Biotechnology Focus May 2012

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

MEDICAGO FIGHTING THE FLU WITH TOBACCO INSIDE:

MabNet:

A strategic Canadian program to develop production technologies for monoclonal antibodies

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MAY 2012 VOLUME 15, NUMBER 5

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contents MAY 2012 – VOLUME 15 – NUMBER 5

11

16 Medicago CEO and president Andy Sheldon discusses how his company is using tobacco to develop innovative vaccines

Opinion

11 New production technologies for monoclonal antibodies

FEATURES MabNet: A strategic Canadian program to develop production technologies for monoclonal antibodies (By Michael Butler)

13 The Crossroad for BioTransfer Canadian innovators showcase their technologies to the biopharma industry (Compiled by Shawn Lawrence)

19 Industrializing the production of Stem cells Why bridging the gap between basic research and large scale manufacturing of stems cells is important and what is required (By Robert Shaw)

DEPARTMENTS 6

Research news

9

Business corner

IN EVERY ISSUE

16 Innovator/Spotlight

28 Calendar of events

8 R&D News

New approaches to coverting under-utilized wood into fuel

www.bioscienceworld.ca

Andy Sheldon, president and CEO of Medicago discusses his company’s pipeline of plant-based product candidates and vaccines, and the secret to his companies success (By Shawn Lawrence)

23 Across Canada

Ontario’s human health technology and bioscience industry gets its ‘Groove Back’ (By Gail Garland)

MAY 2012 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF

Budget 2012 excites some and satisfies most within Canadian Biotech

STAFF WRITERS

Editorial Intern CONTRIBUTING WRITERS

Shawn Lawrence Christopher Rogers Janet Damianopoulos Gail Garland

Michael Butler

Peter Pekos

It took a bit longer than was expected, but the 2012 Canadian Budget is out (announced on March 29th) and while not all are happy, the majority are satisfied and there are those even in the industry who are applauding the changes outlined in the announcement.

So, now that the dust has settled, let’s take a step back and see what we have.

When we first got word of the recommendations made in the Jenkins Report late last year, the industry had questions about how Canada’s SR&ED program would change, and whether new funds would be made available or existing funds would be cut.

It seems the concerns regarding the SR&ED program were heard, with SR&ED’s remaining relatively the same. The SR&ED’s will continue to be based on more than labour costs and the refundability rate will remain at 35 per cent; in both instances what the industry had hoped for would happen.

The new budget also seems to make good on government’s promise to find new ways to move Canadian innovation into a “commercialization ecosystem” where public and private partnerships can easily and effectively bring products to market.

For starters, the Feds have committed $1.1 billion over the next five years to support R&D directly with the goal of producing new products, processes and services to stimulate economic growth and generate jobs. At the same time, an additional $500 million will go directly towards a venture capital fund to promote business-led research initiatives. With venture capital for biotech companies virtually non-existent, this new fund is most welcome.

The good news doesn’t stop there. Genome Canada is poised to receive $60 million to support a new applied research competition in human health, as well as to maintain Science and Technology Centres until 2014-2015. Over the next five years, $500 million will be allocated to the Canadian Foundation for Innovation to support advanced research infrastructure. Also, support for the Industrial Research Assistance Program (IRAP) will double with an extra $110 million annually from 2012-2013. Moreover, the Industrial Research and Development Internship Program will receive $14 million over two years and graduate students will have the opportunity to do research with private companies.

Other beneficiaries include the National Research Council, which will receive $67 million in 2012-2013; CIHR, NSERC and SSHRC where $37 million per year will be invested in support of industry-academic research partnership initiatives from 2012-2013. Also a new Western Innovation Program managed by Western Economic Diversification Canada will offer financial aid to SMEs in Western Canada. Moreover $12 million is being allocated to make the Business-led Networks of Centres of Excellence program permanent; with $95 million allotted for three years from 2013-2014 and $40 million annually afterward.

Not all escaped the axe, as cuts of $309.7 million to the Department of Agriculture and $309.9 million to the Department of Health are expected by 2014-2015, with further details of the cuts forthcoming.

Still, there is much to celebrate in the budget. With the budget now presented to the House of Commons the legislative process to adopt it is already underway.

Terri Pavelic

National Account Manager GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Robert Shaw Marcello Sukhdeo Elena Pankova John R. Jones Mary Malofy

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

EDITORIAL ADVISORY BOARD Celine Bak, Analytica Advisors; Rob Henderson, BioTalent Canada; Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Wordmark Consulting Group Inc.; Ulli Krull, UTM; John Kelly, Erie Innovation and Commercialization; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Cognovie Inc.; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB, a partner with Leger Robic Richard; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, CDRD; Bonnie Kuehl, Scientific Insights Consulting Group Inc. 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 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

Jamie Scott

Simon Fraser University prof receives funding for HIV vaccination research

Jamie Scott, a Simon Fraser University professor and Canada Research Chair in molecular immunity, and three international collaborators are getting a hefty financial boost in their efforts to develop an effective HIV/AIDS vaccine.

The United States National Institutes of Health (NIH) has awarded the four researchers $2.7 million to help them improve the effectiveness of a DNA-based vaccine that Marinieve Montero first conceived of eight years ago. Montero was a student of Scott’s whose work was also funded by the NIH, the U.S.’s largest government-funded medical research agency.

Scott’s current collaborators are at the University of the Basque Country, the University of Massachusetts School of Medicine and the University of California, San Francisco. Together,the researchers will use the funding to strengthen a vaccine they’ve made from a DNA fragment taken from the HIV genome, which encodes the MPER, a region of the HIV envelope that retains mutations at a very low level compared to the rest of the virus’s genome, which continually mutates. According to Scott, the MPER doesn’t retain mutations because they would hamper the virus’s ability to infect cells and duplicate itself.

“The real challenge to creating antibodies that fight a constantly mutating virus like HIV, is finding a region on the virus’s surface protein that rarely mutates. That provides an exposed site that does not change from virus to virus and that antibodies can attack. The MPER is such a site,” explains Scott.

While other researchers have made vaccines that expose a subject’s immune system to a synthetic version of the MPER, the vaccines have not triggered the production of antibodies that recognize and attack HIV. Scott and her partners believe this is because synthetic MPER vaccines to-date have not replicated the viral MPER accurately, but say their new vaccines do a better job.

During the next four years, the researchers will test their improved MPER vaccines, which they hope will induce antibodies that are aggressive enough to prevent HIV from infecting lab subjects.

Sanofi BioGENEius Challenge Canada Regional competitions for the 2012 Sanofi BioGENEius Challenge Canada (SBCC) began on March 30 in Montreal. The SBCC is a national biotechnology research competition that encourages high school and CEGEP students to pursue future studies and careers in the field of biotechnology.

Introduced in 1993, the initiative is coordinated by Bioscience Education Canada and sponsored by Sanofi Pasteur Limited, Sanofi Canada, Genome Canada, the National Research Council Canada/Conseil national de recherches Canada, Canadian Institutes of Health and Research/Instituts de recherche en sante du Canada and the Government of Canada’s Youth Awareness 6 BIOTECHNOLOGY FOCUS

MAY 2012

Program. The initiative is further supported by local biotech and educational organizations, in partnership with universities, colleges, government and industry.

Competitions will also take place in Winnipeg, Vancouver, Edmonton, Saskatoon, London, Greater Toronto, Ottawa and Moncton. Regional competition winners will advance to the national competition held at the National Research Council headquarters in Ottawa on May 7.

First and second place winners of the national competition will compete at the International BioGENEius Challenge in Boston, MA on June 18 (in conjunction with the BIO Annual International Convention).

Clinical Trials & Patents Allon Therapeutics Inc. (Vancouver, BC) has been granted a U.S. patent that covers the use of the company’s neuroprotective technology platform in the treatment of peripheral neuropathy. This includes the company’s lead drug candidate, davunetide, and pipeline product AL-309 as treatments for peripheral neuropathy caused by anti-cancer drugs. Allon previously presented preclinical data at a Society for Neurosciences meeting that showed the activity of AL-309 in chemotherapy-induced neuropathy. AL-309, administered in combination with oxaliplatin (an anti-cancer agent) reduced pain symptoms in a model of peripheral neuropathy.

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Aeterna Zentaris Inc. (Quebec City, QC), announces that a poster on its novel orally active anticancer PI3K/Erk 1/2 inhibitor, AEZS-136, showed the compound’s unique inhibition and excellent activity against PI3K and Erk signaling pathways, and was well tolerated. The anti-proliferative efficacy of AEZS-136 was evaluated in more than 40 human tumour cell lines including breast, ovary, endometrium, multiple myeloma, lung, melanoma, colon, leukemia and prostate cancer cells. In vitro ADMET properties were also widely assessed, while in vivo pharmacokinetics (PK) and anti-tumor efficacy was explored. AEZS-136 was well tolerated and showed dose-dependent inhibition of human colon tumour growth of up to 72 per cent in a Hct116 mouse model. Conclusions included effective dual targeting of Raf-MekErk and PI3K-Akt pathway; unique inhibitor with excellent activity against PI3K and Erk; induction of G1 arrest and apoptosis; broad anti-proliferative activity in vitro; favorable in vitro ADMET and in vivo PK profile; well tolerated up to daily doses of 90mg/kg for four weeks; and in vivo anti-tumour efficacy after oral administration.

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Theralase Technologies Inc. (Toronto, ON) announces that it is pursuing FDA Phase 1 approval for its patented Photo Dynamic Compounds (PDCs). Theralase has successfully identified the leading drug candidate, which will be used for safety and efficacy clinical testing in human cancer patients. In multiple preclinical studies, the leading drug candidate has been selected from Theralase’s library of PDCs and has repeatedly demonstrated extremely high efficacy, virtually 100 per cent kill rate, in various cancer cell lines including brain and colorectal cancers; robust destruction of sub cutaneous (under the skin) cancerous tumours in animals; extremely low toxicity; and high stability, allowing for a long shelf life.

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R & D NEWS Triple Negative Breast Cancer Discovery

Steven Jones

An international team of 59 scientists, including four from Simon Fraser University, has made a pivotal discovery conducting the largest genetic analysis of triple negative breast cancer tumours. The team mapped the genomes of 100 tumours on a computer expecting similar gene profiles. However, they discovered that no two genomes were similar. Results are published in the journal Nature in a paper titled: “The clonal and mutational evolution spectrum of primary triple negative breast cancers.”

Triple negative breast cancer is considered the deadliest form of breast cancer because it does not respond well to modern drug therapies. SFU molecular biology and biochemistry professor and head of bioinformatics research at the BC Cancer Agency Steven Jones, who co-authored the study says the genetic diversity of the tumours likely explains the difficulty of finding an effective treatment, pointing out the importance of personalizing cancer drug treatment to address the specific genetic make-up of individual tumours.

$7.6 million for McGill University and Génome Québec Innovation Centre McGill University and the Génome Québec Innovation Centre have been awarded funding totaling $7.6 million over a twoyear period from Genome Canada’s 2010 Competition: Science and Technology Innovation Centre Operations Support.

The award, a record sum for Québec, will be used to fund the operations of the Innovation Centre as well as the services offered to scientific communities in Québec, the rest of Canada and around the world.

“This funding of $7.6 million from Genome Canada, in addition to an award of $3.25 million from the MDEIE, will enable

May 29, 19, 2012 2011 Montréal, Canada

the Innovation Centre to continue providing excellent services and place Québec in an enviable position in the new genome technology industry,” stated Marc LePage, president and CEO of Génome Québec. “I’d like to stress the fact that the reputation of the Centre as well as the quality-certification processes implemented in the last few years have led to a 15 per cent annual increase in the numbers and satisfaction of users; the client pool now stands at an impressive 800 teams of researchers annually.

In this regard, the Centre is carrying out remarkable work in the scientific community:

it is advancing knowledge in genomics and promoting cooperation between researchers in the academic and private sectors.”

Since 2006, in addition to carrying out its mandate for major Genome Canada and Génome Québec projects, the Innovation Centre and its 63 employees (employees in the framework of this award from Genome Canada), provided services to 1,496 university research teams from the different Canadian provinces, 89 foreign teams and consortiums from 24 countries as well as 74 industrial teams from across Canada and the rest of the world.

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R & D NEWS

The Centre for Research and Innovation in the Bio-Economy (CRIBE) is providing up to $6 million in funding to leverage a total project value of up to $14 million for a partnership between Domtar and Battelle to develop a new approach to converting underutilized wood to fuel.

Domtar, designer manufacturer and distributor of a wide variety of fiberbased products, and Battelle, a private research and development institute, have teamed up to develop a unique, cost-effective system that if successful, will increase operational efficiencies and

create a fossil fuel alternative for transportation fuels.

This system uses “fast pyrolysis” technology, a process that rapidly converts biomass using heat without oxygen to produce crude bio-oil and gas. The key to Battelle’s approach is in the treatment and processing of this crude bio-oil to a “drop-in fuel”, which can be blended directly with gasoline or diesel fuel.

Domtar Dryden will use wood waste that is currently burned for low value, as the biomass feedstock for the process.

If successful, the bio-oil will be used to blend into the fuel for Domtar’s vehicle fleet or it could be used internally to offset the use of natural gas.

“This project points the way to Ontario’s future as a clean technology and innovation leader,” said Brad Duguid, Minister of Economic Development and Innovation. “This groundbreaking process will turn waste wood into fuel we need. That’s good news for the environment and good news for our economy.”

Using metagenomics to protect drinking water Working alongside Simon Fraser University scientists, a team of researchers from the British Columbia Public Health Laboratories at the BC Centre for Disease Control are using metagenomics to help ensure drinking water remains contamination free.

The project, “Applied Metagenomics of the Watershed Microbiome”, is funded by Genome BC, Genome Canada, the SFU Community Trust Endowment Fund research grant and other partners. The project aims to improve methods of identifying fecal contamination (typically indicated by the presence of E. coli) in watersheds and to provide new tools to track sources of water contamination. This will include developing a prototype for more effective water testing and to change the paradigm of culture-based bacterial testing, which is slow and often imprecise.

Researchers involved in the project believe Metagenomics can identify multiple pollutants and enable faster testing at watershed level rather than testing from taps 8 BIOTECHNOLOGY FOCUS MAY 2012

and that source testing will allow for more effective interventions where there is contamination.

A microbial source-tracking tool is being developed that can quickly identify and treat the origin of pollution. In the third year of development, the project will join forces with the Canadian Water Network to pilot the water testing prototype in watersheds across Canada.

The project will be carried out over the next three years at a cost of $3.2 million.

More information about the project can be found at www.watersheddiscovery.ca

Andy Sheldon named CEO of the Year at World Vaccine Congress

Andy Sheldon

Converting wood waste to fuel

Medicago Inc. CEO Andy Sheldon has been named CEO of the Year by the Vaccine Industry Excellence (ViE) Award judging panel. The announcement was made at the World Vaccine Congress recently held in Washington, D.C. “I am honored to be selected as CEO of the Year, and sincerely thank both the ViE judging panel and all who voted to support my nomination for this award,” said Sheldon. “Being chosen as the CEO of the Year is also an acknowledgement of the Medicago team, and I share this award with all employees in recognition of their dedication and industry-leading vision. 2011 was an important year for Medicago, and I look forward to continuing to lead the company to advance our pipeline of plant-based product candidates to further demonstrate our ability to rapidly develop highly effective and cost effective vaccines.”

Medicago’s pipeline includes the initiation of a U.S. Phase 2a clinical trial for a quadrivalent seasonal vaccine with interim data expected in the first quarter of 2013. A Phase 1 clinical trial for a one-dose H5N1 VLP vaccine with a new adjuvant is planned for the second quarter of 2012, in partnership with the Infectious Disease Research Institute (IDRI), with interim data expected in the second half of this year. In addition to vaccines, Medicago is conducting research and development in the area of biosimilar products.

Officially the longest-running and largest vaccine industry event in North America, the World Vaccine Congress delivers a forum where the ever-changing dynamics of the vaccine industry are discussed and acted upon by the industry’s most senior figures. The ViE Awards were created to honor and generate recognition of the efforts, accomplishments, and positive contributions of companies and individuals in the vaccine industry over the previous 12 months.

For more on Andy Sheldon and Medicago, see the feature on page 16 of this issue.

BUSINESS CORNER Valeant moves global head office to Montreal

Valeant Pharmaceuticals International, Inc. announces that the company’s global headquarters will be moving to the Montréal region and that it will establish an R&D center of excellence for consumer dermatology in Laval, Quebec.

Both moves were supported by the Quebec government which kicked in a $6 million incentive to help offset the $38

million cost to move to Montréal.

Valeant will become the first and only multinational pharmaceutical company to have its global headquarters in Quebec. The company, created two years ago when U.S.based Valeant merged with Canada’s Biovail Corp. said it will also beef up its research efforts in the province, with Laboratoire Dr. Renaud and a newly acquired manufacturing facility being critical components of the company’s emerging position as a prominent leader in the dermatology sector.

Valeant has given up its lease on its Mississauga headquarters building, but will retain its employees in Ontario.

Valeant also announces it has signed an agreement to acquire Natur Produkt International, JSC, a specialty pharmaceutical

company in Russia with a strong presence in the over-the-counter segment. Valeant will acquire Natur Produkt for approximately $180 million, with an additional $5 million in potential future milestones. Total revenue in 2011 was approximately $65 million and is expected to deliver double digit growth in 2012. The transaction is expected to close by mid-year 2012.

Michael Pearson, Valeant’s chairman and CEO expressed confidence in the over-thecounter market in Russia, citing it as one of the fastest growth components of the Russian healthcare system. Pearson stated that acquisition of the operation, together with acquired assets from Gerot Lannach will bring the company’s pro forma revenues in Russia to roughly $175 million by the end of the year.

SemBioSys announces voluntary delisting from Toronto Stock Exchange SemBioSys Genetics Inc. has applied to voluntarily delist its common shares from the Toronto Stock Exchange (TSX). In addition, the company is taking immediate steps to execute on restructuring the company The delisting comes as a result of the company believing it currently could not meet the continued listing requirements related

to liquidity to maintain its TSX listing. The company is currently evaluating its ability to list on another Canadian stock exchange.

The current liquidity situation of the company has resulted in termination of the majority of its employees and contractors.

The CEO and several other staff remain working for the company.

May 29 and 30, 2012 F U N D I N G I N N O V A T I V E C O M PA N I E S

St. Andrew’s Club & Conference Centre, 150 King Street West, Toronto

BioFinance 2012

is the leading investor conference in Canada for the life sciences industry.

This event brings together key industry players interested in investment opportunities and issues affecting companies in the life sciences sector. Presenting companies span a range of industries including: biologics, medical devices, drug delivery, vaccines, diagnostics, bio-energy, green technologies, bio materials, industrial biotech, and research services. BioFinance 2012 will also feature 14 investor panels that address specific financing and management issues relevant to this industry.

www.biofinance.ca

• Contact mstinson@biofinance.ca • Tel 1-866-342-4933 MAY 2012 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Life science research in Québec to be fuelled with new investment funds Teralys Capital announces an investment of $35 million in two new funds managed by Lumira Capital: Lumira Capital II and Merck Lumira Biosciences Fund.

Lumira and Teralys representatives expressed enthusiasm for the collaboration stating their companies will benefit from Merck’s expertise and reputation. Merck invested $35 million to the first closing, which totalled $43 million. The Fund’s final closing target is $50 million. Lumira Capital, which has also made an investment commitment to the Fund, will serve as fund manager. In addition to investing in the Merck Lumira Biosciences Fund, Merck is also contributing $5 million to the $101 million first closing of the Lumira Capital II Fund, as part of the company’s broader global strategy to work with leading venture capital partners.

The Merck Lumira Biosciences Fund will be devoted exclusively to Québec companies at the earlier innovation stage, while the Lumira Capital II fund will provide existing businesses with much required new capital to pursue their growth. Combined, these investments should provide a significant boost to the Québec’s life sciences

ecosystem, making financing available to companies in this sector throughout their stages of development. More specifically, the Merck Lumira Biosciences Fund (target closing of $50 million) will invest in Québec biotechnology companies before their products have reached proof-of-concept in humans, while Lumira Capital II (initial closing of $100 million) will focus on biotherapeutic and medical device companies at a later stage of development.

“We defined specific principles that funds in Québec should be structured around in order to better support local businesses: a minimum fund size of approximately $150 million, international mindset and networks, and the participation of strategic partners. Lumira Capital meets all these criteria and we applaud Merck’s commitment to the venture capital industry in Québec,” Jacques Bernier, Managing Partner of Teralys said.

“The creation of Lumira Capital II shows the relevance of the Fonds de solidarité FTQ’s strategy in life sciences.

With Teralys, we are able to attract strategic partners such as Merck that give Québec innovators access to key resources for them to attain their full potential,” declared Alain Denis, senior vice-president, New Economy at the Fonds de solidarité FTQ. Mr. Daniel Hétu, managing partner at Lumira Capital, specified: “It is a very opportune time to be investing in the life sciences sector as there is strong deal flow and promising investment opportunities in truly innovative therapeutics and medical technology companies. We look forward to investing across the spectrum of the development stages of products and technologies and to also playing a significant role in the Québec financing ecosystem of life science companies.”

Dealmakers Bioniche Life Sciences Inc. (Belleville, ON) announces a distribution agreement with a U.S. based veterinary pharmaceutical company to expand Bioniche’s product offerings in Australia. The supplier is providing Bioniche with exclusive distribution rights for four registered injectable animal health products in Australia.

The products include Respiram ™, a respiratory stimulant for dogs, cats and horses, used during and after anaesthesia or for neonatal dogs and cats following dystocia (difficult labour) or caesarian section; Cepetor™, a sedative and analgesic for dogs and cats; Revertor™, for the reversal of the clinical effects of medetomidine in dogs and cats; and Cepesedan™, for use as a sedative and analgesic to facilitate minor surgical and diagnostic procedures in horses. Bioniche also announces it has closed a US$20 million financing from investment funds managed

by U.S.-based Capital Royalty L.P.

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The Centre of Excellence for the Prevention of Organ Failure (Vancouver, BC) is working with Adiga Life Sciences, a joint venture between McMaster University (Hamilton, ON) and Oxford, UK-based biopharmaceutical company Circassia, to improve methods of monitoring novel allergy vaccines’ effectiveness. As part of the joint venture, Adiga will collaborate

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10 BIOTECHNOLOGY FOCUS MAY 2012

with McMaster University-based AllerGen NCE Inc. in a clinical trial wherein blood samples from allergic rhinitis patients receiving treatment with an investigational peptide allergy vaccine will be collected. These samples will be applied to the PROOF Centre’s biomarker discovery and validation program. The biomarker discovery pipeline aims to identify proteins and genes that are responsive to vaccine treatment.

In addition to enhancing understanding of how allergy vaccines work, identification of biomarkers will facilitate development of diagnostic tests that will support development of products to relieve symptoms and manage patients with allergic rhinitis.

Laboratory supply and distribution company VWR International (Radnor, PA) has acquired VITRUM PRAHA S.R.O. and VITRUM ROZNOV S.R.O., two distributors of scientific laboratory supplies headquartered in Prague and Roznov in the Czech Republic. VITRUM’s core business is supplying consumables, instrumentation and chemicals complements. Financial details of this acquisition remain confidential.

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The Canadian Institutes of Health Research (CIHR) and the Japan Science and Technology Agency (JST) have signed a part-

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nership agreement to fund joint research projects on the epigenetics of stem cells. The agreement was established under CIHR’s Canadian Epigenetics, Environment and Health Research Consortium Signature Initiative and JST’s Strategic International Collaborative Research Program. Under the partnership, CIHR has committed up to $6 million and JST to 600 million yen (approximately $8 million Cdn) for total funding of $14 million Cdn over the next five years. The funding will support a maximum of three research teams that will require the participation of Canadian and Japanese researchers.

Gamma-Dynacare Medical Laboratories (Brampton, ON) has entered into an agreement to acquire LifeLabs Québec (Montréal, QC), with Gamma-Dynacare assuming responsibility for laboratory testing and patient services centre operations. Gamma-Dynacare’s Québec operations include a medical diagnostics laboratory in Pointe-Claire and its recently acquired Warnex Medical Laboratory facility in Laval, plus a network of 24 Patient Services Centres in the Montréal and Québec City areas. This acquisition will enhance Gamma-Dynacare’s presence with the addition of LifeLabs’ clinical operations and four Patient Services Centres in the Montreal area.

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By: Michael.Butler

MabNet

Monoclonal Antibodies

A strategic Canadian program to develop production technologies for monoclonal antibodies Glycosylation

MabNet student growing EG2 cells in a bioreactor

Introduction

Manufacturing

There has been a steady increase in the number and demand for biopharmaceuticals for the treatment of human diseases. Global sales of biologics are now reported at $120 billion per annum with an expected increase to $150 billion by 20151 and clearly outpace the growth of small molecule therapeutics.

This economic success has been dominated by humanized monoclonal antibodies (Mabs) produced from mammalian cell culture bioprocesses. Despite the global economic downturn the annual growth rate for Mabs is predicted at 9.5 per cent up to 2015.2 They are the largest and fastest growing class of therapeutic pharmaceuticals with around 28 approved and around 350 in various stages of clinical trials.3 This growth is likely to continue because of their application to areas of unmet medical need and focus on novel targets which are associated with a reduced competitive intensity. The global sales of Mabs in 2011 were estimated at $44.6 billion and are predicted to increase to $58 billion by 2016.4 There are presently six blockbuster therapeutic Mab products on the market (greater than $1 billion annual sales): Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux, all of which have been highly successful in the treatment of specific conditions including rheumatoid arthritis and specific forms of cancer.

Although monoclonal antibodies have been around since the 1970s following the Nobel Prize-winning work of Kohler and Milstein on immortalization of B-lymphocytes, their full potential as therapeutic drugs was not developed until their structures were “humanized” in a form that would not lead to the immunogenic responses associated with mouse antibodies. The present high demand for Mabs as therapeutics brings into question the optimal methods of manufacture. This was a question addressed by a group of Canadian scientists from eight universities, 14 sponsoring companies and three government institutes. The multidisciplinary group of molecular biologists, biochemists, cell biologists and chemical engineers formed a network which has been funded by the manufacturing sector of NSERC to design optimal methods of production of selected antibodies. With the University of Manitoba as host institution, MabNet (www.mabnet.ca) is presently starting its third year of operation with a million dollar per annum operating budget from NSERC. This is supplemented by sponsorship and operating funds from 14 of the most prominent Canadian companies in biotechnology and biomanufacturing, who benefit from the scientific work arising from the network.

The major focus of the MabNet research is the optimization and control of Mab production from mammalian cells in culture. One particular aspect of this is the control of glycosylation of the Mab which relates to the carbohydrate structure associated with the protein part of the molecule. Although at one time the carbohydrate structure (also known as “glycan”) was thought to be an unimportant adornment of glycoproteins, there is considerable data to show that glycan variants of proteins affect biological activity. All antibodies have glycans at a conserved site on the Fc region of the protein. However, for each antibody there may be up to 30 different structural forms of the glycan. Alterations of the glycan profile of antibodies can be affected by the physiological and pathological conditions in vivo, particularly aging, pregnancy or disease.

Decreased terminal galactosylation has been shown for patients with rheumatoid arthritis or several forms of autoimmune disease. Differential sialylation has been shown to affect the inflammatory properties of IgG and has been proposed as a mechanism of a molecular switch to induce an anti-inflammatory condition. It would seem that these alterations in activity are related to the differential interaction of the Fc domain of the IgG with a series of natural receptors.

The glycan profile can be very important for therapeutic Mabs that require multifunctional activities for clinical efficacy. Mabs are complex glycoproteins with functions that include antigen-binding through the Fab variable domain and effector functions through the Fc constant domains. The glycosylation of Mabs is particularly important for the effector functions which are required for most therapeutic applications and may be improved by specific modifications of the glycan. For example recent work with the therapeutic antibody, Herceptin® for the treatment of breast cancer, has shown that a glycoform with no fucose has up to a 100fold higher binding capacity to the receptor that triggers its therapeutic activity, the so called antibody-dependent cell cytotoxicity (ADCC). The enhancement of this activity allows the Mab to be effective at lower doses.

Although fucosylation is a normal activity during glycosylation in mammalian cells, MAY 2012 BIOTECHNOLOGY FOCUS 11

MONOCLONAL ANTIBODIES HUMAN AND LLAMA ANTIBODIES

fucose-free Mabs can be produced by various means including genetic inactivation of the fucosyl transferase gene or by the use of specific inhibitors in the culture.

MabNet The objective of MabNet is to understand the functional properties of specific Mab glycoforms and to be able to develop bioprocesses that enable the production of single glycoforms or at least a restricted glycoform profile. An understanding of the function-structure relationship is key to developing Mabs with enhanced therapeutic properties. The control of glycosylation in the biomanufacturing process is essential at various levels. Firstly, it’s important to ensure consistency of products between different batch runs. Secondly, it’s important to enrich the final Mab product with the glycoforms having the desired effect.

MabNet has chosen to study an unusual but potentially important therapeutic antibody that was derived originally from a llama. It turns out that all camelids (family of camels and llamas) have small antibodies that lack the usual light chains that are present in humans. The selected MabNet antibody is one targeted to epidermal growth factor receptor (EGFR) which is strongly expressed on specific cancer cells. The value of the small size of the camelid antibody is that it exhibits enhanced penetration of solid tissue, giving it good access to the cancer cells in vivo.

The selected clone of the MabNet antibody (labeled EG2) has been fused with a human constant region structure to make it less immunogenic and transfected into Chinese hamster ovary (CHO) cells. These are the most predominant cell line used for biopharmaceutical production because of their ability to synthesise proteins with a human-like structure, particularly with respect to the glycan profile. Although the EG2 Mab has potential as a therapeutic in its own right, the focus of the MabNet program is to use this as a model antibody to develop platform systems that could be applicable to a wide 12 BIOTECHNOLOGY FOCUS MAY 2012

selection of antibodies that require large-scale manufacture. The platforms developed by the network embrace all aspects of production including cell line development, bioanalytics, bioprocess control and downstream processing. These are organized into four themes related to the expertise of individual researchers. The value of this organization is that it cuts across the traditional subject boundaries so that there is strong interaction between different subject areas.

Up to now the MabNet has generated aberrant glycan profiles of the EG2 Mab by the use of specific glycosylation inhibitors, by mutagenesis and by enzymatic re-structuring.

The structures have been determined by a combination of exoglycosidase array analysis, HPLC and mass spectrometry. Specific functional binding and cell-based assays will be performed on these structural variants to see the structure-to-function relationship.

Bioprocesses are being designed based upon the highly successful fed-batch principles used in industry. This involves periodic feeding of nutrients to maintain an efficient metabolism that maximizes cell viability during the later stages of the process. However, it has been shown that limited levels of carbon and nitrogen substrates can compromise glycosylation which can in turn reduce the quality of the final purified Mab. With this in mind, the bioprocess is being modeled by metabolic profiling and flux analysis to ensure adequate control of the fed-batch cultures to maximize the production of high value Mabs. The downstream processing part of the MabNet program is directed to the need for the high level purification necessary for the production of human injectable products. Here it is essential to ensure that the Mabs are maintained in their native and monomeric state as they are concentrated and formulated as clinical products. From a commercial perspective downstream processing has become particularly important because of the high costs involved relative to others parts of the bioprocess.

An equally important objective of the Mab-

Net program is to train postgraduate students in the art of biomanufacturing so as to increase the pool of highly skilled personnel in an industry that is dependent on the availability of trained recruits. At the moment there are 32 graduate students associated with the MabNet program and scattered throughout the country. Co-ordination and communication is maintained regularly by teleconferences and formal presentations at conferences such as the biotechnology sector of the Canadian Society of Chemical Engineering. The network is also preparing a training conference in the fall of 2012 which will focus on the business and commercial aspects of biomanufacturing. The rationale is to ensure that the trained graduate students from the program have both the potential for good science as well as good business acumen. This will be a clear benefit to the Canadian corporate sponsors of MabNet and it is hoped that this pool of graduates will help promote biomanufacturing as a major sector of the Canadian economy in the future.

References 1. Repligen. www.repligen.com. Annual Report 2011.

2. Datamonitor. Monoclonal Antibodies; 2010.

3. Reichert JM. Which are the antibodies to watch in 2012? mAbs 2012; 4:1-3.

4. BCCResearch. Antibody drugs: technologies and global markets. Biotechnology 2012.

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

For more MONOCLONAL ANTIBODIES RESEARCH information visit our DRUG DISCOVERY Web Portal at www.bioscienceworld.ca

Compiled by Shawn Lawrence

Spotlight on BioTransfer

The Crossroad for BioTransfer: Showcasing Canada’s cutting edge technologies On May 29th Canadian innovators from researchintensive institutions across the country will showcase their technologies to biotechnology and pharmaceutical companies during the Crossroad for BioTransfer conference.

This one-day conference gives health-sector companies as well as other key players in intellectual property the opportunity to identify and invest in high-impact technologies, including novel biopharmaceuticals, small-molecule therapeutics, platforms for drug discovery and process manufacturing. As a lead-in to this exciting event, Biotechnology Focus went one-on-one with founder of the event and coordinator of the current steering committee Yves Quenneville to discuss the evolution of the Crossroad for BioTransfer, who should attend and why.

Biotechnology Focus: What is the Crossroad for BioTransfer and what are some of its goals?

Yves Quenneville: The Crossroad for BioTransfer is an annual meeting that showcases licensing opportunities in the human health therapeutics field. On one side, for Canadian research centres, universities and technology transfer offices it’s an opportunity to showcase a selection of their best technologies for commercialization in Life Sciences, while on the other side it offers biotechnology and pharmaceutical companies as well as the venture capital community a unique one-stop venue to access new therapeutic and diagnostic products as well as technologies that promise to advance their drug discovery and development capabilities. The main goal in bringing these two sides together is to encourage the licensing of these

technologies to the industry. The technologies showcased span the entire field of human health, whether it is drug discovery, technology platforms for drug discovery and development, diagnostics or even new platforms to help drug delivery.

BF: How many people do you expect to attend this year?

YQ: We usually draw 250 people each year, and some years the demand has been overwhelming. Big companies often send one or two scouts to cover the event, so the chance to get one-on-one with these companies is very probable.

BF: Can you tell us about the history of the event, its evolution and what’s new for this year?

YQ: This year marks the fifth year for the event in its current form as The Crossroad for BioTransfer, but its history goes much farther back.

It is a derivative of a pre-existing event called the Crossroad of Biotechnology, which if you put it all together, and this year would be the sixteenth edition. Few years ago, the Fondation Biotech Montréal (FBM) which support the event, accepted to realign the conference in the direction of technology transfer to the industry. The technologies at Crossroad for BioTransfer in past years were developed by three premier research institutions: National Research Council (NRC), MAY 2012 BIOTECHNOLOGY FOCUS 13

n

Spotlight on BioTransfer The nature of the event as well as how we gather and consolidate the information to be useful not just the day of the event but years around is very unique. The technical presentations take place throughout the day, and there are roughly 30 to 35 technology presentations at each event.

Yves Quenville

McGill University and the McGill University Health Centre (MUHC), and Gestion Univalor, Limited Partnership, representing Université de Montréal and affiliated hospital centres. In 2010, we held a special edition of the event in Boston partnering with the Massachusetts Technology Transfer Center (MTTC) thus reaching out to a wider audience to showcase the technologies. It was a new twist to the event that looking back was ultimately successful, but we thought that perhaps it was time to expand our focus on showcasing technologies from all Canadian universities and research centres and so for this year that is exactly what we are doing. And likewise we are contemplating the possibility of holding the event at another location, perhaps even Toronto or Vancouver in the future.

BF: What organizations play a role in running the event?

YQ: The event is supported by the Fondation Biotech Montréal and coordinated by a steering committee that consists of Benoit Tremblay, Director General, Fondation Biotech Montréal; Line Béliveau, Communications Officer, andYves Geoffrion, Business Development Officer, both from NRC, Michèle Beaulieu, Associate Director, Commercialization, Office of Sponsored Research, McGill University; Laurence Rulleau, Vice-President, Business Development, Gestion Univalor, LP;; Francis Beaulieu, Project Manager and Communications Director, Montréal InVivo; Isabelle Trempe, Senior Director, Business Development, Paladin Labs, and President, Canadian Healthcare Licensing Association (CHLA); Steven Klein, Director, Business Development, IRICoR;and Jean-Pierre Dubois, OPC Événements. This committee and their respective organizations help to coordinate the event, the technologies to be spotlighted, the topics that will be covered, and the keynote speakers.

BF: Who is the target audience for the event, and who should participate? Likewise, how does the event work?

YQ: The target audience includes pharma and biotech companies that are seeking new technologies for drug discovery development or new drug candidates. This includes technology scouts from both these industries. Innovators in Canada are facing a certain challenge when it comes to licensing their technologies as the market in Canada internationally speaking is relatively small and spread apart. This event is really a showcase that provides the individual researchers and technology transfer offices the opportunity to present their technology in a form that will be of interest to the business community. At the same time, it gives them maximum visibility in front of industry.

On top of this, we recognize that venture capital is a very important 14 BIOTECHNOLOGY FOCUS MAY 2012

ingredient for younger companies to make it feasible for them to license and develop further the products they have, so we have also invited and hope to attract an increased number of venture capital investors to the event.

As for how the event works, we see BioTransfer as an excellent vehicle that gives visibility to new technology, and allows researchers reach out to the industry. The nature of the event as well as how we gather and consolidate the information to be useful not just the day of the event but years around is very unique. The technical presentations take place throughout the day, and there are roughly 25 to 35 technology presentations at each event. We film all of the presentations, each one lasts about ten minutes. The presenter will discuss the business opportunity, the type of license they are looking for and so on. Our platform is pretty unique in this way in that we are probably one of the only sites in Canada that presents various technologies from various academic and institutional organizations to an audience of business people looking to license. The process continues months after the event has taken place because the technology description presentation videos remain available on the website and every year for instance, our websites gets about 9000 unique visitors. The website provides a fairly unique window to the technologies that are available.

Right now we probably have somewhere around 130 technologies in the human health therapeutic field that are currently listed with another30 to 50 technologies that will be there by the time the event takes place. Should these technologies get in-licensed, they get removed from the website. During the day of the event, we also try to facilitate one-on-one meetings, made possible through a partnership section on the website. In our experience those meetings are also extremely valuable have proven successful.

BF: Do you have examples of past success stories from previous events?

YQ: Yes, we definitely have success stories of the technology being presented being licensed. Offhand there have been roughly a dozen licensing’s that are related directly through BioTransfer, as well as BioTransfer having had an indirect effect just by bringing people together and opening the dialogue between innovators on one side and the technology scouts from private sector.

For more BioTransfer information visit our Event listings Web Portal at www.bioscienceworld.ca

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By Shawn Lawrence

Innovator

Medicago Fighting the flu with tobacco

Researchers around the world continue their scramble to find new ways to develop anti-flu drugs, vaccines and provide better flu surveillance. Dealing with a foe that has the ability to mutate, evolve, spread and evade immunity, whether it’s common strains of influenza, or more fatal forms of infectious disease, vaccine developers are under constant pressure to ensure there’s enough vaccine available for public consumption should an outbreak occur.

The situation is all the more critical when one considers that the wheels are already in motion for a pandemic to hit. Our governments are preparing for it, many companies have pandemic plans in place just in case, and concerns of how hard the next one will hit or its severity are ever present.

Having spent the better part of 25 years working in vaccine development both in the private sector, and as a consultant in formulating the Canadian pandemic plan used in 2009 during the H1N1 outbreak, Andy Sheldon understands the pressing need for new technologies to fight the flu. Today he heads up Medicago Inc., a Canadian biotech company that may offer new hope in the race to produce vaccines more quickly, more cheaply and with higher yields. Hired in 2003 as president and CEO, and charged with the task of transforming the company from research outfit into a commercially viable vaccine manufacturer, he’s very close to accomplishing his task. And the prospects for future growth continue to excite Sheldon, as does solving some of the world’s most pressing infectious disease dilemmas.

Medicago was founded in 1999 by current chief scientific officer Louis P. Vezina and Francois Arcand, with the company’s initial IP spurred by investment from Agriculture Canada.

“The idea from the start for Medicago was to use plants as a tool to create pharmaceuticals, vaccines and biologics,” says Sheldon.

While the broader focus hasn’t changed, the company has made serious inroads on the vaccine development side beginning with the development of therapeutic proteins for such infectious diseases as H5N1 and seasonal influenza.

“Compared with traditional egg-based and cell production systems, plants are uniquely capable of efficient protein expression at very high yields, and as such we believe we have the ability to produce vaccines quickly and cheaply using plants,” says Sheldon.

The company’s technology is unique in that it relies on the use of tobacco leaves to produce vaccines. The the tobacco plants are an Australian breed called Nicotiana benthamiana.

“We use its leaves as a key part of a process which results in the production of what we call virus-like particles, or VLPs,” explains Sheldon.

Virus-like particles simply put, look like the virus but don’t have any genetic material, and because they look the virus, they have the ability to stimulate immune pathways within a host to combat the virus.

16 BIOTECHNOLOGY FOCUS MAY 2012

Medicago researchers working with Nicotiana benthamiana tobacco plants.

Photos courtesy of Medicago

Innovator FEATURE

“On the outside, the particles look like the virus, but the particles are actually empty and harmless. Essentially, in the case of humans, they trick the human immune system into mounting a defense,” he says.

The steps to producing the VLP’s are far simpler than one would imagine. First the plant’s leaves are soaked in a liquid that contains genetic material from the flu virus, which allows the plant cells to download the genetic sequence from the virus. In turn the plants’ cell machinery kicks in to make virus-like particles.

The last step is extracting the virus-like particles from the plant.

Medicago’s greenhouse in a suburb of Québec City is full of flats of these plants in various stages of growth. The choice to use this breed of tobacco plant says Sheldon is not accidental.

“We use these plants because they have less contaminant and are much cleaner to work with. This offers advantages in terms of purification. One can see that through the process the plants also lend themselves well as a manufacturing platform for proteins. What makes these plants even more unique is that they are able to assemble virus-like particles themselves. It starts at the plasma membrane level of the plant and it buds out. Our job is then of course to breakdown the cellulose tissue which holds it in place.”

As such, the company’s pipeline has three distinct components to it: the vaccines created through this process, its proprietary manufacturing technologies (such as the plant-based Proficia™ technology) and the virus-like particles (VLPs) themselves.

One of the lessons learned from past flu pandemics is that when it comes to producing vaccines, both capacity and speed are important.

Again, this is an area that Sheldon believes Medicago has a leg up over its competitors. According to Sheldon, Medicago’s process can deliver a vaccine for testing in less than a month after the identification and reception of genetic sequences from a pandemic strain is made.

“Take the last pandemic for instance, which was swine flu (H1N1).

The product was available within six to seven months. During this same outbreak, we did our own test run producing an experimental vaccine with our Australian tobacco plants. In comparison, it took us approximately 19 days to have the first doses of the vaccine ready.

Using that as an example we believe we could get our product up and ready to go in just months after we have the sequence, literally shaving two to three months off the time it would normally take to have a vaccine ready for public consumption. All we have to do is simply download it (the viral genetic sequence) from the internet and off we go. And the best part, this can be done with any antigen.”

Put more succinctly, this production time frame has the potential to allow vaccination of a wider population before the first wave of any pandemic strike. It is this ability to rapidly respond to a prospective crisis that has parties all over the world interested in Medicago’s technology.

Count the U.S. Defense Advanced Research Projects Agency, (DARPA) among them. As part of the DARPA “Blue Angel” project,

DARPA has awarded a US-$21 million grant to Medicago to see if Medicago’s technology can answer the call by putting Medicago’s technology through a ‘rapid-fire’ test.

“The idea behind this project is to produce ten million doses in one month, and from that be in a position to defend U.S. citizens against bio-threats and we expect that we will be able to attain that goal,” says Sheldon.

To facilitate the project, Medicago established a new subsidiary (Medicago U.S.A.) while opening a new facility in the Research Triangle Park in North Carolina. The facility itself is designed to produce up to 120 million doses of pandemic flu vaccine and 40 million doses of seasonal influenza vaccine annually.

Sheldon says the choice to open the facility in North Carolina came down to a number of factors that went beyond the tailoring of the DARPA deal.

“We definitely had some choices in terms of the location when we signed the deal, but the fit was there in North Carolina because of its great workforce and training programs. There is also the fact that tobacco is one of North Carolina’s top crops and teaming with a high volume of life science and biopharma activity, opening the door to partnerships down the line.”

Once Medicago completes the rapid fire test, Sheldon says the company will validate the facility and use it as the manufacturing centre for its influenza vaccines.

MAY 2012 BIOTECHNOLOGY FOCUS 17

Innovator

in this area. But, no one has done much of As for the status of its products, Medicago’s what we’ve done before, and certainly no pandemic H5N1 VLP vaccine has completed one is as advanced as we are in the clinical Phase 2 clinical trials while its seasonal flu pathway,” he said. vaccine is beginning Phase 2. The company On top of its vaccine products, Medicago also has a rabies vaccine which is in the preis also conducting research and developclinical stage, but Sheldon expects it to be ment in the area of biosimilars. in Phase 1 by early 2013. The caveat is that “Making biosimilars entails something there is plenty of cash on hand to take these very similar to our vaccine development products forward thanks to the $65 million process. Basically, we program the plants the company was able to raise in 2011. to secrete a protein, and thus far in our Thus far, 2012 is looking equally as bright. system we have ten different monoclonal “Not only have we continued to advance antibodies. Thus, the plan in the coming our pipeline, but the company has also months is to work on biosimilar targets, usmade significant strides towards expanding our plants to express these molecules.” ing its product candidate pipeline,” says Again, what Medicago could offer says Sheldon, adding that the aforementioned Sheldon, is the ability to produce products rabies vaccine is a new area of focus for at low cost. For example, enzymes that the company, and one with great potential could be used in breaking down a chemical for growth. agent or what could be a product for use in “Rabies is an interesting infectious disease “Making biosimilars entails bio-defense programs. because frequently there are worldwide The company also has two other prodshortages. There’s also the fact that most something very similar to our ucts that for the time being, it is keeping products for rabies are used for post-expovaccine development process. under wraps. One product is being develsure rather than pre-exposure. So there is oped in partnership with a top ten pharma an unmet medical need here. Even more Basically, we program the company, while the other is an undisclosed important we are aiming to try and have a internal target which Sheldon calls a high vaccine that is not only very efficient, but plants to secrete a protein, reward project. also could decrease the number of doses.” and thus far in our system we risk-high “You can say this is the secret to our sucThe company is also involved in a research collaboration with the U.S. Army have ten different monoclonal cess; our partnerships, both technical and in business; Our partnerships have defiMedical Research Institute of Infectious antibodies. Thus, the plan in nitely helped in our financial model, and Diseases for the development of a VLP vaccine candidate for the prevention of Ebola. the coming months is to work I think institutional investors understand the story we’re trying to tell, it becomes And recently, Medicago was successful in on biosimilar targets, using a lot easier to be able to raise money and forming a strategic alliance with Mitsubiquite frankly we have been very successful shi Tanabe Pharma to develop a vaccine our plants to express in both these areas. We will be generating for rotavirus, a condition that is the most these molecules.” revenue through these agreements both common cause of severe diarrhea among from up-front payments and milestones, infants and young children. but also from royalties on net sales from all “In both instances we are hoping to offer something that is unique to what’s currently available for treatment. these projects once we get them to market. It’s a very nice model of For example, in the case of rotavirus, there are vaccines available, revenue generation.”

In the meantime the accolades for both Sheldon and Medicago however they are live vaccines and many countries don’t particularly like live vaccines. Live vaccines are products which have been continue to mount. Recently, Sheldon was named “CEO of the Year” modified, but they are actually going to replicate in the gut. They at the World Vaccine Congress in Washington, D.C. “Being chosen as the CEO of the Year is an acknowledgement I have DNA and they are capable of replicating, and that’s how they stimulate immunity. They’re usually not very efficient and they think of the Medicago team, and what we have accomplished as a don’t appear to have the same efficacy. Our goal is to create an company.”

Yet there is no denying the impact Sheldon himself has had on the intra-muscular or intra-dermal approach where we can combine company. Under his direction, the company is ready for whatever this with other products.”

With all this activity surrounding the company it becomes clear that comes its way. the opportunities for Medicago in this space are huge, and Medicago is well positioned to make the most of them.

“We find ourselves with a technology that is able to produce very strong and broad bodily protective vaccines. There are companies For more Innovator information out there working with tobacco plants, but they’re quite a ways visit our Profiles Web Portal at behind us. As it becomes evident that there is real potential in using www.bioscienceworld.ca these plants in this field, I think over time you’ll see more activity 18 BIOTECHNOLOGY FOCUS MAY 2012

By: Robert Shaw

CEll CUltUrE

Industrializing the Production

oF STeM ceLLS

Stem cells have the potential to yield a readily available, consistent source of many differentiated cell types. This unique property can be leveraged for therapeutic purposes and for facilitating and improving a number of drug discovery and development processes such as toxicity screening (Figure 1).

Large-scale “industrialized” production of stem cells is necessary to enable their advancement into human clinical trials and to effectively deliver the quantities needed for drug discovery screening and lead optimization. However, achieving this level of production while meeting rigorous quality standards will depend on further progress in the areas of cell culture and scale-up, characterization, enrichment and purification to deliver a consistent and reproducible supply of cells.

Large-scale cGMP Production of Stem Cells Advancement of stem cell-based therapeutics into clinical trials requires well-characterized cells produced under tightly controlled, consistent, reproducible culture conditions that adhere to Current Good Manufacturing Practice (cGMP) standards (Figure 2). cGMP standards, established by the FDA, cover the manufacture and testing of pharmaceutical products and dictate that processes are clearly defined, validated, and controlled to ensure consistency and compliance with specifications. cGMP stem cell culture systems will need well-defined, optimized media and supplements to support stem cell expansion and differentiation. The use of efficient, standardized methods Figure 1: Large-scale production of stem cells is necessary to support development of therapeutic applications and drug discovery and development applications.

MAY 2012 BIOTECHNOLOGY FOCUS 19

Cell Culture Figure 2: Bridging the gap between basic research and large scale manufacturing of stem cells requires well controlled, reproducible methods.

for growing and harvesting cells will ensure consistent cell populations with uniform properties and predictable behaviors. cGMP Culture Supplements When used for basic research applications, stem cells are typically grown in small-scale tissue culture flasks using media and culture supplements (e.g. growth factors) that are not always fully defined or characterized and, in some cases, of animal origin.

Human embryonic stem cell cultures were originally grown on “feeder layers” of mouse fibroblast cells. While the soluble factors secreted by the mouse cells help provide the proper environment for stem cell proliferation, use of feeder layers or co-culture systems have significant drawbacks when culturing stem cells for clinical applications.

Furthermore, the use of undefined matrices used for adherent cells is also undesirable.

As more stem cell-based therapeutics progress towards clinical testing, the consistency, quality, and reproducibility of largescale culture systems become imperative.

When manufactured under cGMP conditions, supplements and cell-binding matrices enabling robust proliferation of stem cells in culture will be required. Use of cGMP supplements contributes to high quality, consistent, reproducible culture conditions.

Integrated Cell “Manufacturing” Systems A number of challenges exist across the scaleup process for generating large batches of stem cells for therapeutic use (Figure 3). Because the cells themselves are the “product,” culture systems must: minimize variability; effectively control differentiation; enable har-

vesting and formulation without damaging cells; and incorporate processes to ensure cell viability during storage, transport, and administration to the patient.

Large-scale production of stem cells will require fully integrated, scalable systems that include: • New microcarrier technology or alternative solutions that enable particulate-free culture of stem cells in a bioreactor. When cultured in bioreactors, adherent stem cells must be grown on a solid surface such as small beads (called “microcarriers”). However, small particulates or “fines” are often generated during the microcarrier manufacturing process. The fines can wind up in the culture system. Fines can also result from beads being crushed during the cell harvest process. As stem cell cultures cannot be readily filtered to remove these particulates, any small particles will be co-purified with the cells. The presence of foreign particulate matter such as microcarrier fines is unacceptable for injectable products.

EMD Millipore is collaborating with the Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM) to develop optimized conditions for bioreactor-based cultivation of stem cells. CCRM is a federally incorporated, not-for-profit organization dedicated to supporting the development of foundational technologies that accelerate commercialization of stem cell-based and biomaterials-based technologies and therapies.

The joint project will focus on exclusive development of a monitoring and control methodology enabling robust growth of microcarrier-adherent human pluripotent stem cells in EMD Millipore’s CellReady®

stirred tank bioreactor. Ultimately, the project is expected to result in a commercially available kit containing reagents and associated methodologies for bioreactor culture of stem cells on microcarriers.

• Bioreactors optimized for stem cell culture.

Existing bioreactor technology is designed primarily to support the production of proteins expressed in the supernatant of cell cultures. Supernatant samples are easily extracted from the reactor for analysis.

In the case of stem cell cultures, however, bioreactors must allow rapid sampling of small volumes containing the actual cells.

Stem cell cultures need to be well mixed in the bioreactor prior to sampling as they tend to settle quickly. Because the cells are the actual product (in contrast to protein therapeutics produced by cells) the sample size must be small to avoid wasting valuable product and must be processed rapidly while the cells are still viable.

• Technology for harvesting and packaging of live cells. Existing centrifugation and filtration technologies are not optimized for the harvest and recovery of live cells. While centrifugation is often used to collect cells for research applications, it is not always practical for collection of large numbers of stem cells. Centrifugation is typically not a closed system, and shear forces can damage cells. Once cells are harvested, they must be rapidly concentrated, the media washed away with buffer solution, and packaged into containers for freezing or administration to patients (a process known as “fill/finish”).

No systems currently exist to efficiently manage the fill/finish process for stem cells.

20 BIOTECHNOLOGY FOCUS MAY 2012

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Cell Culture Figure 3: Challenges across the stem cell scale-up process.

Investigative Toxicity Testing In addition to their direct use in the area of regenerative medicine, stem cells offer unique advantages when incorporated into the small molecule drug discovery and development process. Pharmaceutical companies are now using stem cells to elucidate disease mechanisms and pathways, facilitate novel target discovery, assess and optimize lead compounds, and improve metabolic profiling and toxicity evaluation. One area that is receiving a great deal of attention is the use of stem cell-derived human hepatocytes in investigative toxicity studies.

The liver plays a central role in processing and metabolizing drugs and other substances in the bloodstream. Because hepatocytes are responsible for metabolizing most compounds that enter the body, these cells are used during the drug discovery process to predict how drugs will be metabolized and to what extent a drug may be toxic to the liver.

Drug-induced liver injury is one of the principal reasons clinical trials are suspended and approved drugs withdrawn from market. In fact, drug-induced liver injury has been the most frequent single cause of safety-related withdrawals of marketed drugs in the United States over the past 50 years.1 Investigative in vitro liver toxicity studies are typically conducted using primary human hepatocytes or an immortalized (genetically transformed) liver-derived cell line such as HepG2. Despite routine use for investigative toxicity, both of these options present significant drawbacks: • Primary human hepatocytes are derived from fresh liver tissue, typically sourced from cadavers or cancer resections. Supply of these cells can be limited and the tissue can vary widely among donors.

22 BIOTECHNOLOGY FOCUS MAY 2012

• Primary hepatocytes cannot be sustained for more than a few days in culture without losing function. Securing a consistent supply of cells requires repetitive sourcing, which further contributes to variability.

• Immortalized hepatocyte cell lines can be cultured indefinitely, which addresses the supply and variability issues associated with use of primary human hepatocytes.

However, these cells display distinct differences from normal liver cells and may not exhibit normal cell behavior or response.

For example, most cytochrome P450 enzymes (responsible for drug metabolism) are expressed only weakly in HepG2 cells compared to normal human hepatocytes.

The challenges of hepatocyte-based in vitro toxicity testing have led pharmaceutical companies to rely heavily on animal models for preclinical metabolism and toxicity testing. But animal models also have limitations.

Animal models may not be fully and reliably predictive of human toxicity, are low throughput, expensive, and raise ethical concerns for some.

Cost and throughput often relegate use of animal models to the later stages of preclinical development, after a company has invested significant resources and time in a lead compound. This delayed evaluation of toxicity contributes to the high failure rate of compounds in late stage preclinical testing, which is extremely costly.

Earlier, more effective assessment of drug candidate toxicity has the potential to reduce the attrition rate of drugs in later stages of development.

Differentiation and expansion of human stem cells into hepatocytes for use in investigative toxicity studies could overcome the shortcomings of primary hepatocytes

and immortalized cell lines. Use of stem cellderived hepatocytes (and other cell types commonly used for toxicity studies) offers a number of important advantages to investigative toxicity studies including: • Availability of a consistent source of cells that more closely match in vivo phenotype and physiology • Elimination of reliance on donor sources which can have sporadic availability • A more standardized, reproducible process for toxicity testing • Reduction in the use of animal models and animal tissue • Improvement in the predictive capabilities of early toxicity studies leading to reduction in late stage attrition of drugs More efficient and predictive toxicity studies enabled by stem cell-derived cells can be expected to reduce development costs associated with the late stage failure of drug candidates. Identification of drug candidates with toxicity issues earlier in the discovery process will result in improved safety for clinical trial participants and patients.

Reference 1. Guidance for Industry: Drug-induced Liver Injury. US Department of Health and Human Services. July 2009.

Robert Shaw is the Commercial Director for the Stem Cell Initiative, EMD Millipore

For more Cell Culture information visit our Research and Development Web Portal at www.bioscienceworld.ca

By Gail Garland, President & CEO OBIO

ACROSS CANADA

Ontario’s Human Health Technology and Bioscience Industry gets its

‘Groove Back’ On the heels of gloomy economic forecasts for Ontario such as those put forward by the recently- released Drummond Commission on the Reform of Ontario’s Public Service, Ontarians have been alerted that ways must be found to replace the province’s declining manufacturing base if it is to return to a position of economic advantage relative to the rest of Canada.

T

he OBEST strategy was launched to stop the downturn in the human health and biotechnology sector and take up the challenge of pivoting Ontario’s economy towards renewed prosperity and growth. OBEST recognized the need to take action in order to ensure Ontario does not lose the opportunity for building a globallyrecognized bioscience sector that develops and exports new products and services capable of addressing global healthcare priorities. OBEST strategies ensure our in-

vestments in research and innovation will not be lost to other regions that will realize the economic benefits of a growing industry (i.e. revenues, jobs, spin-off ventures, return on investment, and reinvestment of capital).

The OBEST call to action brought together an army of people, from academia, government, patient groups, financial and capital markets, and industry, who worked for six months and 5,000 person hours building a collaborative, iterative and implementable plan for the industry to become an economic engine in Ontario.

With the successful completion and release of the OBEST strategy in June 2011, and the appointment of co-chairs for the implementation teams at the OBIO annual general meeting in December 2011, Ontario’s bioscience community is now fully engaged in the implementation of the OBEST plan.

Nine implementation teams of dynamic volunteers, championed by the co-chairs, are advancing toward industry’s goal of a

sustainable bioscience industry in Ontario.

Also, the coordination of and underlying support for the implementation teams has been fully deployed. A dedicated OBEST Secretariat (including a Project Manager and an Implementation Officer) has been established to support the co-chairs and the activities of the implementation teams.

More than 80 people are directly engaged in implementing the strategy mandated by the bioscience community, demonstrating that a model of “industry supporting industry” continues to resonate with Ontario bioscience stakeholders.

Additionally, the OBEST initiatives will be leveraged to provide immediate benefits to participating Ontario companies through the OBEST Demonstration Class. The Demonstration Class, conceived by OBIO in 2010, provides assistance to developing life science companies while providing a training ground for the OBEST initiatives.

The Demonstration Class runs parallel to and is interconnected with the OBEST imMAY 2012 BIOTECHNOLOGY FOCUS 23

aCroSS CanaDa

OBEST Implementation Teams TEAM 1:

plementation teams thus providing a means of measuring success and ensuring impact.

The implementation teams are working with individual Demonstration Class companies to directly engage and mentor them as they navigate the various challenges facing the industry (as defined by the OBEST strategy).

Industry stakeholders have found a way to “give back” to the bioscience community by nurturing new companies and creating a more integrated and favourable environment for us all to do business in.

Effectively deployed, the benefits of OBEST implementation accrue to Ontarians, Ontario and potentially the world as healthcare technologies developed and commercialized here are exported globally. These benefits, as demonstrated by the bioscience industry’s engagement in OBEST – are well worth the effort.

Education & Awareness

TEAM 2: Build and Expand Pool of Investors and Partners

TEAMS 3/4: Define Industry Priorities & Build Interconnectivity among Local SME’s

about oBIotM The Ontario Bioscience Innovation Organization (OBIOTM) is a private sector, membership-based organization that is Ontario’s leading advocate for the life science sector.

OBIOTM is engaged in advocacy, research and strategy to enable the successful development and commercialization in Ontario of life science technology. OBIO accomplishes this through investment attraction, strategic alliances, stakeholder engagement and industry promotion. Our goal is to build a leading bioscience cluster in Ontario to deliver innovative products and services to a global market.

about oBESttM The Ontario Bioscience Economic Strategy Team (OBESTTM) was developed by OBIO following consultation with leaders of Ontario’s bioscience companies who provided the impetus for developing a province-wide strategic vision to support the growth and viability of Ontario’s bioscience industry.

OBEST includes all stakeholders in the Ontario bioscience community who want to create conditions for sustainable growth of Ontario’s bioscience industry.

For more aCroSS CanaDa information visit our PrOFILES Web Portal at www.bioscienceworld.ca

24 BIOTECHNOLOGY FOCUS MAY 2012

TEAM 5: Encourage “Patient” (LongTerm) Capital

TEAM 6:

MANDATE: Educate and build awareness of the Ontario biosciences sector with clear and consistent messages in the following focus areas: entrepreneurial education; industrial education; awareness of the value of innovation.

CO-CHAIRS: Ulrich Krull, University of Toronto & Jill Kapuscinski, Concept2Clinic MANDATE: Work with stakeholders to create an environment for success that will attract new investors. Articulate and broadly disseminate awareness of the strengths of Ontario’s bioscience industry. Build stronger connections with existing networks of investors and partners that are not currently engaged with the Ontario biosciences sector, including angel networks. This mandate continues the work of OBIO’s Access to Capital Committee formed in 2009.

CO-CHAIRS: Damian Lamb, Genesys Capital & James Parsons, Trillium Therapeutics MANDATE: Deploy industry strategy, leveraging successes, in order to sustainably address marketplace demands and create global recognition within the bioscience community. This will be done by defining the customer and market demands (payer, provider, patients, OEMs) that match Ontario biosciences’ strengths and work collectively (government, academia, industry and investors) to fund and develop solutions to these needs.

CO-CHAIRS: Kenneth Evans, Ontario Cancer Biomarker Network & Stephen Fanjoy, Devera Logic MANDATE: Work with investors, government and other stakeholders to incentivize long term investment in Ontario biotech companies to build a sustainable domestic life-sciences economy. This mandate continues the work of OBIO’s Access to Capital Committee formed in 2009.

CO-CHAIRS: Rob Hall, HTX & Frederic Sweeney, Tornado Medical Systems

Identify and Invest in Provincial Health Priorities

MANDATE: Work with governments and research institutes to identify opportunities to address health priorities for Ontario/ Canada that can lead to export of technology and local job creation.

CO-CHAIRS: Clive Ward-Able, Amgen Canada & Helen Findlay, Actium Research

TEAM 7:

MANDATE: A facilitation role which fields industry inquiries related to process and decisions that affect Ontario’s bioscience industry.

CO-CHAIRS: Anthony de Fazekas, Miller Thompson & Jeremy Grushcow, Norton Rose

Ensure and Clearly Demonstrate Integrity of Process

TEAM 8: Use Provincial Purchasing Power to Drive Market

TEAM 9: Modification of Government Incentives for Industry

MANDATE: Work with government to communicate the value (health and economic) of the biosciences sector to Ontario, and develop policies, solutions and partnering to achieve sustainability and better health outcomes. This mandate continues OBIO’s multi-stakeholder engagement work on innovation procurement and adoption initiated in 2010.

CO-CHAIRS: Dani Peters, Rothwell Group & Robert Merson, Merson Consulting MANDATE: Work with governments to rapidly access and deploy existing funds. Our industry is looking to modify existing policies in order to ensure Ontario’s competitiveness globally, and will attract non-government funding to the sector. This mandate continues OBIO’s industry consultation work initiated in 2009.

CO-CHAIRS: Parimal Nathwani, MaRS Innovation & Simon Goulet, Therapeutic Monitoring Systems

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Held in Vancouver, BC, Canada - host city for the 2010 Winter Olympics - from June 25th to June 27th, 2012, the 10th Annual Retreat will welcome scientists from a variety of research laboratories representing non-profit, academic, biotechnology and pharmaceutical industries. We invite you to join us here in this picturesque location to share knowledge and open new channels for discussion and discovery.

Scientific Advisory Board

Program Sessions

Guests are invited to stay at the beautiful 4 diamond Hyatt Regency Hotel in Vancouver, BC.

Ion Channels as Targets for Pain Ion Channels as Targets for Disease Ion Channel Screening Technologies Cardiac Ion Channel Pharmacology Cardiac Ion Channel Safety Structure & Function of Ion Channels

Arthur “Buzz” Brown (ChanTest) Birgit Priest (Eli Lilly) Jerod Denton (Vanderbilt University) Lu Qiang (Wuxi Pharma) Michael Dabrowski (Astrazeneca) Tina Garyantes (Sanofi-Aventis)

Speaker Announcements Stefan Bittner (University Hospital Muenster) Stuart Dryer (University of Houston) Elaine Gay (RTI International) Mike Iadarola (NIH) Shawn Iadonato (KINETA Inc) Fumihito Ono (NIH)

Xin-Ming Shen (Mayo Clinic) Stephan Steigele (Genedata AG) Andrew Wojtovich (University of Rochester) Takashi Yoshinaga (Eisai Co. Ltd (Japan)) Li Zhang (NIH) Jeffrey Zidichouski (National Research Council)

Corporate Sponsors

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NEW PRODUCTS Heating Ovens Thermo Scientific Heratherm heating and drying ovens are now available in three different models: general protocol, advanced protocol and advanced protocol seecurity. Each unit is available in 60, 100 and 180 litre sizes with a choice of gravity or mechanical convection. Special insulation and a heat-decoupled door reduce energy consumption and minimize heat transfer to the environment. All models include an easy-to-use user interface, automatic over temperature alarm and data interface.

The general protocol ovens are ideal for everyday heating and drying applications, operating up to 250° C. A timer function enables unit operation at defined times to optimize workflow. Where greater flexibility or temperature accuracy is required, the Heratherm Advanced Protocol ovens operate as high as 330° C. An extended timer function offers the choice of weekly, real-time or hour-driven settings for advanced flexibility. The program function can store up to 10 pre-defined cycles making it easy to undertake processes involving complex temperature ramping and holding steps. Fan speed and damper position can be controlled electronically to facilitate optimal heating, while the unique boost function allows rapid heating and reduces long-term energy consumption.

The Heratherm Advanced Protocol Security ovens incorporate an additional under temperature alarm, as well as a lockable door with an alarm, making them ideal for working with precious samples and longterm processes. The auto-dry function shuts the oven down upon completion to maximize energy efficiency, and an optional stainless steel exterior makes it ideal for use in pharmaceutical and clinical laboratories.

sleeve and glove options. Unlike other glove bags, the double O-ring design on the standard polyurethane cuffs allows users to quickly and easily change gloves to meet a variety of dexterity needs. Semi-rigid support rods make the Purair Flex easy to set up and provides increased stability, even if the bag is not inflated to full pressure.

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analysis of pharmaceuticals, grains and oils, as well as food safety applications.

Vivo’s four tungsten halogen sources, arranged for reflection measurements at a 90 degree angle to the detection fiber, can be turned on and off for precision control.

The powerful bulb output enables shorter spectrometer integration times than conventional methods-as fast as 1ms with some system setups. An inner cooling fan reduces the risk of overheating the sample to ensure accuracy. The Vivo can be attached to Ocean Optics’ RTL-stage or other standard for stability and control. Powered by an included universal power supply, the Vivo’s tungsten halogen bulbs are rated for 2,000 hours.

www.airscience.com Syringes Hamilton Company, introduces the Neuros syringe, specifically dewww.oceanoptics.com

signed for the neurosciences. Neuros syringes are available with ultrafine 30, 32 or 33 gauge needles that accurately dispense 50 nL to 100 µL. This enables precision animal brain injections with minimal tissue damage and reduced variability. A unique, adjustable needle sleeve maintains rigidity and ensures a targeted injection path to an exact location. Two needle sleeve options are offered , one with a blind stop for cannulated applications and the other for use with stereotaxic holders, each with adjustable needle exposure of zero to 20 mm.

Vacuum The T-Station 75 is Edwards’ new entry level turbopumping system.

The T-station 75 turbopumping cart is the smallest in Edwards’ range of pumping stations and can pump a chamber to the required vacuum thanks to higher capacity backing pumps. It can be combined with a choice of either an oil sealed E2M1.5 backing pump or an XDD1 diaphragm pump where a totally dry system is desired. The T-Station comes with a TAG (Turbo and Active Gauge) controller fitted as standard which enables single button start/stop of the system.

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www.thermoscientific.com Glove Bags The Air Science Purair Flex with film isolator features an innovative curved film design with versatile tapered 26 BIOTECHNOLOGY FOCUS MAY 2012

Light Source Ocean Optics’ Vivo NIR Source is a compact, tungsten halogen light source for VIS-NIR spectroscopy across the 360-2000 nm range. Compatible with all Ocean Optics spectrometers, optical fibers and sampling accessories, Vivo delivers powerful output for reflection and other measurements. The high powered source is ideal for use in NIR

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NEW PRODUCTS Liquid Handling Workstation Aurora Instruments Ltd. VERSA™ 10 automated liquid handling workstation has been developed to simplify laborious routine

replacement for other 4 to 20 mA output free chlorine (FCI) sensors. The FCLTX is designed for use in water treatment disinfection applications and for use with chlorine generators, pools, etc.

www.omega.com Pumps By providing individual control of each fluidic channel, the new Ismatec® Reglo ICC eliminates the clutter of multiple pumps on the bench top as well as allowing you, the scientist, to solve your application complexity in a single pump. Ismatec

drives will now power three channels, each independently programmable from the pump or the computer. Volumetric dispense options include continuous pumping or precision dispensing, flexibility of bidirectional flow in each channel and easy-to-use tubing cassettes which allow quick changeovers. The pump’s independent channel calibration also minimizes the tube to tube differences resulting in the best calibration accuracy possible in a multichannel peristaltic pump.

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SRC101

protocols by combining automated multichannel dispensing (4 or 8 channels), with single-channel, cherry-picking functionality. The customizable system set-up and optional deck modules allow users to automate a range of applications such as PCR/ qPCR plate formatting, sequence reaction set-up, enzymatic modifications, and general liquid handling. Accommodating all common reagents and labware, VERSA 10 is ideal in hospital research, diagnostics, and agriculture research laboratories. The VERSA 10 also accommodates 96- and 384well formats, and allows PCR set-up in 96well plates in 6 minutes. Each dispense is highly accurate, and the air displacement pipetting prevents cross-contamination so researchers can be sure of reliable and reproducible results. Optional modules such as plate heaters, reagent coolers, and shakers enhance the workstation’s functionality, and with lab space at a premium.

www.aurora-instr.com Chlorine Sensors Omega’s new series of free chlorine sensors feature amperometric measurement technology.

The sensors are available in several ranges for detecting ppm levels of free chlorine.

Sensors can be used in new installations with Omega flow cell or installed as

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CALENDAR MAY 2012

Web: http://.cbr.uvic.ca/conferences

May 15-18

May 27-30

Interdependence 2012 Conference and Exposition Venue: Vancouver, BC Tel: (604) 681-2153 Fax: (604) 681-1049 Email: i2012info@rickhansen.com Web: http://www.rickhansen.com/ What-We-Do/Interdependence-2012/ Conference/conferenceprogram.aspx

CMA4CH Mediterraneum Meeting 2012 Venue: Rome, Italy Email: infocma4ch@uniroma1.it Web: http://w3.uniroma1.it/cma4ch/ index2.html

May 29-30 BioFincanc Venue: Toronto, ON Tel: 1 (866) 342-4933 Email: mstinson@biofinance.ca Web: www.biofinance.ca

May 22-24 C21 BioVentures (C21) Venue: Napa, CA Tel: + 1 (831) 464.4230 Fax: + 1 (831) 515-5070 Web: http://www.techvision.com/c21/

May 25-27 How to Talk about Science Venue: Victoria, BC Email: cfbr@uvic.ca

APIC Annual Conference Venue: San Antonio, TX Tel: (202) 789-1890 / (800) 650-4570 Fax: (202) 789-1899 Email: annual@apic.org Web: www.apic.org

June 11-12

JUNE 2012 June 1-6

June 13-16

CYTO 2012 Venue: Leipzig, Germany Email: rjaseb@faseb.org / leftwich@faseb.org Web: www.faseb.org

15th International Congress on Infectious Diseases (ICID) Venue; Bangkok, Thailand Tel: (617) 277-0551 Fax: (617) 278-9113 Email: info@isid.org Web: www.isid.org

The Crossroad for BioTransfer Venue: Montreal, QC Web: www.biotransfer.ca

China BIO Partnering Forum Venue: Suzhou, China Email: mrannertshauser@ebdgroup.com / info@chinabiollc.com Web: www.ebdgroup.com/cbpf/index/php

June 4-6

Life Science Innovation Northwest 2012 Venue: Seattle, WA Tel: (206) 456-9567 Fax: (206) 456-9561 Email: wbba@washbio.org Web: http://www.washbio.org/ displaycommon. cfm?an=1&subarticlenbr=145

May 29

May 23-24

Tel: (703) 525-4890 Ext. 1210 Fax: (703) 525-1067 Email: education@aami.org Web: www.aami.org

June 2-4 AAMI 2012 Conference & Expo Venue: Charlotte, NC

Company & Advertiser Index COMPANY

Page Website

Aeterna Zentaris........................................................................................... 6............................................................................www.aeternazentaris.com Air Science................................................................................................... 26....................................................................................www.airscience.com AlbertatBay...............................................................................................................25...........................................................................................www.albertatbay.com Allon Therapeutics Inc.................................................................................. 6.........................................................................www.allontherapeutics.com Bioniche Life Sciences Inc............................................................................ 10......................................................................................www.bioniche.com Bioscience Education Canada....................................................................... 6...................................................................... www. bioscienceeducation.ca BioTalent Canada......................................................................................................2.................................................................................................... www.biotalent.ca Dalton Pharmaceuticals............................................................................... 30......................................................................................... www.dalton.com Eppendorf.................................................................................................................32............................................................................................ www.eppendorf.com Genome Canada........................................................................................... 7................................................................................www.genomecanada.ca Génome Québec........................................................................................... 7........................................................................... www.genomequebec.com Hamilton Company..................................................................................... 26.......................................................................www.hamiltoncompany.com ION Channel..............................................................................................................15..................................................................................... www.aurorabiomed.com LifeLabs Québec........................................................................................... 10........................................................................................ www.lifelabs.com Merck Canada Inc......................................................................................... 10............................................................................................. www.merck.ca Omega......................................................................................................... 27.........................................................................................www.omega.com Optuminsight/Canreginc.......................................................................................5................................................ www.optuminsight.com/www.canreginc.com Phoenix Biomedical Products...............................................................................13................................................................................. www.phoenix-biomed.com Sanofi Pasteur Ltd./Sanofi Canada................................................................ 6...................................................................................www.sanofipasteur.ca The Crossroad for BioTransfer...................................................................... 7.......................................................................................www.biotransfer.ca Theralase Technologies Inc........................................................................... 6...................................................................................... www.theralase.com Thermo Fisher Scientific.............................................................................. 26..........................................................................www.thermoscientific.com TVG.............................................................................................................................31..................................................................................... www.techcision.com/c21 VWR International................................................................................................10, 21...................................................................................................... www.vwr.com 28 BIOTECHNOLOGY FOCUS MAY 2012

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THE LAST WORD “Never play by the rules.

Never pay in cash. And never tell the truth.”

— F. Ross Johnson.

Peter Pekos , President and CEO, Dalton Pharma Services

By Peter Pekos

Are We Too Nice. . . or Too Naive. . . or Both?

Since 1994, the year that China devalued its currency against the US dollar, 12 million Chinese manufacturing jobs have been created and over 6 million American manufacturing jobs have been lost. We seem to stand by as helpless witnesses while our manufacturing sector is destroyed by a foreign government that sets goals and commits resources to build its economy. China supports its industry to a degree which is hard for us to comprehend. A five year strategic plan earmarks $1.5 TRILLION for development of seven strategic sectors. One of these is biotech.

In the case of relatively unskilled, labor-intensive industries, movement of jobs to lower cost jurisdictions over time is not unexpected and perhaps not unhealthy. What we are seeing, however, is a government-controlled, deliberate, and systematic program to move targeted industries to China. Their success has already devastated North American manufacturing and seriously eroded the prosperous middle class that our manufacturing jobs once sustained. And the evisceration is ongoing. Like most people who understand what is happening to our economy and society, I am frustrated about our lack of action. It is not my intention to comment here on Chinese government industrial subsidies, trade distortion practices, and shady conduct. These issues have been covered quite adequately by others in news stories and opinion pieces, a few of which are given at the end of this article.

Before going further, I wish to comment on the quotation by F. Ross Johnson which appears above. Johnson was a Canadian who, during the frenzied corporate mergers and takeovers of the 1980’s, ascended to the helm of the tobacco and food giant RJR Nabisco. He is not talking about China. He is summarizing the three rules of Wall Street as he knew them. In that era, insider trading and securities violations were practiced on a scale and with a sophistication that had no precedent. The corruption was so pervasive that most of the perpetrators ceased thinking of themselves as criminals. I have a colleague who from time to time reminds me that seizing opportunities to prosper at the expense of others is a ubiquitous failing within the entire human race.

That said, some Chinese companies, which may indeed be acting without government collusion of any kind, have used deceptive and unethical or illegal assaults on the business and intellectual property of Canadian and US biotech companies. I am aware of many such cases and the damage that has been done, and I could provide details that would shock many outside our industry.

I am acutely appalled that our governments are standing by while our prosperity is dismantled from abroad.

What causes me the greatest distress is that we not only let this destruction happen, we HELP it. Our well-intentioned procurement laws, for example, were designed for a level playing field. Canadian biotech companies in both the service and manufacturing sectors that bid for government or institutional contracts are not the lowest bidders and are shut out. The tragedy is that public funds, our money, is spent on services and products that very often are egregiously inferior. This is not the forum for me to provide details about how our procurement laws work against us, but let me assure you that there are many examples that could be elaborated by myself and other business owners and managers in biotech.

Another area of our naivete is the conference/trade mission abroad sponsored by one of our government programs. What is the outcome? A friend who recently returned from one of these events in China gave me the following succinct summary. “They just wanted to steal our ideas,” he said.

We are slow learners. Canadian money continues to be wasted and Canadian jobs continue to be unsupported.

For decades we have persisted in the delusion that basic principles of fair play are shared by, or will be adopted by, other countries. A foreign power which seizes unprincipled and/or illegal opportunities to protect and advance its industries can never be a trading “partner”.

Why is the obvious invisible? Are we too nice? Are we too naïve? Have we forgotten what we teach children at an early age, that organized games must have rules, and that there must be referees to enforce these rules?

This isn’t a game. Our businesses and our jobs are being ravaged.

Recent Articles: 1. China’s Not-So-Fair Trade, Forbes.com, Apr. 1, 2010.

2. China Puts U.S. Auto Industry at Risk, Manufacturing and Technology News, Feb. 7, 2012.

3. China Consolidates Grip on Rare Earths, New York Times, Sept. 15, 2011.

4. The Chinese Mean to Control the Global Gold Market, Forbes, Sept. 27, 2011.

5. Researcher Follows RSA Hacking Trail to China, Computerworld, Aug. 4, 2011.

@

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30 BIOTECHNOLOGY FOCUS MAY 2012

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Eppendorf is your source for New Brunswick products

Benchtop to Production Whether you’re growing E.coli, yeast or plant cultures, for research or cGMP production, New Brunswick Scientific bioprocessing systems are your fermentation answer.

For over 60 years, New Brunswick has led the way with robust, innovative and versatile fermentation design. And now, our BioFlo® fermentors are available to you through Eppendorf North America.

New Brunswick BioFlo Fermentors feature: Space-saving compact designs  Easy-to-use controls  Customization through multiple options  With support packages for set-up assistance and training, as well as process development, optimization and scale-up 

For more information visit www.eppendorfna.com/nbs

www.eppendorf.com • Email: info@eppendorf.com In the U.S.: Eppendorf North America, Inc. 800-645-3050 • In Canada: Eppendorf Canada Ltd. 800-263-8715

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Full page journal ad Biotechnology Focus – BFO

4/16/12 2:49 PM