Biotechnology Focus June 2010 by Promotive Communications

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

JUNE 2010 VOLUME 13, NUMBER 6

SPOTLIGHT on Canada’s outsourcing service providers

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contents

JUNE 2010 – VOLUME 13 – NUMBER 6

2 13

3 7 A SPOTLIGHT

ON CANADA’S BIOTECH OUTSOURCING SERVICE PROVIDERS While the worst of the economic downturn seems to have passed, pharmaceutical and biotech companies here in Canada are still under unprecedented pressure to find cost-saving alternatives to ensure that they make it to their milestones. As such, most are on the constant lookout for new ways to alleviate the collective crunch of time, resource strains and money shortages that bog down their business. For many companies, outsourcing is a means to address these concerns. The benefits are numerous. Through outsourcing biotechnology organizations are able to address areas in which they are weak. Likewise they are able to redeploy their own valuable in-house talent towards core competencies. Biotechnology Focus recognizes this growing trend but also stresses the importance of choosing the right outsourcing service provider for your needs. In fact, our 2010 Outsourcing Issue reaches your desk with this priority in mind. This issue’s objective is to showcase some of Canada’s leading service providers in the hopes of helping you better understand how they can provide you with expertise and know-how to help you grow your business. The companies included in this industry resource each play a role in their individual areas of expertise, ranging in areas such as clinical trials, contract research, education, lab products, regulatory and legal. Each company is presented through its own narrative so you can get a true sense of its capabilities and personality.

WE HOPE YOU FIND THIS INDUSTRY RESOURCE INFORMATIVE AND USEFUL.

14 Clinical Trial Services

18 Human Resources

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16 Contract Manufacturing

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24 Regulatory

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Outsourcing

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14 24

By Christine Koenig

BEST PRACTICES

CANADIAN

we share the view of the majority of the decision makers in the industry that the management’s team competence is the most important predictor for success, more so than all the rest (see above). But what identifies excellent management? And how do excellent CEOs lead their team to excellence? These questions were the inspiration behind CELL – A Management Study™, the first of its kind. CELL™ is a, for now, Canadawide study that probes into the management practices of Biotech companies, in the areas of Strategy, Marketing, Communication and Leadership. The questions addressed to the CEOs included in this study were designed to elucidate the processes and the how-doyou-do rather that the results and successes. In the course of the study, CEOs of 23 Canadian companies, that have been recognized with national awards and accolades and thereby serve as role models for the Life Science industry were interviewed about their management practices.

EXCELLENCE in Leadership in the Life Sciences Rational drug design, target driven therapeutic approaches, biologics, individualized therapy, molecular diagnostics and biomarkers are the stateof-the-art in a new drug development area, one could think when reading the headlines, but wait – no, we are not quite there yet!

Vision, passion & a sincere interest in people

But why are we progressing so slowly in bringing innovative approaches to the patients? There are a few very good reasons that can be summarized as a serious lack of smart money for early stage commercial development in Canada. æsæ&IRSTLY æITæISæTRUE æTHEæCOLLECTIVEæGLOBALæBIO medical knowledge has exploded since the beginning of the genomics area and the number of data mines (e.g. Genomics, Proteomics and Metabolomics etc.) ready to exploit is growing exponentially. But who is actually exploiting them? Well, it’s that small, early stage and chroniCALLYæUNDERæFUNDEDæ"IOTECHæINDUSTRY æ&EWæ companies indeed eventually do find gold nuggets but most others rapidly retract to survival to adopt new drug development making better tools or providing research strategies and processes (from the Biotech services to those who still hope, keep digindustry). ging and persist. sæ 3ECONDLY æ THOSEæ WHOæ HAVEæ SHAPEDæ ANDæ sæ 4HIRDLY æ MOSTæ INVESTORSæ AREæ RISKæ ADVERSEæ and have burnt their fingers when the dominated the drug development industry IT bubble burst and thus prefer to act as in the past, Big Pharma and their CROs, interested bystanders, hesitantly dipping are spoiled by decades of success with their toes into the water here and there, blockbuster small molecule drugs, and and only jointly and slowly move forward, have build close to no knowledge on how while seeking advice from the experts in to develop innovative biologicals. Most drug development, mostly retired Pharma Pharma giants have only very recently managers now turned into consultants. or not even yet recognized and accepted how important it will be for their future

It seems that being a great leader in Biotech does not depend on academic background or former professional experience. It rather depends on the personality and the conviction and dedication for leading the company, by leading its people towards their com-

What will it take for the Canadian Biotech industry to rise from the valley-of-death, lift off and deliver on its promise to innovate and create new and better diagnostics, therapies, and drugs? Now, there is lots of buzz about what everyone is doing (e.g. patent filings, preclinical and clinical research, tools, technologies, etc.) but little to hardly ever it is talked openly about the how and, more precisely, about how the ones (i.e. CEOs) that orchestrate those tools and systems lead, enable and perform. At Koenig & Consultants Inc.,

mon goals. The excellent leaders we interviewed rely on two pillars to achieve these goals - systems and structures, and efficient and transparent communication with their people. An international experience and understanding of global culture supports these CEOs in communicating with and motivating a diverse team. Many of the companies we interviewed have very well defined internal communication guidelines including the conduct of meetings, email correspondence, use of Blackberries, etc. These ensure a steady, reliable and transparent flow of information while still encouraging informal and creative discussions. Although unanimously considered very important, Leadership development is the area (of the four we discussed) that suffers the most currently. In today’s tight economic environment, leadership and management development programs are red-taped. About half of the companies in our study included ‘leadership performance’ as an assessment criterion in the employee appraisal process, but only a third organized or invested in some kind of leadership & management skills training for their employees.

Adaptable strategy & customer benefit A clear vision is not only an important starting point for developing a strategy, later down the road it serves to re-engage the team when the going gets tough. 70% of the CEOs interviewed make use of the power of vision & mission statements, leaving still a significant number of 30% without it. As one CEO pointed out, “If we know where we are heading, we have a much better chance of getting there”. The majority of the CEOs saw it as their core duty and responsibility to guide a systematic development and review process of their strategy and thus enabling and allowing for adaptation to changing market environments, whenever appropriate. A few of the companies we interviewed have truly understood that the scientists are the ones who must understand the cus-

ACROSS CANADA

The excellent Canadian Life Science managers act as ‘enablers’, driving their company’s strategy and policies, establishing efficient processes in internal and external communication, marketing and business development, and above all, motivating and engaging their people and partners in creating their company’s future. The interviews performed with a select group of recognized companies proved that there are indeed exceptional leaders with outstanding leadership and communication abilities. Many of those are not ‘home-grown’, but have an international background. As analogized earlier, results in the way of revenues, stock prices, or other business performance indicators are too premature to serve as evaluation criteria for management practices. Which is why an evaluation model such as the one adapted for this study might serve as a fairer approach to analyse the Life Sciences companies and their management, at least at this stage of the industry. The fully comprehensive management report based on the analyses of these interviews, along with a collection of show-cases of good practices was been released in March 2010. To receive a hard copy or a PDF mail to: info@ koenigconsultants.ca

For more TO MARKET information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca

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GRAND CHALLENGES

Canada

INNOVATION AND FOREIGN AID ON THE SAME PAGE

Ambitious, altruistic and one-of-a-kind; these are just some of the descriptions that have been thrown around Grand Challenges Canada, a new non-profit organization.

Enabling Excellence

JUNE 2010 BIOTECHNOLOGY FOCUS 27

26 BIOTECHNOLOGY FOCUS JUNE 2010

Governed by its own board of directors and guided by a scientific advisory team (made up of some of the world’s most distinguished medical scientists from both the developed and developing world), the organization has a mandate of identifying and launch five grand challenges over a 5-year period. In all, the Government of Canada committed $225 million over five years to Grand Challenges Canada when it was launched May 6, 2010 through its Development Innovation Fund to “support the best minds in the world as they search for breakthroughs in global health and other areas that have the potential to bring about enduring changes in the lives of the millions of people in poor countries.” As such one of the partners in this initiative is the newly formed Canada International Development Research Centre (IDRC), the Government of Canada’s lead on the Development Innovation Fund. Additionally, Grand Challenges Canada will work with the Canadian Institutes of Health Research, and

tomers’ needs and benefits, because it is their job to generate a product that delivers. It is understood by this group of CEOs that definition and communication of the customer benefit to be delivered is most effective at the interface of product developers/scientists and their champions in the target market. In many cases, the CEOs themselves take care of the marketing and/or business development function by overseeing this interface. However, in the majority (60%) of the companies in our study, this responsibility was taken on by a dedicated marketing/business development function. A vast majority (80%) of the companies included in the study consistently do a product portfolio analysis. This tool helps the CEO monitor and communicate the potential and progress of the portfolio, thereby facilitating the strategic decision-making.

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Grand Challenges Canada’s Chief Executive Officer (CEO) Dr. Peter A. Singer hands Canada’s Finance Minister Jim Flaherty (R) a microscope after Flaherty announced the Government of Canada’s commitment of $225 million dollars to Grand Challenges Canada, in Toronto, May 3, 2010. Grand Challenges Canada is a new not-for-profit organization aimed at solving health problems in the developing world. REUTERS/Mark Blinch (CANADA - Tags: POLITICS BUSINESS HEALTH)

other global health foundations and organizations in this endeavor. CIHR will be responsible for the administration of international peer review, according to international standards of excellence. The results of CIHR-led peer review will guide the awarding of grants by Grand Challenges Canada from the Development Innovation Fund. Additionally, The McLaughlin-Rotman Centre for Global Health based at University Health Network and University of Toronto will be the Home for the organization. The first challenge is “to create a new class of point-of-care (POC) diagnostics that will be easy to use, low cost, multiplex and able

to assess disease stage and provide information on prognosis.” In the case of this first Grand Challenge, the Bill & Melinda Gates Foundation is also a partner. To give our readers a better understanding of how this new organization will work, Biotechnology Focus sat down with Dr. Peter Singer, director of the McLaughlin-Rotman Centre for Global Health and Chief Executive officer of Grand Challenges Canada. We asked Dr. Singer what makes Grand Challenges Canada unique, how the organization will be governed and most importantly how the organization will make good on its commitment to find sustainable solutions to the world’s most pressing health needs.

Q: What makes this organization unique from other national science organizations? Peter Singer: For starters this is a very unique venture in that it is an independent not-for-profit organization dedicated to improving the health and well-being of people in developing countries. Secondly Grand Challenges Canada relies on a strategy of integrated innovation. And what we mean by that is we’re looking for solutions at the sweet spot between science and technology, the social innovation that’s needed to bring things to scale in health systems and the business innovation that’s needed to create new technologies. As such, these are projects that must integrate scientific, technological, business and social innovation both in Canada and in the developing world towards a common goal. What that’s really trying to say is that science and technology is necessary but not sufficient on its own. You need the business innovation in companies to produce the goods and services, and you need the social innovation and health systems to make sure that those goods and services reach those who need them. And our interest is in taking innovation all the way from the labs to village because the people we serve are the people who die unnecessarily and who suffer needlessly in the developing world because of the challenges in global health that they face. Another important thing to note is where the money to support Grand Challenges Canada is coming from. Grand Challenges Canada falls under the international assistance envelope of the Canadian government meaning his is not your usual R&D fund. Meaning this is foreign aid funding, and it comes from a financial envelope that is at roughly $5 billion a year. The reason that’s important is that one of the things people want in foreign aid is they want to know that in ten years we’re not going to be funding exactly the same things we’re funding today. The way to accomplish this is innovation or research and development. . Lastly, Grand Challenges Canada is unique in its approach. Through Grand Challenges Canada we are funding a global community of researchers and related institutions on a competitive basis to address the world’s most pressing challenges by developing breakthrough solutions and ensuring that these solutions are available to those who need them the most. And the people that need these solutions the most can be found in the developing world, where more than eight

WE ARE LOOKING FOR GLOBAL EXCELLENCE AND THE ONE’S THAT WILL GET PRIORITY ARE THE ONES THAT MEET STANDARDS OF GLOBAL EXCELLENCE AND HAVE THE LIKELIEST CHANCE OF IMPACT. million children die every year before their fifth birthday. When you think about that one fact alone, that eight million children die before their fifth birthday; that should give a sense of the size of the problems we’re tying to tackle, the size of the challenges we face. Grand Challenges Canada offers an opportunity to bring positive and sustainable change in overcoming this challenge.

Q: How do you define a Grand Challenge? PS: A grand challenge is really a critical barrier between where we are and where we need to be in global health. Our primary focus is on the comparable inequities in global health. The people in the developing world who are dieing prematurely and suffering unnecessarily are the primary community that we serve. It’s about global excellence and impact we believe innovation saves lives.

Q: Why has diagnosing diseases such as malaria more quickly in developing countries through novel tests the first challenge to be tackled by the organization? PS: It’s about finding the sweet spot between science and technology innovation, social innovation, health systems innovation and business innovation. Point of care diagnostics fits this mold. It involves serious science and technology, it makes things much better and cheaper in the health system and it requires companies to innovate and develop the product. As a practicing physician I can tell you that diagnosis is the prelude to effective treatment Diagnostics has also been relatively neglected in global health and that’s why we focused on it. The estimate for malaria at the point of care alone, diagnostics can save roughly 100,000 lives, and prevent 365 million unnecessary which drives up costs, wastes resources. Imagine there’s a child under five who comes to see a health provider in the developing world. The questions immediately asked are is it malaria, what kind of malaria,

how severe is it and what drugs is it resistant to? And if its not malaria, is it pneumonia or one of a number of other things that can cause fever. What happens next is a sample is taken but it has to be sent hundreds of miles away to a laboratory to be tested. By the time the attending physician gets the results back, often times it’s too late. But, if you bring that diagnostic to the patient’s bedside, it’s like a glucometer for global health. It’s right there with instant results and could really help with treatment. The goal is by bringing diagnostic tools to the patient’s bedside we are saving lives, wasting less resources, providing better care, faster and cheaper. The novelty here is that we are developing point of care diagnostics, at the patient’s bedside and there’s a real need for this in the developing world. And its not just tools that diagnose malaria we’re interested in, we’re interested in diagnostics that can diagnose a number of conditions at the same time.

Q: What is the process of being selected? What proposals will get first priority? PS: We are looking for global excellence and the one’s that will get priority are the ones that meet standards of global excellence and have the likeliest chance of impact. We will be funding, identifying and putting out applications for and helping innovators come up with solutions for five Grand Challenges over a period of five years. Diagnostics is only the first one, and the request for proposals there of up to $12 million that’s targeted at developing world innovators is only the first step in that first challenge. We will be funding 10-20 proposals and up to $12 million for the first of the five grand challenges. The deadline for the first round of applications is July 12, 2010 at 11:59 pm EST. In all, there will be five Grand Challenges identified and launched over a five year period. The challenges will be determined through an exploration process by Grand Challenges Canada, based on advice from its International Scientific Advisory Board. The applicants can be either not-for-profit organizations such as universities or forprofit organizations. JUNE 2010 BIOTECHNOLOGY FOCUS 29

28 BIOTECHNOLOGY FOCUS JUNE 2010

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JUNE 2010 BIOTECHNOLOGY FOCUS 5

PUBLISHER’S NOTE

Building

a sustainable industry It’s hard to gage the current state of the Canadian biotech industry. Ernst & Young’s Beyond Borders annual report recently released at BIO 2010 talked much about our resilience in tough times, but also focused on our shortcomings. On the one side Ernst & Young reported that the Canadian biotechnology industry raised more than US$733 million in 2009, an increase of $255 million from 2008. However, the increase came at an expensive price as the total number of Canadian companies declined from 474 to 325. Likewise the number of public companies shrunk to 64. According E&Y, many companies were forced into survival mode, scaling back their operations. This hindered their ability to maintain R&D investments, capital expenditures and job creation opportunities. In the end, survival came at the cost of new innovation. Paul Karamanoukian, Ernst & Young’s Canadian life sciences practice leader described the situation as such, “This extensive cost-cutting is a double-edged sword, in the short term, the reductions have helped the industry weather the storm, but as the driver of future growth for this sector, the decline in R&D could have long-term repercussions for the industry.” As a clear indication that tough times are still ahead, just last month Sanofi-aventis Canada announced it was cutting close to 70 R&D jobs in the hopes of transforming its Canadian operations. According to the company release, the cutbacks came as a result of the challenges of doing business here in Canada. The company also cited a very interesting reason for its philosophy, the loss of patent exclusivity. “Our patent protection candle is being burned at both ends,” stated Hugh O’Neill adding that the lack of intellectual property protection in Canada has become a real problem for our biotech companies. “We can’t ignore this reality anymore, which runs counter to current trends in large industrialized markets,” he explained. O’Neill added that contrary to the generic drug industry, Canadian innovative pharmaceutical companies have no effective right of appeal when facing intellectual property challenges and that government policy leadership is needed to address these challenges. “Stronger partnerships with governments will lead to a sustainable industry that continues to grow and invest in Canada and that does not become disadvantaged with respect to our international counterparts,” stated O’Neill. At the BIO 2010 Conference in Chicago, Canada’s Minister of Industry and Canadian delegation leader Tony Clement acknowledged that government has a role to play in helping biotech thrive in this country. “Our job as a government is to create the right environment for business through supportive economic policies that make our companies more competitive and our country more attractive to international investors,” he said while praising Canada’s biotechnology industry as an important part of Canada’s innovative economy. The good news we can take from this, is the industry has the government’s attention. Now what is the message we want to get across? Have your voices heard by taking our Hot Button Issue Survey. http://www.bioscienceworld.ca/survey2.

6 BIOTECHNOLOGY FOCUS

JUNE 2010

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITER

INTERN CONTRIBUTING WRITERS

Terri Pavelic Shawn Lawrence Chris Rogers Tim Bryant Christine Koenig

David Saul

Duncan Kay

Michelle Miles

National Account Manager GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER SUBSCRIPTION INQUIRIES

Peter Pekos Patricia Bush Elena Pankova John R. Jones Mary Malofy circulation@promotive.net Fax 905-727-4428

EDITORIAL ADVISORY BOARD Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montreal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Genome Prairie; 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, Mentis Partners; Colette Rivet, BioTalent; Grant Tipler, RBC; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB,a partner with Leger Robic Richard; Dale Patterson, The Bourton Group; Darcy Pawlik, Ag-West Bio Inc; Gail Garland, OBIO; Barry Gee, LifeSciences British Columbia 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.bioscienceworld.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 PAP Registration No. 10952 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.

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R & D NEWS Canada’s scores in Chicago as over 130 Canadian firms partner at the BIO 2010 International Convention The 2010 BIO International Convention, held May 3 to 6 at McCormick Place in Chicago IL, attracted 15 322 attendees from 65 countries to discuss and share the latest developments, challenges and most pressing issues facing the biotech industry. Canada again dominated the show with an event-packed day that drew over 1,000 national and international delegates to network and learn more about Canadian capabilities. From start to finish the exhibition hall was filled with 1,700 plus exhibitors. While this number was down slightly from past years, BIO chairman Stephen Sherwin was very impressed with the number of one-on-one partnering meetings, which ballooned at this year’s event. The Bio Business Forum echoed this sentiment stating that, “BIO 2010 was a record-setting year, with over 17,000 partnering meetings, 5,000 plus meeting requests, and more than 2,000 companies participating in the one-on-one partnering taking place during the Business Forum.” More than 130 Canadian companies used the business forum to partner and 13 companies took part in presentation opportunities on the BIO program. Additionally, several premiers, dignitaries and prominent industry figures made the trek to Chicago including Premiers Jean Charest (QC), Ed Stelmach (AB), and Robert Ghiz (PEI). Likewise, the Canadian Pavilion was the place to

Bio Pavilion Opening at the 2010 BIO International Convention in Chicago, IL be thanks in large part to an event-packed day that drew over 1000 national and international delegates to network and learn more about Canadian capabilities. At the opening of the Canada Pavilion, Tony Clement delegation head and Minister of Industry Canada stressed his government’s commitment to building the biotech

sector, noting his pride at seeing Canadian participation that was yet again the largest delegation at the show. The Minister was joined by the three Premiers as well as Ontario Minister John Milloy and other key economic development and technology ministers from BC, Alberta, Manitoba and Quebec. Governor Pat Quinn of Illinois also stopped by to welcome Canada to the show. All officials spoke of Canada’s strong growth and future in the sector, and jokingly jockeyed for position as each claimed their province as the place to come and do business. After the opening, BIOTECanada members joined the ministers for an exclusive roundtable, discussing the industry’s bio-economy strategy, “Beyond Moose and Mountains.” Additionally Canadian CEO’s had an opportunity to meet with ministers and government officials to discuss the future of the biotech industry in Canada. BIOTECanada once again helped to facilitate show attendance, working with the Government of Canada, the organization provided 80 passes to Canadian firms to attend the Business Forum. In all, more than 130 Canadian companies used the business forum to partner, and 13 companies took part in presentation opportunities on the BIO program. BIOTECanada president Peter Brenders commented that Canadian companies are not just holding their own but are thriving. He expects that over the next 18 months we will see larger Canadian companies hitting their milestones along with several new FDA approvals.

Great People. Great Chemistry.

Reply Card #4744 8 BIOTECHNOLOGY FOCUS

JUNE 2010

R & D NEWS

Dr. Gilles G. Patry

John McDougall

CFI and NRC appoint new presidents New presidents have been named for both the Canada Foundation for Innovation (CFI) and the National Research Council of Canada (NRC). Dr. Elizabeth Cannon, Interim Board chair of CFI, announced the appointment of Dr. Gilles G. Patry as the fourth president and CEO of the

CFI. Dr. Patry succeeds the current president and CEO, Dr. Eliot A. Phillipson, who announced last year that he would be stepping down on June 30, 2010. “The CFI Board was unanimous in its selection,” said Dr. Cannon. “Dr. Patry brings a strong commitment and passion for advancing the nation’s science and technology agenda. He is an accomplished researcher, a highly successful entrepreneur and understands, as a former university administrator and leader, how to work with government at all levels.” Dr. Patry will begin his new responsibilities at the CFI as of July 1, 2010. Dr. Patry is a professor of civil engineering at the University of

Ottawa with a joint appointment in the School of Information Technology and Engineering. He was president and vice-chancellor of the University of Ottawa from 2001 to 2008. He holds a PhD from the University of California at Davis in environmental engineering. Additionally, the Government of Canada appointed John McDougall as the new president of the NRC, and he has already assumed his position. He succeeds Dr Pierre Coulombe, whose five-year term as president ended in February. Until recently, McDougall served as president and CEO of the Alberta Research Council (ARC). Over the course of his 12-year tenure at ARC, the organization evolved into a strong national and international leader, delivering and aligning science and technology solutions to industry’s needs. In addition, he founded and served as senior executive of the DALCOR companies from 1976 to 1998.

Canadian biotech industry recognizes its top perfomers

www.caledonlabs.com

During the BIO International Convention in Chicago, BIOTECanada formally presented awards to the 2010 winners of the prestigious Gold Leaf Awards. Vancouver’s OncoGenex, took top honours as company of the year. “With significant financial and product milestones during the 2009 economic downturn, OncoGenex is a perfect example of the drive and talent of Canadian firms,” said BIOTECanada chairman, Brad Thompson. The early stage company award in the health category went to iCo Therapeutics, a drug developer focusing on innovative reformulations of existing products, and, in the industrial and agricultural category, to CO2 Solution, whose carbon dioxide man-

agement enzyme technology is revolutionizing the carbon capture market. “Both of these firms are stellar examples of Canadian innovative thinking, research and development expertise, and a business acumen that saw them reach significant development milestones even during a challenging economic period,” said BIOTECanada president and CEO, Peter Brenders. “Their technologies are solving critical global problems, and, once commercialized will make a significant contribution to Canada’s bio-economy.” The association also awarded a national industry leadership award to Dr Murray McLaughlin. With a distinguished career in Canada’s biotech sector, Dr. McLaughlin has been a member

of most of Canada’s main funding agencies, associations, and companies in agricultural, industrial and health biotechnology - from East to West. Today, Dr. McLaughlin is the founding president and CEO of the new Sustainable Chemistry Alliance, dedicated to the next stage of biotech innovation in chemistry. An award for association leadership went jointly to Ms. Karen Burke and Mr. Jim Willoughby for their work with Canada’s government on an introductory path for subsequent entry biologics. The Awards are judged by the BIOTECanada board of directors on the basis of strict criteria. The awards are presented annually by BIOTECanada.

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JUNE 2010 BIOTECHNOLOGY FOCUS 9

R & D NEWS

Scherer to lead $50M genomic medicine program at Toronto’s McLaughlin Centre

The University of Toronto announces it has named renowned geneticist Dr. Steve Scherer as the new director of the McLaughlin Centre. This new phase of what was previously known as the McLaughlin Centre for Molecular Medicine will emphasize the advancement of genomic medicine through research and education. The Centre was established in 2000 with a $50 million dollar bequest from the R. Samuel McLaughlin Foundation.

Dr. Scherer, who holds the GlaxoSmithKline-CIHR Endowed Chair in Genetics and Genomics at The Hospital for Sick Children and University of Toronto, said “the time is right to bring to bear the strengths of the Toronto academic health science community to advance genomic medicine in Canada and abroad.” Over the years, Scherer’s group has made numerous contributions to medical genetics including mapping, sequencing and disease gene studies of human chromosome 7. His team also contributed to discoveries of global gene copy number variation (CNV) revealing CNV to be the most abundant type of nucleotide variation of human DNA. His group has also found CNV to contribute to the etiology of autism. The McLaughlin Centre-supported Database of Genomic Variants he founded facilitates thousands of diagnoses each year. Scherer notes that the McLaughlin Centre will fund new projects at the UofT and its teaching hospitals and research institutes, and also further leverage previous investments at prominent Toronto institutions like the McLaughlin-Rotman Centre for Global Health, The Centre for Applied Genomics and the Ontario Genomics Institute, amongst others. “If the formula includes excellence and impact in genomic medicine, we will want to be involved”, emphasized Scherer.

WEX to have abstract published at pain world congress WEX Pharmaceuticals Inc. announces an abstract has been accepted for publication and a poster presentation at the 13th World Congress on Pain in Montreal between Aug. 29 and Sept. 2, 2010. The abstract reports interim results from WEX’s TEC-006OL trial of Tetrodotoxin, which is a multicentre, openlabel, continuation trial of the efficacy and safety of TTX in patients with inadequately controlled moderate to severe pain associated with cancer. All patients enrolled in the TEC-006OL trial first participated in the TEC-006 trial, which is a

10 BIOTECHNOLOGY FOCUS JUNE 2010

multicentre, randomized, double-blind and placebo-controlled trial comparing the efficacy and safety of TTX to a placebo in approximately 120 patients with moderate to severe inadequately controlled cancer-related pain. The interim analysis of TEC-006 will be conducted by an independent data monitoring committee, which will make a recommendation on continuing the trial based on a review of the safety and efficacy assessments. This recommendation is expected to be received during the third quarter of 2010.

Clinical Trials & Patents n Stem Cell Therapeutics Corp. (Calgary, AB) announces the 90-day follow up period for the last patient enrolled in the modified REGENESIS- Phase IIb stroke trial has been reached. The modified REGENESIS- Phase IIb trial, a placebo controlled, double blinded, 3:1 randomized clinical study enrolled 96 patients with acute ischemic stroke between August 2009 and Jan. 24, 2010. This point marks the completion of the patient assessment period and the beginning of the process of compilation, data analysis and reporting of top-line primary endpoint results for this key Phase IIb clinical trial of NTx(R)265 in acute stroke. n PurGenesis Technologies Inc. (Montreal, QC) announces positive results from a Phase I clinical trial on PUR0110, the company’s lead investigational new drug for the treatment of ulcerative colitis. The trial was designed to evaluate the safety and maximum tolerated dose of PUR0110, a botanical drug that modulates both the TNF-alpha/ Il-10 ratio and interleukin 1b levels. These cytokines orchestrate the development of chronic inflammation in ulcerative colitis, psoriasis, rheumatoid arthritis and other inflammatory disorders. n The FDA has accepted for filing Intellipharmaceutics International Inc. (Toronto, ON) abbreviated new drug application for a generic version of the antidepressant Effexor XR®. The company’s application will now proceed to full review by the FDA. Intellipharmaceutics will now seek a commercialization and distribution partner for this product in the U.S. No assurance can be given as to when or if the FDA will approve the Company’s application for the product. n Cytochroma (Markham, ON) announces positive Phase I results for CTAP201 Injection, a product being developed to treat secondary hyperparathyroidism in hemodialysis patients. The study demonstrated that single intravenous doses of 1 and 3 mcg of CTAP201 were safe and well tolerated. It also identified a starting dose of 2 mcg for subsequent pivotal trials intended to establish the product’s safety and efficacy in the targeted population. Analysis of the data concluded that CTAP201 Injection is approximately twice as effective as doxercalciferol injection in raising blood vitamin D hormone levels. Based on this, the therapeutic dose of CTAP201 Injection is expected to be half that of doxercalciferol.

BUSINESS CORNER Biosyntech to file for bankruptcy protection and resignation of all members of board of directors BioSyntech, Inc., announces it is seeking court protection under the Bankruptcy and Insolvency Act in Canada. As a result of current economic circumstances, BioSyntech’s Board of Directors authorized BioSyntech to take this action as the best alternative for the interests of the Company, its employees, partners, creditors and other stakeholders. “BioSyntech took this decision after thorough consultation with its advisors and extensive consideration of all other alternatives contemplated in the strategic review process,” they said. According to a company release, Bio-

Syntech intends to avail itself of the provisions of the BIA and to file a notice of intention. PricewaterhouseCoopers will serve as trustee for the restructuring process. No proposal has yet been elaborated by BioSyntech. All members of the Board of Directors of BioSyntech have submitted their resignation from the Board of Directors. The company will also file a motion with the Court requesting the appointment of an interim receiver, PricewaterhouseCoopers, in order to manage the Corporation in the absence of a Board of Directors.

Warnex Medical Laboratories obtains licence for colorectal cancer blood screening test from Epigenomics

Warnex Medical Laboratories, a division of Warnex Inc. and Epigenomics AG has entered into a non-exclusive licensing agreement for Epigenomics’ colorectal cancer biomarker, Septin9. Under the terms of the agreement, Warnex has obtained the rights to establish a laboratory-developed test for Septin9 and offer colorectal cancer blood testing services in Canada. Warnex plans to launch the testing service in the next few months. As the first laboratory to offer Septin9 testing in Canada, Warnex enjoys a time-limited head-start period of exclusivity for the Canadian market. Epigenomics will be entitled to certain royalty payments. “Warnex is the ideal partner to make colorectal cancer blood testing based on our Septin9 biomarker in Canada. This agreement is an important further step in the international rollout of Septin9 testing, which is already commercially available in the U.S. and Europe,” commented Geert Nygaard, Epigenomics’ CEO.

Viterra to sell its share of Australian Bulk Alliance joint venture Biovail acquires AMPAKINE® compounds for treatment of respiratory depression Biovail Corporation announces its subsidiary, Biovail Laboratories International SRL, has acquired certain AMPAKINE® compounds and associated intellectual property from Cortex Pharmaceuticals, Inc. for use in the field of respiratory depression, a brain-mediated breathing disorder. The acquired compounds include the Phase 2 compound CX717, the preclinical compounds CX1763 and CX1942 and the injectable dosage form of CX1739. BLS has also entered into a field limited license agreement with The Regents of the University of California.

Under the terms of the asset purchase agreement, BLS pays $9 million in upfront fees and expects to pay an additional $1 million upon the completion of a transition period. BLS could also pay up to $15 million in potential milestones contingent on the successful demonstration of the utility of an intravenous formulation of CX717 in treating respiratory depression, the successful completion of a Phase 3 clinical program using an AMPAKINE® compound and approval from the U.S. Food and Drug Administration.

Viterra Inc. has confirmed that it is selling its 50 per cent interest in the Australian Bulk Alliance joint venture to Sumitomo. The acquisition price to be paid is $8.6 million AUS, which was based on an independent valuation of the assets involved. Summit Grain Investment Pty Ltd, which is a wholly owned subsidiary of Sumitomo Corporation, intends to exercise its right under the shareholder’s agreement to acquire all of the shares of ABA owned by Viterra. The purchase was triggered as a result of the change in control of Viterra’s Australian operations, arising from the acquisition of ABB Grain by Viterra in September 2009. Settlement of the acquisition is scheduled to occur on 21 April 2010. Following the acquisition, ABA will become a wholly owned subsidiary of Sumitomo.

Reply Card #4467

JUNE 2010 BIOTECHNOLOGY FOCUS 11

BUSINESS CORNER Biotech industry showing resilience despite challenging conditions: Ernst & Young Canada’s biotech industry has not only survived the global economic crisis, but finished 2009 with a large increase in revenue and significantly reduced losses, due in part to significant cost-cutting measures, according to Beyond borders, Ernst & Young’s annual global biotechnology report. The Canadian industry showed great resilience in 2009, with the revenues of publicly traded biotech companies increasing by nine per cent, to US$2.163 billion from US$1.979 billion in 2008. The industry also saw an astounding 90 per cent reduction in aggregate losses from US $1.1 billion to US $70 million. Globally, established biotech centres reached profitability for the first time in history. However, the gap between the “haves” and the “have-nots” continued to widen, posing challenges for emerging companies in accessing the capital needed for research and development (R&D). R&D spending in Canada dropped 44 per cent to US$354 million in 2009, from US$626 million the previous year. “This extensive cost-cutting is a doubleedged sword,” says Paul Karamanoukian, Ernst & Young’s Canadian life sciences practice leader. “In the short term, the reductions have helped the industry weather the storm, but as the driver of future growth for this sector, the decline in R&D could have

long-term repercussions for the industry.” The industry also saw a decrease in the number of companies in 2009, following the trend of the past five years, during which time the total number of Canadian companies declined from 474 to 325. In 2009, the number of public companies declined from 72 to 64. “What we’ve been witnessing is a ‘survival of the fittest’ scenario, with smaller companies either failing or merging with larger entities,” says Karamanoukian. “While the stronger remaining companies are positioned to capitalize on the growth opportunities of the economic upturn, more than half of the public companies currently have less than one year’s worth of cash.” In addition to higher earnings and lower aggregate losses, another piece of good news was a 52 per cent surge in the industry’s market cap last year. However, there still remains cause for concern. Despite costcutting measures and increased revenues, there was no appreciable movement in the industry’s survival index. Even with the market cap boost, the industry only partially made up for the ground it lost in 2008, when it lost 61per cent of its market value. “The industry survived the financial crisis, but that was only half the battle,” says Karamanoukian. “It remains to be seen if

the industry can fully bounce back from the setbacks of the past few years, and attract capital in 2010, which is going to be a pivotal year for Canadian biotech.” Other key findings include the following: • The Canadian biotech industry saw venture funding of private companies decrease to US$100 million, less than one-third of the average raised over the past 10 years. • Over 40 per cent of the venture funding was in Quebec, followed by British Columbia with 25 per cent and Ontario 20 per cent. • Capital raised increased sharply in 2009 in Canada, where funding reached US$733 million or in excess of US$255 million over 2008; however, one financing accounted for over 40 per cent of the funding. • Strategic alliances in Canada were at record-breaking levels, with six alliances each providing over US$10 million in upfront payments. • Mergers and acquisitions activity was down in Canada, where there was only one large acquisition that approached US$500 million. • Ontario-based companies attracted more total investment than any other province with US$402 million raised. Quebec raised US $161 million, Alberta - US $84 million and British Columbia - US $67 million.

Dealmakers n Therapure Biopharma Inc. (Mississauga, ON) and Viron Therapeutics (London, ON) have entered into an agreement that will see Therapure provide Viron with fill/finish services. Therapure will be expected to complete two fill/finish runs for development-stage products in support of Viron’s on-going clinical trials.

Research Tax Services Ltd. (Lacombe, AB) and Bio-Processing Alliance Inc. (Milton, ON) have partnered to broaden their collective support for Canadian bio-industry. Through this partnership the two companies will offer their technical and financial expertise for the preparation of Scientific Research and Experimental Development (SRED) tax claims. “This strategic partnership continues to expand on our already extensive service offering, providing our clients with assistance beyond biologics development and manufacturing support,” says Terry Cochrane, Bio-Processing’s corporate affairs director. n

n Stellar Pharmaceuticals Inc. (London, ON) has signed a license agreement with medac

12 BIOTECHNOLOGY FOCUS JUNE 2010

GmbH for the distribution and sale of one of its lead products, Uracyst® for the treatment of interstitial cystitis/painful bladder syndrome in Germany and Austria. Uracyst® is trademarked as Uropol® in Germany and Austria. With the approved CE mark for the product already in place, it is expected that medac will launch Uropol® in the third quarter of 2010. The agreement has an initial five-year term with additional two-year renewal periods. Amorfix Life Sciences (Mississauga, ON) and Epitomics Inc. (Burlingame, CA) have entered into an agreement to develop high-affinity monoclonal antibodies against a number of targets for cancer. Amorfix has identified several disease specific epitopes on misfolded proteins with their ProMIS™ computational platform discovery technology, which will be used by Epitomics to generate highly specific monoclonal antibodies. Epitomics, together with its partners, has successfully generated over a dozen humanized therapeutic antibody drug leads targeting immune diseases and cancers using RabMAb® technology and its proprietary Mutation Lineage

Guided (MLG) humanization technology. n A5 Labs signed a letter of intent to acquire contract research assets, including all equipment and fixtures and intellectual properties, and a novel interferon production technology, including all know how and data from previous clinical trials related to the production of gamma interferon, from Vida Pharma, based in Montreal, Canada, in an all share transaction. Closing is expected on or before June 15, 2010. A5 Labs today announced that it has signed a letter of intent to acquire contract research (CRO) assets and a novel interferon production technology from Vida Pharma, also based in Montreal, Canada. The all share transaction is expected to close on or before June 15, 2010. The CRO assets include all equipment and fixtures (tangible) and all intellectual properties including analytical methods, laboratory information management system, standard operating procedures and list of customers. The interferon production technology includes all know how and data from previous clinical trials related to the production of gamma interferon.

A Spotlight

on Canada’s biotech outsourcing service providers While the worst of the economic downturn seems to have passed, pharmaceutical and biotech companies here in Canada are still under unprecedented pressure to find cost-saving alternatives to ensure that they make it to their milestones. As such, most are on the constant lookout for new ways to alleviate the collective crunch of time, resource strains and money shortages that bog down their business. For many companies, outsourcing is a means to address these concerns. The benefits are numerous. Through outsourcing biotechnology organizations are able to address areas in which they are weak. Likewise they are able to redeploy their own valuable in-house talent towards core competencies. Biotechnology Focus recognizes this growing trend but also stresses the importance of choosing the right outsourcing service provider for your needs. In fact, our 2010 Outsourcing Issue reaches your desk with this priority in mind. This issue’s objective is to showcase some of Canada’s leading service providers in the hopes of helping you better understand how they can provide you with expertise and know-how to help you grow your business. The companies included in this industry resource each play a role in their individual areas of expertise, ranging in areas such as clinical trials, contract research, education, lab products, regulatory and legal. Each company is presented through its own narrative so you can get a true sense of its capabilities and personality. We hope you find this industry resource informative and useful.

2 7

Lab Product – Liquid Handling/Green Safety

Fisher Scientific

14 Clinical Trial Services

Contract Manufacturing – Fermentation BioVectra

Lab Product Caledon Laboratory Chemicals CIRION Clinical Trial Services Inc.

16 Contract Manufacturing Dalton Pharma Services

18 Human Resources BioTalent Canada

20 Lab Product – Reagents VWR/ZyGEM

22 Regulatory i3

31 Lab Product – Pipetting, Cyclers and PCR consumables Eppendorf

Clinical Trial Services

CIRION Clinical Trial Services Inc. CIRION is a Contract Research Laboratory and a leading provider of Global Central Laboratory and R&D services for assay development & validation for Global Clinical Trials and Pre-Clinical studies. The company offers a complete range of project management and logistical services, a broad portfolio of safety and esoteric assays, including biomarkers, and high level scientific expertise. CIRION has over 14 years experience in developing and validating assays in a GLP environment. The company is accredited by the College of American Pathologists (CAP), the Centers for Disease Control (CDC) and the NGSP. Our mission is to provide unsurpassed excellence in services through our state-of-the-art Global Central Laboratory which is enhanced by the scientific capabilities and know-how of a highly skilled research laboratory team. Our expertly trained scientists work in an environment supported by high-tech computerized management systems and laboratory equipment. Our expert team is committed to quality assurance exceeding industry standards to ensure reliable results and uncompromised service.

Global, Full Service Central Laboratory: • Global Project Management and Logistics • • • • • • • • • • •

Management of complex studies International Site Support Worldwide Shipment Management and Tracking IATA-Compliant Specimen Collection Kits Customized Study Material Analytical Services with rapid turnaround time Broad Portfolio of Specialized Assays and Biomarkers GLP-Compliant Specimen Storage Flexible Reporting Capabilities Data Management with Real-Time Data Cleaning Web Tools and Remote Data Access

Development & Validation Services Scientific Partners for your Development programs. Our scientific team support GLP and non-GLP services:

Expertise/Large Molecules: Biologics/Biosimilars: we can support your product development, pre-clinical and clinical development by getting involved early in the development process: • PK assays (including ISR) • Immunogenicity testing (ADA, Nab) : Screening, Confirmatory and neutralizing activity antibody Biomarkers: In this area, for small or large molecules, CIRION’s

Biotechnology Focus june 2009

scientists have gained expertise from various technologies with solid knowledge. Method planning can be adapted depending on your study protocol: • Exploratory assay • Partially GLP validated assay • Full GLP validated assays

Technologies: Mass Spectrometry: • LC-MS/MS (QTrap) • Seldi-Tof ProteinChip System Cell based assays: • Neutralizing antibody assay (Nab) • Activity/Potency assay • Cell proliferation • Cell Line conditioning and characterization Immunology: • RIA, IRMA, EIA, ELISA, ELISPOT and binding assays • Single and multiplex assays by Electrochemi-luminescence (ECL) (Meso Scale® platform) • Single and multiplex assays by xMAP technology (Luminex® platform) • Immunophenotyping by Flow Cytometry • Biosensor technology on Biacore® platform Molecular Biology: • DNA and RNA extractions • Real time RT-PCR • Viral quantification Microbiology: • Antibiotic susceptibility (MIC assay and E-test) • Microorganisms identification (API test)

By-the-Book Quality: • Strict adherence to GCP & GLP regulations • CAP/CDC Accredited

Reply Card #4745

Contract manufacturing — gmp

Dalton Pharma Services

“Better, Faster, Cheaper …. We need all three” BY Peter Pekos, CEO, Dalton Pharma Services

The customer-centric variant quoted above stands in stark contrast to the classic, time-worn, vendor-centric, cliché that runs as follows: “You can have Quality, Speed, and Low Price ....... choose two”. The new reality is part of the current business environment in which CMO’s operate. Serving the drug development needs of domestic and international clients has historically required us to be nimble and precise and also to eliminate anything that slows the lead-to-market path. Dalton is geared toward speed because the industry demands it. We are constantly searching for ways to increase efficiency in each of our activities, from chemistry and analytical through to GMP manufacturing. This applies to work flow in and between departments. We have invested heavily in staff training in order to create a company-wide project management culture. Capital efficiency has become paramount. The value that a CRO provides increases when a full spectrum of drug development services is provided. Seamless and integrated services ultimately reduce the risk of lost time. Hand-offs from one vendor to another, add significantly to cost and reduce flexibility if there are delays in the supply chain. The volume of business in contract GMP manufacturing of finished dosages has grown substantially over the past few years. It became increasingly clear to us that if we were developing and manufacturing the API and then doing clinical dose production for our clients, they should not have to go to another party for formulation development. By the fall of 2009, we found our own formulation experts and finished their training to meet all our operational expectations. Our formulation expertise covers sterile and non-sterile liquids, solids, semi-solids and lyophilized formulations for small molecules, proteins, peptides, monoclonal antibodies and high-potency actives. It is not enough to simply create a new department. None of our departments are silos. All of our activities are genuinely integrated into our operational infrastructure to allow us to work as quickly as possible. For example, we expanded our analytical department so that all the requirements of the formulation department could be met in-house. This meant, among other things, adding particle size distribution and dissolution testing capabilities. In all our contract work we have to worry about being blindsided by the unexpected. We have found that what makes a good CMO great is the resilience of the team. Being able to adapt to challenges and changes in priorities is absolutely essential. This is especially true in the early stages of drug development programs. Part of our group leader training, which is constantly reinforced, is risk management analysis. What could go wrong? What can we do to reduce risk and/or reduce the consequences? No matter what causes them, delays in drug development are devastating even for the most financially sound companies in the industry. Their success is our livelihood. We are constantly striving to be “better, faster, cheaper”.

Biotechnology Focus june 2010

Fast-track your drug development Our integrated drug development and manufacturing services help you minimize burn rates and achieve investment milestones. From hit-to-lead, Dalton Pharma Services accelerates your drug discovery and drug development process. Research

Analysis

cGMP Manaufacturing

Steril Fill

Formulation Development

Canada 416-661-2102 1-800-567-5060 chemist@dalton.com www.dalton.com

Reply Card #4746

BioTalent HeadStart E Final:Layout 1

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Focus

Human resources

Looking to get that special project off your to-do list? Get a head start

Every organization has them—important projects that, because of competing priorities, never make it off the to-do list. But they have to get done. BioTalent Canada’s BioTalent HeadStart program can help by providing an eager, motivated post-secondary student to carry out your specific assignment—maybe a web designer who can finish your company site, or a business student to research potential customers. These talented young learners donate their time in exchange for real-world work experience in the biotechnology sector.

What’s in it for you? • Get a project completed at no financial cost • Access the skills of a talented student • Find a potential future employee • Help a student become job-ready

Get what you need. Apply to the BioTalent HeadStart program today: www.biotalent.ca/getaprojectdone

Reply Card #4747

Funded by the Government of Canada's Sector Council Program

Focus Group ad Final:Layout 1

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Your industry. Your needs. Your input. Participate in our Bio-economy Skills Profiles focus groups Finding the right person for a job is hard—especially for biotechnology companies that need people with both technical knowledge and business savvy. To make the process easier, we’re helping define exactly what’s required for specific biotechnology functions. We need your input Right now, we need biotechnology leaders like you to validate six new skills profiles that we’ve developed with industry—making sure they accurately reflect real-world requirements. Take part in our focus groups and: • Help define Canadian biotechnology functions • Network with other industry stakeholders • Discover how skills profiles can benefit your organization • Learn how to plan skills development activities in your organization • Contribute to solving the country’s bio-economy HR challenges

Sign up today. Visit www.biotalent.ca/profiles to join our Bio-economy Skills Profiles focus groups or to evaluate new profiles online.

Existing profiles Chief Executive Officer Vice-President of Manufacturing Regulator Affairs Specialist Intellectual Property Officer Laboratory Worker In development Animal Care Manager Contract Manufacturing Project Manager Quality Assurance Manager Biofuels Plant Manager Bioinformatician Clinical Research Data Manager

Funded by the Government of Canada's Sector Council Program

Lab product – RNA Extraction

RNAGEM™ Tissue – Superior RT-qPCR from

Cells Populations 1-150,000 cells BY MICHELLE MILES, DUNCAN KAY, DAVID SAUL

INTRODUCTION The use of cell lysates for direct RT-qPCR is requisite in many clinical and biomedical research applications where cellular populations, down to single cells, need to be analyzed in isolation. Such sample formats are not readily prepared by column or precipitation based methods because of limited recovery, potential for contamination, and sample loss. Nor are these samples suited to traditional quantitation methods, such as UV absorbance and fluorescent dyes due to limited sensitivity at the lower levels of sample abundance. In such cases the best solution for quantitation is the use of qPCR with the genomic DNA as a template. RNAGEM™, a new rapid cell lysate preparation kit, delivers superior sensitivity for both gene expression profiling and sample mass normalization using qPCR. The kit makes use of a highly-active thermophilic protease which strips protein from mRNA templates whilst lysing cells and destroying RNAses. The enzymes and reagents used in ZyGEM kits have been selected to be fully compatible with most downstream applications thereby removing the need for stop solutions and overcoming salt imbalances common to chemical lysis or proteinase K methods. The result is an RNA extract that is immediately ready for use in sensitive RT-qPCR assays. RNAGEM™ uses a rapid, single-step protocol that releases RNA and DNA with excellent linearity across a wide range of cell numbers. The Method is automatable, closed-tube and does not require further purification of the RNA for accurate RT-qPCR analysis. The reagents efficiently lyse the cells and strip protein complexes from nucleic acids, thereby allowing higher processivity of polymerases. The result is greater sensitivity - especially with low abundance transcripts. Reduced handling, and efficient template preparation means that the RNAGEM™ kits generate mRNA profiles that are as close to the biological reality of the sample as possible.

Gene Expression Analysis by RT-qPCR and Sample Normalisation by qPCR Gene Expression Analysis by RT-qPCR HeLa cell numbers from 10-50,000 were extracted using RNAGEM™ and a commercial acid-phenol extraction kit. Plots were generated from a high abundance mRNA (ACTB; ß-actin) and a low abundance mRNA (BRCA1; breast cancer early onset). The clean traces with gradients similar to the standards demonstrate the lack of inhibition.

High copy number mRNA (ACTB)

Biotechnology Focus june 2010

Reply Card #4748

Low copy number mRNA (BRCA1)

Lab product – RNA Extraction

Volume

RNAGEM™

Incubation time

50,000-100,000

50 μl 25 ul 10 ul 5 ul

1 μl 1 μl 0.5 μl 0.2 μl

5 min 5 min 5 min 5 min

5000-40,000 100-5000 <100

Easily automated Hands - off / Closed - tube 100 90 80 70 60 50 40 30 20 10 0

Incubate in a thermal cycler RNAGEM activated. • Cells lyse, • Ribonucleases destroyed • Nucleoprotein removed

DNA/RNA ready

Cells

RNAGEM Tissue

Add reagents to cells

Untreated HeLa cells were trypsinised in a canted-neck flask, and resuspended in PBS. The cells were counted physically and a dilution series set up for the extractions. Aliquots from 10 – 50,000 cells were added to the followed extraction volumes:

temperature

RNAGEM™ Extraction Procedure

Easily automated

Sample Normalisation by qPCR A prerequisite for using gDNA for sample normalisations is that the extraction efficiency of both DNA and RNA is consistent over the range of cell numbers likely to be encountered. Furthermore, this consistency must apply to both low and high copy mRNAs. To demonstrate RNAGEM™ ability to produce RNA and DNA in consistent, linear proportions, 10-10000 HeLa cells were extracted using RNAGEM™ Tissue. The mRNA was amplified by RT-qPCR using qScript cDNASupermix. DNA was amplified using qPCR with PerfeCTA® SYBR® Green FastMix®, ROX™ (Quanta Biosciences).

Add reagents to cells

temperature

100 90 80 70 60 50 40 30 20 10 0

Hands - off / Closed - tube

Incubate in a thermal cycler

RNAGEM activated. • Cells lyse, • Ribonucleases destroyed • Nucleoprotein removed

Add DNAse + buffer

The HeLa cell dilutions were added to the wells containing the RNAGEM™ reagents with a double aspiration and dispense to ensure mixing. The samples were then subject to a 75°C incubation for 5 minutes, before being ramped to 4°C.

min

RNAGEM Tissue PLUS

Hands - off / Closed - tube

Note: When using standard overnight cultures a single volume and regent ratio can be determined for the growth conditions and range of cellular yields from an given cell-line and growth conditions

RNA RNAGEM inactive.

DNAse active

RNAGEM activated. DNAse destroyed

min

CONCLUSIONS • One mix & one step – closed tube protocol. No danger of contamination, sample loss, or sample skew. • Excellent linearity shown for both qPCR and RT-qPCR across a wide range of cell numbers • The protocol yields excellent linearity of yield for both RNA and DNA as determined by functional quantitative PCR assays. • The technology enables the sensitive and reproducible profiling of low abundance transcripts in small cellular populations. • RNAGEM™ offer the ability to significantly reduce costs in time and reagents usage for many functional cell culture assays, such as: • gene silencing experiments • compound screening experiments • RNAGEM™ allows reliable and reproducible RT-qPCR results from overnight cultures and limited cell populations

Copies of the human GAPDH gene detected by qPCR plotted alongside copies detected by RT-qPCR of three mRNAs. ACTB = 366 copies per cell; GAPDH = 2607 copies per cell; BRCA1 26 copies per cell.

Biotechnology Focus june 2010

regulatory

The teaming of two companies of specialists— i3 & CanReg—makes for one of the world’s most comprehensive regulatory affairs consulting firms. After working together over the years on a number of important projects, i3, the renowned global contract services organization, and CanReg, the premier global regulatory consulting firm, have joined forces to serve as the industry’s definitive one-stop clinical trials and regulatory affairs solution. Building on a legacy of regulatory achievement

Together, the two companies’ combined

To date, CanReg’s unique customized guidance,

expanded Strategic Regulatory Services offering,

education, and training has enabled all manner

positions i3 as one of the most comprehensive

of pharmaceutical, biotechnology, and medical

regulatory affairs consulting firms in the world.

expertise, which is clearly expressed in i3’s newly

device and diagnostics clients to successfully bring more than 500 distinct products to market in

A trusted partner for regulatory and clinical success

more than 60 countries.

With global regulatory agencies continually

navigate every stage of the regulatory process to

revising guidance and regulations, the This remarkable achievement allows i3, through

opportunity to work with a partner that is actively

its acquisition of CanReg, to offer its clients

involved with these changes every day means

enhanced international regulatory submissions

shorter time-to-clinic and, ultimately, shorter

and consulting capabilities of the highest order.

time-to-market.

Direct access to comprehensive specialized services

That actively involved partner is i3—long a

As one of the world’s fastest-growing CROs

organizations worldwide, and now also the Top

serving the pharmaceutical, biotechnology, and

CRO in Europe for 2010 as selected by investigator

medical device industries, i3 delivers direct access

sites in the latest CenterWatch1 survey.

to broad clinical and risk management expertise

1 “2010 Survey of Investigative Sites in Europe,” The CenterWatch Monthly, May 2010.

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By Christine Koenig

Best Practices

Canadian

Excellence in Leadership in the Life Sciences Rational drug design, target driven therapeutic approaches, biologics, individualized therapy, molecular diagnostics and biomarkers are the stateof-the-art in a new drug development area, one could think when reading the headlines, but wait – no, we are not quite there yet! But why are we progressing so slowly in bringing innovative approaches to the patients? There are a few very good reasons that can be summarized as a serious lack of smart money for early stage commercial development in Canada. • Firstly, it is true, the collective global biomedical knowledge has exploded since the beginning of the genomics area and the number of data mines (e.g. Genomics, Proteomics and Metabolomics etc.) ready to exploit is growing exponentially. But who is actually exploiting them? Well, it’s that small, early stage and chronically under funded Biotech industry. Few companies indeed eventually do find gold nuggets but most others rapidly retract to making better tools or providing research services to those who still hope, keep digging and persist. • Secondly, those who have shaped and dominated the drug development industry in the past, Big Pharma and their CROs, are spoiled by decades of success with blockbuster small molecule drugs, and have build close to no knowledge on how to develop innovative biologicals. Most Pharma giants have only very recently or not even yet recognized and accepted 24 BIOTECHNOLOGY FOCUS JUNE 2010

how important it will be for their future survival to adopt new drug development strategies and processes (from the Biotech industry). • Thirdly, most investors are risk adverse and have burnt their fingers when the IT bubble burst and thus prefer to act as interested bystanders, hesitantly dipping their toes into the water here and there, and only jointly and slowly move forward, while seeking advice from the experts in drug development, mostly retired Pharma managers now turned into consultants.

Best Practices we share the view of the majority of the decision makers in the industry that the management’s team competence is the most important predictor for success, more so than all the rest (see above). But what identifies excellent management? And how do excellent CEOs lead their team to excellence? These questions were the inspiration behind CELL – A Management Study™, the first of its kind. CELL™ is a, for now, Canadawide study that probes into the management practices of Biotech companies, in the areas of Strategy, Marketing, Communication and Leadership. The questions addressed to the CEOs included in this study were designed to elucidate the processes and the how-doyou-do rather that the results and successes. In the course of the study, CEOs of 23 Canadian companies, that have been recognized with national awards and accolades and thereby serve as role models for the Life Science industry were interviewed about their management practices.

Vision, passion & a sincere interest in people It seems that being a great leader in Biotech does not depend on academic background or former professional experience. It rather depends on the personality and the conviction and dedication for leading the company, by leading its people towards their common goals. The excellent leaders we inter-

viewed rely on two pillars to achieve these goals - systems and structures, and efficient and transparent communication with their people. An international experience and understanding of global culture supports these CEOs in communicating with and motivating a diverse team. Many of the companies we interviewed have very well defined internal communication guidelines including the conduct of meetings, email correspondence, use of Blackberries, etc. These ensure a steady, reliable and transparent flow of information while still encouraging informal and creative discussions. Although unanimously considered very important, Leadership development is the area (of the four we discussed) that suffers the most currently. In today’s tight economic environment, leadership and management development programs are red-taped. About half of the companies in our study included ‘leadership performance’ as an assessment criterion in the employee appraisal process, but only a third organized or invested in some kind of leadership & management skills training for their employees.

Adaptable strategy & customer benefit A clear vision is not only an important starting point for developing a strategy, later down the road it serves to re-engage the team when the going gets tough. 70 per cent of the CEOs interviewed make use of the power of vision & mission statements, leaving still a significant number of 30 per cent without it. As one CEO pointed out, “If we know where we are heading, we have a much better chance of getting there”. The majority of the CEOs saw it as their core duty and responsibility to guide a systematic development and review process of their strategy and thus enabling and allowing for adaptation to changing market environments, whenever appropriate. A few of the companies we interviewed have truly understood that the scientists are the ones who must understand the customers’ needs and benefits, because it is their

job to generate a product that delivers. It is understood by this group of CEOs that definition and communication of the customer benefit to be delivered is most effective at the interface of product developers/scientists and their champions in the target market. In many cases, the CEOs themselves take care of the marketing and/or business development function by overseeing this interface. However, in the majority (60 per cent) of the companies in our study, this responsibility was taken on by a dedicated marketing/business development function. A vast majority (80 per cent) of the companies included in the study consistently do a product portfolio analysis. This tool helps the CEO monitor and communicate the potential and progress of the portfolio, thereby facilitating the strategic decision-making.

Enabling Excellence The excellent Canadian Life Science managers act as ‘enablers’, driving their company’s strategy and policies, establishing efficient processes in internal and external communication, marketing and business development, and above all, motivating and engaging their people and partners in creating their company’s future. The interviews performed with a select group of recognized companies proved that there are indeed exceptional leaders with outstanding leadership and communication abilities. Many of those are not ‘home-grown’, but have an international background. As analogized earlier, results in the way of revenues, stock prices, or other business performance indicators are too premature to serve as evaluation criteria for management practices. Which is why an evaluation model such as the one adapted for this study might serve as a fairer approach to analyse the Life Sciences companies and their management, at least at this stage of the industry. Dr. Christine Koenig PhD is a Managing Partner Koenig & Consultants Inc. The fully comprehensive management report based on the analyses of these interviews, along with a collection of show-cases of good practices was released in March 2010. To receive a hard copy or a PDF mail to: info@koenigconsultants.ca

For more Best Practices information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca JUNE 2010 BIOTECHNOLOGY FOCUS 25

Compiled by Shawn Lawrence

ACROSS CANADA

Grand Challenges

Canada

Innovation and foreign aid on the same page

Ambitious, altruistic and one-of-a-kind; these are just some of the descriptions that have been thrown around Grand Challenges Canada, a new non-profit organization. Governed by its own board of directors and guided by a scientific advisory team (made up of some of the world’s most distinguished medical scientists from both the developed and developing world), the organization has a mandate of identifying and launching five grand challenges over a five-year period. In all, the Government of Canada committed $225 million over five years to Grand Challenges Canada when it was launched May 3, 2010 through its Development Innovation Fund. The fund was set up to “support the best minds in the world as they search for breakthroughs in global health and other areas that have the potential to bring about enduring changes in the lives of the millions of people in poor countries.” Grand Challenges Canada is working with Canada’s International Development Research Centre (IDRC), the Government of Canada’s lead on the Development Innovation Fund, the Canadian Institutes of Health Research, and other global health founda-

26 BIOTECHNOLOGY FOCUS JUNE 2010

tions and organizations in this endeavor. CIHR will be responsible for the administration of international peer review, according to international standards of excellence. The results of CIHR-led peer review will guide the awarding of grants by Grand Challenges Canada from the Development Innovation Fund. Additionally, The McLaughlin-Rotman Centre for Global Health based at University Health Network and University of Toronto will be the Home for the organization. The first challenge is “to create a new class of point-of-care (POC) diagnostics that will be easy to use, low cost, multiplex and able to assess disease stage and provide informa-

tion on prognosis.” In the case of this first Grand Challenge, the Bill & Melinda Gates Foundation is also a partner. To give our readers a better understanding of how this new organization will work, Biotechnology Focus sat down with Dr. Peter Singer, director of the McLaughlinRotman Centre for Global Health and Chief Executive officer of Grand Challenges Canada. We asked Dr. Singer what makes Grand Challenges Canada unique, how the organization will be governed and most importantly how the organization will make good on its commitment to find sustainable solutions to the world’s most pressing health needs.

ACROSS CANADA Q: What makes this organization unique from other national science organizations? Peter Singer: For starters this is a very unique venture in that it is an independent not-for-profit organization dedicated to improving the health and well-being of people in developing countries. Secondly Grand Challenges Canada relies on a strategy of integrated innovation. And what we mean by that is we’re looking for solutions at the sweet spot between science and technology, the social innovation that’s needed to bring things to scale in health systems and the business innovation that’s needed to create new technologies. As such, these are projects that must integrate scientific, technological, business and social innovation both in Canada and in the developing world towards a common goal. What that’s really trying to say is that science and technology is necessary but not sufficient on its own. You need the business innovation in companies to produce the goods and services, and you need the social innovation and health systems to make sure that those goods and services reach those who need them. And our interest is in taking innovation all the way from the labs to villages because the people we serve are the people who die unnecessarily and who suffer needlessly in the developing world because of the challenges in global health that they face. Another important thing to note is where the money to support Grand Challenges Canada is coming from. Grand Challenges Canada falls under the international assistance envelope of the Canadian government meaning this is not your usual R&D fund. Meaning this is foreign aid funding, and it comes from a financial envelope that is at roughly $5 billion a year. The reason that’s important is that one of the things people want in foreign aid is they want to know that in ten years we’re not going to be funding exactly the same things we’re funding today. The way to accomplish this is innovation or research and development. Lastly, Grand Challenges Canada is unique in its approach. Through Grand Challenges Canada we are funding a global community of researchers and related institutions on a competitive basis to address the world’s most pressing challenges by developing breakthrough solutions and ensuring that these solutions are available to those who need them the most. And the people that need these solutions the most can be found in the developing world, where about eight

We are looking for global excellence and the one’s that will get priority are the ones that meet standards of global excellence and have the likeliest chance of impact. million children die every year before their fifth birthday. When you think about that one fact alone, that eight million children die before their fifth birthday; that should give a sense of the size of the problems we’re tying to tackle, the size of the challenges we face. Grand Challenges Canada offers an opportunity to bring positive and sustainable change in overcoming this challenge.

Q: How do you define a Grand Challenge? PS: A Grand Challenge is really a critical barrier between where we are and where we need to be in global health. Our primary focus is on the comparable inequities in global health. The people in the developing world who are dying prematurely and suffering unnecessarily are the primary community that we serve. It’s about global excellence and impact we believe innovation saves lives.

Q: Why is diagnosing diseases such as malaria more quickly in developing countries through novel tests the first challenge to be tackled by the organization? PS: It’s about finding the sweet spot between science and technology innovation, social innovation, health systems innovation and business innovation. Point of care diagnostics fits this mold. It involves serious science and technology, it makes things much better and cheaper in the health system and it requires companies to innovate and develop the product. As a practicing physician I can tell you that diagnosis is the prelude to effective treatment. Diagnostics has also been relatively neglected in global health and that’s why we focused on it. For malaria at the point of care alone, we estimate that diagnostics can save roughly 100,000 lives, and prevent 365 million unnecessary treatments which drives up costs, wastes resources and causes drug resistance. Imagine there’s a child under five who comes to see a health provider in the developing world. The questions immediately asked are: is it malaria, what kind of malaria,

how severe is it and what drugs is it resistant to? And if it’s not malaria, is it pneumonia or one of a number of other things that can cause fever. What happens next is a sample is taken but it has to be sent hundreds of miles away to a laboratory to be tested. By the time the attending physician gets the results back, often times it’s too late. But, if you bring that diagnostic to the patient’s bedside, it’s like a glucometer for global health. It’s right there with instant results and could really help with treatment. The goal is by bringing diagnostic tools to the patient’s bedside we are saving lives, wasting less resources, providing better care, faster and cheaper. The novelty here is that we are developing point of care diagnostics, at the patient’s bedside and there’s a real need for this in the developing world. And its not just tools that diagnose malaria we’re interested in, we’re interested in diagnostics that can diagnose a number of conditions at the same time.

Q: What is the process of being selected? What proposals will get first priority? PS: We are looking for global excellence and the one’s that will get priority are the ones that meet standards of global excellence and have the likeliest chance of impact. We will be funding, identifying and putting out applications for and helping innovators come up with solutions for five Grand Challenges over a period of five years. Diagnostics is only the first one, and the request for proposals there of up to $12 million that’s targeted at developing world innovators is only the first step in that first challenge. We will be funding ten to 20 proposals and up to $12 million for this part of the first of the five Grand Challenges. The deadline for the first round of applications is July 12, 2010 at 11:59 pm EST. In all, there will be five Grand Challenges identified and launched over a five year period. The challenges will be determined through an exploration process by Grand Challenges Canada, based on advice from its International Scientific Advisory Board. The applicants can be either not-forprofit organizations such as universities or for-profit organizations. JUNE 2010 BIOTECHNOLOGY FOCUS 27

ACROSS CANADA respect to developing world innovators or people who are actually face-to-face with the challenges of diagnosis in global health. We’ll also be linking those investigators from the developing world to innovators in Canada. Canada has a very strong diagnostics community in the country, and what we will be doing subsequently which isn’t part of the request for proposals yet but it is mentioned, we will be encouraging the developing world innovators to link with innovators in Canada where that will be helpful.

On this particular Grand Challenge we are also working with the Bill & Melinda Gates Foundation and they’ve announced a competition of up to $30 million targeted at anybody in the world. We’ve announced $12 million for the time being targeted to innovators in the developing world and so together we’re going to create a community supported up to $42 million focused on the problem of point of care diagnostics for global health and because we’re focused particularly on developing world investigators, we’re enriching that community with

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PS: There are three benefits to Canadians. One is that Canadians are generous people; they realize that it’s just not right that a child in the developing world is more than ten times as likely to die under the age of five as a child in Canada is. So there are benefits in terms of the generosity of Canadians, which is really in part why we give foreign aid in the first place. Canadians recognize the enormous need in the developing world and support our country’s efforts to solve those challenges. As well, Canadians want our country to demonstrate leadership. There is a second benefit though when you think about global health, you just have to think about SARS, or pandemic influenza to realize there are no safe houses in the global village. Diseases have no borders. The problems of health in the developing world are our problems. So there is some self interest in improving health there as well as here. In Canada we may not have been globally minded enough in our approach to innovation, but Grand Challenges Canada does represent a window to be more involved. The third benefit is that some of the solutions that can apply in the developing world can also apply to communities in Canada, especially in remote areas. Some of the solutions are transferable to communities in Canada and vice versa, and it represents a type of globalization of Canadian Innovation. I think when we look back five or ten years from now, we’ll look back and say that this was really a real bold, special and effective move that Canada took and what this actually begins to do is it enhances Canada’s brand as an innovating country among nations, outwardly looking towards the world.

C90 We have the following enewsletters: Numbers for advertised products can be found on the ad and in the advertisers’ index

Q: There is no doubt that Grand Challenges Canada will help redefine Canada’s role in helping the developing world solve some of its most persistent health challenges, but what are the benefits to Canadians and Canadian innovation?

For more Best Practices information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca

CALENDAR

JUNE 2010

August 2010

June 21-25

August 15-19

Nanotech 2010 Venue: Anaheim, CA Tel: (508) 357-2925 Email: info@nsti.org Web: http://www.techconnectworld. com/Nanotech2010/

International IUPAC Conference on Green Chemistry Venue: Ottawa, ON Email: info@icgc2010.ca Web: http://www.icgc2010.ca/

June 21-25 BioNano 2010 Venue: Anaheim, CA Tel: (508) 357-2925 Email: info@nsti.org Web: http://www.nsti.org/ BioNano2010/

June 23-24 ChinaBio Partnering Forum Venue: Suzhou, China Email: mrannertshauser@ ebdgroup.com Web: http://www.ebdgroup.com/ cbpf/index.htm

September 2010 September 12-15 ABIC Saskatoon Venue: Saskatoon, SK Tel: 306-975-1939 Fax: 306-955-0545 Email: abicfoundation@abic.ca Web: www.abic.ca/abic2010

Company & Advertiser Index COMPANY

Page RC

A5 Labs................................................... 12................................. Amorfix Life Sciences.............................. 12................................. BIOTECanada........................................... 8.................................. Bioniche Life Sciences Inc........................ 8.................................. Bio-Processing Alliance Inc..................... 12................................. Biosyntech Inc........................................ 11................................. BioTalent Canada..................................... 18, 19......................... 4747 Biovail Corporation................................. 11................................. BioVectra....................................................... 7............................. 4742 Caledon Labs.............................................. 8, 9................. 4743, 4744

September 15-17

Canada Foundation for Innovation.......... 9..................................

BioPharm America Venue: Boston, MA Tel: 760 930 0500 Email: hmersy@ebdgroup.com Web: www.ebdgroup.com/bpa

Cirion Clinical Trial Services Inc............ 14, 15......................... 4745 Cortex Pharmaceuticals.......................... 11................................. Cytochroma............................................ 10................................. Dalton Pharma Services......................... 16, 17......................... 4746

June 24-28

September 17-24

Epigenomics AG...................................... 11.................................

Focis 2010 Venue: Boston, MA Tel: (414) 359-1670 Email: info@focisnet.org Web: http://www.focisnet.org

IMAGENENATION-National Biotechnology Week www.biotech.ca

Epitomics................................................ 12.................................

September 21-22

Ernst & Young......................................... 12.................................

BIO India International Partnering Conference Venue: Hyderabad, India Email: tdalal@bio.org Web: http://bioindia.bio.org/ opencms/bioindia/2010

Fisher Scientific.......................................... 2, 3.................4739, 4740

June 27-30 World Congress on Industrial Biotechnology and Bioprocessing Venue: Washington, DC Tel: 202-962-6630 Email: worldcongress@bio.org Web: www.bio.org/worldcongress

Eppendorf..................................................31,32............... 4750, 4751

i3..................................................................22,23.......................... 4749 Intellipharmaceutics.................................................................... International Inc..................................... 10................................. National Research Council of Canada...... 9..................................

October 2010

POI.................................................................. 4............................. 4741

June 28-30

October 5-7

PuGenesis Technologies Inc.................... 10.................................

Euro-Biotech Forum Venue: Paris, France Tel: (203) 838-4401 Ext. 237 Email: conferences@windhover.com Web: http://eurobiotechforum.com/ content/main.aspx

CanBio National Conference Venue: Vancouver, BC Tel: (705) 472-2280 Email: info@canbio.ca Web: www.canbio.ca

Stellar Pharmaceuticals Inc..................... 12.................................

June 28-July 1 Microscience 2010 Venue: London, England Tel: +44-1865-254-764 Email: allison@rms.org.uk Web: http://www.rms.org.uk

October 6-7 BioContact Venue: Quebec City, QC Tel: (418) 694-8778 Fax : (418) 694-0614 Email :lysbeth@biocontact.qc.ca Web: www.biocontact.ca

Stem Cell Therapeutics Corp.................. 10................................. Therapure Biopharma Inc....................... 12................................. University of Toronto.............................. 10................................. Viron Therapeutics................................. 12................................. Vida Pharma........................................... 12................................. Viterra Inc............................................... 11................................. VWR/Zygem............................................. 20, 21......................... 4748 Warnex Inc.............................................. 11................................. Wex Pharmaceuticals.............................. 10.................................

JUNE 2009 BIOTECHNOLOGY FOCUS 29

E tHe Last WOrD

By Peter Pekos

We Know the What and the Why.

NOW WE NEED THE HOW. I don’t expect any readers of this issue to recognize the name of Dr. John Dessauer. His immense contribution to the methods we use for innovation, product development and business management was made a generation ago. He built and directed the research team that commercialized a patent for ‘electrophotography’ and turned a little company in Rochester, NY into the Xerox Corporation. The phenomenal growth and success of Xerox in those days has been largely forgotten in the six or seven decades that have since passed. My reason for recalling Dessauer’s contribution is its relevance to what we can do together to maximize the growth of the biotech industry in our province and our country. Dr. Dessauer and the CEO he worked under believed their work had great significance not only for the success of their company, but also for the well-being of mankind. They were aligned in their vision, and their alignment, dedication, enthusiasm and incredible persistence, it took 16 years, was transmitted to the rest of the company and to the stakeholders. One of these stakeholders was the original inventor, Chester Carlson, who provided a pivotal idea at a crucial stage in the product development. The president managed long-term debt, depreciation, irate shareholders and other business challenges in ways that became a model for future North American executives. Dr. Dessauer introduced new R&D practices that we now take for granted, one of these, is the expectation that company engineers must also be inventors. Another is now known as PERT (Performance Evaluation and Review Technique), which originated as a goal-setting and following up type of system. We all know what we want to achieve in Ontario: a flourishing biotech industry whose growth matches or exceeds that of any other global centre and one in which the benefits of this collective growth flow to all of the participants, including established enterprises, new ventures, service providers, suppliers, educational institutions and the community. The question has always been HOW can we make this happen? I have long been convinced we collectively need to embrace the umbrella of basic principles that turned that little Haloid Company into Xerox. These principles consist of shared vision, alignment around this vision, dedication to succeed, responsible goal setting to create a path for success and regular evaluation of the progress towards these goals. At the 2010 BIO International Convention in Chicago last month, I had an opportunity to experience this approach in action. It was, I must confess, an eye-opener. Not only did it involve the application of all of the elements I have just mentioned but the participants exhibited a genuine shared enthusiasm. It was infectious! I was part of a group that met with a top level delegation from the Australian province of Victoria. At 5.4 million people, Victoria is comparable in population to Ontario, and the capital city of Melbourne is in many ways similar to Toronto. I was able to probe many aspects of what they were doing to build biotech in their prov-

ince. During these discussions the officials from Victoria were fully engaged, aligned and focused on their area. The mission of building biotech in Victoria appeared to be run as a business with an overall strategy, clear objectives, and a program of critical review of progress toward these objectives. A major goal for 2010, for example, was the creation of ten firms with a market cap of over AUS$250 million. Victoria’s strategy and objectives are closely connected with the existing, the new, and the evolving national programs of Australia for biotech growth. There is a lot more that could be said about how Victoria is striving for excellence and if you are committed to achievement in Ontario, I strongly recommend that you take a close look. Start with www. ausbiotech.org and www.business.vic.gov.au. One of the keynote speakers at BIO was former US President Bill Clinton. I was not able to attend his lecture, but what I have heard him say on other occasions has struck a resonant chord. After leaving office he established the William J. Clinton Foundation to deal with worldwide issues that demand urgent action. What he tells influential people who want to become involved in one of the causes of the Foundation, be it global warming or AIDS, is “Tell me HOW you are going to turn your good intentions into measurable results?” “I am”, he has said, “going to spend the rest of my life asking ‘How?’”. A few highlights from my own ‘HOW TO?’ list for biotech growth is given below: • Create a long term road map and plan with 3 year evaluation period with clear priorities • Pick technology areas where we are strong, that are leading edge and make big bets • Align Provincial programs with Federal and Regional initiatives to ensure maximum impact • Support innovative export oriented companies • Support the venture community and make it easier to invest in and create innovative companies • Improve research tax credit programs • Appoint a chief scientific officer for the province and federal governments (Ontario is already doing this) • Leverage investment in research centers of excellence by giving vouchers to industry to use service providers in our provinces • Create a Federal SBIR program like that in the US and deliver the funds through IRAP • Convert Heath Care spending to investment in home grown innovation • Have government departments put out calls to solve their problems and give grants to Canadian companies to solve them • Tell stories about our leaders and people helped by technology celebrating our entrepreneurs These are not necessarily original thoughts and I know many of you have ideas as well. Let’s commit ourselves to making a difference.

Peter Pekos, President and CEO, Dalton Pharma Services

“i know how important it is to mold the future rather than to allow the future to mold you.” — John h. dessauer, 1971

Y T

W o in s o e

@ got something to say? Please send your comments/letters to biotechnology_ focus@ promotive.net

30 BIOTECHNOLOGY FOCUS JUNE 2010

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