Biotechnology Focus May 2013

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

MAY 2013 VOLUME 16, NUMBER 4

CLINICAL RESEARCH AND PATIENT ENGAGEMENT IN

PERSONALIZED MEDICINE

INSIDE:

McMASTER UNIVERSITY

opens $22M Biointerfaces Institute

Publication Mail Registration Number: 40052410

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contents MAY 2013 – VOLUME 16 – NUMBER 4

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Opinion

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The new McMaster Biointerfaces Institute

FEATURES WHERE MATERIALS MEET BIOLOGY Wound-healing bandages? Germ-repelling doorknobs? McMaster University opens the doors to its new Biointerfaces Institute (By Blake Dillon)

ENGAGING PATIENTS FOR CLINICAL RESEARCH What’s the general public’s role in drug discovery and innovation?

(By Katherine Bonter)

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14 Engaging patients for clinical research

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DEPARTMENTS 6

RESEARCH NEWS

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BUSINESS CORNER

CAMPAIGNING FOR FULL DISCLOSURE A push for total transparency in all clinical trial results (By Laura Knox-Wallar)

IN EVERY ISSUE

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25 NEW PRODUCTS

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28 CALENDAR OF EVENTS

6 R&D NEWS

Project to develop inexpensive minor stroke test launched in BC

www.biotechnologyfocus.ca

STAMP OF APPROVAL InterVac receives final certification (By Shawn Lawrence)

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INNOVATOR Vancouver’s iCo Therapeutics: an in-licensing success story (By Daniela Fisher)

ACROSS CANADA Standards Council of Canada (SCC) to launch National Biotech Standards Committee (By Kindha Gorman)

THE LAST WORD Building a catalytic reaction across Canada’s life sciences sector (By Raphael Hofstein)

May 2013 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

Terri Pavelic Shawn Lawrence

Daniela Fisher

Editorial Interns

Steven Loung

CONTRIBUTING WRITERS

Laura Knox-Wallar Blake Dillon

Katherine Bonter

Extending the collaboration corridor – all aboard!

Kindha Gorman

Well folks, another year, and another BIO International Convention is behind us. I enjoyed meeting up with you at BIO and getting caught up on the latest trends in the global biotechnology market. It’s always inspiring to see the biotech community working together to map out the future of the industry.

This year’s conference in the Windy City saw representatives from over 3,000 different companies, representing 65 countries around the world. Known as the number one place to network and form partnerships, this year’s BIO Convention was no exception. Canadian companies and organizations announced a number of important research collaborations, including one that aims to extend the life sciences corridor westward and improve Canada’s innovation performance.

On the opening day of the Convention, Merck Canada announced that it’s investing $4 million into three Canadian academic commercialization centres. These three institutions – based out of Québec, Ontario and British Columbia – will focus on helping translate research from discovery through to commercialization.

It’s commonly known that public-private collaborations are enjoying a major moment in the industry spotlight. As we see more partnerships between academia, big pharma and government, everyone is looking to ensure these collaborations aren’t just for the sake of commercialization, and that meaningful research ensues.

Merck’s investment aims to bridge the great commercialization gap between academic research and industry, as well as encourage collaboration across the country.

The funding will go to Montréal’s Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR), the Ontario-based MaRS Innovation and British Columbia’s Centre for Drug Research and Development (CDRD). Together they will commercialize new technologies in healthcare.

“The corridor initiatives we are funding today are part of our new approach to R&D which is about building collaborative research relationships. Private-public partnerships, in particular, will provide a fertile environment for innovation to grow and to quickly reach the commercialization stage in the best interest of patients,” said Dr. Thomas Cannell, president and managing director, Merck Canada. “This is an important milestone for the company as it is broadening its scope to include important research centres that are part of the Québec - Ontario and Québec - British Columbia corridors.”

When it comes to commercializing innovation in Canada, we need to make a concerted team effort to bridge the gap. All aboard!

CONTROLLER

Raphael Hofstein

National Account Manager

Marcello Sukhdeo

GRAPHIC DESIGNER

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, Robic LLP; 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

4 BIOTECHNOLOGY FOCUS May 2013

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R & D NEWS IRCM scientists propose the existence of a new code in biology

Benoit Coulombe, Director, Gene Transcription and Proteomics research unit, IRCM Benoit Coulombe, director of the gene transcription and proteomics research unit at the Institut de recherches cliniques de Montréal (IRCM), and his team are proposing a new code in biology. Being called a ‘chaperone code,’ this discovery is redirecting research efforts and offers new hope for the treatment of degenerative diseases.

Human cells function thanks to a multitude of proteins grouped together into an army of small molecular machines that carry out all functions necessary to life – often referred to as protein machines or the ‘proteome.’ The genetic code acts as a guide for creating these protein machines from DNA. “The resulting proteins are not yet functional or active,” Coulombe said. “They must first be folded into their three-dimensional structures and assembled into machines capable of performing their actions. It has been demonstrated that a series of specialized proteins, called ‘molecular chaperones’ carry out this vital function.”

Several degenerative diseases are caused by defects in protein folding, often resulting from abnormal activity in molecular chaperones. While attempting to better understand how molecular chaperones function, the IRCM research team published one of the key articles in the field in the scientific journal PLoS Genetics.

“We identified a family of modification enzymes (named methyltransferases)

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that target and regulate chaperones,” said Philippe Cloutier, a research assistant in Coulombe’s laboratory. “This discovery indicates that the post-translational modification (PTM) of chaperones plays an important role in controlling their activity.

PTM is the addition of a chemical group to a protein, thereby causing a change in the protein’s function,” he said.

Encouraged by this discovery, the research team then analyzed nearly 200 articles published in scientific literature on the role of chaperone modification. The results of their analysis were then published in the scientific journal Biochimica et Biophysica Acta.”

As a result of this discovery and the analysis of the scientific articles, the IRCM’s team is proposing the existence of a code that regulates the activity of chaperones.

This code consists in various modification arrangements that would control the function of chaperones according to the cells’ needs.

“Just as the genetic code stipulates how to make proteins from our genes’ DNA, the chaperone code would specify how to produce functional proteins by orchestrating their folding and assembly into active molecular machines,” Coulombe said. He added that “The existence of such a code regulating the activity of chaperones is redirecting research efforts, because a better understanding on this code could provide us with new weapons to fight various degenerative diseases.”

“Decrypting the chaperone code is currently my laboratory’s top priority. It offers promising possibilities to reverse cell and tissue degeneration associated with numerous diseases.”

“These findings identify a previously unknown way of regulating a particular chaperone that has been linked to the disease ALS (amyotrophic lateral sclerosis or Lou Gehrig’s disease) and to another rare neuromuscular degenerative disease,” said Dr. Paul Lasko, scientific director of the CIHR Institute of Genetics. “This opens up a new approach for targeting therapies against these and potentially other related disorders.

To see this story online visit http://biotechnologyfocus.ca/ircmscientists-propose-the-existence-of-anew-code-in-biology/

Clinical Trials & Patents n Helix BioPharma Corp. (Aurora, ON) has commenced patient screening for the third dose level cohort in its ongoing Phase 1/2 clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland. This follows completion of the first treatment cycle in the three patients enrolled in the second dose level cohort, in which L-DOS47 therapy was well tolerated as reviewed by the Trial Steering Committee. Patients to be enrolled in the third cohort will receive the next LDOS47 dose level as planned in the study protocol, 0.33 micrograms of L-DOS47 per kilogram of patient body weight. Additionally, the company announced that it will be expanding the study through the addition of two new centres in Poland. The company has identified potential sites and is working towards having these new centres initiated and enrolling patients in the next few months.

An independent data safety monitoring board (DSMB) has recommended that Aeterna Zentaris Inc. (Québec City, QC) discontinue its ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.

Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued. The DSMB reported that it was highly unlikely the study would achieve a significant difference in its primary endpoint, progression free survival. No safety concerns were raised.

n

n Qu Biologics (Vancouver, BC) announces it is seeking Canadian participants for its Health Canada-approved clinical trial for the treatment of Crohn’s disease. The Qu Biologics’ Phase 1/2 clinical trial will recruit 60 adults with active, uncontrolled, moderate to severe Crohn’s Disease and evaluate the potential clinical response and disease remission among participants treated with QBECO. The main purpose of this study will be to test whether this investigational treatment is safe and potentially effective for the treatment of Crohn’s disease. Results could be expected as early as the second quarter of 2014, depending on recruitment. The randomized, placebo-controlled, double-blind study will be conducted in Vancouver under the medical direction of Dr. Brian Bressler, a practising gastroenterologist and recognized expert in inflammatory bowel disease (IBD).

Dr. Bressler also holds clinical appointments at Providence Health Care (St. Paul’s Hospital) and the University of British Columbia.

For more R&D news visit http://biotechnologyfocus.ca/ category/bio-pharma/

R & D NEWS Project to develop inexpensive minor stroke test launched in BC

Vancouver Island Health Authority Dr. Andrew Penn points to an image of a stroke patient’s brain taken on a 320-slice CT perfusion scanner Genome BC and Vancouver Island Health Authority announce the launch of a major research project to develop a quick and inexpensive test to accurately diagnose minor stroke, or transient ischemic attack (TIA).

The research team, co-led by Dr. Christoph Borchers at the UVic-Genome BC Proteomics Centre in Victoria and Dr. Shelagh Coutts from the University of Calgary, is using stateof-the-art genomics and proteomics technologies to develop a blood test that can

diagnose TIA for a fraction of the cost of expensive medical imaging using CT or MRI scans. The test will help physicians decide appropriate next steps in treatment.

“Patients having a heart attack can be diagnosed through a blood test almost immediately,” says Dr. Andrew Penn, principal investigator and medical lead for Vancouver Island Health Authority’s stroke program. “With a similar blood test for patients having a TIA, we can prevent 80 strokes ev-

ery year on Vancouver Island - 4,000 across Canada - through early diagnosis that allows us to give the right patient the right treatment at the right time.”

The research team is a collaboration of researchers from the Vancouver Island Health Authority, University of Alberta, Heart and Stroke Foundation of Canada, University of Victoria, University of British Columbia, LifeLabs and PROOF Centre of Excellence. The project is funded through Genome Canada’s recent Large-Scale Applied Research Competition in Genomics and Personalized Health with contributions from Genome BC, Genome Canada, Vancouver Island Health Authority, Alberta Innovates - Health Solutions, the Heart and Stroke Foundation of Canada, Bruker Daltonics Inc, LifeLabs and the Provincial Health Services Authority.

It is the largest research project ever conducted in the Vancouver Island Health Authority thanks to $10 million in funding from Genome BC, Genome Canada, the Vancouver Island Health Authority and other partners.

To see this story online visit http://biotechnologyfocus.ca/project-todevelop-inexpensive-minor-stroke-testlaunched-in-bc/

May 2013 BIOTECHNOLOGY FOCUS 7

R & D NEWS U of S researchers team up with government, academic, industry labs to improve access to malaria drugs Researchers at the University of Saskatchewan are part of an international team of government, academic and industry scientists that has developed a new way to produce the key antimalarial drug artemisinin faster and more cheaply by using baker’s yeast.

“It’s a great privilege to contribute on a project of this scale that takes us right from discovery to an application that can help people suffering from a life-threatening disease,” said Patrick Covello, adjunct professor with the U of S Department of Biochemistry and senior research officer with the National Research Council of Canada (NRC) in Saskatoon.

According to the World Health Organization, about half the world’s population—3.3 billion people—are at risk of malaria. Of the more than 200 million cases in 2010, about 660,000 people died, mostly

children under five years old in Africa.

The U of S team members—Covello, technician Michael Hepp, graduate student Devin Polichuk and NRC scientist Darwin Reed—contributed on the plant genetics and biochemistry side of the project, isolating two genes from sweet wormwood (Artemisia annua) that are involved in the production of artemisinin. The genes, together with one discovered by California-based company Amyris, were then inserted into a highly engineered yeast strain.

The research team, which includes nearly 50 members from the U.S. and Canada, is led by Amyris scientist Chris Paddon. Its work, published in the April 11 edition of Nature, describes their efficient way of producing artemisinic acid, a chemical precursor to artemisinin, using genetically engineered yeast.

Paddon explained Amyris donated the rights to its technology to be freely used for combating malaria. Healthcare company Sanofi was chosen to manufacture the drug, and expects to produce enough for 70 million treatments this year, which scientists estimate could address one-quarter of the world’s needs.

“The technology we developed with colleagues from the NRC will increase the availability of antimalarial treatments as well as lower the cost to millions of patients” Paddon said. “Artemisinin, sourced from the wormwood plant has been used for centuries in treating malaria, but its availability, cost and quality have been unpredictable.”

To see this story online visit www.biotechnologyfocus.ca/u-of-sresearchers-team-up-with-governmentacademic-industry-labs-to-improveaccess-to-malaria-drugs/

Québec researcher catches DNA ‘spelling mistakes’ linked to breast cancer

Jacques Simard, Professor at Université Laval’s Faculty of Medicine and Researcher at CHUQ (CNW Group/ Génome Québec).

Working with an international consortium conducting research on breast, ovarian and prostate cancer among 200,000 people, professor Jacques Simard, holder of the Canada research chair in oncogenetics at Laval University, was actively involved in the discovery of DNA “spelling mistakes” linked to breast cancer. These mistakes – known as genetic variations – are directly involved in the risk of developing breast cancer.

The research was part of an international study on an unprecedented scale performed by the largest international consortia, the Collaborative Oncological Gene-Environment Study (COGS), and coordinated by professor Douglas Easton of Cambridge University. The findings were featured in a series of articles in the science journal Nature Genetics. The results will also be presented in three additional articles published simultaneously in PLoS Genetics and The 8 BIOTECHNOLOGY FOCUS May 2013

American Journal of Human Genetics.

For over 20 years now, professor Simard has been working at the CHU Québec Research Centre on genetic susceptibility to breast cancer. These latest research findings helped identify 49 new genetic variations involved in the risk of developing this disease, almost tripling the number of variations now known. In the vast majority of breast cancer cases affecting the general population, it is the interaction between these genetic variations and other environmental and lifestyle factors that is involved in the development of the disease.

“The vast amount of genetic information gathered through this study makes it one of the most significant breakthroughs in recent years in terms of understanding the inherited risk factors of breast cancer,” Simard said.

“It is now possible to develop a DNA profile where five per cent of women have one in

four chances of developing the disease.”

By understanding the genetic causes and their interaction with environmental factors, professor Simard hopes to pave the way for better prediction of breast cancer risk.

Half of the samples used in the study – over 100,000 – were analyzed in Montréal by genomic experts working at the McGill University and Génome Québec Innovation Centre.

“It was professor Simard’s leadership that secured the involvement in the project of the McGill University and Génome Québec Innovation Centre,” said Génome Québec president and CEO, Marc LePage. “He positioned the centre’s expertise and attracted many international teams, who could have had their findings analyzed anywhere in the world. This is unequivocal proof that we have built a genomic infrastructure of international repute.”

The $1.5 million investment by the Québec Breast Cancer Foundation played a key role in enabling Québec researchers to take part in the international consortium. Other partners include the Canadian Institutes of Health Research, which funded the international interdisciplinary research team working on the inherited risk of breast cancer spearheaded by professor Simard.

To see this story online visit http://biotechnologyfocus.ca/ quebec-researcher-catches-dna-spellingmistakes-linked-to-breast-cancer/

BUSINESS CORNER Mark Lievonen elected to Canadian Healthcare Marketing Hall of Fame Mark Lievonen, president of Sanofi Pasteur Canada, has been elected to the Canadian Healthcare Marketing Hall of Fame.

Lievonen is a 30-year industry veteran and was given the honour for being an advocate for the advancement of Canadian science and innovation and for being a proponent of Canadian competitiveness.

“I am truly honoured to receive this recognition on behalf of Sanofi Pasteur, my colleagues and my community, and I am proud that we have been able to play a small part in preventing disease and saving lives in Canada and all around the world,” Lievonen said. “I am energized by the work we do, inspired by my passionate colleagues and humbled by our role in impacting human lives each and every day.”

The award was first established in 1988 to honour lifetime achievement in healthcare marketing and is the National Pharmaceutical Congress’ main event.

“Through a career spanning over 30 years, Mark Lievonen has made a lasting impact on the industry and served as a source of inspiration to others,” said Mitchell Shannon, publisher of The Chronicle Newspapers, the award’s sponsor. “The judging committee was impressed by Mr. Lievonen’s extraordinary dedication and commitment to the profession. Under his leadership, Sanofi Pasteur has become a billion dollar enterprise in Canada, and is a symbol of Canadian talent, innovation and R&D excellence.”

Sanofi Pasteur Canada helms the Canadian vaccine division of the Sanofi Group that is also a gateway to the company’s North American vaccine business.

Lievonen first joined the organization in 1983 and has been president since 1999 and in addition to the work he’s helped lead on the vaccine front, including the development of the only five-component acellular pertussis combination vaccine in the world, Lievonen also created the Sanofi BioGENEius Challenge Canada, a competition that aims to nurture the next generation of great Canadian scientists.

Mark Lievonen, President, Sanofi Pasteur Limited is inducted into the Canadian Healthcare Marketing Hall of Fame Award by Mitchell Shannon, Publisher, The Chronicle Newspapers at the Canadian Pharmaceutical Congress, held at the Mississauga Convention Centre. (CNW Group/Sanofi Pasteur Inc.) To see this story online visit http://biotechnologyfocus.ca/mark-lievonen-elected-tocanadian-healthcare-marketing-hall-of-fame/

QLT plans US$200-million cash distribution to shareholders QLT Inc. is planning to distribute US$200 million in cash to its shareholders, or about US$3.95 per share — vastly more than the company’s original target for a return of capital.

The record date for the special distribution will be June 24 and the payout would be the following day, assuming it gets shareholder and other approvals.

The Vancouver-based company was once one of Canada’s most commercially successful biotechnology companies based on the success of its Visudyne treatment for a common form of age-related blindness. However, the company hasn’t come up with another blockbuster product and shareholders have pushed

QLT to downsize, resulting in a reduction of its workforce by more than 80 per cent and the sale of Visudyne.

QLT said its board had initially been authorized to return $100 million in capital but will double that with the proposed distribution, which will be subjected to a shareholder vote June 14.

Combined with a previous repurchase of QLT stock, the distribution will bring the total return of capital to US$227 million over the past 12 months.

To see this story online visit http://biotechnologyfocus.ca/qlt-plans-us200million-cash-distribution-to-shareholders/

May 2013 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Xenon Pharmaceuticals Inc. named BC’s top life science company

Dr. Simon Pimstone, president and CEO of Xenon Pharmaceuticals, receiving the LifeSciences BC Life Sciences Company of the Year Award from Russell Williams, president of Rx&D, Canada’s Research-based Pharmaceutical Companies.

(PRNewsFoto/Xenon Pharmaceuticals Inc.)

Xenon Pharmaceuticals Inc. has been awarded the LifeSciences British Columbia Life Sciences Company of the Year Award for 2013.

Xenon is a privately owned, clinical genetics-based drug discovery and development company engaged in developing therapies for rare diseases.

“We are honoured to be recognized by our industry peers in this way,” commented Simon Pimstone, Xenon’s president and CEO. “This is the beginning of a very exciting year for Xenon. We’ve worked diligently and deliberately to create strong partnerships with top tier pharmaceutical companies and to develop a deep and diverse pipeline of products.”

One of Xenon’s early technologies is now in an approved product to treat lipoprotein lipase deficiency. The company also has a late stage clinical program initiating its pain medicine and an early development stage product for the treatment of anemia.

“We look forward to an exciting year at Xenon as our products advance on the

market and in the clinic,” he added.

In addition, Xenon also announced that Merck has exercised its option to exclusively license small molecule compounds for a novel target for the potential treatment of cardiovascular disease. In 2009, Xenon and Merck entered into a strategic alliance where Xenon employed its human clinical genetics platform to validate novel cardiovascular targets and collaborated on the discovery and development of small molecule compounds for those targets. Under the terms of the 2009 agreement, Xenon received milestone payments, an option fee and is eligible for further research, development and regulatory milestone payments of up to US$86.5 million. In addition, Merck will pay Xenon undisclosed royalties on sales of products resulting from the collaboration.

To see this story online visit http://biotechnologyfocus.ca/xenonpharmaceuticals-inc-named-bcs-top-lifescience-company/

Dealmakers n Dalton Pharma Services (Toronto, ON), Dalton Medicinal Chemistry (Toronto, ON) and Cyclica (Toronto, ON) will collaborate on joint identification and development of a number of new drug candidates. The collaboration will utilize Cyclica’s in silico drug design and optimization services as well as provide access to the company’s extensive databases to be applied to a number of lead molecules previously developed by Dalton Medicinal Chemistry, as well as a host of additional compounds. Dalton Pharma Services will synthesize and manufacture quantities of selected drug candidates in its licensed facilities, for analysis and consideration by a leading global pharmaceutical company’s candidate screening program. The assets developed through this agreement will be equally owned by the parties. The hope is the collaboration will provide a cost-effective source of promising drug candidates for pharmaceutical and biotechnology companies by integrating Cyclica’s Ligand Explorer™ and Intelligent Molecular Redesign™ design tools, with Dalton’s expertise in drug discovery, development and manufacturing. n Aeterna Zentaris Inc. (Québec City, QC) has signed a co-development and profit sharing agreement with Ergomed Clinical Research

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Ltd. (Sulzbach, Germany) for AEZS-108 in endometrial cancer. Ergomed was selected as the contract clinical development organization to conduct the multicenter, multinational, randomized Phase 3 trial with AEZS-108 in endometrial cancer. Under the terms of the agreement, Ergomed will assume 30 per cent (up to $10 million) of the clinical and regulatory costs for the Phase 3 trial with AEZS-108 in endometrial cancer, which are estimated at approximately $30 million over the course of the study.

Ergomed will receive its return on investment based on an agreed single digit percentage of any net income received by Aeterna Zentaris for AEZS-108 in this indication, up to a specified maximum amount. n Actavis Inc. has reached settlement agreements with Medicis Pharmaceutical Corporation, a subsidiary of Valeant Pharmaceuticals International, Inc., resolving outstanding patent litigation related to Actavis’ Abbreviated New Drug Application (ANDA) for Clindamycin and Tretinoin Gel, a generic version of Ziana®, as well as Actavis’ ANDA for Imiquimod Cream, a generic version of Zyclara®. Under the terms of the agreement related to Actavis’ generic version of Ziana®, Actavis may launch its generic product in July 2016, or earlier under certain cir-

cumstances. Under the terms of the agreement related to Actavis’ generic version of Zyclara®, Actavis may launch its generic product on Jan. 1, 2019, or earlier under certain circumstances.

Valeant will receive a share of the economics from the generic products sold under the agreements. Other terms of the agreements have not been disclosed. n The Pan-Provincial Vaccine Enterprise (PREVENT), a national Centre of Excellence for Commercialization and Research (CECR), and the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) have signed a collaboration agreement with the South China United Vaccine Institute (SCUVI) and Guangzhou Institute of Respiratory Disease (GIRD), for the joint development of a Respiratory Syncytial Virus (RSV) vaccine. Under the terms of the agreement, the partners will conduct joint research and development activities in China and Canada with an ultimate goal to develop an effective vaccine for RSV.

For more Business Corner news visit http://biotechnologyfocus.ca/category/ industryintel/

BUSINESS CORNER Zymeworks Inc. to receive second milestone payment from Merck Zymeworks Inc. announces a second research milestone in its collaboration with Merck related to its proprietary Azymetric™ platform for the development of bi-specific antibody therapeutic candidates. In conjunction with the terms of the collaboration agreement, Zymeworks is to receive an undisclosed milestone payment from Merck.

Zymeworks granted Merck, through a subsidiary, a worldwide license to develop and commercialize bi-specific antibodies generated through use of the Azymetric™ platform toward certain exclusive therapeutic targets. Both companies will collaborate to advance the technology plat-

form, with Merck working to progress the bi-specific therapeutic antibody candidates through clinical development.

Zymeworks received an upfront fee and is eligible to receive research, development and regulatory milestones with a potential value of up to US $187 million, as well as tiered royalty payments on sales of prod-

ucts. Merck will have exclusive worldwide commercialization rights to products derived from the collaboration.

To see this story online visit http://biotechnologyfocus.ca/ zymeworks-inc-to-receive-milestonepayment-from-merck/

Duchesnay Inc. sets for international expansion following US approval of Diclegis® by the FDA

Following the U.S. approval of its morning sickness medication Diclegis by the U.S. Food and Drug Administration (FDA), Canadian pharmaceutical company Duchesnay Inc. announced its plans for international expansion.

Diclegis has been available in Canada under the trade name Diclectin® for more than 30 years as the only prescription drug specifically indicated and approved for the management of nausea and vomiting of pregnancy, also known as morning sickness. Diclegis® will be commercialized in the U.S. by Duchesnay USA based in Rosemont, PA. The FDA granted Pregnancy Category “A” status to Diclegis, which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.

To see this story online visit http://biotechnologyfocus.ca/ duchesnay-inc-sets-for-internationalexpansion-following-us-approval-ofdiclegis-by-the-fda/

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May 2013 BIOTECHNOLOGY FOCUS 11

By: Blake Dillon

SPOTLIGHT

Wound-healing bandages?

Germ-repelling doorknobs?

McMaster University opens $22M

BIOINTERFACES INSTITUTE Think of doorknobs that repel bacteria, bandages that heal wounds, home test kits for cholesterol, and contact lenses that rarely need changing.

These are the kinds of technologies being developed at the McMaster Biointerfaces Institute, which officially opened its doors in April, 2013.

The $22 million institute – the first of its kind in Canada, and among the first in the world – will use high-throughput synthesis and screening technologies coupled with advanced surface characterization methods to provide a new understanding of the nature of the biological/material interface, or biointerface for short.

Investigators at the lab will test millions of combinations of biological agents and complex surfaces, in pursuit of rapid solutions to stubborn health, safety and other problems.

Leading researchers from a variety of disciplines will use the sophisticated, biosecure facilities to effectively sift through entire haystacks at a time in search of the proverbial needle.

Work that had taken weeks in the past can now be done in hours.

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John Brennan, Canada Research Chair in Bioanalytical Chemistry and Biointerfaces, and the Director of the Institute, can’t hide his enthusiasm when talking about the potential outcomes.

“We already have researchers working on more comfortable contact lenses and ondemand diagnostic tools for just about (any condition) you might want … We are looking at a lot of exciting things along those lines,” he said.

Simply put, Brennan and other researchers at the Biointerfaces Institute are able to make both materials that have biology built into them and materials that resist interactions with biology.

His colleague, Fred Capretta, an associate professor of chemistry at McMaster and a principal investigator at the Biointerfaces Institute, echoes Brennan’s enthusiasm.

He estimates the lab’s robotic systems and advanced microarray printing and assaying tools can test the reactions of tens of thou-

sands of biological samples against a variety of materials every single day, allowing them to “look for multiple needles in multiple haystacks at the same time.”

Capretta explains it like this. “Traditionally, you’d take a biological sample and surface that you think might work, put them together and study them. If that doesn’t work, you discard that surface and you move on to your next surface.”

But that was then and this is now.

“What we’ve decided to do in this lab is high throughput, and that means doing things many times, very quickly, hundreds and thousands of samples at a time,” he said.

Another McMaster colleague, biomaterials engineer Heather Sheardown, is using the Institute’s high-tech capabilities to experiment with materials designed to improve eye health, including how the eye reacts to contact lenses.

Sheardown confirms that bioengineered lenses could eventually allow people to wear their invisible glasses for longer periods of time, more comfortably. That could eventually mean “the end to eye dryness” associated with contact lenses, she said.

The Institute received funding from multiple sources – the Canadian Foundation for

SPOTLIGHT Fred Capretta (right), a principal investigator in the Biointerfaces Institute talks about the state-of-the-art lab with Ontario’s Minister of Research & Innovation, Reza Moridi (far left), and McMaster University’s president, Patrick Deane (centre).

Attracting that attention will come easier as the Institute begins to commercialize its technologies.

While it’s still early days, Brennan – who has kept a watchful eye over the centre he envisioned and has seen grow from concept to completion – is certain that commercializing some of the Institute’s technologies is not far off.

“We’ve got test strip technology for E. coli and pesticides that we’ve brought to a fairly advanced stage and we’re working with a number of industry partners to move that out of the lab,” he said. “I expect that will be among our first success stories.”

While doing his own research and conversing with colleagues from other disciInnovation, Ontario’s Ministry of Research & Innovation, and support from a number of industry partners, including Bruker Canada, Tecan, Physical Electronics, Scienion, Air Liquide and Pro-Lab Diagnostics.

The provincial and federal investments were based on the knowledge that the facility’s research will ultimately improve the health and economy of Ontario and Canada.

This message was loud and clear at the official opening of the Institute at McMaster University.

“This is the sort of progress the world needs more of,” said Reza Moridi, Ontario’s Minister of Research & Innovation.

“The Ontario government is proud to support McMaster’s new Biointerfaces Institute,” he said. “The world-class research being conducted here could lead to a new generation of medical devices and diagnostics that work with the human body, strengthening Ontario’s innovation economy and improving our quality of life.”

It was a similar sentiment from the Government of Canada, represented by MP David Sweet. “Our investments helped establish this state-of-the-art facility and set up a unique training program in the development of biointerfaces that will create jobs and longterm economic prosperity for all Canadians.”

Canada Foundation for Innovation’s president and CEO, Gilles Patry, added that, “without world-class research and access to state-of-the-art equipment, we simply can’t do the research that attracts the world’s attention.”

this in with all the big standard databases, like PubMed, GenBank, and Swiss-Prot,” said Brennan.

“Our intent is to mine all of the biointerface literature that’s ever been written and catalogue it. On top of that, all of the data that we generate at the Institute will also go into the database.”

Brennan, recognized as a global leader in his field, is also working with clinicians to develop a strip that will rapidly identify the cause of respiratory exacerbation, separating asthma patients from patients with infection in mere seconds.

He believes that the new facility gives McMaster University the opportunity to become the global leader in biointerfaces research and a place that will be accessed equally by industry and academics alike.

“We want this project to be the basis for a much larger set of initiatives,” he said. “We want to be able to spin companies out of it.

We want to create a national centre for biointerfaces. We want academics and industry researchers in Ontario and beyond to be

“One of the main things we’re working on right now is creating the global Database of Biointerface Interactions, or DBI, and to link this in with all the big standard databases, like PubMed, GenBank, and Swiss-Prot.”

— John Brennan

plines, Brennan recognized the need for this kind of facility – a one-stop biointerface shop, if you will, where industrial and academic researchers have both the equipment and data at their fingertips.

That equipment includes dozens of machines, but among them are two robots and two advanced microarray printers that are considered to be “the heart” of the lab. Specifically, these robots and printers will help the researchers to test surfaces in parallel and, very quickly, tell them if it has the components or the reaction for which they are looking.

The data, however, is much more farreaching.

“One of the main things we’re working on right now is creating the global Database of Biointerface Interactions, or DBI, and to link

using it. We want, and we very much plan, to be the global leader.”

Brennan estimates that, in five years or so, several hundred students will have gone through and graduated on into groups that are affiliated with the Institute. He expects they should have several hundred papers published, dozens of patents, several licenses and more than a few spinout companies.

To learn more about McMaster’s Biointerfaces Institute, please visit: www.biointerfaces.mcmaster.ca To see this story online visit http://biotechnologyfocus.ca/ mcmaster-university-opens22m-biointerfaces-institute/ May 2013 BIOTECHNOLOGY FOCUS 13

By: Katherine Bonter

CLINICAL TRIALS

CLINICAL RESEARCH AND PATIENT ENGAGEMENT IN

PERSONALIZED MEDICINE

It is largely accepted now that we are in the midst of a major transformation in drug discovery, clinical development and clinical care, one that has the potential to deliver substantial health, social and economic benefits.

14 BIOTECHNOLOGY FOCUS May 2013

By integrating molecular information with an individual’s medical or personal information, personalized medicine (PM) is a key factor in this transformation. Innovations like Pfizer’s Xalkori, Roche’s Zelboraf, and Vertex’s Kalydeco demonstrate the types of impacts that this transformation provides.

PM can shorten approval times and speed drugs to market. For example, Zelboraf and the companion BRAF V600E test were approved ahead of their goal dates, and the FDA PMA review was less than four months compared to the standard of nine to 18 months. Xalkori was on the market only four years after the discovery of its target and companion diagnostic (ALK) and reviewed and approved by the FDA in less than five months. Furthermore, these drugs have been welcomed by patients, physicians and payors, despite their high cost. They have also provided unprecedented advances in treating two deadly cancers, metastatic melanoma (Zelboraf) and non-small cell lung cancer (Xalkori).

Developing drugs that target small populations in partnership with patient organizations can be a recipe for success in PM. Kalydeco,

launched late in 2012, proved effective in individuals who carry a G551D mutation in cystic fibrosis (CF) gene, which accounts for only four to five per cent of CF cases. Although the CF gene was discovered in 1989, by a team that included Lap-Chee Tsui from Toronto’s Hospital for Sick Children and Francis Collins (now director of the NHI and a prominent advocate for PM), Kalydeco is the first drug to target the defects caused by mutations in the CF gene. The early development of the cystic fibrosis drug Kalydeco by Vertex was funded and supported by the CF Foundation in exchange for a royalty on future sales.1 This was critical for the success of Kalydeco and has set a model for similar partnerships between other foundations/patient groups and drug developers.

In all of this, what is the role of patients, or even the general public? How can they participate in this transformation? What contributions can patients make to accelerate progress?

Co-creating value with patients, healthcare consumers, tapping into their knowledge of disease and healthcare, is increasingly a potential driver of clinical innovation. In

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CLINICAL TRIALS the digitized world, individuals have an unprecedented capacity to create, share and manage valuable personal data.2 Online communities of patients with a ‘Citizen Science’ research objective are beginning to demonstrate the benefits of engaging patients more broadly (see Figure 1 for examples).

The examples in Figure 1 rely on an interactive IT interface to engage, communicate and share with participants. The success and growth of this new paradigm reflects important changes in attitudes toward privacy, individual involvement and the value of broader patient participation in research.16 Engaging patients through an interactive IT interface, where the patient has a level of data control, allows for new types of interactions and more effective mobilization of knowledge between patients and researchers, faster recruitment of participants and longitudinal research.

This approach can streamline consent and reduce the need for anonymized data while facilitating patient participation. This type of engagement transforms research subjects into research partners through matching, dynamic negotiation and citizen science.17 High content clinical research addresses real-world clinical problems defined by patient experience and knowledge. It requires biological samples provided by patients and clinical outcomes data measured based on patient experiences. Patient recruitment is a time consuming and expensive part of most clinical studies and widely recognized as a barrier to translational research in PM.

In contrast, patients have traditionally been engaged largely as a donor or a subject, not as a participant. They are often hesitant to act as a ‘research subject’ and may feel not well informed as to the objectives, outcomes and impacts of the study to which they will contribute. Patients are in fact the most important contributor to clinical research.

Unfortunately, less than five per cent of Canadians participate.

Robust, diverse patient registries and detailed patient data are needed for innovation in PM. We now know that different diseases often share molecular features; registries and information that enable crossdisease studies, such as Reg4all, are likely to be fundamental going forward. To date patient groups have been instrumental in creating disease registries and biobanks.

Patient groups are a trusted source patient information and have a direct and altruistic relationship with patients and can act to mediate and enable patient participation and facilitate researchers’ access to patient data and registries. As in the Kalydeco example, foundations associated with patient groups can effectively partner with companies to accelerate progress. For these reasons, patient groups are well positioned to capture and mobilize patient knowledge, create resources for research and interact with various stakeholders, while representing the best interests of patients. Considering the potential public benefits, it is unfortunate how little funding and support patient groups receive from federal and provincial

governmental bodies.

Another area where patient engagement can enable progress is in real-world research. Demonstrating the clinical utility and value of PM products in real-world practice is essential for realizing key elements of the PM paradigm - improved outcomes, fewer adverse reactions and cost-effectiveness.

Traditional Randomized Controlled Trials (RCTs) often do not accurately reflect or inform real-world use where the population treated is more heterogeneous and practice is less controlled. This is particularly the case for PM as narrower populations are targeted and interventions comprise patient stratification/molecular testing and a treatment steps.

Post-approval research is increasingly mandated by regulatory agencies. Adaptive licensing and early access programs are more and more common; allowing earlier patient access to innovations in highly defined populations while requiring a continuous stream of realworld data to inform licensing extensions.18 Pharmaceutical companies’ interests and investments in this area are also increasing and in fact pharmaceutical companies often work closely with patient groups to execute real-world studies. However, better collaboration, interactions and alignment of incentives between health care systems, research institutions, patient groups and companies in this area could help to make the most of these investments/studies and maximize the benefits for all concerned.

Real-world studies including: market access, pharmacoeconomic, comparative

Figure 1: PatientsLikeMe3

23&Me5

The Genetic Alliance13 CuraRata15

• provides a robust method for patients to record and share data online • engaged a community of 190,000 patients covering more than 1,000 conditions • performs observational studies to assess the real-world effectiveness of treatments • one observational study provided the same conclusion as a clinical trial ongoing in parallel4 (with much less time and expense) • showing how this approach compliments clinical trials

• controversial operations as a direct to consumer genetic testing company • created a cohort of more than 100,000 participants for genetic research (probably the largest in the world) • numerous research contributions6 and peer-reviewed publications7,8,9,10,11 • developing and validating methods and best practices for ‘Citizen Science’12

• in partnership with five US patient groups launched Registries for All Diseases (Reg4ALL)14 a crowd-sourced crossdisease registry • allows patients to contribute personal data, control access to these data and engage directly with clinical researchers • uses privacy and online consent methods that are fully compliant with U.S. laws and regulation • Reg4ALL aims to reach over 9,000 research organizations and 1,200 disease advocacy groups

16 BIOTECHNOLOGY FOCUS May 2013

• a data-sharing partnership between eight hospitals in the Netherlands • partners pool clinical information and biomaterials for research • provides an online interface for patient to access and manage their health care data and preferences for data sharing • supports dynamic negotiation between researchers and participants

Clinical Trials • Engaging and pre-characterizing potential participants, • Defining patient populations and capturing longitudinal data, • Developing patient-centric outcomes measure, and • Mediating or facilitating the recruitment and participation of individuals.

effectiveness and implementation studies can uncover unmet medical needs, burden of disease, optimal clinical decision making and treatment practices as and best practices for health care system implementation. In this way, it provides a rich source of information for pre-clinical research and health services research, can enable patient access and guide the adoption of new practices by physicians and health care systems. Clearly better integration of real-world studies with publically funded research efforts could have a major positive impact. Again, patients and patient groups could play a key role in this type of integration.

Patient and patient groups should be systematically engaged in: • Setting priorities for research, • Collecting patient reported data, • Bridging patient populations nationally and internationally,

There are numerous examples of this type of approach developing internationally including CuraRata and Reg4All mentioned above. Additionally, in the UK, the Clinical Practice Datalink19 has been launched to support sharing anonymous National Health Service (NHS) patient data with private healthcare firms, enabling all patients to become research participants and accelerating innovation. In Canada, the BC Health Agency launched an initiative called ‘Patients as Partners’ in 2008.20 This initiative aims to increase patients’ engagement in their own health care as well as in system design and research. As part of this project a network of BC patients was created and a measurement strategy for patient engagement with the health care system was created.

The role of patients, their contributions and participation in clinical research are rapidly increasing and evolving with the shift toward PM. However, we have a long way to go before the participation of patients in clinical research can be fully harnessed and its benefits realized. To start with, we need to educate the stakeholders (including patients and the public) as well as build strategies, networks, resources and tools for patient engagement, stakeholder interactions and information sharing. At Cepmed, we are eager to create and participate in initiatives that can address these needs and promote patient engagement in clinical research in Canada.

References: 1. http://www.forbes.com/sites/matthewherper/2012/12/27/the-mostimportant-new-drug-of-2012/ 2. FORA. New nature of innovation: understanding policy implications of new forms of innovation. Copenhagen: FORA, 2009.

3. www.patientslikeme.com 4. Wicks, P., Vaughan, T., Massagli, M. & Heywood, J. Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm.

Nature biotechnology 29, 411–4 (2011).

5. https://www.23andme.com/ 6. http://blog.23andme.com/articles/ 7. Eriksson, N. et al. Genetic variants associated with breast size also influence breast cancer risk. BMC medical genetics 13, 53

(2011). Henn, B. et al. Cryptic distant relatives are common in both isolated and cosmopolitan genetic samples. PloS one 7, e34267 (2011). Eriksson, N. et al. Novel associations for hypothyroidism include known autoimmune risk loci. PloS one 7, e34442 (2011). Eriksson, N. et al. Webbased, participant-driven studies yield novel genetic 8. Lill, C. M., et al. “23andMe Genetic Epidemiology of Parkinson’s Disease Consortium; International Parkinson’s Disease Genomics Consortium; Parkinson’s Disease GWAS Consortium; Wellcome Trust Case Control Consortium 2.

Comprehensive research synopsis and systematic meta-analyses in Parkinson’s disease genetics: the PDGene database.”

PLoS Genet 8.3 (2012): e1002548.

9. Kiefer, A. et al. Genome-wide analysis points to roles for extracellular matrix remodeling, the visual cycle, and neuronal development in myopia. PLoS genetics 9, e1003299 (2013).

10. Do, C., Hinds, D., Francke, U. & Eriksson, N. Comparison of family history and SNPs for predicting risk of complex disease.

PLoS genetics 8, e1002973 (2011).

11. Eriksson, N. et al. Novel associations for hypothyroidism include known autoimmune risk loci. PloS one 7, e34442 (2011).

12. Eriksson, N. et al. Web-based, participantdriven studies yield novel genetic associations for common traits. PLoS genetics 6, e1000993 (2010).

13. http://www.geneticalliance.org/ 14. www.reg4all.org/ 15. http://www.curarata.nl/uk/3/patients/ home.html 16. Kaye, J. et al. From patients to partners: participant-centric initiatives in biomedical research. Nature reviews. Genetics 13, 371–6 (2012).

17. Kaye, J. et al. From patients to partners: participant-centric initiatives in biomedical research. Nature reviews. Genetics 13, 371–6 (2012).

18. Eichler H-G et al. Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval, Clinical Pharmacology & Therapeutics (2012); 91 3, 426–437. doi:10.1038/clpt.2011.345 19. http://www.cprd.com/intro.asp 20. http://www.impactbc.ca/patientsas-partners To see this story online visit http://biotechnologyfocus.ca/ clinical-research-and-patientengagement-in-personalizedmedicine/ May 2013 BIOTECHNOLOGY FOCUS 17

By Daniela Fisher

innovator

Making the case for

Search and

T

Development

his is a transformative time for biotech. In response to the economic and market challenges, as well as the rising cost for drug discovery and development, companies are changing the way they conduct their R&D. As industry looks for new approaches to drug design, the focus has shifted to strategic partnerships, collaboration and new business models that offer reduced risk for investors. iCo Therapeutics is a Vancouver-based biotech making impressive progress with the changing R&D model. The TSX Venturetraded company eschews traditional R&D, instead in-licensing drugs and working with strategic partners to develop new therapies, with a focus on ocular indications such as Diabetic Macular Edema (DME). Under the guidance of co-founder and CEO Andrew Rae, the start-up’s approach to R&D is geared more towards drug development than drug discovery.

It’s a model that’s paying off for the company. Since its foundation in 2005, iCo Therapeutics has secured the rights to two drug candidates, as well an oral drug delivery system. All target unmet medical needs.

In February, the company was ranked number one in technology and life sciences on the 2013 TSX Venture 50. It’s also in the midst of a lucrative research partnership for a DME treatment with the JDRF (formerly the Juvenile Diabetes Research Foundation), the world’s leading organization for Type 1 diabetes research.

For a company to achieve these successes within 10 years of starting up is an impressive feat.

“Our business model is basically that we don’t have research facilities, we don’t have 18 BIOTECHNOLOGY FOCUS May 2013

a staff of scientists and we don’t do preclinical work. It’s very much focused on reducing the capital inputs,” says Rae. “We’ve been able to become a Phase 2 clinical stage company with just over $20 million invested into the firm. That is just a fraction of what it has normally taken companies in the past.”

This ‘No Research, Development Only’ (NRDO) business model focuses on getting drug candidates from big pharma or universities that are either off-patent, currently approved or near commercialization. iCo then redoses or reformulates the candidate for new or additional indications.

The model is a sign of the times. In

drug through Phase 3 and to market. Or as Rae explains: “Our focus is really running the second and third legs of a 4 x 100 relay.”

Rae is someone who knows how to get a biotech off the ground – and what business models will succeed in today’s financial environment. A serial entrepreneur, with a Bachelor of Science from the University of Western Ontario and an MBA from Simon Fraser University, Rae is on his third start-up company with iCo. For iCo Therapeutics, setting up shop in Vancouver was an obvious choice says Rae. He and co-founders John Clement and John Meekison wanted to access the human capital in town.

“We’ve been able to become a Phase 2 clinical stage company with just over $20 million invested into the firm. That is just a fraction of what it has normally taken companies in the past.”

— Andrew Rae today’s financial climate, investors are attracted to companies that offer lower levels of risk than traditionally associated with biotech firms. In theory, NRDO models offer drugs that already have preclinical or clinical history, and therefore have a good safety signal and potentially efficacy related data. This in turn helps de-risk assets.

Another important factor is the lure of more efficient drug development. iCo Therapeutics licenses products that can be taken into clinical trials immediately. The company focuses on getting a drug from preclinical to Phase 2 studies, and then on finding strategic partners to advance the

One of those local talents was the company’s chief medical officer, Dr. Peter Hnik, who joined the company a year after it was founded. Dr. Hnik has a medical degree from the Medical Faculty of Charles University of Prague, as well as a Master of Health Sciences from the University of British Columbia.

“I practiced ophthalmology for several years and with the patients who had Diabetic Macular Edema, it was always very frustrating to see the limited treatment options available those days. At that time in many cases one could just watch them lose their vision over the years,” says Dr. Hnik.

Diabetic Macular Edema is a diabetic eye

innovator

“It typically comes in kids, small kids up to twenties in age. They suffer tremendously, and may end up with corneal abrasions, ulcers with potential corneal scarring. There are drugs of course that you can use, but they are only efficacious to a certain point. It’s not enough.”

— Dr. Peter Hnik disease that involves fluid leaking from the blood vessels in the eye, which causes the retina to swell and results in blurring and loss of vision. If untreated, overtime DME can render patients blind.

After joining iCo Therapeutics in 2006, Dr. Hnik began working on the company’s first product iCo-007, a treatment for DME. The drug was designed by Isis Pharmaceuticals, from which iCo first in-licensed the candidate in 2005. When injected in the eye, iCo-007 blocks proteins that promote the growth of fragile blood vessels in the retina which can leak or burst and cause gradual vision loss, thus helping to improve a patient’s sight.

The current standard of care – the only approved product – is a drug called Lucentis, which requires monthly injections. The hope with iCo-007 is that patients would need injections only a few times a year, as opposed to every month, creating a large market opportunity by either replacing Lucentis or being positioned as a combination therapy with Lucentis. iCo Therapeutics announced at the beginning of this year that iCo-007’s iDEAL Phase 2 study, which is being conducted by the Wilmer Eye Institute of the Johns Hopkins University School of Medicine, had passed the patient recruitment threshold and had no drug-related adverse events in patients receiving iCo-007.

The iDEAL study is a rare get for a Cana-

dian start-up. The multi-centre clinical trial can enroll up to 208 patients and is being conducted across the U.S. in some of the world’s leading eye centres. This is due in large part to the strategic partnership developed by iCo in 2011 with JDRF, a U.S. organization that over the years has awarded over US$1.5 billion for diabetes research.

This partnership is one of iCo’s most important to date, says Rae. “This is a significant study. We’ve enrolled 174 patients,” he states. “We believe it’s one of the biggest Phase 2 studies in this space currently, which is quite an accomplishment.”

Companies can realize significant advantages through partnerships of this sort.

“Working with JDRF allowed us to reduce the cost of the study by about 40 per cent and also extend our payment schedule,” says Rae. “That kind of leverage allows us to finance quite economically. We also tapped into a clinical network that our CMO, Peter Hnik, is very close to; we have 27 sites that are involved in this study.”

In addition to iCo-007, the company is also developing iCo-008. Also known as Bertilimumab, the human monoclonal antibody has Phase 2 clinical history. iCo acquired the candidate in 2007 from MedImmune Ltd, the biologics division of top-10 big pharma company, AstraZeneca.

The drug candidate is being developed for severe ocular allergies, including vernal and

atopic conjunctivitis, for which there is no viable treatment.

“It’s a horrible disease,” says Dr. Hnik.

“It typically comes in kids, small kids up to twenties in age. They suffer tremendously, and may end up with corneal abrasions, ulcers with potential corneal scarring. There are drugs of course that you can use, but they are only efficacious to a certain point.

It’s not enough.” iCo-008 aims to help fill this unmet medical need and leverage the value of other indications through partnerships. In 2011, a private Israeli firm called Immune Pharmaceuticals licensed the systemic rights to iCo008, to further develop the drug and to look into possible other indications, such as a treatment for Inflammatory Bowel Disease.

The final product that iCo is developing is iCo-009, its Oral Amphotericin B Delivery System. Amphotericin B, or Amp B, is the current Gold Standard for treating systemic fungal infections. However, Amp B can only be administered intravenously. This is not practical in developing countries with less advanced medical infrastructures, and where fungal infections are very common especially in patients with cancer, diabetes and HIV/ AIDS. iCo is the first company to develop an oral form of the IV-administered drug.

Currently at the preclinical stage, the Oral Amp B system was licensed from the University of British Columbia, with whom iCo is still working closely to develop the delivery system. Along with academic partnerships, the Oral Amp B System also secured government funding for iCo Therapeutics.

In 2012, iCo received $1.1 million in research funding from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) for the delivery system. The funding came under the Canadian HIV Technology Development Program.

“Acquiring the Oral Amp B Delivery System from the University of British Columbia was really about moving further up the food chain, because we were identifying a platform that could be used with generic products,” says Rae. “It is really an asset.”

In the future, along with further developing its pipeline assets, the company aims to find a license partner to get iCo-007 to Phase 3 and market. In addition, iCo is focused on finding global partnerships and joint ventures to further establish its presence as a leader in British Columbia’s ophthalmologic market.

To see this story online visit http://biotechnologyfocus.ca/ making-the-case-for-searchand-development/

May 2013 BIOTECHNOLOGY FOCUS 19

By: Shawn Lawrence

inFECtioUS DiSEaSE

FEDERAL REGULATORS GIVE

intervac

stamP of aPProval

A

fter nearly a decade since the original concept was conceived, federal regulators, including the Public Health Agency of Canada and the Canadian Food Inspection Agency, have given the stamp of approval to the Vaccine and Infectious Disease Organization’s containment level 3 (CL3) facility – the International Vaccine Centre (VIDO-InterVac) at the University of Saskatchewan (U of S).

The facility, built at a cost of $144-million, is one of the world’s most advanced CL3 vaccine research centres and one of the largest of its kind. It is the product of a funding partnership among the Government of Canada, Canada Foundation for Innovation, Government of Saskatchewan and City of Saskatoon, with support from the U of S and one can’t emphasize enough the importance of the work that will go on here.

“We’ve got a facility that ensures the 20 BIOTECHNOLOGY FOCUS May 2013

safety of the public and the people physically located in the building and now we can proceed with defining the research that will go on,” says VIDO-InterVac director and CEO Dr. Andrew Potter, acknowledging that while certification did not come as quickly as he hoped, he is excited to see a decade of planning, design and construction come to fruition.

The question of course is, what took so long? Potter explains it was simply a case of the nature of the facility.

“For starters, it had to meet the safety and operational standards of both agencies since both animal and human viruses and pathogens will be studied. By definition the research that will go on in the facility could be considered risky, both to the public but more so the people working in it due to the nature of containment level three pathogens. As such, the regulators examine the facility with a fine tooth comb.”

According to Potter, this included vigorous testing of all the building’s systems and backup systems, ensuring that they function safely, properly and effectively, providing

answers to questions like what happens if there is a power outage or simply mimicking system failures to ensure backup systems work properly.

“Being cutting edge, InterVac has all the new bells and whistles. As an example, in the animal portion of the facility, typically submarine-like doors are used to maintain pressure, but we’re using a totally different technology that has inflatable bladders to seal the doors. And because of the scope and size of the facility, in cases even when the technology isn’t new, it becomes new.”

Potter cites the facilities high efficiency particulate air (HEPA) filters, which handle air filtration at InterVac as an example.

While sometimes found in houses and office buildings, at InterVac there are hundreds of these filters. Monitoring them and ensuring they work properly becomes a more complex process which is done robotically.

Overall, the 145,000-square foot facility is designed to remain operational in the instance that any system fails. This includes three backup generators that will activate in

INFECTIOUS DISEASE

“Anyone in the country is welcome to use it whether they be public sector, private sector, whether they be government, universities, it doesn’t make any difference.”

— Dr. Andrew Potter, VIDO-InterVac director and CEO

the event of a power failure – only one is required to run the facility properly.

InterVac is made up of two wings, one housing six CL3 labs for the study of human and animal health, the other housing 18 CL3 isolation suites that house the animals.

In terms of the work that will go on at InterVac, Potter says it’s really a mixed bag, but will expand on VIDO’s strengths.

“I think first and foremost one of the things that we’ve done well with VIDO over the years is trying to develop platform technologies that can be applied to multiple diseases and we will continue to do this with InterVac on a larger scale with CL3 pathogens. InterVac also goes a long way to not only improving our capability to carry out basic research, but also applied research. The name of it is the International Vaccine Centre, but of course it can do any type of work in the infectious disease field that requires containment, not just vaccines.

Anyone in the country is welcome to use it whether they be public sector, private sector, whether they be government, universities, it doesn’t make any difference.”

The next step he says is prioritizing which projects will be undertaken at the facility.

“If we were to list what projects we’re looking at, certainly tuberculosis -- both animal and human -- prion diseases, such as chronic wasting disease, influenza and hepatitis C all rank highly. There’s also exotic diseases, such as African swine fever and we’re talking to the department of defence here as well as in the United States about developing protection for bioterrorism agents. Finally, there’s also some of the old standbys such as bubonic plague which we’re currently working on with a scientific group in Kazakhstan and discussing bringing some of that research to Canada now that we have this facility. From a user perspective, there’s a long list involving academic partners, government, VIDO scientists and commercial partners. There isn’t any one source either geographically or by sector that will be the first users of the facility, it will be a mixture.”

Likewise, by virtue of the animal rooms that have been constructed InterVac can also focus on diseases that can cross species – termed zoonotic.

“Animal rooms tend to be very mundane things, but we’ve got some phenomenal technologies that are going to allow different things to be done. This includes Canada’s only aerosolized pathogen lab and one of only 25 worldwide. It’s elaborate equipment that can measure out viruses at the level of a single virus particle, and infect animals via aerosol. And while many groups can do aerosol work, we can do certified aerosol work. This makes a huge difference.”

Such a technology could prove useful in the coming months with the emergence of a new strain of avian influenza, such as H7N9, that has emerged in China during

the last few months. Of the more than 120 people reported to be infected thus far, 27 have died , with many more still severely ill in hospital (Figures as of May 1, 2013). It’s likely if Canada needed to quickly develop a vaccine for this new strain of pandemic influenza, there could be research done at the Saskatoon facility.

He adds that regulators will still review and issue permits for each individual project, but such project approvals should happen quickly - within weeks.

All told, Potter estimates that it will take three years until scientists are using InterVac to its full potential. At the same time, he adds, the facility may not be finished growing or expanding on its services.

“The way the facility is built, both the laboratories and animal rooms are modular in nature, so you can set up anything you want in any of the rooms,” said Potter. “As such it’s very adaptable to the needs of our clients. Likewise, we have some empty areas in the building because it was actually more cost effective to build InterVac with some empty space, engineering design dictated that. So, one of things we’re looking at for InterVac is to build a process development and pilot scale vaccine manufacturing facility which could be accessed by anyone in the country who wants to use it, by a variety of mechanisms. It’s something that we’re already discussing from a feasibility perspective with potential users and investors, both private and public.”

To see this story online visit http://biotechnologyfocus.ca/ federal-regulators-giveintervac-stamp-of-approval/ May 2013 BIOTECHNOLOGY FOCUS 21

By: Laura Knox-Wallar

Clinical Trials

Campaigning for Full Disclosure

I

n a time that personalized medicine is gaining popularity, the effects and efficacy of traditional pharmaceutical drugs is coming under question. In particular, access to information about these traditional drugs is becoming a bigger and bigger issue amongst health care providers and practitioners.

Pharmaceutical drugs typically go through three phases of clinical testing, (called Phase 1, 2 and 3 clinical trials) to determine the efficacy and side effects of the drug being developed. For each phase of the trail, a study occurs in which there are results, both positive and negative, that are recorded. Of all of these reports, less than half are published.

While this has been a known fact in the industry for quite some time, just recently an organization in the U.K. spear-headed by Ben Goldacre, a British physician, academic and the author of “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” has taken up a cause to have all drug companies legally obligated to publish in total transparency all clinical trial results.

The campaign, called All Trials, has gained traction with almost 50,000 signatures on record, including drug giant GlaxoSmithKline.

The majority of signatures are from physicians and research organizations that prescribe the pharmaceutical drugs to patients. Its goal is to have greater transparency and accountability within the drug development process.

Due to the lack of data regarding the clinical results of many drugs on the market, health care practitioners feel that their decisions when buying drugs and prescribing drugs are inhibited by a lack of information. Studies have shown that trials with significant positive results are more likely to be published than those with non-significant or negative results. This publication bias also carries over into the sale of the drug resulting in the prescription of drugs that may be more expensive and not ideal or effective for the patient taking them.

“It would mean that all of the data is available rather than just the data that companies want to make public. That would mean that meta-analyses and clinical guidelines would be based on all of the available knowledge and in my opinion would mean that doctors’ prescribing would be improved and patients’ would be more likely to be helped by the medications that they get and less likely to be harmed,” says Lexchin about the positive consequences of having the industry publish all results from their trials.

22 BIOTECHNOLOGY FOCUS May 2013

Though it has received more publicity in the U.K., the issues raised by the All Trials campaign have special significance to the Canadian industry. According to Dr. Joel Lexchin, practicing physician and professor at York University, unlike the FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., Canada has no registration or regulatory system for the publication of clinical trials. This means that any Phase 1, 2 or 3 trial conducted by a Canadian pharmaceutical company does not need to be registered with HealthCanada. Therefore, companies can publish, or not publish, whichever trial results they wish.

Recent attention in the media regarding the ‘muzzling’ of Canadian scientists and incomplete sales pitches to physicians by pharmaceutical salesmen and women that disregard negative side effects of drugs raise even more questions about the All Trials debate. According to a recent Maclean’s article (Nov. 2012), American pharmaceutical companies are subject to a fine of $10,000 per day for trials failing to register or report the results of clinical trials. In Canada, only federal funded research is subject to such requirements, with industry, this is not the case. There are portals that exist to facilitate registration or reporting of clinical trial results, such as clinicaltrials.gov and the International Federation of Pharmaceutical Manufacturers and Associations’ Clinical Trials Portal, however, publication is not mandatory for Canadian firms.

According to Lexchin, HealthCanada has considered setting up its own online registration system as far back as 2005, but nothing has come to fruition. Regarding the All Trials campaign itself Lexchin notes that the agency has remained silent.

While there are a number of reasons Canadian pharmaceutical and biotech companies may not wish to publish their trial results, whether for time, expense or issues regarding publication bias, the lack of transparency raises important questions about our regulatory environment that echo the goals and aspirations of the All Trials campaign in the U.K.

To see this story online visit http://campaigning-for-full-disclosure/

By Kindha Gorman

Across canada

SCC to Launch

National Biotech Standards Committee Canadian subject matter experts who develop standards are unsung heroes. They may not wear capes and fight crime, but they help us be more productive, safe and healthy by lending their expertise to develop standards.

A

s an essential part of technology, innovation and trade, standards ensure products become more effective and efficient. Standardization provides an invisible infrastructure ensuring our cars start in the morning, our computers turn on, and our microwaves reheat our leftovers.

The same is true in biotechnology. Standardization in this industry ensures our water is safe to drink, our crops are fruitful, and our medicine works when we’re sick.

On a national level, it also helps us make advancements, promotes innovation and facilitates international trade.

Recently, the International Organization for Standardization (ISO) member body for Germany submitted a new work item proposal for a developing field of technical activity on biotechnology. The proposal aims to launch a new technical committee on biotechnology standards to develop internationally recognized terms and conditions, analytical and diagnostic methods, computing tools and other useful resources. The idea is to reduce duplication while promoting collaboration between like-minded international organizations.

Plus, subject matter experts around the world can participate in the process, share their knowledge and integrate the results of specific standards into their work. The aim is to build an effective international link between researchers, industry and regulatory organizations.

In response, the Standards Council of Canada (SCC), the Canadian member of the ISO responsible for ensuring a Canadian voice in international standardization, announced its intention to establish a Canadian committee on biotechnology. This Canadian committee will provide Canada’s position and views into the development of international standards. These Canadian committees are also known as mirror committees.

“We consulted Canadian subject matter experts in industry, government and consumer groups to see if there was interest in standardization in this promising new area of work,” says Sylvie C. Lafontaine, SCC’s vice-president, Standards and International Relations. “The response was very positive. Stakeholders are eager to commit to representing Canada by participating in the development of international standards May 2013 BIOTECHNOLOGY FOCUS 23

Across canada “We consulted Canadian subject matter experts in industry, government and consumer groups to see if there was interest in standardization in this promising new area of work. The response was very positive. Stakeholders are eager to commit to representing Canada by participating in the development of international standards for biotechnology.”

— Sylvie C. Lafontaine, SCC’s vice-president, Standards and International Relations

for biotechnology.” Through this process, Canada voted to approve the creation of a new international technical committee on biotechnology and to establish a Canadian mirror committee.

As Canada’s national standards body, SCC represents Canada on the two major international standardization bodies, the ISO and the International Electrotechnical Commission (IEC). SCC’s Canadian mirror committee related to the ISO’s biotechnology committee, will be working in consultation with biotechnology stakeholders in industry, government and academia, and will monitor the development of the international standard to vote for or against its acceptance based on Canada’s interest. The advancement of Canada’s economy, the facilitation of domestic and international trade, and the well-being of Canadians weigh heavily on these decisions.

With the Government of Canada’s release of the latest budget, the timing of this ISO biotechnology committee is excellent. The federal budget’s commitment to advancing biotechnology research and innovation showcases the government’s support of the biotechnology sector. Standardization will continue to increase in importance as the influx of funding takes effect and bolsters advancements.

24 BIOTECHNOLOGY FOCUS May 2013

While improving our competitive edge is a valuable benefit, the establishment of a Canadian committee on biotechnology also ensures Canada’s unique biotechnology research and industry landscapes are represented internationally and ultimately have a positive impact on the average Canadian.

In the field of biotechnology, compliance with standards is vitally important. “The establishment of ISO standards for biotechnology may be very useful in advancing health, safety and the welfare of workers and the public by emphasizing the need for both human and environmental safety and security throughout the development and commercialization of new products of biotechnology,” says Arash Shahsavarani, Unit Head, Regulatory Science and Policy Unit in the Biotechnology Section at Environment Canada. “Standardization in the production stage can mitigate potential risks to workers and ensure the quality of the end product.”

“Biotechnology is evolving rapidly,” says Lafontaine. “Given our growing population, changing environmental factors, and advancements in healthcare, standardization in biotechnology is critical to maintain functional, valid and sound innovation.”

Canada is certainly no stranger to advancements in biotechnology. “Canada is a world leader in some areas of biotechnology, in particular the area of nanocrystaline cellulose from wood pulp,” says Dr. Robert Crawhall from ICEage Digital Detection. “We already play an important role nanotechnology. Involvement in the biotechnology standards would strengthen our competitive advantage internationally.”

Standards that are developed internationally are becoming increasingly valuable.

They complement uniform methods of production and reduce transit time and red tape. Establishing a Canadian mirror committee on biotechnology will help Canada

continue to establish itself in the field and assist Canadian companies as they face competition on a global basis. By helping to shape the international standards landscape, Canada gains an important advantage.

This new committee supports other Government of Canada initiatives in this sector.

Health Canada’s Canadian Biotechnology Strategy (CBS) complements the regulatory and research activities of various federal departments related to the emerging field of biotechnology. In line with the CBS, Canada’s participation in this new international technical committee will ensure that Canadian needs are voiced and positions are reflected to further “ensure that Canadians have access to, confidence in and benefit from safe and effective biotechnology-based products and services.” (CBS) This Canadian technical biotechnology committee would also showcase Canada as a responsible front-runner in the industry.

SCC is a federal Crown corporation that promotes efficient and effective standardization in Canada. SCC is Canada’s ISO representative and is responsible for coordinating Canadian participation in the development of international standards. It also accredits standards development and conformity assessment organizations.

For more information on how to participate in SCC’s Canadian mirror committee on biotechnology, please contact: Mick Lord, director of Standards Operations, at mlord@scc.ca.

To see this story online visit http://biotechnologyfocus.ca/ scc-to-launch-national-biotechstandards-committee/

NEW PRODUCTS of process parameters. It is designed for cultivation of mammalian cells in suspension culture and can also be used for applications ranging from general life sciences research to seed train operations and full Good Manufacturing Practice (GMP) production at the two-to-20 litre scale.

Balances Sartorius announces the launch of its new Secura® laboratory balance designed for users who work in regulated environments and need high-quality results. The balance monitors its ambient conditions automatically, thereby preventing handling errors. Nine different models of the Secura balance are available, covering a range of weighing capacities from 120 grams to 5,100 grams, and a readability of 0.1 to 10 milligrams. The balance is also equipped with various assistance systems designed to prevent further processing of uncertain weighing results, which frequently occur through operating errors during weighing. If errors occur, the balance identifies the uncertain weighing results in the display and blocks their transmission. In addition, the balance’s calibration and adjustment function, isoCAL, informs the user and automatically adjusts the balance using internal weights.

Every adjustment is documented and can be traced for quality assurance purposes.

Web: www. sartorius.com Sample Preparation The Metrohm 909 UV Digester is a digestion instrument for UV photolysis of water samples with low to medium organic loads. Intended for sample preparation in trace element determination by means of voltammetry, ion chromatography and spectroscopy (AAS, ICP), this instrument features an operating unit and wet end as well as air

Web: www.pall.com/bioreactors

buffers and media from liquid-to-liquid and power-to-liquid, as well as re-suspension applications. It has a docking station with an adjustable top-mounted, angled mixing system for either a single-use bioprocess container bag or liner in stainless steel or standard plastic drums that can accommodate volumes from 50 to 300L with a 5:1 turn down ratio.

Web: www.thermofisher.com Load Cells Omega introduces its new series of waterproof, low profile load cells for wet or washdown applications. The high accuracy LSHD has an all stainless steel construction for harsh industrial environment with one per cent interchange-

ability for scale applications. It features a three metre waterproof cable but longer lengths are available. Ideal for industries involving chemical, water petroleum and scales.

Web: www.omega.ca Bioreactors Pall Corporation launches cooling and automatic control of digestion temperature and time. It can take up to 12 samples with a maximum of 12 mL sample volume each.

Web: http://metrohm.com Mixers The new HyPerforma Single-Use Mixer (SUM) DS 300 system from Thermo Fisher Scientific Inc. is a single-use mixer ideal for pilot-scale liquid preparations for vaccine and biologic manufacturing. The system can be used for both upstream and downstream processing, and is designed for multiple uses including mixing

Sensors Gems Sensors & Controls’ new CAP-100 Series Capacitive Liquid Level Sensors feature a non-contact/nonintrusive sensor that senses from outside non-metallic reservoirs or bottles with wall thicknesses up to 0.39” (10mm) thick

its XRS 20 Bioreactor System. The new bioreactor incorporates a single-use Allegro™ 3D biocontainer and a touchscreen interface for easy monitoring and control

without attaching the bottle. The sensor supports aqueous or non-aqueous liquid detection, with a choice of Wet- or Dry-Sink switch actuation. The CAP-100 sensors are CE-approved and incorporate LED signal and power indicators with an integrated potentiometer that allows for sensitivity field adjustments. The compact sensors are ideally suited for vessels containing biohazardous liquids and medical applications such as waste, reagent, buffer or diluent as well as dark, sticky or viscous fluids.

Web: www.gemssenors.com Temperature Controllers Oven Industries Inc. announces its new laboratory ramp and soak temperature controller.

The enhanced 5R6-900 bench top unit is contained all in one enclosure and can be plugged into the wall as a self-contained temperature control system with its own power supply. The device can be used universally, which allows the user to use the device wherever they are located. As a solid state MOSFET bidirectional compact unit featuring an internal power supply, it is also capable of loading currents up to 10A and is user-friendly and PC programmable.

Web: www.ovenind.com May 2013 BIOTECHNOLOGY FOCUS 25

NEW PRODUCTS Peristaltic pump Aalborg® Instruments TPU1 and TPU2 Pump Heads are designed to move liquids of low to high viscosity from source to destination at user-set speeds according to the motor installed. Each head is mounted on a front panel with an adjustable occlusion wall and safety cover. Installation is quick and

easy, simply attach the pump head to your motor using the existing mounting holes or modify them to fit your need.

Web: http://www.aalborg.com/ Balances and Scales Mettler Toledo PINMOUNT SWC515 weigh modules let you add weighing capabilities to your process by converting a tank or conveyor or other structure into a scale. They are designed for static and dynamic applications where loading involves horizontal forces. PINMOUNT is available in capacities of 7.5t, 15t, 22.5t, 30t, 50t and 100t. The incorporated load

Company measure only 6mm in diameter and 8mm in length and they come available in standard lasing wavelengths from 635nm to 852nm with standard output powers from 0.9mW to 75mW although customised versions can be manufactured to order. They have an elliptical output beam with a collimated diameter of only 2.5 x 2mm which is bore-sighted for greater precision. The output beam can be collimated or focused as necessary.

Web: www.oe-company.com/ Evaporator The new KD Scientific Centrifan™ PE is a compact evaporator/ concentrator for research, pharmaceutical, and biotech labs working with samples such as DNA, RNA and protein.

Its self-generated blowdown technology eliminates the potential problems with common evaporation systems such as vacuum centrifuges, rotary evaporators, nitrogen blow-down and freeze dryers. It also dries samples without the monitoring required by a rotorvap. In addition, the system works well for processing fractions collected from flash liquid chromatography.

from the improved accuracy and reproducibility of results, the EasyDirectTM titration software stores and collates all records and archives data to minimize confusion, errors and misinterpretation of results. Start your routine analysis with a LongClick™ on the home screen. The intuitive navigation speaks 15 languages. iTitrate Intelligence makes method programming simple with EasySetup guidance. Set only the minimal parameters and the titrator programs the rest, including correct calculations based on desired measurement units.

Web: www.mt.com/easyplustitration Hot Plate The new EchoTherm™ Model HS61 Large Surface Programmable Stirring Hot Plate from Torrey Pines Scientific, Inc. comes equipped with precise temperature ramping for use in chemical, pharmaceutical, environmental, biochemical and other laboratories where reproducible, accurate, hands-off sample preparation and experimentation are a must. The unit stores 10 programs in its memory of as many as 10 steps. Each step is a temperature,

Web: www.kdscientific.com

cells host an on-board microprocessor to monitor internal and external influences that affect weighing accuracy. It compensates for temperature changes, vibrations, hysteresis and non-linearity, providing accurate results.

Web: http://ca.mt.com/ca/en Laser diode collimators Optoelectronics Company has introduced a range of tiny laser diode collimators with high alignment accuracy specifically aimed at OEMs and system integrators using laser-based technology in their products. The laser diode collimators from the Optoelectronics 26 BIOTECHNOLOGY FOCUS May 2013

Titrator The Mettler Toledo EasyPlus™ is a compact and simple titrator specifically designed for basic requirements and first time users of automatic titrators in the food and chemical industries. This new model focuses specifically on accurately automating routine titrations. Apart

temperature ramp rate, stirring speed and time. Each program can be made to repeat itself automatically from one to 98 times or infinitely if desired. All programs are stored electronically. Temperature ramping rates are settable in 1ºC/Hour increments from 1ºC/Hour to 450ºC/Hour. The heater plate is a 12” x 12” solid ceramic for excellent chemical resistance and quick heating from ambient to 400°C. Accuracy is 1 per cent of the reading using platinum RTD circuitry.

The units are supplied with temperature calibration certificates traceable to NIST and solution probe. Stirring speed is 100 to 1500 rpm and controlled by optical coupler to 10 rpm.

Web: www.torreypinesscientific.com/

NEW PRODUCTS Particle Analyzer The Beckman BioPhotometers The Eppendorf BioCoulter DelsaMax PRO light scattering and Photometer D30 is the third generation of zeta potential analyzer provides precise Eppendorf BioPhotometers. Measurement measurement of the size, structure and data with this device can be recorded for charge of particles 0.4 to 10,000 nm in fixed wavelengths, making it ideal for routine new card:Layout 9:09 AM Page 1 detection instrument portdiameter in as little as one second. 1Its1/31/2013 applications.

The folio of Eppendorf is supported by accessories and consumables, such as the UVette®, a UV-transparent disposable cuvette, and the new semi-micro and macro Vis Cuvettes.

Additional accessories that include reference filter sets and a microvolume measurement cell, the µCuvette G1.0, to measure sample volumes of only 1.5µL, are available.

Web: www.eppendorf.com

SRC101

Avalanche photodiode detector provides size measurements and 31 independent photodetectors measure zeta potential, dramatically reducing analysis time.

Chemistry and material applications are facilitated in the PRO through fast, reliable measurement of sub-10 nm particles, weak scatters and dilute systems. Measuring zeta potential in particles down to 1 nm means that small biologicals can be analyzed and proteins in native conditions are not damaged. This allows stable and reproducible assessment of zeta potential and isoelectric point even at very low volumes and low concentrations.

Web: www.delsamax.com/ Gas Chromatography The new Tracera gas chromatograph from Shimadzu Scientific Instruments integrates a new barrier discharge ionization detector, making it possible to reveal trace components not easily detected by other devices. Capable of providing high-sensitivity analysis of organic compounds, permanent gases and light hydrocarbons, the device’s barrier discharge ionisation detector responds to all compounds except He and Ne.

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CALENDAR JULY 2013

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July 7-9 Biotechnology & Human Health Symposium Venue: Georgetown Royalty, PEI Tel: (902)367-4400.

Email: jennifer@peibioalliance.com Web: http://biotechnologyandhumanhealth. com/

July 15-17 Third International Conference on Environmental Pollution and Remediation Venue: Toronto, ON Tel: +1-613-695-3040 Email: icepr2013@International-ASET.com Web: http://icepr2013.international-aset.com/

July 20-23 Protein Society 27th Annual Symposium Venue: Boston, MA Tel: 301-634-7277 Fax: 301-634-7271 Email: cyablonski@proteinsociety.org Web: http://www.proteinsociety.org/ symposium/

July 20-24 2013 ACA Annual Meeting Venue: Honolulu, HI Tel: 716-898-8690 Fax: 716-898-8695 Email: marcia@hwi.buffalo.edu

AUGUST 2013 August 4-8 Microscopy & Microanalysis 2013 Venue: Indianapolis, IN Tel: 703-234-4115 Fax: 703-435-4390 Email: MMRegistration@microscopy.org Web: http://www.microscopy.org/ MandM/2013/index.cfm

August 4-7 12th International Conference on Ceramic Processing Science Venue: Portland, OR Tel: 240-646-7054 Fax: 240-396-5637 Email: customerservice@ceramics.org Web: http://ceramics.org/meetings/ 12th-international-conference-onceramic-processing-science

August 5-8 AAPM Annual Meeting Venue: Indianapolis, IN Tel: 301-209-3350 Fax: 301-209-0862 Email: 2013.aapm@aapm.org Web: http://www.aapm.org/ meetings/2013AM/

August 5-7 Fourth International Conference on Nanotechnology: Fundamentals and Applications Venue: Toronto, ON Tel: +1-613-695-3040 Email: icnfa2013@International-ASET.com Web: http://icnfa2013.international-aset. com/

August 10-14 2013 APS-MSA Joint Meeting Venue: Austin, TX Tel: 651-454-7250 Fax: 651-454-0766 Email: aps@scisoc.org Web: http://www.apsnet.org/meetings/ annual/Pages/default.aspx

SEPTEMBER 2013 September 8-12 246th ACS National Meeting & Exposition Venue: Indianapolis, IN Tel: 202-872-6061 Email: nationalmeetings@acs.org Web: http://portal.acs.org/portal/acs/ corg/content?_nfpb=true&_pageLabel=PP_ SUPERARTICLE&node_id=1051&use_ sec=false&sec_url_var=region1&__ uuid=d87ec41d-c0d7-4095-86592307a79d2d40

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AeternaZentaris Inc..................................................................................................6................................................................................................... www.aezsinc.com Albert at Bay.......................................................................................................31..................................................................................... www.albertatbay.com Best Western Victoria Park Suites...................................................................31....................................................................................www.victoriapark.com Children’s Miracle Network...............................................................................7.................................................................www.childrensmiraclenetwork.ca City of Mississauga............................................................................................11......................................................................www.mississauga.ca/business Cyclica........................................................................................................................10................................................................................................www.cyclicarx.com Dalton Pharma Services ........................................................................................10....................................................................................................www.dalton.com Duchesnay Inc..........................................................................................................11............................................................................................ www.duchesnay.com Eppendorf...........................................................................................................32.......................................................................................www.eppendorf.com Government of Canada.....................................................................................7...................................................................................www.publichealth.gc.ca Helix BioPharma Corp.............................................................................................6....................................................................................www.helixbiopharma.com Merck.........................................................................................................................11.................................................................................................... www.merck.com Optum...................................................................................................................5.................................................................................. www.optuminsight.com POI........................................................................................................................17........................................................................................................ www.poi.ca QLT Inc........................................................................................................................9.......................................................................................................www.qltinc.com Qu Biologics...............................................................................................................6............................................................................................www.qubiologics.com Valeant Pharmaceuticals International Inc........................................................10.................................................................................................. www.valeant.com VWR.......................................................................................................................2.................................................................................................... www.vwr.com Xenon Pharmaceuticals.........................................................................................10.....................................................................................www.xenon-pharma.com Zymeworks...............................................................................................................11...........................................................................................www.zymeworks.com 28 BIOTECHNOLOGY FOCUS May 2013

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THE LAST WORD

By Raphael Hofstein

Building a Catalytic Reaction across Canada’s

Life Sciences Sector

I

n chemistry, according to Encyclopædia Britannica Online, a catalyst is any substance that increases a reaction’s rate without itself being consumed. Kinetically, Wikipedia tells us, catalytic reactions are typical chemical reactions where the reaction rate depends on the reactants’ frequency of contact in the rate-determining step. Usually, the catalyst participates in this slowest step, and rates are limited by the amount of catalyst and its “activity.”

Raphael Hofstein, I would like to propose a second defipresident & CEO, nition within the context of knowledgeMaRS Innovation based economies, where a catalyst is the minimal funding that allows promising early-stage technologies to bridge the “Valley of Death.”

As a chemist by training, catalysis intuitively describes for me what it takes to successfully translate sensational discoveries into transformational healthcare advancing processes and products.

But in Canada’s life science sector, true catalysts are quite rare.

More accurately, angel investors willing to advance scientific findings from the bench to the bedside are not abundant entities in Canada.

And without this particular brand of catalysis, the chemical reaction that produces the sweeping rates of innovation and company creation desired by government, investors and Canadians seeking highly-qualified jobs in their native land will proceed at a very low rate.

Correspondingly, the likelihood of Canadians benefitting from their country’s sizable research investment and its contingent outcomes is low to nil.

The federal government’s recent initiative to revitalize the Canadian venture funding industry through the $400 million now earmarked for venture capital activity, demonstrates the government’s equal concern regarding this rate of return. While it is a very significant and positive move in the right direction, one has to ask the key question: is it relevant to the medical science sector? What kind of catalysis will it produce?

While it remains a positive signal, this funding’s successful implementation depends on various players taking the right steps to prime the venture capital ecosystem. The kinetic barrier has to be reduced by de-risking the assets in play, which remains the responsibility of both provincial governments and angel investors.

Yet, Canada has lost the energy required to address de-risking simply because no significant financial tools came to replace labor-sponsored funds, the main engine of the 1990s. Provincial governments created certain vehicles to fill the void, but clearly at suboptimal levels; simultaneously, angel investors did not emerge in sufficient numbers to assist the life sciences sector.

It is time to address the need for a mechanism to bridge the valley of death’s chasm. The first step is comparing notes with other jurisdictions where governments have moved to close the gap. Massachusetts’ $1 billion campaign, which enabled that state’s life science industry to 30 BIOTECHNOLOGY FOCUS May 2013

overcome hurdles that inflicted other economies, is a prime example.

Massachusetts remained attractive to a wide spectrum of strategic partners, including Sanofi, Pfizer, GlaxoSmithKline and Novartis.

Strategic alliances exist wherever early-stage technology development is extensively and creatively addressed. Yet as any entrepreneur will tell you, angel investors aren’t likely to come to the table in a significant way until early-stage technology is sufficiently de-risked for their purposes. To ensure their participation at an early stage, even earlier catalytic financing is required to establish a mutually-tolerable comfort zone.

The task of taking the necessary action required to ensure that tolerable risk in the ratios that produce significant results falls to federal and provincial governments alike. While numerous agencies, including MaRS Innovation, have been tasked to cover the gap, the level of financial support remains suboptimal.

As in the case of chemical catalysis, there ought to be a certain minimum concentration of the catalyst, still very small relative to the whole, which allows the innovation reaction’s kinetics to safely cross the barrier the valley of death represents and better society for all of us.

So what is MaRS Innovation’s role as an example of an early-stage catalyst?

We first need to define our identity within Canada’s innovation ecosystem: namely, as the catalyst that ensures a reaction will take place with the minimal energy cost. Others and I have already said much concerning the best practices to translate academic research to a commercialization-driven program.

Yet the chasm between the two remains, and is significant enough to be called the valley of death. Bridging that valley is the first ratelimiting step required to successfully establish a life-sciences based knowledge economy.

Those of us contributing to this successful transformation are the Catalytic Bridge—it is our responsibility to address the complexities of de-risking early-technologies for a community that has grown somewhat risk-averse in recent years. It’s clear our federal and provincial partners recognize both the potential and their obligation to contribute.

The Boston Red Socks’ legendary third baseman Wade Boggs, once said, “A positive attitude causes a chain reaction of positive thoughts, events and outcomes. It is a catalyst and it sparks extraordinary results.”

MaRS Innovation exists to bring one catalytic positive action.

The extraordinary results we and others spark will speak for themselves.

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