heart Institute Coordinating Centre and the Montréal Heart Institute Biobank in its projects. It is a Centre of Excellence for Commercialization and Research (CECR) and supported by the Canadian Government, Genome Québec as well as private partners including Pfi zer, AstraZeneca, Novartis and Merck.

Biotechnology Focus: Can you give us a brief description of what personalized medicine is?

Dr. Clarissa Desjardins: A common defi nition for personalized medicine is that defi ned in the President’s Council of Advisors on Science and Technology (PCAST) “Priorities for Personalized Medicine” September 2008, “Personalized medicine is the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specifi c treatment. Preventative and therapeutic interventions can then be concentrated on those who will benefi t, sparing expense and side effects for those who will not.”

Personalized medicine may also be described as giving the right treatment, to the right person, at the right time. A patient’s genetic profi le can indicate susceptibility to certain diseases (eg. BRAC1 and BRAC2 for breast cancer, LQTS for inherited arrhythmias) before they become manifest and allow the patient and physician to set out a plan for monitoring and prevention. In addition, a patient’s genes or proteins, as found in blood or other tissues, can indicate whether they are candidates for certain targeted drugs (eg. Her-2-positive breast tumors for Herceptin, BCR/ABL positive for Gleevec, CCR5 receptor for Selzentry HIV treatment), whether they should avoid certain treatments and side effects due to lack of effi cacy in their particular tumour type (KRAS mutations, Erbitux, OncotypeDx) and whether certain treatments protocols should be modifi ed to account for their particular way of processing drugs (P450 metabolic enzymes for a large number of current prescribed drugs).

This new healthcare paradigm has been aptly named P4TM medicine by Leroy Hood (Institute for Systems Biology) in reference to its four key attributes: it is personalized, taking into account a person’s genetic or protein profi le; it is preventative, anticipating health problems and focusing on wellness, not disease; it is predictive, directing appropriate treatment, and avoiding drug reactions; and it is participatory, empowering patients to take more responsibility for their health and care.

Therefore, the term personalized medicine is a concept, alternatively used to describe a social movement, technologies, medical approaches or specifi c diagnostic tests.

BF: In your opinion, why is personalized medicine such an important thing to invest in and research?

CD: Personalized medicine is a disruptive technology and a potential disruptive innovation to the healthcare industry, which means in has the potential to transform healthcare into products and services which are both cheaper and more effective.

BF: Do you feel the government is doing enough as far as supporting research in the area of personalized medicine?

CD: First, the government invested in an organization like Cepmed specifi cally dedicated to personalized medicine and we are grateful for this. Second, although the usual discourse is to claim that the government needs to invest more in any particular fi eld of research, this does not tell the full story. Although it is true that the Canadian government has historically invested a smaller fraction of GDP in research than certain other countries, it is also a fact that Canadians have not done as well as most other countries in transferring the results of their research into commercial activity. The reasons for this are numerous and complex and not just a factor of the total R&D investment in a specifi c fi eld.

BF: Do you think the private sector is playing a role in funding?

CD: The private sector’s role in funding personalized medicine is a key issue. In fact, personalized medicine will not become integrated into our healthcare system without the private sector’s support and involvement. If we’re just talking about pharma’s involvement in funding clinical trials which incorporate biomarkers and PGx studies, then the answer is relatively easy: yes, pharma is increasingly playing a role in funding. All major pharmas now have biomarker and PGx strategies which they are in various stages of executing. They have understood that regulators, particularly in Europe, will insist that they segment their target populations (if clinical data suggest that subgroups for effi cacy or toxicity exist) so they might as well have the biomarkers in hand. However, the critical issue here isn’t just funding for novel biomarker discovery, the much more critical issue is integration of personalized medicine products into our healthcare system. The issue with personalized medicine is that many of its products are diagnostics, and diagnostics have traditionally held very little of their true value. There are little incentives for companies to invest in these products. In our single –payer system, the “benefi ciary” of products which can decrease side-effects of drugs, or allow more optimal choices for therapies or alert you to a certain disease risk, is the government since they are the ones who will benefi t from decreased costs of hospitalizations and healthcare in the future. However, the government is not a market….We are the taxpayers… IT companies etc… need buyers….need a free market to foster innovations….A wise person once told me that we are debating issues of the past while the future unfolds before us.

ABOuT DR. DeSJARDINS:

Prior to becoming CEO of Cepmed, Dr. Desjardins had been a serial entrepreneur, taking part in all aspects of company creation, from conception, to fi nancing, to the marketplace.

She was the founder of Advanced Bioconcept, a research reagent and diagnostics company which was sold to NEN Life Sciences (Perkin Elmer) in 1998. She also co-founded Caprion Pharmaceuticals Inc., a biotechnology company focused on proteomic biomarker discovery and drug development where she was Executive Vice-President of Corporate Development (now Thallion, a TSX-listed company).

Dr. Desjardins received the BRIO award for outstanding contributions to the biotechnology industry from the Québec Biotechnology Association, was nominated to Ernst&Young’s Entrepreneur of the Year award and was named one of Canada’s top young Canadians likely to infl uence the future by the Globe and Mail. She has been a Board Member on numerous private and public companies including most recently the Populomix Cancer Research Institute. She earned a Ph.D. in Neurology and Neurosurgery from McGill’s Faculty of Medicine, and was a Medical Research Council postdoctoral fellow at the Douglas Hospital Research Centre.