Biotechnology Focus May 10

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

MAY 2010,

VOLUME 13, NUMBER 5

Ontario Minister of Research and Innovation John Milloy Dr. William Reichman

Ontario

Solving the Age Crisis

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contents

MAY 2010 – VOLUME 13 – NUMBER 5

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FEATURES

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A Perfect Setting Ontario is ready to accept its place as a leader in life sciences

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BY CHRIS ROGERS

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Transforming the way people age Baycrest, world-class cognitive neuroscience institute embedded within a very rich continuum of senior care services

BY SHAWN LAWRENCE

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Reshaping Brain Theory Neuroscientist Randy MacIntosh is driving urgently needed innovation around brain health

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Neuro-imaging

Neuro-imaging

By Chris Rogers

Neuroscientist Randy MacIntosh is driving urgently needed innovation around brain health

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Located at Baycrest, a world leading academic health science centre, RRI (Rotman Research Institute) is at the forefront of this fight to understand how the brain ages and mitigating the factors surrounding the development of diseases such as Alzheimer’s and problems such as stroke. By bringing together world-renowned researchers in a broad spectrum of disciplines, from cognitive neuro-psychologists to computer scientists, RRI is able to tackle its goal of comprehending the workings of memory and the executive functions of the brain.

“The focus of the research institute at Baycrest is to understand both the aging brain as well as age related diseases and disorders,” said Dr. Randy McIntosh, senior scientist and director of RRI. Dr. McIntosh is a leader in the CNS field. His own research is geared to the development of a unified theory of brain operation that emphasizes the integrative capacity of the brain.

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— Dr. Randy McIntosh

At RRI, perhaps the best example of this process incorporates a combination of strong cognitive theory and modern neuro-imaging technologies while looking at the computational or informatics aspects and trying to merge theory with data to develop large-scale computational models of the brain and how it changes as we age.

“One of the next focuses is developing what’s been called the virtual brain which is actually a model of the human brain that allows us to understand not only how the brain functions in a normal state but also how the brain functions as we age,” said McIntosh. “You can make a virtual brain that actually ages, a virtual brain that gets Alzheimer’s disease, a virtual brain that gets a stroke, and develop the algorithms that help explain how the brain tries to adapt to age and adapt to damage and disease.”

McIntosh explains that the brain is designed based on the structural information they are collecting from neuroimaging at RRI in combination with functional information and brought together with high-level mathematics to model the brain in action.

“We’re really merging the math with the ‘wet-brain’ as it were, architecture would then put the necessary dynamics in that are captured in the math that drive the model,” said McIntosh.

Trying to explain the way the model works to someone not in the know can be a trying experience but McIntosh breaks it down.

“You get a structural MRI, for example, that you can use to image the connections in the brain. Then you use that as your architecture and then impose the dynamics on top of that using the neuro-network theory.”

“The virtual brain actually ends up being an amalgamation of both normative data but also the clinical that we have access to as well,” he said Bringing the research back to its real-world applications and the looming concerns of an aging population, the end-goal of the research, at least in terms of clinical research, is prediction. People generally associate Alzheimer’s disease with the aging brain but what about those who develop these diseases in their 40’s.

“The idea would be to use the virtual brain as a way of testing whether that person is showing some kind of random abnormality, over and above what you can see with the regular clinical imaging.”

He explains that using the information gathered from the neuro-imaging technologies and apply a specific persons characteristics to the virtual brain. From this, researchers can then compare brain functions in the virtual environment to see how

“The idea is to understand how different kinds of mental functions change as we age, how they can be worse if there is accompanying disease but also understand ways to try to stave off that change,” he explains.

Part of his research focus is to understand the neuro-basis of those changes in terms of cognitive theories for memory and attention.

“The main component of that, using modern neuro-imaging technology [is] to then use that information to develop more effective ways of staving off the declines, that’s with cognitive rehabilitation strategies as well as remediating it if there is a more protracted kind of decline that comes with things with mild cognitive impairment, dementia and/or stroke, and then tracking the efficacy of those therapies again going back and using the neuro-imaging technology as a way to validate that these therapies have direct benefit.”

The benefit of working at an institution such as RRI is that it brings together a group of researchers from a diverse range of disciplines, all devoted to solving a common problem. The varied backgrounds of the scientific staff at RRI allows for unique solutions to be engineered.

“If you address that problem from a number of different perspectives, the solutions to that problem end up being much more innovative then they would be if they were addressed with a typical kind of constrained focus from a given discipline,” says MacIntosh.

In trying to understand memory, he explains that the typical approach is to let psychologists address it in a traditional environment such as a university. But the idea behind RRI has a much broader scope. A diverse group of psychologists, engineers, neurologists, physiologists and computer scientists, all approach memory from different avenues with their contrasting backgrounds allowing them to foster new solutions.

“What you do is have the same problem but address it from different perspectives and that brings different ideas to the table, and you end up coming up with solutions that would not be possible if you focued on only one particular way of looking at the world,” said McIntosh. “It’s the idea of bringing different perspectives to the same problem and coming up with innovative solutions, I think it’s what differentiates the kind of work that we do with some other places.”

He is quick to point out that this approach is also true for other research institutes across Ontario.

the virtual brain’s patterns show similarities to someone who has, for example, dementia.

“It ends up being a sort of diagnostic tool and a prognostic tool,” said McIntosh. “Because in theory, you could use that virtual brain to help guide the course of therapy to help decide what potential pathways you could try and invoke. In a stroke for instance, to facilitate those pathways to help the brain recover. “ And don’t take those comments the wrong way, recovery is definitely what they’re after.

Previously, it was thought that the brain didn’t change after the first 20 to 25 years of life. RRI is leading the charge to reshape that theory.

CONTINUED ON PAGE 22

BY LINDA QUATTRIN

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Biotechnology Focus / May 2010

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Big Ideas-Big Business How OICR is helping Toronto become a global centre of excellence for innovative early stage oncology development

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Ontario’s Neuroscience

Matters of the Mind An overview of Ontario’s neuroscience excellence

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With Ontario’s population getting older, innovations in the CNS (central nervous system) field, which deals primarily with diseases and repercussions of the aging brain are becoming more important than ever.

BY CHRIS ROGERS

“There is this idea of plasticity or adaptability that’s in brain function throughout life, and what that does is it actually provides the potential, I guess you could almost say hope that you can make use of that flexibility, then potentially remediate cognitive function.”

RESHAPING BRAIN THEORY

BY FRANK STONEBANKS

Ontario’s Neuroscience

By Linda Quattrin Neurosurgery at Toronto Western Research Institute is cited by the US National Institutes of Health (NIH) as a world leader in DBS technology, which is being used to treat patients with treatment-resistant depression and Parkinson’s disease. This group published the first reports of using DBS for treatmentresistant depression.

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MOLECULAR AND CELLULAR BIOLOGY Ontario is rich in capable molecular neurobiologists working in cell biology, signal transduction, neural development, the regulation and plasticity of synaptic transmission, neurotransmitter receptor biology and RNA biology. A major focus

NEURODEGENERATIVE DISEASES University of Toronto has an impressive array of affiliated research hospitals: Baycrest, Bloorview Kids Rehab, Centre for Addiction and Mental Health (CAMH), Hospital for Sick Children, Mount Sinai Hospital, St. Michael’s Hospital, Sunnybrook Health Sciences Centre, Toronto Rehab, University Health Network and Women’s College Hospital, many of which have long and storied traditions in outstanding neuroscience research. That strength extends outward in Ontario, with nodes of cross-disciplinary expertise in Alzheimer’s, multiple sclerosis, Parkinson’s and beyond.

GENETICS AND GENOMICS Ontario geneticists have made major contributions to understanding the genetic influences that contribute to neurodegenerative diseases and psychiatric diseases. Some highlights: sæ2ESEARCHERSæATæ4ORONTO Sæ#ENTREæFORæ!DDICTIONæANDæ-ENTALæ Health have been leaders in relating gene variants in the receptors for dopamine and serotonin to psychiatric disorders and to treatment response. sæ#!-(æ RESEARCHERSæ HAVEæ LEDæ IMPORTANTæ INVESTIGATIONSæ INTOæ unstable DNA mutations in mental illness and are expanding that work to a range of disorders. sæ.EWæLINESæOFæRESEARCHæINCLUDE æCOMBININGæGENOTYPINGæANDæ MRI to explore genetic determinants of stroke recovery; and pharmacogenetic studies— discovering gene variants associated with good and bad responses to specific drugs— an area with great commercial potential. sæ4HEæ #ENTREæ FORæ !PPLIEDæ 'ENOMICSæ ATæ THEæ (OSPITALæ FORæ 3ICKæ Children is a fast-growing centre producing excellent research on autistic spectrum disorders.

DEEP BRAIN STIMULATION (DBS) Toronto has one of the largest neurosurgery clinical and teaching groups in North America, and the Department of

COMPUTATIONAL NEUROSCIENCE This discipline is an Ontario strength as well as a clear need in contemporary neuroscience research. It is increasingly essential as a means to understand how both cells and brains compute and to model the interfaces between levels of function (e.g., between cells and circuits and between patterns of neural activity and cognitive performance). Institutional strengths are found in the psychology and computer science departments at the Universities of Ottawa, Toronto, Waterloo, and York. Scientists have developed computational models of neural network mechanisms responsible for high-level cognition, including analogy, concept application, theory evaluation, and emotional decision-making. Others have developed algorithms to simulate (and thus understand) learning processes in the visual system.

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LEARNING AND MEMORY Cognitive neuroscience has been an internationally recognized strength of Ontario and of Canada generally for at least 50 years, with theoretical and experimental studies of human memory foremost in the cluster. Strengths include theoretical models, applications to neuropsychological cases, and the neural bases of memory via neuroimaging. A further focus has been the understanding of normal age-related declines in memory, with the group at the Rotman Research Institute designated as “best in the world” during a recent site visit.

BRAIN PLASTICITY

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Scientists around the province are working on plasticity, from genes to behaviour and rehabilitation. Efforts are also being made to link plasticity and neural regeneration to stem cell biology. Induced pluripotent stem cells (iPS cells) are being developed to create nerve cell diseases in a dish as well as patient-specific stem cells, with the goal of using such cells as substrates for drug toxicity experiments and therapeutics. In addition to making discoveries on molecular mechanisms regulating synaptic transmission, Ontario researchers have made major discoveries on mechanisms of learning and memory, and their dysfunction. Examples of key discoveries include neuronal competition in memory formation, the erasure of fear memories in the amygdala, and the role of the anterior cingulate cortex in fear learning.

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BY CARMELA DELUCA AND MICHELINE GRAVELLE

The Samuel Lunenfeld Research Institute of Mount Sinai Hospital

By Karin Fleming

DEPARTMENTS

How the Samuel Lunenfeld Research Institute of Mount Sinai Hospital is advancing neuroscience research in Canada

ONTARIO

This year marks the 25th anniversary of the Samuel Lunenfeld Research Institute of Mount Sinai Hospital in Toronto, one of the world’s top 10 centres in biomedical research, and Canada’s gold standard for genetics research and molecular medicine.

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No Longer Under the Sun BRCA Gene Patents Held Not Patentable in the U.S.

A LEADING CENTRE FOR INNOVATION, EXPERTISE, AND DISCOVERY

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Samuel Lunenfeld Research Institute This year marks the 25th anniversary of one of the world’s top 10 centres in biomedical research

With the enormity of this challenge also comes tremendous opportunity: the opportunity to grow a significant neurotechnology industry from Ontario’s already extensive track record in neuroscience research. At stake are huge economic rewards, long-lasting effects on employment, infrastructure development and regional competitiveness. Devices aside, the global neuromedicine market alone is valued at over USD$144 billion and has become larger than any other therapeutic market with projected market growth of 10 per cent per year, outpacing both cancer and cardiovascular markets.

So where do Ontario’s strengths lie?

In 2009, a group of distinguished international scientists took an in-depth look at the province’s research prowess. Led by eminent Canadians Dr. Joseph B. Martin, Dean Emeritus, Harvard Medical School, Joseph L. Rotman, businessman and philanthropist, Dr. Fergus Craik, Professor at the University of Toronto and Rotman Research Institute and Dr. Richard Murphy, President and CEO of Salk Institute for Biological Studies (retired), here’s a snapshot of what they found:

of Ontario neurobiologists is in characterizing fundamental molecular mechanisms mediating neural transmission. Many Ontario researchers have made transformative discoveries on the fundamental principles of neurotransmitter release and uptake at nerve-cell-connecting synapses in the brain and spinal cord.

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If it were an infectious disease, the prevalence would qualify as a global epidemic.The constellation of neurological and psychiatric-related disorders – from Alzheimer’s to anxiety – touches fully one in three Canadian families, according to Neuroscience Canada. And the picture, as we know, is only getting greyer given the aging demographic in the developed world.

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BRAIN IMAGING Brain imaging (also called neuroimaging) is a major strength in Ontario, with a high concentration of research in MRI, PET, MEG, EEG and some optical techniques. Major centres include the Rotman Research Institute at Baycrest, Sunnybrook, Robarts Research Institute at London’s University of Western Ontario, CAMH, and, for complementary mouse imaging, a consortium of hospitals and their affiliated research institutes, including Mt. Sinai Hospital, the University Health Network and the Hospital for Sick Children.

An overview of Ontario’s neuroscience excellence

The Lunenfeld’s Centre for Neurodevelopment and Cognitive Function focuses on understanding the fundamental processes that underlie the development and function of the nervous system, specifically at the molecular and genetic level.

Neuroscientists at the Lunenfeld have developed a unique vision for this fascinating and important area, and their discoveries provide new insight and approaches to understanding diseases and injuries that affect nerve growth and function, including psychiatric disorders, Alzheimer’s disease, epilepsy, autism and spinal cord injury, as well as learning and memory.

THE FUNDAMENTALS OF NERVE GUIDANCE AND NERVOUS SYSTEM DEVELOPMENT Understanding the process of nerve guidance and migration during devel-

opment has been a life-long obsession of Dr. Joseph Culotti. A Senior Investigator at the Lunenfeld and the 2005 recipient of the Barbara Turnbull Award for Spinal Cord Research, Dr. Culotti conducts fundamental research to understand the development and function of the nervous system. In particular, he looks for genes involved in directing the precise growth of neurons, and his research has significant implications for the development of new treatments for spinal cord injury.

“By understanding the mechanisms involved in the development of the spinal cord, we may ultimately be able to replicate it, enabling severed neurons to reconnect and repair an injured cord,” says Dr. Culotti.

To study the nervous system, Dr. Culotti uses the nematode C. elegans, which he describes as “a simplified spinal cord.” Its simplicity makes C. elegans an ideal research model, and Dr. Culotti has discovered startling similarities between the growth of its neurons and those in the human spinal cord. What he learns from C. elegans therefore has great relevance to our understanding of the development and regeneration of the human nervous system.

Working in collaboration with researchers at Johns Hopkins University in 2001, Dr. Culotti found that similar

molecules guide the growing neurons along the same axis in the developing human spinal cord as they do in C. elegans. He and his team were the first to identify a neuron guidance cue called UNC-6 that gives information to growing neurons, in essence telling them which direction to grow. Dr. Culotti’s lab has also identified five new genes involved in forming the paths that guide axons, and has successfully isolated three of these, enabling their in-depth study.

In February 2009, Dr. Culotti published a landmark study in Nature Neuroscience that revealed how opposing chemical signals help define the appropriate positioning of neurons and their axons, with respect to other neurons and supporting cells.

Other projects in Dr. Culotti’s lab involve identifying mutations in homologues of genes known to affect axon guidance in vertebrates.

A FOCUS ON THE GENETICS OF EPILEPSY, SCHIZOPHRENIA, LEARNING, AND COGNITION Important insights into the genetics of epilepsy have been revealed through the research of Dr. John Roder, an acclaimed neurobiologist and Senior Investigator at the Lunenfeld who holds a Canada Research Chair in Learning and Memory. An original member of the Molecular

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Research News

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Business Corner

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Ontario Innovation Hubs

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Calendar of Events

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The Last Word

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MATTERS OF THE MIND:

Biotechnology Focus / May 2010

Biotechnology Focus / May 2010

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PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITER

INTERN

Ontario has the Answers

Shawn Lawrence Chris Rogers Tim Bryant

CONTRIBUTING WRITERS

Karin Fleming

Linda Quattrin

Frank Stonebanks

Ulrich Krull

Carmela DeLuca

National Account Manager

With BIO upon us once again it’s time to roll out all the stops for our Ontario issue. What is so striking about this year’s issue is the overwhelming support we have received from the Ontario biotech community in presenting the most complete view of the province’s world-class life sciences industry.

It’s no secret that 2011 looms over all of us as the year the first of the baby boomers will turn 65. The added cost to health-care systems with age related conditions, especially CNS disorders is driving intense research in this field and Ontario is at the forefront of the push to innovate.

We interview Rotman Research Institute’s Dr. Randy McIntosh, whose team of researchers are collaborating on a virtual brain which will give new insight into how the brain works and develops diseases such as Alzheimer’s. McIntosh’s concern is that we not only need to understand how a disease affects the brain but we also need to know how a healthy brain functions so we can better discern how to maintain brain wellness.

We also sat down with Ontario’s Minister of Research and Innovation, John Milloy.

Under Minister Milloy, Ontario has decided to reshape and improve some of their funding programs and he answers pressing questions about the provinces future and how his ministry is helping all sizes of biotech commercialize.

As a world-leading centre for studying aging, we would be remiss if we did not cover Toronto’s Baycrest centre. Bill Reichman, president and CEO of Baycrest, speaks with us about translational research and taking a leadership role in transforming aging. Baycrest is leveraging its research pillars to create solutions to the challenges of cognition, mental health and aging.

Although Ontario has tremendous strength in CNS it is important to recognize the provinces’ robustness. MaRS discovery district presents the results of an in-depth look at Ontario’s research strengths by some of Canada’s preeminent life science minds, the results are more than captivating and encouraging to anyone considering Ontario as a base of operation.

A relative newcomer to the scene, the Ontario Institute for Cancer Research (OICR) has quickly established itself as a leader in the R&D commercialization domain. This issue features an inside look at how OICR is helping pharmaceutical, medical device and biotech companies reduce their risk by creating R&D partnerships with scientists around the world through its global commercialization program.

The life sciences industry will always tackle the hard questions, innovate where there seems to be no hope. It is our job to ask those difficult questions and show both the struggles and triumphs of biotech, so it is refreshing to present to you an issue of Biotechnology Focus which provides so many answers.

Terri Pavelic

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Photo: Donald F. Weaver, Dalhousie University

R & D NEWS Researchers’ work merits $1 M in grant money Eight outstanding Canadian researchers have been awarded a total of $1.12 million in the 43rd annual competition for Killam Research Fellowships, administered by the Canada Council for the Arts. The Fellowships provide $70,000 a year for two years to each of the researchers.

The recipients are chosen by the Killam Selection Committee, which comprises 15 eminent scientists and scholars representing a broad range of disciplines.

Among the selections were: For Health Sciences, Medicine: Donald F. Weaver, Dalhousie University, for the design and discovery of a curative drug for Alzheimer’s disease. The research will build on work already underway to develop a drug to halt the progression of Alzheimer’s disease. This would go beyond current drugs which are used to relieve the symptoms of the disease.

For Natural Sciences, Chemistry: Philip Jessop, Queen’s University, Switchable Chemistry. The project will examine the design of switchable materials (materials that change their properties on command) in order to reduce the environmental impact of human activities. The research will explore a number of areas including a method to remove contaminants from water, switchable solvents

to extract vegetable oils from seeds instead of using the current energy-intensive distillation process, and switchable paints that would harden on the wall, not in the can.

For Natural Sciences, Chemistry: Eugenia Kumacheva, University of Toronto, Combining microfluidics and polymer science to create biological environments for cell studies. The research will enable the use of microfluidics (the flow of liquids through micro channels) to create biological microenvironments where they can study the behaviors of cells. A second component would create a 3D microenvironment to study stem cell growth.

The fellowships are awarded to the individual recipients to devote time to full-time research, but the funds are paid to and administered by universities or research institutes. The awards support scholars engaged in research projects of outstanding merit in the humanities, social sciences, natural sciences, health sciences, engineering and interdisciplinary studies within these fields.

Among Canada’s most distinguished research awards, the Canada Council for the Arts Killam Research Fellowships are made possible by a bequest of Mrs. Dorothy J. Killam and a gift she made before her death in 1965.

Prion mentorship award recognizes Dr Donald Rix Dr Donald Rix (1931-2009), was the first chairman of PrioNet Canada and a leader and advocate of prion science in Canada. In recognition of the contributions he made to furthering prion research in Canada and his exceptional mentoring abilities, PrioNet Canada (PrioNet) and the Alberta Prion Research Institute (APRI) have announced that they are offering a one-time mentorship award.

The Dr Don Rix Memorial Prion Mentorship Award will support an outstanding prion researcher to mentor a graduate student, postdoctoral fellow or young professional in prion research.

A one-time award of $20,000 over

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one year will be made to the mentor to support mentoring activities. The award must commence no later than January 1, 2011.

The mentor will be responsible for the direction and use of funds, in support of the awardee’s prion research endeavors on a currently funded PrioNet and/or APRI research project for costs including training, research operating costs, books, and travel and expenses for a conference approved by the mentor.

For eligibility and other criteria, visit www.prionetcanada.ca. Applications are due June 30, 2010.

Clinical Trials & Patents n Allon Therapeutics Inc. (Vancouver, BC) announces its lead neuroprotective drug candidate, davunetide, has been granted Orphan Drug Status in the European Union (EU) for the treatment of Progressive Supranuclear Palsy (PSP). PSP is a rapidly-progressing and fatal degenerative brain disease. Allon announced in January that the U.S. FDA granted davunetide Orphan Drug Status for PSP treatment in the United States. Gordon McCauley, president and CEO of Allon, said the EU designation extends both the scientific validation and the potential market for davunetide as a treatment for PSP as well as other degenerative brain diseases with similar pathologies. n Medicago Inc. (Quebec City, QC) has completed its first clinical trial in humans for its H5N1 avian influenza vaccine. The vaccine was found to be safe, well tolerated and also induced a solid immune response. “We achieved positive Phase I results from our first ever clinical evaluation of our plant-based pandemic H5N1 Influenza VLP vaccine, we successfully produced the H1N1 VLP antigen within 14 days of receiving the DNA sequence, we signed agreements with select countries for a pandemic vaccine production facility and we closed a significant equity financing with institutional investors,” said Andy Sheldon, Medicago’s president and CEO. n Cangene Corp. (Winnipeg, MB) reports it has received European Commission approval to market its ImmunoGam™ (human hepatitis B immunoglobulin), indicated for immunoprophylaxis of hepatitis B. The product, marketed as HepaGam B® in North America and Israel, is a hyperimmune antibody product containing antibodies specific for the hepatitis B surface antigen. As the application for this marketing authorization was submitted via the centralized procedure, its issuance means ImmunoGam™ is approved for sale and use in all 27 member states of the European Union. n Cipher Pharmaceuticals Inc. (Mississauga, ON) announces its New Drug Submission to Health Canada for CIP-TRAMADOL ER and its extended-release formulation of tramadol has been accepted for review. Cipher expects the review to be completed by early 2011. “With a fast absorption profile, no food effect and 24-hour pain coverage, we believe our product would provide an attractive treatment option for moderately severe pain. This submission is consistent with our plans to target additional markets for our three existing products,” said Larry Andrews, president and CEO of Cipher.

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R & D NEWS Hamilton hospital welcomes new research facility Photo (L-R): Dr. Salim Yusuf, vice-president of research and chief scientific officer at Hamilton Health Sciences, and executive director of the Population Health Research Institute; Mrs. Wahida Yusuf; Dr. Julie Masterson; Dr. Eliot Phillipson, president and CEO, Canada Foundation for Innovation; Mr. David Braley, president Orlick Industries; Dr. Alain Beaudet, president and CEO, Canadian Institutes for Health Research; David Sculthorpe, CEO, Heart and Stroke Foundation of Ontario; Nancy Gordon; Mark Rizzo, vice chair, board of directors, Hamilton Health Sciences; Murray Martin, president and CEO, Hamilton Health Sciences; Dr. Jeffrey Weitz, director of the Thrombosis & Atherosclerosis Research Institute

Hamilton’s role as one of the world’s leading centres in cardiac, vascular and stroke research has been cemented with the grand opening of the David Braley Cardiac, Vascular and Stroke Research Institute at the Hamilton General Hospital site of Hamilton Health Sciences.

The 18,000 sq. metre facility occupies a six-storey building, and contains research space, laboratories, meeting rooms, offices

and breakout spaces. Also included is Canada’s largest biobank, which contains more than 1.8 million tissue and genetic research samples from nearly 250,000 participants globally. The total project, including stateof-the-art equipment, totalled close to $100 million.

The grand opening event was attended by many notable dignitaries including the Federal Minister of Industry, Tony Clem-

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ent. “The Government of Canada is proud to partner with the David Braley Cardiac, Vascular and Stroke Research Institute,” said Clement. “The superior research, treatment and healthcare service that will take place here will benefit not only the Hamilton-Niagara region, but indeed all of Canada.”

The building is named after business leader and Orlick Industries’ president David Braley, who donated $10 million to the project.

BUSINESS CORNER Fulcrum Regulatory Services opens office in Vancouver Biovail Corporation subsidiary, Biovail Laboratories International SRL (BLS), has acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex Pharmaceuticals, Inc. for use in the field of respiratory depression, a brain-mediated breathing disorder.

The acquired compounds include the Phase 2 compound CX717, the preclinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739.

As part of the acquisition transaction, BLS has also entered into a field limited license agreement with The Regents of the University of California.

Under the terms of the asset purchase agreement, BLS has paid an upfront fee of $9 million, expects to pay an additional $1 million upon the completion of a transition period, and could pay up to $15 million in potential milestones contingent on the successful demonstration of the utility of an intravenous formulation of CX717 in treating respiratory depression, the successful completion of a Phase 3 clinical program using an AMPAKINE® compound and approval from the U.S. Food and Drug Administration (FDA). BLS may also owe certain development milestones and/or low single-digit royalties on net sales to third parties.

Paladin enters into South African market Paladin Labs Inc. has completed an investment in South Africa’s Pharmaplan Ltd. The deal marks Paladin’s most significant corporate development initiative to date.

Pharmaplan is an independent South African specialty pharmaceutical company dedicated to the execution of a searchacquire-commercialize business model in

the sub-Saharan African region. Under the terms of the agreement, Paladin acquires an initial 34.99 per cent ownership interest and has committed to increase its ownership position over time.

Dr. Gert Hoogland, founder and CEO of Pharmaplan, has committed to continue to lead, control and manage the Pharma-

plan business as CEO without any foreseen changes in his experienced management team.

According to IMS Health, the value of the South African pharmaceutical market is estimated to be $3 billion which represents a 13.6 per cent increase over the prior year as measured in local currency.

BERESKIN & PARR_Biotechnology Focus_May2010.qxd

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MAY 2010 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Therapure Biopharma Inc. signs fill/finish contract with Kane Biotech Inc. Therapure Biopharma Inc. has reached a fill/finish agreementt with Kane Biotech Inc.), a Canadian biotechnology company based in Winnipeg, MB. Under the terms of the agreement, Therapure will provide custom fill/finish services for a key development-stage product for Kane Biotech. Financial terms were not disclosed.

Kane Biotech is a biotechnology company engaged in the development of products to prevent and disperse bio-

films. Biofilms are a major cause of a number of serious medical problems including chronic infections and medical device related infections. Biofilms develop on surfaces such as catheters, prosthetic implants, teeth, lungs and the urogenital tract. They are pervasive, costly to deal with and approximately 80 per cent of all human bacterial infections involve biofilms. The healing of chronic wounds alone costs the US health care system $20 billion per year.

Bioscience industry applauds Ontario government for investment in research and innovation According to the Ontario Bioscience Industry Organization (OBIO), urgently needed capital should become more accessible to Ontario’s bioscience companies and help create jobs in the biotechnology sector, thanks to Ontario’s 2010 budget.

The announced increase in the budget of the Ministry of Research and Innovation coupled with anticipated adjustments to existing funding programs designed to encourage research and innovation were also applauded.

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Reply Card #4725 10 BIOTECHNOLOGY FOCUS MAY 2010

In 2009, chief executive officers of Ontario-based bioscience companies identified the industry’s most pressing challenges and presented their recommendations for promoting growth in the sector to the Ontario Government. These recommendations of OBIO sought modifications to make existing funding programs more accessible and to accelerate commercialization, but did not ask for new money.

Dr. David Young, chair of the board of directors of OBIO, and managing partner, Actium Equity Partners, said: “The Ontario Government is listening to our industry and recognizing the economic potential of a vibrant and growing bioscience industry that can produce many of the medical therapies and technologies we now import and can create jobs. We encourage the Ontario Government in its commitment to innovation and the life-science sector by addressing the critical issue of access to capital.”

Program modifications sought by OBIO included adjustments to the Biopharmaceutical Innovation Program (BIP), owing to difficulties for Ontario life-science companies in accessing funds. The province has since announced the winding down of BIP as a prelude to adjustments in other programs that will reflect industry input.

OBIO also has struck expert committees to work with industry CEOs on finding new ways to leverage global risk capital into Ontario and on developing a strategy to maximize the scientific and economic potential of biotechnology.

Launched by chief executive officers of Ontario-based bioscience companies, OBIO provides executive-level input into provincial policies and economic strategy in order to advance the life-science sector. It is supported by members and sponsors, among whom are Amgen Canada, AstraZeneca Canada, Dalton Pharma Services, Dalton Medicinal Chemistry, The Equicom Group, Gowlings, HealthComm, Merck Frosst, Pfizer Canada, PricewaterhouseCoopers, Purdue Pharma Canada, RBC Royal Bank, Rx & D and VWR.

Ontario

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Ontario Minister of Research and Innovation Baycrest: Transforming the way people age Reshaping brain theory MaRS overview of Ontario’s neuroscience excellence

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OICR-Big Ideas-Big Business Samuel Lunenfeld Research, advancing neuroscience research in Canada

A Spotlight on Innovation and Research in Ontario

Ontario Ministry of research and innovation

By Chris Rogers

a perFeCt setting

OntariO

As we rode the five floors up to the OICR (Ontario Institute for Cancer Research) offices it was easy to get excited.

MaRS, the centre of Toronto’s research initiatives and arguably the heart of Ontario’s Innovation Agenda sped by, and the glass walled elevator rose up over the offices revealing the Ontario legislature, Queen’s Park and beyond that the bustling University of Toronto.

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The lift slowed and we made our way into the OICR laboratories to meet Ontario’s Minister of Research and Innovation, John Milloy. Scouting the best possible places for our cover shoot we were shown around the busy labs - brimming with the state-of-the-art technology that graces the New Product section of Biotechnology Focus each month. Researchers hopping from station to station, collecting data.

This is where innovation happens.

Snapping a few quick pictures, I immediately felt like I was holding everyone up, like I was delaying some massive discovery. The researchers asked if they were getting in the way of a good picture. “I’m the one getting in the way,” was all I could think.

Biotechnology Focus / May 2010

As the Minister arrived he was immediately just as interested in the happenings around the labs as we were. As we set up for pictures, he eagerly began asking questions of the staff about the data they were collecting; about the research going on.

We made our way from the labs to a board room overlooking MaRS and U of T, a perfect setting considering the tone of the conversation. I was expecting a 10,000 metre overview of the province’s research infrastructure and a slew of lofty goals but what I got was an honest appraisal of the province’s innovation landscape and realistic assessment of the life science climate in Ontario.

Lofty goals? Sure, those were there too, but Milloy and his team at MRI understand where the potential lies and are poised to make Ontario live up to these expectations.

“We have an outstanding healthcare system here,” said Milloy. “We have one of the most diverse populations on earth which every researcher I meet tells me is amazing.”

Holding concurrent positions as Minister for MRI and TCU (the Ministry of Training, Colleges and Universities), has given Milloy a firm understanding of Ontario’s major research areas and strengths.

“We have incredible strengths in many of the issues related to aging and neuroscience is our theme at BIO this year. There is important work going on in colleges in terms of healthcare delivery related to aging. We have the strength here in Ontario – just look at U of T, the University of Western Ontario, and Baycrest – we have this wonderful

John Milloy

Ontario is ready to accept its place as a leader in life sciences

healthcare platform,” Milloy boasts.

“These are incredible strengths that we can use to not only solve our problems here at home but also to deal with efficiencies in the healthcare system and issues around patient care. Why can’t we export our technologies and products around the world? I think Ontario is poised to be a global leader.”

It’s a fair assessment of Ontario’s strengths, but this industry has been rocked by a lack of investment in recent years and MRI had just announced it was no longer accepting applications for one of its more lucrative, albeit contentious programs, the Biopharmaceutical Investment Program (BIP). Criticisms levied against the program included being narrow in scope with funds that were almost impossible to access. While not a failure, the short-lived program did fund a number of initiatives and there are still promises of more to come as the final applications are reviewed.

“BIP was a successful program and although we’re not accepting new applications we’re still in the process of evaluating some applications that are still outstanding,” Milloy explains. “It provided much needed support and led to the creation of 1,400 jobs.”

That’s acceptable, but in a gesture that really shows they’re listening to the concerns of the industry, MRI is rolling out a new program which will broaden the scope of the initiative. Hopefully allowing many more start-up companies access to the funding they desperately need.

“Even though [BIP] was important and it had a very positive impact on the sector, we want to roll out something

that’s a bit broader in terms of life sciences. We have indicated to the sector that we will be coming out with a life sciences commercialization strategy in the near future,” he says.

“The new strategy will build on Ontario’s strengths in terms of life sciences.

We obviously want to look at marketing and how we can pull in new investments. We want to build our academic excellence because we have some outstanding researchers here in Ontario.

How can we attract more researchers, how can we nurture those researchers, how can we work with the industry and the academic community and bring them together? Those are the pillars of our strategy.”

Given our physical setting, in a place where academia and industry are driving remarkable breakthroughs, it’s hard to disagree. But I was curious what it meant for fledgling biotech companies struggling with finances.

“I think start ups in the biotech field have a different challenge,” Milloy says.

“Quite frankly, they’re on a different trajectory than start ups in a lot of other industries. They have different challenges and different time frames. In bringing forward this strategy we’re trying to answer the question – how can we make our programs a little more friendly to the biotech world? There are issues around clinical trials and having a more appropriate or enhanced infrastructure for clinical trials. We’re also going to be

paying special attention to medical devices. That’s another piece of the puzzle in the life sciences field. Finally we will look at genomics and commercialization opportunities.”

With the promise of a new program to help start ups in the industry, the focus of the conversation shifts to commercialization. Without the proper commercialization strategy, Ontario could not expect to complete at the towering levels it strives for. Yet, the province already has a firm foundation in this area which is being fleshed out by the new Ontario Network of Excellence (ONE).

Already, Ontario has a number of regional innovation centres which attempt to foster innovative new products by guiding them down the commercialization path. While they do an exceptional job, the new ONE network holds the promise of a new era of commercialization strategies for Ontario start ups. The biggest push for the new program is the focus on making geographic challenges a thing of the past.

“Whether you’re in the farthest reaches of Northern Ontario or downtown Toronto, you’re going to be able to access the full range of services from the local organization in the network,” he says. “We want to look at various technologies to link people together and we want to create a true network because there has been a certain unevenness up until now.”

It’s the recognition that perhaps ser-

vices like commercialization assistance aren’t as easy to access for some that adds a tone of optimism to the rest of the conversation because at the same time, the ministry wants to make sure that its services are available to a much broader spectrum of innovators.

“There’s a lot to celebrate in Ontario in terms of the supports that exist,” Milloy says. “If you look at the continuum in both directions – for researchers that are looking at commercialization opportunities [and] at the same time, for industry that’s looking to get a hold of the best research to deal with some of their problems and challenges…there is good infrastructure, but it’s not as connected as it should be. There are, quite frankly, some geographic challenges. I think a researcher in one part of the province might have better access to programming than a researcher in another part of the province. We have a number of outstanding regional innovation organizations, the question is: how can we link them together? How can we link them to anchors like MaRS and OCE and create a network which covers every inch of the province?”

As the interview winds down, it’s reassuring to hear that Milloy and his team are not naive to the challenges they face; this is a fiercely competitive field but they believe now is the time to act.

“We’re not the only place thinking this way, but we’ve got some real strengths and we have to take action right now.

That’s why our [focus is on] life sciences and commercialization,” he says.

“A real focus on commercializing this research in the life science industry is going to be very important for us, but we know there is a lot of competition out there.”

Leaving MaRS, I couldn’t help but feel Ontario has big expectations and goals for the life sciences industry. But this is a sector that’s been clamouring at the door, crying for the opportunity to prove themselves and Ontario’s new initiatives, are going to give them a chance to succeed. Coupled with some changes to federal tax reporting laws (the infamous Section 116), removing what most in the industry and venture capital saw as impediments to Canadian companies getting proper international funding, Ontario may have the answers many in this industry are looking for.

Ontario

John Milloy

MRI

Ontario Minister of Research and Innovation John Milloy gets shown around the OICR labs Biotechnology Focus / May 2010

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innovative Leader

By Shawn Lawrence

BaYCrESt a centre of excellence for innovation in aging

OntariO

Fully affiliated with the University of Toronto and located in Toronto, Baycrest is a centre that provides care and services to approximately 2,500 people a day through its geriatric heath care system. To any outsider, it looks like a large hospital.

But a closer look reveals Baycrest as a place where world recognized cognitive neuroscientists and talented clinicians have created a dynamic venture research environment focused on brain health and successful aging.

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“It’s one of the very few places in the world where you have a world-class cognitive neuroscience institute embedded within a very rich continuum of senior care services,” explains Baycrest president and CEO Dr. William Reichman. “That’s what’s amazing about this place, you have these world-class scientists working side-by-side with clinicians, and that means we can more readily translate the science into practical application that benefit people. It’s

Biotechnology Focus / May 2010

an extraordinary opportunity to be able to conduct research in a real-world setting, with such a rich and varied aging population.”

What Dr. Reichman is alluding to is the presence of the Kunin-Lunenfeld Applied Research Unit (KLARU) for clinical research and the Rotman Research Institute (RRI) for brain research at Baycrest. The former conducts research alongside clinicians applying the results directly to client care; the latter a world leader in cognitive neuroscience.

Usually such institutes are either free standing or they’re on the campuses of universities and are not in close relation to settings of actual care. According to Dr. Reichman, how all of these enterprises come together is what makes Baycrest unique.

“RRI scientists have made significant contributions to helping us understand how we remember things, what areas of the brain are involved, and not only how we remember but also how we actually execute and get things done on a day-to-day basis,” he says, adding that the end goal is to take these findings and use them to improve the aging experience and to better understand brain function.

Every five years Baycrest research undergoes an external review conducted by highly respected scientists from around the world. In their most recent review experts called the cognitive neuroscience programs at Baycrest‘s RRI “world-class,” listing them among the best in the world alongside

UC Berkeley, UCLA, University College London and MIT. Moreover, the panel pointed to Baycrest as a “wonderful resource” for targeted brain fitness product development efforts with both government and private investors.

“That’s just an extraordinary achievement for a place that many construed for so many decades to be just a nursing home on Bathurst Street. Very few people I think fully understood what was going on behind the scenes at our centre in terms of the sophistication and caliber of the research,” he says, adding that it was the long standing reputation of research excellence at Baycrest that convinced him to leave his position as an internationally-known expert in geriatric health and dementia in the U.S., and accept the position of CEO and president of Baycrest.

In addition to being backed by a strong research pillar, Baycrest has made significant gains in leveraging these strengths into partnerships with government and collaborations with health science organizations. The Baycrest Centre for Brain Fitness, which was launched in 2008, owes its existence in large part to this collaborative activity. The centre was established with a $10 million investment from the Ontario Ministry of Research and Innovation, plus $10 million in donor support.

The chair of Baycrest’s board of directors, Dr. Tony Melman, notes some of the innovations associated with the centre could save the Ontario healthcare

Innovative Leader potential, Dr. Ween states, “this is an innovative and leading edge development and will need further R&D to be an enterprise class concern.”

As to who the target users are, Dr. Ween comments the tool will be most attractive to clinicians involved in stroke care or cognitive assessments in other populations. The tool should also be very interesting to pharma companies conducting multi-centred drug trials and clinical groups with multiple sites/participants. Ideally it will have applications throughout the medical community.

“Potentially, there is a huge market for this cognitive assessment tool,” says Dr. Ween.

The prototype has been used on hundreds of stroke and MS patients so far, ranging in age from late 20s to 100.

The test, a portable wireless system, will lead to faster and more accurate diagnosis of brain diseases associated with aging, facilitating earlier interventions.

“It allows clinicians to measure, in a simple and rapid manner, memory and processing in people who have had a stroke, may have Alzheimer’s or other memory challenges, or a traumatic brain injury. What the blood pressure cuff did for cardiac care, this tool has the potential to do for brain health,” Dr. Ween comments.

Another initiative of equal importance to both Baycrest and its Centre for Brain

Fitness is its spin-out company Cogniciti.

Established through a partnership between Baycrest and the MaRS Discovery District (an organization that helps science, technology and social entrepreneurs build their companies), Cogniciti is a for profit company in the business of creating and marketing products designed to help adults extend their cognitive abilities longer in the lifespan.

According to Dr. Reichman, Cogniciti represents the true spirit of collaboration in that Baycrest, through RRI, is able to provide scientific validity to Cogniciti’s products, while MaRS brings expertise in executive leadership, branding and marketing experience to the table.

Cogniciti’s first product, Memory@ Work™, targets the aging brain in the workplace by strengthening and maintaining the user’s cognitive abilities. Dr. Reichman describes the product as an exercise tool for the brain.

“As you get older it gets harder to lift heavy things and so can you learn new techniques of how to lift things, and how to build up your muscle strength so it’s not as hard. Memory@Work works the same way, except it’s not your muscles that are being worked, it’s your brain,” he says.

Cogniciti is also developing more general brain exercises and fitness products that can be played on web-based and hand-held devices scheduled for test-marketing in 2011 and 2012.

T U R N I N G I N N O V AT I O N I N T O E C O N O M I C G R O W T H Business, education and government in the Hamilton, Halton and Niagara regions combined forces to energize our existing biosciences strengths and help turn breakthroughs into business success.

Join us as we grow this regional initiative! Help transform the Golden Horseshoe into a knowledge-based, economic powerhouse of research, growth and investment.

Visit our web site at www.ghbn.org to find out more!

Reply Card #4726

Ontario

system up to $1 billion annually by helping aging adults live at home longer. In addition, he believes the Ontario government’s investment will help the province participate in the global brain fitness market, that has the potential to grow to between one and five billion dollars by 2015 (according to a May 2009 report issued by U.S. market research firm, SharpBrains).

“There are few things as frightening as the prospect of declining brain fitness as we age and the loss of our mental faculties. Baycrest’s strengths in aging brain research, cognitive assessment and rehabilitation make it well positioned to develop innovative, market driven research products that will transform the way we age,” states Dr. Melman.

Already research conducted at Baycrest has led to the development of innovative products such as a neurocognitive assessment tool that is currently being developed in collaboration with Sunnybrook Health Sciences Centre. The tool is a small computer tablet called INCAS (Integrated Neurocognitive Assessment System) which assesses memory, processing and reasoning in patients. Dr. Jon Ween, medical director of The Louis and Leah Posluns Stroke and Cognition Clinic; Dr. Donald Stuss, Baycrest; and Dr. Sandra Black, Sunnybrook are the principal investigators in the development of this tool.

As to the tool’s commercialization

w w w. g h b n . o r g Biotechnology Focus / May 2010

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OntariO

innovative Leader

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“We’re starting to learn a lot from the science that’s accumulating that we can actually exercise our brains and improve our cognitive abilities. The trick though is to embed the training into activities that people are willing to do and enjoy.”

Dr. Reichman believes the company has a tremendous opportunity to make headway in the brain fitness market as both a pioneer and as a leader. The need has never been greater as demographic characteristics in developed countries are changing, especially in the Greater Toronto Area where it is expected that the senior’s population will grow to 1.5 million by 2025.

“Many more people who are 65 today are still quite healthy, dynamic and vital.

They’re not ready to retreat from the world or retire. I think that the boomers are going to stay in the workforce longer for economic as well as other reasons and they want to stay on their game.

They want to still be productive and effective at work. That’s why Memory@ Work™ is an idea that’s resonating as a good market opportunity for us, and it’s a really nice extension of the science we do here.”

For a centre that has traditionally been more focused on the research than the development side, this is a huge step, but it is one that Dr. Reichman believes the centre is more than capable of taking. It’s also a great example of how collaboration can lead to the successful commercialization of scientific excellence.

“Cogniciti is a very important lesson of how no one part of society can do this on its own. We’ve had private philanthropy get us started with the science, it then gets matched by a government investment (through MRI), it’s then partnered up with an incubator or a think-tank that understands commercialization (MaRS), and then you bring the academic community into it.

This is our model. As long as everyone’s aligned with a common purpose, that’s when the great chemistry starts to happen. This is a really good example of a private-public partnership that can help position Ontario, certainly Canada, in a sector that wasn’t well positioned before. It’s a great thing, and I’m hopeful that our success will lead the Ontario government to continue to invest in these kinds of innovations.”

Biotechnology Focus / May 2010

Lead scientists involved in the product development for Cogniciti are:

Dr. Fergus Craik Dr. Fergus Craik, a senior scientist with the Rotman Research Institute and Professor Emeritus at the University of Toronto, has contributed immensely to the understanding of how human memory works and the effects of aging on those processes. His research has found that certain types of cognitive processes hold up better than others in later life. Dr. Craik has published extensively in scientific journals, written book chapters, and co-edited nine books, including The Oxford Handbook of Memory (with co-editor and Gairdner Award recipient Endel Tulving). In 2009, Dr. Craik was elected as a Fellow of The Royal Society of London for his experimental study of human memory processes.

Dr. Brian Levine Dr. Brian Levine is a senior scientist at the Rotman Research Institute at Baycrest and a professor in the departments of Psychology and Medicine (Neurology) at the University of Toronto. Dr. Levine has his Ph.D. in clinical psychology and completed his postdoctoral fellowships in clinical and research neuropsychology. Dr. Brian Levine represents Baycrest as a Site Director for the Heart and Stroke Foundation Centre for Stroke Recovery.

Dr. Levine’s key areas of interest are assessment of executive function, episodic memory and recovery, and reorganization of brain function following traumatic brain injury.

Dr. Kelly Murphy Dr. Kelly Murphy is a Clinical Neuropsychologist in the Cognitive and Behavioural Health Program. Her research focuses on cognitive aging, memory intervention, and mild cognitive impairment (MCI). She specializes in early detection and treatment of memory decline in older adults with mild cognitive impairment who are at risk of developing future dementia.

Dr. Murphy runs a clinical service at Baycrest comprised of the Memory Intervention Program which provides education around lifestyle factors affecting memory ability plus memory training in practical techniques for use in everyday life as well as psychosocial support for clients with MCI and their family members.

Dr. Donald Stuss Dr. Stuss is a senior scientist at the Rotman Research Institute at Baycrest and former Vice-President of Research.

He was named the first Director of the Rotman Research Institute (RRI) at Baycrest in 1989, and under his stewardship the RRI evolved into a world-class centre for aging brain research He has dedicated 30 years to the study of human frontal lobe function and has made significant contributions to better understanding the human mind. He is the Reva James Leeds Chair in Neuroscience and Research Leadership, and a University of Toronto Professor of Psychology and Medicine (Neurology and Rehabilitation Science). He has published several books, including co-authoring the 1986 classic reference, The Frontal Lobes. He is a former Scientific Director for the Heart and Stroke Foundation, Centre for Stroke Recovery.

Dr. angela troyer Baycrest clinical neuropsychologist and director of Psychology Dr. Angela Troyer is an adjunct faculty memory, Faculty of Graduate Studies (Psychology), York University and an internship supervisor, Neuropsychology Assessment and Memory Intervention rotations. Dr. Troyer’s primary clinical practice involves neuropsychological evaluation of dementia and memory intervention in normal aging and early dementia. Her research interests focus on memory changes in normal aging and dementia; effectiveness of memory interventions; and relationship between executive functions and memory.

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Reply Card #4728

neuro-imaging

By Chris Rogers

resHaping Brain tHeOry neuroscientist randy Macintosh is driving urgently needed innovation around brain health

OntariO

With Ontario’s population getting older, innovations in the CNS (central nervous system) field, which deals primarily with diseases and repercussions of the aging brain are becoming more important than ever.

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Located at Baycrest, a world leading academic health science centre, RRI (Rotman Research Institute) is at the forefront of this fight to understand how the brain ages and mitigating the factors surrounding the development of diseases such as Alzheimer’s and problems such as stroke. By bringing together world-renowned researchers in a broad spectrum of disciplines, from cognitive neuro-psychologists to computer scientists, RRI is able to tackle its goal of comprehending the workings of memory and the executive functions of the brain.

“The focus of the research institute at Baycrest is to understand both the aging brain as well as age related diseases and disorders,” said Dr. Randy McIntosh, senior scientist and director of RRI. Dr. McIntosh is a leader in the CNS field. His own research is geared to the development of a unified theory of brain operation that emphasizes the integrative capacity of the brain.

Biotechnology Focus / May 2010

“The idea is to understand how different kinds of mental functions change as we age, how they can be worse if there is accompanying disease but also understand ways to try to stave off that change,” he explains.

Part of his research focus is to understand the neuro-basis of those changes in terms of cognitive theories for memory and attention.

“The main component of that, using modern neuro-imaging technology [is] to then use that information to develop more effective ways of staving off the declines, that’s with cognitive rehabilitation strategies as well as remediating it if there is a more protracted kind of decline that comes with things with mild cognitive impairment, dementia and/or stroke, and then tracking the efficacy of those therapies again going back and using the neuro-imaging technology as a way to validate that these therapies have direct benefit.”

The benefit of working at an institution such as RRI is that it brings together a group of researchers from a diverse range of disciplines, all devoted to solving a common problem. The varied backgrounds of the scientific staff at RRI allows for unique solutions to be engineered.

“If you address that problem from a number of different perspectives, the solutions to that problem end up being much more innovative then they would be if they were addressed with a typical kind of constrained focus from a given discipline,” says MacIntosh.

In trying to understand memory, he explains that the typical approach is to let psychologists address it in a traditional environment such as a university. But the idea behind RRI has a much broader scope. A diverse group of psychologists, engineers, neurologists, physiologists and computer scientists, all approach memory from different avenues with their contrasting backgrounds allowing them to foster new solutions.

“What you do is have the same problem but address it from different perspectives and that brings different ideas to the table, and you end up coming up with solutions that would not be possible if you focued on only one particular way of looking at the world,” said McIntosh. “It’s the idea of bringing different perspectives to the same problem and coming up with innovative solutions, I think it’s what differentiates the kind of work that we do with some other places.”

He is quick to point out that this approach is also true for other research institutes across Ontario.

Neuro-imaging

“There is this idea of plasticity or adaptability that’s in brain function throughout life, and what that does is it actually provides the potential, I guess you could almost say hope that you can make use of that flexibility, then potentially remediate cognitive function.”

— Dr. Randy McIntosh

the virtual brain’s patterns show similarities to someone who has, for example, dementia.

“It ends up being a sort of diagnostic tool and a prognostic tool,” said McIntosh. “Because in theory, you could use that virtual brain to help guide the course of therapy to help decide what potential pathways you could try and invoke. In a stroke for instance, to facilitate those pathways to help the brain recover. “ And don’t take those comments the wrong way, recovery is definitely what they’re after.

Previously, it was thought that the brain didn’t change after the first 20 to 25 years of life. RRI is leading the charge to reshape that theory.

continued on page 22

Ontario

At RRI, perhaps the best example of this process incorporates a combination of strong cognitive theory and modern neuro-imaging technologies while looking at the computational or informatics aspects and trying to merge theory with data to develop large-scale computational models of the brain and how it changes as we age.

“One of the next focuses is developing what’s been called the virtual brain which is actually a model of the human brain that allows us to understand not only how the brain functions in a normal state but also how the brain functions as we age,” said McIntosh. “You can make a virtual brain that actually ages, a virtual brain that gets Alzheimer’s disease, a virtual brain that gets a stroke, and develop the algorithms that help explain how the brain tries to adapt to age and adapt to damage and disease.”

McIntosh explains that the brain is designed based on the structural information they are collecting from neuroimaging at RRI in combination with functional information and brought together with high-level mathematics to model the brain in action.

“We’re really merging the math with the ‘wet-brain’ as it were, architecture would then put the necessary dynamics in that are captured in the math that drive the model,” said McIntosh.

Trying to explain the way the model works to someone not in the know can be a trying experience but McIntosh breaks it down.

“You get a structural MRI, for example, that you can use to image the connections in the brain. Then you use that as your architecture and then impose the dynamics on top of that using the neuro-network theory.”

“The virtual brain actually ends up being an amalgamation of both normative data but also the clinical that we have access to as well,” he said.

Bringing the research back to its real-world applications and the looming concerns of an aging population, the end-goal of the research, at least in terms of clinical research, is prediction. People generally associate Alzheimer’s disease with the aging brain but what about those who develop these diseases in their 40’s?

“The idea would be to use the virtual brain as a way of testing whether that person is showing some kind of random abnormality, over and above what you can see with the regular clinical imaging.”

He explains that using the information gathered from the neuro-imaging technologies and apply a specific persons characteristics to the virtual brain. From this, researchers can then compare brain functions in the virtual environment to see how

Reply Card #4727

Biotechnology Focus / May 2010

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Ontario’s neuroscience

By Linda Quattrin

Matters OF tHe Mind: an overview of Ontario’s neuroscience excellence

OntariO

If it were an infectious disease, the prevalence would qualify as a global epidemic. The constellation of neurological and psychiatric-related disorders – from Alzheimer’s to anxiety – touches fully one in three Canadian families, according to Neuroscience Canada. And the picture, as we know, is only getting greyer given the aging demographic in the developed world.

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With the enormity of this challenge also comes tremendous opportunity: the opportunity to grow a significant neurotechnology industry from Ontario’s already extensive track record in neuroscience research. At stake are huge economic rewards, long-lasting effects on employment, infrastructure development and regional competitiveness. Devices aside, the global neuromedicine market alone is valued at over USD$144 billion and has become larger than any other therapeutic market with projected market growth of 10 per cent per year, outpacing both cancer and cardiovascular markets.

So where do Ontario’s strengths lie?

In 2009, a group of distinguished international scientists took an in-depth look at the province’s research prowess. Led by eminent Canadians Dr. Joseph B. Martin, Dean Emeritus, Harvard Medical School, Joseph L. Rotman, businessman and philanthropist, Dr. Fergus Craik, Professor at the University of Toronto and Rotman Research Institute and Dr. Richard Murphy, President and CEO of Salk Institute for Biological Studies (retired), here’s a snapshot of what they found:

MOLeCuLar and CeLLuLar BiOLOgy Ontario is rich in capable molecular neurobiologists working in cell biology, signal transduction, neural development, the regulation and plasticity of synaptic transmission, neurotransmitter receptor biology and RNA biology. A major focus

Biotechnology Focus / May 2010

of Ontario neurobiologists is in characterizing fundamental molecular mechanisms mediating neural transmission. Many Ontario researchers have made transformative discoveries on the fundamental principles of neurotransmitter release and uptake at nerve-cell-connecting synapses in the brain and spinal cord.

neurOdegenerative diseases University of Toronto has an impressive array of affiliated research hospitals: Baycrest, Bloorview Kids Rehab, Centre for Addiction and Mental Health (CAMH), Hospital for Sick Children, Mount Sinai Hospital, St. Michael’s Hospital, Sunnybrook Health Sciences Centre, Toronto Rehab, University Health Network and Women’s College Hospital, many of which have long and storied traditions in outstanding neuroscience research. That strength extends outward in Ontario, with nodes of cross-disciplinary expertise in Alzheimer’s, multiple sclerosis, Parkinson’s and beyond.

genetiCs and genOMiCs Ontario geneticists have made major contributions to understanding the genetic influences that contribute to neurodegenerative diseases and psychiatric diseases. Some highlights: • Researchers at Toronto’s Centre for Addiction and Mental Health have been leaders in relating gene variants in the receptors for dopamine and serotonin to psychiatric disorders and to treatment response.

• CAMH researchers have led important investigations into unstable DNA mutations in mental illness and are expanding that work to a range of disorders.

• New lines of research include: combining genotyping and MRI to explore genetic determinants of stroke recovery; and pharmacogenetic studies— discovering gene variants associated with good and bad responses to specific drugs— an area with great commercial potential.

• The Centre for Applied Genomics at the Hospital for Sick Children is a fast-growing centre producing excellent research on autistic spectrum disorders.

deep Brain stiMuLatiOn (dBs) Toronto has one of the largest neurosurgery clinical and teaching groups in North America, and the Department of

Ontario’s Neuroscience Neurosurgery at Toronto Western Research Institute is cited by the US National Institutes of Health (NIH) as a world leader in DBS technology, which is being used to treat patients with treatment-resistant depression and Parkinson’s disease. This group published the first reports of using DBS for treatmentresistant depression.

Brain imaging

Computational neuroscience

Learning and memory

Brain plasticity

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Cognitive neuroscience has been an internationally recognized strength of Ontario and of Canada generally for at least 50 years, with theoretical and experimental studies of human memory foremost in the cluster. Strengths include theoretical models, applications to neuropsychological cases, and the neural bases of memory via neuroimaging. A further focus has been the understanding of normal age-related declines in memory, with the group at the Rotman Research Institute designated as “best in the world” during a recent site visit.

Scientists around the province are working on plasticity, from genes to behaviour and rehabilitation. Efforts are also being made to link plasticity and neural regeneration to stem cell biology. Induced pluripotent stem cells (iPS cells) are being developed to create nerve cell diseases in a dish as well as patient-specific stem cells, with the goal of using such cells as substrates for drug toxicity experiments and therapeutics. In addition to making discoveries on molecular mechanisms regulating synaptic transmission, Ontario researchers have made major discoveries on mechanisms of learning and memory, and their dysfunction. Examples of key discoveries include neuronal competition in memory formation, the erasure of fear memories in the amygdala, and the role of the anterior cingulate cortex in fear learning.

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This discipline is an Ontario strength as well as a clear need in contemporary neuroscience research. It is increasingly essential as a means to understand how both cells and brains compute and to model the interfaces between levels of function (e.g., between cells and circuits and between patterns of neural activity and cognitive performance). Institutional strengths are found in the psychology and computer science departments at the Universities of Ottawa, Toronto, Waterloo, and York. Scientists have developed computational models of neural network mechanisms responsible for high-level cognition, including analogy, concept application, theory evaluation, and emotional decision-making. Others have developed algorithms to simulate (and thus understand) learning processes in the visual system.

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Brain imaging (also called neuroimaging) is a major strength in Ontario, with a high concentration of research in MRI, PET, MEG, EEG and some optical techniques. Major centres include the Rotman Research Institute at Baycrest, Sunnybrook, Robarts Research Institute at London’s University of Western Ontario, CAMH, and, for complementary mouse imaging, a consortium of hospitals and their affiliated research institutes, including Mt. Sinai Hospital, the University Health Network and the Hospital for Sick Children.

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Biotechnology Focus / May 2010

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Ontario’s Neuroscience Perception and action Ontario has notable strength in studies of the relations between visual perception and motor action, and investigators have recently formed a consortium of 33 scientists (CAPnet) drawn largely from Toronto’s York University, Kingston’s Queen’s University, and the University of Western Ontario in London. CAPnet’s research goal is to understand how the brain uses sensory information to construct an internal perceptual representation of the world that guides purposeful movements, both in health and in sickness.

Stroke The province has established a strong network for the prevention, care, education and treatment of stroke patients.

Because vascular incidents have been associated with many forms of cognitive decline and dementia, the stroke network links stroke with neurodegenerative disease and cognitive and behavioural changes. Insights from work done by the Centre for Stroke Recovery—involving scientists and clinicians from Ottawa and Toronto – have led to the important realization that there is time to interfere therapeutically to return blood flow to the affected region, which in turn led to the successful tissue plasminogen activator (tPA) therapy in acute stroke.

Medical devices Ontario’s medical device community is extremely active, with critical mass and expertise. Strengths include: • Microfabrication, nanotechnology, EEG (64-channel recording), and microfluidics, which could lead to lab-on-a chip analysis and implantable devices.

• Intelligent in-home technologies for supporting the daily

living of elderly people, such as monitoring home settings to detect falls, talking systems to prompt or instruct dementia patients through basic routines and eye-tracking technology as a diagnostic for stroke and Parkinson’s disease.

• Virtual reality robotics, now in development for testing sensory, motor and cognitive function, as well as rehabilitation robotics.

Developing the ecosystem to effectively move these and other promising discoveries out of the lab and into the marketplace is at the heart of the mission of MaRS Discovery District. Located in Toronto and networked across Canada and internationally, MaRS is focused on building Ontario’s next generation of technology companies – in life sciences and health care, information and communications technology, cleantech and innovative social purpose enterprises.

Working with a range of public and private-sector partners – from an architecturally inspiring urban location where more than 2,000 people across the innovation spectrum come to work each day – MaRS provides entrepreneurs with business advice and mentorship, market intelligence, entrepreneurship education, seed capital and access to critical talent, customer and partner networks. And with more than 1,700 entrepreneur-clients served across the province since MaRS began offering advisory services in 2006, the critical mass in commercialization is clearly building in Ontario.

Linda Quattrin is Director, Communications at MaRS Discovery District. Her work involves engaging scientists, entrepreneurs, stakeholders and the media in building and promoting the next generation of global companies from Canadian science, technology and social innovation. To learn more about MaRS, visit www. marsdd.com; to learn more about Ontario’s strength in neurotechnology, download MaRS’ 2009 report here: http://www.marsdd.com/buzz/reports/neurotechnology

Ontario

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“The most significant work coming out of Rotman has to do with the recognition that the aging brain is in fact…malleable,” said McIntosh. “The notion was for a number of years that once you’re past 20 to 25, the brain doesn’t change anymore - what we’ve shown is that the brain does change the way it does things pretty much across its lifespan. There is this idea of plasticity or adaptability that’s in brain function throughout life, and what that does is it actually provides the potential, i guess you could almost say hope that you can make use of that flexibility, then potentially remediate cognitive function.”

It truly is hope to the millions affected by these problems, a fact that certainly isn’t lost on McIntosh. The translation from research to reality can be long and arduous but these problems are fast becoming some of the most pressing concerns in life sciences.

“There’s been a difficulty I think with that translational aspect. Part of it is structural, in that a lot of research is done without a direct link into the clinical domain and part of it is sociological as well; once this stuff gets published it takes a while for it to filter down to be applied into things,” he said.

“There are models developing. That’s one thing we’re trying to do at Rotman, it’s trying to make sure that the clinical research and the translational component is actually part of the way the

Biotechnology Focus / May 2010

institute is structured. So that when there is the potential for translating the basic findings into a clinical or applied domain, we can do that in-house and actually get the validation part of it done much more rapidly. That way you facilitate the translation so it is, in fact, implemented much more quickly.”

With baby boomers now reaching their ‘golden years’ there is an urgent need for new treatment options for the unprecedented large proportion of older Canadians. It makes the CNS field and particularly RRIs groundbreaking research very timely. In the past, McIntosh says that neuroscience has been about explaining things after it’s too far-gone. Now a shift is occurring where trying pick up the warning signs early is taking over as the dominant view point.

“As people age the number of these core morbidities are going to factor into quality of life and become more difficult to manage so the more we can get it early, the better off we are,” said Dr. McIntosh. “That’s why I think it’s important to not only understand the disease brain but what keeps the brian healthy for a longer period of time. And that’s why this research into the brain and aging is so important because we can understand not just the bad parts about aging and the brain but also the good parts and how to make the good parts more prevalent for the boomers.”

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OiCr

By Frank Stonebanks

Big ideas – Big Business How OiCr is helping toronto become a global centre of excellence for innovative, early stage oncology development

OntariO

The Toronto region is one of North America’s top four economic powerhouses, along with New York, Los Angeles and Chicago and is ranked third for biomedical/biotechnology. The Ontario Institute for Cancer Research is a new arrival on the scene but has quickly established a reputation as an agile, innovative player in the R&D commercialization sphere.

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Dr. Tom Hudson, president and scientific director of the Ontario Institute for Cancer Research (OICR), shows visitors the view from the 8th floor of the South Tower of the MaRS Centre, in the heart of the Discovery District in downtown Toronto and tells them about the 5,000 scientists and physicians within walking distance, at the University of Toronto and in the hospital-based research institutes. They are surprised to find out how rich the Discovery District is in

Biotechnology Focus / May 2010

talent and accomplishment. It is one of Toronto’s best kept secrets.

Established in December 2005, OICR is a new, innovative cancer research & development institute dedicated to prevention, early detection, diagnosis and treatment of cancer. The Institute is an independent, not-for-profit corporation funded by the Government of Ontario through the Ministry of Research and Innovation. OICR has 300 scientific staff (located at its headquarters and in research institutes and academia across the Province of Ontario) and an $85 million annual operating budget. It has key research efforts underway in small molecules, biologics, stem cells, imaging, genomics, informatics and biocomputing, from early stage research to Phase I clinical trials.

OICR’s global commercialization program identifies and develops opportunities to collaborate with corporate strategic investors and private equity players in oncology; spearheads the intellectual property program to maximize OICR’s extensive intellectual property pipeline, and identifies and accelerates transformative early stage research and development projects using novel business models.

Pharmaceutical, medical device and biotechnology firms looking to reduce their investment risk and create novel R&D partnerships with access to world class science and people find OICR an excellent choice. The Institute provides a low risk, variable cost, basic research to proof-of-concept approach which

is producing a steady stream of novel products.

OICR’s Intellectual Property Development and Commercialization Program (IPDC) provides seed funding for late stage academic projects that meet specific market-oriented criteria. OICR takes an equity stake and/or royalty in the entity. In return the technology gets funded, de-risked and the participating entrepreneurs gain access to OICR’s global commercialization team and its resources.

Despite the success of these early stage seed funds there is a gap between IPDC funding and clinical proof of concept (POC). OICR plans to close this gap with the introduction of a new POC accelerator. This accelerator, developed by OICR and MaRS Innovation (MI), will provide selected entrepreneurs and their assets a proof of concept “sandbox” in which they can form a company, receive milestonedriven funding, development expertise and other resources, giving the entrepreneur the chance to take the offering to the next meaningful value inflexion point (Phase I/II POC), at which point it could be licensed, sold or spun out.

Investors in the accelerator will have an option on these products.

OICR is a member of MI, which provides an integrated commercialization platform that harnesses the economic potential of the discovery pipeline of 14 leading Toronto academic institutions.

A non-profit organization, MI is funded through the Government of Canada’s

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Innovative Science & early development Leadership & Unique early stage business models

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Capital Expertise Full development scale

Variable cost, de-risked Pipeline

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76%

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Contract research organizations and generic drug makers**

Biopharmaceutical sector*

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When it comes to investing in the discovery of new medicines and vaccines in Canada, the biopharmaceutical sector leads the way with both in-house and external research and development of over one billion dollars last year.

Source: Statistics Canada, Industrial Research and Development: Intentions, 2008, Table 18-1, Research and development expenditures on therapeutic health products – By type of organization, 88-202-XWE, March 31, 2009. *Including Research-based pharmaceutical companies, biopharmaceutical companies and biotechnology companies. **Statistics Canada has not revealed expenditures on therapeutic health products for either “Contract Research Organizations” or “Generic pharmaceutical companies” individually in Table 18-1.

Biotechnology Focus / May 2010

OntariO

Ontario Institute for Cancer Research and MaRS Innovation

Networks of Centres of Excellence in Commercialization and Research, and through contributions from member institutions.

The effort will be jointly led by OICR and MI, and it will include strategic investors/partners such as pharmaceutical, medical technology and diagnostic firms, as well as leading private equity groups. By co-investing with OICR, these external participants will gain access to the cutting edge oncology platforms, scientists and products as discoveries emerge from Ontario universities and hospital-based research institutes. The Province of Ontario also plays a key role as it provides OICR balance sheet stability, significant tax credits for foreign investors, access to a world class talent pool, and an entrepreneurial working environment in Toronto’s Discovery District.

OICR is meeting today’s challenges in the R&D environment and capital markets by offering a unique business model for partnership, tailored to reduce cost and risk, and support early-stage innovation. For more information, please visit the website at www.oicr.on.ca.

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the samuel Lunenfeld research institute of Mount sinai Hospital

By Karin Fleming

a Leading Centre FOr innOvatiOn, eXpertise, and disCOvery How the samuel Lunenfeld research institute of Mount sinai Hospital is advancing neuroscience research in Canada

OntariO

This year marks the 25th anniversary of the Samuel Lunenfeld Research Institute of Mount Sinai Hospital in Toronto, one of the world’s top 10 centres in biomedical research, and Canada’s gold standard for genetics research and molecular medicine.

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The Lunenfeld’s Centre for Neurodevelopment and Cognitive Function focuses on understanding the fundamental processes that underlie the development and function of the nervous system, specifically at the molecular and genetic level.

Neuroscientists at the Lunenfeld have developed a unique vision for this fascinating and important area, and their discoveries provide new insight and approaches to understanding diseases and injuries that affect nerve growth and function, including psychiatric disorders, Alzheimer’s disease, epilepsy, autism and spinal cord injury, as well as learning and memory.

tHe FundaMentaLs OF nerve guidanCe and nervOus systeM deveLOpMent Understanding the process of nerve guidance and migration during devel-

opment has been a life-long obsession of Dr. Joseph Culotti. A Senior Investigator at the Lunenfeld and the 2005 recipient of the Barbara Turnbull Award for Spinal Cord Research, Dr. Culotti conducts fundamental research to understand the development and function of the nervous system. In particular, he looks for genes involved in directing the precise growth of neurons, and his research has significant implications for the development of new treatments for spinal cord injury.

“By understanding the mechanisms involved in the development of the spinal cord, we may ultimately be able to replicate it, enabling severed neurons to reconnect and repair an injured cord,” says Dr. Culotti.

To study the nervous system, Dr. Culotti uses the nematode C. elegans, which he describes as “a simplified spinal cord.” Its simplicity makes C. elegans an ideal research model, and Dr. Culotti has discovered startling similarities between the growth of its neurons and those in the human spinal cord. What he learns from C. elegans therefore has great relevance to our understanding of the development and regeneration of the human nervous system.

Working in collaboration with researchers at Johns Hopkins University in 2001, Dr. Culotti found that similar

molecules guide the growing neurons along the same axis in the developing human spinal cord as they do in C. elegans. He and his team were the first to identify a neuron guidance cue called UNC-6 that gives information to growing neurons, in essence telling them which direction to grow. Dr. Culotti’s lab has also identified five new genes involved in forming the paths that guide axons, and has successfully isolated three of these, enabling their in-depth study.

In February 2009, Dr. Culotti published a landmark study in Nature Neuroscience that revealed how opposing chemical signals help define the appropriate positioning of neurons and their axons, with respect to other neurons and supporting cells.

Other projects in Dr. Culotti’s lab involve identifying mutations in homologues of genes known to affect axon guidance in vertebrates.

a FOCus On tHe genetiCs OF epiLepsy, sCHiZOpHrenia, Learning, and COgnitiOn Important insights into the genetics of epilepsy have been revealed through the research of Dr. John Roder, an acclaimed neurobiologist and Senior Investigator at the Lunenfeld who holds a Canada Research Chair in Learning and Memory. An original member of the Molecular

Biotechnology Focus / May 2010

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OntariO

the samuel Lunenfeld research institute of Mount sinai Hospital

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Immunology and Neurobiology Division since the Lunenfeld’s inception in 1985, Dr. Roder has led a prodigious career marked by milestone breakthroughs in neurobiology research.

In August 2009, Dr. Roder published a study offering new evidence that a faulty version of a gene known as ATP1A3 is linked to epileptic seizures in mice.

“The human ATP1A3 gene matches the mouse version of the gene by more than 99 per cent, so we’ve already started to screen DNA samples from epilepsy patients to investigate whether ATP1A3 gene defects are involved in the human condition,” says Dr. Roder.

In addition to research in epilepsy, Dr. Roder has made important discoveries recently in the genetics of learning and cognition. Last summer, he and other investigators discovered a molecular link between intelligence and curiosity, which may lead to the development of new drugs to improve learning. In a September issue of Neuron, Dr. Roder reported the interaction of two proteins in the dentate gyrus, which plays an important role in long-term memory and spatial navigation. They found a molecular link that holds promise for future cognitive therapies.

“If John was a baseball player, he’d be in the Hall of Fame for hitting the ball out of the park so often,” says Jim Woodgett, the Lunenfeld’s Director of Research. “Part of his consistency of success in neuroscience derives from his foresight in applying new genetic techniques to questions of brain function. But John is also one of the most dedicated scientists I’ve known—he is a compulsive thinker.”

Dr. Roder also made national headlines in 2007 for his groundbreaking research in schizophrenia. In a pivotal study, he demonstrated for the first time in mouse models that malfunction of the gene DISC 1, previously associated with schizophrenia and depression, causes symptoms of those disorders. This was the first study to discern a common genetic link between the two illnesses—a discovery he hopes will one day lead to new, more effective treatments for schizophrenia.

“From a psychiatric point of view, this

Biotechnology Focus / May 2010

was important. It could change the way we think about diagnoses, and could open the door to new treatments,” says Dr. Roder.

Dr. Roder is currently exploring the role of neuronal connections (synapses) in a process known as long-term po-

tentiation (LTP), learning and memory using engineered mice that lack specific receptors for neurotransmitters.

His lab is investigating the complex cascade of events that lead to LTP, which is the means by which memory is established.

Ongoing research at the Lunenfeld’s Centre for neurodevelopment and Cognitive Function dr. Mei ZHen

Dr. Mei Zhen, a Principal Investigator who holds a Canada Research Chair in Brain and Behaviour, is investigating the development of synapses. Her goal is a breakthrough in understanding brain development, synapse formation, and ultimately, the onset and treatment of mental illnesses.

Using C. elegans as a model, Dr. Zhen has already identified a number of new genes involved in the development and function of synapses. In the last few years, her lab has discovered novel “ion channel” proteins that affect the communication between neurons and neural circuits, and are also implicated in developmental defects. Her research team and colleagues have also identified several proteins that affect neuron differentiation and growth by re-organizing the products of genes. These findings give researchers a greater understanding of the fundamental cellular mechanisms that affect the molecular and genetic mechanisms underlying cognitive development and function, and are potentially implicated in mental disorders.

In collaboration with other clinical investigators, Dr. Zhen is currently using animal models to understand the development of ciliopathy (a genetic disorder of the cellular cilia, which are the tail-like projections attached to some cells), and neurodegeneration.

dr. saBine COrdes

Dr. Cordes, Senior Investigator, is using molecular techniques and analyses of pre-existing and newly generated mouse mutations to understand early neural development, especially that of the vertebrate hindbrain organization and serotonergic neurons.

Variations in genes required for the development and function of the serotonergic system show particularly strong associations with psychiatric conditions.

Dr. Cordes is interested in identifying new genes required for the development and maintenance of a healthy serotonergic system, with the hope that these will ultimately help improve diagnoses and treatments for mental health patients.

Dr. Cordes is also collaborating with scientists at the Centre for Addiction & Mental Health in Toronto to test what roles any newly identified genes may play in psychiatric conditions such as depression, bipolar disorder, schizophrenia, autism and phobic disorders.

dr. keniCHi OkaMOtO

The work of the Lunenfeld’s newest recruit, Dr. Okamoto, will build onto the Institute’s already leading-edge optical capabilities, with the construction of a new microscope equipped with lasers that allow for simultaneous visualization and manipulation of specific proteins in real time and in live neurons.

Dr. Okamoto’s research focuses on understanding the molecular mechanisms that control brain functions such as learning and memory. His research is at the leading edge of neurobiology and microscopy employing modern laser optics, and his approach to developing specific therapeutics for brain diseases is globally unique.

Dr. Okamoto aims to better understand the relationship between synapses and how they are able to reorganize themselves, such as occurs during learning and new memory formation. His work will provide further insights into the study of brain diseases as well as strategies for neural repair.

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Ontario innovation Hubs

OntariO innOvatiOn HuBs MARS DISCOVERY DISTRICT http://www.marsdd.com

The MaRS Centre is in the Discovery District, between the country’s leading teaching hospitals and three major universities. It is the home to start-ups, mid-size companies, multinationals, investors, researchers, professional, service firms and retailers. With 700, 000 square feet of lab facilities and offices, MaRS has intentionally assembled a powerful mix of organizations to provide the environment for success to stimulate connections, investment and innovation.

OntariO

OTTAWA CENTRE FOR RESEARCH AND INNOVATION LIFE SCIENCES http://www.ocri.ca/lifesciences

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OCRI is Ottawa’s lead economic development agency. OCRI leads the city in sustained economic development to build wealth and enhance our quality of life by nurturing innovation and accelerating entrepreneurial organizations; connecting business, research, education, government and the community; developing and attracting world-class talent and skills; enhancing the quality of education in the region through innovative and collaborative programs; and marketing the region’s capabilities globally.

With over 740 members including start-ups, SME’s, multinationals, research laboratories, academic institutions and government, OCRI promotes sustainable economic development to maintain our high quality of life.

OCRI’s Life Sciences programs address the challenges that face innovative life sciences organizations by helping them advance life sciences and health care research to commercial development; by enabling strategic partnerships and knowledge transfer; and by accessing integrated global networks.

EASTERN LAKE ONTARIO REGIONAL INNOVATION NETWORK http://www.elorin.ca

ELORIN provides business assistance through training, peer-to-peer networks and connections with the right financial and Biotechnology Focus / May 2010

informational resources to reduce business risk and help accelerate growth for new and growing enterprises in Eastern Ontario

GREATER PETERBOROUGH INNOVATION CLUSTER http://www.innovationcluster.ca

The Innovation Cluster is a not-for-profit corporation with a mandate to facilitate an economic environment in which high paying jobs are created, wealth generated, and an increased quality of life established in the Greater Peterborough Area. The Innovation Cluster assists in advancing life sciences, environmental, DNA and other innovative research in the Peterborough, Ontario region to help promote and sustain a strong local knowledge-based economy.

RESEARCH INNOVATION COMMERCIALIZATION (RIC) CENTRE http://www.ric-centre.on.ca

RIC Centre helps new entrepreneurs and seasoned business people take the next great idea to market in the fields of aerospace, advanced manufacturing, life sciences and emerging technology sectors through defined strategic actions: proactively connect industry, academia and investment to gain meaningful results that support commercialization.

GOLDEN HORSESHOE BIOSCIENCES NETWORK http://www.ghbn.org

GHBN is focused on driving innovation, exploiting bioscience resources and strengths, and forging new partnerships that will create jobs and investment. Working within an urban population of more than 1 million, the network has been a main player in funding and piloting a medical-device clinical trials program in Hamilton, building an emerging bioproducts economic cluster in Niagara, and in creating a life sciences coalition in Ontario to support the vital biosciences industry.

ACCELERATOR CENTRE, WATERLOO RESEARCH AND TECHNOLOGY PARK

http://www.acceleratorcentre.com The centre is a co-op consisting of the Federal and Ontario governments, the Regional Municipality of Waterloo, the City of Waterloo and the University of Waterloo. It is the site of a community-based initiative to foster innovation in the region.

SOUTHWESTERN ONTARIO BIOPRODUCTS INNOVATION NETWORK http://www.sobin.ca

SOBIN’s mission is to strengthen the economy of Southwestern Ontario by cultivating new bioproducts, fostering energy conservation and expanding alternative energy sources. SOBIN envisions progressive companies leading the world in growing all facets of the bioproducts industry in Southwestern Ontario leading to a vibrant regional economy.

INNOVATION INITIATIVES ONTARIO NORTH http://www.iion.ca

The vision of IION is to firmly establish itself as the regional ‘go-to’ address for innovation and commercialization at the public-private sector interface, particularly but not entirely exclusively in the areas of Bioscience and Medicine as well as Bioproducts from renewable and sustainable sources.

YORKBIOTECH http://yorkbiotech.ca

YORKbiotech is a catalyst organization within Ontario’s Regional Innovation Network that harnesses the wealth of intellectual, technical and commercial resources in York Region to foster economic development in knowledge-based industries such as Advanced Health Technologies, Biotechnology, Clean-tech, ICT, Digital Media, Pharma Research and Advanced Manufacturing.

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Reply Card #4734

Funded by the Government of Canada's Sector Council Program

Ontario innovation Hubs GUELPH FOOD TECHNOLOGY CENTRE http://www.gftc.ca

GFTC is a non-profit, non-subsidized food technology centre providing technical solutions, training, consulting and auditing services to the Canadian agri-food industry.

THE STILLER CENTRE FOR TECHNOLOGY COMMERCIALIZATION http://www.stillercentre.com

The Stiller Centre for Technology Commercialization, located in UWO’s Research Park, is designed for startup life sciences and technology-based companies. Tenants are offered a range of business network services which include market research, mentoring and operations analysis by BioMBA graduates. With partner organizations, innovation at the Centre is promoted within local, national and international communities, helping bring their innovation to the market place.

WINDSOR-ESSEX ECONOMIC DEVELOPMENT COMMISSION http://www. choosewindsoressex.com

WEEDC seeks to maximize economic diversity, growth and prosperity in the WindsorEssex Region. It also works to connect the region’s industry centres in advanced manufacturing technologies, R&D and engineering, agri-business and food processing and education and tourism.

COMMUNITECH (WATERLOO REGION TECHNOLOGY ASSOCIATION) http://www.communitech.ca

OntariO

Communitech is a industry-led organization driving the growth and success of Waterloo Region’s technology sector through leadership, connections and promotion, with over 550 network members, many of whom are big names in the global technology industry.

32

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION http://www.imagingprobes.ca

The CPDC is located in the McMaster Innovation Park and is the world’s first facility focusing on all areas related to the development of molecular imaging probes – chemical compounds that provide a non-invasive means to diagnose disease at its earliest stage.

Biotechnology Focus / May 2010

GOLDEN HORSESHOE VENTURE FORUM http://www.ghvf.org/home.htm The GHVF is a volunteer-run, non-profit organization aimed at fostering the growth and success of entrepreneurial ventures by creating an environment for them to network with the financial, professional and technical communities.

UNIVERSITY OF TORONTO – MISSISSAUGA CAMPUS http://www.utm.utoronto.ca

The University of Toronto’s Mississauga campus offers one of Canada’s only Master of Biotechnology programs.

WESTERN GTA CONVERGENCE CENTRE http://www.wgtacc.com

The Western Greater Toronto Area Convergence Centre provides resources about health and life sciences as well as biomedical and biotechnological information to the health community. This will encourage both the healthcare professionals, keen learners and everyone else to get involved into forming a healthy society and to further enhance human resource and community health environments.

NSERC INTELLECTUAL PROPERTY MOBILIZATION PROGRAM http://www.nserc-crsng.gc.ca/ professors-professeurs/ rpp-pp/ipM-Mpi_eng.asp MITACS ACCELERATE http://www.mitacs.ca/index. php

A national internship program managed by MITACS which connects companies and other organizations with the vast research expertise in Canada’s universities from applied sciences, engineering, social sciences and business to arts, life sciences and much more. Run in partnership with a consortium of leading Canadian research organizations.

SAULT STE. MARIE INNOVATION CENTRE http://www.ssmic.com

Focused on business incubation, support services to assist small to medium enterprises and market development projects.

NORTHERN ONTARIO ENTERPRISE GATEWAY http://www.noeg.ca

An organization in the North created to stimulate increased investment by Northern Ontario investors into Northern Ontario companies. This is accomplished by improving the flow of investment capital and management expertise into high-growth potential northern companies through the creation of angel investor groups.

INTERNATIONAL CONSORTIUM ON ANTI-VIRALS http://www.icav-citav.ca

An international consortium on anti-virals dedicated to the discovery and development of anti-viral therapies for neglected and emerging diseases, through the international collaboration of scientists, governments and industry.

NATURAL RESOURCES DNA PROFILING AND FORENSIC CENTRE http://web.nrdpfc.ca

The centre strives to compile genetic information on many species of plants and animals in the Canadian ecosystem.

LAWSON HEALTH RESEARCH INSTITUTE http://www.lhrionhealth.ca

Lawson is one of the largest hospital-based research institutes in Canada and is the research arm of the London Health Sciences Centre and St. Joseph’s Health Care.

GUELPH PARTNERSHIP FOR INNOVATION http://www.guelphinnovation. com

Guelph Partnership for Innovation uses the combined power of business, research and the public sector to build technologybased business in Canada’s most dynamic ag-bio region with strength in biomaterials, bio-based energy, nutraceuticals, functional foods, cleantech and related bio-based technology. Using cutting-edge tools from biotechnology and information sciences, Guelph has a global reputation as an agbio powerhouse, developing and commercializing healthier foods and nutraceuticals to reduce health care costs, creating novel materials for the auto and other industries and capturing bio-based energy to reduce reliance on petroleum and shrink carbon footprints, and using engineered life forms to clean up air, soil and water.

Reply Card #4735

By Carmela DeLuca and Micheline Gravelle

No Longer Under the Sun

BRCA Gene Patents Held Not Patentable in the US

O

n Monday March 29th, 2010, in a highly anticipated decision, the U.S. District Court of the Southern District of New York ruled in favour of the plaintiffs in Association of Molecular Pathology et al v. U.S. Patent and Trademark Office et al., No. 09-CIV4515 (“BRCA”), granting partial summary judgment and finding the claims in several patents on BRCA1 and BRCA2 invalid for encompassing non-statutory subject matter.

The plaintiffs included the American Civil Liberties Union (ACLU), various medical 34 BIOTECHNOLOGY FOCUS MAY 2010

organizations, the Public Patent Foundation (PUBPAT), breast cancer and women’s groups, and various doctors, researchers and individuals diagnosed with breast cancer.

The defendants included the United States Patent and Trademark Office (USPTO) and Myriad and the University of Utah Research Foundation. Defendant Myriad owns or licenses the seven patents that were at issue.

The subject patents included claims directed to 1) isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence and 2) methods for “comparing”

Intellectual Property

or “analyzing” BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer or screening for potential cancer therapeutics. Both types of claims were found invalid for including unpatentable subject matter.

The Court rejected Myriad’s argument that purification of naturally occurring compounds that do not exist in nature in pure form renders such compounds patent eligible. According to the Court, purification of a product of nature, without more, cannot transform the product into patentable subject matter - the claimed invention must possess “markedly different characteristics.” The Court found that “in light of DNA’s unique qualities as a physical embodiment of information,” structural and functional differences cited by the defendants between native and the claimed isolated DNA do not render the claimed DNA “markedly different.” Isolated DNA “containing” naturally occurring sequences were found unpatentable.

In addition to impacting patenting of isolated nucleic acids corresponding to naturally occurring gene sequences, this decision may be problematic for claims directed to primers and/or probes. The Court, in rejecting Myriad’s argument that isolated DNA is markedly different since it may be used as a probe or primer, indicated that the basis for this utility is primarily a function of the nucleotide sequence identity between native and isolated BRCA1/2 DNA (BRCA, page 131). It is unclear on the above reasoning if chimeric or optimized (e.g. codon optimized) nucleic acid molecules and/or labeled primers and probes whose utility is primarily a function of the nucleotide sequence identity between the native and modified sequence, will similarly be found unpatentable in the event that the decision is upheld.

According to the Court, the decision is directed to naturally occurring DNA sequences and does not impact the patent eligibility of other isolated naturally occurring biomolecules. The Court explicitly stated that its decision did not extend to other molecules occurring naturally in the body and capable of conveying information, such as adrenaline (BRCA, page 124).

Contested diagnostic method claims were found invalid under the “machine or transformation” test pronounced In re Bilski 545 F.3d 943 (Fed. Cir. 2008). The Court found that because “the claimed comparisons of the DNA sequence are abstract mental processes,

Intellectual Property

they also constitute unpatentable subject matter.” The Court distinguished the in-suit claims, to therapeutic claims found allowable in Prometheus Laboratories Inc. v.

Mayo Collaborative Services (Case No. 2008-1403 (Fed. Cir. 2009).

In Prometheus, the “determining” step had been found to be transformative since determining the levels of the claimed metabolites in a subject necessarily involves a transformation as those levels cannot be determined by mere inspection. The Court added that the “determining” step in Prometheus was construed to include the extraction and measurement of metabolite concentrations. The subject claims in contrast were directed to “comparing” and “analyzing” gene “sequences.” The Court acknowledged, while the purpose of the claimed method was, for example, to “detect a germline alteration in a BRCA1 gene,” the method actually claimed was “analyzing a sequence of a BRCA1 gene.” “Analysing” a sequence and/or “comparing” a sequence can arguably be carried out by mere inspection e.g. where the sequences have already been determined, suggesting an unfortunate choice of claim terms may have provided a technical argument to ground invalidity of these claims. Claim terms “from a human subject” or “from a nontumor sample” were found to specify the identity of the DNA or RNA sequence to be “analysed” or “compared” and not as establishing a physical transformation associated with obtaining DNA from those sources. The Court alluded to claim elements that would be allowable suggesting diagnostic method claims using isolated DNA, if carefully crafted, are patentable subject matter in the U.S. More surprisingly, a method claim to identifying potential cancer therapeutics by utilizing cells modified to comprise an altered BRCA1 gene, was also invalidated on the ground that it sought to patent a basic scientific principal even though it arguably included transformative steps. The basic scientific principle according to the judge is “that a slower rate of cell growth in the presence of a compound indicates that the compound may be a cancer therapeutic.”

The claim in question however employs a “transformed” eukaryotic host cell contain-

ing an “altered BRCA1 gene” and involves growing the transformed eukaryotic host cell in the presence and absence of a compound suspected of being a cancer therapeutic, determining the rate of growth of the host cell in the presence and absence of the compound and comparing the growth rate of the host cells, wherein a slower rate of growth of the host cell in the presence of the compound is indicative of a cancer therapeutic.

The claim would seem more accurately described as an application of a particular fundamental principle, e.g. the application being to cells comprising an altered BRCA1 gene, which according to the judge’s own recitation of dicta, is patent eligible under the Bilski machine or transformation test (BRCA, page 136).

The constitutional claims against the USPTO were dismissed without prejudice, as the claims were held invalid as containing nonpatentable subject matter. The Court noted that “a decision by the Federal Circuit or the Supreme Court affirming the holding … would apply to both the issued patents as well as patent applications and would be binding on all patent holders and applicants as well as the USPTO.” The immediate effects of the decision may be circumscribed – the decision is for now

limited to the Southern District of New York and to the specific patent claims at issue in the case. Whether the decision will have any affect on Myriad’s position in the marketplace is also unclear. Although 15 claims in seven BRCA patents owned or licensed by Myriad were found invalid, the remaining 164 claims in these patents were not. Further, Myriad licenses or owns 16 other patents relating to its BRCA tests that were not challenged.

The decision may however open flood-gates to additional gene patent challenges.

Not surprisingly, Myriad has already announced its intention to appeal the decision to Court of Appeals for the Federal Circuit. If upheld, this decision could jeopardize issued patents that claim isolated nucleic acids that contain naturally occurring sequences and methods using these nucleic acids that do not meet the Bilski machine or transformation test. The invalidity of the method claims could however be short lived. The U.S. Supreme Court is expected to hand down its decision in Bilski any day now. If overturned, the basis for invalidity of the BRCA method claims would no longer exist calling into question the longevity of the BRCA decision.

In any case, the decision appears to move away from the long held view that “any thing under the sun” is patentable in the U.S. For now at least, the invalidated BRCA gene patent claims are sheltered from the sun.

Carmela DeLuca, Ph.D. (Exp. Med.), J.D. is an associate lawyer with Bereskin & Parr LLP’s Biotechnology and Pharmaceutical Practice group. Carmela can be reached in Toronto at 416.957.1619 or cdeluca@bereskinparr.com.

Micheline Gravelle, B.Sc., M.Sc. (Immunology) is the leader of Bereskin & Parr LLP’s Biotechnology and Pharmaceutical Practice group. Micheline can be reached in Toronto at 416.957.1682 or mgravelle@bereskinparr.com.

For more intellectual property information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca

MAY 2010 BIOTECHNOLOGY FOCUS 35

CALENDAR MAY 2010

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May 17-18 Discovery 2010 Venue: Toronto, ON Contact: Catharine Ogilvie Tel: (416) 861-1092 Ext. 1019 Email: catharine.ogilvie@oce-ontario.org Web: http://www.oce-ontario.org

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May 29-June 2 The 93rd Canadian Chemistry Conference

Company & Advertiser Index

SRC101

COMPANY

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print

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Institute.................................... 6.........................

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

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Bereskin & Parr.............................9...................4724

Name:_________________________________Title: ____________________________________

Biovail Corporation................... 9.........................

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Cangene Corp........................... 6.........................

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TITLE 50 51 52 53 54 55

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

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McGill University.........................10..................4725 McMaster......................................33..................4735 Medicago Inc............................. 6.........................

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Reply Card #4736

THE LAST WORD

By Ulrich Krull

The extent of miscibility

of Canadian universities and commercialization

Ulrich Krull is appointed as a Professor of Analytical Chemistry and holds the endowed AstraZeneca Chair in Biotechnology at the University of Toronto.

At present he handles the portfolio of VicePrincipal: Research at the University of Toronto Mississauga, and serves as an editor for the Elsevier journal Analytica Chimica Acta. His research interests are in the areas of biosensor and diagnostic technologies.

The role of Canadian universities in commercialization continues to generate substantial debate, prompted by signals from government and industry about a need to directly contribution to economic competitiveness and prosperity. With a mandate to broadly teach about and explore sciences, social sciences and humanities, from a platform that protects freedom of ideas and that stimulates debate, a purist might view the fundamental aspirations of universities to be contradictory to the competitive world of commercialization. It is intriguing though that most every academic will indicate that they personally are innovative, and to note that the process of commercialization is one form of innovation. Innovation is described as the reduction of creativity into something of practical relevance, be it a new product, a new policy, or some other outcome. It is the bridging from creative idea to reduction to practice that lies at the root of the tension that universities experience in the process of commercialization.

The participation of universities in commercialization reflects a gradient of activities, largely driven by the actions of individuals who have specific expertise, and sometimes with efforts towards coordination by means of a central administrative structure. From activities including the filing of patents and licensing of intellectual property, to equity positions, leasing of space to spin-off initiatives, consulting, and contract research, universities have become involved in a spectrum of activities that support commercialization. It is clear that a significant amount of activity is in place across the country – so why is there a sense that while universities are open, they are not really “open for business”. This may have roots in the lack of a consistent appreciation about what activities are appropriate and welcome. It is crucial to realize that a response to this suggestion cannot be based on “one size fits all”. For example, the differences in university policies of ownership of intellectual property immediately sets conditions regarding how industry, inventors and a university can align for partnerships. It is also the case that universities by virtue of their talent pools are particularly adept at creativity, with innovation appearing frequently only in some subject areas, and commercialization typically representing one avenue of innovation in which universities tend to have less experience.

Examining a snapshot that reflects current conditions suggests that there is a path in this evolutionary process that would safeguard the academic mission while promoting opportunity to support socio-economic development.

This path is suggested by a fundamental truism of commercial success – focus on core competency. Industry has the “know how” and talent to drive commercialization, and industry should lead in these initiatives. Universities offer a wealth of creativity and a healthy appetite

to innovate, offering a pipeline for commercialization.

Suggesting that commercialization should be a mandate handed to universities does not at this juncture represent an activity that builds on a core competency.

Alignment of research outcomes with commercialization activities is deemed to be an obvious need by critics of the present system, but the connection of universities with industry remains ineffective in the absence of an attractive bridging mechanism. The functional elements of such a mechanism arise from the opportunity that universities have to identify novel developments within their operations, and to subsequently become active in the protection and promotion of innovations. An efficient mechanism that offers awareness for those in industry to evaluate and access advantageous technologies and processes represents an investment that both universities and industry can embrace.

Perhaps one of the most effective developments that universities might consider in partnership with industry and government is the creation of a national intellectual property network/pool, with business development officers that can both identify synergistic technologies and also connect with industry to promote these opportunities for scrutiny. A noteworthy fundamental limitation at present is that universities have tended to operate as individual agents in competition, which creates a situation where synergies between technological developments cannot be identified. An initiative to pool intellectual property resources would set in motion opportunity for improved attraction of funding in Canada, and improved potential for commercial impact by virtue of the depth of technological innovation that is made possible by bundling of technologies. This notion of institutions partnering to achieve advantage in terms of collective impact of intellectual property is being explored by “MaRS Innovation”. In an experiment supported by the Government of Canada through the Networks of Centres of Excellence program, 14 different academic institutions, hospitals and commercialization operations in the Greater Toronto Area have created a partnership that seems to be uniquely positioned to bundle technology assets, and through this, to develop solutions to address market opportunities. Imagine the power of such an approach if the creativity at universities could be accessed and aligned across our country. I am eagerly looking forward to seeing data from the prototype represented by MaRS Innovation.

@

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