Biotechnology Focus October 2010

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OCTOBER2005 2010, NOVEMBER VOLUME 13, NUMBER VOLUME 8, NUMBER 11 9

Québec edition

Québec: CARVING OUT ITS NICHE IN THE CANADIAN LIFE SCIENCES INDUSTRY

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QUÉBEC PROGRAMS, RESEARCH, PROJECTS AND FUNDING in the life sciences industry

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OCTOBER 2010 – VOLUME 13 – NUMBER 9

Québec edition

12 FEATURES

10

Personalized Medicine

Taking a look at the role Québec plays in this ever important area COMPILED BY TONYA COSTOFF

12

Biopolis Québec

Cross-regional collaboration at its finest

BY SHAWN LAWRENCE

12

18 CQDM

Superstar Scientist

By Daniel Pharand

Compiled By: Tonya Costoff

THOSE THAT ADAPT TO CHANGE WILL SURVIVE

Taking a look at Canada’s position in personalize medicine

WITH DR. CLARISSA DESJARDINS Biotechnology Focus recently sat down with Dr. Clarissa Desjardins, chief executive officer of Cepmed, to discuss personalized medicine.

There have been a number of trends in the biotech funding world since its last bubble and bust in the early 90’s. Those were the trends that attracted funding from venture and angel investors. Some of you who have been around for awhile will surely remember some of these. Here are just a few.

The problem here is when financing dries up, like in these days, then it is a racing car and a race car driver without gas!

“You need innovative therapeutic technologies”. No veterinarian, no medical device, no diagnostic just something a large pharma would want.

Well that’s over! Investors now want to see sales and profit or close to making some. What else? Veterinarian (what a growing market that deserves

an article on its own), medical device and diagnostic are just that.

“The company needs to focus” on registration of one indication in order to optimize the cash.

When that failed then the company really crashed.

“The company needs a platform technology” that can lead to a multitude of application.

Maintaining such technologies re-

18

18

Biotechnology Focus / October 2010

10

QUÉBEC

QUÉBEC

REMEMBER THESE: “It takes management”. There can be great technology but if there is no management then it is a racing car without a race car driver. Even a mediocre technology with great management will result in the biotech getting funded. This model would require the full C Level Team. The Chief Executive Officer, the Chief Finance Officer, the Chief Science Officer, and the Chief Operating Officer.

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

Biotechnology Focus: Can you put together a short description of just a couple of sentences of what exactly personalized medicine is/ means?

Dr. Clarissa Desjardins: A common defi-

nition for personalized medicine is that defined in the President’s Council of

10

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 specific treatment.

Preventative and therapeutic interventions can then be concentrated on those who will benefit, 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 profile 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 efficacy in their particular tumor type (KRAS mutations, Erbitux, OncotypeDx) and whether certain treatments protocols should be modified 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 DANIEL PHARAND

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 profile; 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 specific diagnostic tests.

21

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

BY SHAWN LAWRENCE AND TONYA COSTOFF

CD: First, the government invested in an organization like Cepmed specifically 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 field of research, this does not tell the full story.

Although it is true that the Canadian government has historically invested a

24

BioQuébec

Basic research has made important advances in understanding the causes of cancer resulting in the discovery of a new generation of therapeutic drugs targeted to specific malfunctions in cancer cells. However, each cancer type represents a unique disease, which harbours a variety of genetic mutations allowing cancer cells to grow and

Infection with herpesviruses is associated with important human diseases including the development of cancers.

Temporal or permanent deficiencies in the immune system can facilitate infection with these viruses. Patients who receive organ transplants are

The scientific basis underlying the diagnosis of schizophrenia, bipolar disorder and major depression is unclear. This generates uncertainties about the classification of patients in clinical research settings and for efficacious treatment.

develop resistance to many current therapies. Typically, these hurdles are addressed by confucting a large number of human clinical trials with a wide variety of patients and drug combinations, a process which often requires several years before determining which

Biotechnology Focus / October 2010

QUÉBEC

CQDM Mentorship Program

Supporting biopharmaceutical research in Québec COMPILED BY SHAWN LAWRENCE

Project: Integrated platform to identify synthetic lethality opportunities in cancer therapy Principal Investigator: Gordon Shore, McGill University and Gemin X Pharmaceuticals Inc.

Project: Profiling of patients with major psychiatric disorders using electroretinography Principal Investigator: Michel Maziade, Centre de Recherche Université Laval Robert-Giffard (CRULRG) and Neuropsychiatrie Découverte et Innovation Inc. (NDEI)

technology for antivirals Principal Investigator: Matthias Götte,

22

We propose a novel approach, based on the use of electroethinography, which measures the response of the retina to light stimulation. The retina, as part of the central nervous system, constitutes a powerful site of investigation for understanding brain disorders such as schizophrenia.

Previous work by Maziade and Hébert supports this approach and the changes in electroretinography observed in patients reflect a disturbance in the chemistry of the brain. Using this approach, we propose to develop an array of biomarkers that will tag the different sub-groups of patients within these diseases, both at the stage of the disease and in the years preceding its onset.

McGill University

Project: A novel phage-based screening

22

considered to be the most vulnerable population. Ideally, those individuals are treated with antiviral agents to prevent infection.

Unfortunately, the use of approved drugs is often associated with severe side effects, the development of drug resistance and a limited spectrum of activity against the various members of the herpesvirus family. Thus, there is an urgent medical need to discover and to develop novel anti-herpetic agents.

However, technical obstacles have hampered the development of effective drugs against many of these viruses. Here we propose to dvelop a surrogate system that takes advantage of the structural and functional similarities among viral DNA polymerases and their orthologs in phages. The central hypothesis is that phage-derived chimeric polymerases containing critical parts of the substrate binding site of the viral enzyme can be used to identify novel classes of compounds that inhibit essential functions of the virus.

The Québec Consortium for Drug Discovery (CQDM)

The CQDM is putting the needs of pharma front and centre

CD: Personalized medicine is a disrup-

Biotechnology Focus / October 2010

the future of healthcare. It allows the monitoring of biological response during in vivo animal experimentation with minimal animal sacrifice and discomfort as well as a reduction in cost and development time. In a clinical setting it also improves the accuracy and rapidity of diagnosis and permits ultimately the implementation of personalized medicine approaches and the development of artificial organs such as an artificial pancreas for the optimal control of diabetes.

The proposed project involves the development and validation of a new generation biosensor that offers unique and broadly applicable capabilities, combining the capacity to monitor several analytes simultaneously in real time, for use ex vivo and in vivo. Relying on the evanescent field-based detection of the fluorescence of Quantum dots, the proposed biosensor brings together expertise in electrical engineering, physics, pharmacology, chemistry and physiology. As a first step, the integration of the various components will provide a pHactuated biosensor. In a next step, it will be optimized for the individual detection of glucose and insulin.

Adapting to Change

Examining the trends in the funding world since the last bubble and bust in the early 90s.

DEPARTMENTS

6

Research News

8

Business Corner

27

Across Canada

29

Calendar of Events

30

The Last Word

.

www.bioscienceworld.ca

OCTOBER 2010 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE PUBLISHER/ EDITOR-IN-CHIEF SENIOR WRITER STAFF WRITER

CONTRIBUTING WRITERS

Québec shines in the life sciences industry

W

Tonya Costoff Shawn Lawrence Chris Rogers Daniel Pharand

Laurence MacPhie

Noel Courage

Pierre Bourassa

John Lawson

National Account Manager

Patricia Bush

GRAPHIC DESIGNER

elcome to our second annual Québec edition of Biotechnology Focus. This month’s issue will take a look at the province and the many issues it’s tackling such as financing, research, innovation and commercialization.

It seems fitting that the Québec issue would be in the month of October, the same month BioContact Québec 2010 takes place. The event was gave an opportunity for more than 120 biopharmaceutical companies from Canada, the United States, Asia and Europe a chance to present in different sectors of activities, such as: diagnostics, therapeutics and services. We wanted to follow up such an important event with an issue that addresses some of the same topics.

In this issue we’ll be looking at some of the hotbeds in Québec such as the Biopolis, which encompasses the areas of Montréal, Québec City and Sherbrooke; personalized medicine with Dr. Clarissa Desjardins; a look at the bubble and bust in the life sciences industry during the early 90s and The Québec Consortium for Drug Discovery (CQDM) including the projects it has initiated as well as its mentorship program.

Key stakeholders in the province have recognized the importance of getting the message out there to the international communities, that Québec is the place of biotechnology. It is for this reason that three key regional organizations reached out to each other, creating Biopolis Québec - Québec International (Québec City), Montréal InVivo (Montréal) and Sherbrooke Innopole (Sherbrooke). Biopolis Québec is the brand name used to represent the collaboration between the three regions.

As well there is an article discussing the Québec government’s recent launch of a new R&D and innovation strategy (Stratégie québécoise de la recherche et de l’innovation- SQRI). This strategy will invest $2 billion over three years and includes the creation of Teralys Capital, a venture fund of funds.

When it comes to genomics research, Québec is clearly in the lead with the province housing more than 40 per cent of the industry. Beyond genomics research it also has strong research infrastructure with such institutions as the Biotechnology Research Institute (BRI), the Innovation Centre at McGill University, Genome Québec and the Montréal Heart Institute.

According to stats from BIOTECanada, about 30 per cent of Canadian biotechnology firms working in all sectors and 30 per cent of Canadian biotechnology for human health (therapeutic, biomaterials, diagnostics, genomics and proteomics) are located in Québec.

Terri Pavelic

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4 BIOTECHNOLOGY FOCUS

OCTOBER 2010

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R & D NEWS RX

Research on moon dust lands national award for undergraduate

Full Moon as seen from Apollo 11.

Photo: NASA

Michelle Thompson accepts her award for the best research poster in the physical and earth sciences division at the Rising Stars of Research conference. Thompson’s research is going to help protect the health of NASA astronauts and she recently received a national undergraduate research award for her work.

The fourth-year Queen’s student garnered the top prize in the physical and earth sciences research poster competition during the Rising Stars of Research conference at the University of British Columbia.

Thompson’s poster summarizes her study of the composition of moon dust, which she completed during a National Aeronautics and Space Administration (NASA) internship at the Johnson Space Center last summer. Thompson examined lunar soil that was collected during the Apollo 11 mission. She found that the dust is composed of glass and a high concentration of reduced iron.

The research is vital because NASA plans to return to the moon and build a sustainable, long-term human presence. The iron in moon dust poses a health risk to humans if they breathe it in and it enters their bloodstream. NASA will have to design equipment and machinery that can withstand the build-up of dust in the mechanics of the instrument.

Edmonton breaks ground on new municipal wasteto-biofuels facility The Canadian Renewable Fuels Association lauded the ground breaking of Enerkem Inc.’s new waste-to-biofuels facility as a prime example of global Canadian leadership in the development of next generation biofuels.

At a ceremony attended by Alberta Premier Ed Stelmach and Edmonton Mayor Stephen Mandel, Québec based Enerkem broke ground on a new 36 million litre a year municipal waste-tobiofuels facility. It is the first facility of its kind in the world.

“Today, Canada breaks new ground in the development of advanced biofuels,” said Gordon Quaiattini, president of the CRFA. “This plant is a concrete example of Canadian leadership in renewable fuels. This plant is good news for our energy supply, good news for the local economy, and good news for the environment.”

6 BIOTECHNOLOGY FOCUS OCTOBER 2010

Enerkem’s advanced biofuels plant, which will be located in Edmonton, AB, is the world’s first industrial-scale biofuels project to use municipal solid waste as feedstock. Using Enerkem’s proprietary clean technology, the $ 80 million biofuels facility will produce enough biofuels to fuel over 400,000 cars per year running on a 5% ethanol blend. It will be built, owned and operated by Enerkem Alberta Biofuels, a wholly-owned subsidiary of Enerkem. The City of Edmonton and Enerkem Alberta Biofuels have signed a 25-year agreement to convert 100,000 tonnes of municipal solid waste into biofuels annually.

The advanced biofuels facility will create more than 180 direct and indirect jobs during the operations, construction and engineering phases. It will contribute to the federal and provincial Renewable Fuel Standards, taking effect in 2010.

Clinical Trials & Patents

Oncolytics Biotech Inc. (Calgary, AB) announces that the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer (GOG186H). The study has been approved and will be sponsored by the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, under its Clinical Trials Agreement with Oncolytics. Oncolytics will provide clinical supplies of REOLYSIN for this study. The Study Chair will be Dr. David E. Cohn of The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “Ovarian cancer is typically diagnosed at the later stages, because earlier stage disease usually has no obvious symptoms,” said Dr. David E. Cohn. “On this basis, surgical interventions used in earlier stages are often supplemented by chemotherapy; however, there are limited treatment options for patients with recurrent disease.”

n

n Xenon Pharmaceuticals Inc. (Vancouver, BC) has initiated a Phase 2 clinical trial evaluating its novel topical XEN402 therapy for the treatment of PHN. XEN402 has been developed by Xenon as a topical ointment formulation and recently concluded a 21-day cumulative dose safety tolerability phase 1 study in normal human volunteers. The product was well tolerated and achieved good drug concentrations in the skin. Topical XEN402 is being developed by Xenon for painful neuropathic disorders such as PHN and targets the sodium channel sub-type Nav1.7. This target is highly expressed in sensory nerve endings and its expression has been shown to be upregulated in chronic painful conditions such as PHN. “This is an important step forward in the development of topical XEN402,” said Xenon President & CEO, Dr. Simon Pimstone. n YM BioSciences Inc. (Mississauga, ON) announces the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. CYT387 has shown significant activity in reducing spleen size and controlling constitutional symptoms in these patients. To date, 15 patients have been enrolled into the Phase II portion of the study. Given the favourable biological activity and safety data, the company intends to expand the present program from 60 to 120 patients at up to six centres in the United States, Canada and Australia, subject to regulatory approval. Detailed safety and activity data for CYT387 are planned to be presented at the American Society of Hematology (ASH) meeting in Orlando, FL in December this year.

R & D NEWS U of T researchers identify trio of genes that help Salmonella cause disease University of Toronto researchers have uncovered three genes in the Salmonella bacteria critical for it to cause disease and withstand antibiotic treatment and may hold the key to improved disease treatment.

The study was published in the journal Molecular Cell and conducted in partnership with laboratories headed by Dr. Michael Ibba at Ohio State University and Dr. Ferric Fang at the University of Washington in Seattle. The team found that three bacterial genes called poxA, yjeK and efp work together to protect the bacterial cell from stresses it encounters during infection and antibiotic treatment. Mice infected with Salmonella strains lacking any one of these genes do not get sick. Even more crucial is the discovery that these Salmonella strains are also highly sensitive to treatment with a variety of antibiotics and disinfectants.

“Salmonella continues to be a major source of food poisoning in North America. In the past few years we have seen numerous recalls of food products including a major recall of peanut products just two

years ago and a current outbreak in Canada resulting in the recall of headcheese.” said Professor William Navarre of U of T Faculty of Medicine’s Department of Molecular Genetics and lead author of the study.

“We now aim to develop drugs that can inactivate poxA, yjeK or efp. By preventing these bacteria from responding appropriately to stress, we predict we will be able to prevent bacterial disease and decrease their resistance to antibiotics. We’re excited by the fact these genes exist in other bacteria that cause disease including E. coli so our strategy may work in cases beyond Salmonella.”

The three genes are critical for bacterial resistance to chemical stress. “Despite their small size bacteria are actually quite sophisticated” said Navarre, “Salmonella and E. coli bacteria grown in a mild amount of disinfectant or antibiotics are able to make adjustments so that they can survive without too much of a problem. In order to do this they must be able to detect that they are in trouble and activate the genes necessary to make the appropriate changes to their metabolism and cell structure.

The researchers, in collaboration with the University of Toronto Structural Genomics Group headed by Professor Aled Edwards and Professor Alexei Savchenko, also determined the molecular structure of the PoxA protein and found that it was strikingly similar to a “tRNA synthetase,” an enzyme that modifies tRNA. “It’s a beautiful case of molecular mimicry where a molecule that usually modifies a tRNA evolved to instead modify a protein that looks like a tRNA.”

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Dealmakers

Canada holds tremendous investment opportunity in biotech

Agriculture, and particularly agricultural research, is fast gaining attention as the place to invest as the world struggles to feed a growing population and wean itself from fossil fuels, says Dr. John Hamer from the U.S. life sciences investment firm Burrill & Company.

Hamer gave the first of two keynote addresses to kick off the first day of the Agricultural Biotechnology International Conference (ABIC 2010) in Saskatoon. He spoke of past challenges in agbiotech investment, as well as future opportunities.

Hamer says that while a small information technology firm might be able to start out of someone’s garage, the long regulatory times involved in agbiotech innovation make this impossible. This makes finding a partner with deep pockets essential, which means a willingness to share knowledge of the innovation.

“Most of these companies are working with university germ plasm, which puts

them about eight to 10 years from commercialization,” said Hamer.

Another challenge is that some venture capital firms had their fingers burned both in the economic crisis of 2008, and in investments that were “oversold and under-delivered,” such as in biotech and solar energy. Venture capitalists are now cautious, waiting for proof that the company really has figured out how to capture value from their ideas.

Along with his words of caution, Hamer also spoke of promising territory in agbiotech: bioenergy. Bioenergy promises to lower carbon emissions, and even allow farmers to grow their own fuel and increase their efficiency in the process. A critical component of bioenergy is feedstocks, that is, what to use to make the energy, whether it be hybrid poplar trees, cereal straw or palm oil.

“We see Canada as a place of tremendous opportunity,” Hamer said.

Viterra makes changes to its corporate management team

Doug Wonnacott

Viterra Inc. will make a change to its legal services function in recognition of its global market position. As a result, Ray Dean, Viterra’s senior vice president, General Counsel/Corporate Secretary will step down effective immediately to pursue other interests. Viterra will undertake a global search for a new leader.

As well, Viterra will formally integrate its financial products group within Agri-Products under the leadership of Doug Wonnacott, senior vice president of Agri-products.

Financial product will become an integrated product line within the Company’s service offering to western Canadian grain and livestock producers, complementing its portfolio of seed, fertilizer, crop protection products, equipment, feed and forage product offerings. This integration will result in the elimination of the senior vice president of Financial Products position previously held by George Prosk.

8 BIOTECHNOLOGY FOCUS OCTOBER 2010

n MethylGene Inc. (Montréal, QC) enters into an agreement with Dutchess Opportunity Cayman Fund Limited (“Dutchess”) for an Equity Line Facility (ELF) of up to $15 million of capital over 36 months, at MethylGene’s discretion, through the subscription of newly issued common shares.

“This facility provides us with flexible access to capital at reasonable terms to help us achieve our goals,” said Charles Grubsztajn, president and chief executive officer of MethylGene. “We continue to progress our pipeline, with a focus on completing the three clinical trials evaluating MGCD265, our proprietary multi-targeted (Met) kinase inhibitor, in preparation for a randomized Phase II trial in non-small cell lung cancer patients.

Accessing this new capital, coupled with our commitment to leverage the opportunities that our proprietary pipeline offers, is a positive step forward that demonstrates our dedication to enhancing shareholder value.”

Stem Cell Therapeutics Corp. (Calgary, AB) announces budgetary approval of the SCT-sponsored investigator-lead Phase IIa study entitled “A Phase IIa, Single Center, Open Label Study to Characterize the Safety of Human Chorionic Gonadotrophin (hCG) and Epoeitin Alpha (EPO) in Traumatic Brain Injury”. After strategic discussions between management and the board of directors a decision was made to go forward with the TBI clinical study. SCT will provide the funding necessary to complete the enrollment of 10 TBI patients in a single center open label study, lead by Dr. David Zygun, to characterize the safety of hCG and EPO in traumatic brain injury.

A series of efficacy endpoints are part of the trial design in order to access various aspects of neurological status. Dr. Alan Moore, president and CEO of SCT said “We are excited to fund this study, which is a significant milestone, and demonstrates the Company’s commitment to the advancement of our programs. This is an important step for SCT as we move forward and highlights our dedication to prospering in the biotechnology area. We are in the process of evaluating all our programs and plan to make announcements as decisions are made.”

n

n Novadaq Technologies Inc. (Toronto, ON) completes the final design review for the integration of the company’s SPY® imaging technology into the 3-D high definition imaging capabilities of the Intuitive Surgical, Inc. da Vinci® Surgical Robotic System. Final design review completes the requirements of the final milestone outlined in Novadaq’s License and Development Agreement with Intuitive, which was signed in January 2009.

Novadaq also announced that it has received the second $500,000 of the final $1M milestone payment from Intuitive. The first $500,000 of the final payment was previously received from Intuitive in May 2010 for completing the first human use of the system. Novadaq also entered into a Supply Agreement with Intuitive in January 2009. Under terms of that agreement, Novadaq will manufacture and supply the key components required to enable fluorescence imaging with da Vinci® during robotic surgery.

Québec: A Spotlight

on Innovation and Research

10 12

Personalized Medicine Biopolis Québec: Cross-regional collaboration at its finest

18 21 24

Financing and Funding Bubbles and Busts CQDM 2009-2010 Initiated Projects Mentorship Program

Compiled By: Tonya Costoff

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 officer of Cepmed, to discuss personalized medicine.

quéBec

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 Pfizer, AstraZeneca, Novartis and Merck.

10

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

Dr. Clarissa Desjardins: A common definition for personalized medicine is that defined 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 Biotechnology Focus / October 2010

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 specific treatment.

Preventative and therapeutic interventions can then be concentrated on those who will benefit, 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 profile 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 efficacy in their particular tumour type (KRAS mutations, Erbitux, OncotypeDx) and whether certain treatments protocols should be modified 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 profile; 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 specific diagnostic tests.

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

CD: Personalized medicine is a disrup-

tive 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 specifically 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 field 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 specific field.

Personalized Medicine 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 efficacy 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 “beneficiary” 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 benefit 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.

marker 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 influence 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.

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Prior to becoming CEO of Cepmed, Dr. Desjardins had been a serial entrepreneur, taking part in all aspects of company creation, from conception, to financing, 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 bio-

OL?F@) IIM .--. Pnr^ob*Sf`qlof^ * ?il` B * 5qe cillo Jlkqob^i) Nrb_b` E/W /?4 Qbi+7 2.1 654*3/1/ ttt+ol_f`+`^ fkcl=ol_f`+`lj

quéBec

ABOuT DR. DeSJARDINS:

Reply Card #4785

Biotechnology Focus / October 2010 Client: Robic Agence: MP1 (Sylvie Ferland 514.979.7470) Parution: Biotechnology Focus Magazine

11

Québec’s bio-economy

By Shawn Lawrence

BIOPOLIS QUÉBEC: Cross-regional collaboration at its finest

Montréal BIG PHARMAS

Over 80 subsidiaries of foreign companies

PRIVATE RESEARCH CENTRES There are four large pharmas’ basic research centres in Montréal, namely those of Merck Frosst, GlaxoSmithKline, Boehringher Ingleheim and Astra Zeneca.

RESEARCH INSTITUTES

The NRC-Biotechnology Research Institute The Montréal Heart Institute The Institut de recherches cliniques de Montréal (IRCM) The Montréal Neurological Institute The Institut Armand-Frappier McGill University (25 institutes and research centres, six affiliated hospitals) The Université de Montréal (24 research centres, ten affiliated hospitals)

QUÉBEC

GENOMICS RESEARCH CENTRES

12

The McGill University and Genome Québec Innovation Centre The Biotechnology Research Institute The Centre Robert-Cedergren at Universite de Montréal The Québec Proteomics Centre Beaulieu-Saucier Université de Montréal Pharmacogenomics Centre

TECHNOLOGY PARKS Technoparc Saint-Laurent The Biotech City Angus Technopole >>

Biotechnology Focus / October 2010

There are good things happening in Québec when it comes to the life sciences. It is a province where universities and colleges, R&D centres and the business community are constantly finding new ways to work together to leverage the province’s strengths in the sector and make the business of biotech viable.

In the private sector alone Québec companies spend a fair share (approx. $4 billion) on scientific research and development, or close to 30 per cent of the Canadian total. Some 20 international pharmaceutical companies have their Canadian head offices in Québec. Heavy investment in scientific research and experimental development is nurtured by the fact government measures and policies are favourable to doing business in this province.

Likewise, key stakeholders in the province have recognized the importance of getting the message out there to international communities that Québec is great place for biotechnology. It is for this reason that three key regional organizations: Québec International (Québec City), Montréal InVivo (Montréal) and Sherbrooke Innopole (Sherbrooke) reached out to each other creating Biopolis Québec in the fall of 2009.

The brainchild of Michelle Savoie, general manager, Montréal InVivo, the organization’s launch coincided with the government of Québec’s announcement at BIOContact of its biopharmaceutical strategy. In line with this strategy, already the Biopolis Québec partnership is giving the whole province better visibility at the international level.

“The main purpose of Biopolis was to put together and present the overall expertise and resources that we have in the province of Québec as it relates

to life sciences and health technology,” states Savoie. “We have a complementary expertise in our different regions and our objective is to create a greater critical mass when we go and present and compete at the international level.

So it has two purposes – one which is promotion of the sector, but as well to identify potential areas of collaboration for our three regions.”

The formation of Biopolis Québec was made easier due to the fact that the three regions had just finished working together in establishing an international partnership with the Life Science Corridor, in France. The process was made easier by the three organizations having worked together under one umbrella temporarily. During talks with the Life Science Corridor the three regions found it easier to sell their ideas as a whole province and to emphasize the province’s strengths. A conclusion was reached going forward to establish something permanent “We are seeing a new trend developing in the world where regions are coming together to increase their critical mass – and I would say that’s where the idea of creating Biopolis Québec originated from,” states Savoie.

“It was a logical choice to form an association like we can see in several other prominent regions, such as Medicon Valley,” adds Pierre Belanger. “The goal of Biopolis Québec is to promote Québec’s Life Sciences around the world, and it makes sense to work together, because together we are stronger. As such, we want to promote Québec the place to go in Canada for life sciences whether it’s to establish a subsidiary or to gain a gateway into the American market. Companies abroad often know little about Canada, and even less about Québec. If every Canadian city promotes

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Final

Montréal InVivo >> BUSINESS INCUBATOR’S

The Québec Biotechnology Innovation Centre The Health Technology Campus

CONTRACT RESEARCH

One of the largest clusters of service providers in North America -20 national and international contract research companies 1/3 of the Phase 1 beds in NorthAmerica

SCIENCE AND TECHNOLOGY PLATFORMS Pharmacogenomics Centre The National Immune Monitoring Laboratory The McGill University and Genome Québec Innovation Centre

HEALTH TECHNOLOGIES / MEDICAL DEVICES

More than 100 private companies world-class research centres • Polytechnique • École des technologies supérieures

Québec Metropolitain Area MAIN RESEARCH INSTITUTES Infectious Disease Research CHUL Research Centre Laval Hospital Research Centre Institute of Nutraceuticals and Functional Foods Universite Laval TransBioTech

BUSINESS INCUBATOR’S Ag-Bio Centre

TECHNOLOGY PARKS

QUÉBEC

Québec Metro High Tech Park Innoparc – Lévis

14

CONTRACT RESEARCH AND SERVICE PROVIDERS AEterna Zentaris Anapharm- Pharmanet BD Diagnostics-GeneOhm Chlorion Pharma Diagnocure Endoceutics Gene POC GlaxoSmithKline Biologicals Medicago

Biotechnology Focus / October 2010

“The goal of Biopolis Québec is to promote Québec’s Life Sciences around the world, and it makes sense to work together, because together we are stronger. ” —Pierre Belanger its own activities, people can easily get confused. Biopolis wants to attract their attention to Québec as a whole. We want them to know that they have other options than the United States. Then, and only then, can we talk about the different regions of Québec.”

Belanger goes further explaining that when talks reach this point with international partners, only then does each of the organizations work independantly for its own region. To ensure this arrangement is followed, the three parties of Biopolis Québec have signed a code of ethics and all parties agree to these principles. Thus far, the relationship is working fine.

What makes the partnership work is that the three sides bring a lot to the table. For starters, Sherbrooke, Montréal and Québec City represent approximately 95 per cent of all that is happening in biotech in the province.

In Montréal, Montréal InVivo, a non-profit organization, is the brand name for the life sciences and health technologies cluster of the metropolitan area. The cluster itself is comprised of more than 620 organizations, including 150 research organizations, and 80 subsidiaries of foreign companies.

The city itself is the university research capital of Canada, and also ranks first in terms of funds dedicated to university research, the number of university researchers and the largest number of research centres. The cluster is also unique in Canada, and is one of the few places in the world, where a company can conduct every phase of creation of a new drug, from basic research through to commercialization. It has developed a world-class mass of expertise in several areas such as aging, cardiovascular, metabolic diseases and personalized medicine. The cluster provides a productive environment for every company in the life sciences and health technologies. As such, it is a fertile breeding ground for innovation, creativity and

business.

Sherbrooke is itself a city of innovation and great synergy. Sherbrooke brings many assets to the table in this partnership, with experts in pharmacology, oncology, molecular imaging, genomics, aging, metabolic diseases, diagnostics and medical technologies.

Sherbrooke Innopole is the regional organization overseeing all this activity.

It operates as an economic development organization whose goal is to attract or create new businesses based on Sherbrooke’s research and ingenuity, as well as supporting existing industries, including the life sciences and biotechnology, in their efforts towards expansion, innovation and internationalization. The mandate of Sherbooke Innopole is to stimulate the growth and innovation of businesses and to actively support them.

“Life Sciences are at the heart of Sherbrooke’s development with two universities generating more than 1,000 graduates each year in the several Life Sciences related programs,” explains Josée Blanchard director, business development, Life Sciences.

“The University of Sherbrooke owns more than 330 patents and generates from its discoveries and inventions some of the highest annual revenues in Canada. Sherbrooke University Hospital alone employs more than 5,200 people, 550 doctors and 150 scientists.”

Sherbrooke also has a large industrial footprint in the biotech space.

“Our Life Sciences industry dynamic, with about 30 companies, supported by more than 20 research centres in various fields such as molecular imaging and genomics. Sherbrooke has been chosen by some major players including Charles River Laboratories and Baxter,” comments Belanger.

Québec City provides cutting-edge expertise in the areas of biopharmaceuticals and diagnostics, natural health products (nutraceuticals and cosmeceu-

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Reply Card #4787

Montréal InVivo Sherbrooke SCIENCE PARKS

Sherbrooke Science Park Sherbrooke Innovation Park

RESEARCH INSTITUTES

The CHUS (University Hospital Centre of Sherbrooke) Centre de recherche clinique Étienne LeBel (CRC-Étienne LeBel) The Pharmacology Institute of Sherbrooke Agriculture Canada-Dairy and Swine Research and Development Centre Functional genomics Centre of the University of Sherbrooke Research Centre on RNA biology Molecular Imaging Centre of Sherbrooke Research Centre for the Efficacy of Diangnostics Bioprocesses Development Laboratory Research Centre on Aging of the University Institute of Geriatics of Sherbooke

LIFE SCIENCE COMPANIES

QUÉBEC

Baxter Nova Envirocom Diex Research Charles River Gamma Medica Ideas IBIOM Instruments Tranzyme Pharma Q&T Reserch

16

ticals), of medical technology and information technology related to health. In fact, many innovative companies in the province reside in this region, AEterna Zentaris, Anapharm-Pharmanet, BD GeneOhm, Diagnocure, GlaxoSmithKline, and Medicago to name a few.

Many biopharmaceutical companies in the metropolitan region of Québec are derived from research conducted at the University Laval. This reflects the quality of research being done in its laboratories and the power of technology platforms that they develop. Québec International is responsible for economic development of the industry in this region through its life science arm.

Together, the three regional organizations hope to meet many goals going forward. In addition to promoting the sector at the international level, each is looking at new ways to impact the development of the sector in the province.

An example of this is the organization’s involvement in the Québec-France Biotechnology Focus / October 2010

“I think that this is quite unique, having the three regions partnering together and working together to develop a provincial strategy.”

— Michelle Savoie Symposium-Biotechnologies. The three sides are working together to promote this event in Québec and particularly in its own region. Each region has also planned to bring a small delegation to this event to develop partnerships with France.

The three sides also worked together at the 2010 BIO International Convention held in Chicago. The event was the organization’s first official opportunity to promote Québec as a whole instead of focusing on the three different majors.

As part of the BIO 2010, Biopolis Québec also signed an agreement with Biocat, the most influential life science cluster in Spain. The collaboration agreement will foster the completion of projects between Spain and Québec and stimulate sharing in the sectors identified as highly strategic between the two.

Essentially, the partnership will produce benefits for life science companies on both sides of the ocean.

Savoie explains that the objectives of this agreement are not only look at potential areas for partnership, but also to look at the potential for knowledge transfer.

“Right now there is discussion between us and Biocat, exploring the possibility of developing or creating a summer school in life science. So that is a project that is currently being looked at,” said Savoie “We believe this agreement can not only lead to fruitful collaborations between Spanish and Québec companies, but eventually, to the establishment of foreign subsidiaries in Québec,” adds Belanger In terms of priorities on the research side, Montréal InVivo proposed to its partners within Biopolis Québec to concentrate its efforts in developing a personalized medicine initiative in the province of Québec. As part of this initiative players from all three regions,

including university, private sector and public; the pharmaceutical, the biotech, medical device, and diagnostic technology industries will be involved.

“Personalized medicine is a world wide trend and we feel Sherbrooke, Montréal and Québec City have everything at hand to become a leader in this field,” states Belanger citing his own regions great expertise in Imaging, Diagnostics, and Genomics as examples.

The nice thing about personalized medicine adds Savoie, is the fact that it’s not actually related to one specific disease area.

“Each of the regions have developed certain expertise in the personalized medicine space, whether it’s developing biomarkers, developing some type of platform technology, we all have overall resources that we will need to compete at the international level,” she says.

Overall, all three partners find working within the Biopolis Québec framework very similar to working within their own individual organizations. The challenges are pretty much the same, but so are the goals.

Savoie explains that as you bring together groups within your own clusters, and within your own regions, it’s always a challenge to get people to agree on common objective. But as soon as you agree on the objective then it becomes easier. Biopolis Québec has already agreed on the common objective and identified issues or potential opportunities that are common in our three regions. Most importantly, they have agreed on the goal.

“I think that this is quite unique, having the three regions partnering together and working together to develop a provincial strategy, states Savoie. “I think that this is the first time that this is happening, but based on the success so far, it probably won’t be the last.”

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web ad

Funding

By Daniel Pharand

THOSe THAT ADAPT TO cHANGe WILL SuRVIVe

There have been a number of trends in the biotech funding world since its last bubble and bust in the early 90’s. Those were the trends that attracted funding from venture and angel investors. Some of you who have been around for awhile will surely remember some of these. Here are just a few.

quéBec

ReMeMBeR THeSe:

18

“It takes management”. There can be great technology but if there is no management then it is a racing car without a race car driver. Even a mediocre technology with great management will result in the biotech getting funded. This model would require the full C Level Team. The Chief Executive Officer, the Chief Finance Officer, the Chief Science Officer, and the Chief Operating Officer.

The problem here is when financing dries up, like in these days, then it is a racing car and a race car driver without gas!

Biotechnology Focus / October 2010

“You need innovative therapeutic technologies”. No veterinarian, no medical device, no diagnostic just something a large pharma would want.

Well that’s over! Investors now want to see sales and profit or close to making some. What else? Veterinarian (what a growing market that deserves an article on its own), medical device and diagnostic are just that.

“The company needs to focus” on registration of one indication in order to optimize the cash.

When that failed then the company really crashed.

“The company needs a platform technology” that can lead to a multitude of application.

Maintaining such technologies required enormous funding and investors quickly lost confidence after one or two failures.

“The company needs an IP strategy developed by high price US lawyers.”

This strategy is a very expensive endeavor that leaves little money and resources for anything else.

More recently the “RTO” (reverse take over) or SPACs (special purpose acquisition companies in the US) craze.

This created public companies with poor liquidity and usually left them as orphan status on the trading floor of the exchange. One of the major problems with this source of financing is that many venture funds’ by-laws prevent them from investing in public

companies. This restriction is quite unfortunate since this provides for great valuations.

Here are a few more buzz words that attracted financing: “Early Stage and Late Stage,” which meant something different to everyone.

“Blockbuster,” which has been rarely seen emerging out of the Canadian Biotech scene.

These days these trends or buzz words are not sufficient to attract money anymore.

NeW TReNDS One of these new trends is “Project Base Financing”. This model is in its infant stage and may prove to be a challenge in itself. The theory is that ventures would invest in “Projects”. These projects would be administered virtually while outsourcing would be the flavour of the day. A team of C Level experts would guide the technology through its value building milestones from product development through its licensing out.

The objective would be to have a number of projects being directed by the same team. This would certainly optimize funds for product development.

Is there a project deal flow market?

The answer is without a doubt yes.

The deal flow would come from biotechs themselves, like the Platforms referred to above, that do not have sufficient funds to explore other in-

Continued on page 20

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Funding Continued from page 18

within a very particular niche since it would never have the breadth of experience to take on projects in different sectors.

One solution to this dilemma is to have these projects run by CROs (Contract Research Organization). Of course the CROs must have this strategy in their business model. They have the wide experience and ability to drive these projects through their development path in a very cost efficient way. The deal structure can consist of

dications. Another contributor would be the biotechs that went bust. Even pharma becomes a source through their mergers with spin outs of projects that are no longer in their marketing focus.

The success of Project Base Financing will depend on the experience of the team and its ability to guide the projects through their development stage. The success will depend on the C Level Team that can concentrate

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Biotechnology Focus / October 2010

simple risk and reward sharing model.

Another increasingly popular financing trend is the conversion of sweat equity by service providers. This has many advantages aside from the obvious of reducing the burn rate. Some of these advantages are having the service provider with a stake in the company and thereby sharing the same goals of success as the other shareholders. This practice usually increases the confidence level of other investors or potential investors. Of course the largest service provider in a Biotech is its own CRO. The service provider now has the opportunity to participate in an interesting upside.

Therefore those that can adapt to changes will gravitate towards these types of creative and innovative financing tools and CROs will offer this new financing tool.

Daniel Pharand, C.A. is a Chartered accountant with over 25 years of experience in the pharmaceutical, biotech and life sciences industries with a proven track record. He currently serves as a Principal of Cato BioVentures and as Chief Financial Officer of Cato Research, as well as Chief Strategic Officer and Chief Financial Officer of Cancer Advances.

Mr. Pharand was the Chief Financial Officer of Pharmacia Canada and of Pharmacia KK (Japan). He subsequently became an entrepreneur with a successful Canadian distribution company of innovative pedicular screws systems in orthopaedic therapies. Pharand later was involved in the Biotech Venture with Innovatech Grand Montréal over his five years as Portfolio Manager. Pharand has also acted as a director and has served on various boards for more than 30 publicly traded or life sciences corporations, including Corautus Genetics Inc. (NASDAQ: VEGF), Bio 1 Inc. (now TSX-V: ARU), LAB International Inc. (TSX: LAB) and Mistral Pharma Inc. (TSX-V: MPI).

CQDM

By Shawn Lawrence and Tonya Costoff

CQDM PUTS THE NEEDS of the pharmaceutical industry front and centre

The Québec Consortium for Drug Discovery (CQDM) now has two years of experience under its belt.

Established in 2008, it set out to put the needs of the pharmaceutical industry front and centre, while at the same time looking for ways to allow both the public sector and the pharmaceutical industry to invest more into R&D and increase the productivity of its investments in Canada.

OF GROWTH Reply Card #4789

Here is a brief description of the projects that have been initated: Project: A new biosensor paradigm

for continuous detection of multiple analytes Principal Investigator: Emanuel Escher, Université de Sherbrooke

The capacity to monitor selected drugs, analytes or biomarkers in living organisms is crucial for drug discovery and

Montréal InVivo works as a dynamic and mobilizing lever for the creation of an ecosystem favourable to the creation of innovation and wealth in the life science and health technology (LSHT) sector in the greater Montreal.

QUÉBEC

ACTOR OF INNOVATION ACTOR

In order to fulfill these needs the CQDM created a funding program that is designed to support the development of promising new generation technologies that have the potential to transform biopharmaceutical research. The competition invites researchers from industry and academia to put forth a unique project idea and create tools and technologies to accelerate the drug discovery process.

So for the second year in a row, the CQDM has now initiated four outstanding research projects resulting from its annual competition.

“What we’re hoping to do is keep our research agenda very broad and we want to make sure we have strong projects that will have an impact on biopharmaceutical research,” said Diane Gosselin, vice president, Research and Business Development, CQDM. “As long as the projects are addressing a crucial challenge that the industry is facing right now, and as long as the project will come up with clear applicable results right away, we are satisfied with that.”

Montréal InVivo has three priority thrusts: MOBILIZATION: Rally public and private players around co-projects or strategic action.

HUMAN CAPITAL: Initiate and support the implementation of innovative action plans to attract, develop and keep high-calibre talent.

AN INTERNATIONAL NETWORK: Establish extensive networks to stimulate strategic partnerships and pave the way to new markets for our partners.

Montréal InVivo, a key player in propelling the LSHT industry forward.

Biotechnology Focus / October 2010

21

CQDM

the future of healthcare. It allows the monitoring of biological response during in vivo animal experimentation with minimal animal sacrifice and discomfort as well as a reduction in cost and development time. In a clinical setting it also improves the accuracy and rapidity of diagnosis and permits ultimately the implementation of personalized medicine approaches and the development of artificial organs such as an artificial pancreas for the optimal control of diabetes.

The proposed project involves the development and validation of a new generation biosensor that offers unique and broadly applicable capabilities, combining the capacity to monitor several analytes simultaneously in real time, for use ex vivo and in vivo. Relying on the evanescent field-based detection of the fluorescence of Quantum dots, the proposed biosensor brings together expertise in electrical engineering, physics, pharmacology, chemistry and physiology. As a first step, the integration of the various components will provide a pHactuated biosensor. In a next step, it will be optimized for the individual detection of glucose and insulin.

Project: Integrated platform to identify synthetic lethality opportunities in cancer therapy Principal Investigator: Gordon Shore, McGill University and Gemin X Pharmaceuticals Inc.

McGill University

psychiatric disorders using electroretinography Principal Investigator: Michel Maziade, Centre de Recherche Université Laval Robert-Giffard (CRULRG) and Neuropsychiatrie Découverte et Innovation Inc. (NDEI)

Infection with herpesviruses is associated with important human diseases including the development of cancers.

Temporal or permanent deficiencies in the immune system can facilitate infection with these viruses. Patients

The scientific basis underlying the diagnosis of schizophrenia, bipolar disorder and major depression is unclear. This generates uncertainties about the classification of patients in clinical research settings and for efficacious treatment.

develop resistance to many current therapies. Typically, these hurdles are addressed by confucting a large number of human clinical trials with a wide variety of patients and drug combinations, a process which often requires

technology for antivirals Principal Investigator: Matthias Götte,

québec

We propose a novel approach, based on the use of electroethinography, which measures the response of the retina to light stimulation. The retina, as part of the central nervous system, constitutes a powerful site of investigation for understanding brain disorders such as schizophrenia.

Previous work by Maziade and Hébert supports this approach and the changes in electroretinography observed in patients reflect a disturbance in the chemistry of the brain. Using this approach, we propose to develop an array of biomarkers that will tag the different sub-groups of patients within these diseases, both at the stage of the disease and in the years preceding its onset.

Basic research has made important advances in understanding the causes of cancer resulting in the discovery of a new generation of therapeutic drugs targeted to specific malfunctions in cancer cells. However, each cancer type represents a unique disease, which harbours a variety of genetic mutations allowing cancer cells to grow and

Project: A novel phage-based screening

22

who receive organ transplants are considered to be the most vulnerable population. Ideally, those individuals are treated with antiviral agents to prevent infection.

Unfortunately, the use of approved drugs is often associated with severe side effects, the development of drug resistance and a limited spectrum of activity against the various members of the herpesvirus family. Thus, there is an urgent medical need to discover and to develop novel anti-herpetic agents. However, technical obstacles have hampered the development of effective drugs against many of these viruses. Here we propose to dvelop a surrogate system that takes advantage of the structural and functional similarities among viral DNA polymerases and their orthologs in phages. The central hypothesis is that phage-derived chimeric polymerases containing critical parts of the substrate binding site of the viral enzyme can be used to identify novel classes of compounds that inhibit essential functions of the virus.

Biotechnology Focus / October 2010

Project: Profiling of patients with major

cqDM

The 2010-2011 competition is now underway, with the deadline for the submission of the letters of intent being Oct. 25. In 2010-2011, CQDM will fund three to five innovative projects for up to $2 million per project.

Looking ahead The 2010-2011 competition is now underway, with the deadline for the submission of the letters of intent being Oct. 25. In 2010-2011, CQDM will fund three to five innovative projects for up to $2 million per project. CQDM’s funding will be awarded following a competitive process in two stages.

The selection of the letters of intent will be overseen by the CQDM’s Strategic Orientation Committee. Only applicants whose letter of intent will be selected will be invited to submit a full project proposal before Feb. 14, 2011.

Evaluation of the proposals will involve an international peer review led by the Fonds de la recherche en santé du Québec (FRSQ) and a risk analysis performed by CQDM. Announcement of the final selection will be made in April 2011.

For a complete description of the 2009-2010 projects that have been initiated, please visit the CQDM website at www.cqdm.org.

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Reply Card #4790 SD0922

Biotechnology Focus / October 2010

quéBec

several years before determining which patients will ultimately benefit.

One approach to address this issue is the concept of synthetic lethality, which refers to the identity of two genes that when eliminated individually are unobtrusive to the cancer cell, but together their elimination results in cell lethality.

In cancer therapy, this can be achieved either by combining two or more drugs chosen to stop the function of the two synthetically lethal genes or by selecting patient populations that harbour a tumour mutation that allows enhanced responsiveness to a specific drug.

23

Mentorship Compiled by: Shawn Lawrence

cqDM MeNTORSHIP PROGRAM supporting biopharmaceutical research in québec

quéBec

In September 2009, the Québec Consortium for Drug Discovery (CQDM) initiated a mentoring program led by the biopharma industry to support the continuous alignment of its three funded projects from its first competition.

The CQDM launched the program (the first of its kind in Canada), with the needs of the biopharmaceutical industry in mind.

24

Biotechnology Focus / October 2010

As part of the program, each of the three funded projects announced last year was supported by three mentors appointed by CQDM’s pharma sponsors; AstraZeneca, Merck and Pfizer from their own global organizations.

The mentors were chosen for their specific expertise relevant to the field of research and thus paired to off with the three CQDM projects announced last year. These projects included: the Caprion Proteomics project, lead by Eustache Paramithiotis, for the development of new biomarkers for early diagnosis and monitoring of diabetes and for prediction of therapeutic response; the Medicago project, lead by LouisPhillippe Vezina, for the development of a novel, high throughput technology (VLP express) to accelerate the discovery and development of new vaccine antigens based on virus-like particles; and the Université de Montréal project, lead by Michel Bouvier, for the devel-

opment of multiplexed biosensors for identifying and monitoring cellular events associated with drugs therapeutic efficacies and side effects.

Although the program was started only a year ago, already both the researchers and mentors are seeing very positive and tangible benefits from this unique initiative.

“We could see from the start we were onto something. We know how it works and we know that it’s already delivering,” states Diane Gosselin, vice president, Research and Business Development CQDM. “Working with the lead scientists and their teams, the mentors responsibilities include assisting the investigators in understanding the specific needs of the biopharmaceutical industry; ensuring that the projects would bring concrete solutions oriented to the needs of the industry; and lastly providing industrial and scientific support in the successful completion of the project. This includes giving advice to researchers and the right guidance on how to get the project to where they (the pharma sponsors) want them to go,” explains Gosselin.

“The mentor’s are not there to evaluate the project; they are there to support the project. They are part of the project and they want it to succeed and as quickly as possible.”

According to Gosselin, the mentors also aid in providing resources for the project when possible, such as clinical samples or access to specific databases.

The mentors have their own great networks to turn to and they will provide whenever possible to their protégé’s access to these networks, whether it’s social or scientific.

Mentorship

“We could see from the start we were onto something. We know how it works and we know that it’s already delivering.”

— Diane Gosselin

Our Work Gives Life — Life to local economies in Canada, turning Canadian research into health care solutions. Our work gives hope to millions suffering from chronic disease — prolonging life, easing pain. Our work delivers better health care and faster recoveries, through prevention as well as cure. Our work in Canada helps save lives here at home and around the world through innovative research into medicines and vaccines.

Our work gives hope.

www.canadapharma.org

québec

“In one case the project needed specific expertise in informatics, something that was really possible to find in the pharma industry, it was done through the mentors.” Moreover because the mentors are the end users of the technology being developed, they are also the best ones to give advice on the technology. As the mentors are very knowledgeable in the field of the research, the comments and discussions are extremely relevant and constructive.

Within the CQDM projects, the pharma sponsors have the right to use the technology for research purposes.

“So they’re really well positioned to say first of all, if you’re going to develop that specific tool, maybe you should consider this characteristic or you should orient your project this way because you will align your project or results with the needs of the industry,” states Gosselin. “They are thus well positioned to identify the optimal characteristics and performance objectives of the technology that are needed to accelerate or facilitate the research.

Not only do they provide significant industrial expertise but they also facilitate access to a wide industrial network for the protégés. This can also be useful in terms of having access to things like clinical samples, databases and other specific equipment.”

She adds that because the mentors are well positioned to understand the technology and to talk about the technology in their own organizations, it also increases the interest of the pharma company for the research project.

In the case of the Michel Bouvier project, the intervention of the mentors has made the pharmas express very early on their interest to use the technology.

This is considered an extraordinary achievement since this isn’t a partnership with a biotech company but rather an academic lab.

For Bouvier, it was opportunities such as these that motivated to even apply for CQDM project status.

“It’s really a program that just fit with what we wanted to accomplish at our lab. There’s a void in taking basic discoveries and transferring them to applications. Sometimes it’s too early to really go to one partner, and say we think this will be fantastic, here’s the data. And the risk is often too high for one company to buy such technology that early on. But with the CQDM there

Reply Card #4791

Biotechnology Focus / October 2010

25

Mentorship

quéBec

“It’s really a program that just fit with what we wanted to accomplish at our lab. There’s a void in taking basic discoveries and transferring them to applications. ” — Michel Bouvier

26

are multiple partners involved to dilute the risk, and as such they were willing to get behind the technology, especially with public sector money also behind these projects,” says Michel Bouvier.

Beyond the opportunity of making his technology a reality, Bouvier has also especially appreciated the efforts of the mentors working with him and team on his project.

“We can have their views of how the project is progressing, as well as a much better understanding of the needs that the pharma industry has from the project. We’ve benefited from some very good suggestions on directions that we did not consider taking with the technologies we are developing, or improving on specific items of the project that we’re trying to do,” he said.

The opportunity for researchers at his lab to work with key scientists, establishing direct relationships at the three pharma sponsors research centres was also too good to pass up he says.

The mentors are also well position to bring the results of the research to the attention of the decision makers in their respective organizations, which could ultimately lead to the immediate use of the technology as well as the establishment of future partnerships.

“Overall, I think that the projects have been improved by the mentoring.

They have made suggestions, which have improved some items in the project that’s for sure. They also helped us orient the priorities with their ultimate needs, which was important. And as they (the pharma sponsors) saw the progression of the technology that we are generating and validating in the course of the project, they have already expressed interest in transferring some of its application in some of their research centres. This wasn’t supposed to happen til the end of the projects, which is three years down the road.

Biotechnology Focus / October 2010

So you can say there have been immediate results. The fact that they are there, they hear about it, they see the data, they go back to their colleagues in their research centres and share what they’ve learned and what they’ve heard, it clearly accelerated the transfer of these applications,” he said.

Bouvier’s project is not the only one to have doors opened for it thanks to the mentor’s involvement. In fact for both Medicago and Caprion Proteomics, the two biotech’s funded by CQDM, the interactions with the mentors have accelerated discussions with the pharma’s at the global level. As Gosselin explains, to build strong links with the pharma industry is an important asset for a biotech company. In fact, as a result of the strong links nurtured through these projects, discussions are now in an advanced state in at least one case for a new partnership.

As a further point that this is not your usual mentor and protégé relationship, many of the protégé’s are pretty experienced in their own right. As such, the mentorship program also brings strong benefits for the CQDM pharma sponsors as the mentors have a privileged access to highly innovative external research and very talented groups of investigators. The pharma’s are thus in the perfect position to truly appreciate the value of the technology and to create strong links that could eventually lead to fruitful collaborations.

For all these reasons, Gosselin states that the CQDM will continue to follow this model with this year’s four projects.

“We were not expecting such immediate results, we were hoping that perhaps by the end of the project this would take place but not within the first year, so this has been a very interesting development and one we hope to duplicate in the future,” states Gosselin.

Name of the mentors for the cqDM projects PRINCIPAL INVESTIGATOR: Eustache Paramithiotis, Caprion Proteomics

FIeLD OF ReSeARcH:

Development of new biomarkers for early diagnosis and monitoring of diabetes and for prediction of therapeutic response

NAMe AND AFFILIATION OF THe MeNTORS:

1) Ranabir SinhaRoy Director Diabetes and Obesity Site Lead, External Basic Research, Merck & co, USA 2) Sotorios Karathanasis, Vice President Bioscience AstraZeneca, Mölndal, Sweden 3) Judy Treadway, Research fellow, Translational Biomarker Laboratory, Pfizer Inc., Groton, CT, USA

PRINCIPAL INVESTIGATOR:

Michel Bouvier, Université de Montréal

FIeLD OF ReSeARcH:

Multiplexed biosensors for identifying and monitoring cellular events associated with drugs therapeutic efficacies and side effects

NAMe AND AFFILIATION OF THe MeNTORS:

1) Laura Rokosz, Director External Basis Research, Biology Diabetes & Obesity, Merck & Co., Rahway, NJ, USA 2) Anne Schmidt, Senior Director Primary Pharmacology group , Pfizer Inc., Groton, CT USA 3) Manon Valiquette, Director of the InVitro Biology and DMPK department, AstraZeneca R&D Montréal

PRINCIPAL INVESTIGATOR: Louis-Philippe Vezina, Medicago

FIeLD OF ReSeARcH:

VLP express: a novel, high troughput technology to accelerate the discovery and development of new vaccine antigens based on virus-Like particles (VLPs)

NAMe AND AFFILIATION OF THe MeNTORS:

1) Amy Espeseth, Director Antiviral and Vaccines, External Basis Research, Merck & co, West Point, PA, USA 2) Joann Suzich, Vice president, infectious disease, MedImmune, Gaithersburg, MD (USA) 3) To be named (Pfizer)

By Laurence MacPhie and Noel Courage

ACROSS CANADA

The Evolution of Patentable Subject Matter Avoiding Threats of Extinction Recent Developments in Patenting Gene-Based Biotechnology The sequencing of the final nucleotides in the human genome 10 years ago was a landmark event in biotechnology1, 2. Despite rapid progress in the understanding of human genetic variation, many of the promises of genomics, such as personalized diagnostics and medicine, are still at a very early stage of development. Efficient transfer of advances in genetics ‘from bench to bedside’ has proven technically difficult. Biotechnology companies are also challenged by the uncertainty of unresolved regulatory and legal issues surrounding commercialization of powerful new tools such as genetic engineering, gene therapy and genome-based biotechnology.

In particular, the types of inventions in biotechnology that can be patented have become increasingly contentious. For an invention to be patentable, it must first fall into a category that is considered patentable subject matter. What constitutes patentable subject matter is therefore an important threshold question. For example, laws of nature, physical phenomena, and abstract ideas are not patentable categories. In Canada, methods of surgery are excluded from patentable subject matter, but are considered patentable in the United States. In a decision involving the Harvard oncomouse, the Supreme Court of Canada held in 2002 that multicellular life forms were not patentable subject matter3.

This prompted concern in some quarters over the scope of protection available in Canada for certain genetic technologies.

However, two years later the Schmeiser Supreme Court decision confirmed that isolated, genetically transformed cells were patentable subject matter4. This case showed that patenting the methods and genetic tools for making a transgenic plant could fully protect the invention, even though the trans-

genic plant itself was not patentable.

Traditionally, inventions in biotechnology in the United States have had relatively little difficulty in qualifying as patentable subject matter. However, a series of recent, questionable court decisions may potentially affect the scope of patentable subject matter for genes and diagnostic methods. As set out below, the law relating to patentable subject matter is still in a state of flux, so inventors should continue to actively research in this area and pursue aggressive patent strategies in order to be able to adapt to any potential outcomes.

Isolated Genes - The Battle over BRCA On March 29, 2010 a U.S. District Court in New York found the claims in several of Myriad Genetics’ patents on breast cancer genes BRCA1 and BRCA2 invalid as not being patentable subject matter5. This case is under appeal. The claims covered isolated DNA containing the BRCA1 and BRCA2 gene sequences. The decision stated that the purification of a product of nature, without more, cannot transform it into patentable subject matter and that the purified product must possess “markedly different characteristics”.

In this case, isolating the BRCA1 and BRCA2 DNA from genomic DNA and other cellular components was not considered sufficient to render the molecules “markedly different”.

This decision is inconsistent with prior US federal cases that considered gene claims on other grounds involving validity or infringement. Many patent practitioners feel that the Court of Appeals will side with the long-standing practice of allowing claims to isolated DNA molecules and likely overturn the decision in Myriad. Hopefully, the Court will also provide some clear guidance specifically on the patentability of subject matter related to biotechnology and by so doing provide some assurance for investors and companies working in gene technology.

Diagnostic Methods that Analyze Genes - BRCA & Bilski There have been inconsistent results in several recent court cases involving diagnostic methods using genetic analysis of patient samples.

These cases will all be reconsidered in view of a recent US Supreme Court case, called Bilski v. Kappos6, that set down general principles for determining what is patentable subject matter. We provide a short summary of the diagnostic method cases and Bilski below.

In the Myriad case, the District Court also invalidated claims for methods of “comparing” or “analyzing” BRCA gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer. Other method claims were also invalidated that involved screening for potential cancer therapeutics. The Court stated that the ‘machine-or-transformation’ test for patentable subject matter required that methods be “tied to a particular machine or apparatus” or “transform a particular article into a different state or thing”. The Court ruled that the claimed comparisons of the DNA sequence failed the ‘machine-ortransformation’ test and were unpatentable “abstract mental processes”.

In a case called Classen v. Biogen7, the OCTOBER 2010 BIOTECHNOLOGY FOCUS 27

ACROSS CANADA US federal Court of Appeals applied the ‘machine-or-transformation’ test to invalidate claims for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in different treatment groups. In contrast, the same level of court applied this test in the Prometheus v. Mayo8 case to uphold patentability of claims directed towards a method of optimizing therapeutic efficacy of a drug by administering the drug, determining its level and adjusting the treatment protocol. It is difficult to draw general principles from these cases.

The United States Supreme Court subsequently released its decision in Bilski, which clarified that while the ‘machine-or-transformation’ test is a useful indicator of the patentability of method claims, it is not the sole test for determining whether a method is patentable subject matter. Since the diagnostic method cases all appeared to have applied a single test, they will need to be reconsidered using this broader approach. Moving away from a strict, single test should be a positive development for the patent owners. As well, since the ‘machine-or-transformation’ test remains an option, it may potentially provide a “safe harbour” of patentable subject matter for diagnostic methods that can meet the test, such as in Prometheus. The ultimate outcome for diagnostics is still uncertain because the Supreme Court provided limited guidance on how the test should be applied in a biotechnology setting. On balance, the Bilski decision was encouraging in that the Court did not preclude claims to diagnostic methods and acknowledged that new tests

for subject matter patentability may need to be developed to take into account new types of inventions as technology evolves.

The Court seemed to suggest that whether a claim is unpatentable subject matter depends on whether it encompasses a ‘fundamental principle’, such as a “law of nature, abstract idea or physical phenomenon”.

Inventors and biotechnology companies should stick to long-term strategies when deciding to pursue patent protection. This is partly because patent applications filed today will not likely be examined for years at which point the law regarding patentable subject matter may have shifted again. Over time, the strongest patent applications are generally those that focus on good science and that skillfully demonstrate an innovative idea and show a clear practical application.

The last decade has seen some spectacular scientific advances in the development of research tools that will support and encourage genetic research, such as the emergence of high-throughput and low cost sequencing platforms. A strong patent system is also necessary to support and encourage genetic research directed towards gene-based technologies and clinically relevant diagnostic tests. Patents are an important asset that attract investment and drive research and development into risky, new genetic technologies.

Fulfilling the promises of genomic medicine will require many more years of patient research and investment. Hopefully the courts will adopt a practical approach and avoid a narrow definition of ‘patentable subject matter’ that could create uncertainty, discourage investment in biotechnology and hamper the

transfer of scientific advances to the clinic.

References 1. Lander et al. Initial sequencing and analysis of the human genome. Nature. 2001 Feb 15;409(6822):860-921.

2. Venter et al. The sequence of the human genome. Science. 2001 Feb 16;291(5507):1304-51.

3. Harvard College v. Canada (Commissioner of Patents) 2002 SCC 76.

4. Monsanto Canada Inc. v. Schmeiser 2004 SCC 34.

5. Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al. (“Myriad”) United States District Court, Southern District of New York. 09 Civ. 4515. March 29th, 2010.

6. Bilski et al. v. Kappos, 561 U.S. ____ (2010), opinion issued June 28, 2010.

7. Classen Immunotherapies, Inc. v. Biogen Idec. (Fed. Cir. 2008) 8. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009) Laurence MacPhie, Ph.D. (Human Genetics), J.D. is an associate lawyer with Bereskin & Parr LLP’s Biotechnology and Pharmaceutical Practice group. Laurence can be reached in Toronto at 416-957-1684 or lmacphie@bereskinparr.com.

Noel Courage, B.Sc. (Biochem.), LL.B. is a partner with Bereskin & Parr LLP and a registered Canadian and U.S. Patent Agent. His practice focuses on the patenting and licensing of chemical, biotechnological and pharmaceutical inventions.

He can be reached in Toronto at 416.957.1655 or ncourage@bereskinparr.com.

Great People.

Great Chemistry.

Reply Card #4792

28 BIOTECHNOLOGY FOCUS OCTOBER 2010

CALENDAR

OCTOBER 2010 October 11-13 Translational Research Excellence 2010 Venue: Brisbane, Australia Web: www.trx10.com.au

October 12 CONNECT: Next Happens Here Venue: Vancouver Convention Centre – West, Vancouver, BC Tel: (604) 683-2724 or 1-800-665-7222 Fax: (604) 683-6567 Email: info@bcic.ca Web: www.connectnext.ca

Company & Advertiser Index

Tel: 212-379-6322 Fax 212-379-6319 Email: enquiry.us@terrapinn.com Web: www.terrapinn.com

COMPANY

November 16-17

Bereskin & Parr...........................................7, 27..........................4784

9th Annual Market Access Summit Venue: Four Points Toronto Airport, Toronto, ON Contact: Jennifer Mirara (ext. 253) Tel: 1-866-298-9343 Fax: 1-866-298-9344 Email: mirara@strategyinstitute.com Web: www.marketaccess.ca

BioTalent Canada.........................................15............................4787

November 16-17

Page

RC

ABIC......................................................... 8..................................

Brady............................................................. 23............................4790 Burrill & Company.................................... 8..................................

Caledon Labs............................................... 28............................4792 Canadian Renewable...................................................................

Fuels Association..................................... 6..................................

Caprion Proteomics................................ 26.................................

Canadian Science Policy Conference 2010 Venue: Montréal, QC Email: dsiele@sciencepolicy.ca and Melissa@sciencepolicy.ca Web: http://www.sciencepolicy.ca/ cspc2010

Stem Cells USA & Regenerative Medicine Congress 2010 Venue: Washington, DC, USA Tel: (212) 379-6322 Fax: (212) 379-6319 Email: enquiry.us@terrapinn.com Web: www.terrapinn.com

October 28-29

November 17-20

Fisher Scientific............................................ 2.............................4782

British Columbia Preclinical Research Consortium (BCPRC) Inaugural Symposium Venue: SFU Harbour Centre, Vancouver, BC Web: www.bcprc.ca

MEDICA 2010 Venue: Dusseldorf, Germany Tel: (416) 598-1524 Fax: (416) 598-1840 Email: messeduesseldorf@ germanchamber.ca Web: www.messe-duesseldorf.de

Genome Québec..................................... 10.................................

October 20-22

October 30 – November 2 14th Canadian National Conference and 5th Policy Forum on Drinking Water Venue: Sheraton Cavalier Hotel Saskatoon, SK Tel: (613) 747-0524 Fax: (613) 747-0523 Email: admin@cwwa.ca Web: www.cwwa. ca/14thconference_e.asp

NOVEMBER 2010 November 8-10 HealthAchieve Venue: Toronto, ON Tel: (416) 205-1300 Fax (416) 205-1301 Email: info@oha.com Web: www.oha.com

November 15-17 Influenza Congress USA 2010 Venue: Washington, DC, USA

Cato Bioventures.........................................13............................4786 Cepmed.................................................. 10.................................

Enerkem Inc............................................. 6..................................

Eppendorf.................................................... 32............................4794

Medicago................................................ 26.................................

MethylGene Inc. ...................................... 8..................................

Montréal Heart Institute........................... 8..................................

Montréal InVivo...........................................21............................4789

DECEMBER

Novadaq Technologies Inc....................... 8..................................

December 5-8

Oncolytics Biotech Inc............................. 6..................................

9th Canadian Immunization Conference Venue: Québec City, QC Tel: (613) 941-8189 Fax: (613) 998-6413 Email: immunconf@phac-aspc.gc.ca Web: www.phac-aspc.gc.ca/cnic-ccni/ index.html

POI..................................................................31............................ 4791 Québec International.............................. 12.................................

Québec Consortium.................................................................... for Drug Discovery.................................. 21.................................

Robic..............................................................11............................4785

December 5-7

Roche............................................................. 5.............................4783

BioPartnering China Venue: Renaissance Shanghai Pudong Hotel, Shanghai, China Web: www.techvision.com/bpc

Rx&D............................................................. 25............................4793

December 11-14

University of Toronto............................... 7..................................

Pacific Rim Summit on Industrial Biotechnology and Bioenergy Venue: Honolulu, Hawaii, USA Email: pacrim@bio.org Web: www.bio.org/pacrim

Sherbrooke Innopole.............................. 12.................................

Stem Cell Therapeutics Corp................... 8..................................

Viterra Inc................................................ 8..................................

VWR................................................................17............................4788 Xenon Pharmaceuticals Inc...................... 6..................................

YM BioSciences Inc................................... 6..................................

OCTOBER 2010 BIOTECHNOLOGY FOCUS 29

By Pierre Bourassa and John Lawson

THE LAST WORD

Hang in there, guys!

In these difficult times it is extremely challenging to start a new biotechnology enterprise.

Money is scarce and financing is very difficult to find. Investors are shielding companies in which they have already invested and are reluctant to invest in new ventures. Focus is the name of the game with small and medium size companies not even considering filling up their pipelines. Interesting projects are being killed for lack of money. We feel that, as a community, we are creating a new problem: there will be soon no pipeline with which to work.

However, there is light at the end of the tunnel. Hopefully, it is not a train!

The Québec government has recently launched a new R&D and innovation strategy (Stratégie québécoise de la recherche et de l’innovation- SQRI), investing $2 billion over three years and has created Teralys Capital, a venture fund of funds. Teralys has over $700 million in capital commitments. It is currently the largest fund in Canada. Unfortunately, not a single penny has been invested in Life Sciences so far (La Presse, August 26, 2010) because “no one has asked for it” confirmed Bernier, Teralys’ president. As we say in French “Ben voyons donc !”. No-one? Really? Can I apply? Ok! Maybe returns have not been reaching expectations but some recent exits were fairly rewarding (e.g. Virochem was sold more than $500 million). We are convinced that there are a lot of fine biotechs across Canada that are close to generating substantial benefits. Angiochem in Montréal and Asmacure in Québec City appear, for instance, to be very promising.

Meanwhile, may we present a few suggestions?

Follow the

6

principles of success:

Passion, Pleasure, Professionalism, Perseverance, Performance and, of course, Partnership.

A partnership is an arrangement where entities and/or individuals agree to cooperate to advance their interest.1

1. Passion: Keep the passion burning for what you are doing.

2. Pleasure: Enjoy what you are doing. Sing along: “Hi Ho! Hi Ho! Off to work we go.”

3. Professionalism: Stay professional with employees, colleagues and business relations.

4. Perseverance: Try and try again. Do not quit. Getting an initial ‘no’ never killed anyone.

5. Performance: Always ensure that your project is the best one around.

6. Partnership: Leverage your partnerships.

Look around. There are a lot of potential partners to assist you.

Many government agencies are willing to take risks at the outset.

The ministère de développement économique, de l’innovation et de l’exportation du Québec (MDEIE) has launched a program to help support technology value generation and transfer (PSVT) through universities and research centres. This could help to mature your technology and move it towards spin-off.

30 BIOTECHNOLOGY FOCUS OCTOBER 2010

The Québec Consortium for Drug Discovery (CQDM) initiative, discussed elsewhere in this issue, is also an interesting possibility for those working on technology platforms.

The MDEIE SQRI has announced that it will also support new strategic initiatives in the Life Sciences sector. So hurry up and check it out.

The National Research Council Industrial Research Assistance Program (NRC-IRAP) is also a good start. Meet your local IRAP Industrial Technology Advisor (ITA) and talk about your project, whether it is a start-up or simply a new research project.

These ITAs are experienced people who have developed considerable networks in many fields over the years. In Québec, the Réseau Conseil en Technologies et en Innovation (RCTi) is supported by NRC-IRAP and Economic Development of Canada (EDC-DEC) and provides invaluable advice. If they do not know it themselves, they know someone who does.

Recently NSERC has launched the Research Partnerships Program (RPP) that fosters collaborations between university researchers, colleges and industry, in order to develop new knowledge and expertise, and to transfer this knowledge and expertise to Canadian-based organizations. An excellent way to leverage your research dollars is to take advantage of university and college specialists. NSERC has offices in Moncton, Montréal, Toronto, Winnipeg and Vancouver to help to deliver this program. For more information please call you local NSERC office or visit the NSEC website (http://www.nserc-crsng. gc.ca). The Business Development Bank of Canada (BDC), besides venture capital, has a possibility of subordinate financing for acquisitions, shareholder buyouts, working capital and intangible assets. Legal, accounting, and many other advisors have development strategies designed to help “entrepreneurs en herbe.”

As you can see, these are only a few pointers. There are a lot of possibilities out there: Just hang in there. The rain will eventually stop.

References: 1. “Become a Partner or Sponsor,” http:// www.uberstudent.org/mod/resource/ view.php?id=27 Pierre Bourassa, B.Sc. MBA is a former entrepreneur who has worked more than 10 years with the NRC-IRAP program. He is currently under secondment to the NSERC, managing the Québec Montréal office. You can reach him at pierre.bourassa@nserc-crsng.gc.ca John Lawson, DBA, MBA, BPharm is a business consultant with Tri:M-V Inc., a member of the BioStrategis consortium. He often assists innovative companies during their early stages of development. He can be contacted on john@ biostrategis.com.

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