Biotechnology Focus October 2013 by Promotive Communications

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

QUÉBEC

HOW PUBLIC-PRIVATE PARTNERSHIPS ARE REVITALIZING THE BIOPHARMA SECTOR INSIDE:

U.S. Supreme Court finds ‘isolated DNA’ unpatentable

Publication Mail Registration Number: 40052410

OCTOBER 2013 VOLUME 16, NUMBER 8

si biotechnology focus.pdf

CMY

12-05-07

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October 2013 – VOLUME 16 – NUMBER 8

QUÉBEC ISSUE

contents FEATURES 7

The US Supreme Court finds ‘isolated DNA’ unpatentable

Is this a canary in the mine shaft for personalized medicine patents? BY CARMELA DELUCA

BY SHAWN LAWRENCE

CRCHUM set to open its doors

BY SHAWN LAWRENCE

Sherbrooke: a hotspot for life sciences Special report on the city of Sherbrooke and its innovation cluster

Personalized Medicine Partnership for Cancer

A one stop shop for drug development The NEOMED Institute: the missing link in the drug development chain

The first phase of Montréal’s new super hospital is near completion as CRCHUM prepares to open BY SHAWN LAWRENCE

Transformation Strategy Talking about company growth with Aeterna Zentaris’ President and CEO David Dodd

The innovation engine – sparking drug discovery in Québec The CQDM celebrates its 5th anniversary BY DANIELA FISHER

The Last Word Spotlight on BioContact Québec BY JEAN-PIERRE TRUDEL

A public-private partnership for personalizing cancer treatment BY DANIELA FISHER

www.biotechnologyfocus.ca

October 2013 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF SENIOR WRITER STAFF WRITER Editorial Interns

CONTRIBUTING WRITERS

Bringing back biopharma Every October, we delve into Québec’s life sciences and biotech industries. This year, we’re profiling the province’s most successful public-private partnerships and the hottest clusters of innovation in the province. Québec is undertaking a major shift in its global positioning strategy for the life sciences focusing more on collaborations and partnerships in order to align itself with the new business model of the pharmaceutical industry. To this end, some the province’s leading public-private partnerships are gearing up to help revitalize Québec’s biopharmaceutical sector. These partnerships tap into integrated networks of academia, healthcare institutions and industry partners that span across Québec. The province has worked to build these networks as ideal places for biotech companies and global pharma to carry out their research and clinical trials. Recently, a major pharmaceutical company announced that it will be increasing its presence in Québec with a $16.3 million investment in the life sciences industry and healthcare technologies in Laval. Servier Canada, the Canadian subsidiary of the Servier Research Group (France’s second largest pharmaceutical company), is building a new centre of excellence in clinical research in the Biotech City. The project, supported by Laval Technopole, Montréal International (MI), the Biotech City and Montréal InVivo, will see the construction of a 30,000 square foot complex in the Biotech City in Laval. The clinical research centre will be devoted to researching cardiovascular diseases, cancer, and neuropsychiatry. Already, Québec’s Ministere de Finances et de l’Economie confirmed that it will award $1 million in non-repayable funding to help advance this project. This initiative from Servier Canada is a great get for Laval’s life sciences cluster. It will boost the attractiveness of the Greater Montréal Area, and Québec in general, among global leaders in life sciences and healthcare technologies. It will also draw attention to the Biotech City, which is a true life sciences innovation cluster, with a university, research labs, a business incubator and many major biotech and biopharma companies based out of the region. And this is just one area of Québec – there are also innovative projects going on in Montréal, Québec City and Sherbrooke, to name just a few. Put together all of Québec’s life science clusters and its numerous organizations based on public-private collaboration, and you have a province that’s capable of bringing biopharma research and investments back to Québec. Happy October!

Terri Pavelic Shawn Lawrence Daniela Fisher Kayla Sippel Anan Rahman Carmela DeLuca

Jean-Pierre Trudel

National Account Manager

Marcello Sukhdeo

GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Elena Pankova John R. Jones Mary Malofy

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

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

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

4 BIOTECHNOLOGY FOCUS October 2013

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R & D NEWS Investment of close to $300M in Québec’s agricultural sector The federal government and the Québec government announced recently the launch of Growing Forward 2 in Québec. The joint agreement to implement Growing Forward 2 contains programs totalling $293 million to support Québec’s agriculture and agri-food sector. “Québec’s agricultural producers and food processors are among the best in the world,” said the Minister of State (Small Business and Tourism, and Agriculture) Maxime Bernier. “The Growing Forward 2 bilateral agreement recognizes that increased innovation, productivity and competitiveness are key drivers of Québec’s agriculture and agri-food sector.” Growing Forward 2 is a renewal of funding from the federal, provincial and territorial governments to ensure that Canada’s agricultural sector remains profitable. By giving priority to innovation, competitiveness and market development, the programs are designed to help the industry reach its full potential. Québec will use the amounts committed under the agreement to implement eight major types of programs for the agricultural and food processing sectors. These programs are focused in the following areas:

• • • • • • • •

agri-food research and innovation; the environment; support for businesses; diversification and development of nearby markets; support for sector development projects; traceability; adaptation of businesses; and assurance systems relating to food safety, biosecurity, traceability and animal welfare.

Close to $27 million in federal funding will go towards the Prime-Vert program announced by Québec on May 10, 2013. The two governments will also provide close to $90 million in support for agriculture and agri-food businesses and for the delivery of consulting services to promote their improved performance. The details of the other programs will be released at a later date. In addition to investments in strategic initiatives, Growing Forward 2 maintains the existing business risk management (BRM) programs. The federal and Québec governments will continue to offer ongoing funding for a suite of BRM programs, including AgriStability, AgriInvest, AgriIn-

Cangene extends biodefence contract with U.S. government

Cangene Corporation has announced that its contract with the Centers for Disease Control and Prevention (CDC) has been expanded. Under the contract, Cangene supplies Vaccinia Immune Globulin Intravenous (VIGIV) into the

6 BIOTECHNOLOGY FOCUS October 2013

U.S. Strategic National Stockpile. VIGIV is a hyperimmune product to be used in treating and preventing certain types of severe complications associated with smallpox vaccination. Cangene’s contract, which relates to the U.S. government’s biodefence programs, has been extended by 18 months and modified to include three additional option periods that extend through 2017. Under the terms of the contract extension, Cangene will conduct additional services to support licensure maintenance activities for VIGIV that could generate up to approximately $6.9 million in revenue over the next 18 months. The contract extension also includes future optional services to support licensure maintenance activities for the product, as well as options for additional manufacturing and plasma collections. The optional periods, if exercised, could generate an additional $45 million in revenue if the base-

surance and AgriRecovery, to ensure that producers are protected from market fluctuations and natural disasters. These programs will be managed, as before, by La Financière agricole du Québec.

line scope of work is implemented or up to an additional $77 million in revenue if the maximum scope is implemented. “The extension of our VIGIV contract underscores Cangene’s leadership in biodefence contracting, which complements our pipeline-focused strategy in the specialty biopharmaceutical space,” said John A. Sedor, president and CEO of Cangene, in a release. “We look forward to continuing to work together with the U.S. Government and the CDC to ensure preparedness against the threat of smallpox.” Cangene originally entered into a fiveyear contract for the supply of VIGIV in 2002, which was extended to a 10-year term, before entering into a new contract with the Centers for Disease Control and Prevention in 2012. Its VIGIV product was first accepted into the U.S. Strategic National Stockpile in 2002 and was licensed in the U.S. by the U.S. Food and Drug Administration in 2005 and in Canada by Health Canada in 2007.

Across Canada

By Carmela DeLuca

The U.S. Supreme Court finds “isolated DNA” unpatentable Canary in the mine shaft for personalized medicine patents?

ersonalized medicine holds the promise of more individually focused diagnostics, strategies for preventing disease and tailored therapeutic regimens that are more effective and/or have fewer drug side effects – basically smarter medicine. However, as the drama around the legal battle over gene patents culminating in the recent U.S. Supreme Court decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (“AMP v. Myriad”)1 unfolded, it showed that personalized medicine is fraught with contentious moral/ethical and legal, including intellectual property, issues. AMP v. Myriad addressed the debate on gene patents that has been raging in the U.S. for some time. As is well known in the personalized medicine industry, the Supreme Court tried to lay down a bright line test, invalidating claims to naturally occurring “isolated” DNA and affirming the patentability of laboratory made synthetic DNA that is not naturally occurring. But as can sometimes be the case, the bright line distinction, in this instance the distinction between naturally occurring and synthetic DNA, is actually blurry and nuanced. The AMP v. Myriad drama took over four years to wind its way through the courts. The suit was launched in 2009 by the ACLU and the Public Patent Foundation who represented a group of plaintiffs including the Association for Molecular Pathology (AMP) and other medical associations, medical professionals, universities and breast

The plaintiffs claimed that patents on BRCA1 and BRCA2 were unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”

cancer patients. The suit took aim at invalidating patents to human genes generally and invalidating Myriad’s patents on two breast cancer susceptibility genes (BRCA1 and BRCA2) more specifically. The plaintiffs claimed that patents on BRCA1 and BRCA2 were unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.” The challenged claims included claims to isolated DNA, methods of detecting germ-line mutations and drug screening. Interestingly claims to vectors comprising BRCA DNA, cells comprising such vectors, DNA primer pair sequences for detecting BRCA mutations and isolated DNA comprising BRCA1 regulatory sequences were not challenged. By way of background, Myriad Genetics was founded in 1991 as a spin-off company from the University of Utah. In August 1994, researchers at Myriad, the University of Utah, the NIH and McGill University published the sequence of the BRCA1 gene and later that year, Myriad and its collaborators filed its first BRCA1 U.S. patent application. Subsequently, Myriad and University of Utah researchers isolated and sequenced the BRCA2 gene and the first U.S. BRCA2 patent application was filed in 1995. In 1996, five years after the company’s inception, Myriad began offering its BRACAnalysis® testing service for hereditary breast and ovarian cancer testing and aggressively guarded its patent position, launching lawsuits against for profit institutions that tried to offer services that infringed of one or more of its patents.2 As a result of its patent position, Myriad became effectively the only commercial provider of BRCA diagnostic testing in the United States.3 Interestingly, Myriad reportedly saw its first profit only in 2012, 17 years and $500 million in development costs later, costs which could presumably be born because of its patent position.4 In a decision that sent shock waves through the personalized medicine industry, the federal district court in New York invalidated all of Myriad’s challenged patent claims. The Federal Circuit then reversed the district court’s rulings on isolated DNA patent claims, holding unanimously that synthetic DNA such as “cDNA”, which is a form of DNA artificially synthesized, is patentable subject matter and holding 2 to 1 that isolated genomic DNA is patentable as well.

Biotechnology Focus / October 2013

Across Canada

The Federal Circuit affirmed the district court’s ruling that Myriad’s method of interpreting mutations by analyzing sequences was not patentable as the “analyzing” step did not meet all the requirements for patentability, but reinstated Myriad’s claims to methods of testing drug efficacy. The plaintiffs petitioned the Supreme Court asking it to review the case. The Supreme Court granted the petition and on March 26, 2012, sent the case back to the Federal Circuit to be reheard in light of its recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In what was interpreted by some as a snub to the Supreme Court, the Federal Circuit in a 2-to-1 decision in favor of Myriad held its ground and issued a new court opinion that was nearly identical to the original. The plaintiffs again petitioned the Supreme Court. The petition was allowed for the single question “Are human genes patentable?” On June 13, 2013, Justice Clarence Thomas delivered the opinion of the Supreme Court in a decision that seemed to allow both sides to claim victory.5 The Supreme Court held that claims to “isolated” DNA were not patentable as “isolated” was insufficient to confer patentability - genes and the information that they encode “are not patent eligible…simply because they have been isolated from the surrounding genetic material”. The Supreme Court also stated that “uncovering of the precise location and genetic sequence” of the BRCA1 and BRCA2 genes (identified as the principle contribution of Myriad) did not “create or alter the genetic structure of DNA”. This finding overturned long standing law with regards to patentability of isolated DNA that is isolated from its surrounding genomic context. The Supreme Court took a more favourable view on claims related to synthetic DNA such as cDNA. The Court held that since cDNA is devoid of certain regions found in genomic DNA called “introns” and since it can only be made in the laboratory, it therefore cannot be a product of nature. Simply stated, naturally occurring DNA, even when isolated from adjoining DNA, is not patentable whereas synthetic DNA that is not found in nature would appear to be patent eligible. When discussing fragments of synthetic DNAs, the Supreme Court noted that a short cDNA may be indistinguishable from natural DNA and hence not patentable. This results in the strange situation where a cDNA corresponding to a full gene may be patentable but a shorter sequence of that same cDNA that may useful, for example for synthesizing or sequencing DNA (e.g. primers) or for detecting specific mutations (e.g. probes) may not be patent eligible unless it spans an intron-exon junction or includes non-gene sequence or a non-naturally occurring element such as a label. Shorter fragments

Biotechnology Focus / October 2013

however are typically not found in nature and generally could only reproducibly be made in a laboratory the same criteria used to find cDNA patentable. This is doubly ironic since claims too short DNA sequences including primers and probes were not challenged by the plaintiffs. What level of modification would be sufficient to render a naturally occurring DNA patentable remains to be defined. Based on the patentability of cDNA, the required level of modification may be minimal. Also the Supreme Court noted that “Myriad’s claims are simply not expressed in terms of chemical compositions” (p. 14). Hence compositions of naturally occurring DNA and specific diluents not found in nature may also render a DNA in composition form patent eligible. It also remains to be seen whether the Court’s reasoning regarding “isolated” DNA will be extended to other types of “isolated” biomolecules such as proteins, cells, organisms and other natural products. The Supreme Court does caution at page 11 of its decision that “[t] he rule against patents on naturally occurring things is not without limits”. It is conceivable that the decision’s “limit” may be to “isolated genes” as indicated in the Court’s conclusion: “[W]e merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material” (p. 18). The Supreme Court was also clear to emphasize what is not implicated by the decision - “[t]his case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered” (p. 17-18). As the Supreme Court acknowledged many of Myriad’s unchallenged claims are limited to applications using knowledge of BRCA1 and BRCA2. These would presumably be at least in principle patent eligible. Is the AMP v. Myriad decision likely to prevent patenting of new personalized medicine tests? Given the high development costs involved with bringing a diagnostic to market, this could dramatically deter new test development. Unlikely – at least going forward. As full genome sequencing has led to the disclosure of most human DNA sequences, the effects of the decision may be circumscribed if the reasoning is limited to isolated naturally occurring DNA. Identifying disease mutations however is an important and active area of biotech research and investment. One effect of the decision is that it could encourage patentees to pursue greater secrecy over early stage discoveries. Also, the Supreme Court decision seems to have left the door open to a variety of claim types. Although the decision allowed both sides to claim victory as noted in Myriad’s press release - “the Court ruled that five of Myriad’s claims covering isolated DNA were not patent eligible. Following today’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test.” Myriad and likely the personalized medicine industry in general would seem to still be in a pretty healthy patent position. One potential land mine, however, may be in regards to the many existing issued patents. Many issued patents include claims to “isolated DNA”. In light of the above, where the “isolated DNA” can include both non-naturally occurring and genomic DNA, such claims it is expected will be invalidated if challenged. In the futute, a review of existing patents would seem warranted and the assessment of options where “isolated DNA” claims are present would be prudent.

AcroSS cAnAdA

When discussing fragments of synthetic DNAs, the Supreme Court noted that a short cDNA may be indistinguishable from natural DNA and hence not patentable. References 1. No. 12-398 (569 U.S. June 13, 2013) 2. Although Myriad began offering BRACAnalysis in 1996, Myriad underwent 3 years of clinical trials to obtain the endorsement from medical societies key for obtaining insurance reimbursement and encourage adoption by doctors. 3. Although Myriad also beneﬁts from owning or being a licensee of CA patents related to BRCA susceptibility testing and cease and desist letters were sent out to the Ontario and British Columbia governments, no lawsuits were launched in Canada. See CMAJ February 19, 2002 vol. 166 no. 4 f available at http://www.cmaj. ca/content/166/4/494.1.full. 4. JJ Colao “How A Breast Cancer Pioneer Finally Turned A Proﬁt”, November 5, 2012 issue of Forbes. 5. The ACLU reported on its website “ACLU VICTORY! Supreme Court

sides with ACLU: genes cannot be patented!” Myriad also issued a press release with the heading “Supreme Court Upholds Myriad’s cDNA Patent Claims; Court Also Highlights Patent Eligibility of Method Claims”. Carmela DeLuca is an associate and registered patent agent at Bereskin & Parr LLP. Carmela’s practice focuses on patent matters, including advising on the management of patent portfolios in Canada and abroad, the preparation and prosecution of patent applications in the life sciences and the analysis of patent issues such as validity, infringement and freedom to operate. To see this story online visit http://biotechnologyfocus.ca/?p=9064

INCUBATING INNOVATION AND INGENUITY

CSPC 2013 HIGHLIGHTS   

CONFERENCE HONORARY CO-CHAIRS The Honourable Michael H. Wilson Chairman Barclays Capital Canada Inc. Chancellor University of Toronto

600+ participants,150+ speakers, 28 panel sessions 3 Pre-Conference Workshops/Symposiums Inauguration of the Awards of Excellence in Science Policy - a first in Canada

Mandy Shapansky President and Chief Executive Officer Xerox Canada Ltd.

Early bird Deadline: October 20th, 2013

@sciencepolicy /canadiansciencepolicy Canadian Science Policy Conference

www.cspc2013.ca

Biotechnology Focus / October 2013

Spotlight on Québec

québec

By Shawn Lawrence

CRCHUM: A world class research centre gets a new home

A new research hospital is set to open in downtown Montréal this fall and is poised to invigorate the local biomedical sector. Occupying nearly 48,000 square metres in total surface area, the building is to be the new home of the University of Montreal Hospital Research Centre (CRCHUM). The new CRCHUM will house leading-edge technology platforms to advance and develop innovative applications that will directly contribute to the hospital’s mission: health care, teaching, research, health promotion and technology evaluation. Dr. Vincent Poitout is the scientific director of the research centre. He explains what sets the CRCHUM apart from most hospital research centres is its exceptional capacity for basic research, as well as its approach to clinical research and population health research. “It’s a beautiful institution which is populated with outstanding scientists who do very relevant and important research for the populations of Québec, Canada and people in general. We are part of the hospital, so we’re not an isolated centre that is strictly focused on one disease, nor are we focused solely on basic or even clinical research. We have a mission to be transformative for the patient and for the population. That’s integral to our position as the research arm of the hospital,” states Poitout. He adds that the CRCHUM’s greatest strength lies in its ability to tackle a health problem from the basic science at the bench to the bedside with the patient at the clinical level and back to the bench with new research questions, both of which inform and are informed by population health research. He refers to this dynamic and integrated convergence as “The research continuum.” Indeed, this expression has become the centre’s trademark. “What this means is we house a full research continuum that includes basic science, clinical research and population health research. This is really what sets us apart having these three different areas not working alone in silos but working together for the benefit of the patient and the larger population. That you have these three aspects under one roof is very unique in the context of a hospital research.” More importantly, the new centre allows the CRCHUM to bring together its personnel who are currently distributed over six other locations under one roof. As such the facility itself is built in a way that it will promote collaboration and interaction. “This concentration of expertise will create an incredible synergy

Biotechnology Focus / October 2013

benefitting researchers and the population alike,” he explains. In all, the centre has 360 researchers (35 per cent basic researchers, 55 per cent clinical researchers and 24 per cent population health researchers; the total exceeds 100 because several researchers have a foot in more than one area) and around 450 students whose significantly collective output has contributed to maintaining an international reputation (an average of 2000 publications per year). Many, he comments, have high international visibility. “We have a very strong group of clinical scientists in prostate cancer, for instance, that are involved in many different Canadian and international trials and programs. We also have very strong basic scientists in ovarian and breast cancer, as well as large tissue banks of these different cancers being used by several pan-Canadian programs. In cardio-metabolic diseases we have strong scientists who have made major discoveries in type 2 diabetes, pancreatic β cell function, and the same can be said in the area of hypertension.” The areas of focus for the new CRCHUM are grouped into eight themes, with five of these focuses (cancer; cardio-metabolic diseases; tissue injury, infection, immunity, inflammation; neurosciences, imaging and engineering) covering the spectrum of universal pathologies. The others (global health; health risks; evaluation, health care and services) are concerned with population health. “We reviewed the strengths of our researchers and decided on these eight because we are well represented with some of the best and brightest in these areas,” says Poitout, adding that moving into the new building will only strengthen the CRCHUM’s capabilities in these areas. For starters, the new centre is equipped with instruments on the cutting edge of technology along with advanced facilities that include 75 laboratories, 36 clinical examination rooms, and 15 Phase 1, 2a and 2b beds for clinical trials. In each case it is also possible to adapt the space configuration and to modify the equipment according to the needs of individual research projects and technological advances. “It is very open to allow people to interact as much as possible; our facilities are conducive to that type of environment. We have four floors of open laboratory space, generic in nature for basic scientists. We have an entire building of dry space for population health and epidemiology studies, and in the basic science building we have one floor of state-of-the-art core facilities for genomics, metabolomics, flow cytometry, etc. We also have two floors of highly specialized animal facilities that surpass the standards of animal care in Canada and can support a lot of different experiments and procedures including imaging, phenotyping, etc.” Researchers will also have access to a world-class medical imaging platform, including a new 18 MeV cyclotron which “will significantly enhance our already strong human and animal imaging facility which is currently mostly based on NMR-MRI,” Poitout says. A cyclotron works by generating very short lived radioactive tracers that can be injected into people or animals at very low doses for what

Spotlight on Québec

More importantly, the new centre allows CRCHUM to bring together its personnel who are currently distributed over six other locations under one roof. is called Positron Emission Tomography (PET) scanning, a frequently used molecular imaging procedure that will allow researchers to image various organs, tissues and, more importantly, metabolic activity. “It’s not looking at the physical structure of a tissue, but rather at the metabolic activity. It’s used a lot in oncology to localize a tumour by its activity. It is also used in other applications, including cardiovascular diseases, neurology, etc. The tracers are time sensitive, they can’t be made elsewhere and shipped for example. You need to use them within a half hour of producing them, so having this ability in house will certainly make things much easier for us.” Moreover, the centre already has the distinction of being at the forefront of clinical research, hosting 1,000 clinical trials in 2011. Strikingly, 30 per cent of those came from the private sector and 150 partner companies. Coupled with having access to major cohorts of patients, the CRCHUM will be more attractive to potential partners and, as such, Poitout believes these numbers should grow at the new centre. “There are definitely major improvements with the new building on the clinical research side. First of all, we now have a centralized clinical research floor (6500 sq. metres of space), and because of its centralized nature we can pool staff, expertise and equipment for these clinical studies.” The other change is the addition of the applied clinical research unit (ACRU). “This benefits both the clinical research and population health units. It is not complete yet but when it is, it will be a methods and expertise centre. Methods in the sense that you will have expertise in biostatistics, in study design, in bioinformatics and essentially a set of resources available for clinicians who want to do a clinical study. It provides expertise of people who are involved in this kind of research and can provide advice and mentorship to the clinicians in the hospital and in the research centre who want to engage in these activities.” He believes there is an opportunity for public/private partnerships

that can result from both the assets and the people that make up the CRCHUM, and this is something he and his team are very proactive in exploring. “I believe that as academic researchers, we don’t exploit publicprivate partnerships enough. So, this is something that we really want to develop in the new research centre with our assets and our people. Already we’re trying to put together internal programs to help identify projects, including therapeutic target projects, so that we can provide support to scientists in bringing their ideas to the next level in the early phases of drug development. We’ll look at all avenues, including working with other institutions, to get this off the ground. We still have a big gap to fill. I think that, like most academic institutions, we’re not well prepared or well equipped for this transition, but it’s a transition that has to happen, all the more so now that the private sector has pulled back from early phases of research and development in many aspects.” Part of this transition is ensuring the development of new generations of researchers committed to research excellence and attracting the best and brightest to work at the centre. “This is an important part of our mission. At any given time, we train about 450 graduate students and postdoctoral fellows from various programs at the University of Montréal as well as from universities throughout the world. Of course, these are the living bodies that make up our laboratories and we’re very proud of them. We strongly believe that you can’t be a highly competitive research centre if you don’t attract the best and the brightest young people because those young scientists are the ones who make the important discoveries. Adequately supported and mentored by senior scientists, junior researchers represent the future of our institution.” To see this story online visit http://biotechnologyfocus.ca/?p=9079

Biotechnology Focus / October 2013

SPecIAL RePORT:

SHERBROOKE: a Hotspot for Life Sciences

Sherbrooke boasts another scientific park, Université de Sherbrooke Innovation Park, and 6 industrial parks that offer an environment conducive to business. All possess modern infrastructures and are served by high-performance transportation networks.

DIVERSIFIED RESEARCH SPECIALTIES

At the heart of the Estrie region, Sherbrooke is not only a great place to live and play, it 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 in Sherbrooke enables the realisation 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! Sherbrooke has two universities: Université de Sherbrooke (francophone) and Bishop’s University (anglophone) that attract students from around the world in several Life Sciences programs such as medicine, biology, chemistry, pharmacology, gerontology, imaging, and many more. Sherbrooke therefore possesses abundant and qualified human capital. The stability of the workforce is recognized by local employers and represents true added value in a sector where competition is fierce.

MAJOR INNOVATION CLUSTER The development of medical technologies is rapidly evolving, especially with the leading edge businesses and state-of-theart research centres of the Sherbrooke University Pole, including the Interdisciplinary Institute for Technological Innovation (3IT), the Research Centre on Aging, the Centre de recherche clinique Étienne-Le Bel (Clinical Research Centre) and the Accélérateur de création d’entreprises technologiques (Accelerator for the creation of technological businesses). The Estrie region and its capital, Sherbrooke, were recognized in July 2010 for their cluster in Biotech Santé within the ACCORD (regional development) program. The Sherbrooke Science Park sets a good example by bringing together a large number of research, education and industry leaders. Found wherein are the Health Campus of Université de Sherbrooke and its Faculty of Medicine and Health Sciences, the Centre hospitalier universitaire de Sherbrooke (CHUS – Sherbrooke University Hospital Centre), the Centre de recherche clinique Étienne-Le Bel, the Centre d’imagerie moléculaire de Sherbrooke (Molecular Imaging Centre), Charles River – a multinational company –, and the Pavillon de recherche appliquée sur le cancer (Applied Cancer Research Building). The proximity of these industry leaders greatly optimizes results leading to noteworthy discoveries and greater international recognition.

Biotechnology Focus / October 2013

For more details, visit the Faculty’s website: www.usherbrooke.ca/medecine

BUSINESS EXPERTISE THAT STANDS OUT Sherbrooke has a lively development climate in many Life Sciences sub-sectors and Université de Sherbrooke fosters the emergence of a growing number of new businesses offering a variety of products and services. Sherbrooke businesses offer expertise in medical devices and equipment, pre-clinical and clinical research, as well as nutraceutical, dermaceutical, and therapeutical products. Over 40 businesses and 1395 jobs constitute the Life Sciences key sector in Sherbrooke. Among them: • DIEX Research: Clinical research, phases 1 to 4, neuroscience, pain management, vaccines, women’s health, obesity, etc. diex.ca • Q&T Research: Clinical research, phases 1 to 3, vaccines, major depression, mood disorders, allergies, cardiology, etc. qtresearch.com • Charles River: Preclinical services spanning the entire drug de-

Photo: Sherbrooke Innopole

Centre de recherche clinique Étienne-Le Bel du CHUS

Université de Sherbrooke’s Faculty of Medicine and Health Sciences and its affiliated research centers have developed expertise in many different fields: • Mother-child • Inﬂammation and pain • Cancer: biology, prognosis and diagnosis • Diabetes, obesity and cardiovascular complications • Aging • Health – populations, organization and practices • Medical imaging • RNA biology • Pharmacology

Sherbrooke businesses have developed high-level expertise, especially in the design and fabrication of various medical instruments and equipment, as can be seen here with IBIOM.

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velopment process, from discovery through market approval. criver.com IPS Thérapeutique: Specialty Contract Research Organization, specialized in the cardiac safety of new drugs at an early stage of their development, by using validated and highly predictive models. ipstherapeutique.com IBIOM: Manufactures ergonomically designed biomedical equipment. ibiom.com Imeka: Specializes in custom software development for visualisation and analysis of medical images. imeka.ca Kinops: Offers three contact support technologies developed for different applications, all aiming at the goal of improving comfort. kinops.com Lumed: Provides cutting edge software solutions to assist healthcare workers and researchers. lumed.ca Biocean: Dermaceutical, nutraceutical, and skincare products under the brand Ocean+. oceanplus.com Neptune Technologies and Bioressources: Natural health ingredients for the nutraceutical and pharmaceutical industries. neptunebiotech.com The Color Group: Formulation, research & development, compounding and manufacturing, filling, assembly & labeling, and sourcing for the cosmetic industry. cdncustompackaging.com

GREAT BUSINESS ADVANTAGES IN A HUMAN-SCALE LIVING ENVIRONMENT In addition to offering an unparalleled quality of life in an enchanting natural setting, Sherbrooke possesses unique business advantages. This city has all the characteristics of a major urban centre, administrative and industrial, fuelled by innovation, and which offers a dynamic business environment at a very competitive price. Sherbrooke offers competitive implementation and operating conditions to businesses. According to the comparative study Competitive Alternatives (2010) performed by KPMG, the cost of manpower, electricity, transportation, telecommunications, interests, and taxes are globally lower in Sherbrooke, with an index of 91.2, based on the US comparative of 100, than in most of other cities in developed countries. Sherbrooke’s location in the southeast portion of the Province of Québec is an undeniable advantage: the city is located 30 minutes from the US border and it takes less than 24 hours to reach a market of 140 million consumers.

Sherbrooke Innopole 819 821-5577 1 877 211-5326 info@sherbrooke-innopole.com www.sherbrooke-innopole.com facebook.com/sherbrookeinnopole twitter.com/SherbInnopole flickr.com/photos/sherbrooke-innopole/ slideshare.net/sherbrookeinnopole/ youtube.com/user/SherbrookeInnopole linkd.in/sherbinno

Sherbrooke also benefits from a diversified and strong economy. In 2012, the Sherbrooke census metropolitan area (CMA) – which includes Magog – experienced an unemployment rate of 7.5% while the average for Québec stood at 7.8%. The greater Sherbrooke area therefore finds itself lower than the average for Québec for a fourth year in a row.

Photo: Destination Sherbrooke

If you are looking for a place to do business in Canada, Sherbrooke Innopole, the economic development organization of Sherbrooke, will be glad to assist you. The team of experts offers advisory services and personalized financing solutions, whether you are at the pre-marketing, start-up, expansion, innovation, globalization or outsourcing stage. Sherbrooke Innopole possesses many financial tools to support your start-up, productivity improvement, expansion, and globalisation or implementation project. To do so, the team of professionals favours a one-stop shopping approach, offering a single gateway to access a host of financing sources, from investment funds to banking institution loans, drawing from government programs, business angels, and venture capital funds. Sherbrooke has access to an Anges Québec cell, the most important business angel network in Québec, which works in synergy with Sherbrooke Innopole.

SHERBROOKE INTERNATIONAL LIFE SCIENCES SUMMIT

Building Opportunities Together!

Right at this very moment, Sherbrooke is in full effervescence, with delegates arriving from around the world, and gathered here to participate in the first edition of Sherbrooke International Life Sciences Summit, September 26th and 27th 2013. The goal of this event is to give major pharmaceutical and medical technology players a forum to discuss their newly defined needs and expectations in terms of collaboration with small businesses and institutions. And to promote discussion even more, a matchmaking service for one-on-one meetings is offered. Major Sherbrooke talents and expertise will also be showcased through the “Spotlight on Sherbrooke” section. Just to name a few, Sanoﬁ, Novartis, Merck, Pﬁzer, CAE Healthcare, Roche and Eli Lilly are there to speak about collaboration to an audience composed of international delegations from Canada, USA, Sweden, Spain, Germany and the UK! www.sils-sherbrooke.com

Biotechnology Focus / October 2013

Spotlight on Québec

québec

Personalized Medicine Partnership for Cancer At the beginning of this year, Québec’s life sciences sector made headlines with its commitment to create a cross-sector partnership devoted to personalizing cancer treatment. The Personalized Medicine Partnership for Cancer (PMPC) was established to develop and implement clinical biomarkers and other personalized healthcare solutions in Québec’s healthcare system. The not-for-profit partnership is also aiming to position Québec as a global leader in the field of personalized medicine. Officially announced in February, the PMPC emerged from a call for proposals under a Government of Québec initiative called the Stratégiequébécoise de la rechercheet de l’innovation (SQRI). The initiative’s aim was to advance knowledge and speed up the process of getting personalized medicine solutions deployed in the province’s healthcare system. Led by Caprion Proteomics, a Montrealbased company developing proteomic biomarkers, discussions started about the possibility of creating a major partnership for cancer research. “One of the main objectives of the PMPC is to establish a network and an infrastructure that will bring together the forces at play in the personalized medicine field in Québec,” says Martin LeBlanc, president and CEO of

Biotechnology Focus / October 2013

Caprion. “Achieving this will allow us to position this network and Québec as a credible integrated solution for discovering, validating and deploying biomarkers in the healthcare setting.” The PMPC, in collaboration with the Ministère de la santé et des services sociaux (MSSS), was also created to strengthen the relationship between the private and public research sectors. Caprion and a number of other major industry partners joined forces with the Québec–Clinical Research Organization in Cancer (Q-CROC), whic as a hospital and university network would provide the private partners with access to public research. Under the leadership of Caprion, the PMPC forged partnerships with industry partners OncozymePharma Inc., Pfizer Canada Inc., Sanofi Canada Inc., Amgen and TELUS Health. At its inception, the PMPC received $21.1 million in total funding, with $10 million from the Québec government and $11.1 million from private partners, to carry out a four-year project devoted to bringing personalized medicine solutions from concept to concrete.

A new healthcare model With personalized medicine, it’s possible to map out a patient’s disease path and select the most effective treatment option. By using the information obtained from a patient’s blood, tumour or other specimens, one can tailor medical decisions and treatments specifically to each patient. This holds great promise for developing more effective drugs and biomarkers, especially in the realm of cancer. The underlying molecular mechanisms in cancer are influenced by genetic, epigenomic and environmental factors. A better understandingof these factors will help researchers develop more effective biomarkers and drugs that are, as the organization describes, ‘the right drug, for the right patient, at the right time.’ This type of treatment will also save the healthcare industry millions of dollars in diagnostic tests. The projects supported by the PMPC will use genomic, proteomic, bioinformatics and information technology platforms to develop and install these biomarkers and targeted therapies in Québec. The main targets are biomarkers and therapies for lung, colon and breast cancers.

Spotlight on Québec

“We are the living proof that you can attract significant amount of private sector funding, and that we can work very well together.” Currently, the PMPC has eight or nine projects on the go. Some of those projects involve developing entirely new biomarkers. Others involve taking initial biomarkers and developing them further, or validating and commercializing biomarkers already at an advanced stage. The rest involve taking existing drugs that have a companion diagnostic or are approved in the U.S. but not yet fully in Canada, and deploying them and conducting real-world health economic assessments of these biomarker-enabled drugs in the Québec healthcare system. One of the major projects is being led and performed by Caprion and involves biomarkers for the detection of lung cancer nodules that were developed in collaboration with a Seattle-based company called Indi Dx(formerly Integrated Diagnostics). Indi is planning to initiate commercialization of the diagnostic test in the U.S. later this year, while Caprion will be Indi’s partner for development and commercial deployment of the test in Québec and Canada.

Private-public sector working together In carrying out these projects, the PMPC brings together a broad network of public and private partners from various fields including molecular biology, genomics, proteomics, medical imaging, clinical management, pharmacoeconomics, ethics, bioinformatics and information technology. This model has succeeded in attracting funding from both private sector and the government. “We are the living proof that it is possible to attract significant amount of private sector funding, and that industry and academia can work very together in a synergistic manner,” says LeBlanc. “The consensus was that together, we combine all of the necessary technology, research and clinical components of an integrated personalized medicine solutionthat no single partner can offer on its own.” Not only has getting academia, biotechs BER BioFocus_Mar2011_OUT.indd 1

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Spotlight on Québec processes, delivery of quality results within predicted timelines and budgets.” Another goal of the PMPC is that by developing an integrated clinical and biomarker platform for personalized medicine, Québec will make itself more attractive to global pharma companies looking for sites to conduct their clinical trials. “The vision here is that we’ve got the key opinion leaders and clinicians representing all major cancers across more than 10 major hospitals in Québec,” says LeBlanc. “They’ve all pledged to work together to recruit patients, to deploy personalized medicine solutions in clinical trials, to monitor patient outcomes and share data under one common umbrella, in a way that should allow pharmaceutical companies who are developing companion diagnostics and biomarker-enabled drug programs to conduct their trials in a more rapid and coordinated manner in Québec.”

Positioning Québec as a world leader Left to Right: Dr. Gerald Batist, Co-director Q-CROC; Élaine Zakaïb, Minister for Industrial Policy and the Banque de développement économique du Québec; Nicolas Marceau, Minister of Finance and the Economy; Martin LeBlanc, President and CEO, Caprion. Photo: Benoït Desjardins.

“This is a new emerging field where we still have an opportunity to be world leaders. It’s not like this game has been won by any particular jurisdiction, so Canada and Québec can still be leaders.”

Biotechnology Focus / October 2013

and pharma to work together resulted in critical funding; it has helped the PMPC tap into a greater integrated network. “By combining over 10 leading university research hospitals into a single clinical network,we are able to tap into a population of over five or six million people,” says LeBlanc. “That allows you to be as credible or powerful as some of the biggest university hospitals or research centres in the United States. If we can harmonize our procedures, and make it such that all these hospitals are working in an integrated manner to conduct personalized medicine clinical studies, we can more rapidly and effectively conduct a biomarker-enabled trial on a subset of the overall patient population than can be achieved anywhere else.”

New role of pharma in Québec With its public-private partnership model, and access to many of Québec’s academic and healthcare institutions, the PMPC hopes to demonstrate to pharma that Québec is an attractive choice for clinical biomarker research, says LeBlanc: “We can offer to pharma, a credible platform and environment for them to conduct externalized biomarker research, because we’ve figured out how to get academic and clinical researchers to work together with private sector biotechs and contract research organizations in a manner that successfully delivers on the expectations and standards of pharmaceutical industry partners with regard to project management

In terms of Québec becoming a leader in personalized medicine, LeBlanc is optimistic: “This is a new emerging field where we still have an opportunity to be world leaders. It’s not like this game has been won by any particular jurisdiction, so Canada and Québec can still be leaders.” Critically, for Québec to be a global leader, it first has to position its healthcare system in the province to be able to receive and implement these personalized medicine solutions. Over these next four years, LeBlanc hopes that the PMPC will be able to complete the projects currently on the docket, and help prepare the province’s healthcare system for broader-scale innovation and deployment of personalized medicine. “I definitely believe that we will execute on our mission successfully complete the projects of the PMPC with the funding that we’ve already secured.” says LeBlanc. “But we would like to go further, and see the role of the PMPC be expanded to perform many other projects with pharma. We’d like to see other pharma partners join the PMPC, and to have the government further support it for a few more years in order to broaden the network, bring in more hospitals and broaden the number of drugs we’re working on.” To see this story online visit http://biotechnologyfocus. ca/?p=9067

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Spotlight on Québec

québec

By: Shawn Lawrence

Transformation Strategy Aeterna Zentaris president and CEO David Dodd

new CEO and president is said to have 100 days to make a real difference in their organization. For David Dodd, stepping into the role of CEO and president of Aeterna Zentaris in April of this year, those first hundred days may have gone by rather quickly, but he is already well on his way to implementing his strategy for the company, going from a sole focus on R&D to becoming a company that is ready to take the next step, commercializing the promising compounds in its pipeline. One would say it’s because of the maturity of this pipeline that Dodd was sought out to head up the Québec-based company in the first place. While his wealth of experience in the sector made him a leading candidate for the role, it wasn’t just a case of Aeterna Zentaris wanting him. Dodd also wanted to be part of Aeterna Zentaris. In fact, he was so impressed by what he saw in the company and its potential when the courting process started, that prior to assuming the role of president and CEO, he also became a shareholder in the company. “I wanted to send them a clear message of interest not in just the position but also in the company. My goal was to find a company that I could really sink my teeth into, one that was well positioned, and Aeterna Zentaris was exactly what I was looking for,” he says. If there’s an individual who knows an opportunity when he sees it, it’s Dodd. A business oriented individual, Dodd’s executive management experience in the pharmaceutical and biotechnology industries

Biotechnology Focus / October 2013

spans more than 35 years. He’s worked with small biotech firms (Serologicals, BioReliance, Stem Cell Sciences, Geo Vax) mid-sized pharma (Solvay) as well as big pharma (Abbott, BMS and Wyeth). One of his greatest achievements was during his six-year tenure as president, CEO and director of Serologicals Corporation, where he increased the market value of that company from $85 million in June 2000 to the point where it was acquired in an all-cash sale by Millipore Corporation in July 2006 for $1.5 billion. He believes that Aeterna Zentaris has the pipeline to achieve the same type of success. “I guess for starters, I really like the idea of a biopharmaceutical company that has products in oncology and endocrinology. These are two very speciality type markets where I believe you’ll find a lot of opportunity if you deliver good products and services,” he says. It all starts with the company’s lead product: macimorelin acetate (formerly AEZS-130). Macimorelin acetate is an oral diagnostic for adult growth hormone deficiency (AGHD), a condition where there is a negative impact to the pituitary gland which causes hormonal imbalance or disruption. The product is an orally-active ghrelin agonist that when ingested it stimulates a GH secretion in a patient, making it easier to diagnose AGHD. “Typically it’s hard to diagnose AGHD, most current means need to be injected. Ours is the first that can be taken orally; it works faster and has a favorable safety profile. You simply take the blood from a patient who has taken AEZS-130, and conduct a confirmatory test on the blood sample to determine whether the patient has AGHD. The product can be used in a confirmatory manner, and there’s opportunity to expand that very rapidly from a marketing standpoint.” Even more exciting is the fact that the company is now in the final stages of filing a NDA for a commercial licence in the U.S. Moreover, the same product is also being assessed in Phase 2 trials as a therapeutic treatment for severe chronic diseases such as cancer induced cachexia. Likewise, on the oncology side, the company has a second lead product in its pipeline, zoptarelin doxorubicin (formerly AEZS-108) which is in a Phase 3 program for endometrial cancer. Endometrial cancer develops when cells in the inner lining of the uterus (the endometrium) become abnormal and grow uncontrollably. “This molecule is part of a targeted cancer treatment; it allows specific targeting of tumour cells expressing the LHRH receptor. For example, when you use standard chemotherapy to treat a patient,

Spotlight on Québec you affect healthy cells as well as cancer cells. With AEZS-108 you’re targeting specific characteristics (LHRH receptors) of the cells, and your drug is delivered to those cells only. The target receptor is present on cancer cells but not on non-cancer cells.” According to Dodd, like AEZS-130, there is no approved product in the U.S. for endometrial cancer, so once again Aeterna Zentaris is aiming to be the first. The company has already dosed its first patient in its Phase 3 trial in this indication. “We’ve opened 11 sites, four in the U.S., and seven in Israel and now we are ironing out details on our last regulatory and contracting details for the Canadian sites. Moreover we also have other trials in Phase 2 with the same molecule for additional cancers like ovarian, prostate, bladder and triple negative breast cancer,” said Dodd. In both cases, Dodd believes the company is on the verge of delivering some really nice value in its pipeline. Of course, there’s always an underlying fear due to the uncertainty inherent in this industry that the possibility of failure is always lurking around the corner. This is especially true in Aeterna Zentaris’ case where circumstance has dealt its share of mishaps to the company. “You can say Aeterna Zentaris has had some bad luck over the years when it comes to Phase 3 trials,” Dodd comments alluding to the company’s recent failure in a Phase 3 study of a product it has since dropped: perifosine. After promising Phase 2 results, the Phase 3 trial was discontinued only a month before he came on board. Prior to that, the company had several other products reach Phase 3 and bow out. For these reasons, one of the first orders of business for Dodd was ensuring that the company would not just focus on internal R&D, but rather look externally for new opportunities. “This is a topic I’ve spoken much about since joining the company, whether it is looking at opportunities to in-license or to someway obtain already-on-the market products that align with our strengths, be it oncology or endocrinology. It’s important to show not only what we alone can develop, but also to be able to provide a high value differentiated portfolio because at the end of the day that is what builds value in a company.” Moreover, by adding already on the market products Aeterna Zentaris will be able to create a revenue stream to help finance its portfolio of oncology candidates. Lastly, part of his strategy is ensuring that the company honours its commitments to strengthen the company’s reputation in the eyes of investors. “It’s very important to us that when we make commitments we deliver on those and in time. Over the past few months, we have successfully met four out of the five critical objectives set for ourselves when I joined the company including: (1) the transfer of Cetrotide® manufacturing rights to Merck Serono; (2) the initiation of patient recruitment and dosing of the first patient, as well the signed agreement with Ergomed as CRO for our very important Phase 3 ZoptEC trial in endometrial cancer; (3) successfully raising financing in support of our ongoing operations and development programs; and (4) making significant efforts to obtaining on-the-market products that

Moreover, by adding already on the market products Aeterna Zentaris will be able to create a revenue stream to help finance its portfolio of oncology candidates. will accelerate our strategy aimed at transitioning to a revenue and cash generating company. As for the fifth objective, we are finalizing our preparation for submitting the NDA for macimorelin acetate (AEZS 130) as the only approved oral diagnostic test for adult growth hormone deficiency.” Perhaps most importantly, he believes that the talent as much as the pipeline is Aeterna Zentaris’ greatest asset to sustaining success. “In any leadership change, the easiest thing is just to change people, but to me that isn’t true leadership. I think leadership is the ability to go into an organization and work with the organization and show them that they can achieve more than they thought they could. I think this is something I do well, helping people realize their potential. And having sat down with every employee, there is a very strong belief among them in what we have developed is strong, sound and capable of really improving people’s lives. Our people have the will to succeed, and I wouldn’t be here if I didn’t believe in them and this company.”

To see this story online visit http://biotechnologyfocus.ca/?p=9070

Biotechnology Focus / October 2013

Spotlight on Québec

québec

By Shawn Lawrence

The Neomed Institute:

A one stop shop for drug development The news was very bad for the Québec life science industry in February, 2012, when global pharma giant AstraZeneca announced it was closing its research facility in Québec. The province was already facing huge job loss numbers in the sector as one-by-one, global biopharmaceutical giants were moving or scaling back their R&D operations in Québec. Who would have thought back then that the former AstraZeneca building in the Saint-Laurent technology park would ever see better days again. And yet, that is exactly what has happened over the past 18 months. Thanks to the launch of the NEOMED Institute, there is a research renaissance happening in Québec’s biopharmaceutical community. Hailed as a new type of translational research centre, the NEOMED Institute is part of a major shift in philosophy for life sciences and drug development in Québec. This philosophy is one that stresses the importance of public-private partnerships in facilitating early stage drug discovery. Backed by the Québec Government, Pfizer Canada, and of course AstraZeneca, the NEOMED Institute operates in two parts, firstly as an organization (NEOMED), and secondly on a larger scale, a building or institute that houses, today, 10 life science companies. So how did two competing pharma companies come together with the Government of Québec on a common goal? For starters, the creation of the NEOMED Institute happened in large part thanks to two individuals: current President and CEO of NEOMED and the NEOMED Institute Dr. Max Fehlmann, and NEOMED’s CSO, Dr. Philippe Walker. Fehlmann explains that the wheels were already in motion for an organization like NEOMED long before the AstraZeneca closing. “We in the life science community were prepared to imagine something that could be the missing link in all the chain of players

Biotechnology Focus / October 2013

in the Biopharma ecosystem and when the opportunity of using AstraZeneca Research Centre arose, we were given the tool to address this missing link.” Like Fehlmann, Walker also saw opportunity with the closing. Until June 2012, Walker was vice-president and head of the AstraZeneca R&D Montréal (AZRDM) research centre that delivered multiple drug candidates to the AstraZeneca portfolio. “I had actually been recruited from Switzerland to Canada in 1994 to build the Montréal facility so I had a long history with the research facility. Moreover, I was also part of the global leadership team for AstraZeneca, so I was aware of the challenges that they and other pharma companies were facing, and understood their need to reduce their internal R&D activity. When I was told we were closing the site, it was not surprising, on the one hand I was very sad for the impact this was going to have on about 150 families, but knowing how valuable the facility itself was, I also saw an opportunity to use the facility in another way.” Together, the two decided to work together to create something that could fill the void left by the big pharma’s exodus, but also something that could act as a catalyst for the local life science sector. “Using the logic that pharma companies were saying we’re going to reduce the risk by acquiring outside R&D programs, there would need to be someone or something to fill a niche of advancing these R&D programs in smaller biotech companies to the stage they’d be acquired,” says Walker. Filling such a niche was only part of the equation. As a member of the Fonds de Recherche du Québec, Walker also had the opportunity to see the great science and innovation underway in academic institutions in Canada, but also the huge challenges in transforming this great work into solid proposals for industry. He thought that perhaps

Spotlight on Québec

“I had a very strong relationship with Pfizer at CQDM and while there, we discussed a drug repositioning project using Pfizer assets that had been shelved and abandoned after unsuccessful Phase 2 trials.” — Dr. Max Fehlmann NEOMED could act as a bridge for transforming basic research into products worth investing in. “The fact is there are very few academic groups who are able to bring a program forward to a stage where pharma is interested in investing. The mission of academia is different in a sense that they work on the basic science or in some instances the causes of disease. They understand the pathophysiology of the disease but very few are able to design compounds. So, the first week after we heard about the closure, I went to the Ministry of Finance of Québec and I presented this idea that we could create something in Québec to help bridge academia and deliver programs. They were quite taken with the notion that it was good for the science community, good for the economy and good for the life science sector in general.” The Québec government was willing to contribute $28 million toward the project. From there, Walker and Fehlmann began negotiations with AstraZeneca to convince them to back NEOMED and in the end, hand over the facility. The end result was AstraZeneca kicking in the research facility, the equipment along with $5 million in cash, as well as the intellectual property for three potential pain drugs. In all their contribution was valued at $35 million. “I think what made it easy is that they knew that they had benefitted from a lot of support in Québec, and in Canada. They wanted to be a good citizen and leave in the right conditions, but at the same time they were quite eager when they saw how this could be a winwin proposal,” says Fehlmann. Pfizer’s involvement in NEOMED is a slightly different story. Prior to joining NEOMED, Fehlmann was president and CEO of CQDM, the Québec Consortium for Drug Discovery, a pre-competitive drug discovery consortium formed by seven major pharmaceutical companies. One of those pharmaceutical companies happened to be AstraZeneca, another was Pfizer. “I had a very strong relationship with Pfizer at CQDM and while

there, we discussed a drug repositioning project using Pfizer assets that had been shelved and abandoned after unsuccessful Phase 2 trials. Our joint hope was to find new indications for those molecules and although such a project was out of the scope of CQDM, it was exactly the type of project we wanted for NEOMED. I proposed to Pfizer that we merge this project with NEOMED and they accepted.” In all, Pfizer Canada provided a financial contribution of approximately $3.5 million and an agreement was reached giving NEOMED the rights to work with these shelved assets. Of all these assets, the inherited projects from AstraZeneca are what have Walker most excited. For starters, he is perhaps the most knowledgeable person when it comes to these molecules having overseen their development while at AstraZeneca. The most advanced of the three is a Cannabinoid CB1/CB2- Agonist (NEO1940) that has already completed a number of Phase 1 trials at AstraZeneca. “At AstraZeneca it was advanced as a pain medication for low back pain. Unfortunately when it was tested in volunteers, it was noticed that there was a dose-dependent weight gain provoked by the molecule, so AstraZeneca decided to shut it down. However, we felt we could reposition the molecule in an area that there is a tremendous need, specifically in Cachexia which is present in patients with cancer, COPD and heart failure problems, and so we asked them for the rights to this molecule and they complied.” Walker believes that the molecule’s effects could be exploited in patients with Cachexia ensuring they don’t lose energy and muscle tissue. “We are at the stage with this program where we can enter proofof-concept quickly and we are looking for co-investors to share the risk and reward on this.” The second acquired program is NEO6860, a TRPV1 Antagonist. TRPV1 is a channel that exists on nerves and participates in the regulation of sensory neuron functioning and perception. According to Walker, many pharma companies have had TRPV1 antagonist

Biotechnology Focus / October 2013

Spotlight on Québec

“I truly believe NEOMED and the NEOMED Institute are a big plus both for Québec but for Canada as well. We’re creating an entity that has a good connection with academia, identifying great ideas.” — Dr. Philippe Walker

programs mostly for chronic pain. Many went into the clinic, but most failed, all for the same side effects. “The problem was when you block this receptor you trigger deregulation of body temperature, elevation of temperatures and a failure to read temperatures. We have made some scientific discoveries since helping us avoid these side effects, and we have advanced the compound devoid of these side effects because it has a different pharmacology. This compound is at the GMP tox stage and if it goes through, we should have an IND application next year for Osteoarthritis pain.” The third program Walker considers less advanced. It is for NEO5937 P2X3, an antagonist for bladder pain and other similar pains. NEOMED is currently gathering pre-clinical information to advance it forward. Together these three programs form the core of its portfolio along with the drugs that NEOMED will repurpose from Pfizer. But there is another key strategical area that NEOMED wants to focus on. Specifically, identifying prospective projects in academia or small biotech enterprises and bringing them to a point where they are of value to be sold back to the biopharma industry. “It is in this area that I think we have aligned ourselves very well with the new business model of the pharmaceutical industry. It’s well known that there is a considerable gap between basic research and later-stage drug development. With NEOMED we seek to cre-

Biotechnology Focus / October 2013

ate a bridge, as well as a bridge between academic research and life sciences companies, essentially, the NEOMED model allows pharma companies to fund early stage startups, researchers and perhaps invest heavily in some biotechs until later-phase clinical trials can be considered.” says Fehlmann. Already, NEOMED is in the process of reviewing new programs coming from young biotech and academia to add to its portfolio. The process is very lean and effective says Fehlmann. “Internally we have 15 experts at NEOMED, in all the major fields of drug discovery and they have all worked in industry. This is really our trademark. When we receive an application we can make a rapid evaluation on whether we want proceed with it. For the projects we select, we agree with the owners/investigators on a development plan, take control of the development and outsource all the work. Part of the work could be done at the university where the investigator comes from, or it could be CROs. We benefit from the flexibility of being virtual and the proximity of the CROs that we know very well in the area. The goal is to bring the projects to a pinnacle proof of concept (Phase 2a), and hopefully if all works well, we sell the projects to our pharma members. I think this is really our value in that we look at academic projects with the eyes that industry would look at them. This is what we are able to sell to the academic investigators, that we can help them to heighten their project and development of molecules in such a way that we can anticipate the regulatory problems, the preclinical/clinical requirements, and make the process of drug development easier.” While selling more mature projects to pharma is the preferred exit strategy, NEOMED has also left the door open to the investor community, meaning company creation. “This isn’t necessarily the first line of action with a new technology, but it is always a possibility. There are certain assets that we believe the industry will not take on easily or immediately because it may not be the type of indication that our partners like or for other reasons. In these instances there is potential to create companies and invite continued on page 28

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Spotlight on Québec

By Daniela Fisher

cqDM

celebrates its 5th anniversary

The innovation engine –

sparking drug discovery research in Québec

One of the most successful organizations helping advance drug discovery in Québec is the Québec Consortium for Drug Discovery (CQDM).The consortium has become a powerful engine, driving innovation and collaboration in the biopharmaceutical industry. Its mission is to identify, fund and support research projects conducted jointly by academia and the private sector. Projects funded by the CQDM target the development of new tools and technologies that accelerate drug discovery. In addition to numerous funding programs and competitions, the CQDM has a unique mentorship program in place. Every project funded by the CQDM is supported by mentors that are appointed by the CQDM’s pharma partners (Pfizer, Merck and AstraZeneca). The mentors are senior scientists from their respective global corporations, chosen for their relative expertise in a project area. This year, the CQDM is celebrating its fifth anniversary. In the five years since its inception, the consortium has met with quite a few successes. Three of its projects have recently been completed, and have had significant impact on the scientific community and the

pharmaceutical industry. In several cases, the tools developed in the projects are being used by CQDM pharma members, who will contribute to the future development of the technologies or who have expressed an interest in acquiring these tools. These three projects are: the Université de Montréal project, led by Michel Bouvier, for developing multiplexed biosensors to identify and monitor cellular events associated with drug therapeutic efficacies and side effects; the Montréal Heart Institute project, led by Jocelyn Dupuis, demonstrating the safety of PulmoBind and its ability to non-invasively image the lung; and the Caprion Proteomics project, led by Eustache Paramithiotis, for developing new biomarkers for early diagnosis and monitoring of diabetes and prediction of therapeutic responses. These projects, as well as many others, have produced positive and tangible benefits for both researchers and mentors. As the mentors are well-positioned to understand the technology and talk about the technology at their own organizations, this also increases the likelihood of attracting the interest of the global pharma companies. For Michel Bouvier’s project, the CQDM pharma members were interested in the project from very early on. Through the mentorship program, Pfizer, Merck and AstraZeneca began testing his team’s biosensors, for potentially licensing them in the future. The interest of the pharmaceutical partner is an important validation of the technology, says Bouvier, and one that he hopes will lead to collaborations beyond the CQDM network.

“For us, the interest generated by the technology is very important. It recognizes its potential for drug discovery.” — Michel Bouvier 24

Biotechnology Focus / October 2013

Spotlight on Québec

her

“You indirectly get the backing of the CQDM partners. I think that gives a lot of value to a project and demonstrates that there’s really interest by the pharmas in our technology.” — Jocelyn Dupuis

“For us, the interest generated by the technology is very important. It recognizes its potential for drug discovery. To us to have large biopharmaceutical companies using these biosensors is recognition of the value of the technology. What we’re hoping is that, the fact that leaders in drug discovery are showing interest in these biosensors will increase the general interest that other companies, which were not part of the CQDM originally, or even smaller biotech companies may have in our technology.” In developing the technology, Bouvier says it was very useful to have the pharma mentors working with him and his team on the project. “It was very interesting for us to be able to directly ask ‘What would be the most helpful for you? Would that biosensor be more helpful than this other one?’ We could do hundreds of biosensors, so in order to select the one that would be the most useful to them and also to us it was nice to have their opinion. Through dynamic interactions, we knew what was their interest and why, and understood better what their drug discovery process was and how they thought about the biosensors. That was a cultural change for some of the investigators involved in the project, allowing them to better understand what are the needs and what are the hurdles for the companies to jump over.” Through the mentorship, Pfizer has committed additional funding for the development of signaling signatures and commercial applications for these tools. In a follow-up project, the group is validating the information that the biosensors can give in terms of drug discovery for specific targets that Pfizer has internally.Bouvier’s enabling technology first caught the eye of Anne Schmidt, Senior Director Primary Pharmacology Group at Pfizer, who was a mentor for the project. Being able to work with academic researchers in developing and testing the technology has proved a rewarding partnership for Pfizer. “With the CQDM philosophy of exchanging reagents, we have now taken on some of the reagents and been able to play with them internally, and we have a much closer collaboration,” says Schmidt.“We had a couple folks from our group travel up to Michel’s lab, and not only our group, other groups within Pfizer travel up to Michel’s lab and be able to work side-by-side with the scientists there to understand the nuances of using the technology.” In addition to this high-profile collaboration, a separate spinoff company is also in the works. From the CQDM project, a new service-based company to be established in Montréal will use the biosensors for drug screening and profiling. It will offer its services to pharma companies looking to outsource their research. For a spinoff company to have emerged from this academic research project shows the success of the CQDM in enabling the commercialization of tools and technologies for drug discovery. Bouvier’s project is not the only one to have doors opened thanks to a mentor’s involvement. For Jocelyn Dupuis’ project at the Montréal Heart Institute, one CQDM pharma member is taking Dupuis’ technology further, working in collaboration to develop a PETimaging version of his molecular imaging technology and to test it in non-human primates. It will share the results with the researchers and other pharma members. Moreover, the CQDM pharma member has exercised its license option to use the results generated by the project. For Dupuis, all this recognition, as well as the initial funding, made his project possible. At the time of applying to the CQDM, his project was at an early stage of development which made finding funding

difficult. Being at the CQDM greatly accelerated the development of his imaging technology. “Financially it was extremely important but I’d say also scientifically having an external organization like this review the application, and basically give a stamp of approval in the competitive context, demonstrates the quality of the project,” says Dupuis. “You indirectly get the backing of the CQDM partners. I think that gives a lot of value to a project and demonstrates that there’s really interest by the pharmas in our technology. We had initially met with individual pharma before that trying to get funding, but pharmaare not imaging companies, they’re not into imaging. So individually they considered the project to be at too early a stage for them, but with the CQDM project and their partners, it changed their perspective.” For Caprion Proteomics, the CQDM project saw the company diversify its pipeline by enabling the discovery and verification of a promising set of clinically relevant biomarkers for type 2 diabetes, to track disease progression and monitor treatment. Originally a service provider, the project allowed Caprion to progress towards the goal of becoming a clinical diagnostic company as well. Through the mentorship program, Caprion received invaluable insight from a pharma point of view on which biomarkers would be most useful. “I’ve been in biotech for almost 20 years now,” says Martin LeBlanc, president and CEO of Caprion. “I’ve not run across very many programs like the CQDM, that have figured out how to bring together the biotech and pharma industry with academic researchers in a true collaborative and successful fashion. They solicit and fund projects that truly respond to industry needs.” The project has also spun out further collaborations and more business opportunities for Caprion: “The project helped us with our service business, because the mentors acted as an internal reference inside of their pharma global R&D organizations for other uses of our technology in other projects that weren’t related to the CQDM. This meant better relationships between Caprion and these three pharma companies (AstraZeneca, Pfizer, Merck). In all three cases, we were able to sign subsequent partnerships related to diabetes in many cases and in other cases, to other therapeutic areas. All of it was made possible by this project. It connected us better with the pharma universe of these three companies and brought us credibility in the diabetes area that was central to establishing additional collaborations with at least three other pharma companies.” Helping academics and local biotechs build strong links with the pharma industry is one of the key roles of the CQDM. Through these collaborations and many others, the CQDM is establishing Québec as a great place to go for excellence inbiopharma research. To see this story online visit http://biotechnologyfocus.ca/?p=9073

Biotechnology Focus / October 2013

NEW PRODUCTS Software Bio Rad Laboratories, Inc. KnowItAll® Informatics System 2013 spectroscopy software offers solutions for spectral analysis, identification, search, data management, and reporting.

It supports multiple instrument vendor file formats and techniques (IR, Raman, NIR, NMR, MS, UV-Vis). The software can be used by chemists in combination with the company’s spectral reference collections data (over 1.4 million spectra). The system also includesAdditions to ATR-IR, IR, Raman, NMR, and MS reference spectral collections, enhanced Raman spectrum management, performance optimizations and workflow simplifications as well as advanced GC-MS database building and linking capabilities.

Centrifuges The Allegra X-5 air-cooled benchtop centrifuge from Beckman Coulter Life Sciences is designed specifically for clinical sample preparation.Bundled packages, which include swinging bucket rotors and common adapters, enable fast and convenient setup, are offered for a range of clinical sample prep applications, and make it easy to order these energy efficient units.Throughput and productivity are enhanced through seamless integration with the Beckman Coulter Automate 2500 family of sample processing systems. Furthermore, Beckman Coulter UniCelDxC and UniCelDxI sample racks can be spun directly in the centrifuge, eliminating transfer steps. A small footprint allows the unit to fit comfortably on the benchtop, while still providing capacity for up to 140 blood collection tubes. Maximum speed of 4700 rpm and centrifugal force of up to 4470 x g shortens run times.

Web: www.bio-rad.com/en-us/ spectroscopy Liquid Handling Mettler Toledo subsidiary Rainin Instrument has released Liquidator 96, a bench-scale, 96-channel high through manual pipette. The Liquidator 96 allows pipetting in 96- and 384-well plates, PCR plates, 8- and 12-channel reservoirs as well as 96-deepwell plates. Its

handling speed represents a critical pipetting benefit, particularly when working with time-critical ELISA test procedures. Also, because Liquidator 96 works just like a manual pipette, it can be used by lab technicians at any experience level. The Liquidator 96 fits any bench-top or laminar-flow cabinet making it suitable for cleanroom conditions.

Web: www.mt.com/liquidator 26 BIOTECHNOLOGY FOCUS October 2013

Web: www.BeckmanCoulter.com Meters AALBORG® Instruments’ announces the launch of its new ACRU line of Acrylic Flow Meters. These unique meters are being offered with any one of the interchangeable direct reading scales for Air, Water, Argon, Oxygen, Carbon Dioxide, Nitrogen, Helium or Hydrogen.Dual scales display flow rates in both metric and English units. Optional scales can be developed for diverse flow conditions facilitating OEM applications. The yellow colored Back Plate enhances scale readability and minimizes eye fatigue. The meters are configured for “in-line ¼” Female NPT connections. Web: www.Aalborg.com Titrator JM Science’s AQUACOUNTER® Volumetric Karl Fischer Titrator (AQV-300) is rugged, reliable, easy-to-use andhas

performance features which allows measure of moisture content from low to high concentrations quickly and accurately. Measurements are simple and routine with calculation functions that include concentration, factor standardization, statistics, and recalculation. The AQV-300 has six built-in calculation modes to accommodate solid, liquid and gas samples. Four files with preset conditions can be stored in memory and allows instant recall of data for up to 20 samples. This unit comes with a small footprint with integrated magnetic stirrer. A newly designed buret tip ensures precise titration. Two RS-232C ports are convenient for balance and computer interfaces for GLP and ISO documentation. It is CE approved. The titrator comes with DVD training movie, plasticized quick-start guide for use in the lab, paper and pdf manual. Also included, complete accessories, download software for transferring results to a laptop or PC, and RS-232 cable.

Web: www.jmscience.com Temperature Controller The 5R7570(A) RoHS compliant open board electronic temperature controllers from Oven Industries are specifically designed with a proportional integral control algorithm to provide precise control to thermoelectric modules (Peltier). Its H-bridge temperature control provides a seamless transition between heating and cooling eliminating dead spots. Green LED for heat and blue LED for cooling indicate mode and simultaneous illumination indicates the load circuit is off due to an open sensor. Pulse width modulation controls the power level in the thermoelectric module at a base frequency of 1Khz. Power resolution is one of ±250 steps in the load circuit control. This small package temperature controller 1.75” x 3.5” X 3” with input voltage: 6 to 28VDC, Output Voltage: 0 to 36VDC, Load Current 0.1 to 12.5 Amps, 450W output power control, control stability: ± 0.1°C and temperature range of -20 to 150°C. Web: www.ovenind.com

NEW PRODUCTS Pumps Thenew Legato 110 Dual Rate Syringe Pump System (Legato 110 DRS) from KD Scientific offers researchers complete flexibility to start two pumps simultaneously for delivery of two independent flow rates. The pumps are synchronized through a special input/output cable included with the system.It comes complete with two programmable infuse/withdraw syringe pumps along with an input/output communications cable to synchronously operate the pumps.All control is set through the innovative Legato touch

screen user interface. No external programming or computer is required.Both syringe pumps in the system have a wide flow rate range from 1.28 pl/min to 88.28 ml/min. Each pump can be individually set for whatever the experiment requires.

Web: www.kdscientific.com Titrator The HI 904 Karl Fischer CoulometricTitrator for moisture analysis is an extension of Hanna’s titrator platform. The HI 904 combines a precision dosing system with optically-regulated magnetic stirring, endpoint determination, dosing and

background drift correction algorithms. The result is an extremely adaptable titrator. The titrator measures 1ppm to 5 per cent, requires no titrant, instead using a generator electrode and can be used for liquids or solids. A pulsed DC current is applied to the generator electrode and results in oxidation of free iodide to iodine (the titrant) at the platinum anode. Alcohol, sulfur dioxide and base (pyridine or imidazole) present in the reagents react to form a salt that is oxidized

by the generated iodine. This reaction consumes water present in the cell in a 1:1 ratio (iodine:water). Once all of the water is consumed, the excess iodine is detected using a bilvoltammetric detector electrode and signals the end of the titration. The result is calculated from the amount of current applied to complete the reaction and the length of time that the generator electrode is active.

Web: www.hannainst.com. NMR Spectrometry Academic and industrial laboratories can collect routine high-resolution nuclear magnetic resonance (NMR) data on molecules in solution using the Thermo Scientific picoSpin 80, a portable NMR spectrometer built for benchtop operation. The instrument’s magnet, rated at 2 Tesla, is designed to provide superior resolution of chemical and structural characteristics not available using lower magnetic field strengths. ThepicoSpin 80 spectrometer features include its lightweight, portable design intended to make it easy to share the instrument across multiple laboratories and easy-to-operate fluid capillary system that does not require NMR tubes or other consumables. Web: www.picospin.com. DNA-Sequencing The NEXTflex™ Rapid DNA-Seq Kit from Bioo Scientific enables construction of sequencing-ready libraries in less than 2 hours, with a flexible input range from 1 ng to 1 µg of DNA. A bead-based, gel-free size selection protocol and the availability of up to 96 unique adapter barcodes facilitate high-throughput applications. The NEXTflex Rapid DNA-Seq Kit is ideal for use with genomic DNA, FFPE samples, ChIP DNA and low input clinical samples. This kit also features Enhanced Adapter Ligation Technology, offering improved ligation efficiency and resulting in library preps with a larger number of unique sequencing reads.

Web: www.biooscientific.com

Cabinets Air Science introduces its new line of biological safety cabinets. The Purair BIO is designed to protect individuals, the environment, and products from a variety of biological particulates, serving as the primary barrier in life science research and experimentation. As a Class II Type A2 Biosafety Cabinet, the Purair BIO minimizes and contains Biosafety Level 1 to 3 agents, maintaining negative pressure inside the cabinet during operation to prevent contaminants from escaping the work area. HEPA filtration scours 70% of the

incoming room air to protect the products, while the remaining 30% of the exhausted air is filtered by a second HEPA filter.

Web: www.AirScience.com Tubing Flexicon announces the release of its next-generation of Accusil™ high accuracy dispensing tubing developed for use with its peristaltic fillers. The platinumcured silicone tubing is manufactured in Flexicon’s state-of-the-art extrusion facility to ensure the highest quality product for pharmaceutical, biopharmaceutical, and diagnostic applications.The right tubing inside the right pump is essential for accurate and reliable dispensing. Consistent wall thickness and bore size ensure the correct liquid flow rate, while the proper tube strength and restitution allow the pump to function successfully.Flexicon’sAccusil tubing has been designed with each of these requirements in mind to maximize related performance. When combined with a Flexicon filler, Accusil tubing provides industry leading precision of ±0.5%, thereby reducing costly overfilling.Accusil is produced in a cleanroom ISO 14644-1 Class 7 environment to ensure pharmaceutical compliance, including full biopharmaceutical compliance with USP Class VI, Ph. Eur. 6.8 Chapter 3.1.9, ISO 10993, and FDA CFR 177.2600. Tubing is also double bagged to provide additional protection. Web: www.watson-marlow.com October 2013 BIOTECHNOLOGY FOCUS 27

Spotlight on Québec continued from page 22

VCs to fund the project. This is something I’ve discussed with many VCs that of course like the idea.” On a larger scale, the goal of the NEOMED ayout 1 1/31/2013 9:09 AM Page 1 or the building itself, is to bring Institute, researchers, universities, biotechnology and pharmaceutical companies and venture capital funds under the same roof, working together in an open, collaborative environment. The resident companies within the NEOMED Institute come from diverse backgrounds, ranging from companies directly

involved in the discovery and the development of drugs, to consulting services and other service providers. “Those companies could be CROs, consultants or investors and all are in pursuit of drug development.” In only one calendar year the Institute has already attracted 10 tenants. Having such a convergence of diverse company in one area also helps in promoting the sharing of resources and knowledge within the Institute itself, Fehlmann adds. Plus there is space for even more companies to join he says.

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Other opportunities for synergy and collaboration An example of a strategic collaboration that NEOMED is involved in is its partnership with the Institute for Research in Immunology and Cancer – Commercialisation of Research (IRICoR). The organisations will use their complementary strengths and capabilities in the value chain going from target identification to human proof-of-concept to deliver potential therapies for unmet medical needs. “We will share access to each other’s stateof-the-art facilities, equipment, expertise and resources to advance jointly selected projects,” says Fehlmann. Moreover, NEOMED and AstraZeneca announced in May that they were expanding their strategic partnership, with AstraZeneca agreeing to provide NEOMED with access to up to 250,000 high-quality compounds from its small molecule compound library. “This is exceptional because not only is it an outstanding collection of compounds that AstraZeneca has built over the years but we can use this as means to attract the best projects around, at the same time, identify compounds that could potentially become new medicines for a broad range of diseases,” says Fehlmann. In a short period of time, the NEOMED Institute has definitely come a long way. Today, the partners are AstraZeneca and Pfizer, but down the line that number is expected to grow. “We have had open discussions with many others and my goal is to have four within the next year. The dynamics say you cannot go too fast, and of course people want to see what you are able to do before they commit. But I think now we have a lot of people looking at us and how we have performed and they are quite pleased. And likewise I’m impressed with what we’ve accomplished. Walker is equally impressed with how far they’ve come. “I truly believe NEOMED and the NEOMED Institute are a big plus both for Québec but for Canada as well. We’re creating an entity that has a good connection with academia, identifying great ideas. There are plenty of potential customers for good programs once they have reached a stage of maturity. Not only can this be exciting scientifically, I’m sure if we do it well, we can add lots of value for Québec and Canada. This is what will define our success.” To see this story online visit http://biotechnologyfocus. ca/?p=9076

CALENDAR OCTOBER 2013 October 2-3 BioContact Québec Venue: Québec, QC Tel : 418-694-8778 Fax : 418-694-0614 Email: lysbeth@biocontact.ca Web: www.biocontact.qc.ca

October 12-16 Combined Meeting of the Orthopaedic Research Societies Venue: Venice, Italy Tel: 847-823-5770 Fax: 847-823-5772 Email: info@cors2013.org Web: http://www.cors2013.org/

October 15-17 Biofibe 2013 Venue: Winnipeg, MB Tel: 204-272-5095 Fax: 204-272-2961 E-mail: biofibe@lsam.ca Web: www.biofibe.com/ 2013 Award Recipients’ Symposium

October 24 2013 Gairdner Awards Receptients’ Symposium Venue: Toronto, ON

Email: sheila.robinson@gairdner.org Web: www.gairdner.org/content/ about-our-events

October 27-31 Materials Science & Technology Conference and Exhibition combined with ACerS 115th Annual Meeting Venue: Montréal, QC Tel: 614-794-5894 Fax: 614-899-6109 Web: http://www.matscitech.org/

NOVEMBER 2013

12th Annual Market Access Summit, Canada Venue: Toronto, ON Tel: 1-866-298-9343 Fax: 1-866-298-9344 Email: customercare@strategyinstitute.com Web: www.marketaccesscanada.ca

November 26, 2013 Global Health Conference Venue: Toronto, ON Tel: 519-661-2111 Email: healthinnovation@ivey.ca Web: http://sites.ivey.ca/healthinnovation/

DECEMBER 2013

November 3-8 AIChE 2013 Annual Meeting Venue: San Francisco, CA Tel: 800-242-4363 Fax: 203-775-5177 Email: jeffw@aiche.org Web: http://www.aiche.org/conferences/ aiche-annual-meeting/2013

December 1-6 2013 MRS Fall Meeting & Exhibit Venue: Boston, MA Tel: 724-779-3003 Fax: 724-779-8313 Email: info@mrs.org Web: www.mrs.org

November 4-6

December 2-4

HealthAchieve 2013 Venue: Toronto, ON Tel: 416-205-1434 Email: mromero@healthachieve.com Web: www.healthachieve.com

10th Annual Canadian Renewable Fuels Summit Venue: Montréal, QC Tel: 613-594-5528 Email: a.kent@greenfuels.org Web: www.greenfuels.org/en/ industry-information/summit.aspx

November 13-14

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AALBORG..................................................................................................... 26........................................................................................www.aalborg.com Albert at Bay.............................................................................................................17...........................................................................................www.albertatbay.com Beckman Coulter Life Sciences ................................................................... 26..........................................................................www.beckmancoulter.com Bereskin& Parr..........................................................................................................15.........................................................................................www.bereskinparr.com Best Western Victoria Park Suites.........................................................................17..........................................................................................www.victoriapark.com Bio Rad Laboratories.................................................................................... 26...................................................... www.bio-rad.com/en-us/spectroscopy BIOO Scientific.............................................................................................. 27.............................................................................. www.biooscientific.com Canadian Government Executive........................................................................23.......................................................... www.canadiangovernmentexecutive.ca Cangene Corporation................................................................................... 6....................................................................................... www.cangene.com CSPC ...........................................................................................................................7.................................................................................................... www.cspc2013.ca Eppendorf.................................................................................................................32............................................................................................ www.eppendorf.com Hanna.......................................................................................................... 27....................................................................................www.hannainst.com JM Science................................................................................................... 26....................................................................................www.jmscience.com KD Scientific................................................................................................. 27................................................................................. www.kdscientific.com Mettler Toledo............................................................................................. 26..............................................................................www.mt.com/liquidator Oven Industries ........................................................................................... 26.......................................................................................www.ovenind.com Sherbrooke................................................................................................................2.......................................................................... www.sherbrooke-innopole.com Thermo Scientific......................................................................................... 27...................................................................................... www.picospin.com VWR.............................................................................................................................5.......................................................................................................... www.vwr.com October 2013 BIOTECHNOLOGY FOCUS 29

THE LAST WORD

By Jean-Pierre Trudel

Spotlight

on BioContact Québec

Ca so lif

Jean-Pierre Trudel, President of Jean-Pierre Trudel & Associates.

ver 300 participants are expected to attend BioContact Québec 2013, a biopharmaceutical partnership international symposium that will take place in Québec City from October 2 to 3. The 19th edition of the symposium will be attended by some 75 Canadian, U.S., and European biopharmaceutical companies, universities, investment bankers, and government representatives. Dr. Martin Godbout who initiated the Symposium back in the mid-1990 explains, “BioContact is today the only event remaining in Canada during which the contents of the meetings, presentations, and events are specifically tailored to meet the needs of the pharma as well as the biotech industry.” According to the event program, diagnostics, therapeutics, and services, and disciplines such as cancer, cardiology and immunology will be at the heart of many of the presentations. This year’s event will take place at a time when developers of innovative and more targeted medicines and treatments associated with personalized health care are facing new challenges. According to Dr. Godbout, 40 per cent of BioContact’s program will include presentations from companies. The remaining 60 per cent of the program will be split in two. The first part will include thematic sessions in which subjects such as orphan drugs and intellectual property will be discussed. The second part of the program will be devoted to the Amorchem KNOCK-OUT Event in which pre-selected academic life science researchers will compete promoting their technology and its applications in front of a live audience and panel of seasoned biotech executives. A winning researcher could be granted an Amorchem financing of up to $500,000 to further develop their project (Amorchem is

30 BIOTECHNOLOGY FOCUS October 2013

Don a venture capital fund located in Montréal). “Although the pharmaceutical sector worldwide has experienced many changes that have affected its business model during the past five years, the biotech sector is presently learning to adapt itself to these changes,” said Dr. Godbout. As many large pharma companies have been affected by patent cliffs and reduced R&D productivity, outsourcing research has become for many an interesting avenue to ensure future growth. In this new environment, large pharma companies are scouting more than ever before for innovative ideas. In order to achieve their goal, these companies are most interested in investing in promising life science projects originating from universities and research centers. Through commercial partnerships with universities and prominent scientists that have already reached critical milestones, pharma companies today channel more funds directly towards the development of compounds that have the potential to reach the market. “BioContact 2013 will be reflecting this new reality,” Dr. Godbout said. As many participants indicated during last year’s symposium, research is very good in Canada and we can expect an increase in collaborative ventures between large pharma companies and scientists. As the biotech sector is learning to adapt its business model to meet the pharma industry’s needs, Dr. Godbout remains optimistic in the future of the biopharmaceutical sector in Québec and Canada.

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