Biotechnology Focus November 2011

NOVEMBER 2011

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

VOLUME 14, NUMBER 10

Personalized Medicine The arrival of personalized healthcare is inevitable.

Are we up to the challenge?

INSIDE:

UP-DATE ON OWNERSHIP OF INTELLECTUAL PROPERTY IN CANADIAN UNIVERSITIES Publication Mail Registration Number: 40052410

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contents NOVEMBER 2011 – VOLUME 14 – NUMBER 10

23

Alberta: supporting an environment where innovation and ingenuity are recognized and rewarded

FEATURES

11 The Arrival of Personalized Healthcare is Inevitable The Question is are we up to the Challenge?

(By Michelle Savoie, Howard Bergman, Daniel Denis, Patrice Hugo and Nathalie Ouimet ) Opinion

18 Ownership of IP in Canadian Universities Reviewing policies relating to intellectual property in universities across Canada (By Nika Ketis)

11

23 Across Canada

Personalized healthcare and how it will change the ways in which health, disease and the medical practice are managed

An overview of research activities currently underway in Alberta (By David Evans and Marek Michalak)

DEPARTMENTS

IN EVERY ISSUE

6

Research news

9

Business corner

29 Calendar of events

30 The Last Word

Genomics and the role it will play in the next generation of scientific discovery (By Pierre Meulien)

16 INNOVATOR

6 R&D News

Using nicotinic agonists to treat asthma, Asmacure’s lead product ASM-024 could offer new hope for asthma sufferers (By Shawn Lawrence)

Feds invest in BC proteomics research www.bioscienceworld.ca

NOVEMBER 2011 BIOTECHNOLOGY FOCUS 3

BioMan

PUBLISHER’S NOTE PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

GSK gives Canadian Innovation a shot in the arm

I

t’s no secret that there is funding gap facing drug developers in Canada. In October 2009, the Coalition for Action on Innovation in Canada (CAIC), a think tank co-chaired by GlaxoSmithKline Inc. (GSK) CEO Paul Lucas and former Liberal Deputy Prime Minister John Manley, published , “The Action on Innovation” report in an effort to find ways to address this gap. One of the key findings of this report was that the business community, specifically big pharma, could play a role in helping to alleviate this gap, and that it was in their best interest to do so. So it should come as no surprise that Lucas’ company GlaxoSmithKline is doing its part to get more involved, announcing a new $50 million innovation fund to invest in early stage breakthrough research.

The ‘GSK Canada Life Sciences Innovation Fund’ will identify strategic investment opportunities within Canada’s life sciences industry including academic and health institutions, translational research centers and start-up companies.

“It will provide a competitive advantage to Canada’s life sciences industry and help advance the commercialization of research,” Lucas said in a statement while adding that GSK already has similar funds in place in both the UK and the U.S. The new capital is welcome, but at the same time, the support GSK intends to provide through the fund will go beyond investing in the projects. In fact, GSK plans to provide mentorship and coaching to those who qualify for the fund, to help start or spin-off biotech companies.

According to Lucas, GSK will take equity positions in these firms, but will not own them outright. They will be free to sell products on their own, or form partnerships with GSK or other drug companies.

As risk capital is needed to turn discoveries into real products, one can only hope that this fund will be an important catalyst ensuring Canadian innovation is supported and commercialized.

Terri Pavelic Shawn Lawrence Christopher Rogers

CONTRIBUTING WRITERS

Daniel Denis

David Evans

Howard Bergman

Marek Michalak

Michelle Savoie

Nathalie Ouimet

Nika Ketis

Patrice Hugo

National Account Manager GRAPHIC DESIGNER CONTROLLER

Pierre Meulien Patricia Bush Elena Pankova John R. Jones

MARKETING MANAGER

Mary Malofy

CIRCULATION DIRECTOR

James Watson

circulation@promotive.net

EDITORIAL ADVISORY BOARD Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Genome Prairie; Ulli Krull, UTM; John Kelly, Erie Innovation and Commercialization; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Cognovie Inc.; Grant Tipler, RBC; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB, a partner with Leger Robic Richard; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, LifeSciences British Columbia; Bonnie Kuehl, Scientific Insights Consulting Group Inc. Biotechnology Focus is published 10 times per year by Promotive Communications Inc. 24-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 www.bioscienceworld.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 24-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

If you would like to order hard copy or electronic reprints of articles, contact Sandra Service 905-727-3875 x221 reprints@promotive.net ABC Membership Applied For.

4 BIOTECHNOLOGY FOCUS NOVEMBER 2011

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R & D NEWS New partnership between Canada’s Centre for Drug Research and Development and Japan’s University of Tokyo strengthens international drug development pipeline The Centre for Drug Research and Development (CDRD) and TODAI TLO Ltd., a technology transfer organization for the University of Tokyo, have reached an agreement facilitating joint research projects between the two organizations.

“We are pleased to be sharing knowledge and resources across the Pacific, and to be building this bridge between CDRD and the University of Tokyo, home to one of Japan’s pre-eminent medical research institutes and a top-ranking university by global standards,” commented Karimah Es Sabar, CDRD’s senior vice president of Business and Strategic Affairs. “Recognizing the global nature of the life sciences industry, CDRD is strongly committed to establishing and collaborating with a network of international affiliates representing the world’s

top research institutions,” she said.

TODAI TLO, which manages all intellectual property from the University of Tokyo, received 648 invention disclosures last year. Health research discoveries made at the university will now have an opportunity to be advanced towards commercialization via CDRD’s specialized drug development infrastructure and professional project management, and scientific and business expertise.

President and CEO of TODAI TLO, Takafumi Yamamoto noted, “in general, most of the inventions disclosed at the university are pre-commercial technologies that require much further development.

We believe that this affiliation agreement with CDRD will bring many benefits to the university and researchers to address this gap in the commercialization path.”

Feds invest in BC proteomics research

Dr. Howard Brunt, Dr. Catherine Mateer and Ms. Marnie Swanson Proteomics research continues to flourish on Vancouver Island, thanks to $663,000 in Western Diversification Program (WDP) funding given to the University of Victoria (UVic). The funding will enable the university to purchase and operate two pieces of specialized equipment for the UVicGenome BC Proteomics Centre.

Proteomics is the study of the structure and function of proteins — the enzymes, antibodies and other molecules that make up our cells and tissues. There are an estimated one million different proteins in the human body, and the role of many of them is unknown. The two new instruments are mass spectrometers that will be used to provide fast and highly sensitive analysis of biological samples, such as blood, to detect protein biomark6 BIOTECHNOLOGY FOCUS

NOVEMBER 2011

ers, which are molecules that indicate the presence of disease, conditions and degenerative changes in the body. Scientists hope that by validating proteins as biomarkers, doctors will eventually be able to identify patients prone to a particular disease before symptoms appear and tailor treatment to the individual.

The UVic-Genome BC Proteomics Centre has been providing protein analytical services to academic, biotechnology, pharmaceutical and government laboratories worldwide since 1982. Supported in part by a collaborative relationship between the University of Victoria and Genome BC, the centre is a not-for-profit proteomics facility that operates on a fee-for-service, cost recovery finance model.

Other project costs include acquiring supplies and a data storage server, laboratory upgrades to accommodate the new equipment, and hiring a mass spectrometry technician.

“We are very grateful to WDP for this investment in our proteomics research facility,” said Dr. Howard Brunt, UVic’s vicepresident Research. “The UVic-Genome BC Proteomics Centre now has the highest concentration of mass spectrometers at any Canadian university and one of the highest in North America, making it one of the most advanced centres in the world.”

Clinical Trials & Patents n Allon Therapeutics Inc. (Vancouver, BC) has successfully achieved its enrollment objective of 300 patients in the Phase 2/3 pivotal clinical trial evaluating its lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease. Gordon McCauley, Allon’s president and CEO, said the company expects to complete the treatment phase of the study and release data near the end of 2012. The trial is being conducted under a Special Protocol Assessment (SPA) with the FDA, which ensures that the agreed clinical trial design meets the FDA’s expectations.

Allon has obtained Orphan Drug and Fast Track Status in the U.S. and Orphan Status in the EU. The pivotal trial is based upon statistically significant efficacy demonstrated in patients with amnestic mild cognitive impairment (a precursor to Alzheimer’s) and cognitive impairment associated with schizophrenia. The trial is being conducted at leading medical institutions in the U.S., Canada, the U.K., France, Germany, and Australia. Allon Therapeutics Inc. also announces it has been granted a U.S. patent covering the composition of matter for the D-isomer of NAP (davunetide). The D-isomer of davunetide is known as AL-408 in the company’s pipeline.

This new patent strengthens Allon’s intellectual property estate which includes 15 patent families, 58 issued patents and over 30 pending applications worldwide. n Protox Therapeutics Inc. (San Diego, CA and Vancouver, BC) has completed dosing of the first cohort of patients in its transrectal study of PRX302 for the treatment of benign prostatic hyperplasia (BPH). In this U.S.based, double-blind, multi-centre, placebo controlled study, approximately 56 patients with moderate to severe BPH will be randomized to one of four planned dose cohorts.

The decision to escalate dose levels will take place when all the patients in a cohort have been administered study drug in accordance with the protocol and have been followed for safety for at least 15 days post study drug administration. In this study, PRX302 is administered as a single treatment via transrectal ultrasound guided (TRUS) intraprostactic injection, the traditional route of assessment of prostate health. The primary endpoint of the study is to evaluate the three month safety and tolerability of escalating doses of PRX302. The safety data from this new route of administration of PRX302 will be compared with the safety profile obtained from the previously conducted Phase 1 and 2 studies utilizing a transperineal route of administration.

R & D NEWS Federal R&D Panel reports with six major recommendations for Federal R&D spending The expert panel leading the “Review of Federal Support to R&D” chaired by Tom Jenkins submitted its final report in October to Canada’s Minister of State for Science and Technology, Gary Goodyear.

The report titled “Innovation Canada: A Call to Action,” provides advice in respect to the effectiveness of federal programs to support business and commercially oriented R&D, the appropriateness of the current mix and design of these programs, as well as possible gaps in the current suite of programs and what might be done to fill them.

The report recommended a simplified and more focused approach to the $5 billion worth of R&D funding provided by the federal government every year.

“Government needs to do a better job helping our innovative SMEs grow into larger, world-competitive companies in Canada. Relative to the size of the Canadian economy, government support for business R&D in Canada is among the most generous in the world, yet we’re near the bottom of the pack when it comes to seeing business R&D investment,” said panel

chair Tom Jenkins. “Our report took a hard look at this problem and with valuable input from businesses, scientists, and the academic community; we’ve come up with some practical solutions.”

With a mandate to provide advice on how to enhance federal programming in support of a more innovative economy, the Jenkins panel met with more than 160 stakeholders across Canada, received 228 written submissions, surveyed over 1,000 businesses, and consulted with numerous experts in Canada, Europe, Australia, Asia and the U.S. The review could neither increase nor decrease overall funding, nor could it touch regulatory research done by federal laboratories or basic research conducted by institutions of higher education.

“What we found was a funding system that is unnecessarily complicated and confusing to navigate,” said Jenkins. “There are also significant gaps that hinder the ability of our businesses to grow and that keep Canada from taking full advantage of this country’s innovations.”

In brief, the report (referred to as the Jenkins report) makes six recommendations aimed at promoting business innovation, which include: • simplifying the Scientific Research and Experimental Development (SR&ED) tax

Panel Chair Tom Jenkins, along with Arvind Gupta, Monique F. Leroux and Nobina Robinson, present their report Innovation Canada: A Call to Action, to the Minister of State (Science and Technology) Gary Goodyear on October 17, 2011.

Not shown are panel members David Naylor and Bev Dahlby. credit and redeploying funds from the credit to direct intiatives that support small and medium-sized enterprises (SMEs); • transforming the institutes of the National Research Council (NRC); and • helping high-growth innovative firms access risk capital.

The government will review the recommendations over the coming months. The full report is available online at www.rdreview.ca.

Reply Card #4964

NOVEMBER 2011 BIOTECHNOLOGY FOCUS 7

R & D NEWS

Livestock Gentec 2011

Canadian institutions partner to invest $20m in livestock genomics research

Genome Alberta is leading a group of funding partners on two large-scale genomics projects that will help improve Canada’s livestock sector.

The first project, “Application of Genomics to improve Swine Health and Welfare,“ is a $12.4 million research project led by Graham Plastow from the University of Alberta, John Harding from the University of Saskatchewan and Bob Kemp from PigGen Canada. With the mapping and sequencing of the pig genome, scientists have an opportunity to apply genomic-based tools to the pork industry. Similar tools are already part of the Canadian cattle industry and have revolutionized the dairy industry around the world. Researchers will apply

genomics to help reduce the impact of two of the most common diseases in commercial pig production - Porcine Circovirus Associated Disease and Porcine Respiratory and Reproductive Syndrome. Scientists involved in the project will study mechanisms in pigs that make them genetically less susceptible to these diseases, providing important new diagnostic tools for breeders and expanding our understanding of disease control mechanisms.

The second project: “Whole Genome selection through Genome Wide Imputation in Beef Cattle” is an $8.2 million research project led by Stephen Miller, University of Guelph, and Alberta researcher Stephen Moore who has recently been appointed as

GreenCentre funding for Green Innovation

Mimicking the antifreeze proteins that enable deep-sea fish to survive in belowfreezing waters, Dr. Ben’s technology prevents the formation of clathrates more effectively than existing inhibitors, and is active in extremely minute quantities. Low cost and non-toxic, it offers an economical and environmentally friendly alternative for the protection of overland oil and gas pipelines in colder regions, and in deep well gas and oil exploration.

“This technology has the dual benefits of being more potent, meaning less needs to be used, while also being more environmentally friendly,” says Andrew Pasternak, Commercial Development Director at GreenCentre Canada. “Its potential to prevent pipeline damage offers considerable environmental benefit to the oil and gas industry.”

Dr. Derek Pratt, also of the Department of Chemistry at the University of Ottawa, received $30,000 to create the next generation of his “reversible” anti-oxidant molecules.

A “green” antifreeze and better product protection are the targets of two University of Ottawa green chemistry discoveries recently awarded $60,000 in proofof-principle funding from GreenCentre Canada.

The researchers’ discoveries are based on unique properties displayed in two natural sources: fish and garlic. Their technologies have potential applications in oil and gas pipeline sector and in product manufacturing.

Dr. Robert Ben of the Department of Chemistry received $30,000 to further develop biological antifreeze molecules for use in the gas and oil pipeline industry. Dr. Ben’s technology prevents the formation of clathrates, lattices of frozen water crystals that surround gas molecules, forming clumps and blocking pipes, causing breakage and subsequent environmental damage.

8 BIOTECHNOLOGY FOCUS NOVEMBER 2011

director, Centre for Animal Science at the University of Queensland in Australia.

Canadian researchers were directly involved with a major international undertaking to sequence the bovine genome and are now at the forefront of developing genomic selection techniques to boost genetic improvement in cattle. This project will target traits that are difficult to improve through conventional means. Low-cost tests are being developed that will allow an animal’s genome to be inferred from a relatively small number of genetic markers, giving valuable information about its breeding value at a very early age. In addition, the project will examine the potential market barriers for adoption of these genomic technologies.

An international science review board recommended both projects for funding based on scientific excellence, the potential to translate the research results to benefit Canadian livestock producers, and the internationally recognized project leadership.

Funders for the projects include Genome Canada, Genome Alberta, the Alberta Livestock and Meat Agency, PigGen Canada, Genome Prairie, an international consortium led by the U.S. Department of Agriculture, Western Economic Development, and a number of international agencies and organizations. The projects build on Genome Alberta’s Applied Livestock Genomics Program which was launched in Dec. 2010.

Dr. Pratt’s technology targets free radicals, the molecules that cause substances to break down when they are exposed to ultraviolet light. Anti-oxidants slow down the process of UV degradation, and are currently used in a wide variety of consumer products, including UV-resistant coatings, personal care products such as sunscreen, and food packaging.

Based on the anti-oxidant mechanism seen in garlic, Dr. Pratt’s molecules are unique in their ability to produce antioxidants on demand while reverting to an inactive state when UV light is not present, resulting in longer-lasting UV protection.

“Their reversible properties mean they only produce antioxidant when needed,” says Lynn Leger, Commercialization director at GreenCentre. “This gives them the potential to have a longer shelf life than many standard antioxidants.”

To date, GreenCentre has awarded more than $350,000 in proof of principle funding to 14 researchers at 13 universities across Canada.

BUSINESS CORNER Impact investing gets Canadian home base MaRS Discovery District has been awarded $1.3 million by the Rockefeller Foundation and J.W. McConnell Family Foundation to launch a centre for impact investing to be housed at MaRS. “MaRS is proud to receive funding from The Rockefeller Foundation and the J.W. McConnell Family Foundation and to continue our role as a convener and collaboration hub. The Centre for Impact Investing will compound and centralize the already significant but widespread momentum for the development of impact investing in Canada. This is a terrific example of convergence innovation - linking a growing array of social entrepreneurs with investors seeking both a financial and social/environmental return,” said Ilse Treurnicht, CEO

Neptune receives TSX conditional approval

Neptune Technologies and Bioressources Inc. have received conditional approval for a listing of its common shares on the Toronto Stock Exchange (TSX) under the same symbol, ‘’NTB’’.

Upon filing and acceptance of the final listing application and related documentation, the company’s shares will commence trading on the Toronto Stock Exchange and be de-listed from the TSX Venture Exchange.

The company anticipates its listing date to be before the end of 2011.

of MaRS Discovery District and chair of the Canadian Task Force on Social Finance.

She added that the Centre for Impact Investing will build upon the foundational work of MaRS and Social Innovation Generation (SiG), including the landmark report, Mobilizing Private Capital for Public Good, by the Canadian Task Force on Social Finance.

The goal is to establish the centre as a national hub for increasing awareness around social finance and to catalyze new capital, talent, and initiatives dedicated to tackling social and environmental problems in Canada.

Additionally, the Centre will act as a point of global connection for Canadian efforts into the emerging field of impact investing, delivering programs and initiatives focused on research and policy, market and product de-

velopment, and education and engagement initiatives to build the collective ability to mobilize private capital towards public good.

With this contribution, both Rockefeller and McConnell have issued a call to action for Canadian investors to support the Centre and engage with this emerging market.

The centre is expected to open for operation in early Winter 2011.

Large Chinese pharmaceutical company to commercialize SemBioSys’ plant-based manufacturing technology SemBioSys Genetics Inc. has signed a product and platform development collaboration agreement with Tasly Pharmaceuticals, Ltd. and its wholly owned subsidiary Tasly U.S. Upon receiving government approval, a new company based in China called TaslySemBioSys Pharmaceuticals, Ltd., will be incorporated in Tianjin, China, the third largest city in China.

Tasly is one of China’s largest pharmaceutical companies and is China’s second largest producer of traditional Chinese medicines (TCM), which are derived from plants.

Its lead drug, Tasly Cardiotonic pill, is the number one selling TCM in China and has held that position for the last seven years.

SemBioSys is a biotechnology company that utilizes its renewable, patented plant seed oil body and protein expression technology platforms to develop and make high value proteins and oils and drug candidates for health and wellness products. The agreement is the most comprehensive partnering commercialization endeavor by SemBioSys to date.

The new company will be structured as a

Sino-Foreign Equity joint venture and will develop and commercialize a variety of products including pharmaceutical, functional foods and nutraceuticals for China and the world. Development work on the first products will begin immediately.

SemBioSys will be entitled to 30 per cent ownership and profit sharing of the joint venture’s profits for contributing global rights to develop and manufacture its plant made insulin and insulin analogues (excluding select territories in which SemBioSys is already engaged in active development discussions), as well as licensing rights to research and development activities of additional products for the pharmaceutical and healthy living markets. Tasly will contribute 100 per cent of the cost of the joint venture’s global research, development and product commercialization. Further, Tasly will facilitate preclinical, clinical, regulatory services, manufacturing and commercial expertise and utilize its significant sales force to commercialize the joint venture’s products in China.

Compass expands relationship with Pangen Biotech and enters reagents market Compass has entered into an expanded relationship with PanGen Biotech of South Korea, which will allow Compass to offer a globally marketed comprehensive laboratory reagents product line for sale under the Compass Biotech name.

Compass Biotech will initially prepare to offer lab reagents known as cytokines along

with various cell growth factors. From SEC filings of leading companies in the cytokine and growth factor area, it is estimated these lab products represent an estimated $350 million market in the EU and the U.S. which has been growing steadily in the 15 per cent range over the last five years.

“With Compass focused on developing

protein therapeutics, biosimiliar and vaccine products, we felt being able to also offer these important laboratory reagents on a worldwide basis would allow a congruence of our expertise and knowledge base, while allowing us access to faster and nearer term revenue from sales of these reagents and cell culture media supplements” commented Compass CEO Garth Likes.

NOVEMBER 2011 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER New York Court grants summary judgment in favour of Bioniche Life Sciences Inc. A New York court has granted summary judgment in Bioniche Life Sciences Incorporated’s favour, dismissing all claims in a lawsuit brought by a former licensing advisor, Ferghana Partners, Inc. The lawsuit was filed by Ferghana in Dec., 2009, seeking payment of six per cent of the funds received under Bioniche’s strategic partnership related to Urocidin™. In its lawsuit, Ferghana claimed it was entitled to a “finder’s fee” in relation to an advisory agreement with Bioniche. This claim was made in relation to an outreach never

disclosed to Bioniche, made without the Company’s approval and in violation of the terms of the advisory agreement.

In the 19-page ruling granting Bioniche’s motion for summary judgment of the case, the New York court dismissed all of Ferghana’s claims. The court also denied Ferghana’s cross motion to amend its complaint to include additional allegations and claims. Bioniche was represented in this matter by Dewey & LeBoeuf LLP, led by partner William Primps and including associates Jeffrey Amato and Eric Levine.

Medicago completes $25 million private placement Medicago Inc., a biotechnology vaccine development company announces it has increased the size and closed its previously announced private placement offering of 38,462,600 common shares at a price of $0.65 for gross proceeds of $25 million.

The offering was completed through a syndicate of agents co-led by Bloom Burton & Co. Inc., Desjardins Capital Markets and

Paradigm Capital Inc. Roth Capital Partners acted as financial advisor to the company for the transaction.

Net proceeds from the offering will be used for continued clinical development of the company’s plant-based manufactured Influenza VLPs vaccines, to fund the development of additional potential product candidates and for other general corporate

and working capital purposes.

The company has also obtained an advance ruling from the Ministère du Revenu du Québec confirming that the Corporation is a qualified issuing corporation for the purposes of the Québec Stock Savings Plan II and that the common shares to be issued as part of the pffering will be “qualified shares” for a QSSP II qualified mutual fund.

Dealmakers n The Centre for Drug Research and Development (Vancouver, BC)and the Brain Research Centre, a partnership between Vancouver Coastal Health Research Institute and the Faculty of Medicine at the University of British Columbia have entered into a preferred collaboration agreement. The two organizations will work together, sharing their resources and expertise to facilitate joint drug development research projects focusing on the acceleration of discovery, development and commercialization of technologies for the diagnosis and treatment of neurological and psychiatric disorders. The CDRD and the Brain Research Centre are already now working together on a number of research projects, where the CDRD is providing key scientific and business expertise, state-of-the-art drug development infrastructure, and funding from its three Innovation Funds established with public and private sector strategic partners Genome BC, Pfizer Canada and Johnson & Johnson. This newly formed CDRD/BRC alliance will see further development of these projects, as well as a formalization of the relationship between the two organizations and additional future research collaborations going forward.

Patheon Inc. (Mississauga, ON) has signed a three year $18 million development agreement for two projects with Boehringer Ingelheim.

The projects are both fixed-dose combination drugs in development for the treatment n

10 BIOTECHNOLOGY FOCUS NOVEMBER 2011

of the growing population of type II diabetics.

In commenting on the announcement, Mark Kontny, Patheon’s president of Pharmaceutical Development Services and Chief Scientific Officer said, “I am very gratified that Boehringer Ingelheim recognizes our expertise in formulating, scaling and successfully launching complex formulations such as these molecules. It is this kind of support and recognition that has enabled us to develop our market leading position in pharmaceutical development services. “ n Paladin Labs Inc. (St. Laurent, QC) has completed its previously announced acquisition of all of the outstanding common shares of Labopharm Inc. (Laval, QC). “The acquisition of Labopharm will add to our top line, through the addition of established international revenue streams, and will provide us the opportunity to build upon our existing operational capabilities.

Moreover, Labopharm’s worldwide partnerships provide us with an exciting opportunity to continue cultivating important relationships internationally,” stated Mark Beaudet, interim president & CEO of Paladin Labs Inc. n Dalton Pharma Services (Toronto, ON) has entered into a contract for service with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) to supply and provide sterile fill services for a cGMP grade capsule conjugate vaccine against

Campylobacter jejuni developed by the Naval Medical Research Center (NMRC) and prof.

Mario Monteiro (University of Guelph). Dalton will scale up the conjugation and purification process of a capsule-protein conjugate vaccine intended for use in Phase 1 human clinical trials conducted by NMRC. “Our expertise and capabilities in conjugation chemistry, sterile API manufacturing and our strength in aseptic filling, solidified the manufacturing agreement,” said Peter Pekos, president and CEO of Dalton.

“Dalton is committed to supporting the efforts of the Navy and the University of Guelph for novel vaccine research and development.” n Warnex Medical Laboratories (Laval, QC), a division of Warnex Inc. and deCODE Genetics, a human genetics company, based in Reykjavik, Iceland, announce that they have signed an exclusive distribution agreement in Canada for 10 of deCODE Genetics’ DNA-based tests for assessing the risk of developing certain common diseases.”New genetic tests are now available to guide physicians in personalizing each individual patient’s healthcare program,” said Mark Busgang, president and CEO of Warnex. “We are excited to collaborate with deCODE Genetics to offer these advanced genetic risk tests in Canada. These tests will provide Canadian patients and healthcare providers the ability to assess the genetic risk for certain diseases and then make decisions regarding prevention, screening and/or treatment.”

By: Michelle Savoie, Howard Bergman, Daniel Denis, Patrice Hugo, and Nathalie Ouimet

THE ARRIVAL OF PERSONALIZED HEALTHCARE IS INEVITABLE

Personalized Medicine

Article translated by Pamela Lipson

The question is, are we up to the challenge?

The developments and discoveries in disciplines such as genomics, proteomics, imagery, Information Technology and Communications (ICT) and community health ensure that we can now expect to reach the goal set by Hippocrates to determine preventive and treatment approaches for the right person at the right time.

F

or many, personalized healthcare (PHC) represents a revolutionary approach that will fundamentally change the ways in which health, disease and the medical practice are managed.6 Personalized medicine – more specifically, PHC – constitutes a tailored response to the healthcare challenges of the 21st century and especially to chronic disease, which is the leading cause of morbidity and mortality in modern societies and generates the most demands on the healthcare system.

PHC fuels the hope of improving individual and community health of individuals and of better controling the rising healthcare costs.

PHC tools more accurately stratify the different sub-types of illnesses, thereby ensuring that only the patients who will benefit from a therapy will be treated. For example,

HerceptinTM (TrastuzumabTM) cannot be used to treat all patients suffering from breast cancer because only 20-30 per cent of them can benefit from treatment.7 However, there exists a PHC tool/diagnostic test to identify women whose tumours exhibit the protein HER2, the target of HerceptinTM, and which are therefore able to benefit from the HerceptinTM treatment. This diagnostic test, used in conjunction with the drug Herceptin,TM increases the response rate to close to 80 per cent.8 As a result, the use of PHC enables patients to not only avoid adverse side effects, but also helps optimize the therapeutic use and achieve substantial savings because, depending on the therapeutics, between 20 per cent and 70 per cent of patients fully benefit from the therapies that are implemented.

PHC has the potential to not only better target treatments and lower the proportion of

patients who could suffer from side effects, but also helps to adjust the treatment dosage and identify the types of patients most at risk for developing an illness (targeting patients who could benefit from preventive treatment). By stratifying the healthcare services being offered, PHC therefore has the potential to radically change the practice of medicine and transform the role of the individual with respect to his own health and that of the organization of the healthcare system.

Nevertheless, the hope fueled by PHC should not give the impression that a quick change or highly short-term results are on the agenda. Rising to these challenges is more analogous to a marathon than to a sprint, but it’s a marathon in which Québec must enter because the arrival of PHC is inevitable.

The development of PHC involves issues and challenges that Québec cannot avoid: technological, socioeconomic, industrial, as well as those challenges related to research financing, regulatory approval, intellectual property, training of those involved and management of the healthcare system.

Major changes in the health sector and in industries in this sector are in fact necessary NOVEMBER 2011 BIOTECHNOLOGY FOCUS 11

Personalized Medicine Issues and Challenges to Fully Benefit From the Potential of Personalized Health Care (PHC)

example, in Québec, following approval by Health Canada, the decision to implement the majority of PHC diagnostic tests is currently under the responsibility of healthcare institutions’ budgets. This decision-making process, which is complex for manufacturers, also potentially hinders the general availability of tests in the different regions of the province and, as a result, the healthcare services offered are not harmonized. Also, the approval process by federal regulatory authorities has not evolved at the same pace as the development of PHC. The process will therefore need to be modernized to align the requirements for approval of the new genomic diagnostic or companion diagnostic test with those for approval of a new drug intended to improve the profitability prospects of marketing PHC tools.9

Research investment opportunities to seize

to be able to fully benefit from the potential offered by this approach.

Optimizing a PHC industry business model The development of PHC can not only be beneficial for individuals’ health and an efficient healthcare system, it can also create economic wealth and fuel research.

The development of PHC is based on a value-creating chain of activities for the organizations that drive it. The creation, marketing and use of PHC solutions stimulate several high value-added sectors (biotechnologies, pharmaceutics, health technologies, research centres, ICT, etc.). Internationally, PHC market growth was buoyed by the combined effects of several factors including the need to optimize the drug development process, the reduced cost of human genome sequencing, the emergence of other high-throughput analysis technologies, preliminary results that demonstrate the effectiveness (and safety) of therapeutic products stemming from PHC solutions, the launch of programs to foster the development of biomarkers/genetic tests by agencies such as the FDA , the high demand for more effective care solutions, and 12 BIOTECHNOLOGY FOCUS NOVEMBER 2011

increased investment in the sector.

A very important component of the PHC market is the diagnostic industry. The global market of biomarkers in companion diagnostics (i.e., that accomany a specific therapeutic approach: such as the detection of HER2 and the treatment with HerceptinTM) and inherent therapeutic solutions was valued at $26 billion in 2010 (irrespective of the sales of other diagnostic and followup products and services).4 The market has experienced robust growth over the last five years and will continue to grow at an accelerated pace over the next five years (for example, the growth in the biomarker, companion diagnostics and targeted therapeutic solution market is expected to be close to 15 per cent per year). PHC is not only a scientific reality; it is also an economic one.

More than 50 biomarkers and companion diagnostic tests are already available on the market while an even greater number are still undergoing preclinical or clinical testing or awaiting validation.

The profitability of this industry sector is certainly not optimal according to many and is greatly limited by the complexity of the marketing development process. For

PHC is still in its early stages. The realization of current and future potential in PHC requires significant continued efforts in terms of research, new approaches and new collaborations. These new investigative developments are vital to the pursuit of desired innovation. Growth of the PHC tools market thereby represents a growth opportunity for research investments in Québec.

Currently, in many regions of the world, significant efforts are being invested to enhance PHC research and ensure it remains in line with user needs. Clinical validation with large cohorts is a prerequisite to the application of PHC. The means to assemble large stratified groups of patients and access to data, samples and patients constitute obstacles to the clinical validation of biomarkers and companion diagnostics. Québec already has an enviable reputation across North America and internationally in many areas of research, particularly in PHC-associated fields. The public research network has developed an effective infrastructure and can advantageously position itself so as to attract the analytical and clinical validation studies of PHC tools.

From this perspective, to stand out, we need to offer extensive clinical databases quality tissue banks. Aside from CARTaGENE1, Québec wealth is dispersed throughout several databanks and pathology-specialized biobanks. To promote this asset, we need to harmonize practices with respect to the collection and conservation of samples, based on recognized international standards.

Additionally, public databanks could prove to be a major competitive advantage for Québec, with its unique healthcare sys-

Personalized Medicine tem. Our public healthcare system should enable us to review problems related to healthcare and to the way in which healthcare is organized. However, in some cases, access to data is highly restrictive. Mechanisms (methods) designed to improve access and make better use of these databases are required to be able to fully capitalize on this Québec asset.

The clinical utility of PHC: demonstration and validation issues Though recent developments in PHC have been significant, most PHC tools are still at the preclinical validation or proof of concept (analytical or clinical) stage. Many specialists nevertheless agree that the real challenge resides more in the implementation of PHC in healthcare systems than in the advancement of scientific knowledge.

Efforts must first be deployed to transform the existing knowledge into available products to treat patients. PHC’s tangible benefits on healthcare and healthcare systems must still be demonstrated, especially their measured cost-benefit ratio. A product’s clinical utility measures its impact on the healthcare professional’s clinical decision and on the improvement of an individual’s health. The impact of the implementation of PHC on healthcare costs and the efficiency of healthcare must also be clearly demonstrated.

To achieve this, we have to develop a more systematic vision of healthcare institutions. Considering the features of its healthcare system, Québec is well positioned to demonstrate the systemic effects of introducing PHC into a healthcare system. It’s a major undertaking but also an opportunity for international distinction. All the states understand the potential PHC represents but few among them know how to effectively implement it in their healthcare systems.

Digital infrastructures and connectivity The technological limitations of dataprocessing platforms and the performance of ICT tools are also slowing down the development and implementation of PHC. Stratification of the patient cohorts requires a highly effective digital platform; our existing infrastructures need to evolve.

The development and deployment of PHC in Québec should be supported by the implementation of technological infrastructures required to improve the healthcare system and adapt the existing tools to PHC. The connectivity between the different data sources (patient’s clinical file, environment,

family history, drugs, diagnostic test results, etc.) and the real-time access to this information will ensure successful implementation of PHC in a healthcare system.

Organizational and applicability issues within the healthcare system The organizational impact is one of the key elements influencing the adoption of change and innovation in a given environment. While the clinical validation of PHC tools using large and well-characterized cohorts constitutes a key development stage, it is also vital to convince the healthcare sector of the necessity and relevance of adopting these new healthcare approaches.

PHC may bring about significant changes to the practice of medicine and other healthcare professions and to the organization of the healthcare system. For example,

For example, should an individual’s predisposition to a debilitating disease be measured if there exists no treatment? What are the acceptable societal risks of misinterpreting the results? Should the sale of “direct to consumer” sequencing services be permitted, knowing that the genetic predisposition is only responsible for a portion of the susceptibility factors?11 Faced with the proliferation in staff sequencing services, mainly in the United States, the use of data and results of such tests needs to be properly monitored. More specifically, it is vital to prevent an insurer from being able to adjust eligibility for insurance products on the basis of results of such tests and of a person’s relative risk of developing a given health problem. In this regard, in 2003, an inter-ministerial committee, the “Commission de l’éthique de la science et de la technologie” [Ethics of science and

PHC’s tangible benefits on healthcare and healthcare systems must still be demonstrated, especially their measured cost-benefit ratio. A product’s clinical utility measures its impact on the healthcare professional’s clinical decision and on the improvement of an individual’s health. where will the tests be administered, who will analyze them, who will absorb the costs, who will decide upon what treatment the patient will receive? Furthermore, the growing availability of PHC tests will also require further attention to be paid to the quality (predictability) of the results of these tests. The new tools used in PHC often use sophisticated techniques, less controlled than those currently found in hospital laboratories. In addition to assessing the cost-benefit ratio of the new personalized solutions, it will be important to measure the impact of the introduction of these solutions on the medical profession, the roles within the medical profession, the ways in which the services are organized, training needs, available tools, compensation, etc.

Ethical and regulatory issues The PHC approach also raises important ethical questions on aspects such as the protection of personal information, social equity, and the interpretation and especially the transmission of diagnostic tests results.

Most of predictive gene tests are not certified and can lead to misinterpretations, causing psychological impacts for those involved and inciting unwelcome practices.

Any major change in practice raises ethical questions on necessary, desirable intensity.

technology commission] focused on genetic medicine.2 The committee’s recommendations concerned mainly the imposition of a moratorium on the use of genetic data by employers and insurers, until legislation is amended and adopted. Such a moratorium is still vital to progress toward deployment of PHC. In 2003, a declaration made by UNESCO3 also addressed this idea: “ …Every effort should be made to ensure that human genetic data and human proteomic data are not used for purposes that discriminate in a way that is intended to infringe, or has the effect of infringing human rights, fundamental freedoms or human dignity of an individual or for purposes that lead to the stigmatization of an individual, a family, or a group or communities…”

Furthermore, the regulatory authorization process is not yet ready and most of the discoveries in personalized therapeutic solutions have not yet been approved by regulatory agencies or have not been repaid, particularly in Canada. These are crucial issues and cannot be minimized.

In Québec, the Institut national d’excellence en santé et en services sociaux (INESSS) has been mandated to make recommendations concerning the assessment and development of practice guides, repayment of healthcare technologies and drugs (previously under NOVEMBER 2011 BIOTECHNOLOGY FOCUS 13

Personalized Medicine the responsibility of the Conseil du médicament), creation of registers and the obtaining of information on use and price.5 Section 7 of the Act Respecting the Institut national d’excellence en santé et services sociaux stipulates the criteria used by INESSS during the evaluation of a drug, including the drug’s therapeutic value, carried out using clinical studies provided by the manufacturer and the available evidence; fairness of the price; cost-effectiveness ratio; and the consequences of the drug’s registration on the health of the population and on the other components of the health and social services system. In light of the recent merging of responsibilities of the Conseil du médicament and those of INESSS, the terms of evaluation and repayment linked to a drug and a companion diagnostic test need to be defined.

Several states have adopted reimbursement processes focused on performance or the achievement of a therapeutic effectiveness threshold. The PHC tools will allow us to better select patients before having access to given treatments. PHC offers an opportunity to optimize our reimbursement evaluation processes for access. In the past, Québec was able to adopt flexible regulatory approaches that promoted innovation while respecting ethical aspects. New and additional efforts will, however, be required .

Involvement of the population and clinicians

Implementation of PHC in a healthcare system also requires the involvement of physicians and other clinicians, particularly regarding the choice of tests, treatments and healthcare protocols for patients. PHC solutions will therefore need to simplify clinical decisions and render the healthcare process more effective (clinical utility).

Finally, the PHC approach requires the population to be involved, whether in the management of its health or in its understanding of the solutions being proposed.

Education of the population and management of expectations constitute basic aspects of the success of the PHC approach. Though Québec’s population is more informed than ever on health issues and patients know more about their illnesses and potential solutions, additional efforts are still required. The generalization of the PHC approach requires the full participation of the population and all stakeholders. This involvement will entail means other than those aimed simply at awareness-building and education and must lead to a participative approach.

Conclusion Solutions and tools stemming from the PHC approach are currently being implemented and will especially gain prominence in Québec’s healthcare system in the years to come. Québec must prepare, plan and facilitate joint actions so that PHC becomes a differentiating factor to ensure higher quality patient services, better disease prevention and an efficient public healthcare system.

The health of individuals and the population will improve, and Québec’s productive potential will increase.

References 1. http://www.cartagene.qc.ca/ 2. Recommendations February 13, 2003 by the Commission de l’éthique de la science et de la technologie, “Les enjeux éthiques des banques d’information génétique” [Ethical issues of genetic information banks”] 3. International declaration by UNESCO on human genetic data, October 23, 2003 4. Arrowhead Publishers (2010). Personalized Medicine 2010, May 2010, 261 pages.

5. An Act Respecting the Institut national d’excellence en santé et services sociaux R.S.Q., Chapter I-13.03, (hereafter cited “Loi sur l’INESSS »), art. 5, 12, 13, et 62.

6. Bergman, Howard (2010). Initiative to develop a personalized health care strategy for Québec, July 2010 7. Bange, J; Zwick E, Ullrich A. (2001). Molecular targets for breast cancer therapy and prevention.” Nature Medicine 7, pages 548–552.

8. Gianni et al. (2011). Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2positive early breast cancer: a 4-year follow-up of a randomised controlled trial. The Lancet Oncology, Vol.12, Issue 3, Pages 236- 244.

9. Little, Stephen (2008). Business op-

portunities and commercial challenge in personalized medicine, April 2008. http://www.ivdtechnology.com/article/ business-opportunities-and-commercialchallenges-personalized-medicine 10. An Act respecting the Institut national d’excellence en santé et services sociaux R.S.Q., Chapter I-13.03.

“Ensuring that Québec capitalizes on the development of personalized health care – A business proposal by the Québec network for personalized healthcare,” January 2011 11. Torr-Brown, Sheryl R (2010). Future of Medicine/ Personalized medicine, “Regulatory and ethical challenges of personalized medicine,” September 2010, Vol. 7, No. 5, pages 465-468, DOI 10.2217/ pme.10.49 Michelle Savoie, MBA, MPH, Ph D is Co-President, Interim Steering Committee, Québec Network for Personalized Healthcare, General Manager, Montréal InVivo and Guest Professor, Faculty of Pharmacy, Université de Montréal Dr. Howard Bergman is Former Co-President, Interim Steering Committee, Québec Network for Personalized Healthcare (PHC), the Dr. Joseph Kaufmann Professor of Geriatric Medicine, Professor of Medicine, Family Medicine and Oncology, McGill University and Jewish General Hospital Daniel Denis, MSc is a partner, SECOR Conseil Patrice Hugo, PhD is Expert Advisor, Québec Network for Personalized Healthcare and Chief Scientific Officer, Clearstone Central Laboratories, a Labcorp Company Nathalie Ouimet, MSc, MBA is a Project Manager, Montréal InVivo

Acknowledgements: This article was prepared for the “Quebec economic 2011” of the CIRANO (http://ge.cirano. qc.ca) and is drawn from consultations led by the Québec Network for Personalized Healthcare in 2010 and 2011.

For more Personalized Medicine information visit our Drug Discovery Web Portal at www.bioscienceworld.ca

14 BIOTECHNOLOGY FOCUS NOVEMBER 2011

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3/21/2011 10:26:47 AM

By: Shawn Lawrence

Innovator

Asmacure:

Using nicotinic agonists to treat asthma

N

icotine is one of the most addictive drugs in the world, reviled as a villain because of its association with smoking and addiction. However, nicotine in freebase form has been proven to have remarkable therapeutic effects and in some cases the ability to alleviate symptoms. The trick has been to find ways to mimic these positive therapeutic effects without the drawbacks of its addictive properties.

In the course of his pulmonology and respiratory practice, internationally recognized pulmonologist Dr. Yvon Cormier was intrigued by the effects of smoking on his patients with pulmonary issues. Specifically he observed that a number of patients in his practice remarked to him that smoking would actually often alleviate their symptoms. Clinical data out at the time suggested that smokers actually had a lower rate of inflammatory disease, including hypersensitivity pneumonitis, a pulmonary disease caused by an increased immune response to inhaled antigens. Recognizing this puzzling association, Dr. Cormier sought to understand the role of nicotine in inflammation and he began studying nicotinic receptors. From his research, he concluded that there were benefits of nicotinic receptor agonists for inflammatory diseases, specifically in treating asthma. Again, the trick would be developing a product that would target nicotinic receptors, but without the side effects or addictive properties of nicotine.

With that in mind, Dr. Cormier founded Asmacure in 2002 with the help of Evelyne Israël Assayag. By 2007, the company had selected its lead compound ASM-024, a novel molecular entity. Almost a decade after the creation of the company, ASM-024 has demonstrated activity in pre-clinical in vitro, ex vivo and in vivo models of inflammation and asthma, including in mice, dogs and human cells and pulmonary tissue in pre-clinical trial. The results from these trials have also suggested that the nicotinic agonists are able to regulate both inflammation and bronchoconstriction, two important components of this disease constituting a new interesting approach for the treatment of asthma.

Martin Driscoll, the newly appointed CEO for Asmacure, explained this exciting technology and what differentiates it from nicotine and potentially from current treatments for asthma.

“We’re optimistic that we may have a unique compound, our molecules are derivatives of nicotinic receptors and are designed specifically not to cross the blood-brain barrier. They are designed to avoid any of the addictive properties and that has been the case thus far in our studies,” he said.

Moreover, Driscoll believes ASM-024 offers new hope for asthma sufferers because it is an entirely new approach to treating the disease.

“There is definitely a need for new therapeutic approaches to the disease as current treatments have hardly changed over the past 10 to 15 years. Many asthma sufferers have to rely on a combination of therapies to control their exacerbations.”

16 BIOTECHNOLOGY FOCUS NOVEMBER 2011

INNOVATOR

“IT’S ALL ABOUT GETTING THINGS DONE QUICKER. YOU WANT TO GET TO PROOF OF CONCEPT IN THE CLINIC AS QUICK AS YOU CAN AND FIGURE OUT WHETHER THE COMPOUND DOES WHAT YOU THINK IT DOES.”

The compound is currently being studied in clinical trials utilizing a solution form.

The solution form is a liquid that is delivered via a nebulizer (a device used to administer medication in the form of a mist inhaled into the lungs).

“Currently, we’re studying it in two Phase 2 studies, one in patients with mild asthma, and the other in patients with stable moderate asthma,” said Driscoll while adding that the two proof-of-concept Phase 2 studies are ongoing to assess the anti-inflammatory, broncho-dilating and broncho-protective properties of ASM-024 administered by inhalation. There is also a thought that a nicotinic receptor agonist compound may have fewer side effects than the currently available standard of care treatment for these patients, namely fixed-dose combinations of inhaled corticosteroids and long-acting beta agonists.

If the current clinical studies for ASM-024 prove successful, Driscoll said the company will bridge to a dry powder for inhalation formulation. The reason being he said is that the majority of people who are treated for asthma chronically prefer to get their medicine through an easy-to-administer powder.

“At its basic level, dry powder devices are very portable, and can be carried anywhere.

The way the powder can be delivered to the patient depends on their own inspiration and they literally inhale it in a matter of seconds. Nebulizers may be becoming more and more portable, but they are usually some kind of motorized device, a little more bulky, more expensive, and typically when you’re delivering something via nebulization it has to be delivered over seven to 15 minutes. The fundamental difference for patients is a matter of convenience. The more convenient for the patient, the more likely they will take their medicine.”

Driscoll further commented that it is very common with respiratory medications to do proof-of-concept studies in a solution form first, because a solution formulation is generally less difficult to manufacture and develop than powder formulations.

“It’s all about getting things done quicker.

You want to get to proof-of-concept in the clinic as quick as you can and figure out whether the compound does what you think it does.”

Driscoll said the company is proud of the fact that the vast majority of its clinical work has been done here in Canada, with the first Phase 2 trial taking place in research centers

in Québec, Hamilton and Saskatoon. The second Phase 2 study is also being conducted in centers in Hamilton and Québec.

The company recently had its first meeting with the U.S. FDA with plans to pursue the development of the drug in the U.S. market.

This is part of the reason that Driscoll was hired on, his past work experience fits in with the company’s current drug development strategy. For example, prior to joining Asmacure, Driscoll was CEO and director of Javelin Pharmaceuticals, before that he ran one of the respiratory businesses for one of the bigger players in the industry, Schering-Plough Corporation. His track record in raising capital for both private and public companies will prove important as the company continues forward with its Phase 2 proof-of-concept studies and prepares for Phase 3.

While his familiarity with investors is an asset, Driscoll believes that investor interest in the drug and the company will come naturally.

“I think investors and potential pharmaceutical company partners are already showing great enthusiasm for this product.

They’re very intrigued with the notion of this new mechanism that could have both the anti-inflammatory and broncho-dilatory properties in the same molecule. It’s also a sizable market as asthma affects eight to 10 per cent of the North American population.”

Driscoll says the end-game is to develop the product to a point where it can be handed off to a larger pharma firm.

“It’s not our intent ultimately to become a commercial enterprise with this lead compound, but that said, we have the capital to develop it as far down the road as we need to. But our preference is to pass it along to an established respiratory pharma firm who has the global capabilities to maximize the program.”

Should Asmacure find the right partner, the company will continue to focus on the other analogues or other molecules in its pipeline.

“The best way to describe it is our intent is to be a development company in the inflammatory diseases business.”

For more InnOVATORS information visit our PROFILES Web Portal at www.bioscienceworld.ca

NOVEMBER 2011 BIOTECHNOLOGY FOCUS 17

By Nika Ketis

Intellectual Property

Up-date on Ownership

of Intellectual Property in Canadian Universities It has been a number of years since the earlier research on reviewing policies relating to intellectual property in Canadian universities was done. The current report updates and compares approaches taken by different universities to (a) protection of all types of intellectual property, including software and (b) the sharing of revenues obtained from commercialization as of March, 2011 in comparison to December, 1998.

The production of knowledge and scholarship lies at the heart of universities’ mission. Although financial gain from research is not part of the mission of universities, the recognition of value of the intellectual capital that is generated has spurred universities to develop strategies to disseminate that information to the public domain. Universities are actively pursuing avenues that best serve their needs and priorities.

Several universities are in the process of re-evaluating their policies including Guelph University, Mount Alison University and McGill University. A number of universities (e.g., Acadia University, University of Alberta, Brock University, and Concordia University) manage their intellectual property through the Collective Agreement of the Faculty Association (Table 1).

Many universities have moved to a less restrictive intellectual property policy (Table 1) where the creator owns the intellectual property. Most of the universities confer ownership in intellectual property to their creator.

However, the detailed policies among the universities vary widely (Table 1). The universities provide for a number of mechanisms by which the creators are compensated for their inventions when the intellectual property is commercialized by the universities (Table 2: Available online at www.bioscienceworld.ca/ intellectualpropertyinCanadianuniversities).

Despite an increased sophistication by the universities in the management of intellectual property produced, there is a lack of unifying policy. Canadian universities continue to set 18 BIOTECHNOLOGY FOCUS NOVEMBER 2011

their own policies for intellectual property.

An examination of the distribution of net revenues generated subsequent to assignment of intellectual property to the university (Table 2) continues to reveal that different policies in respect of patents, know how and copyright can dictate dramatically different results in respect of commercialization. Generally, however, universities require disclosure of any discovery that may have potential commercial value; the technology transfer office of that university reviews the disclosure and the inventors are subsequently informed of the options available to them under that university policies or the Collective Agreement.

Software is now covered under the patent and copyright regimes at various universities.

In the recent decade, there has been an intentional and active effort by the Canadian government and universities to increase incentives for collaborative work between industry and academia in order to spur innovations that may have practical implications. The universities are trying to maintain a balance between commercialization of inventions and basic dissemination of scholarly knowledge and discoveries that are central to academic life. Harmonization of Canadian intellectual property policies may increase the interaction between universities and industry.

In the United States, the Bayh-Dole Act was established to provide a uniform system for universities to license innovation. However, there are statistics that show that university patenting and licensing systems in the United States, despite being quite extensive, have not substantially contributed towards the revenue of universities by accounting for less than 5% of the research funds at AUTM (Association of University Technology Managers) universities. There appear to be mixed reviews as to the impact and benefits of the post Bayh-Dole Act in the United States.

It appears from Tables 1 and 2 that harmonization of intellectual property policy may be useful in some respects, such as dealing with various granting agencies, but negotiations may be equally successful. In addition, as the university policies vary substantially one from another (Tables 1 and 2) the possibility for potential conflict increases. As only a small portion of research produces intellectual property, the challenge has been, and is, to foster university-industry relations and collaborations and to maintain the basic values and missions of universities to cultivate knowledge, creativity and collaboration.

(Table 1 is on pages 20, 21, 22 and 26; Table 2 is available online at www. bioscienceworld.ca/intellectualproperty inCanadianuniversities) I would like to thank the universities for their generosity in facilitating the collection of this data. The data published herein is based on information that is available through publicly available sources or through the universities. I do not claim this study to be comprehensive. In addition, I would like to thank Barbara Murchie for reviewing the aforementioned text and providing useful suggestions.

Nika Ketis is a member of the Biotechnology, Corporate Commercial, IP Litigation, and IP and Technology law groups at Bennett Jones LLP. Bennett Jones LLP is a full service law firm with lawyers that can provide expertise across industry sectors to address legal and strategic issues relating to Canada, the United States and abroad.

Continued on page 20

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Intellectual Property University

Ownership Policy

Acadia

The creator owns the IP. If the U decides to proceed with commercialization, the inventor assigns the IP to the U. Obliged to pay 75% of the net income (gross income-expenses) to the U. Comments: The IP policy is part of the Collective Agreement. Contracts supersede the Collective Agreement.

British Columbia

U retains ownership of the IP. If the discoveries, inventions, audiovisual & computer materials arise from the use of U facilities or funds administered by the U, disclosure must be made to the U & rights assigned to the U, unless there is a prior arrangement with a sponsor of research. Obliged to pay 50% of the net income (gross income-direct costs) to the U. Comments: All U members (including students) must disclose potential IP. The U may choose to assign the rights to the inventor. Copyright or “literary works” belong to the creator.

British Columbia Institute of Technology

U retains ownership of the IP. If the U declines to undertake commercialization of the IP, the U offers to assign the ownership of the IP to the inventors. If the U undertakes commercialization it undertakes the costs. Obliged to pay 20% of the income from commercialization & the inventor must reimburse to the U the cost for commercialization.

Comments: If the U made a commitment to an external client to deliver the IP, the U will do so once the commitments to the client are fulfilled.

Brock

Creator owns the IP with some exception, e.g., IP created as part of employment and if there is a contract/licence, the contract/licence supersedes the policy.

Comments: The IP policy Ownership of IP is contained in Collective Agreement. The IP policy applies to students, PostDoctoral Fellows and Teaching Assistants.

Calgary

Creator of IP whether scientific, humanistic, literary & artistic endeavors owns the work (as of April, 1994). However, if they use U facilities & support to create the work, the U has the right to share in the net revenues if commercialized.

Revenue sharing will occur where the IP arose from grants or contracts between external sponsors & the U or when the U participates in commercializing of the IP development, financing, manufacturing, license & sale of property.

Comments: Exceptions are when the U is the owner of the IP created under contract between the U & the creator; if the IP results from a contract for service/agreement/commission; if the IP is the result of work assigned to the U pursuant to a contract of employment; or the owner of the IP can voluntarily assign rights to the U. Where the U is the owner of the IP, it can voluntarily assign IP rights to the creator.

Carleton

The creator of the IP owns the work with exceptions, e.g., when the employer the U contributed assistance in the creation of the IP beyond that which is normally provided to the member. The employee may assign IP to the U. Comments: Ownership of IP is contained in the Collective Agreement. The I can exploit the IP themselves or through the Innovation Transfer Office. Parties exploiting the IP enter into an agreement regarding ownership of IP and revenue sharing.

Concordia

U retains ownership if the Inventor is under Collective Agreement. The inventor grants the U a non-exclusive, royalty free, irrevocable, indivisible, non-transferable license, including to sub-license, to use the invention for any U purposes. Obliged to pay 50% of net proceeds to the U. Comments: The IP policy is superseded by the Collective Agreement. U retains ownership of research output & students cannot commercialize or use, improve or exploit such research without the consent of the U.

Dalhousie

U makes no claim to the IP of the creators. The creators may choose to assign the IP to the U or commercialize it themselves.

Comments: IP ownership for faculty members is defined by the Faculty Collective Agreement. The U takes full assignment of the IP if commercialization occurs through the U technology transfer office. In addition, there is no obligation to disclose arising inventions, unless the funding source for the research requires otherwise.

Guelph

Faculty members own IP. Comments: IP rights in relation to non-faculty are subject to a number of policies.

20 BIOTECHNOLOGY FOCUS NOVEMBER 2011

Intellectual Property University Lakehead

Ownership Policy The U waves any claim to ownership. The rights are subject to Canadian law, research contracts, research grants & any agreement or policy between the U & creator. Disclosure of IP is required by the U. U IP commercialization process is governed by the U policies governing the operation of the Innovation Management Office.

Comments: U owns works created during the course of employment. Copyright is covered by the Collective Agreement.

The U owns copyright in any assessment, grading, report or correspondence produced in the normal administrative duties. An individual covered by the Collective Agreement must grant the U an irrevocable, worldwide, royalty free license for teaching assignments, IP created in the course of the teaching assignment, any journal or magazine published at the U & Distributed Learning Course materials. Students retain copyright in their work but the physical documents are the property of the U.

Laurentian

The creator owns the work with some exceptions, e.g., where U funds, personnel or equipment are used then the I must assign all rights to the U. The I may choose to commercialize the invention themselves and will be entitled to all proceeds except where U funds, personnel or equipment is used. Disclosure of IP to the U is mandatory.

Comments: IP policy is part of the Collective Agreement. I shall grant a non-exclusive, royalty free, irrevocable, indivisible and non-transferable license to use the invention for U internal use.

Lethbridge

The creator will own the IP and will be expected to share proceeds from the commercialization of such IP with the U. Disclosure of IP to the U is mandatory. Contracts supersede IP policy. A royalty-free usage of the IP will be retained by the U where ever possible for educational and research purposes.

Comments: Presently, the IP policy applies only to Faculty. The U is currently in the process of drafting a new IP policy that would apply to all members of the U community.

Manitoba

The IP policy for Faculty is set out in the Collective Agreement. The policy for students & external parties (adjunct appointments, nil-salaried appointments, senior scholars, professor emeriti &/or retirees), employees other than UMFA members is effective as of March 16, 2010. U retains ownership of the IP. Obliged to pay 50% of all economic benefit to the U. Comments: U owns copyright in works created by a U member & the creator waives all Moral Rights in the work.

McGill

IP policy is not available as the policy is undergoing revision.

McMaster

U retains ownership of the IP (as of January, 2005). The provisions of contracts, grants, sponsorships & research agreements will supersede the IP Policy. If the U has no interest in the IP, at the request of IP creator, the IP may be transferred to the IP creator. Obliged to pay 50% of net-revenue (gross revenue – expenses incurred by the U) from commercialization to the U. If the creator commercializes the IP, then obliged to pay 25% of the net-revenue to the U. The creator has the right to decide whether to seek commercialization.

Comments: Ownership of IP may be assigned away from the U providing that (a) a royalty free non-exclusive perpetual license for non-commercial academic use is retained by the U; (b) consent to further assign or transfer the IP to other parties by the U; & no U resources will be used.

Memorial

U retains ownership of the IP from inventions, discoveries & creations arising from the U. The inventor assigns all patent rights to the U. If commercialization is not pursued by the U, the inventors may request reassignment rights to them.

Comments: Ownership of IP is defined in the Collective Agreement with Faculty. Contracts supersede the Collective Agreement.

Montreal

The U retains ownership of the work if created during the course of employment. U confers the ownership of the work (invention, discovery or creation) that does not arise from the U related activities.

Comments: Ownership of IP is part of the Collective Agreement. Contracts take precedence over the Collective Agreement.

Mount Allison

No IP Policy available at this time. In accordance with the Collective Agreement, all faculty own 100% if their IP. Any commercialization with the U is negotiated on a case-by-case basis. A draft U IP policy is presently being developed.

NOVEMBER 2011 BIOTECHNOLOGY FOCUS 21

Intellectual Property University New Brunswick

Ownership Policy The U waives, disclaims, and abandons any interest or claim to ownership of IP developed by Employee(s) (as defined by the Collective Agreement) through the use of normal U resources. Administrative correspondence & documents are owned by the U. Computer programs developed for internal administrative use are owned by the U, unless there is a written agreement with the Employee(s) to the contrary. Upon written request by Employee(s), U will grant the creator a license to use & to exploit the IP. When the IP was developed with U resources over & above normal U resources, then the Employee(s) retains ownership of the intellectual property, unless an agreement is negotiated with the University of New Brunswick to share or transfer ownership (IP agreement will specify the share of net proceeds based on relative contribution; in absence of agreement, the fees, royalties or other income shall be shared 50/50).

Comments: Ownership of IP is defined by the Collective Agreement. The I is solely responsible for commercialization of the IP. Disclosure of the IP to the U is required within one (1) month prior to filing of a patent application or intellectual property sale and Employee(s) shall affirm in writing at that time whether or not the discovery has been made or developed with the use of U resources over and above normal U resources. The U has a right to negotiate an agreement with the Employee(s) to own and/or manage the intellectual property.

Ottawa

The policy is being updated but it is not expected to substantially change. Some details of the IP policy are updated every three years as part of the Collective Agreement. Disclosure of inventions is voluntary by researchers that are interested in potential commercialization. U retains ownership to patentable IP. When the U decides not to pursue a patent & relinquishes its rights to the invention, the employee shall be free to act as it wishes in regard to the invention & patent rights revert to the inventor. If a patent issues, the inventor must reimburse the U for disbursements incurred to obtain the transfer of information. The U retains a royalty-free, irrevocable & non-transferrable license to the invention for internal purposes, not including any activities funded by grants or contracts administered by the U. Grants & contracts supersede the IP policy.

Comments: Unless a faculty or staff members position involves the development of copyrightable material for the institution, copyright normally belongs to the creator.

PEI

IP ownership is governed by the Collective Agreement. I owns and U has interest in the IP. Contract determines the IP ownership. The U attempts to maintain ownership of the IP. The U at all times retains the right to use the IP and Research Results for internal teaching and research purposes.

Comments: Contracts must state that research publication rights remain with the U and may be subject to 1 year delay in publication.

Queen’s

All IP is owned by the person who creates the IP. The IP can be assigned by the creator to other party through an agreement in advance for certain types of funding or contract.

Comments: IP is part of the Collective Agreement of Queen’s University Faculty Association. It includes patents, copyright & trademarks. The agreement applies also to a creator of a portion of a piece of IP on a pro rata basis. The creator has the right to make all decisions concerning the development & use of IP including commercialization. A creator who intends to commercialize must disclose to the U. PARTEQ, the U technology transfer agent, may become a vehicle for commercialization. However, PARTEQ is under no obligation to accept the endeavor. If PARTEQ elects to proceed with protection and commercialization, an assignment to Queen’s University must be made. PARTEQ will have access to any improvements to assigned IP.

Ryerson

IP policy is currently under review. The creator owns the IP with certain exceptions, e.g., if under contract, involves extraordinary use such as funding from the U to support data collection.

Comments: Profit sharing from IP is directed by the Office of Research Services.

Saint Mary’s

The creator owns the work except in the following cases: a contract overrides the policy and where the U provides funds, resources and facilities beyond those required under usual employment. Disclosure to U of invention is mandatory. If the I pursues commercialization on their own without the U assistance, the I will be entitled to all the proceeds.

Comments: Ownership of the IP is contained in the Collective Agreement. Contracts take precedence over the Collective Agreement.

Saskatchewan

U faculty and staff assign certain IP to the U on appointment to the U. Contracts supersede the IP policy.

Comments: IP is part of the Collective Agreement with the Faculty Association. Under contract, the U is free to submit

22 BIOTECHNOLOGY FOCUS NOVEMBER 2011

Continued on page 26

By Dr. David Evans and Dr. Marek Michalak

acroSS canaDa

Research in

ALBERTA

The province of Alberta is probably best known for its resource wealth, spectacular scenery, and cowboys; a “Texas North” in the minds of some. What may not be so well known are the world-class infrastructure and academic programs at Alberta universities and the important role that provincial investments have played in supporting an environment where innovation and ingenuity are recognized and rewarded. Alberta’s ingenuity is exemplified by the historic role that the University of Alberta and the Alberta Research Council played in developing technology for oil sands extraction, long before it was considered economically viable to do so. Today, Alberta holds one of the largest recoverable oil reserves in the world, and the wealth generated by its traditional resources continue to be invested in an “innovation agenda”.

One of the long-standing areas of major investment has been in health research and these investments are now paying dividends in the form of a vibrant life sciences research community and state-of-the-art health services. Alberta invested aggressively to build its health research continuum through the establishment of two endowed Alberta Heritage Foundations. These were the Heritage Foundations for Medical Research and for Science and Engineering Research (now Alberta Innovates — Health Solutions and Alberta Innovates — Technology Futures, respectively).

Starting in the 1980’s, these agencies have played a critically important role in recruiting “high quality personnel” to Alberta and in establishing much of the research infra-

structure.

More recently the province, in collaboration with the Government of Canada, has greatly expanded this infrastructure to meet the growing demand for health workers and for training in research laboratories.

For example, the University of Alberta, in Edmonton, has just completed two new stateof-the-art research buildings (the Li Ka-Shing Institute for Health Innovation and the Katz Centre for Pharmacy & A reactor suite, Health Research) part of Gilead’s that comprise manufacturing ~65,000 m2 of operation in new space housEdmonton, AB. ing 1,600 people, linked to two existing research buildings, two of western Canada’s largest tertiary care, research and teaching hospitals, the Provincial Laboratories of Public Health, and the new Mazankowski Alberta Heart Institute (one of only three in Canada). An additional facility, designed to support a multi-disciplinary program in allied health sciences (the Edmonton Clinic Health Academy), is currently being populated.

This academic cluster now comprises one of Canada’s largest contiguous medical research complexes and can provide researchers with access to the latest tools for imaging (optical, electron, MRI, and PET),

UofAlberta Li Ka-Shing Institute of Virology

genomics, proteomics, metabolomics and structural biology. The infrastructure also includes specialized facilities that support access to nanotechnology (the National Institute for Nanotechnology is located on campus), new infectious pathogens facilities (the Centre for Prions and Protein Folding Diseases), animal models, clinical trials, ABSL3 biocontainment suites, and radioisotope production. Similar investments in advanced infrastructure have been made at the University of Calgary.

With this funding, the province has been able to support a variety of programs in health research and this had led to the development of a number of areas of specialized research strengths. There has been a long history of support for infectious disease research, dating back to the establishment of some of Canada’s first molecular virology NOVEMBER 2011 BIOTECHNOLOGY FOCUS 23

acroSS canaDa studies by Dr. J. Coulter in the 1960’s. A signal success was the pioneering work done

by Drs. L. Tyrrell and M. Robbins in the 1980’s, and which led to the development and worldwide use of lamivudine (3TC) as a therapeutic for treating hepatitis B virus infections by GlaxoSmithKline Inc. In more recent years the province has built upon these foundations to support other related projects in infectious and inflammatory disease research in both Edmonton and Calgary. These projects include the Centre of Excellence in Gastrointestinal

Inflammation & Immunity Research, Alberta Transplant Applied Genomics Centre, Alberta Ingenuity Centre for Carbohydrate Science, Alberta Prion Research Institute, and the Snyder Institute for Infection, Immunity & Inflammation. These institutes and centres are active participants in a network of collaborating western research organizations including Defense R&D Canada (whose biodefense research laboratories are located in Suffield, Alberta), PrioNet Canada, the Western Canadian Vaccine Network, Saskatchewan’s Vaccine & Infectious Disease Organization, Manitoba’s high-containment Canadian Science Centre for Human & Animal Health, and British Columbia’s new Preclinical Research Consortium.

Amongst these many leading edge activities, a particularly successful recent venture has been the establishment of the University of Alberta’s new Li Ka-Shing Institute of Virology. The institute was made possible by large infrastructure awards from the provincial and federal governments, which were then greatly enhanced by generous gifts in support of research, in 2010, from GlaxoSmithKline Inc. and the Li Ka-Shing Foundation of Canada. In all, nearly $100 million is 24 BIOTECHNOLOGY FOCUS NOVEMBER 2011

Alberta Innovates and Alberta Biomaterials Development Centre

being invested in building, equipping, and endowing the new institute, which currently supports basic and translational research using different viruses and sophisticated models such as mice bearing humanized livers (the NIH-supported “KMT mouse”) or transplanted tumours. This activity has created an unparalleled environment for attracting new faculty and research trainees. Alberta has recently become the new home for the laboratory of Dr. M. Houghton, a Canada Excellence Research Chair and Lasker Award winning scientist, and co-discoverer of hepatitis C virus. Additional young faculty are currently being recruited to the associated Department of Medical Microbiology & Immunology to expand the institute’s research capacity. The Li Ka-Shing Institute has been especially active in pursuing international partnerships and has been particularly focused on building partnerships with researchers and institutions based in the U.S. northwest, China and Europe. However, it has also been working closer to home to build connections with companies such as Gilead Inc. (who already have a significant manufacturing presence in the city of Edmonton) and to build its own portfolio of spin-off companies.

One of the manifestations of the activity in the area of virology has been development of plans for two upcoming conferences in Edmonton and Calgary. These conferences will attract leading experts from around the world and provide an excellent mechanism in which to investigate the provincial expertise, intellectual property, and research facilities that can be accessed to support commercial infectious disease research. The special joint virology conference sponsored by the Gairdner Foundation and the Li Ka Shing Institute of Virology is planned for the end of May and will cover a broad array of

topics relating to general virology (May 31June 1, 2012). Later in August, the annual International Herpesvirus Workshop will be held in Calgary (August 4-9, 2012).

For further information about these conferences please go to: www.herpesvirusworkshop.com/2012/ www.gairdner.org/ www.likashinginstituteofvirology For more information about the opportunities available to support any of the topics touched on in this review, or to secure key contacts within Alberta, please contact the Alberta Innovates Connector by telephone at 1–877– 828–0444. We can also be reached through email to connector@albertainnovates.ca.

Dr. David Evans is a professor and chair, Medical Microbiology & Immunology Dr. Marek Michalak is vice-dean, Research, Faculty of Medicine & Dentistry University of Alberta Edmonton, Alberta, Canada

For more ACROSS CANADA information visit our PROFILES Web Portal at www.bioscienceworld.ca

Intellectual Property University

Continued from page 22

Ownership Policy for publication research results within one year from the termination of the project or submission of the final report, whichever is later.

Simon Fraser

In the absence of an agreement, rights to patentable IP vest in the creator. The creator is free to exploit the invention on his own, through the University Industry Liaison Office [UILO]. If the commercialization process proceeds through the UILO, the creator is required to assign the IP to the U. Comments: The IP created in the form of textbooks, instructional website or other instructional materials rest with the creator. The creator may voluntarily assign the IP to the U.

Toronto

U & I own the invention jointly. I may offer the invention to the U for commercialization and, if accepted by the U, the U becomes sole owner. Alternatively, I may request personal ownership and take responsibility for commercialization or appoint the U as I’s exclusive agent to commercialize the invention. U owns all rights to inventions created in the course of employment by administrative staff and the allocation of revenue from such an invention is at the sole discretion of the U. Comments: If the U does not enter into an agreement with a 3rd party to commercialize the invention within 2 years, the I can request to assume full responsibility for commercialization and the U will assign full ownership of the invention to the I. Agreements entered into before the disclosure of the invention to the U can limit U policy. Invention policy does not apply to copyright, other than software that is not instructional software; rights in copyright are governed by a separate policy.

Trent

Waterloo

IP is inventor owned as per the Faculty Collective Agreement.

Comments: Disclosure of invention to the U of an invention is mandatory. The creator has the right to make all decisions regarding their IP and its commercialization. U has the 1st option to carry out development of IP to commercialization.

The I is obliged to enter into an agreement with the U in respect to the work. For inventions, the I must grant to the U a non-exclusive, royalty-free, irrevocable, indivisible and non-transferable license to the IP, its improvements, design or development. For computer programs, the creator must grant non-exclusive, royalty-free, irrevocable, indivisible and nontransferable license to the U for U’s internal use.

The ownership of the IP rest with the creator with some exceptions, e.g., U retains ownership of IP created as “assigned tasks” in the course of administrative activities; creators grant the U a non-exclusive, free, irrevocable license to copy and/or use scholarly works created in the course of teaching and research; and sponsored or contract research are governed by the terms of the contract. The I can choose to commercialize the IP themselves or, if choose to use the assistance of the University, assignment and sharing agreements are signed. Disclosure of invention to the U is mandatory.

Comments: The creator owns the copyright except for the following: works created or modified in the course of employment or works of joint authorship.

Western Ontario

In the absence of an agreement, the U claims no right to the IP of the creator(s). The inventor can choose to patent the invention through the U or commercialize it themselves. If the I chooses to go thru the University’s Patent Plan then the IP must be assigned to the U. Comments: Copyright may be owned jointly by the University and the creator. In such cases, the division of ownership is settled by negotiation.

Wilfred Laurier

The creator owns the work with some exceptions, e.g., contract takes precedence or the U funds , resources or facilities are used beyond regular academic work.

Comments: The creator grants to the U a non-exclusive, royalty free, irrevocable, indivisible and non-transferable right to use for internal, non-commercial and research use.

Windsor

The creator owns the work with exceptions, e.g., ownership and profits are negotiated in an agreement with the U. Disclosure of IP to the U is mandatory if U facilities, support personnel, services, materials or equipment are used. The I assigns the invention to the U. Comments: The IP policy is within the Faculty Association Collective Agreement. The collective Agreement is current to June 30, 2011.

York

York University has an inventor-owned intellectual property practise, as governed by the YUFA Collective Agreement 23.01

26 BIOTECHNOLOGY FOCUS NOVEMBER 2011

NEW PRODUCTS Spectrometer Ocean Optics has added triggering functions to its Maya2000 Pro back-thinned CCD miniature spectrometer to provide accurate timing and synchronization between the spectrometer and other devices. Three low-jitter trigger and normal operating modes are now possible. Applications include pulsing a light source to occur when acquiring a spectra and synchronizing spectral acquisition to coordinate with samples moving through a process stream or sensors reaching a certain temperature level.

In addition to triggering, Ocean Optics has enhanced Maya2000 Pro performance with support for RS-232 communications and improved optoelectronics that increase dynamic range (to 15000:1), lower trigger jitter (to 100 ns) and decrease dark noise (to 6 RMS counts). The Maya2000 Pro has a 30-pin connector and 10 user-programmable digital I/Os. Its onboard programmable high-speed FPGA controller enables triggering and provides other performance advantages. Available operating modes are Normal (spectrometer continuously acquires spectra) and the three trigger modes: external hardware level trigger, external synchronous trigger and external hardware edge trigger. The Maya2000 Series spectrometers are ideal for low light-level applications such as fluorescence, DNA sequencing and measurement of certain biological samples. The spectrometer can be used in the VUV (to ~150 nm) with the addition of a nitrogen purge box to help lessen the absorption of water and oxygen in the VUV.

Reply Card #4970 Pump Edwards’ new nXDS pump is an environmentally-friendly oil-free vacuum pump that has no lubricants in the vacuum. This eliminates the need for regular oil changes and users can benefit from low maintenance. It is fully serviceable in the field, which results in low downtime.

It has reduced power consumption with minimum environmental impact and low

acoustic noise levels, making it an ideal ‘fit and forget’ pump for the laboratory. The pump also features green modes, enabling users to reduce their carbon footprints and save energy costs.

also serving to store the compound, the dispensing head improves the containment of dangerous compounds during weighing, and provides new ways for laboratories to maximize compound yields and to improve workflows. The Quantos Q2 and QL2 kits are available to anyone with a previously installed or newly purchased XP Series analytical balance having 0.1mg or 0.01mg readability. Complete retrofit services, including equipment qualification is also available from METTLER TOLEDO.

Reply Card #4972

Reply Card #4971

Liquid Handler The Thermo Fisher Scientific Inc. Scientific CV2000 automated aliquoting liquid handler is a newly developed second-generation platform that enhances laboratory efficiency through workflow automation. The CV2000™ can accurately dispense liquid volumes from 100-875 µL and process up to 1000

Dispensing Auxiliary Modules METTLER TOLEDO introduces new Quantos® powder and liquid dispensing auxiliary modules that can be added to any 0.1mg or 0.01mg XP Excellence Series analytical balance. The addition of automated powder and liquid dispensing functionality to the balance increases laboratory efficiency, improves results, and eliminates errors in weighing, sample preparation, dilution and transcription. Additionally, the Q2 powder dispensing module lets users take advantage of Quantos dispensing head technology which automatically dispenses the compound to a target weight and replaces the tedious activity of weighing out powders by hand with a spatula. By

samples per hour. With its robotic arm and rotary height sensors, it fits easily into automated workflows to boost sample throughput. The system is compatible with a wide variety of sample management software, but can also be used as a standalone instrument. The system effectively manages samples to boost efficiency and productivity with zero cross-contamination. Fully compatible with multiple rack formats, the CV2000 system allows users to change the loading and dispensing routine to suit their needs. A unique tip preservation system allows the instrument to only discharge used tips, reducing waste while eliminating contamination.

Capable of holding up to 300 samples and accommodating both 45 and 90 mL urine containers, the system can automate the process of aliquoting urine from primary samples to analyzer racks. Furthermore, the CV2000 system creates a batch report that is compatible with downstream analysis instrumentation, which is used to process the urine samples.

Reply Card #4973 NOVEMBER 2011 BIOTECHNOLOGY FOCUS 27

NEW PRODUCTS The Syrris Asia 330 is an integrated flow chemistry system that expands on the capabilities offered by other Asia systems by including the FLLEX module for flow aqueous work-up and the Asia Sampler and Dilutor, which allows integration of analytical devices such as liquid chromatography mass spectrometers (LCMS). Factors such as reaction time, temperature and reagent ratio can be varied and each reaction is collected and analysed automatically. Furthermore, the automatic control of syringe pumps, injection reagents, synthesis and waste diversion enable hundreds of solutions or

phase experiments to occur. Easy to use Asia Master PC software allows 1000’s of system configurations, single or multi step reactions, graphical display of data and full data logging. The system also incorporates

I wish to receive/continue to receive a complimentary subscription to

Yes

print

Format Preference:

digital

Reply Card #4974 Containers Thermo Fisher Scientific Inc. offers a complete portfolio of Thermo Scientific Nalgene bottles, carboys and containers, suitable for a broad range of applications. Each Nalgene bottle comes with a leak-proof guarantee to protect valuable liquids. Sizes range from 4 mL to 50 L, so scale-up can occur without the need to re-validate materials as projects progress from research into production. The bottles and containers are also available in a wide range of certified resins for laboratory, food and pharmaceutical use. Furthermore, an online bottle and selection guide, available at www.thermoscientific.com/ safecontainer, aids users in choosing the optimal container for each application.

Additional the bottles and containers come in a variety of sizes and shapes, with both narrow and wide mouth configurations.

SRC101

BIOTECHNOLOGY FOCUS

maximum chemical resistance with wide temperature (-15 to 250 °C) and pressure (0-20 bar) ranges.

No

both

Signature:____________________________________Date: ___________________________

Name:_________________________________Title: ____________________________________ Company: ______________________________Dept: ___________________________________ Business Address : _______________________________________________________________ City:_____________________________Prov: __________Postal Code: ____________________ Telephone: ___________________________Fax: ______________________________________ E-mail: ________________________________________________________________________ On occasion, BIOTECHNOLOGY FOCUS will send third-party information on products & services related to the lab and life science industries. These may be cancelled at any time. Please check here if you do NOT wish to receive these.

TITLE 50 51 52 53 54 55

Executive Mgmt.

Academic Research Quality Control/Assurance R&D Mgmt.

Lawyer Student

COMPANYs PRIMARY BUSINESS ACTIVITY 50 Private Industry 51 University/College 52 Hospital/Medical Centre 53 Research Institute/Foundation

56 Financial Management 57 Business/Corporate Development 58 Consultant 59 Lab Technician/Research Assistant 60 Sales/Marketing 61 Regulatory Affairs/Validation 99 Other (Specify): ______________________ 54 Pharmaceutical Co. 55 Government 56 Financial Services 99 Other (Specify): ______________________

B Recommend

A B C D E F G

Analysis Instruments Basic Lab Equipment Chemicals/Biochemicals Chromatography – Gas Chromatography – Liquid Filtration, Water Purification LIMS

H I J K L M Y

Liquid Handling & Sample Prep Microscopes, Optics, Cameras Safety & Hygiene Spectroscopy Testing Systems/Equipment Vacuum Equipment None of the Above

C88 Product Development Stage (check all that apply) A Research/Development B Pilot/Scaleup

C86 Buying Influence A Authorize

C87 Which products are used in your lab?

C Production/Manufacturing D Tech Transfer E Not applicable

C Specify

PLEASE ENTER THE READER SERVICE CARD NUMBER TO RECEIVE INFORMATION

C89 Are you building a new lab?

Yes

Reply Card #4975 Heaters Omega’s new AHPF series heaters are used to heat low flows of air, gas, water, or aqueous solutions with air/ gas flow up to 15 CFM and air/gas out temperature up to 430 degrees Celsius (800 degrees Fahrenheit). This 316 Stainless Steel constructed heater can handle pressures up to 100 PSI and 50 watts per square inch. Applications include those where clean air is necessary, as in laboratories, environmental testing areas, packaging and sealing. The heaters are ideal for automotive, petroleum and manufacturing industries.

No

C90 We have the following enewsletters: Numbers for advertised products can be found on the ad and in the advertisers’ index

1 Biotechnology Focus Weekly 2 Laboratory focus Weekly 3 Drug Discovery

4 Commercialization 5 Bio-energy 6 Nutritional Products

For a quick response please fax: 905-727-4428 or e-mail: circulation@promotive.net 28 BIOTECHNOLOGY FOCUS NOVEMBER 2011

Reply Card #4976

CALENDAR NOVEMBER 2011

Tel: (203) 840-6255 Email: conferences@windhover.com Web: http://www.tapartnerships.com/

November 15 BioConnect 2011 Venue: Montréal, QC Email: bioconnect2011@gmail.com Web: www.bioconnect2011.mcgill.ca/ registration.html

DECEMBER 2011 December 4-6 BioPartnering China Venue: Shanghai, China Tel: 1-831-464-4230 Fax: 1-831-464-4240 Web: www.techvision.com/bpc/

November 16-18 Canadian Science Policy Conference Venue: Ottawa, ON Email: info@CSPC2011.ca Web: www.CSPC2011.ca

December 6 Connecting the Corridor Ontario/Quebec Venue: Toronto, ON Web: www.lifesciencesontario.ca

November 16-19 Medica-World Forum for Medicine Venue: Dusseldorf, Germany Web: www.medica.de

December 8-9

November 17 MaRS Future of Medicine 2011 Venue: Toronto, ON Web: www.futureofmedicine.marsdd.com

November 28-30 Canada Renewable Fuels Summit Venue: Calgary, AB Web: www.greenfuels.org

November 30-December 2 Therapeutic Area Partnerships 2011 Venue: Boston, MA

January 30-31 Bio Manufacturing Summit Venue: San Diego, CA Tel: (416) 214-1144 Fax (416) 214 3403 E-mail: melissa.youngsing@wtgevents.com Web: www.biomansummit.com

FEBRUARY 2012 February 4-8 Society for Laboratory Automation and Screening 2012 Venue: San Diego, CA Tel: 630-256-7527 Fax: 630-741-7527 Email: slas@slas.org Web: www.slas.org

FDA/CMS Summit Venue: Washington, DC Tel: (203) 840-6272 Email: p.cardone@elsevier.com Web: www.windhover.com/windhover/ content/conferences/fda-cms.aspx

February 13-14

JANUARY 2012

February 16-20

January 9–11

AAAS Annual Meeting Venue: Vancouver, BC Tel: 202-326-6400 Fax: 202-842-1065 Email: meetings@aaas.org Web: www.aaas.org

Biotech Showcase™ 2012 Venue: San Francisco, CA Email: update@ebdgroup.com Web: www.ebdgroup.com/bts/index.php

Bio CEO & Investor Conference 2012 Venue: New York, NY Email: bd_registration@bio.org Web: www.bio.org/events/conferences/ bio-ceo-and-investor-conference/700-0

Company & Advertiser Index COMPANY

Page RC

COMPANY

Page RC

AlbertatBay.......................................................... 19......................................4967

Genome BC.....................................................6.........................................

Allon Therapeutics Inc....................................6.........................................

Green Centre Canada......................................8.........................................

Bioniche Life Sciences....................................10........................................

Medicago Inc..................................................10........................................

BioTalent Canada................................................. 5.......................................4963

Mettler Toledo...............................................27................................ 4972

Boehringer Ingelheim....................................10........................................

Neptune Technologies ...................................9.........................................

Canadian Science Policy Conference............. 31......................................4968

Ocean Optics..................................................27................................ 4970

Centre for Drug Research..........................................................................

Omega...........................................................28................................ 4976

and Development........................................ 6, 10......................................

Patheon Inc....................................................10........................................

Childrens Miracle Network................................ 7.......................................4964

Paladin Labs Inc.............................................10........................................

Compass Biotech............................................9.........................................

Protox Therapeutics Inc..................................6.........................................

Dalton Pharma Services..................................10,19...................................4966

SemBioSys Genetics Inc..................................9.........................................

deCODE Genetics...........................................10........................................

Syrris..............................................................28.................................4974

Edwards.........................................................27................................ 4971

Thermo Fisher Scientific............................. 27, 28.................... 4973,4975

Eppendorf............................................................ 32......................................4969

VWR....................................................................... 15......................................4965

ESBE Sanyo............................................................ 2.......................................4962

Warnex Medical Laboratories.........................10........................................

Genome Alberta..............................................8.........................................

NOVEMBER 2011 BIOTECHNOLOGY FOCUS 29

THE LAST WORD

By Pierre Meulien, PhD

Next Generation Science

F

Pierre Meulien, PhD President, Genome Canada

or generations, we have struggled with the perceived gap between the amazing scientific discoveries occurring in our universities and research institutions and the applications of these findings to the social and economic fabric of our country. We have tried to describe the myriad complex interactions leading to true innovation in neat little ways.

Usually, these descriptions tend to parse an incredibly complicated activity into bits of limited scale or scope.

This has led to an array of labels that are in use today.

Terms like innovation gap, commercialization gap, research and development, basic versus applied research, and bench to bedside populate much of our writings and discussions about this pipeline, suggesting a linear flow of ideas to results.

I say it’s time to think about all of this in a new way.

Let’s recast how it all works and start with a new phrase to reflect new thinking. That phrase is: next generation science.

There are many challenges still to be addressed by traditional methods of generating commercial or other gain from scientific discovery. The realization of the significant nature of these challenges and the need to address them is increasing, particularly within North America. Canada is not immune.

A variety of systemic stressors such as a global leveling of the economic playing field, recognition of Asian countries (especially China) as future drivers of the global economy and innovation, the rising costs and relatively low success rate of incumbent approaches, and other factors are contributing to widespread desire to craft a more successful system.

There appears to be strong interest in moving from a “push” based approach wherein scientific discoveries are used to fuel downstream activities to a “pull” based model wherein science is conducted in the context of a defined challenge. This is not the same as emphasizing one word over the other in the term “research & development”.

Rather it is growing pragmatism that recognizes there is no point in solving a problem without a need to solve it.

Increasingly, downstream expertise (to continue the pipeline analogy) is required to get past the science to create something of significant impact. It is about innovation.

Research and innovation serve different purposes. The former is about building knowledge, deriving insight and suggesting possibilities. The latter is about bringing to bear aspects beyond the science to generate an economically or socially useful result.

Increasingly, emphasis is being placed on the translational aspects of research, in terms of both process and content, with a view to accelerating discoveries into ap-

30 BIOTECHNOLOGY FOCUS NOVEMBER 2011

plications that benefit society in economic or other ways.

In turn, this is strengthening interdependence among the scientific, industrial, government and other communities who play a part in the overall process of innovation. It is about creating truly integrated and multidisciplinary teams and platforms. It’s also about speed.

Scientists have made great strides in developing multidisciplinary teams coming from different areas of science to address there never ending thirst for knowledge.

Many of these talented people now wish to go further in being able to take some of this new knowledge created and apply it in the real world. However this can be challenging for many reasons and we need to create a more fertile environment for innovation to occur in a more efficient way.

At Genome Canada, we’re applying this thinking to the field of genomics research. We have just launched a new program called Entrepreneurship Education in Genomics (EEG) which aims to instill in our researchers some of the considerations and characteristics of the “downstream” community. The idea is to cultivate next generation scientists that speed the translation of discoveries into innovations of economic or social benefit. They are equipped with the knowledge and encouragement to form networks and connections to other members in the community. They recognize the economic or social value of their work.

We believe this approach will change everyone’s thinking, away from the linearity of pipeline thinking to a rich matrix of connections that form, reshape and reform as needed. The result is a continuum of innovation driven by anyone, anywhere. In this model, basic research can continue to flourish but can also be influenced by challenges that come from beyond the science. In this environment, a next generation scientist will be worth gold.

A next generation scientist will reflect the innovation continuum. He or she will excel in science and have entrepreneurial, business networking, and other innovation skills. In the same way that genomics is a key building block for so many aspects of our economy and society, so too will a next generation scientist be a key building block for generating many aspects of innovation. When was the last time you heard science talked about in this fashion?

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