Biotechnology Focus August/September 2015

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

August/september 2015 VOLUME 18, NUMBER 4

QUÉBEC On the verge of a new Biotech Era?

INSI D E : Green Cross Biotherapeutics:

The new kids on Montréal’s biopharma block

Publication Mail Registration Number: 40052410

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August/September 2015 – VOLUME 18 – NUMBER 4

contents

FEATURES 10

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Sherbrooke: A Dynamic City Cradled in Nature At the heart of this life science regional cluster is a critical mass of research centres, technology platforms and complementary businesses.

By Sherbrooke Innopole

By Shawn Lawrence

Through GSK partnership, NEOMED continues to redefine drug development

By Shawn Lawrence

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Compiled by Shawn Lawrence

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By Montréal InVivo

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First Patent Program launched in Québec New program will assist Québec-based small and medium enterprises in obtaining protection for their intellectual property assets.

Laying the blueprint for Québec’s science strategy

Compiled by Shawn Lawrence

Montréal and life sciences: solution architects Spotlight on the life science cluster in Montréal.

By Québec International

Biotechnology Focus catches up with Québec chief scientist Dr. Remi Quirion to discuss the state of the life science sector in Québec.

Q&A with Québec Minister Economy, Innovation and Exports Minister Jacques Daoust discusses his government’s new approach towards supporting the life science sector.

Québec City The technology revolution serving the needs of healthcare.

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The new kids on Montréals biopharma block Thanks to one of the largest foreign investments in the province’s biotech sector in over a decade, South Korean drug-maker Green Cross Biotherapeutics is the newest player on Quebec’s life science scene.

New Centre of Excellence will build on the scientific heritage of the former Glaxo Smith Kline Laval vaccine and biologics development site and NEOMED’s innovative business model.

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By Carmela De Luca, Amy Dam and Tom Zhang

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The Last Word Bellus Health president and CEO Roberto Bellini believes there’s enough evidence to suggest we are seeing the dawn of a new Québec biotech era.

By Roberto Bellini

www.biotechnologyfocus.ca

August/September 2015 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF SENIOR WRITER CONTRIBUTING WRITERS

Québec’s life science sector bounces back When it comes to supporting the life science sector, Québec has become known for thinking outside of the box. This was especially so when the industry was disrupted by the economic crisis of 2008. As many of the big global industry players considered contraction, stakeholders from both the private and public sectors responded promptly ensuring Québec retained its place as a biotech hub of business and talent. The result was cross-pollination of academics, biotechs, big pharma and others leading Québec into a new biotech era. It’s also why this issue is focused entirely on Canada’s own “Beautiful Province.”

Focusing first on the biotech hubs and hotspots, we’ll take you on a tour of Québec’s most promising cities. The first stop is Sherbrooke, located in the province’s southeast region. A definite up-and-comer with a plethora of life science startups, the city is set to host the second edition of the Sherbrooke International Life Sciences Summit. Up next is the province’s capital, one of Canada’s oldest cities now undergoing a technological revolution. And how could we tour Québec without mentioning Montreal, a dynamo of scientific talent and enterprise? It’s these cities that are housing some of the industry’s most valuable ideas.

Next we shed some light on some of the province’s most promising partnerships, including an exciting pact between NEOMED and Glaxo Smith Kline.

Further evidence that Québec has bounced back with fierce resiliency is the addition of South Korean drug-maker Green Cross to the provinces lineup of Biopharma powerhouses. The company has established a North American subsidiary and is constructing the first biologics manufacturing and plasma fractionation plant in Canada.

At the heart of many of these incredible initiatives is true science leadership. On that front, senior writer Shawn Lawrence speaks one-on-one with two of Québec’s most influential. Hear first from Québec chief science officer Dr. Remi Quirion, the man behind the Fond de recherche du Québec. Then, flip forward to catch the interview with Jacques Daoust, Québec’s Minister of Economic Development, Innovation and Export Trade.

Lastly, hear from Roberto Bellini as to why he believes that within the next few years, the biotech industry in Québec will flourish.

From these opening remarks to Bellini’s last word, we hope this issue will give you a glimpse of the fast-paced action in Canada’s largest province. With new innovations happening daily, we can’t wait to see what’s next.

4 BIOTECHNOLOGY FOCUS August/September 2015

Terri Pavelic Shawn Lawrence Amy Dam

Carmela De Luca

Luc Mainville

Roberto Bellini

Tom Zhang

Director, Content & Business Development

José Labao

GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Elena Pankova John R. Jones Mary Malofy

CIRCULATION DIRECTOR Mary Labao circulation@promotive.net Tel: 289-879-4272

EDITORIAL ADVISORY BOARD Christine Beyaert, Cohn&Wolfe; Pierre Bourassa, IRAP, Montréal; Murray McLaughlin, Sustainable Chemistry Alliance; Ulli Krull, UTM; John Kelly, KeliRo Company Inc.; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Robert Foldes, Viteava Pharmaceuticals Inc.; Gail Garland, OBIO; Barry Gee, CDRD; Bonnie Kuehl, Scientific Insights Consulting Group Inc.; Raphael Hofstein, MaRS Innovation; Roberto Bellini, Bellus Health; Peter van der Velden, Lumira Capital; Albert Friesen, Medicure Inc.

Biotechnology Focus is published 6 times per year by Promotive Communications Inc. 23-4 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 – 23-4 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 sales@promotive.net

Special Report

By Luc Mainville, MBA President & CEO

Company Profile • Characterize bio-pharmaceutical products using equipments such as SDS-Page, microplate reader, particle size analyzer, DSC, Type III dissolution apparatus, etc.

Other services include: • Dedicated 8,000 s.f. microbiological laboratory offering customary analyses, sterility, endotoxins, antibiotic testing and bioburden; • We can handle oral solid forms, semi-solid forms, liquids, suspensions, sterile products, for all materials including cytotoxic and controlled substances, for API, in-process samples and finished products; • Testing on all types packaging components; • 15,000 c.f. of stability capacity for all ICH conditions on regular/ narcotics products.

F

ounded in 1990, Neopharm is a full service GMP analytical testing laboratory serving the global pharmaceutical industry as well as the biotechnology, natural health, veterinary and cosmetics markets.

Licensed by Health Canada, the company has successfully been audited by the FDA since 1995. Neopharm provides unique quality control /consulting services, and performs a wide variety of analysis, including fine chemistry, microbiology, sterility testing, method development and validation, technology transfer, and stability studies. To date, Neopharm has successfully developed/validated/transferred in excess of 3,000 analytical procedures.

Our capabilities are unmatched with 45 HPLC/UPLCs systems equipped with a full range of detectors such as IC (electrochemical and conductivity), UV/Vis, Fluorescence, ELS, RI and MS/ QTOF. Neopharm can perform reversedphase, normal-phase and size exclusion chromatography, derivatization, chirality and other techniques of chromatography. Our GC’s are equipped with MS/MS, FID or TCD detectors for capillary and packed column, using direct or headspace injections.

Neopharm’s capabilities have evolved to better adapt to the needs of the bio-pharmaceutical market. The Company can: • Handle large molecules with/without double bonds for antibiotics, peptides/polypeptides, proteins (PEG, Glycosylated), and hormones; • Perform assays, molecular weight, identity, impurity profile and more; August/September 2015 BIOTECHNOLOGY FOCUS 5

R & D NEWS CQDM and CIHR fund two promising personalized medicine research collaborations CQDM and CIHR, through its institutes of Cancer Research, Genetics and Infection and Immunity, are kicking in $1.5 million in funding for two translational projects in personalized medicine.

One project will be led by Dr. Henry Krause from the University of Toronto and the other by Dr. Jeff Wrana from the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital. The two projects will also count on additional in-kind contributions of $530,000 from the participating SMEs involved, namely $250,000 from InDanio Bioscience in Krause’s project, and $155,000 from Encycle Therapeutics and $125,000 from Mount Sinai Hospital Research Services in Wrana’s project.

In addition to developing new cuttingedge technologies in personalized medicine, the two research collaborations between academia and SMEs will also benefit from CQDM’s mentorship program which brings industrial support and expertise to the projects and helps better align the research with the needs of the pharmaceutical industry. This also builds on investments of over $234 million made by CIHR and its partners since 2012, in the context of CIHR Personalized Medicine Signature Initiative to enhance health outcomes through patient stratification approaches by integrating evidence-based medicine and precision diagnostics into clinical practice.

“We are delighted to partner with CIHR to fund these two research projects that will open new avenues in personalized medi-

From left to right, Jane Aubin, Chief Scientific Officer and Vice-President, Research and Knowledge Translation at the Canadian Institutes of Health Research (CIHR); Diane Gosselin, President and CEO of CQDM and Étienne Richer, Assistant Director, CIHR Institute of Genetics. cine,” said Mario Chevrette, vice president, scientific affairs at CQDM. “This joint program reflects the strengths of its partners: the academic research supported by CIHR and the translational industrial research supported by CQDM.” “CIHR is proud to support these researchers, whose work will focus on developing innovative technologies necessary to accelerate drug discovery and development in

BioAmber opens world’s largest succinic acid plant in Sarnia BioAmber, a Montréal-based chemicals company, along with partner Mitsui, have officially opened the world’s largest biosuccinic acid manufacturing facility in the heart of the Sarnia-Lambton chemistry cluster.

The $141.5 million facility will make renewable chemicals from sugar instead of petroleum. These sustainable chemicals from agricultural feedstock can be used in a variety of everyday products including plastics, food additives and personal care products. Currently, the plant has created 60 high value jobs. The plant will be in full commercial operation in Q3 2015, and will have a capacity to annually produce 30,000 metric tons of bio-succinic acid.

As part of the growing bio-industrial

6 BIOTECHNOLOGY FOCUS August/September 2015

cluster in Sarnia Lambton BioAmber Sarnia has received support from the Government of Canada as well as the Government

Canada. Partnering with CQDM allows small and medium enterprises to collaborate with CIHR-funded researchers to find the best solutions to improve the health of Canadians,” said Jane Aubin, chief scientific officer and vice-president, Research, Knowledge Translation, and Ethics Portfolio at CIHR. To see this story online visit http://biotechnologyfocus.ca/?p=15329

of Ontario through its Ministry of Economic Development, Employment and Infrastructure’s Strategic Jobs and Investment Fund. BioAmber Sarnia’s financial partners include Export Development Canada, the Farm Credit Corporation and Comerica Bank.

“We’re excited that our renewable chemicals made from sugars are making everyday applications around the world more sustainable,” commented JF Huc, CEO BioAmber. “We believe our disruptive biotechnology is going to profitably deliver benefits for the environment, our customers, our shareholders and the Sarnia Lambton community.”

To see this story online visit http://biotechnologyfocus.ca/?p=15335

R & D NEWS CCRM takes on commercialization role with “Medicine by Design” initiative Toronto, ON – The Centre for Commercialization of Regenerative Medicine (CCRM) reports it will act as the commercialization partner for “Medicine by Design,” a new medical research program launched at the University of Toronto.

The program, backed by a $114 million federal investment, is part of the government’s Canada First Research Excellence Fund.

“I am delighted that the federal government is making this significant investment into regenerative medicine to keep Canada at the forefront of this developing field, expected to grow to $50 billion by 2019,” says Michael May, president and CEO, CCRM. “Medicine by Design will propel Canada to a leadership position in the global medical industry and CCRM is excited to help Canada deliver on that promise.”

Dr. Peter Zandstra, chief scientific officer of CCRM, Canada Research chair in Stem Cell Bio-engineering and a key architect of the initiative, says he is looking forward to the outcomes that will result from this funding.

“We anticipate making Canada a magnet for investment and innovation in regenerative medicine, leading to a robust biotechnology

sector that takes full advantage of the leadership, research capability and advanced manufacturing that exists here,” Zandstra says.

As part of the “Medicine by Design” initiative, a new centre for regenerative medicine will be established at the University of Toronto. Researchers at the centre will focus on discovering new therapies based on the design and manufacture of molecules, cells, tissues and organs that can be used safely and effectively to treat degenerative diseases. CCRM’s role in the partnership will be to focus on technology development, company creation and clinical translation, helping to bridge the commercialization gap.

In June 2015, CCRM launched its first spin-off – ExCellThera – a clinical stage biotechnology company that is focused on developing robust and cost effective ways of growing blood stem cells for therapeutic use.

Dr. Peter Zandstra, chief scientific officer of CCRM, Canada Research chair in Stem Cell Bio-engineering and a key architect of the Medicine by Design

To see this story online visit http://biotechnologyfocus.ca/?p=15279

August/September 2015 BIOTECHNOLOGY FOCUS 7

BUSINESS CORNER Life sciences drives growth in VC activity for first half of 2015-CVCA reports Canada’s private capital community believes current economic conditions are favourable for investment, and yet venture capital and private equity activity are trending in different directions.

According to the Canadian Venture Capital & Private Equity Association (CVCA)’s 2015 half year (H1) market activity reports, venture capital was up significantly in terms of both deal activity and disbursement levels. 2015 H1 saw 244 venture capital completed deals, capturing $939 million – up 21 per cent and 23 per cent respectively over the same period last year.

Meanwhile, private equity saw a similar number of completed deals year over year (145 deals in 2015 H1 versus 147 deals in 2014 H1), however the amounts invested dropped significantly with deal value down from $11.4 billion in 2014 H1 to $7.8 billion in 2015 H1.

The surge in venture capital activity came in the second quarter of 2015 – the amount invested was up 53 per cent from the first quarter. Life Sciences played a significant role with the sector more than doubling the amount invested from Q1 at $92 million to Q2 at $211 million. Overall, Life Sciences accounted for 39 deals, capturing $303 million in H1. Regionally, there were also massive spikes of VC activity in Q2. In British Columbia, deal ac-

tivity grew by 123 per cent quarter over quarter, and disbursement levels soared by almost 150 per cent. In Québec, disbursements nearly tripled due to a surge in life sciences investments with two big deals driving growth (Clementia Pharmaceuticals, $73.9 million and Milestone Pharma, $20.9 million).

“A refreshed approach to venture capital in Canada, combined with recent successes and rising stars are creating a lot of market momentum,” said Mike Woollatt, CEO, CVCA. “Private investment is leveraging public investment very well and they are working together

to generate robust growth.”

The trend toward greater private capital deal activity is expected to continue. Data collected from a comprehensive survey of CVCA members in July 2015 showed that the vast majority (82 per cent) believe economic conditions favour the private capital industry, and 66 per cent believe a lower Canadian dollar improves the business outlook. As for possible exits, 60 per cent expect IPO and M&A activity will remain the same for the rest of 2015.

To see this story online visit http://biotechnologyfocus.ca/?p=15269

BELLUS Health narrows timelines for its Phase 3 study of KIACTA™

BELLUS Health Inc., a drug development company focused on rare diseases, has narrowed the timelines for its Phase 3 confirmatory study for KIACTA™ in AA amyloidosis.

To date, approximately 85 per cent of the required events to complete the Phase 3 study have occurred. The study is an eventdriven trial that will conclude when 120 patients have experienced an event linked to the deterioration of kidney function. Based 8 BIOTECHNOLOGY FOCUS August/September 2015

on the event rate, the company anticipates the study will meet the 120 events required to complete the trial by the end of the first quarter of 2016.

Concurrently, management expects that top-line data from the study, which is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis, will be available in the middle of 2016.

“We are excited about our progress with the KIACTA™ program and these narrowed timelines,” said Roberto Bellini, president and CEO of BELLUS Health.

“We are approximately six months away from study completion, and less than a year away from providing KIACTA™ topline data.”

A total of 261 patients are participating in the study. KIACTA™ is partnered with global private equity firm Auven Therapeutics. Auven Therapeutics is conducting the KIACTA™ study and funding 100 per centof the development costs, including the Phase 3 confirmatory study and other related activities, which total costs are currently estimated to be in excess of US$60 million. Overall proceeds from potential future revenue of KIACTA™ will be shared between Auven Therapeutics and BELLUS Health based on a pre-agreed formula, and assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally.

To see this story online visit http://biotechnologyfocus.ca/?p=15360

BUSINESS CORNER IRCM and Nuclea Biotechnologies team up to validate mass spec diabetes assays

Dr. Benoit Coulombe, director of the Translational Proteomics research unit and the Proteomics Discovery Platform at the IRCM.

The IRCM (Institut de recherches cliniques de Montréal) and Nuclea Biotechnologies Inc. are teaming up on a new initiative to validate quantitative mass spectrometry-based assays for insulin, proinsulin and c-peptide.

The end goal is to develop new assays that will help determine risk and the progression of type 2 diabetes.

Dr. Benoit Coulombe, a researcher at the IRCM, uses a translational proteomics platform, based on mass spectrometry, to develop assays ranging from biomarker discovery to validation.

Nuclea focuses on diagnostic development and validation, with a recent emphasis placed on mass spectrometrybased assays.

The partnership will include measuring clinical samples taken from patient

cohorts and analyzed in both locations (the IRCM and Nuclea) to demonstrate the precision, sensitivity, and reproducibility of the assays. Nuclea will incorporate these new assays into its CLIA lab (clinical laboratory improvement amendments) in Cambridge.

“We are enthusiastic to partner with Nuclea on this project,” says Dr. Coulombe, director of the Translational Proteomics research unit and the Proteomics Discovery Platform at the IRCM. “Validation of these assays across the two laboratories will represent an added value in clinical and research environments.”

To see this story online visit http://biotechnologyfocus. ca/?p=15381

European Commission grants orphan drug designation for Prometic’s plasma-derived plasminogen drug The European Commission has granted ProMetic Life Sciences Inc. an orphan drug designation status for its human plasma derived plasminogen drug as a treatment for plasminogen deficiency.

Orphan Drug Designation is granted to novel drugs or biologics that treat a rare disease or condition affecting fewer than 250,000 patients in the European Union.

The designation provides the drug developer with a ten year period of marketing exclusivity upon marketing approval for the designated indication, as well as reduced fees for regulatory activities, the ability to apply for marketing authorization centrally in the European Union and protocol assistance.

ProMetic is currently investigating the

safety, tolerability and pharmacokinetics of the drug and says that it expects to provide a preliminary report on its program shortly. If approved, the product could provide replacement therapy for patients who suffer from a congenital lack of the normal plasminogen protein and/or its functional activity. Plasminogen deficiency leads to severe clinical manifestations, primarily associated with fibrous depositions on mucous membranes throughout the body.

It is a multisystem disease that affects the eyes, ears, sinuses, tracheobronchial tree, genitourinary tract and gums.

Ortho RTi acquires regenerative medicine technology Private Canadian biotechnology company Ortho Regenerative Technologies Inc. (Ortho RTi) has entered into an agreement with Gestion Univalor, L.P. and Polytechnique Montréal to acquire a platform technology for the repair and regeneration of damaged joints, including the knee and shoulder.

The platform uses formulations specially designed to transform from a freezedried polymer into therapeutic microparticles, either upon contact with surgically prepared lesions or when combined with blood fractions enriched for cells that stimulate wound healing. The company says it will use the technology as a foundation to develop a portfolio of products that help regenerate joint tissue.

“This platform is built on solid scientific research by leading experts in the field of joint and tissue repair,” said Steve Saviuk, president of Ortho RTi. “The first focus will be on repair of torn meniscus in the knee.

We have seen encouraging data from a recently completed pilot animal model showing the ability to stimulate meniscus healing in joints treated with our technology. Additional clinical targets include the repair of articular cartilage and of the rotator cuff.”

Currently, only a small percentage of surgical procedures to repair tears to the meniscus, rotator cuff and articular cartilage result in satisfactory regeneration. Ortho’s continuing development will focus on this large percentage of tears that require biological stimulation to heal properly.

Under the terms of the agreement, Univalor has agreed to transfer several patent applications and their related know-how to Ortho RTi who in turn has awarded a three year contract to Polytechnique Montréal to carry out a research and development program to further advance the related technologies.

To see this story online visit http://biotechnologyfocus.ca/?p=15377

To see this story online visit http://biotechnologyfocus.ca/?p=15317 August/September 2015 BIOTECHNOLOGY FOCUS 9

Spotlight on Québec

Sherbrooke: A Dynamic City Cradled in Nature

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ocated in the South-East of the Province of Québec, Sherbrooke is Québec’s sixth largest city and the regional capital of the Eastern Townships. The city is blessed by its proximity to Montréal, Québec City, Boston and New York, and its unique atmosphere is enriched by the presence of people from many cultural heritages.

It is also a city where nature abounds and spectacular scenery accents its natural beauty. Nestled in the heart of the Appalachian Mountain chain, the region’s irregular landscape consists of beautiful hills and valleys with two major rivers converging in the downtown area, bestowing unique charm and character to the city known as the Cité des rivières (City of Rivers). Sherbrooke also has two lakes; one of which, the lac des Nations, is nestled in the very center of the city and is surrounded by a promenade and paths used by hundreds of citizens throughout the year who enjoy walking, cycling or skating in the city’s beautiful surroundings.

At the heart of the Life Sciences regional cluster, Sherbrooke is ideally located for research and business because of the critical mass of its research centres, technology platforms and complementary businesses. The concentration of key players enables the realization of a complete research project, from fundamental or applied research, to product marketing, including pre-clinical and clinical research: a unique characteristic and advantage not to be dismissed! The proximity to the U.S. border (30 minutes from Vermont) makes it an ideal gateway to the American market.

The Estrie region was recognized in July 2010 for their SAGEInnovation cluster (Health/Life Sciences/Autonomy and gerontotechnologies) within the ACCORD (regional development) program.

Sherbrooke Science Park sets a good example by bringing together a large number of research, education and industry leaders. Found within the park are the Health Campus of Université de Sherbrooke and its Faculty of Medicine and Health Sciences, the Centre hospitalier universitaire de Sherbrooke (CHUS – The Sherbrooke University Hospital Centre), the Centre de recherche du CHUS (CHUS Research Centre), the Centre d’imagerie moléculaire de Sherbrooke (CIMS – Molecular Imaging Centre), the multinational company Charles River and the Pavillon de recherche appliquée sur le cancer (PRAC – Applied Cancer Research Building). The research expertise present in the Science Park is diverse and covers areas like cancer, diabetes, imaging and research on aging.

Research on aging is a particular strength of Sherbrooke. The high level of development of this specialty in Sherbrooke stems from two factors: the existing close collaboration between industry and the University Pole, as well as the expertise of organizations whose purpose is to market the results of research work. Among the major strengths that Sherbrooke can rely on in this area, there are: the University Institute of Geriatrics of Sherbrooke (CSSS-IUGS), the Research Centre on Aging (CDRV) and the Interdisciplinary Institute for Technological Innovation (3IT).

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Biotechnology Focus / August/September 2015

The Cyclotron TR24 at the Sherbrooke Molecular Imaging Center of the CHUS. The first in the world, ready to produce medical radioactive isotopes for research and diagnostic.

Moreover, Sherbrooke’s Research Centre on Aging (CDRV) is one of the largest expertise centres of its kind. Hosted by the University Institute of Geriatrics of Sherbrooke (CSSS-IUGS), CDRV relies on interdisciplinarity, bringing together researchers from five faculties and more than 15 Université de Sherbrooke departments. In addition, several research chairs are devoted to this specialty in order to prevent delay or palliate the loss of autonomy of aging persons.

Some promising start-ups Sherbrooke also has a lively development climate in many Life Sciences sub-sectors. The presence of the Accélérateur de création d’entreprises technologiques (ACET – Accelerator for the creation of technological businesses) at the Université de Sherbrooke fosters the emergence of a growing number of new businesses offering a variety of products and services. The city also has a brand new incubator downtown. This facility offers space and services to companies in different fields, setting the table for a very lively entrepreneurial community. Here are a few of these businesses at the leading edge of their respective sectors.

Imeka (www.imeka.ca) Founded in 2011, IMEKA specializes in software development for visualisation and analysis of medical images. These solutions are aiming at accelerating market access to pharmaceutical compounds by quantifying data in medical images in the clinical trials process.

IMEKA develops revolutionary software that changes the industry of

Spotlight on Québec

IMEKA develops revolutionary software that changes the industry of clinical research and offers turnkey services based on them.

Immune Biosolutions (www.ibiosolutions.com)

clinical research and offers turnkey services based on them. They offer medical imaging analysis and visualisation service and software development including: Diffusion MRI, Preclinical PET imaging and CT imaging, tissue analysis. Applications are numerous : Neurology, Cardiology, Oncology, Orthopaedic, and much more!

Physipro (www.physipro.com) Physipro is a Canadian manufacturer specialized in design, manufacture and marketing of special equipment for people with reduced mobility. It aims at efficiently solving problems of reduced mobility clients by offering wellness and freedom through comfort and mobility. A few examples of what Physipro can do for you are: Clinical evaluation, Posture aids, Seat/backseat cushions (gel, air, dispersion foam), Wheelchairs, Daily living aids, etc.

Ibiom (www.ibiom.com) Founded in 1978, IBIOM is specialized in the manufacturing of ergonomic equipment intended for healthcare industry professionals. All products have been developed in order to improve the quality of life of healthcare workers.

By improving their working position, IBIOM contributes to the enhancement of performance and the prevention of work related injuries. IBIOM develops Ergonomic electric ultrasound stretchers, Ergonomic electric endoscopy stretchers, Office and specialty seating, Dialysis treatment chair, Phlebotomy chair, Ergonomic phlebotomist work stations and Evacuation stretchers.

Lumed (www.lumed.ca) LUMED provides cutting edge software solutions to optimize clinical practice and improve the quality of patient care. APSS is the first Canadian automated antimicrobial prescription surveillance system.

It uses state of the art evaluation algorithms to monitor the clinical status of patients over time. Every prescription dose is reviewed to account for newly available information. APSS helps ensure that patients are receiving appropriate treatment at all times. The benefits are numerous, they include: Reduction of antimicrobial use, Reduction of antimicrobial spending, Reduction of length of stay, Reduction of adverse events, antimicrobial resistance and hospital-acquired infections

Immune Biosolutions is an antibody producer for the biomedical, biotech and pharmaceutical industries along with academic research labs. Immune Biosolutions has a dedicated team of antibody experts who focus on creating high-quality antibodies for molecular tools used in detection, quantification and vizualization. Instead of killing or exsanguinating animals, the highly-specific antibodies are extracted from chicken and ostrich eggs. This allows them to generate huge quantities of high-quality antibodies faster, more effectively, and using a more humane approach.

BioIntelligence Technologies (www.biointelligence.com) BioIntelligence Technologies creates and commercializes intelligent sensors and instruments to increase in real time profitability of biological processes. Their products perform real time scientific analysis as well as financial analysis of biological cultures, whether being bacteria, cells, algae or yeast. These products are employed by R&D and Scale-up teams to develop new bioprocesses as well as by production and bio-treatment teams at industrial scale. The Bio-Analyst allows: Automated capture of culture related information (probes, data files, samples analysis), Real time high-level scientific analysis (ex.: yields, rates), Real time financial analysis (ex.: production costs, profitability), Customized Reports and Dashboards. The Optical probes developed by BioIntelligence permit automated identification of significant signals and real time monitoring of cell metabolites and products.

SILS While you are reading this article, the Sherbrooke’s Life Sciences community is participating in the Sherbrooke International Life Sciences Summit. This marks the second edition of this conference and it will attract more than 300 people to discuss topics around this year’s theme: Autonomy and aging. Big players from the pharma and med tech industry, SMEs, academic institutions from Canada and abroad are expected to gather in Sherbrooke to develop and harness innovative initiatives and find solutions to the challenges we are facing with the aging of the population.

To see this story online visit http://biotechnologyfocus.ca/shebrooke-a-dynamiccity-cradled-in-nature/

Biotechnology Focus / August/September 2015

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Spotlight on Québec

By Shawn Lawrence

Through GSK partnership, NEOMED continues to redefine drug development

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aul Lirette still remembers the day he got word from GlaxoSmithKline’s head office that the company was pulling the plug on its R&D center in Laval, Québec. As more and more pharma companies globally look to externalize their R&D efforts, the closure of such facilities have become more common.

While saddened by the news, he also felt a need to act.

“I was determined as a GSK shareholder, employee and Québecois that we had to do all that we could to protect the excellent science in Québec, the high level of innovation, and the expertise we had built with our employees,” he recalls. As the president of GSK Canada Pharmaceuticals, Lirette knew that such a facility could be put to good use by the right people.

At the top of this list was Max Fehlmann. It had only been two and half years since Fehlmann, with the help of Philippe Walker, had launched NEOMED, an organization who when AstraZeneca made its decision to close its research centre in Montréal, stepped into the facility and transformed it into a unique one-stop-shop for drug development. Moreover, as CEO and president, Fehlmann had in a short time positioned NEOMED as a key contributor to both the success and sustainability of the biopharmaceutical industry in Québec. Lirette’s hope was that NEOMED could do with GSK’s Laval site what it had done with the AstraZeneca R&D Centre.

“We would talk from time-to-time about the great science resources gathered in Québec, and kick around various ideas to build

“The site has some of the best in class lab space for biologics, having been a North American leader in developing flu vaccines and antibodies.” — Paul Lirette

on this, and when I told him about my ideas for our facility, he was receptive and before long a new partnership was born.”

The first announcement that the two sides would work together came in February 2015, and by April an official agreement was reached to repurpose the building into a new Biologics and Vaccine Centre of Excellence.

The agreement included the lease and sublease of the facility to NEOMED and a framework for R&D collaboration between the two entities. This includes GSK paying the entire cost for leasing the facility for five years; representing an investment of $10 million.

Additionally, the 66,000 sq. ft. facility would be transformed into a multi-tenant hub for independent, small and medium-sized enterprises focusing on the development of biologics and vaccines.

Another caveat of the proposed partnership is that it will ensure that the expertise remains in Montreal. Specifically, it will allow

The Laval site was inaugurated in April 2015. The building has a total area of 70,000 square feet, 62% of which is directly available for research and development activities.

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Biotechnology Focus / August/September 2015

both the preservation of jobs and the eventual creation of new positions. Of GSK Laval’s 122 permanent employees, approximately 60 per cent have been transferred over to the new Centre of Excellence.

“I’m very proud to say that we’ve been able to maintain more than half. At the original announcement in February the number was 50 percent so I could not be more thrilled it has grown,” says Lirette. He adds that people should stay tuned, because he believes the number of jobs in this partnership will continue to grow.

Fehlmann says that for NEOMED, the timing of this opportunity couldn’t have been better. Having already filled the once vacant AstraZeneca R&D Centre with 23 independent small and medium-sized companies employing 175 people, he recognized the opportunity as a chance to do it all again.

“For a while now we have needed to add a second top-class facility for research and development as we are completely full and have very long waiting list of potential tenants at our Saint Laurent site,” says Fehlmann.

“Additionally, when we started NEOMED, it just happened that the Centre we inherited from AstraZeneca was completely equipped and dedicated to medicinal chemistry. We continued along that line and built everything according to that first specialization. Of course, we were missing the other part of the story in the life sciences value chain.”

That other part pertains to the emergence of “biologics,” drugs that consist of giant molecules, hundreds of times the size of a conventional drug molecule, which are manufactured inside animal cells or micro-organisms such as bacteria as treatments for disease. He explains

Spotlight on Québec that half of today’s pharmaceutical market is biological products, and that number is only going to continue to grow.

“The incorporation of this facility into NEOMED now means we have the entire pharmaceutical market covered, which translates into more opportunity” says Fehlmann.

Lirette also believes the building has all the tools needed to help NEOMED get to where it wants to go. “The site has some of the best in class lab space for biologics, having been a North American leader in developing flu vaccines and antibodies,” he says.

Both men agree that small and mediumsized companies that move into this new centre will benefit from GSK’s scientific heritage as well as from its research facilities, labs and highly specialized equipment.

“The centre will provide many Québec, Canadian and foreign companies with access to state-of-the-art facilities and remarkable expertise,” says Max Fehlmann.

Both sides are now actively working to transform the site and already they have had a number of start-up companies interested in beginning their activities at the Centre. As for other tenants they are hoping to recruit, they say the focus will be in the biologics and vaccine space. However, there are other select requirements.

“We will be very open to ideas, but the feasibility of the project has to be high. Feasibility is the key word,” Fehlmann says. “As an example, we won’t go for say Alzheimer’s, because we know it’s too difficult, expensive and takes too long for us to get possible revenue from out licensing within a reasonable time. We will avoid those indications that we know are too expensive and too long. However, there’s no decision to restrict ourselves to certain indications as long as we can test the appetite of pharma for any indication that is coming for the proposed project.”

In terms of the R&D collaboration, GSK and NEOMED say they will each invest $10 million to fund up to five product research and development projects that will be transferred from GSK. “These projects will be conducted by us according to a plan and a budget agreed upon by both parties using that $20 million and then, at a given milestone, GSK has the right to take its project back. In that case, they will pay us a success fee. In the case they decide not to take it back for any reason, they have to leave the project with us through an exclusive license. It means we are both sharing the risks, the costs and the benefits of taking these projects forward,” explains Fehlmann.

In terms of the logistics of the new building, Fehlmann says much of what they are

“The goal is still to create a hub in which the different parts of the value chain are under one roof, as well as developing promising ideas that emerge from the university milieu and biotechnology companies” — Max Fehlmann trying to do with the GSK building is the same as it was with AstraZeneca, but with some subtle differences. The biggest of which is the creation of a specialized Contract Research Oorganization (CRO). According to Fehlmann, the CRO, called NEOMED Labs, will occupy about one-quarter of the building. “It will market its biology and clinical immunology services to the business community,” he says.

Additionally, the 60 people transferred from GSK, who are mostly researchers and technicians, will all be part of this CRO. GSK has already signed on to buy clinical testing services from this CRO for at least three years, representing an investment of $27 million and the total overall GSK has committed to the Centre’s establishment to $47 million.

Despite these differences with AstraZeneca deal, Fehlmann says the end goals remain the same for NEOMED. “The goal is still to create a hub in which the different parts of the value chain are under one roof, as well as developing promising ideas that emerge from the university milieu and biotechnology companies,” says Fehlmann.

In this sense he likens NEOMED to a bridge, taking the best projects from universities and linking them with the needs of pharma and trying to make it “a win-win situation where everybody can be happy with the results of the development of the project.”

“Everyone knows how good our universities are in the field – with the needs of the industry, those needs are not just Canadian but they are global needs in the industry, this is something very valuable. This is also a way of attracting private investment in R&D in Canada and attracting the attention of the global industry towards Canada. I think those are very positive parameters for us, for NEOMED, for Montreal and Québec, but also for Canada.”

He is very adamant about this last point,

specifically that for Québec, this partnership is a fantastic opportunity.

“It’s about keeping good jobs and expertise in Canada, maintaining a fantastic heritage of drug discovery that came with having these different companies and their research Centre’s located here. Most importantly, I truly believe that we can duplicate all that we’ve previously accomplished at the AstraZeneca facility here. It’s win-win for all involved,” Fehlmann says.

Commenting on the partnership, Lirette says it is a testament to how visionary the province of Québec has been in putting infrastructure in place to seize opportunities stemming from global changes in pharma research models.

“The NEOMED concept was born and bred in Québec as Montréal In Vivo and the Québec government worked hard to create NEOMED years ago. With NEOMED - the Silicon Valley of Québec as I like to call it Québec has created a unique and favorable environment to leverage the continuing externalization of R&D and GSK is pleased to work with NEOMED to create this Centre of Excellence.”

He also echoes Fehlmann’s statement that this is a win-win for all parties.

“We’ve worked hard, and invested a lot, in putting this new arrangement in place. And, obviously, we will be seeking to leverage it as much as possible. I don’t see any limits.

And remember, these facilities are not just for GSK R&D but are open to others pursuing the most advanced science. For these reasons, I truly believe this is the dawn of a new and promising era for pharmaceutical research in the Montréal region.”

To see this story online visit http://biotechnologyfocus.ca/ on-the-map-belgium-is-readyto-be-a-leader-in-the-lifesciences

Biotechnology Focus / August/September 2015

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Spotlight on Québec

By Québec International

Québec City: A technology revolution serving the needs of health care Medicago and government representatives at the May 19, 2015 announcement.

Photo credit: City of Québec

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he technology revolution that has taken hold in Québec City over the past few decades has spawned a number of life sciences success stories, paving the way for the development of a wide array of technologies in numerous fields. The life sciences sector alone employs nearly 6,000 people in Québec City and generates annual sales of over $1 billion, according to figures compiled by Québec International.

Backed by Québec International, vaccine and diagnostic industry stakeholders in Québec City ensure the growth and development of their sector by sharing cutting-edge information on best practices, business opportunities, technology transfers, and training/ specialized worker needs with participating research centres and companies with the best interests of the community in mind.

Medicago sets its sights on Québec City to produce tomorrow’s vaccines On May 19, Medicago, a highly successful biotech start-up, announced a $245 million

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ric Diagnostics, presented the Mo PODTM, a mobile lab for performing low-cost medical diagnostic tests in remote and hard-to-get-to areas.

Opsens is a Québec City-based optics and photonics company that manufactures fibre optic sensors for various industries. It recently received regulatory approval from Japan, Europe, and the U.S. to market its OptoWire and OptoMonitor products there. These two products are used to measure fractional flow reserve in heart disease patients. The company also recently announced an expansion project to boost its manufacturing capacity and accommodate its growing workforce. investment to build a vaccine bioproduction plant and an R&D centre. The company plans to invest a total of $800 million over the next 10 years to produce its vaccines for the future. Upon completion, the new complex, which will occupy the entire Estimauville Innovation Space, will be one of the largest biotech enterprises in Canada and will bolster Québec City’s international reputation as a leading hub for infectiology, vaccines, and diagnostics.

Optics and photonics serving the healthcare sector Alain Chandonnet launched Handyem in 2011 while he was an entrepreneur in residence at the National Optics Institute (INO).

One year later the company brought its first portable cytometer to market. The device allows users to perform rapid cell counts using an innovative fibre-optic-based multi-fluid technology. Handyem’s ultimate goal is to equip every doctor’s office with one of its devices. In the meantime, at the recent BIO Conference in Philadelphia, the Québec City firm, together with U.S. company FlowMet-

Biotechnology Focus / August/September 2015

Ninth Québec City Healthcare Industry Forum Mainstreaming innovations in healthcare will be the theme of the upcoming Québec City Healthcare Industry Forum to be held on December 1, 2015, at the Québec City Hilton during the Semaine de l’innovation en santé (Healthcare Innovation Week).The event will feature talks by experts, case studies, workshops, and a plenary session on this unifying theme of importance not only to industry actors (innovative solutions and technologies) but also to health network managers, clinicians, and scientists. Over 200 people are expected to attend. For more information on the Forum, go to www.Québecinternational. ca/forumsante (in French only).

To see this story online visit http://biotechnologyfocus.ca/ Québec-city-a-technologyrevolutions-serving-the-needsof-health-care/

Spotlight on Québec Compiled by Shawn Lawrence

Creating a blueprint for Québec’s science strategy Q&A with Québec chief scientist Dr. Remi Quirion

Biotechnology Focus: What is your role as the Chief Scientist of Québec?

When it comes to supporting science and growing the life science industry, the province of Québec has always been ahead of the curve. This is particularly so when it comes to establishing policy and launching new innovative strategies that bridge the gap between both the public and private sectors. As an example, in July 2011, Dr. Remi Quirion was appointed Québec’s very first chief scientist and chairman of the Fond de recherche du Québec, the first such appointment in Canada. This month Biotechnology Focus catches up with Dr. Quirion to discuss the state of the life science sector in Québec and what looks to be a very promising future.

A: It’s a bit complicated these days with a lot of reorganization, but generally, I serve as the bridge between the research community and government. Specifically, I advise government – reporting directly to the Minister of Education, Higher Education and Research in particular - in the development of research, innovation and scientific development issues. I also interact often with other Ministries and Ministers including Health and Social Sciences, Economy, Innovation and Exports and with the PMO (Premier’s office) directly. Another key role I play is that I chair the boards of the three Québec research funds (Fonds recherché du Québec): health, nature and technology, and society and culture, coordinating joint research activities with their scientific directors. I have a few other associated responsibilities such as promoting the visibility of our science community both domestically and internationally as well as trying to find new ways of informing the public about science.

BF: Québec was the first province/territory to create this position, and recently other Canadian provinces are in discussions to follow Québec’s lead. What do you think was the motivation behind the Government of Québec’s decision to name a chief scientist?

A: I think it all started at the BIO International Convention a number of years back when the then Minister of Economy, Innovation and Exports was in attendance. He noticed that a number of countries had sent their chief scientists to the convention. This was followed by a trade mission to Israel and he saw that Israel had as many as eight representing various ministries. He liked the idea of having one person like that, to interact with, to link the Ministry with the rest of the community. He felt this person would be ideal in dealing with the heads of the various funding organizations in Québec, to be one point of contact and try to link a little bit more the groups doing research in Québec.

Biotechnology Focus / August/September 2015

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Spotlight on Québec

BF: When you gave up your position as scientific director at the Douglas Institute Research Centre to take this post, what did you want to see accomplished? What were your priorities and goals?

A: Certainly I wanted to try to inform government about research and innovation, and hope that they would use some of this information in developing strategies. It was about setting the stage for a more informed decision-making process. I also wanted to find ways to bring scientists from different disciplines – like engineering, health, social science and art –more closely together, to create an environment where they exchange best practices and ideas. Related specifically to the life sciences, since that is my background, I wanted to define some niche or priority areas for our scientists. The fact is, Québec is small and we cannot be excellent in everything, so we have to make choices on what areas we need to focus our efforts, life sciences being one of them. And maybe the last point is I wanted to ensure that infrastructure is in place for the training of the next generation scientists. This has become very important under my watch and a big reason that 40 per cent of the budget of the three funding organizations is spent in this area. We need to provide them with abilities that we weren’t supposed to in the past: leadership type of training, accounting, management, ethics. And we need to develop that further.

BF: Take me through your daily routine as chief scientist.

A: That depends on the day. As chief scientist you are very busy and your schedule is changing all the time. I have a lot of meetings with various groups and organizations, including of course scientists, high level officials at universities and colleges, then of course government representatives and officials. On one hand you could have a series of planned meetings in one day, and then you get a phone call from someone in the Minister’s office asking for data on a certain topic, and then you have to work on finding it. You have to be very flexible. Additionally, I meet with people at the higher levels from the three funding organizations, usually with the scientific director or director on some subtopic, as well as having meetings with scientists or organizations – local or international – that want to get advice or know if a topic is a priority or how to move the research agenda forward. One minute I’m talking about the healthcare system, the next the mining industry and so on. Through it all I’m trying to make sure that people partner and that there is more and more integration of research and innovation activity in Québec. It’s not like my neuroscience research days.

BF: You’ve mentioned your position overseeing the three research funds. Who do the funds support exactly? Are we talking university researchers?

A: It’s mostly academia, both college and university. But there are some programs where we partner with the private sector. For example, the CQDM. We’ve also created partnerships with Pfizer, Merck and other companies. In total, I would say roughly 80 to 85 per cent of our budget goes to support research activity in academia.

BF: How does investment on the part of Québec government in basic and applied science compare to other provinces and jurisdictions?

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Biotechnology Focus / August/September 2015

A: The model for funding and supporting science in Québec is unique since we have the three funding councils via the Fonds de Recherché Québec, so one council for the health sector, one for the engineering sector and one in the social science and humanities area.

For us, the strategy in the case of the health sector for the last 50 years, independent of the government of the day, has been to invest into programs in Québec that will give them an edge at the federal or international level. What we do in terms of funding is usually complementary to funding programs at the federal level. We spend a lot on training and providing salary awards, supporting various types of infrastructure. We don’t support as much in terms of direct costs of a project, we leave that to federal government bodies like CIHR and others, that has been positive and over the past three years, even if the government has said that for example, “we need to balance the budget now,” we have sustained that investment into research.

This demonstrates that government is sensitive to health research in Québec, and hopefully when the book will be balanced there will be reinvestment in the field.

BF: What have you defined as some niche or priority areas for Québec scientists to focus their efforts in and in what areas of life science research does Québec stand out?

A: Québec stands out in several areas; it would be difficult to list them all. Certainly when it comes to life sciences we are strong in genomics research supported in part by Genome Québec, in the areas of neuroscience and cardiology as well. Québec has a long history of brain research excellence, which is why neuroscience is one of the niche areas. Personalized medicine is another one where the Québec government in partnership with the private sector, has made quite a bit of investment over the past few years. The same can be said of cancer.

These are the main ones. I didn’t mention research on aging, but it’s very important to Québec with the aging of our population. The average age in Québec is second only to Japan, so we’re older than the rest of Canada. So that poses challenges in terms of our workforce, but also presents an opportunity for our science community.

BF: Do you work with industry, specifically the pharma, biotech and life sciences sectors where public-private partnerships have become the new norm?

A: Yes, I do quite a bit of that. Partnerships with industry, with small and medium size enterprises and very large firms are critically important. The same goes for non-profit organizations. Of course we support research and excellence, but if we can do that in partnership with industry stakeholders, the impact of what we are trying to in many cases increases. In the health science sector, of course, Montréal and Québec have a fairly strong industry presence. So there is a lot of opportunity for partnerships between industry and various government programs.

BF: On the topic of public-private partnerships, it must be encouraging to see the recent opening and reopening of facilities in the province and the increasing role that industry is playing in these public-private partnerships. It has really resurrected the life science sector in Québec, hasn’t it?

A: Yes it has, and I think it was much needed. The industry has changed quite a bit over the past few years, and losing large facilities

Spotlight on Québec

like Merck and Astra Zeneca was troubling. And the closing of big pharma facilities went beyond Québec; it was a worldwide industry problem. There was a need for some sort of intervention, and government in partnership with the industry tried to react and say, “Okay, the model is changing, how can we adapt to this new model of externalization of research capacity?” So there was an uptake in partnership activity between government and the private sector that led to the creation of initiatives like CQDM and NEOMED. Likewise, to attract private sector capital, government and VC’s successfully tried to partner with industry on new VC funds. Of course it’s still early, but with CQDM and NEOMED, it seems we have found a recipe for success and now there is reinvestment in the sector province-wide. Through these initiatives we’re finding ways to keep high quality jobs here in Québec and it’s also strengthening the breadth of research in Québec. The life sciences sector is definitely very important to our economy and very strong in Montréal and now Québec City as well. It’s definitely a very critical sector for us but we have to make sure we continue to nurture it. Of course we have a large concentration of universities in Montréal, and having a more positive forum for these university and research institute scientists to link with industry is a positive thing.

BF: One partnership that seemed to shift to the backburner, but re-emerged at this year’s BIO International Convention was the Life Science Corridor alliance with Ontario. Can more still be done between the two provinces?

A: Yes, I was involved a few years back when we were talking about that, and almost nothing happened for various reasons. The timing

may be much better this time around. First, budget constraints everywhere have limited what we can do on our own, so that sometimes facilitates a need to seek out partnerships and collaboration. Another big reason is we’re seeing collaboration between the two provinces in other industries and our Premiers get along very well and have shown a willingness to work together. They both signed the agreement related to climate change and sustainable development, and I think the opportunity to build on this alliance is very much present in the life science sector. It’s definitely important for us, Ontario and Québec and for the public and private sector to work together and say “Let’s join forces instead of competing; we’d be so much stronger.”

BF: So you think we’re back on track with this initiative?

A: I hope so. Of course we still need to work hard, but I think the announcement at BIO between CQDM and MaRS Innovation for example is a positive step in that direction. So now, we have to come up with stronger types of proposals, maybe one that could be focused on clinical research. I believe if you join forces, especially in the area of clinical trials, then you increase patient population making us collectively more attractive to the private sector.

To see this story online visit http://biotechnologyfocus.ca/creating-a-blueprintfor-Québecs-science-strategy-qa-with-Québec-chiefscientist-dr-remi-quirion/

MEDICAL BREAKTHROUGHS MAY COME OUT OF THE LAB.

BUT THEY BEGIN IN THE HEART. For more than 150 years, a very special passion has driven the people at Merck. Our goal is to develop medicines, vaccines and animal health innovations that will improve the lives of millions. Still, we know there is much more to be done. And we’re doing it, with a long-standing commitment to research and development. We’re just as committed to expanding access to healthcare and working with others who share our passion to create a healthier world. Together, we’ll meet that challenge. With all our heart.

Copyright ©2015 Merck Sharp & Dohme Corp., All rights reserved.

Biotechnology Focus / August/September 2015

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Spotlight on Québec

By Shawn Lawrence

Green Cross BioTherapeutics: The new kids on Montréal’s biopharma block

From L to R : Dr. Eun Chul Huh (President of Green Cross Corporation), Mr. Alan DeSousa (Mayor of the Borough of Ville St. Laurent), Mr. Young Ho Kim (CEO of Green Cross Biotherapeutics Inc.), Mr. Jacques Daoust (Minister of Economy, Innovation and Exports), Dr. Il Sup Huh (Chairman of Green Cross), Mr. Pierre Desrochers (President of the Executive Committee of Montreal), Mr. Jin Hur (Consul General and Ambassador) andMr. Mario Monette (President & CEO of Technoparc Montreal).

T

here’s a new player on Québec’s life sciences scene with South Korean drug-maker Green Cross setting up shop via its new North American subsidiary, Green Cross BioTherapeutics (GCBT).

Not only does the company’s entry into the Canadian market mean the creation of new jobs in the manufacturing space, it represents one of the largest foreign investments in the province’s life science sector in over a decade, totaling $315 million. Moreover, the company has shovels in the ground at Montréal’s Technoparc constructing its new 225,000 square foot biologics manufacturing and plasma fractionation facility, the first plant of its kind in Canada.

GCBT is planning to recruit over 200 highly qualified scientists, engineers, microbiologists, chemical engineers and other professionals, who will all contribute to the production and distribution of plasma protein products from the facility. Once it reaches full operations in 2019, GCBT expects to generate annual revenue of over $300 million from its own manufactured products, exceeding $500 million in total sales turnover, including all distributed and imported goods.

According to Joon Hee Han, managing director of GCBT, the company’s Canadian expansion is about capitalizing on growing

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Biotechnology Focus / August/September 2015

opportunities in the North American market as well as augmenting its business initiatives in Asia.

“We see a lot of opportunity for our technologies and plasmaderived medicines here, with the market for Immunoglobulin (IVIG) growing in Canada and North America representing 40 per cent of the global market,” he says.

He comments that the first phase of this project will include establishing a manufacturing presence with Intravenous Immunoglobulin (IVIG) for patients with infectious and immune disorders and albumin products to treat burns and bleeding disorders by replenishing blood plasma volume among the products to be produced at the plant. When complete, it will have the capacity to fractionate up to one million litres of plasma a year.

“This plant will supply the Canadian market but also export to other countries, including the U.S. and China,” he says. Han adds that because Canada currently relies mostly on imports for its IVIG, Canada will benefit from having Green Cross as a domestic manufacturer.

According to Han, the decision to come to Canada was the result of a long intensive review process for which Green Cross hired Deloitte.

“First our strategy was to acquire a company in the United States

Spotlight on Québec

and we found it wasn’t going to be easy, so we looked at companies to acquire in Canada but they too didn’t fit what we were looking for either. In the meantime, we discovered that there weren’t any plasma protein manufacturers in Canada and that the Canadian government relies 100 per cent on imports from the U.S and Europe. As such, we thought we might provide a great advantage to the government, and at the same time we felt we could capitalize on being the sole player in Canada.”

Negotiations commenced with the Canadian government, and then the company asked the provinces of Québec and Ontario what incentives they could offer. In the end Montréal was deemed the best fit.

“Montréal already accommodates many biopharmaceutical companies and is home to a great R&D cluster made up of a highly-qualified workforce. Its central location and proximity to the U.S. logistically were ideal as well.”

He mentions that the support offered by Hema Québec and the Québec Government including Investissement Québec sweetened the deal. In all, the Québec government intends to chip in an $8 million grant and has provided a $17 million loan, to be repaid in six years, to help pay for the new facility. He also adds that the Federal government supported this project.

The recent Free Trade Agreement reached between South Korea and Canada didn’t directly facilitate the deal, but it was helpful as well he says.

“I think it was a stepping stone to garnering Québec government interest in our project, and a big reason our project was well supported by the government.”

There were other factors in the choice to come to Canada that had to do with the company’s broader business strategy. Specifically, the parent company, which was founded in 1967, has built a very strong plasma-derived medicines business overseas in South Korea and China. However, these plants are having had a hard time keeping up with the high demand for Albumin, especially in China.

In contrast, Albumin is abundant in North America. On the other side of the coin, when it comes to IVIG, the supply and demand is reversed, with Asia having the overabundance and North America and Europe facing shortages. Han says that establishing a North American presence comes down to meeting this supply and demand demographic on a global level. He likens this cost structure of producing various proteins from blood plasma to that of an oil refinery producing oil.

“Once you get the crude oil, the more products you make the more profitable you can be,” he explains. “Right now we have a leftover intermediate product for IVIG in the Asia market, and we believe we can sell this in the U.S. or Canada. Likewise we want to sell the albumin produced in North American markets in Asia. It’s about maximizing the utilization of a precious raw material.”

Going further, he says that Green Cross already has a leg up on its competition with its Asia presence. Expanding into North America only widens this gap.

“It’s not easy for foreign companies to penetrate into the Chinese market, however, Green Cross built a facility there in 1995 so we are very well positioned in that market. By having a very strong presence in China, we are able to pursue this kind of project. And like I said,

penetrating into IVIG market in North America will actually improve the profitability of our business.”

This doesn’t mean the company won’t distribute albumin in North America. On the contrary, even though the Chinese market is big, Han says that the U.S market can be just as lucrative for albumin because there are premium prices for this product in the U.S. and still a very large population there as well.

In terms of Green Cross’s technologies and the manufacturing process, Han explains that there are three basic steps to producing IVIG and albumin. It begins with fractionation, subjecting plasma to various changes of temperature and chemical conditions, causing each of the proteins with therapeutic properties to separate out.

“We fractionate various types of proteins out of human plasma using what is called the Cohn-Ethanol fractionation method. When you make products out of human plasma, there is a risk of diseases being present and these can be transmitted. As such, these proteins have to be purified and formulated or processed through a series of virus inactivation/ removal steps before they can be used as medicines. In the case of the immunoglobulin and albumin, we use nano-filtration and solvent detergent. The last step is fill and finish, where after the formulation of these proteins, we put them in vials and package them as finished products.”

The new Canadian facility will have the means to perform the entire process says Han. In addition to manufacturing and providing fractionation services, Han says that eventually GCBT will also be the North American hub for distribution of a variety of other Green Cross therapeutics.

“The first product happens to be the plasma proteins; however we have vaccines, recombinant products, cell therapies and many other high value products.”

In terms of direct distribution deals, one of the partners that have already signed on with Green Cross Biotherapeutics is Hema Québec.

“We will be supplied with plasma and we will be providing them with our fractionation services,” Han says. “They have their own plasma collection centres where they will take what they collect and send it to us to process and then we deliver the finished product back to them. Additionally, they will have access to plasma we bring in from our collection sites in the U.S.” According to Han, support from Héma-Québec was also a key consideration in Green Cross’s decision to establish its plant in Montréal.

But in general, he has been pleasantly surprised by how the province has really rolled out the red carpet for Green Cross. He believes that Green Cross will repay this kindness by having an impact on the Québec economy.

“It goes beyond strengthening the province’s manufacturing and life science sector and keeping jobs here. Just building the facility has led to the hiring of engineering firms, construction companies etc.”

He’s also very excited about the potential collaborations that might arise by operating in Montréal, and he’s leaving an open invitation to those who wish to partner with Green Cross.

“We are manufacturing and making products, however, we are a big customer of technologies. So, if universities or research centres in Canada approach us with new technologies that help us with a process or improving our business, we’ll be happy to discuss these opportunities.”

To see this story online visit http://biotechnologyfocus.ca/green-cross-biotherapeuticsthe-new-kids-on-montreals-biopharma-block/

Biotechnology Focus / August/September 2015

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Spotlight on Québec Compiled by Shawn Lawrence

Q&A with the Québec Minister of Economy, Innovation and Exports

Jacques Daoust

The last three years has seen the Government of Québec take an active role in helping to revitalize Québec’s life science sector, whether it’s through backing public-private partnerships, stepping to the plate with financial commitments towards strategic venture funds, or launching programs geared towards nurturing the next generation of leading scientists and researchers. In conversation with Biotechnology Focus, Jacques Daoust, the Québec Minister of Economy, Innovation and Exports, discusses Québec place as a hotbed of creativity and what government is doing to help the province maintain its status as a leading life science jurisdiction.

Biotechnology Focus: The province of Québec has always stressed that the biopharmaceutical, life science and biotech industries are key pillars to its economy. When it comes to these industries, what differentiates Québec from other jurisdictions and how do you think these industries in Québec stack up against international competition?

A: We’ve undergone a lot of change here in the last ten years, and while we aren’t as strong as we once were, I think the industry in Québec is still buoyant. It’s still a good industry and a sector that’s going to grow. You see it when we participate every year at the BIO

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Biotechnology Focus / August/September 2015

International Convention; we are keeping pace, if not outpacing the competition. We are also still home to seven out of the ten major players in the biopharma space and we’re always looking for new ways to ensure we maintain this position. Moreover, when it comes to research excellence and being at the cutting edge of scientific discoveries, Québec truly stands out. This comes down to having the talent and infrastructure necessary. As I’ve said we are looking for ways to get better. For example, we have also just opened a very large research hospital that is linked to McGill University, and we will also be opening another in a few months that will be associated with the University of Montréal. Both hospitals will link R&D leaders to cutting

Spotlight on Québec

edge research centers and exceptional labs, enabling discoveries. Additionaly, when it comes to the scientific talent in the province, we rank right up there with the best. Our universities in terms of statistics for the number of graduates per capita, is right up there with Boston.

In Montréal alone, we have four major reputable universities that act as feeders for our research centres providing some of the best talent worldwide.

BF: You mention you are always on the lookout for new ways to maintain this excellence. What role does the Ministry of Economy, Innovation and Exports play in helping the life science industry thrive in Québec?

A: It’s no secret that the life science industry has undergone a lot of change in the last five to 10 years, both here and abroad, and this change has required us to be more proactive in the way we support this industry. Government subsidies were at one time the thing to do. We had a spray and pray approach; we spray the money and we pray it works. And it wasn’t working. So we’ve changed the way we intervene and help these industries grow, taking on an equity partner position, whether by making financial investments, I stress not subsidies, and by encouraging public and private collaborations. In terms of our financial commitments, we make them through Invest Québec, a bank managed with two funds, propriety funds and an investment fund that comes directly from the Québec government.

These funds are used to financially back companies through direct investments and loans. By taking this approach, we become vested partners in their business. For example, if you are a company or a research center and you have a market cap of let’s say $200 million, well maybe we will be in for $30 million invested. We don’t want to be a majority shareholder, we just want to say that we are there when they need the money and we’re ready to be good partners. If they lose money, we lose money. Likewise, if they find success, we will be part of that success. That’s the way we approach it. Essentially it comes down to if government doesn’t have the mentality or the will to develop the industry, it won’t work. We also are very active in terms of trying to attract both foreign businesses to Québec. For example Invest Québec has 12 offices around the world, working in tandem with our ministry, we identify the areas where we want to grow and go prospecting. We’re also prospecting for investments from those 12 offices, in places like Germany, the UK, the U.S, China, and India. So if there’s a specific company that we target in the world, we have an office to take care of it. If it’s necessary, I will even go myself to the country and negotiate with those companies or investors, alongside the president of Invest Québec to tell our story and why they should bring their businesses, their jobs and their dollars here.

BF: What are the biggest challenges facing the industry in Québec and what is government doing to help industry overcome them?

Biotechnology Focus / August/September 2015

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Spotlight on Québec

A: I would say it’s no secret that access to capital is the biggest challenge. Businesses have to invest a lot of money into R&D and taking products through for example the clinical trial process. Money is the difference maker and the deal breaker. So we as a Ministry strive to help companies get their hands on this much needed capital. I stress the fact we don’t subsidize, we invest. We do this through our involvement in a number of strategic venture funds and public-private business collaborations. An example of what we are trying to do is the Teralys Capital Innovations Fund, where we have invested collectively $700 million into that fund, and more than 25 per cent of that money is dedicated to the life science sector. We have also partnered with big pharma on venture funds, as was the case with the $50 million Merck Lumira Bioscience fund. The fact is developing these innovative molecules requires money, and we have a responsibility as a government to put our fair share in, in the hopes of attracting money from the private sector. And if through our investment just one molecule ends up with FDA approval or reaches the marketplace, it’s a big win for us, not to mention a big win for the businesses we are trying to support.

I think another challenge, and it’s one that all jurisdictions and industries face, is we have to match the graduates from our universities to the needs of industry. Whether it’s the aerospace, gaming, IT or in this case the life science industry, we have young men and women graduating from universities into sectors where the opportunity to find a job is tough, so we as a government have to work harder at helping match these graduates to the needs of the market. We have, for example, in the last budget a program, it’s a measure that we have where you have passport innovation for your first job as a researcher.

If you’re a young graduate and you have a Ph.D. or a post doc you’re given a kind of a passport for your new job in that specific sector. So when you graduate you know that you have a job in a sector where you can grow. We are building new programs onto this, but we will review within another year all our policies in the life science sector so we stay ahead of the game instead of falling behind.

Another challenge we face is the changing dynamic of the pharma industry. All the big players are looking to scale back their internal R&D activities and thus they are changing their business models. For a province that has always traditionally been invested in this space, we have to do our part to keep the big players present, keep the jobs and tax dollars here. This is why we helped set up the NEOMED research centre, a unique consortium that is financed partially by the Québec government, and today has 23 companies working together to advance research in a centre that otherwise would have been left empty. Life sciences is not one company developing a specific molecule alone because it’s almost no longer possible to finance that. So they regroup in labs, they join forces, and that is what a center like NEOMED allows them to do.

BF: Why is this the new business model in life sciences and why do you think it’s the right approach to growing the sector?

A: There is a long list of international pharmaceutical companies that have forged public-private partnerships with health research centres

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Biotechnology Focus / August/September 2015

in Québec, and they have done so with our support. And like I’ve said, we have seen a shift in philosophy for many international pharmaceutical companies globally where they looking for new ways to reduce their exposure to risk and that means governments kicking in a helping hand. I’ve mentioned that NEOMED is a very good example of that approach where we invest money alongside other stakeholders. With good partners, and sharing risk, there’s a good chance of finding success. That’s why we want to invest and there is a need. For example, there are times when the banking sector or when private sector just can’t kick in that little bit extra, so when you’re missing 20 per cent of the transaction, we will be there. And we’re uniquely position to do just that. As a former investment banker I used to think that there was no flexibility in doing business with the government. But, to the contrary, I have found that in fact there is even more flexibility in the public sector than the private sector. The private sector is very strict on its risk rule, on the way they manage the file. Government has the flexibility of doing the things you might not normally do, especially in our case if it’s for the greater good of Québec. At the end of the day if we’re bringing new businesses here or helping an existing company towards a big win, all because of a 10 or 20 per cent financial contribution, it’s worth it to us.

BF: On the topic of government initiatives that have helped to bring new businesses and expansion to existing ones, GreenCross Therapeutics recently started construction on a $350 million facility in Montréal and Medicago recently began construction on a new $275 million facility in Québec City. These announcements have really resurrected the biotech and life science industry in Québec haven’t they?

A: I think that the Medicago and the Green Cross deals , the fact they’re creating jobs and investing hundreds of millions of dollars, I think it proves we are on the right track The industry is changing and we’re trying to change with it. It’s the only way we can survive and I think we have become quite good at adapting. We constantly review exactly what we’re doing in the life sciences, because we want to make sure we’re ahead of the game and not behind the game. One thing we have put in place is a project that we call Creativity Québec.

Creativity Québec is a form of financing that comes from government, for a specific project where you improve on an existing process or product. In the life science, it’s very important, and we have a budget of $150 million for this, so we think this program can be significant for this industry. Frankly, when you are looking at programs like this as an investor, it’s much easier to find financing from the finance department of our treasury board than if you’re just subsidizing. We think that the policies we’ve put in place, like Creativity Québec, are a good way to help the industry to grow and to be more attractive to bring companies here.

To see this story online visit http://biotechnologyfocus.ca/qa-with-jacques-daoustQuébecs-minister-of-economy-innovation-and-exports/

Spotlight on Québec

Montréal and life sciences: Solution architects

T

o build a solid, high-performing and competitive life sciences industry, Montréal InVivo, the life sciences and health technologies cluster of the Montréal metropolitan area, is joining forces with leaders in the sector to face the challenges of the market and propose innovative and effective solutions. Spinoffs are generated through a solid support network, growing industry reach and scope and original initiatives, which benefit the Montréal, Québec and Canadian economy.

Creating wealth and economic growth Montréal is a strategic location in North America to grow a life sciences business. The presence of new world-class teaching hospital infrastructure, unique and recognized expertise of its researchers and clinicians, the proven performance of its technological platforms and the sector’s interdisciplinary collaboration create an economic lever of choice. In addition, the economy’s stability, booming new technologies and potential business collaborations give it a significant comparative advantage.

Montréal is also one of the rare cities in the world in which it is possible to move forward with all steps in the development of a new treatment. Furthermore, competitive costs, concentration of pharmaceutical, biotechnology, manufacturing and contract research companies, access to a population of patients and the high level of medical expertise, make the region a leading market for clinical studies.

A place for the labour force and intellectual vitality With close to 45,000 jobs, Montréal ranks sixth among the largest metropolitan areas for the concentration of life sciences jobs.

The city contains the largest number of university teaching and research institutions in Québec. With eight higher education institutions offering life sciences programs, two of the four faculties of medicine in Québec, three university hospitals and many research centres, it also boasts a significant pool of future talented professionals, which places

Photo: ©iStock.com / © Tony Tremblay

Montréal among the North American leaders for its intellectual vitality. Focusing on these strengths, the Bio Succès Mentoring Network, implemented and administered by Montréal InVivo, fosters interaction between members of the next generation and wellestablished entrepreneurs. With these 21 active mentoring pairs, it is an example of initiatives that contribute concretely to the sector’s success.

On its way to becoming the global benchmark in early clinical trial expertise In 2015, extensive mobilization of the community resulted in a business proposal to make Montréal a global hub of effective and efficient expertise in the achievement of early clinical trials and of clinical proofs of concept. The objective is to double in five years the number of patients participating in these trials. Accordingly, Montréalers will potentially be able to be among the first in

the world to access treatments that could not otherwise be provided elsewhere. Capitalizing on the major investments made in public infrastructure, this initiative, piloted by Montréal InVivo, will furthermore optimize the effectiveness of the research activities undertaken. It will also stimulate attraction of foreign capital, in addition to creating 500 new jobs. Spinoffs are already expected to benefit more than 50 per cent of companies in Montréal’s life sciences cluster.

For more information about the early stage clinical trial initiative and the life sciences sector of the Montréal metropolitan area, visit: Montréal-invivo.com To see this story online visit http://biotechnologyfocus. ca/montreal-and-life-sciencessolution-architects/

Biotechnology Focus / August/September 2015

23

Spotlight on Québec

By Carmela De Luca, Amy Dam and Tom Zhang

First Patent Program launched in Québec Québec has vibrant and innovative life sciences and clean-tech industries and boasts a highly skilled and diverse workforce that ranks among the world’s best. In addition, private public collaborations provide new models for stimulating innovation in Québec.

Despite having attractive R&D tax incentives and significant natural resource endowments, Canada lags behind other highly developed countries and has been ranked 13th out of 16 when compared to other peer countries in terms of innovation indicators.1 By several measures of innovation, Québec leads the country – 30 per cent of Canada’s R&D jobs are found in Québec and Québec is home to 40 per cent of all Canadian companies doing R&D.2 Patent filings, which are also a measure of innovation and are considered a good indicator of innovation paint a different picture. By this measure, however Québec is outpaced by other provinces.

The Databank of Official Statistics on Québec provides detailed information of Québec’s performance in terms of issued patents by the United States Patent and Trademark Office (USPTO).3 The reported figures indicate that Québec trails Ontario and Alberta in terms of issued patents per capita and that Québec trails all other provinces except for the Atlantic provinces in terms of issued patents per R&D spending. Further, the number of issued patents in Québec has been decreasing steadily over the last decade. In the biotechnology sector, the reported statistics reveal that just over 20 per cent of all Canadian biotechnology-related patents issued by the USPTO in 2012 were owned by Québec entities, whereas over half of biotechnologyrelated issued patents were owned by Ontario entities.

A new program aims to address this discrepancy. On July 17, 2015, the Ministère de l’Économie, de l’Innovation et des Exportations (MEIE) announced the implementation of the long-awaited Programme Premier Brevet (“First Patent Program”).4 The First Patent Program will assist Québec-based small and medium enterprises (SMEs) in obtaining protection for their intellectual property assets.

The First Patent Program was first announced in October 2013, but due to changes in government, its implementation was delayed until recently. The First Patent Program provides technical and financial assistance to Québec-based SMEs having 250 or fewer employees for protecting patents, industrial designs and integrated circuit topographies. The financial aid can be used for a variety of activities including establishing an intellectual property strategy, patentability searches and opinions, validity and infringement opinions, as well as for patent, industrial design and integrated circuit topography applications filed in Canada or abroad as well as other related activities.

The funds can be used for a variety of services including professional services costs and filing fees. Up to 50 per cent of eligible costs and a maximum of $25,000 can be obtained per project. There is no limitation on the field of technology - however the products or services targeted by the First Patent Program must have been subject to a substantial R&D component. There are some limitations – patent maintenance fees are not eligible expenses and a company applying

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Biotechnology Focus / August/September 2015

for financial aid under the First Patent Program cannot have previously filed a patent application or industrial design application, although it remains unclear whether companies that have filed only a provisional application will be eligible to apply. According to the MEIE, the eligibility of such applicants may be assessed on a case by case basis. Also, the eligibility of applicants applying for the protection of other types of intellectual property, including Plant Breeders’ Rights, may also be assessed on a case by case basis. Further details are expected soon.

Québec has a rich tradition of innovation in different sectors including the life sciences. The First Patent Program should further incentivise the innovative culture in Québec and is expected to have a positive and tangible impact on spurring Québec entrepreneurs in the life sciences industries. Please contact us if you have any questions on the First Patent Program or protecting IP in the life sciences and clean tech industries.

References 1. Industry Canada, Innovation Canada: A Call to Action, Executive Summary, released October 2011, available at rd-review.ca/eic/ site/033.nsf/vwapj/EecutiveSum-sommaireExe-eng.pdf/$FILE/ EecutiveSum-sommaireExe-eng.pdf [accessed July 19, 2015].

2. Investissement Québec, Innovations and commercial successes, available at http://www.investQuébec.com/international/en/ why-Québec/innovations-and-commercial-successes.html [accessed July 19, 2015].

3. Government of Québec, Databank of Official Statistics on Québec, (February 25, 2014) available at http://www.bdso. gouv.qc.ca/pls/ken/Ken2122_Navig_Niv_2.Page_Niv2?p_ iden_tran=REPEREWNA2736-59548706013%29V9LR&p_id_ss_ domn=805 [accessed July 19, 2015].

4. Ministère de l’Économie, de l’Innovation et des Exportations, Programme Premier Brevet, available at http://www.economie.gouv. qc.ca/index.php?id=20817 [accessed July 19, 2015].

About the authors

Amy Dam is an associate at Bereskin & Parr LLP and member of the Life Sciences practice group. Carmela DeLuca is a partner with Bereskin & Parr LLP and member of the Life Sciences practice group. Tom’s Zhang is an associate with Bereskin & Parr LLP. To see this story online visit http://biotechnologyfocus.ca/first-patent-programlaunched-in-Québec/

NEW PRODUCTS Cameras Vision Research introduces a new camera series for its popular Phantom® Miro® line. Specifically engineered

equipped with a standard RJ-45 Ethernet connector and standard BNC connections for signaling. Additionally the cameras have the option of using the popular CineFlash non-volatile data storage system.

Web: www.visionresearch.com Small batch chemistry Supercritical Fluid Technologies introduces a new, high

for laboratory and office settings where the camera is connected to a computer for storage, control and image analysis, the high speed Miro LAB-Series camera comes in seven different performance levels giving users the ability to choose a camera model that best meets their needs for image resolution and acquisition speed. Models in the series range from the 1Mpx Miro LAB110 to the 4Mpx Miro LAB340. Maximum resolution ranges from 1280x800 to 2560x1600 with maximum frames per second ranging from 410 to1850. It comes

pressure reactor specifically designed for small batch reaction chemistry. The HPRMicro Reactor is well suited for applications in green solvents such as supercritical carbon dioxide as well as traditional organic solvents. Common applications in green supercritical carbon dioxide include: Catalytic studies, polymerization, hydrogenation, oxidation, isomerization, and dehydrogenation. The HPR-Micro Reactor comes standard with a 10 millilitre Iconel 718 reactor vessel for operation up to 10,000 psi (689 Bar / 68.9 MPa), inlet and outlet valves and a pressure gauge.

Optional 25 ml and 50 ml vessels are available. Depending upon the temperature option selected, operation from -40°C to 150°C is possible. The vessel closures are the hand tight type where no wrenches are needed. The reactor is equipped with magnetically coupled stirring for optimal mixing. All high pressure components are ASME compliant designed and overall assembly is protected by a rupture disc assembly for safe operation. The Micro Reactor is also compact and can fit into a fume hood.

Web: www.supercriticalfluids.com

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Biotechnology Focus / August/September 2015

25

NEW PRODUCTS Chromatography As the latest addition to the Thermo Scientific Vanquish product family, the Vanquish Flex ultra

high-performance liquid chromatography (UHPLC) system is designed for high speed, resolution and sensitivity, allowing users to perform biocompatible analysis to obtain high quality and consistent data.

By incorporating an integrated modular design, users have the ability to mix and match modules depending on the demands of the application. Additionally, the system provides sharp peaks at high throughputs, allowing more data to be analyzed in less time. Data quality is ensured via the robustness and repeatability of the system to ensure that large sample sets can be analyzed for comparison during QC protocols. Other key features include a new quaternary gradient pump module, excellent performance operating at 1,000 bar maximum pump pressure, with flow rates of up to 8 mL/min to allow for highresolution separations and application flexibility. Moreover a new fluorescence detector for increased sensitivity complements the absorbance detector module for high sensitivity and extended linearity and the new charged aerosol detector module for non-volatile compounds.

combine 15 x 25g (375g) analytical units, rather than testing each unit individually, so saving time when analyzing lower risk food products. Combined with the Seward 400 Circulator, it provides food laboratories with a high performance blender capable of homogenizing sample volumes ranging from 1,000 to 4,500mL. Highly efficient, it also has programmable settings to ensure the best preparation protocol is used for microbial extraction, depending on the food sample under analysis. The blender comes with a range of accessories including standard (65 microns thickness; coded BA6042) and heavy duty (80 microns thickness; coded BA6042/HD) Stomacher bags, large size bag racks and clips.

sample scale and is ideally suited to high throughput, standard throughput and multiple user environments. Advanced software features such as ‘Recently Used Programmes’ allows users to quickly access their most commonly used protocols without the need to navigate through folders to find them. A novel program wizard generates protocols based specifically from users primer sequence and template source, while individual logins ensure this time-saving feature is available to multiple users and secures user protocols to their specific login should they wish. Greater connectivity and real-time monitoring with a hand-held reporting device (such as a smart phone or tablet) then enables users to track their process to ensure that data quality never suffers. Finally, active sample cooling delivers sharper and minimal nonspecific amplification.

Web: www.pcrmax.com.

Fume Hoods Air Science introduces its new Purair ECO™ line of energy-saving ductless fume hoods. Designed for both chemical and particulate protection over a

Web: www.seward.co.uk Thermal Cycler The quad is back as PCRmax (a Bibby Scientific Company) has launched the Alpha Cycler 4, a thermal cycler that is capable of performing four totally independent runs simultaneously, all within a compact instrument footprint.

Performing high throughput PCR can be a costly and resource intensive process.

The Alpha Cycler 4’s innovative ‘quad’ bay design and smart software features overcome these limitations by expediting PCR and easing operation, while delivering precise DNA amplification. Configurable in any combination of 96 to 384 well formats across its four bays, the Alpha Cycler 4 system provides a flexible platform for any

Web: www.thermoscientific.com/ Vanquish Blender The Stomacher® 4500 BAM laboratory blender from Seward Ltd. is specifically designed for large-volume food testing procedures, such as the FDA’s Bacteriological Analytical Manual (BAM), in which 375g composite samples are required for the microbiological analysis of food. Consequently, the new large volume Stomacher enables food manufacturers to 26 BIOTECHNOLOGY FOCUS August/September 2015

broad range of laboratory and industrial applications, the Purair ECO minimizes stress on facility HVAC systems without compromising protection for personnel and the environment. The Purair ECO is available with a choice of controllers including the company’s new ECOair™ touchpad control with colour display interface. An optional BACnet network interface connects all cabinet control, monitoring and alarm functions to an open-source facility monitoring system. The system is based on an industrywide, non-proprietary ASHRAE compliant protocol for green building management. It comes available in five standard sizes from 30” wide to 69” wide.

Web: www.airscience.com

NEW PRODUCTS High Throughput Prep kits The NEXTflex™ mtDNA-Seq Kit offers a robust method for mitochondrial DNA (mtDNA) isolation and construction of mtDNA libraries for Illumina-compatible targeted or whole mitochondrial sequencing. The kit selectively digests linear nuclear DNA, facilitating the isolation of mtDNA from genomic DNA; enriching the mitochondrial genome 100 to 350 times. After mtDNA isolation, mtDNA single read or paired-end Illumina-compatible mtDNA-Seq libraries are constructed using the reagents included in the kit. The availability of up to 96 barcodes allows for high-throughput multiplexing to reduce sequencing costs.

Clinical chemistry analyzer In vitro

four channels can run identical or different LC-MS assays simultaneously, which provides flexibility for varying clinical separations and maximizes mass spectrometer utilization.

diagnostics company EKF Diagnostics announces the international launch of the Altair™ 240 clinical chemistry analyzer.

This new bench-top platform is fully au-

Web: www.thermofisher.com.

Web: www.biooscientific.com Metal Analyzers SPECTRO Analytical Instruments has introduced two new SPECTROLAB Arc/Spark optical emission spectrometers for high-performance metal analysis in metals industry research and development (R&D) and process/quality control. The new hybrid SPECTROLAB metal analyzer combines analog photomultiplier tube (PMT) detectors with digital charge coupled device (CCD) technology

tomated and represents EKF Diagnostics’ first fully integrated chemistry system. The fully automated system with LIS bi-directional connectivity is capable of performing up to 480 tests per hour. Supported by EKF’s broad menu of Stanbio ready-to-use, bar coded, liquid reagents for routine and special chemistries, the Altair™ 240 also provides the flexibility to configure open channel applications for many esoteric assays. Because it runs on Windows® 7, operators can easily navigate its intuitive, touch screen menu. Features such as the capability to use bar coded, primary sample tubes, auto-rerun, auto-dilution and STAT interruption, all function to maximize the system’s overall efficiency.

Bioreactor EMD Millipore, the life science business of Merck KGaA has added to its stirred tank bioreactor portfolio (from 3 to 2000 litres) with the Mobius® 2000 litre single-use bioreactor. The new bioreactor features a pull-out drawer and self-deploying bag, making Flexware® assembly installation and inflation safe and easy. This design minimizes operator intervention and requires no hoist during Flexware® assembly installation and removal. A patent-pending baffle design creates superior, homogenous mixing. The 5:1 turndown ratio allows users to inoculate and harvest at lower volumes, creating a wider, more flexible process window for

Web: www.ekfdiagnostics.com.

Chromatography and Mass Spectrometry The Prelude LX-4 MD is the

for ultra-accurate simultaneous measurements in R&D, trace metal measurement, and precious metals analysis. Additionally, the new all-CCD technology SPECTROLAB spectrometer provides speed, accuracy and flexibility for process control and QC of fabricated and finished goods. Features of both new high-performance metal analyzers include ultralow limits of detection with improved background correction.

Depending on application and analytes, SPECTROLAB can easily ascertain trace values in single parts per million (ppm).

The two devices also offer elemental flexibility, in most cases eliminating hardware reconfigurations. An optional softwareextendable configuration enables changes to the elemental setup without requiring calibration.

Web: www.spectro.com/lab

newest addition to the family of Thermo Scientific chromatography and mass spectrometry instruments and software for the clinical lab. Listed with the FDA as a Class I medical device for general clinical use, the Thermo Scientific Prelude LX-4 MD HPLC quadruples the productivity of a single-channel HPLC delivering up to four separations in a single instrument. This helps to streamline LC-MS workflows and reduce mass spectrometer idle time. The

seeding, growth, and collection strategies.

The bioreactor also includes an external SensorReady loop connected to the Flexware® assembly via Lynx® connectors to provide greater flexibility for process monitoring and control. Unlike traditional bioreactors in which sensors are inserted into the Flexware® assembly, the SensorReady loop enables users to incorporate additional sensors without modifying the Flexware® assembly. The Mobius® 2000 liter single-use bioreactor can be supplied as a fully-integrated system with intuitive GMP-compliant software that reduces the learning curve for operators and allows for easy integration into plant automation strategies. The automation is simple and enables users to easily customize and control their processes. For customers with plant-wide common automation strategies, the single-use bioreactor can be integrated into third party automation platforms.

Web: www.emdmillipore.com August/September 2015 BIOTECHNOLOGY FOCUS 27

CALENDAR SEPTEMBER 2015

October 27-28

BioPort Atlantic Venue: Halifax, NS ABIC 2015 Tel: (902) 421-5705 ext. 2 Venue: Melbourne, Australia Email: jgillis@bionova.ca Email: kgrimwade@ausbiotech.org Web: http://bioportatlantic.ca/2015/02/06/ Phone: +61 (0) 3 9828 1400 save-the-date-for-bioport-atlantic-2015-octnew card:Layout 1 1/31/2013 9:09 AM Page 1 Web: http://www.abic.ca/abic2015/ 27-28th-2015/

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September 23-24 Pharma & Clinical Trials in Canada Venue: Toronto, ON Tel: 1-888-777-1707 Fax: 1-866-777-1292 Email: cs@alm.com Web: www.insightinfo.com/15th-pharma-clinical-trials-in-canada-summit/

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THE LAST WORD

By Roberto Bellini

DAWN OF A NEW Québec BIOTECH ERA?

Roberto Bellini, President and Chief Executive Officer, BELLUS Health Inc.

Many in our industry remember the golden era during the mid-1990s when biotech flourished in Québec.

At that time, there was a thriving group of biotech companies supported by a varied cast of players that helped these companies push their projects forward.

Québec was also home to the big industry players including many of the Canadian regional arms of the large pharmas, which contributed expertise and human resources; a deep group of contract organizations providing valuable support services; and a large number of venture capital groups to spur startups.

There was also a modest banking industry in Montréal to help raise capital and both Toronto and New York were only an hour’s flight away.

The “fleuron” of Québec’s biotech industry was Biochem Pharma, a company run by my father Dr. Francesco Bellini.

It grew from a fledgling spinoff of L’Institut Armand Frappier with six employees to a biotech behemoth. At its peak, it had a market capitalization of $6 billion. More importantly, it was a fully integrated global player with more than 1,000 employees, strong recurring revenues and an independently sustainable business plan.

Unfortunately, our Québec biotech industry has largely suffered and generally not recovered – unlike our biotech counterparts in the U.S. – since the global tech and biotech bust in the early 2000s.

There is, however, reason to believe that within the next

Life Science Funds Created Since 2011 With Québec Activities

few years, we will see a flourishing biotech industry in Québec. The following are key factors to support that:

Growing Access to Venture Capital With approximately 35 per cent of their $1.5+ billion fund of funds committed to biotech, the establishment of Montréal-based Teralys in 2009 was hailed as a major step towards rebuilding the biotech venture capital community.

While it has taken a number of years to see the fruits of their labour, Teralys’ capital has contributed to kickstarting a number of new funds and an overall unprecedented amount of venture capital dedicated to biotech.

With the announcement of CTI Life Sciences II earlier this year, it’s estimated that seven funds have been created with varying forms of Québec investment commitments in the last four years. These funds have approximately $875 million of capital to deploy.

While many of these funds can invest across Canada (and often globally), much of the focus is on Québec.

This group of funds also excludes the evergreen funds at Le Fonds FTQ and BDC Capital, as well as certain foreign VCs who are known to invest in Québec, including Domain Associates, Forbion, SR1 and Orbimed.

More importantly, the VC community has been rebuilt with a vision and purpose in mind. There are a diversity of investment strategies (incubators, single purpose vehicles, traditional company building) ranging from seed stage to clinical proof-of-concept.

This new generation is also comprised of a diverse group of VCs that have been supported with new capital (CTI, Lumira) and foreign VCs that have been attracted to set up offices in Canada (TVM, Sanderling).

While early stage capital is plentiful, Canada is still lacking market depth for later stage development companies to find the financing they require. IPO and follow-on financing markets have been routine lately in the U.S. and several Canadian companies have already accessed this market or are in the planning process to take advantage of this. However, domestic support is lacking.

Rise of Specialty Drugs Providing Growth Opportunity to Small Companies Spending in the U.S. on specialty drugs, which have traditionally been developed and commercialized by biotechs, will likely surpass the spend on traditional drugs by 2018 according to market analytics firm Artemetrx.

Specialty drugs are typically higher-cost therapies used to treat complex and chronic conditions. These drugs have several important characteristics that favour the biotech development model: • shorter development timelines • lower cost of development Biotechnology Focus / August/September 2015

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THE LAST WORD • and, most importantly, the ability to sell these specialized and high-priced drugs through smaller targeted sale-forces.

Canada’s Lost Decade of Biotech Investment

Without the need for large pharma’s extensive sales and distribution systems, biotech companies can now independently launch and grow their more specialized products.

While this has been true for cancer therapies for several years now, new product categories are emerging for smaller biotechs to develop and launch their own therapies.

This couldn’t be more true than in the area of rare diseases as these drugs fully embody these values (potentially very low cost trials and rapid access to market with extremely high pricing).

For a local company developing a specialty drug, they no longer absolutely need a commercial partner with an existing sales and distribution infrastructure. In this new environment, a ‘go-commercial’ strategy is becoming more and more viable.

Drugs for rare diseases have been the launch pad for some of the most successful upstart biotech companies of recent memory including Vertex in cystic fibrosis, Alexion in paroxysmal nocturnal hemoglobinuria, and BioMarin in enzyme replacement therapies.

While these are all American firms, there is no reason this same success can’t be reproduced north of the border.

Management and Investor Aspirations A crucial factor to building a successful ecosystem is a psychological one: the will and the persistence of key stakeholders to do it.

The period from 2003-2012 is considered ‘Canada’s Lost Decade of Biotech Investment’ (Overall Canadian performance in biotech is a good proxy for Québec performance).

Even through this lost decade, there were a number of drug candidates and technologies developed successfully. This is to be expected from as rich a basin of strong scientific research.

These led to some of the best exits in Québec biotech history including the 2009 Virochem sale to Vertex ($500 million) and the 2011 Enobia sale to Alexion ($600 million upfront plus $500 million in milestones, and one of the largest returns on investment in Canadian biotech history).

Overall though, successes between 2003-2012 were few and far between resulting in little appetite from both management teams and investors to even take late-stage development risk (in both the Virochem and Enobia examples, the lead products were in Phase 2).

That mindset seems to be changing. Prometic, Québec (and Canada’s) largest biotech by market capitalization (~$2B) generates substantial recurring revenue from its protein purification platform and has commercial aspirations for its drug candidates. Clementia, in Phase 2 for an ultra-rare indication, has recently raised $60 million in a mezzanine financing. That level of financing support has not been seen in Québec for many years and could pave the way for Clementia’s drug through Phase 2 and beyond.

Are there challenges facing Québec biotech companies that are competing on an international stage? Absolutely. Intellectual property law, government policy towards biotech, attracting/keeping talent and a poor science translational efficiency rate are obstacles hampering the development of our companies. On the financing side, there is a also lack of public investors for Québec biotech stories though interest is increasing in other markets (Ontario, Western Canada and the U.S.).

But they don’t fundamentally undermine the notion that Québec is gearing up for a new positive era in biotech. This new era should produce several more success stories. These emergent companies can even surpass the star of the last Québec biotech boom**.

Roberto Bellini is the CEO of BELLUS Health (TSX: BLU), a Montréal-based company developing therapeutics for rare diseases, starting with conditions that affect the kidneys. Follow Roberto (@rbellini) on Twitter * **

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Biotechnology Focus / August/September 2015

Source: Public documents including company website and press releases A recent article I wrote in February surmises that Canada will have a Gilead of the north within 10 years. This belief relies on many of the same facts mentioned above. Hopefully, one or more of these breakout companies will be in Québec.

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