Biotechnology Focus November 2012

NOVEMBER 2012

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

VOLUME 15, NUMBER 10

Maximizing the impact of

NEUROSCIENCE COLLABORATION, INTEGRATION AND ENTREPRENEURSHIP

Publication Mail Registration Number: 40052410

World’s finest genomics minds set to hit Canada

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contents NOVEMBER 2012 – VOLUME 15 – NUMBER 10

12

12

Maximizing the impact of Neuroscience

Mitomics Inc. is pioneering the next generation of molecular testing

FEATURES Maximizing the impact of Neuroscience What do a physicist, neuroscientist and engineer have in common? If you ask the Ontario Brain Institute: good ideas.

(By Alison Fenney)

Opinion

16 The promise and power of genomics The world’s finest genomics minds are coming to Ottawa as part of a special commemorative event (By Shawn Lawrence)

24 Spotlight

The business of monoclonal antibody production (By Michael Butler)

DEPARTMENTS 6

Research news

9

Business corner

IN EVERY ISSUE

19 Innovator

In the world of early disease detection Mitomics Inc. is pioneering the next generation of molecular testing (By Daniela Fisher)

28 new products 29 Calendar of events

22 Across Canada

6 R&D News

Orphanet-Canada online portal launched

www.biotechnologyfocus.ca

Techna: the new research and development institute of the University Health Network is looking to advance technology for the health sector (By Luke Brzozowski)

30 The Last Word

Building a better biotechnology mousetrap (By Raphael Hofstein) NOVEMBER 2012 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

November is upon us, and with it comes the exciting news of the launch of our new website www.biotechnologyfocus.ca, a fresh new take on covering Canada’s biotech sector. We’ve redesigned our site entirely, making it easier to read and navigate with a more user-friendly theme. For many years, you’ve known Biotechnology Focus as a print magazine. As we enter the digital world, we’re offering you the same high quality print coverage on the web.

Visitors to the site can stay on top of breaking biotech news, learn insights from industry insiders, and read up on future trends.

Here at Biotechnology Focus, we are expanding our focus to include all facets of biotechnology. We’ve retooled our web portals into six categories or communities that encompass a broader range of biotech applications. These new communities are: Agri-Food, Bio-Medical, Bio-Pharma, Clean Tech, Healthcare and Industry Intel.

Readers can find coverage of drug discovery, development and commercialization in our Bio-Medical and Bio-Pharma categories. Our Healthcare section focuses on recent innovations or progress in Canada’s healthcare system, and the Clean Tech portal zeroes in on environmental news and technologies. Also new is Industry Intel which looks at people on the move in Canada’s biotech sector, from the latest business deals and appointments to insider info from industry leaders and innovators.

Also prominently featured, are sections devoted to our various social media, from YouTube to Twitter and Facebook, and an interactive calendar of biotech events occurring across Canada.

You can also find out about the latest news by signing up for our eBulletin newsfeed, which provides you with up-to-the-minute industry news across all communities.

To enhance your Biotechnology Focus experience, you can sign up for a premium membership and receive a package deal of subscriptions to our print and digital magazines, as well as our e-Newsletter that highlights insightful articles not featured in the magazine, and all of our online archived stories from previous issues of the magazine. You can also join the Biotechnology Focus community by signing up for a free membership to the site, which allows you to enter the discussion and comment on articles on the site, and access the month’s digital edition.

We have entered a new era here at Biotechnology Focus, and are excited to share our new website with you. We hope you take the chance to check us out online at www.biotechnologyfocus.ca.

Shawn Lawrence

Daniela Fisher

CONTRIBUTING WRITERS

Alison Fenney

Luke Brzozowski

Michael Butler

Raphael Hofstein

National Account Manager

Marcello Sukhdeo

GRAPHIC DESIGNER

Come check us out!

Surf our way

Terri Pavelic

CONTROLLER MARKETING MANAGER

Elena Pankova John R. Jones Mary Malofy

CIRCULATION DIRECTOR James Watson circulation@promotive.net Tel: 705-812-0611

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

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

4 BIOTECHNOLOGY FOCUS NOVEMBER 2012

R & D NEWS Orphanet-Canada online portal launched

Clinical Trials & Patents n CO2 Solutions Inc. (Québec, QC) has been granted U.S. Patent 8,277,769, for its process treating carbon dioxide containing gas. The patent broadly covers the use of the enzyme carbonic anhydrase (CA), or an analogue thereof, for the efficient capture of carbon pollution from various gas streams with any aqueous solvent or solution. Significant industry applications of the patent for carbon management include power generation, oil refining, metals production, cement making, amongst others.

Critical Outcome Technologies Inc. (London, ON) announces that a number of preclinical tests that it initiated earlier this year have been successfully completed for the CHEMSAS® derived drug candidates synthesized for its acute myelogenous leukemia (AML) program. The compounds were evaluated for their in vitro effectiveness, kinase targets and in vitro ADME/Tox properties. A number of the compounds were found to be active in multiple leukemia cell lines including human cell lines with the FLT3 mutant kinase which is found in 40 per cent of AML cell lines. Evaluation of kinase screening results from two independent labs confirmed in vitro activity against FLT3 mutant kinase as well as wild type FLT3 kinase. The in vitro ADME/Tox screen did not identify any liabilities that would preclude further development of the compounds. As the next step in the program, the company is undertaking a detailed assessment of the test data to identify a potential lead and back up compound prior to proceeding with the determination of maximum tolerated dose (MTD) and animal studies.

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Lab technician Megan Vanstone, Minister Aglukkaq, and Sean Grover, a young patient with a rare disease, conduct a lab test. (CNW Group/Health Canada) Canada Minister of Health Leona Aglukkaq recently announced two initiatives aimed at bringing new hope to Canadians with rare diseases and sparking new approaches for the authorization of “orphan drugs” by launching Orphanet – a comprehensive database of information and services for rare diseases.

Minister Aglukkaq said Orphanet will better support the development and authorization of drugs for rare diseases and assist patients in finding the information and services they need.

A rare disease is a life-threatening, seriously debilitating, or serious chronic condition that only affects a very small number of patients. It’s estimated that there are over 7,000 unique rare disorders, many of which are genetic. While some of these rare disorders may affect only a handful of Canadians, in all hundreds of thousands of Canadians are dealing with these conditions and need effective treatments. Drugs used to treat rare diseases are often referred to as orphan drugs. Today, when an orphan drug is not available in Canada, the patient’s doc-

tor can apply individually for each patient through Health Canada’s Special Access Programme. While facilitating access - the current approach also represents a significant burden to the healthcare system. A regulatory framework designed and used specifically to approve drugs to treat small, vulnerable populations will more effectively address this need. A key focus of this new approach will be on international information-sharing and collaboration for the development and regulation of orphan drugs.

The new framework will be designed to spur research and innovation in Canada.

Building on existing international experience and knowledge, it will provide Health Canada with new tools to gather and share information, including the registration of clinical trials. It will also facilitate patient participation in this highly specialized area.

Orphanet-Canada was launched with support from the Canadian Institutes of Health Research.

To see this story online visit http://biotechnologyfocus.ca/?p=2110

$48M for health research in BC The B.C. government has invested $48 million into an 11-year-old institution that supports health research for diseases such as ovarian cancer and childhood diabetes.

The Michael Smith Foundation for Health Research (MSFHR), named after Dr. Michael Smith — a preeminent B.C. scientist who won a Nobel Prize for chemistry in 1993, funds research teams and services to support scientists across the province studying diabetes, ovarian cancer 6 BIOTECHNOLOGY FOCUS NOVEMBER 2012

and the management of chronic diseases.

In its first decade, the foundation has funded more than 1,800 research-related positions, including 1,491 researchers funded directly. These positions range from students through to well-established researchers who have created strong research programs to address critical health issues.

To see this story online visit http://biotechnologyfocus.ca/?p=2197

Sanofi (Toronto, ON) and its subsidiary Genzyme announce that key data from the TOWER trial was presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In the study, once-daily, oral AUBAGIO® 14 mg significantly reduced the annualized relapse rate and slowed progression of disability in patients with relapsing forms of multiple sclerosis (MS) compared to placebo.

In addition, the proportion of patients treated with AUBAGIO® who were relapse-free was significantly higher compared to placebo.

TOWER (Teriflunomide Oral in people With relapsing multiplE scleRosis) is a randomized, double-blind Phase 3 trial that enrolled 1,169 patients with relapsing MS across 26 countries and compared 7 mg or 14 mg once-daily, oral AUBAGIO against placebo. The company announced positive top-line results in June.

In September, the FDA approved AUBAGIO as a once-daily oral treatment for patients with relapsing forms of MS.

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For more R&D news visit http://biotechnologyfocus.ca/?cat=71

R & D NEwS

Dr. Michael Hill

Canadian team reports world’s first successful clinical trial to protect the brain from stroke A team of Canadian scientists and clinicians, led by Dr. Michael Hill of the Calgary Stroke Program at Foothills Medical Centre and University of Calgary’s Hotchkiss Brain Institute (HBI), have demonstrated that a neuroprotectant drug, developed by Dr. Michael Tymianski at the Krembil Neuroscience Centre, located at the Toronto Western Hospital, protects the human brain against the damaging effects of stroke.

The study, “Safety and efficacy of NA-1 for neuroprotection in iatrogenic stroke after endovascular aneurysm repair: a randomized controlled trial,” published online in The Lancet Neurology, was conducted concurrently with a laboratory study published in Science Translational Medicine, that predicted the benefits of the stroke drug.

This landmark clinical trial was a randomized, double-blinded, multi-centre trial that was conducted in Canada and the U.S. The study evaluated the effectiveness of NA-1[Tat-NR2B9c] when it was administered after the onset of small strokes that are incurred by patients who undergo neurointerventional procedures to repair brain aneurysms. This type of small ischemic stroke occurs in over 90 per cent of aneurysm patients after such a procedure, but usually does not cause overt neurological disability.

In the clinical trial, patients were randomized to receive either Tat-NR2B9c or placebo. Those treated with Tat-NR2B9c showed a reduction in the amount of brain damage sustained as a result of the aneurysm repair procedure. Also, in patients who had ruptured brain aneurysm, which comprise a population of patients at very high risk of neurological damage, those treated with TatNR2B9c all had good neurological outcomes, whereas only 68 per cent of those treated with placebo had good outcomes.

“The results of this clinical trial represent a major leap forward for stroke research,” said Dr. Hill. “There have been over 1,000 attempts to develop such drugs, which have failed to make the leap between success in the lab and in humans.”

“This clinical trial is, to our knowledge, the first time that a drug aimed at increasing the resistance of the brain to stroke has been shown to reduce stroke damage in humans. No efforts should be spared to develop it further,” said Dr. Michael Tymianski, who oversaw the development of Tat-NR2B9c from its invention in his lab through to clinical trials.

Currently, t-PA is the only widely approved acute stroke therapy.

It works by unblocking the arteries to the brain. However, this treatment is only beneficial for a portion of stroke victims. It also has serious potential for side-effects, including bleeding in the brain.

“Through our lab research and clinical trial, we now have a better method of predicting whether a stroke drug may be effective in humans and we now have the evidence that there is a neuroprotectant that can prevent damage in the brain caused by reduced blood flow,” said Dr. Tymianski, inventor of NA-1 and one of the study’s authors. “The benefits of this can be explored not only for stroke, but for other conditions such as vascular dementia.”

To see this story online visit http://biotechnologyfocus.ca/?p=2183

The Voice of

Life Sciences in Ontario

Capitalizing on Life Sciences In Ontario Thursday, December 13th, 2012 8:30am – 5:30 pm MaRS Centre, Auditorium 101 College Street, Toronto, ON For the program and registration visit: www.lifesciencesontario.ca In partnership with

Success A CELEBRATION OF

Annual

Awards

Gala

Dinner

Wednesday February 27th, 2013 Liberty Grand ŸExhibition Place ŸToronto For Sponsorship & Table Sales Contact the LSO Office "Diversity of Members, Unity of Voice” Our mission is to represent and promote the economic and social benefits of Ontario’s life science technologies and encourage their commercial success globally.

For more information on becoming an LSO Member or Partner, please contact us:

admin@lifesciencesontario.ca

P: 416-426-7293

www.lifesciencesontario.ca NOVEMBER 2012 BIOTECHNOLOGY FOCUS 7

R & D NEWS Scientists deepen genetic understanding of MS Five scientists, including two from Simon Fraser University, have discovered that 30 per cent of our likelihood of developing Multiple Sclerosis (MS) can be explained by 475,806 genetic variants in our genome.

Genome-wide Association Studies (GWAS) commonly screen these variants, looking for genetic links to diseases.

Corey Watson, a recent SFU doctoral graduate in biology, his thesis supervisor SFU biologist Felix Breden and three scientists in the United Kingdom have just had their findings published online in Scientific Reports, a sub-publication of the journal Nature.

An inflammatory disease of the central nervous system, MS is the most common neurological disorder among young adults.

Canada has one of the highest MS rates in the world. Watson and his colleagues recently helped quantify MS genetic susceptibility by taking a closer look at GWAS-identified variants in the major histocompatibility complex (MHC) region in 1,854 MS patients.

The region has long been associated with MS susceptibility.

The MS patients’ variants were compared to those of 5,164 controls, people without MS. They noted that eight percent of our 30-per-cent genetic susceptibility to MS is linked to small DNA variations on chromosome 6, which have also long been associated with MS susceptibility. The MHC encodes proteins that facilitate communication between certain cells in the immune system.

Outside of the MHC, a good majority of genetic susceptibility can’t be nailed down because current studies don’t allow for all variants in our genome to be captured.

“Much of the liability is unaccounted for because current research methods don’t enable us to fully interrogate our genome in the context of risk for MS or other diseases,” says Watson.

The researchers believe that one place to look for additional genetic causes of MS may be in genes that have variants that are rare in the population. “The importance of rare gene variants in MS has been illustrated in two recent studies,” notes Watson, now a postdoctoral researcher at the Mount Sinai School of Medicine in New York. “But these variants, too, are generally poorly represented by genetic markers captured in GWAS, like the one our study was based on.”

To see this story online visit http://biotechnologyfocus.ca/?p=2194 8 BIOTECHNOLOGY FOCUS NOVEMBER 2012

Cholera discovery could revolutionize antibiotic delivery Three Simon Fraser University scientists are among six researchers who’ve made a discovery that could help revolutionize antibiotic treatment of deadly bacteria. Lisa Craig, Christopher Ford and Subramaniapillai Kolappan, SFU researchers in molecular biology and biochemistry, have explained how Vibrio cholerae became a deadly pathogen thousands of years ago.

V. cholerae causes the diarrheal disease cholera, which is endemic in many developing countries and can emerge in regions

SFU associate professor Lisa Craig is one of three SFU researchers involved in a new international study that could help revolutionize antibiotic treatment of deadly bacteria.

devastated by war and natural disasters. An outbreak following the 2010 earthquake in Haiti has killed at least 7,500 people. Two genes within V. cholerae’s genome make it toxic and deadly. The bacterium acquired these genes when a bacterial virus or bacteriophage called CTX-phi infected it.

The SFU researchers and their colleagues at the University of Oslo and Harvard Medical School propose that a Trojan horse-like mechanism within V. cholerae enabled CTX-phi to invade it. The CTX-phi latches onto a long, hair-like pilus filament floating on the surface of V. cholerae. The filament then retracts, pulling the toxin-gene-carrying CTX-phi inside the bacterium where it binds to TolA, a protein in the bacterial wall.

The process transforms V. cholerae into a deadly human pathogen.

The Journal of Biological Chemistry has just published a paper written by the researchers describing the atomic structures of the CTX-phi protein pIII alone and bound to V. cholera TolA. The authors recommend that pilus filaments be explored further as a transport mechanism to deliver antibiotics into a bacterium.

To see this story online visit http://biotechnologyfocus.ca/?p=2199

Baxter and MaRS Innovation Form Strategic Partnership Baxter International Inc. and MaRS Innovation have entered into a strategic partnership to commercialize early-stage technologies that present innovative methods in therapeutics and drug discovery technologies.

Through the partnership, Baxter and MaRS Innovation will identify investment opportunities emerging from well-validated scientific research discoveries within MaRS Innovation’s 16 member institutions, including the University of Toronto and its nine affiliated teaching hospitals. Baxter will provide up to U.S. $1 million in funding over a three-year period to support promising individual projects based on their positive due diligence, which will be leveraged with financial support from MaRS Innovation.

The hope says Dr. Rafi Hofstein, president and CEO of MaRS Innovation is the combined support will accelerate the development and validation of healthcare technologies within the largest academic cluster in Canada.

“This partnership is another testament to the excellence in the innovation pipeline that MaRS Innovation’s members represent. Baxter is a significant global player in delivering healthcare technologies. We are excited that they view the Ontario ecosystem as a hub of innovation for development and commercialization. Partnerships like this one represent a significant opportunity to not only attract financial resources, but also expertise and market validation for technology development,” he said.

“We value this opportunity to partner with Ontario’s leading universities and research institutions through MaRS Innovation to advance innovative technologies and product platforms that have the potential to improve outcomes for patients, while contributing to reducing the total cost of care,” commented Norbert G. Riedel, PhD, chief science and innovation officer for Baxter.

To see this story online visit http://biotechnologyfocus.ca/?p=2186

BUSINESS CORNER Health Canada lifts hold on Novartis flu shots

John Dorsey, head, Vaccines and Diagnostics at Novartis Pharmaceuticals Canada Inc. receives Agriflu® influenza vaccine. (CNW Group/Novartis Pharmaceuticals Canada Inc.) Novartis Pharmaceuticals Canada Inc. is resuming distribution of two seasonal influenza vaccines in Canada, Fluad® and Agriflu®, following the announcement by Health Canada that it has completed its review of safety information for Agriflu® and Fluad® and is releasing the two vaccines for immediate use. As a precautionary step, Health Canada had asked Novartis to suspend distribution of Agriflu® and Fluad® on October 26, 2012.

Health Canada indicated it looked at the results of its own testing, conducted a health risk assessment, and reviewed infor-

mation from its European partners as well as data submitted by Novartis in making its decision. None of the information reviewed

by Health Canada indicated a safety issue.

Novartis anticipates no further interruption for those customers relying on Novartis vaccines.

“We have remained confident in the safety and efficacy of our vaccines. We are pleased that Health Canada’s assessment confirms this today and we can resume shipments to customers,” said John Dorsey, head, Vaccines and Diagnostics at Novartis Pharmaceuticals Canada Inc. “This resumption of supply will enable healthcare professionals to keep immunizing people against seasonal influenza.”

The Public Health Agency of Canada is now advising health care professionals in possession of these vaccines that they can start using them once again. The Public Health Agency of Canada closely monitors vaccination-related adverse events and, to date, it has received no reports of serious or unexpected adverse events related to these vaccines. The Public Health Agency of Canada and Health Canada will continue to work with Novartis to monitor the safety and effectiveness of the vaccines used here in Canada.

Should a safety concern be identified immediate and appropriate action will be taken.

To see this story online visit http://biotechnologyfocus.ca/?p=2201

MedMira successfully concludes debt restructuring MedMira Inc., a developer of rapid diagnostic technology and solutions has completed debt settlement arrangements with its debt holders and is no longer in a default position on any of its loans.

Building on a debt reduction of $11,834,592 completed in June 2012, the company paid an additional $312,992 to eliminate a further $1,021,503 in debt.

The company has continued to improve its financial position with these new debt holder agreements that will see interestonly payments during the current fiscal year. Going forward, MedMira will be subject to no debt interest rates above three per cent.

NOVEMBER 2012 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Economic impact of Canada’s pharmaceutical sector exceeds $3 billion Three new reports released by Canada’s Research-Based Pharmaceutical Companies (Rx&D) provide a combined snapshot of the enormous impact the discovery and development of innovative new medicines play in the lives of people across the country.

The reports—prepared independently by KPMG, RiskAnalytica and SECOR—were commissioned by Rx&D to get a firmer understanding of the health and economic benefits generated by research-based pharmaceutical companies in Canada. They contain the first new data set detailing the economic and social impact of Canada’s innovative pharmaceutical industry in five years.

“Our investments help Canadians feel better and stay healthy, allowing them to keep working so they can continue to provide for their families and contribute to a more productive Canadian economy,” said Rx&D president Russell Williams. “At the same time, these investments ease the burden on our healthcare system and ensure that safe, effective medical care is available when people need it.”

Not only do these medicines save lives, prevent illness and ease chronic pain, the reports also detail a combined investment

of more than $1 billion last year in research into innovative medicines, and a total contribution of at least $3 billion to Canada’s economy.

Critical new findings delivered by the three reports include: • Canada’s research-based pharmaceutical companies invested more than $1 billion last year in research into innovative new medicines.

• This work contributes more than $3 billion to the Canadian economy and supports 46,000 well-paying jobs.

• Since January 2011, pharmaceutical companies invested nearly $1.5 billion into research infrastructure across the country.

• Last year product donations to patients through compassionate use and special access programs increased by 47 per cent—to $133 million, up from $90 million.

• Over 3,000 clinical trials are currently underway in Canada, which represents an investment of roughly $750 million into Canadian communities and provides patients and medical professionals access to new, potentially life-saving medications.

• New therapies give Canadians increasingly customized care that meets their needs by using family history and details about individual habits and lifestyle to identify the most effective personalized treatment.

The three reports have been streamlined into one document that outlines the current picture of research-based pharmaceutical companies’ contributions to Canada.

“Saving Lives - Transforming Care” is available at www.canadapharma.org.

To see this story online visit http://biotechnologyfocus.ca/?p=2077

Dealmakers n Toronto’s Humber River Regional Hospital (HRRH) and GE Healthcare (Mississauga, ON) announce a 15-year agreement that will implement a Managed Equipment Services (MES) to provide long term, sustainable access to innovative medical equipment and services.

The MES will provide HRRH a strategic approach to the ongoing acquisition, replacement and maintenance of hospital technology across a wide array of programs: surgery; cardiac care; diagnostic imaging and more. This model will help the hospital to further enhance the quality of care it currently provides. Humber’s patients will benefit from access to the latest in medical equipment to improve both quality and safety of care. The MES agreement covers approximately 1,320 pieces of equipment. HRRH expects that this new approach to the acquisition of critical equipment will save the hospital approximately $20 to 25M ($CA) over the 15-year term. n Mitomics (Thunder Bay, ON) announces an agreement with Laboratory Corporation of America® Holdings (LabCorp®)(Burlington, NC). Under the agreement, urologists will be able to order Mitomics’ flagship laboratory

10 BIOTECHNOLOGY FOCUS NOVEMBER 2012

test, the Prostate Core Mitomic Test™ (PCMT), through DIANON Systems, Inc., a specialized laboratory subsidiary of LabCorp focusing on anatomic pathology, including uropathology.

The PCMT was developed by Mitomics and will be performed at Mitomics CLIA laboratory in Aurora, Colorado.

The merger of Tornado Medical Systems (TMS) and Arjae Spectral Enterprises (ASE) has been approved by the shareholders of both companies. The new entity, Tornado Spectral Systems (Ithaca, NY), will continue to provide the industry with innovative optical spectroscopy products for the defense and security, environmental, biomedical, and industrial markets. Conventional optical dispersive spectroscopy has been constrained by the trade-off between light throughput and spectral resolution. Tornado Spectral’s proprietary High Throughput Virtual Slit (HTVS) technology overcomes this trade-off to deliver high resolution and high throughput simultaneously. Tornado is also developing ground-breaking OCT (optical coherence tomography) on chip technology.

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Paladin Labs Inc. (St. Laurent, QC) has en-

tered into a licensing and distribution agreement with Dynamiclear Australia, an Australian-based natural healthcare company, under which Paladin receives the exclusive rights to market and sell Dynamiclear Rapid™ in Canada.

Dynamiclear Rapid™ is a novel, over-the-counter product for the symptomatic treatment of cold sores. In addition, Paladin also received an option to acquire the same territorial rights to Dynamiclear’s antiviral formulation for Herpes Simplex Virus-2 infections which is currently under development. Financial details related to the agreement were not disclosed. n Valeant Pharmaceuticals International, Inc. (Montréal, QC) and Medicis Pharmaceutical Corporation have entered into a definitive agreement under which Valeant will acquire all of the outstanding common stock of Medicis for $44.00 per share in cash. The transaction, which values Medicis’ common stock at approximately $2.6 billion, was unanimously approved by the boards of directors of both companies.

The transaction is expected to close in the first half of 2013.

For more Business Corner news visit http://biotechnologyfocus.ca/?cat=78

BUSINESS CORNER New migraine treatment hits Canadian market Canadian physicians and patients have a new treatment option for migraines as Stellar Pharmaceuticals Inc. and its operating division, Tribute Pharmaceuticals announce that CAMBIA® is now available to patients across Canada.

CAMBIA® (diclofenac potassium for oral solution), is a water-soluble, buffered diclofenac potassium powder engineered using Dynamic Buffering Technology™, a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., a Swiss drug delivery and drug development company. The product was specifically developed to address a widespread need among migraine sufferers by offering fast and effective relief of migraine pain.

“The prescription migraine market in Canada is valued at about $150 million and we anticipate that CAMBIA® has the potential to gain a significant proportion of Canadian sales over the life of the product’s patents,” said Rob Harris, president and CEO of Stellar.

In randomized clinical trials, CAMBIA® was shown to be effective not only in treating migraine pain, but also photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea, symptoms commonly associated with migraine

attacks. CAMBIA® was also shown to provide statistically significant onset of relief of migraine pain within 30 minutes.

CAMBIA® which received approval from Health Canada in March 2012, is marketed

by Tribute under an exclusive Canadian license from Nautilus Neurosciences, Inc., a neurology focused specialty pharmaceutical company located in Bedminster, NJ. The product is currently marketed in several European countries by Novartis Pharma AG, via a license from APR. Nautilus and APR have been granted patents that cover CAMBIA® through 2026.

To see this story online visit http://biotechnologyfocus.ca/?p=2072

Theralase expands into China Theralase Technologies Inc. announces it has expanded the distribution of its products into mainland China by signing an exclusive distribution agreement with medical device distributor, Chengdu Disi Industrial Co. Ltd. (Chengdu Disi).

Under the terms of the exclusive dis-

tribution agreement, Chengdu Disi will market, sell and provide customer support on Theralase therapeutic lasers to government, public and private hospitals, in China, training them in the safe and effective operation of this cutting edge technology.

CSPC 2012 Themes

CANADIAN

SCIENCE

POLICY CONFERENCE CALGARY ALBERTA

• • • •

Innovating on energy supply and demand for more sustainable resource management: a critical test for the integration of science, technology and policy Re-imagining Canadian Healthcare: How innovation in science and policy can contribute to a more sustainable system Food, Fuel and Farmers: Agriculture at the convergence of multi-disciplinary science policy issues Science-Technology-Society-Nexus Honorary Co-Chairs: Preston Manning Dr. Eric Newell Dr. Elizabeth Cannon

21 Panel Sessions | 80 Speakers 3 Days of Conference, Workshop: Science Policy 101 Info@cspc2012 | www.cspc2012.ca | @sciencepolicy

NOVEMBER 2012 BIOTECHNOLOGY FOCUS 11

By Alison Fenney

NEUROSCIENCE

Maximizing the impact

OF NEUROSCIENCE: COLLABORATION

ENTREPRENEURSHIP INTEGRATION

What do a physicist, neuroscientist and engineer have in common? If you ask the Ontario Brain Institute: good ideas. The trouble with good ideas is that they don’t keep. As famed English mathematician and philosopher Alfred North Whitehead said, “something must be done about them.”

This ‘something’, in the case of neuroscience in Ontario, was detailed in two seminal reports. The first, written by the Ontario Innovation Trust in 2009, proposed the formation of a new neuroscience research institute in Ontario, one that would model new methods of collaborative research, bringing together research strengths across the province. The second, commissioned in 2011, confirmed that Ontario does have the potential for an economic cluster in neurosciences. That potential comes from our well-developed infrastructure as well as patient and customer demand, but is challenged by lack of access to capital and management talent.

These reports detailed a call to action, to create a collaborative institution to catalyze research activity, and develop programs to im12 BIOTECHNOLOGY FOCUS NOVEMBER 2012

prove access to capital and increase managerial talent. In response to this call the Ontario Brain Institute (OBI), partially funded by the Government of Ontario, was formed.

rich source of information gathered into an informatics bank called Brain-CODE, as well as enhanced knowledge translation throughout the research programs.

The Ontario Brain Institute

New Models of Collaborative Research

The OBI was established with the goal of maximizing the impact of neuroscience through integrating and funding pan-Ontario research programs, commercialization, health informatics, and knowledge translation to improve the lives of people with neurological disorders, create companies and jobs, and improve care for brain disorders in Ontario. These new models of collaborative research, called Integrated Discovery programs yield standardization of tools and the collection of research data. This provides a

The OBI’s Integrated Discovery programs offer an innovative approach to large scale brain research initiatives. These are rooted in the drive to improve patient outcomes by fostering research collaborations between basic scientists and clinical scientists; by standardizing patient assessments across Ontario; and by engaging patients in every stage of research and development.

Core innovation teams, composed of major players in research and industry, maximize

NEUROSCIENCE the translation of research ideas into viable products by monitoring research progress, providing strategic direction and offering commercialization expertise to the research teams.

The first three ID programs involve epilepsy, cerebral palsy and neurodevelopment which include autism spectrum disorders, attention deficit-hyperactivity disorder, obsessive-compulsive disorder, and intellectual disability.

The neurodegeneration (Alzheimer’s disease, Parkinson’s disease, fronto-temporal lobar degeneration, amyotrophic lateral sclerosis, and vascular cognitive impairment), depression, addiction and concussion programs are currently receiving pilot funding to further develop strategies and run small proof-of-concept studies. A total of $7.7 million is flowing to these programs over 18 months. Currently at the half-way point, our programs have already achieved notable outcomes, including two new companies spin-outs, one peer-reviewed publication, one manuscript submission and two intellectual property disclosures.

The OBI’s Integrated Discovery programs are employing highly trained scientists, and generating basic, translational, and clinical research data. This data not only provides publications, public education and intellectual property for products and devices, but feeds into the OBI’s informatics program called Brain-CODE, which will maximize the value and impact of this work.

Maximizing the Impact of Neuroscience Brain-CODE is a secure, virtual resource to advance understanding of CNS diseases. This informatics platform will allow researchers to collect, share and analyze “big data” across multiple technologies, data sources and diseases. Brain-CODE will augment the value of patient’s research data by integrating it with accrued health information from other research programs and databases. For Ontario’s economy, Brain-CODE means speeding the development of novel treatments and diagnostics, making the Brain-CODE model financially sustainable by creating many different revenue streams and the potential for greater government investment in CNS research and development. Brain-CODE also leverages the province’s extensive prior investments in infrastructure, capacity and expertise, making “big data” available to researchers and projects of all sizes and capacities.

Knowledge translation plays a key role in ID Programs and Brain-Code, informing and educating professionals and lay persons alike of the work going on in the province,

Brain-CODE is a secure, virtual resource to advance understanding of CNS diseases. This informatics platform will allow researchers to collect, share and analyze “big data” across multiple technologies, data sources and diseases. and its implications for Ontarians, regardless of age, gender or health status. Specific knowledge translation activities include ‘Talk & Listen’ tours, designed to open dialogues with community and interest groups across the province, sharing information about capacity, strengths and areas for improvement; to webinars, with expert panelists providing accessible information about topics from clinical trials to diseases and disorders.

Bridging the Capital and Talent Gap To improve access to capital for the commercialization of research and development of early stage products in neuroscience, the OBI has brought together and currently coordinates a group of 14 neurotechnology projects, supported by the Federal Economic Development Agency for Southern Ontario (FedDev Ontario), through its Technology Development Program (TDP). Each project involves collaboration between a not-forprofit organization and an industry partner, and is funded by industry and the federal government, with a total investment exceeding $24 million and involving 28 partners.

Projects range from neurotechnology devices to software packages for cognitive training.

The Experiential Education Initiative (EEI) was established to address the lack of mana-

gerial talent in neurotechnology in the province. This initiative includes three distinct offerings: entrepreneurship awards, internship placements and management fellowships.

The inaugural Ontario Brain Institute (OBI) Entrepreneurs Program provides a glimpse of what the province has to offer. The program enables young researchers to transport research out of their lab and into commercially viable products and innovations. Candidates are required to pitch their idea to a panel of experts, providing both the science and business case to support their proposal. Trained in academic institutions across the province from Ottawa to Thunder Bay, across a variety of disciplines, these young scientists are intelligent, driven and destined to make an impact on the neurotechnology cluster - a geographic concentration of components or value chain of an industry, from research and development to production and sales.

This year is the inaugural offering of the award, a $50,000 cash prize in addition to expert mentorship, training and networking opportunities. Within two weeks of posting the opportunity, the OBI received over 30 strong applicants. Fifteen of them were selected to pitch to the expert panel, and seven were ultimately selected for funding. Several candidates are co-funded through a partnership with the Ontario Centres of Excellence, just one of many relationships enabling the OBI to leverage funds and maximize impact.

Projects range from advances and improvements in medical imaging and therapies, to applications designed to re-train the senses.

Each entrepreneur is matched with a mentor, placed in a regional incubator and connected to local and provincial networks of experts, including academics, healthcare and industry experts. The entrepreneurs benefit from the support and promotional efforts of the OBI and our partners, and the province benefits from the innovative products and experience driven training of highly skilled researchers across the province.

Each entrepreneur not only represents a new or improved product, and a new company, but an investment in the human capital of the province of Ontario. These individuals are tackling some of the major challenges in neuroscience and CNS disease, including medical imaging technology, and rehabilitation of both mind and body.

One area of interest is medical imaging, which has opened up a world of possibilities in diagnosis of disease and evaluation of treatment. However, it’s been said that possibility always comes at a price, requiring large capital expenditures that complicate the availability of these products and services.

NOVEMBER 2012 BIOTECHNOLOGY FOCUS 13

NEUROSCIENCE

• Oleksandr Bubon, a research physicist from Lakehead University, is developing a new block detector system that will dramatically reduce the physical size requirements of positron emission tomography detectors. Making PET detectors portable would change the face of medicine in northern Canada, not to mention emerging markets like China and India.

• Xingxing Xing, also a physicist, from University of Toronto, has created a new company SONOLA. Xingxing is tackling distortion in ultrasound imaging caused by the skull, hoping to improve resolution to enable effective and inexpensive brain imaging. Once again, this is a novel use of an existing tool, with implications for healthcare within and beyond our borders.

• Dan Hosseinzadeh, an electrical engineer from Sunnybrook and now cofounder of Pathcore, has created a new system for image analysis for labs and clinics. Pathcore is a software platform and digital pathology tool that makes it easier to analyze complex, large size whole slide images.

Rehabilitation of the body and mind is a topic of great interest, with advances in technology spurring innovation in treatment.

14 BIOTECHNOLOGY FOCUS NOVEMBER 2012

• Michael Chrostowski, a neuroscientist and engineer from McMaster University, is exploring the use of computational modeling of brain activity to improve sound therapy for persons with hearing damage.

Michael has started a company, SoundOptions, and is preparing for trials that will test the effectiveness of the sound therapy customized to individuals suffering from hearing loss.

• Brian Hu, an engineer from the University of Toronto, has created the company SenseIntelligent. His goal is to perfect an application he designed to help deaf persons experience sound through vision.

The technology opens opportunities for a number of applications, and is being designed for use on Android smartphone and tablet platforms.

• Aliasgar Morbi, a mechanical engineer from Carleton University, through his company GaitTronics, has developed a robot to assist in walking practice, for use in rehabilitation and research. This product has the potential to not only provide a safer environment for rehabilitation, but boost the number of patients treated by reducing staff time requirements for these programs.

• Mehran Talebinejad, a biomedical engineer, and his team at NeuroQuore are working on reducing the cost and increasing the longevity of transcranial magnetic stimulation devices. The intended use for these more durable and less expensive units is for the treatment of depression.

Each of these entrepreneurs and their projects has the opportunity to engage and support other programs at the OBI, whether through the Integrated Discovery programs, FedDev Ontario sponsored projects, or by eventually contributing trial data to Brain-CODE. All these initiatives are designed to support and be supported by the neurotechnology cluster, translating knowledge, through education, engagement and commercialization of products to impact patient outcomes and improve the caliber of care.

Supporting the Neurotechnology Cluster All the activity created through this growing network of research, information sharing, education, training and commercialization is sustained by the newly formed Ontario Brain Innovation Council (OBIC). The OBIC is a group of experts across academics, healthcare, industry, patient groups and not for profits, created to advise on the strategic direction of programs for innovation in neuroscience in Ontario, to provide networks of expertise for participants in OBI programs and working in the neurotechnology space. This OBIC is a call to action, to engage the greater community to contribute, support and benefit from the research and economic activity of the cluster.

There is a wealth of good ideas in Ontario, the OBI is catalyzing the development and commercialization of these neurotechnology innovations and products with the ultimate goal of improving patient care and outcomes in neurological disorders.

Alison Fenney is a program lead, Entrepreneurship & Management Training Ontario Brain Institute To see this story online visit http://biotechnologyfocus. ca/?p=2203

D

Read it here first.

Canada’s foremost news source on the Canadian life science industry.

Don’t get left behind.

www.biotechnologyfocus.ca

By: Shawn Lawrence

Genomics

tHE PRoMisE AND PoWER

oF GENoMics Ten years ago, the Gairdner Foundation brought together some of the world’s finest minds for a series of signature presentations examining what was then a comparatively young science: genomics.

That event, organized by Genome Canada and the Gairdner Foundation, was one of the first to put Canada in the genomics race. In the time since, advancements in the field both here and abroad have reached critical mass, so it seems fitting that the two sides have come together once again to put on another genomics extravaganza.

The special two day conference will take place on Nov. 27 and 28 in Ottawa. Many of those same scientists that attended in 2002 will be back as well as a host of new superstar scientists. Billed as “The Power and Promise of Genomics,” this event not only marks 12 years of progress in the genomics field in Canada, but also the remarkable expansion of genomics research and its applications in sciences that stretch beyond human health.

“Looking back 10 years later, I think genomic research has really transformed both biology and medicine,” says John Dirks, president and scientific director of the Gairdner Foundation and the individual mostly responsible for putting the original event together. For Dirks, the timing for such an event couldn’t be any better.

“On the human health side, we’ve identified over 3,000 new monogenetic inherited diseases and many genome wide syndromes, such as type 2 diabetes and so on. Overall, a lot has happened in this field. Moreover not 16 BIOTECHNOLOGY FOCUS NOVEMBER 2012

enough attention has been given to genomics and its achievements since the Human Genome project, and this is partly why we approached Genome Canada to hold this milestone event once more.”

Dirks adds that what sets this forum apart from its predecessor is that it not only brings together an impressive mix of genomics researchers and academics, but also includes end users, as well as public and private research agencies and funding organizations.

Genome Canada president and CEO Pierre Meulien adds that much thought has gone into planning this once-in-a-decade forum, which includes a remarkable compilation of speakers spread amongst panels in all areas of the life sciences.

“The first day is very much on the human

health piece, while the second day shines a light on all the activity going in biofuels, crops, livestock, food security, forestry and fisheries and so on,” he says.

The reason for including these other sectors in the event program is simple, genomics has expanded into these other fields and is delivering results in the bioeconomy.

“Genomics is evident in many areas of science and not just human health, but few people realize this. That’s really the goal here, to not only try and bring together those same people from the original event, but to also bring new players in that have taken the findings and the technology and applied it right across the spectrum,” says Meulien.

While the advancements on the human health side are more known, Meulien stresses

“We weren’t able to bring back all our winners from 2002, but in order to deal with the topics we selected there likely wouldn’t have been room for them all. It’s almost the nature of the beast if you will. And having all these people together could lead to other great things, future collaborations and future successes.”

— John Dirks

Genomics the opportunities are endless as our ability to peer at, understand, and manipulate the building blocks of all life continues to evolve.

“I think that the power of the technology is the pervasive nature of it, being able to apply it in so many fields, the promise is that we will be able to solve some real life problems, both social and environmental using these technologies. Even now, we’re not quite fully able to grasp the remarkable things to come, the parade of advances and wide breadth of areas that genomics research influences, nor the powerful new tools the genomics research has uncovered.”

The lineup in the event includes many internationally known scientists.

You’ve got international experts like Steven Mayfield, who is coming in from San Diego, to talk about biofuels. There’s Sally Aiken who will discuss genomics in relation to trees and Michel George who is coming in from Liège, Belgium to talk about livestock genomics and then we have people looking at salmon of course and food security.”

The event’s ability to attract a stellar international lineup has much to do with the reputation that the Gairdner Foundation has built over the years, shining a light on the great science being conducted both here and abroad.

“I think it’s helped certainly in getting people like Eric Lander, Svante Paabo and others. We weren’t able to bring back all our winners from 2002, but in order to deal with the topics we selected there likely wouldn’t have been room for them all. It’s almost the nature of the beast if you will. And having all these people together could lead to other great things, future collaborations and future successes,” says Dirks.

The event also presents an opportunity for Canadian genomic researchers to show they are still at forefront of what others have coined the genomics revolution.

“I think we’ve seen genomics embraced here in Canada. It’s a very active area and I think Canadian genomic scientists are highly respected in the field. In the health area especially, you see several leading scientists like Michael Hayden, Tom Hudson, Stephen Scherer and of course Bartha Knoppers to name a few,” says Dirks.

Meulien also believes Canada has much to be proud of.

“Canada is a country where we’ve seen progress that has caught international attention, and it is a driving force for Canadian science. Today, we have these five science and innovation technology centres located throughout Canada, three of them are on the nucleic acid, high throughput sequencing and bioinformatics, two others specializing in proteomics and metabolomics.”

“Genomics is evident in many areas of science and not just human health, but few people realize this. That’s really the goal here, to not only try and bring together those same people from the original event, but to also bring new players in that have taken the findings and the technology and applied it right across the spectrum.”

— Pierre Meulien

This coupled with the fact that each region is represented by its own Genome organization he says only helps to expedite advancements in the field.

“I think we have a pretty unique model or approach that allows our regions to capitalize on their own specific strengths.

It wouldn’t be surprising that for example what we’re doing in the microbial communities in the oil sands, and all the energy stuff is located in Alberta, along with most of the livestock projects (ex. Alberta beef), or that the wheat and canola projects are in the prairies (Genome Prairie), and the fish stuff is divided up (cod in the east, salmon in the west) or that forestry is pretty much focused in British Columbia, Alberta and Québec.”

And both the Gairdner Foundation and Genome Canada are excited to see where this field is going.

“There’s report after report stating just how good fundamental research is in Canada and in this envelope Canadian genomics research can be included. We are punching well above our weight in terms of productivity,” says Meulien.

Yet, there are the same number of reports that indicate Canada has not been very good at the applied end and converting those great academic discoveries into social economic benefits for Canadians. As such, there has been a shift he says in how Genome Canada is funding its projects.

“We’re not cutting the flow off to the cutting edge discovery research, because in genomics if you do that you’re going to be dead in six months because the technology is moving so quickly, but we are very much engaging with end users including the private sector, industry and others to get genomics technology pulled out of academia and put into use.”

Moreover he says that government has embraced genomics as part of its agenda.

“They are very keen of what we do and I think that we have very good support from Industry Canada.”

Looking at the sponsor list for this event, it’s also evident that private industry is also

embracing genomics.

“All of our sponsors for this event have some form of personalized medicine department in their company model and genomics is part of their business plans now. Likewise, we’ve spun off about 20 companies of our own from Genome Canada projects over the years. I think that’s just the tip of the iceberg, I think there’s huge potential for us to create an industry around this.”

Still, even with progress, the consensus is more can be done to drive awareness around genomics. This is the reasoning behind hosting the conference in Ottawa.

“It’s a two-fold reason, one is that we like to stage science events here because you have major decision makers, federal agents to demonstrate the importance of the science.

Of course it’s also where Genome Canada’s headquarters are located,” says Dirks.

“The hope is that science policy people will be interested in attending this and recognize that it’s relevant to Canadians. The goal really is to get people excited about genomics, and I think so far we have a pretty eclectic audience,” adds Meulien.

Of course, that is only the first step, as the real goal is to ensure that Canadians in general understand how broad the applications are for genomic technologies.

Dirks explains, “I think they only understand to a modest degree. They hear a lot about personalized medicine and good science and medical writers are discussing its potential. But I think for the most part the public has a feeling of mystery around this field. And to truly realize its potential we need to make them more aware.”

For more information about Genomics: the Power & the Promise event visit www. genomicspowerandpromise.cvent.com.

To see this story online visit http://biotechnologyfocus. ca/?p=2205

NOVEMBER 2012 BIOTECHNOLOGY FOCUS 17

Genomics SOME OF THE PROMINENT SPEAKERS/PANELISTS Michel Georges A veterinary geneticist, Dr. Georges focuses on animal breeding of medically important and valuable traits. His research is related to commercial livestock such as sheep and dairy cattle. Dr. Georges’s work involves the fine mapping of production traits and health in dairy cattle, for example. He studies DNA sequencing that influences milk production and applies them to breeding schemes. Georges’s laboratory has studied important characteristics including Crohns disease in humans as well as animals. He is Director, Animal Genomics, at the Faculty of Veterinary Medicine at the University of Liège.

Tom Hudson A physician, scholar and mentor, Dr. Hudson moved from bedside to bench becoming a protégé of Eric Lander in deciphering the human genome. He returned to Canada as a dynamic leader of several genome research projects aimed at understanding human diseases, including the international Haplotype Map Consortium. Dr. Hudson’s laboratory at the Ontario Institute for Cancer Research is primarily focused on the genetics of colorectal and pancreatic cancer. Dr. Hudson is co-founder of the International Cancer Genome Consortium. He participates in several translational research activities related to personalized medicine and targeted therapies.

Peter Anthony Jones Jones’ research has helped strengthen the medical arsenal in the fight against cancer. Known for his studies on the molecular biology of cancer, Jones’ focus is the basic mechanisms of DNA methylation and its role in maintaining or modifying cellular function. Abnormal patterns of DNA methylation may contribute to the development of cancer. This is referred to as an epigenetic modification because it does not change the coding sequence of DNA. He is former director of the USC Norris Comprehensive Cancer Center and now Distinguished Professor of Biochemistry & Molecular Biology at USC.

Eric Lander One of the great scientific ‘thought leaders’ of our time – Eric Lander is President Barack Obama’s top science adviser. A mathematician turned geneticist, Lander was named one of The Most Influential People in the World by Time Magazine in 2004. His team made the largest contribution to the Human Genome Project, the decoding of the human genetic information, in 2001. He is the founder of the Broad Institute, which brings together MIT wizards, Harvard University gurus, and biomedical researchers from the Harvard-affiliated hospitals to understand and solve important illnesses using genomics.

Peter Langridge A plant biochemist, Langridge was named South Australia’s 2011 Scientist of the Year for his pioneering work in developing genetic technologies and new strategies to improve cereal crops resistant to drought and saline oils. He serves as international adviser in Europe, the UK and Australia in relation to plant genomics as a solution to global food security.

He has helped establish breeding programs in India and China to enhance drought tolerant cereal crops. Langridge is a professor in plant science at the University of Adelaide and CEO of the Australian Centre for Plant Functional Genomics.

Stephen Mayfield A scientist and entrepreneur, Mayfield’s research focuses on the molecular genetics of green algae in engineering therapeutic proteins and biofuel molecules. His laboratory has shown the potential of exploiting green algae - commonly known as pond scum - as a source of renewable energy. Mayfield is scientific founder of Sapphire Energy, which is developing tools for biofuel production. He is also founder of Rincon Pharmaceuticals, a company employing algae as a platform for low-cost engineered protein production. He is director of the San Diego Center for Algae Biotechnology, and the John Doves Isaacs Chair of Natural Philosophy at University of California, San Diego.

Svante Paabo Think of Charles Darwin with a gene chip and a DNA sequencer. Paabo is an archeological geneticist who first isolated DNA from an Egyptian mummy in 1985. In 2007, Paabo was named to Time Magazine’s 100 Most Influential People of the Year.

Paabo is decoding fragments of DNA from Neanderthal bones. His research to provide a complete Neanderthal genome will help science solve what makes us human. The director of the department of genetics at the Max Planck Institute for Evolutionary Anthropology, Paabo is recognized as the inspiration behind Michael’s Crichton’s blockbuster: Jurassic Park.

Stephen Scherer A world leader in exploring and characterizing autism susceptibility genes, Scherer was a collaborator in the Human Genome Project under Craig Venter’s team. His contributions to medical genetics includes mapping sequencing and disease gene studies of human chromosome 7. His recent international studies involve duplicated sequences of DNA in neurodevelopmental, neurological, and behavioral disorders. Duplicated sequences are important sources of gene innovation and structural variation within the genome. Scherer is Director of The Centre for Applied Genomics at the Hospital for Sick Children in Toronto and a Professor of Medicine at the University of Toronto.

18 BIOTECHNOLOGY FOCUS NOVEMBER 2012

By: Daniela Fisher

Mitomics:

I

n the world of early disease detection, Mitomics Inc. is pioneering the next generation of molecular testing.

The Thunder Bay-based company is charting new territory with an innovative approach to the screening and diagnosis of cancer by using mitochondrial DNA (mtDNA) based biomarkers instead of traditional nuclear DNA-based biomarkers.

Its Prostate Core Mitomic TestTM (PCMTTM), released in 2011 for the more accurate detection of prostate cancer, has attracted much industry attention for its unique approach to detecting disease using its patented Mitomic TechnologyTM. “We have a technology that we know can compete head-to-head with any other evolving or developing next-generation diagnostic technology,” says Robert Poulter, CEO and president of Mitomics. “But what makes us unique is the mitochondrial DNA, the significant early detection component, and our ability to pick a disease, go off and discover.”

Poulter, a Thunder Bay native with a background in banking and finance, joined the company in 2007, using his experience to take Mitomics’ PCMT from research and development to market. The company itself was founded in 2001 under the name Genesis Genomics, later becoming Mitomics – a blending of the words mitochondria and genomics.

Mitomic technology is what sets the company apart from others. It focuses on large-scale deletions in mitochondrial DNA, which can indicate cellular changes that can be associated with cancer development.

“The mitochondria have their own unique DNA,” says Poulter. “It’s a circular loop, and it’s very, very small but easy to monitor for alterations. We are able to determine where pieces, or sequences,

innovator FEATURE

the next generation of molecular testing

of that DNA effectively go missing when disease hits. We can tell you what DNA sequence goes missing depending on what type of disease.”

That’s opposed to looking at the nuclear DNA, which has the ability to repair itself and fix the damage to the cell, until it is overwhelmed and has no choice but to change into a diseased cell. The mitochondria have no ability to repair themselves.

The idea to look at mtDNA deletions came from the company’s co-founders: a group of scientists primarily out of Lakehead University, including Mitomics’ CSO Ryan Parr.

With a PhD in biological (molecular)

Hopkins that talked about using mtDNA as a detector for different types of cancer because of its fast mutation rate.

“We thought, ‘Wow, we work really hard on ancient mtDNA, this sounds like a good idea for us’,” says Parr. “That was actually the genesis of Genesis Genomics, the idea that you could use mitochondrial DNA to detect disease, and since we had worked with it, we felt like we may have an advantage in setting up a company to do early cancer detection.”

Their first target was prostate cancer, as they felt there was an unmet need in that area for better screening, diagnostic and treatment methods. Parr set to work

“Our test takes that same negative tissue, and analyzes it for this unique large-scale deletion of the mtDNA. If we can detect the deletion event or determine whether this piece has gone missing, we can tell the physician, ‘That tumour is in that prostate and you’ve missed it in your biopsy process. Go back in and find it, diagnose this patient.”

— Robert Poulter anthropology from the University of Utah, Parr was at Lakehead working on analyzing and sequencing mtDNA extracted from the skeletal remains of ancient Egyptian populations. In the late 1990s, Parr and the other researchers came across a paper from Johns

researching and developing mtDNA-based biomarkers, and one of the company’s first milestones was the results from a study meant to determine if they could find prostate cancer just by looking at mutations or alterations in the mtDNA. “I remember very distinctly that we looked at the mtDNA from the prostates of individuals who had prostate cancer, and who’d had their prostates removed for that issue, compared to individuals who didn’t have prostate cancer,” says Parr.

“We found there was quite a dif-

NOVEMBER 2012 BIOTECHNOLOGY FOCUS 19

innovAToR ference between those who did and those who didn’t have prostate cancer. Moreover, we found that if you have a cancer lesion in your prostate, you will have the same mtDNA mutations in tissue that looks normal but is some distance from that tumour.”

At first, the results were a puzzle to Parr: “I remember going back into the lab at night thinking ‘What have I done?’ Because the results aren’t correct, I should see differences between the tumour and the tissue

“We found there was quite a difference between those who did and those who didn’t have prostate cancer. Moreover, we found that if you have a cancer lesion in your prostate, you will have the same mtDNA mutations in tissue that looks normal but is some distance from that tumour.”

— Ryan Parr that looks normal.”

The answer, Parr soon found, lay in the tumour field effect, first devised in the 1940s

by D.P. Slaughter and a group of researchers, and published in a 1953 study. The tumour field effect occurs when the presence of a tumour affects all of the surrounding tissue.

While this doesn’t necessarily mean that tissue will become malignant, it does not mean that tissue is excluded from becoming malignant either. There is a molecular potential for surrounding tissue to become malignant.

For Parr’s study to have revealed this effect was significant, especially for the detection of prostate cancer.

“This field effect extends the range of the sampling error of the core itself, so you can actually detect the presence of a tumour even by sampling histologically normal tissue,” says Parr.

The group published their work in 2006 on how mitochondrial DNA mutations showed the cancerization field effect. After years of hard work and dedication, the next milestone was discovering that this field effect could be monitored with a simple assay by looking at large-scale deletion. This led to the company’s central product, PCMT, and its commercialization in 2011.

PCMT gives Mitomics a leading edge in the detection of prostate cancer. Men suspected of having prostate cancer will undergo a prostate biopsy, recommended for those with elevated PSA (Prostate-Specific Antigen) blood test scores. In a prostate biopsy, a physician typically uses 12 needles to investigate the prostate which is approximately the size of a walnut. If the needles 20 BIOTECHNOLOGY FOCUS NOVEMBER 2012

miss the tumour, a patient receives a false negative and can be called back for a second or third biopsy, an incredibly painful procedure that also carries risk of serious infection.

Poulter explains further: “Our test takes that same negative tissue, and analyzes it for this unique large-scale deletion of the mtDNA. If we can detect the deletion event or determine whether this piece has gone missing, we can tell the physician, ‘That tumour is in that prostate and you’ve missed it in your biopsy process. Go back in and find it, diagnose this patient.’ ” Because PCMT has a negative predictive value of 92 per cent, and a sensitivity of 85 per cent, one of the most significant advantages of the assay, says Poulter, is its ability to clear up false negatives.

“If you had cancer, would you want to know?” says Poulter. “Absolutely. The earlier you detect cancer, the higher you’re ability to treat the disease and to survive. The problem here is in prostate cancer – it’s a disease that goes undetected for many years and it’s not because the physician is doing anything wrong, in fact the physician is doing everything right, but they just can’t pinpoint or locate the tumour.”

With PCMT, physicians can order a test on the existing prostate tissue samples. There is no need for a second biopsy.

Currently, the samples are analyzed out of the company’s CLIA-certified commercial laboratory in Aurora, Colorado. While its commercial lab is located in the U.S., Mitomics remains headquartered out of Thunder Bay, the location of its head office, R&D and financial operations. In a recent develop-

ment, Mitomics announced an agreement with U.S.-based LabCorp, where urologists will be able to order PCMT through DIANON Systems Inc. It is the fourth such U.S. distribution agreement inked for PCMT, and Mitomics has also forged agreements with distributors in Canada, the UK, Ireland, Germany, Australia and New Zealand.

Along with further marketing of PCMT, Mitomics is pushing toward the future with an active R&D program based on its mtDNA platform. The company aims to develop a urine test for screening prostate cancer, which holds the promise of potentially replacing PSA testing. Also in the pipeline are a number of other mtDNA tests for early detection of a variety of diseases including: breast cancer, uterine cancer, cervical cancer, colorectal cancer, endometriosis, melanoma, skin cancer and other dermatological conditions. Parr is convinced that the answer to early disease detection may well lie with the mitochondrial genome.

“Research has always concentrated on the nuclear genomes, but what we’re starting to find out is that the mitochondria are the nexus of many biochemical reactions,” says Parr. “The mitochondria may really be the master of the orchestra. The whole story is not written in the nuclear library.”

For Poulter, this potential puts Mitomics’ biomarkers at the forefront of personalized diagnosis and treatment: “Our technology just fits perfectly in the pharmaceutical world. The buzz word today is personalized medicine. Our platform is exactly that. It’s being able to personalize the identification of disease, and then marry that up with the appropriate treatment for that disease. And that’s what our technology is targeted to do.”

The future is bright for Mitomics.

To see this story online visit http://biotechnologyfocus. ca/?p=2207

Join Genome Canada and the Gairdner Foundation in ottaWa on november 27–28, 2012 For

Genomics:

poWer promise

the & the

This once-in-a-decade event will celebrate advances in genomics and its transformative impact on human health, agri-food and the environment.

World-renowned international and Canadian scientists will present their achievements and share their vision of genomic-based solutions to some of the most pressing global challenges.

We hope to see you there!

http://genomicspowerandpromise.cvent.com

By Luke Brzozowski

Across Canada

ADVANCING TECHNOLOGY

FOR HEALTH

Over the last several years Ontario has made extensive investments into the healthcare system, education, and research programs.1,2,3,4,5 In order to capitalize on these investments, Ontario’s life sciences sector is following global trends and undergoing a rapid transformation, especially in the field of medical technology. There has been a re-alignment of federal and provincial funding priorities. Translational research and industry-academia partnerships in life sciences are at the forefront of the funding strategy, as exemplified by the $161 Ontario Life Sciences Commercialization Strategy.

This trend has led to the inception of new translational projects.

Simultaneously, there is an emergence of innovative spirit, a cultural shift towards the development of end-products supported by entrepreneurs and innovators. Universities, hospitals, and other organizations such as the MaRS Discovery District, MaRS Innovation, and Health Technology Exchange are participating in this shift, and in many cases are able to find supportive private Canadian and international co-investors. Collectively, the industry-academia-government Triple Helix is nurturing the birth of the medical technology industry in Ontario.

The task at hand now is to mature this growing sector. Maturing and ensuring the sustainability of the Ontario medical technology sector will require dedication to translation and creation of partnerships. A critical mass of innovators has to share the mindset that the metric to measure the success of a project is seeing its outcome implemented into a clinical practice. In order to become self-sustainable, the Ontario medical technology sector will need to continue to steadily diminish its reliance on public 22 BIOTECHNOLOGY FOCUS NOVEMBER 2012

funding and move towards partnerships with local and multinational companies, angel- and venture-funded start-ups, profitable SMEs, and increasing Ontario’s presence of multinational corporations’ research and development centres, as opposed to purely sales, marketing, and distributions offices.

Enter the Techna Institute for the Advancement of Technology for Health.

The Institute ‘Techna’, the medical technology analog of pharma, is a new research and development institute of University Health Network (UHN) in partnership with the University of Toronto (UofT), Techna is focused on the accelerated development and exploitation of technology for improved health. A longer term vision for

Techna is that it would expand its scope to include other Toronto partners. It is led by Dr. David Jaffray, the UHN Head of Radiation Physics, and a Professor of Radiation Oncology, Medical Biophysics, and IBBME at UofT who holds the Orey and Mary Fidani Family Chair in Radiation Physics at the Princess Margaret Hospital. Start-up funding for the Institute of $10 million was initiated by a $5 million “challenge” donation to the Princess Margaret Hospital Foundation from Toronto-area philanthropist Carlo Fidani.

The Techna Institute was conceived to help innovators to shorten the time interval from technology discovery and development to application for the benefit of patients and the health care system. “It stimulates and facilitates the innovation cycle through a

Across Canada

Modus Operandi and Resources

continuum of clinically-driven initiatives to promote innovation, technology and process development, translational research and commercial outcomes,” says Dr. Jaffray. “Techna represents a paradigm shift towards demanddriven activities, and the organizational alignment of the needs of the research hospital and the research enterprise.”

Techna is the first UHN-wide institute – it builds on the medical technology, clinical strengths, and commercialization successes of the largest Canadian research hospital.

Techna’s leadership is assembled from a diverse group of accomplished clinicians, scientists, engineers, and business development personnel, all devoted enthusiasts of the Techna mandate. The role of Techna core leaders is to assemble existing expertise and assets, and identify required resources and talent to bridge the gap from clinically-driven technology needs to solutions.

The Technology Techna brings together the technologies of its five cores: Informatics and Communication Technologies (ICT), Photonics, Guided Therapeutics (GTx), Nanotechnology and Radiochemistry, and Design and Engineering for Health. Each core is championed under dual clinical and scientific/engineering leadership, representing the needs of the research hospital.

The ICT Core focuses on integrating hardware and software solutions for the storage, retrieval, sharing and manipulation, management, analysis, visualization, interpretation, and use of information for health service delivery and translational research. Solutions developed in this core utilize internet and mobile technologies to provide health care providers and patients with systems to visualize, analyze, communicate, and transfer information.

The focus of the Photonics Core is the development and application of new therapeutic and diagnostic techniques based on the

use of lasers and other optical technologies, including using photodynamic therapy to treat cancerous tissue, imaging using tissue fluorescence and contrast agents, and optical dosimetry for radiation medicine.

The GTx Core is dedicated to the development and testing of new technologies in imaging merged with developing and applying new physical therapies including surgery, radiation therapy, and radiofrequency ablation. The integration of imaging and repair treatment technologies combine to provide a “GPS” for surgeons – where surgical tools, the surgical target, and the surrounding anatomy are visualized and manipulated precisely in real-time three-dimensional images.

The Nanotechnology and Radiochemistry Core is focused on the development and implementation of novel nanoparticles and radiopharmaceuticals for both therapeutic and diagnostic applications, including multimodality imaging agents and cancer treatments. This novel biotechnology has not only demonstrated the ability to improve drug efficacy by mimicking nature’s own nanoparticles but has also enabled a powerful and versatile biophotonic tool.

Often new medical technology is used incorrectly or its sophisticated features are never employed due to the poor design of the device. The investigators in the Design and Engineering for Health Core perform tests on medical devices and work with the device designers to ensure a medical device is optimally designed for the end user without sacrificing functionality. This core’s state of the art facility not only provides realistic settings and scenarios but also utilizes actual users when testing devices. Issues related to human error due to weak design are addressed before the product is released. This leads to a faster integration of the device into routine practice since the device intuitively makes sense and shorter training sessions are required.

The management of projects at Techna builds on the best global practices for medical technology innovation, adapted to the local ecosystem. It is directed towards enhancing and facilitating existing initiatives in Toronto for the translation and commercialization of medical technology products. Techna projects are incorporated into a centralized project management and operations support stream. It is built for business-to-business and operates in a stagegated fashion.

Throughout its lifetime, each project is periodically evaluated according to its technical development timeline, funding pathway, pre-clinical and clinical evidence, and legal and regulatory standing and strategy. Techna’s projects are supported by the Institute’s personnel in the areas of communications and knowledge transfer, process redesign, and commercialization. Dedicated officers from UHN’s Technology Development and Commercialization (TDC) office secure licensing deals, complete gap analyses, aid in raising seed funding, and connect with incubators and other commercialization institutions. Through tradeshows, conferences, and its distribution lists and website (www. techninstitute.com), Techna helps in marketing projects to the global community.

Techna investigators are actively collaborating with over 40 local and global industrial partners. These partner companies include startups, medium-size entities, and multinationals. Techna links its members with industry and helps to secure joint development funding ensuring that there is a path to commercial outcome. Techna works with both ‘spin-in’ and ‘spin-out’ strategies. Currently Techna develops technology from internal projects, however, it is also interested in assisting and supporting external industry and other institutional partners with the maturation and implementation of ideas and projects. In the end, the source of the original IP is not a bias, so long as it is aligned with Techna’s mission and objectives.

The multi-dimensional relationships Techna has with industry is one of the strengths of Techna. Relationships which extend from early translational activities to clinical implementation drive the results. At the same time, every relationship, every deal, every project is different. The ability to tailor to the strengths of the research hospital, the Continued on page 27 NOVEMBER 2012 BIOTECHNOLOGY FOCUS 23

By Michael Butler

spoTliGhT

Monoclonal antiBody Production The business of

MabNet ran a course on the Business of Monoclonal Antibody Production at the Biotech Research Institute, Montréal. Pictured above are the 65 participants.

MabNet, the national Monoclonal Antibody Network sponsored an advanced course: “The Business of Monoclonal Antibody Production” at the NRC-Biotechnology Research Institute, Montréal September 10-11, 2012. The advanced course was designed to provide education and training on industrial and business aspects of monoclonal antibody production. There were approximately 65 delegates in attendance that included 30 experts from industry and government and 35 MabNet trainees. The Natural Sciences and Engineering Research Council of Canada (NSERC) provided support for the course, including travel for MabNet trainees, through a grant under the Strategic Network Enhancement Initiative.

The objective was to ensure that all participants gained a grasp of the implementation of state-of-the-art Monoclonal Antibody (Mab) technologies in an industrial setting.

Business, financial and intellectual property issues were also covered, providing a comprehensive review aimed at current and future business executives and industry managers. The course was organized as a series of lectures delivered by invited speakers from the bio-industry and included discus24 BIOTECHNOLOGY FOCUS NOVEMBER 2012

sion following formal presentations at the end of each day. Opening the meeting were Michael Butler, MabNet Scientific director, who emphasised the important role of a national network like MabNet in enhancing the biotechnology industry in Canada and David Shindler, chair of MabNet’s board of directors, who noted that during the very early development of monoclonal antibodies, the technology was dismissed as of no commercial value when first assessed for patent protection!

The first speaker, Marcel Mongeon gave an exceptionally lively opening lecture on patent law and practice. Describing himself as an “Intellectual Property Coach,” Mongeon elucidated the basic requirements to establish a patent. Using relevant examples he demonstrated the necessity to establish novelty and utility of an invention but cautioned on the complexity and cost of establishing patents worldwide. Only a small proportion of all patents (probably < one per cent) recover the costs of filing and become money earners. Nevertheless, industry executives and managers must establish patent portfolios and protect inventions in order to be world-competitive.

There followed a series of lectures on the business basis of contract manufacturing in biotechnology. Jason Dowd of Apotex described the challenges that can exist between client and provider. The client can often be a virtual company that may well underestimate the full financial cost of development of a novel product. Bioprocess scale-up often comes the competing challenges of maintaining high productivity and product quality assessed by for example the degree of sialylation of a glycoprotein.

Challenges of developing a biosimilar can be associated with misinformation of the correct amino acid sequence because of discrepancies in available databases. Gregor Awang of Cangene developed these points by emphasising the need to establish realistic end-points at each stage of scale-up. There are various choices to be made in developing a potential glycoprotein product including the choice of cell line and the control of the defined serum-free media. Strategies that avoid intellectual property issues are important. The quality profile of the final product needs to be monitored closely to ensure consistency as scale-up is developed from cell banks, shake flasks and to larger multiple liter bioreactors. Devender Sandhu of Therapure then explained the business strategy associated with custom manufacturing organizations (CMOs). The number of licensed biologicals is increasing rapidly.

This includes an explosion of interest in drug conjugates with the ability to bind to two separate receptors. This increase in products has enhanced the importance and need for CMOs. The growth of the client base of Therapure in Toronto was described as an example of a rapidly expanding CMO. Richard Mateles, an independent biotechnology consultant from Chicago expanded this theme by explaining that contracting out specific tasks for bioproduction is a common industry practice, as there are only a few stand-alone CMOs globally.

Ziawei Fung of GE Healthcare gave a description of the importance of downstream processing as a stage in bioprocessing. High throughput methods have been developed

by GE and designated as Fasttrack technology. This offers possibilities for rapid and

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Modelling of pharmacokinetics (PK) and pharmacodynamics (PD) of monoclonal antibodies and simulation of clinical trials were discussed as a tool to support decision making in drug development. adaptable turn-key 2-column chromatographic methods for purifying monoclonal antibodies.

The first day was concluded by a presentation from Bernard Massie, program director at the National Research Council (NRC). He described in detail the new strategic plan of the NRC that includes “pillars” which are scientific themes that allow interaction between the different national sites of the NRC. Course organizers expressed appreciation to NRC for providing the ideal venue for the course.

The second day was opened by a presentation from Jean-Francois Marier of Pharsight Consulting Services on modeling and simulation to support clinical development of monoclonal antibodies. Dr. Marier discussed the historical 50 per cent failure rate of drugs in Phase 3 clinical studies and how modelling and simulation of clinical trials may have prevented these failures based on a priori knowledge available in Phase 1 to 2 studies. Modelling of pharmacokinetics (PK) and pharmacodynamics (PD) of monoclonal antibodies and simulation of clinical trials were discussed as a tool to support decision making in drug development. These considerations are such that clinical trials involving monoclonal antibodies need to be designed differently than small molecule therapeutics in order to ensure successful outcomes in late stage clinical development.

Pranav Desai of GE Healthcare continued with a presentation on the trends in mono26 BIOTECHNOLOGY FOCUS NOVEMBER 2012

clonal antibody process economics. Early decisions are critical in the development of a novel product connected with the predicted quantity of the material that will be required.

The specific productivity of the producer cell, length of culture and down-stream processing protocols are all major parameters of early decision making. Such decisions have a bearing on the size of bioreactor and whether to employ single-use bioreactor components. Although disposable bioreactors have been popular lately, there may be distinct advantages of using stainless steel bioreactors at larger volumes (>10,000 litres).

Jennifer Maynard from the University of Texas then discussed the clinical basis of antibody therapy. She emphasised the importance of studying the binding capacity of therapeutic Mabs and pointed to past examples of the use of polyclonal antibodies in the treatment of conditions including diphtheria and snake bites. These examples point to the value of targeting multiple epitopes of the clinical target. A mimic of the older therapies might be considered with a cocktail of Mabs for the same target. This can be a better strategy than improving the binding capacity of a single Mab, a strategy which has been shown to not always improve the clinical outcome.

Carlos Bosques of Momenta Pharmaceuticals gave a presentation on the potential immunogenicity and potential side effects of therapeutic Mabs. Emphasising that a Mab formulation may well contain a mixture of

isoforms based upon variations in the source material, cells and the control of the bioprocess. As recently as the late 1990s it was maintained that CHO cells, typically used for industrial Mab production, did not have the capacity to produce the well-known immunogen, gal-α1,3 gal. However in a recent paper Carlos and others showed that indeed the genetic capacity for producing this unwanted immunogen is present in the CHO cell lines commonly used in large-scale biopharmaceutical production. Donald Gerson continued with a description of his experiences of building a large-scale production plant for protein biopharmaceuticals in a newly developed area of Incheon, South Korea. Initial funding of $200 million ensured that the plant was state-of-the-art with an enormous potential for rapid development of novel biological entities. Donald has now returned to Canada taking up the challenge with PnuVax Inc of building a biomanufacturing facility in adjoining ground to the NRC building in Montréal.

The meeting was concluded with a presentation by John Babcook from the Centre for Drug Research and Development in Vancouver with an overview of current trends in antibody-based therapeutics. Many of his examples were taken from the so-called SLAM technology using a xenomouse program that led to multiple examples of FDA approved Mabs.

In conclusion, it was felt that the two-day meeting provided a unique opportunity for attendees to gain new insights into a dimension of the commercial production and clinical aspects of monoclonal antibodies For trainees, the course complemented their experiences in their laboratory-based projects.

This meeting provided a platform that helped participants to understand various critical aspects of the Monoclonal Antibody sector, that is gaining an enormous global importance.

Michael Butler is a Distinguished Professor at the Department of Microbiology, University of Manitoba, Winnipeg, Manitoba and Scientific Director of MabNet. He can be reached at butler@ cc.umanitoba.ca.

To see this story online visit http://biotechnologyfocus. ca/?p=2192

Across Canada Continued from page 23 needs of the private sector partner, and the demand from global healthcare markets provides an industry-friendly atmosphere.

Co-development and licensing deals are already enriching Techna’s track record.

Since its launch in November 2011, Techna has been actively commercializing products through the UHN TDC, four of which are generating revenue. Revenues are reinvested into the projects for further development, creating a self-sustaining model that is rare amongst public and academic institutions.

Almost all these products have a close industry partner to help manufacture, sell, and distribute the technology.

As an institute of UHN, Techna has access to over 500 hospital researchers, 13,000 clinical staff, and 1300 technical staff. Through its partnership with UofT, Techna has access to thousands of faculty and researchers in the fields of medicine, applied sciences and engineering, business, and the physical sciences. Techna is the gateway for industry and private inventors to utilize these human resources. Techna helps with evaluating the clinical need of new technologies developed internally and externally. It can advise on the value proposition, and commercial viability prior to further development of the product.

The Techna Network research infrastructure is integrated throughout the campuses of UHN, MaRS Discovery District, UofT, and through other affiliated partner facilities.

The infrastructure includes hardware and software laboratories, MR scanners, x-ray CT suites, multimodality PET-CT suite, preclinical laboratories at the STTARR facility (http://www.sttarr.com/), Healthcare Human Factors laboratory (http://humanfactors.ca/), and machine shops. Additional infrastructure will become operational in 2012 and 2013 – MR-PET, MR-guided radiotherapy (MRgRT) suite, cyclotron and radiochemistry laboratory, magnetoencephalography (MEG) facility, NanoMedFab facility, Guided Therapeutics (GTx) laboratory, and TRIGOR-A x-ray and optically guided operating room. Techna also helps its investigators and partner institutions secure lab and office space.

Techna is expanding and is hiring fully funded faculty and accepting applications for cross-faculty appointments. Techna management works with UHN and UofT leadership to offer an exciting environment that will attract the best talent and scientific, clinical, and engineering trainees.

References:

Techna@rmp.uhn.on.ca

1. Advanced Medical Devices in Ontario – Healthcare Solutions for Global Markets (08/2008) 2. Clinical Trial in Ontario (05,2009) 3. Oncology (05/2009) 4. Research and Development in Ontario – Incentives for Innovation (11/2010) 5. eROI – Report on Ontario Investment, Spring 2012

Luke Brzozowski Ph.D. is a Director of Operations and Engineering at the Techna Institute for the Advancement of Technology for Health University Health Network

To see this story online visit http://biotechnologyfocus. ca/?p=2209

For more information regarding Techna, please visit the website or email at

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NEW PRODUCTS Data Logger: Omega introduces its new series of precision RTD temperature data loggers. The OM-CP-RTDTEMP101A accepts 2-, 3- or 4-wire 100 pt RTD input and features a long battery life of 10 years, multiple start/stop function, ultra high speed download, 670,000 reading storage capacity, memory wrap and programmable

Measuring: The new Eppendorf µCuvette G1.0 is designed for the accurate and reliable measurement of small volumes of highly concentrated biomolecules, such as proteins and nucleic acids. Users can work easily with samples as small as 1.5 μL without the need for a time-consuming dilution step. The µCuvette G1.0 expands the measuring range of the Eppendorf BioPhotometer and the Eppendorf BioSpectrometer. Synchronized apertures mean that a closed system is created when used alongside Eppendorf detection instruments, for optimum results and reliable operation.

high and low alarms. RTD temperature data loggers are ideal for chemical, water and food industries and for lab, HVAC and R&D applications.

Web: www.omega.ca Pipettes: Eppendorf presents its new electronic pipette Eppendorf Xplorer plus®. The intuitive operating concept and ergonomic display of the Xplorer set new standards in simplicity, precision and reproducibility. The Eppendorf Xplorer is specially designed for users working with complex or long pipetting series requiring the utmost in exact setting of parameters, maximum reproducibility and low operating force. Now with the release of the Xplorer plus there are additional intelligent applications, adjustable fixed-volumes and individual programming tasks are performed much faster and easier. The Xplorer plus also includes a history function that automatically saves the last parameters for faster handling! A password can be entered to guarantee the highest degree of protection for personal programming and settings. These features mean no more delays due to complicated programming or inflexible processes. Instead, get precisely adjustable parameters, maximum reproducible results, fatigue-free work and consistent, full control over the pipetting processes.

Web: www.eppendorf.com/xplorer 28 BIOTECHNOLOGY FOCUS NOVEMBER 2012

while the surface temperature is above 50°C even if the unit is unplugged.

Web: www.stuart-equipment.com Particle Characterization: Malvern Instruments Morphologi G3-ID is ideally suited to solving complex particle characterization problems where particle size and shape do not provide sufficient information. The Morphologi G3-ID is designed to meet a wide variety of needs and to enable all users, from particle characterization scientists with limited spectroscopy experience right through to experienced spectroscopists, to gain an in-depth understanding of particulate samples. Simple SOP operation takes the user from integrated sample dispersion for dry powders through to size, shape and chemical analysis, with automatic selection, targeting and chemical classification of thousands of individual particles.

Measurements can be made on dry powders, suspensions and membrane filters.

Web: www.eppendorf.com Hotplate Stirrers: Undergrad Hotplate Stirrers from Stuart® are tailored to fit effortlessly into all kinds of laboratory settings. Undergrad Hotplate Stirrers have a small footprint, and can be stored on their side to reduce the amount of space required for storage even further. A recess underneath the unit accommodates a retort stand, which slides underneath for easy assembly. This removes the need for screwing a retort rod into place, meaning a shorter set-up time and more efficient working practices. The hotplate stirrers also come with a choice of ceramic or coated metal surfaces, and are compatible with the Stuart temperature controller for accurate sample temperature control. Safety is a major priority, with each unit having a unique LED temperature indicator and a power independent hot light, which remains illuminated

Web: www.malvern.com/ morphologi-g3-id Mills: Retsch Cyclone Mills are ideally suited for temperature-sensitive samples and the grinding of solids depending on the material properties. The rotation of the mill’s rotor or a connected vacuum cleaner produces a rotating air flow inside the cyclone, thus optimizing the air throughput. As a result, sample and grinding tools are cooled and material discharge is improved. These effects are particularly beneficial when grinding temperature-sensitive materials. Further advantages are the complete recovery of the sample material as well as the possibility to process larger sample volumes.

Retsch line of laboratory mills includes various models which can be equipped with a cyclone. Whereas the rotor mill TWISTER has an integrated cyclone, the Ultra Centrifugal Mill ZM 200 can be optionally equipped with a cyclone and collecting vessels of various sizes.

Web: www.retsch.com

CALENDAR November 2012

Canadian Renewable Fuels Summit Venue: Ottawa, ON Tel: 613-594-5528, ext 223 Email: d.elson@greenfuels.org Web: http://greenfuels.org/en/ industry-information/summit.aspx

November 26-30 2012 Materials Research Society Fall Meeting Venue: Boston, MA Tel: 724-779-3003 Fax: 724-779-8313 Email: hastings@mrs.org Web: www.mrs.org

December 10-11 FDA/CMS Summit Venue: Washington, DC Tel: (800) 332-2181 Email: custcare@elsevier.com Web: http://www.elsevierbi.com/mkt/Conf/ FDA-CMS/2012

November 27-28 Genomics: the Power & the Promise Venue: Ottawa, ON Tel: 613-563-1984 Web: http://genomicspowerandpromise. cvent.com

DECEMBER 2012 December 2-4 4th Annual BioPartnering China Venue: Shanghai, China Web: http://www.techvision.com/bpc/

December 3-5

PITTCON 2013: Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy Venue: Philadelphia, PA Phone: 412-825-3220 Fax: 412-825-3224 Email: info@pittcon.org Web: www.pittcon.org

APRIL 2013 April 13-16

ASCB 52nd Annual Meeting Venue: San Francisco, CA Tel: 301-347-9300 Fax: 301-347-9310 Email: ascbinfo@ascb.org Web: www.ascb.org

*ACRP 2013 Venue: Orlando, FL Phone: 703-254-8100 Fax: 703-254-8101 Email: office@acrpnet.org Web: http://www.acrp2011.com/acrp2011/ public/enter.aspx

January 26-29

BioFIT 2012: Fostering Innovation & Transfer Venue: Lille, France Web: http://www.biofit-event.com/

March 17-22

December 15-19

JANUARY 2013

December 3-4

MARCH 2013

2013 Annual Meeting of the ORS Venue: San Antonio, TX Tel: 847-823-5770 Fax: 847-823-5772 Email: ors@ors.org Web: www.ors.org/

April 20-24 Experimental Biology 2013 Venue: Boston, MA Phone: 301-634-7075 Fax: 301-634-7008 Email: eb@faseb.org

Company & Advertiser Index COMPANY Page

Website

AlbertatBay...............................................................................................................25...........................................................................................www.albertatbay.com Canadian Science Policy Conference..................................................................11................................................................................................... www.cspc2012.ca Children’s Miracle Network....................................................................................9.......................................................................www.childrensmiraclenetwork.ca CO2 Solutions Inc.......................................................................................... 6................................................................................ www.co2solutions.com Critical Outcome Technologies..................................................................... 6............................................................................www.criticaloutcome.com Eppendorf.................................................................................................................32............................................................................................ www.eppendorf.com Gairdner Foundation..............................................................................................21.................................................www.genomicspowerandpromise.cvent.com GE Healthcare.............................................................................................. 10...............................................................................www.gehealthcare.com Genome Canada......................................................................................................21.................................................www.genomicspowerandpromise.cvent.com KPMG........................................................................................................... 10..................................................................................... www.kpmg.com/ca Life Sciences Ontario...............................................................................................7.................................................................................. www.lifesciencesontario.ca MaRS Innovation........................................................................................ 8, 30........................................................................ www.marsinnovation.com MedMira Inc.................................................................................................. 9...................................................................................... www.medmira.com Mitomics Inc................................................................................................ 10................................................................................www.mitomicsinc.com Novartis Pharmaceuticals Canada Inc........................................................... 9........................................................................................... www.novartis.ca OptumInsight............................................................................................................2................................................................................. www.optuminsight.com/pv POI Business Interiors.............................................................................................31.............................................................................................................. www.poi.ca RX&D............................................................................................................ 10..............................................................................www.canadapharma.org Sanofi............................................................................................................ 6...................................................................................www.sanofipasteur.ca VWR.............................................................................................................................5.......................................................................................................... www.vwr.com NOVEMBER 2012 BIOTECHNOLOGY FOCUS 29

THE LAST WORD

By Raphael Hofstein

Building a better biotechnology mousetrap

Raphael Hofstein, President & CEO, MaRS Innovation

In the midst of a global recession, how do you create a strong biotechnology cluster from an academic base?

When I arrived at MaRS Innovation in 2009, Toronto’s experiment with a centralized commercialization office had just begun, and with approximately half of the impressive and continuous flow of new intellectual property from the research community grounded in medical research, I was tasked with precisely that challenge.

In the literature, several recurring elements are often mentioned as necessary constituents of an ecosystem capable of producing a cluster of successful startup companies: time, critical mass, availability of financing, and an entrepreneurial work force. Less often cited, but of critical importance in the current economic climate, is an approach that de-risks early stage technologies, in order to attract investment at a time when both industry and venture partners are increasingly selective. This approach requires staff with significant relevant management experience and an outreach program that engages industry well in advance of any expectation of a transaction.

In some respects, we were fortunate to have emerged at a time when industry was in the midst of revolutionizing the way it conducts research and development, as the drastic changes made it clear that new strategies would be required. Gone are the days of large-scale, well-funded, in-house departments with resources to liberally support academic and startup collaborations. Financial pressures and the economic downturn have made it clear that the go-it-alone model is no longer sustainable, and industry players are recognizing that they don’t have a monopoly on research acumen and disruptive ideas. Simultaneously, industry has expressed less interest in investing in early-stage technologies that carry significant risk.

They remain receptive to the research emerging from academic enterprise, but need a means of bridging the gap that technologies face as they move from the bench to the market.

By doing the heavy work of determining a technology’s best path to market, liaising with industry early in the development process, forming a solid business plan and placing embedded management within the nascent company or burgeoning technology, many of us have been successful in providing industry with innovations that surpass their technological or execution risks and enter the market ready to compete. De-risking involves a high-touch approach to developing assets. Seasoned management may draw upon its own expertise and leverage local and international industry networks to do literally whatever it takes to develop the correct business

30 BIOTECHNOLOGY FOCUS NOVEMBER 2012

plan, meet development targets, and breathe life into the exciting, yet very early opportunities accepted for assessment and promotion. This requires an entrepreneurial mindset, which should be encouraged throughout the organization at all stages and also necessitates input from academicians, commercialization officers and industry representatives, all of whom offer a compass through to a market eventuality.

A key component in trying to de-risk in the early stage is pre-seed funding. Industry is open to creative financial tools that can bridge over the financial chasm early on.

Industry partners have become forthcoming in recent years as providers of modest amounts of funding and, perhaps more importantly, have agreed to assist with the selection and development of strategies for nacsent technologies. Framework funds have become popular with the goal of bringing forward technologies that address the lessened tolerance for risk among potential partners, are more valuable, and provide a first look without financial or administrative burden. Academic clusters need more industry engagement, and by opening up doors to earlier engagement, without the expectation of any immediate “deal”, academic clusters and industry both win.

Are there challenges ahead? Absolutely. Commercialization of academic assets remains a high-risk venture.

However, I am confident that employing a de-risking strategy will be a key factor in the success of any cluster, and I certainly attribute MaRS Innovation’s successes to date to our adherence to this strategy.

Andy Warhol suggested, “They always say time changes things, but you actually have to change them yourself.” We must be able to follow suit!

@

To see this story online visit http://biotechnologyfocus.ca/?p=2190

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40%

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off second rotor

5-year

warranty FREE!

Purchase a 58xx series centrifuge package and qualify for a MixMate® at a reduced cost.

Performance you can count on!

FREE extended warranty on Eppendorf Centrifuge 5804/R and 5810/R packages Eppendorf centrifuges 5804/R and 5810/R with their renowned quality and reliability offer you cost efficient solutions for your medium to high-throughput applications—now and in the future. Whether your applications require spinning many tubes at a time or centrifugation of larger volumes at high-speed, these multipurpose centrifuges with their variety of rotors and adapters cover virtually any application in tubes, flasks and microplates.

Choose the right model for your application:

Compact multipurpose models 5804/5804 R— ideal for applications in deepwell plates or for high-speed centrifugation of volumes up to 100 mL. Versatile models 5810/5810 R—in addition to high-speed centrifugation of larger volumes these workhorses also accommodate large swing-bucket rotors to fulfill all high-capacity needs in tubes and plates.

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Product features and benefits

Large rotor selection and speed up to 20,800 x g (14,000 rpm) for a wide range of applications Quiet operation to benefit your work environment Low profile for ergonomic loading and unloading of rotors Soft-touch lid closure for ergonomic lid locking Maximum placement flexibility due to 120 V power supply Saves up to 35 user-defined programs

Refrigerated versions 5804 R and 5810 R also feature: Environmentally friendly CFC-free refrigerant FastTemp function for fast and accurate pre-cooling Standby cooling keeps set temperature when lid is closed ECO shut-off engages after 8 hours of nonuse to reduce energy consumption and extend compressor life Built-in condensation drain to eliminate water accumulation Patented, dynamic compressor control (DCC) for extended compressor life and energy savings

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