Laboratory Focus August/September 2014

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Dr. Tak Mak

Tak Mak study in Cancer Cell maps decade of discovery to potential anticancer agent

The journal Cancer Cell has just published research led by Dr. Tak Mak mapping the path of discovery to developing a potential anticancer agent.

“What began with the question ‘what makes a particular aggressive form of breast cancer cells keep growing?’ turned into 10 years of

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systematic research to identify the enzyme PLK4 as a promising therapeutic target and develop a small molecule inhibitor to block it,” says Dr. Mak, director of The Campbell Family Institute for Breast Cancer Research at the Princess Margaret Cancer Centre, University Health Network and an internationally ac-

claimed immunologist renowned for his 1984 cloning of the genes encoding the human T-cell receptor.

In the lab, Dr. Mak`s scientific team used an approach that combined functional RNAi analysis with gene expression analysis in breast cancer-derived cell lines and in human breast cancers replicated in mice. Using these multidimensional data sets for human breast cancer, PLK4 was identified as a candidate target among 10,000 other targets for the development of anticancer therapeutics.

“The research showed that the aggressive form of basal breast cancer cells may be dependent on PLK4 for survival and that depleting it induced cell death,”

says Dr. Mak. “This finding led to the identification of CFI-400945, a selective and orally active inhibitor of PLK4, which was shown to have significant anti-tumour activity as a single agent in a variety of preclinical tumour models.”

Another key finding was observing the inhibitor effect on tumour models with a gene PTEN deficiency as a biomarker – of huge interest because PTEN, a tumour suppressor, is known to be defective in as many as half of all advanced solid tumour cancers.

“If clinical testing supports our hypothesis that PTEN is a predictive biomarker for CFI-40095, we will have another way to tailor personalized cancer medicine based on an individual’s genetics,” he says.

Although breast cancer was the initial focus and featured in the study that was published, the team has also conducted experiments with other types of solid tumours, with similar results. The next phase of research will involve testing in humans, which was approved last year by Health Canada and the U.S. Food and Drug Administration.

“It may take several more years to determine the benefit for patients,” says Dr. Mak, “but we are happy to be able to provide this opportunity for our patients. We remain optimistic that we may have found a novel way to treat cancer.”

The research was funded by The Princess Margaret Cancer Foundation, the Canadian Institutes of Health Research and Genome Canada.

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neWs versant ventures launches incePtion sciences Inception Science Vancouver. enterprises. incubator in montrÉal, Qc biotechnology “We have recognized a By establishing new scientific Global life science venture firm Versant Ventures continues to expand into Canada with the launch of its newest initiative, Inception Science.

Inception Science – Versant’s third type organization in Canada – aims to accelerate the commercialization of Québec’s scientific research and

attract funding for research programs along the way. It will be located in Montréal, QC. Brad Bolzon PhD, the managing director of Versant Ventures, and co-founder Peppi Prasit, are hopeful that Inception Science will encourage the translation from scientific discoveries to

real opportunity in Montréal, and across Canada, where both world-class academic research and drug discovery talent are prevalent,” said Bolzon.

Versant’s other Canadian programs include Torontobased biotechnology incubator Blueline Bioscience and

research initiatives in three Canadian life science hotspots, Versant believes it has the potential to replicate its previous American and European successes.

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news

A breakthrough for organic reactions in water Green-chemistry researchers at McGill University have discovered a way to use water as a solvent in one of the reactions most widely used to synthesize chemical products and pharmaceuticals.

Professor Chao-Jun Li and Dr. Feng Zhou of McGill’s Department of Chemistry report that they have discovered a catalytic system which for the first time allows direct metal-mediated reactions between aryl halides and carbonyl compounds in water. The findings, published in Nature Communications, mark a potential milestone in efforts to develop organic reactions in water.

For the past two decades, researchers have been exploring ways to do away with chemists’ traditional reliance on non-renewable petrochemical feed stocks and toxic solvents.

One important method has involved

replacing the toxic solvents used in metal-mediated reactions with water – something that was previously considered impossible.

While researchers at McGill and elsewhere have succeeded in using water in metal-mediated reactions between carbonyl compounds and other halides, attempts to do so for the most challenging reaction, between aryl halides and carbonyl compounds, have never worked – until now.

Li, a Canada Research chair in green chemistry and. Zhou, a postdoctoral fellow, found that rhodium -- a metal primarily used in the catalytic converters of automobiles -- as a catalyst together with zinc as a mediator can make the reaction possible in water. This new technique bypasses a number of challenges posed by conventional practices in carrying out

this reaction, which is widely used in synthesizing fine chemicals, biologically active molecules and pharmaceuticals. Traditional methods, discovered more than a century ago, require that moisture and air be carefully excluded from the process.

The new aqueous approach promises to “streamline synthetic sequences and make them safer and more efficient,” said Li.

The research was supported by the Canada Research Chairs program, the Fonds de recherche du Québec – Nature et technologies, the Natural Sciences and Engineering Research Council of Canada, and the Canada Foundation for Innovation.

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New Canadian health sciences accelerator launched at BIO 2014

Hoping to address the gap between academic discovery and commercialization by industry in Canada, a group of Canadian CECRs along with BDC Venture Capital have launched a new national hub for health science company creation.

The announcement was made at the BIO International Conference in San Diego, CA. The new entity, called the Accel-Rx Health Sciences Accelerator (Accel-Rx) will focus on maximizing new health sciences company creation, and ensuring start-ups have the resources they need to grow and become a new generation of strong health sciences companies.

In all, Accel-Rx brings together five of Canada’s leading health sciences Centres of Excellence for Commercialization and Research

(CECR) to foster cross-Canadian cooperation and to address the health science company creation challenge in Canada. They include: • The Centre for Drug Research and Development (CDRD); • MaRS Innovation (MI); • The Vancouver Prostate Centre’s Translational Research Initiative for Accelerated Discovery and Development (PC-TRIADD); • The Centre for Commercialization of Regenerative Medicine (CCRM); and, • The Centre for Probe Development and Commercialization (CPDC).

CDRD Ventures Inc. (CVI) will provide the initial management to launch Accel-Rx operations, while a proposed seed funding partnership with BDC Venture Capital would be the main funding mechanism for companies

created at Accel-Rx. Parties say the intent is to invest in up to three to four companies annually, with that number potentially increasing as the partnership progresses. Selected companies would each receive a $500,000 convertible note from BDC Venture Capital, which might also allow companies to attract similar, if not greater investments from the private sector.

“The fact is: the healthcare industry in Canada holds great promise, with over $6 billion invested in basic research annually. However, a gap exists in terms of transforming this research into commercially-viable businesses.

We believe that our collaboration with Accel-Rx will help tackle this problem,” commented Jérôme Nycz, executive vice president, subordinate financing and venture capital at BDC. To date, all BDC-backed accelerators have been primarily in the digital media and ICT sectors. This proposed partnership marks BDC’s first step in expanding their support to the health sciences sector.

Natalie Dakers, president and CEO of CVI, and the inaugural Centre director of Accel-Rx added, “Together with our network of partner CECRs across the country, Accel-Rx is now supporting the next stage in the development continuum, and acting as a robust national accelerator for new company creation.

With the new resources it brings to the table, Accel-Rx will provide Canada with a more well-informed, well-resourced, and effective approach to company creation; and ensure that opportunities arising from the country’s strong foundation of innovative

discovery research and technology development are fully capitalized upon through the launching of a critical mass of robust companies based on exceptional innovative, pre-validated (scientifically and commercially) technologies.”

“Over the last seven years, the CECR program has demonstrated its value as a pan-Canadian engine, greatly improving the commercialization prospects for biotechnology assets in this country,” said Dr. Raphael Hofstein, MI’s president and CEO. “Creating companies around these most promising early-stage technologies allows for investment and is a crucial step in advancing them to market. This collaboration between Accel-Rx and BDC Venture Capital will provide new opportunities to address seed-stage funding rounds for health sciences companies prior to Series A financings or other strategic alliances.

We at MI look forward to providing opportunities to Accel-Rx for new company creation.”

In all, Accel-Rx will deliver five key Program Pillars: Business Planning and Investment Strategy Development, Funding, Technology Development Planning, Mentorship, and Access to Infrastructure (through preferred partnerships with the five founding CECR organizations noted above).

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news Manitoba ag-bio sector gets boost from feds and province

Manitoba’s Composites Innovation Centre is receiving over $1.9 million in combined federal-provincial funding from Agriculture and Agri-Food Canada and Manitoba Agriculture, Food and Rural Development to support North America’s first agriculture fibre grading program, FibreCITY. “Biofibres are a growing and very exciting part of Manitoba’s agricultural industry. Strategic investments in the Composites Innovation Centre will ensure we will continue to be a leader in the years ahead, creating opportu-

nities for growers, processors, innovators and their customers. By working together, Manitoba will achieve its goal of a $2 billion bioproducts sector by 2020,” said Manitoba Agriculture, Food and Rural Development Minister Ron Kostyshyn.

Coupled with this funding, the Composites Innovation Centre will receive up to $715,000, provided under Agriculture Canada’s Growing Forward 2 (GF2) AgriInnovation Program, to install a unique suite of equipment specifically dedicated to the evaluation of fibre crops. In addition, funds will be used to develop the world’s first informatics system for agricultural fibre grading and establish standards for fibre and product quality. An investment of up to $1.27 million, through the GF2 costshared Growing Innovation Program, will go towards establishing a quality testing site for natural fibres used in biomaterial applications and product development projects.

“One of our main objectives is to conduct technology development and commercialization activities that link agricultural producers to consumers, generating an increased level of income and opportunities at the farm

Become a certified chemical technologist (cct) cCT certification offered by the Canadian Society for Chemical Technology (CSCT) • Is recognized nationally by employers • Is based on Canada-wide technology standards • Allows for greater career mobility CSCT members in good standing who have attained the required combination of education and experience in chemical technology need only apply once for the cCT for the one time fee of $25 plus tax. Certification remains valid as long as CSCT membership is maintained.

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gate and in rural communities,” said Sean McKay, president and CEO of the Composites Innovation Centre. “We are appreciative of Agriculture and Agri-Food Canada and the Province of Manitoba in further supporting our efforts to overcome a major barrier for the industrial adoption of natural fibres by developing methods and standards that will be used to guarantee their quality.”

Founded in 2003, the Composites Innovation Centre’s mandate is to support and stimulate economic growth through innovative research, development and industrial application of composite materials technology.

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BIOTECanada honours Gold Leaf Award winners at BIO 2014

The BIOTECanada Gold Leaf Awards were presented during a ceremony at the BIO International Convention in San Diego, CA at the Canada Place Pavilion with Saskatoon’s Agrisoma receiving the prestigious “Company of the Year” honour.

Other winners included Trillium Therapeutics Inc. (Emerging Health), Ceapro Inc. (Emerging Agriculture), Medicago Inc. (Game Changing Technology), Sanofi Group Inc. (Contribution to Canadian Communities) and David Main for Industry Leadership.

“These winning companies are symbolic of the industry broadly and the opportunity biotech innovation represents. From life saving vaccines, technologies offering lessened environmental impact, innovative medicines, and reinvigorating traditional industries, all facets of the Canadian biotech industry are represented by this year’s group of Award winners,” commented Andrew Casey, president and CEO BIOTECanada.

BIOTECanada sponsors the awards, which are nominated and judged by biotechnology industry leaders.

Headquartered in Saskatoon, Agrisoma is an agricultural company that has commercialized carinata, a non-food oilseed crop designed for sustainable production of biofuels.

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Sourcing most of its crops from southern Saskatchewan, Agrisoma sells carinata seed products under the Resonance® brand name that delivers a reliable source of renewable oil that can be used as a “drop in” feedstock for biojet and biodiesel fuel manufacturing processes.

“Agrisoma is honored to receive the Gold Leaf Award,” stated Steven Fabijanski, Agrisoma president and CEO. “Agrisoma’s Resonance® Carinata, Canada’s first non-food crop that produces oil uniquely suited for biofuel production, was used to fuel the world’s first 100 per cent renewable biojet fuel flight here in Canada.

Agrisoma has worked hard to demonstrate how our industry provides sustainable solutions as well as the role of biotechnology in securing our energy future.”

Casey added that “Agrisoma’s innovation is a fantastic demonstration of how biotechnology helps to provide the solutions needed to address the pressing challenges facing our society and environment. The vision and dedication of Agrisoma offers inspiration and promise for the economy and society more broadly.”

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August/September 2014

National genomics research and development initiative renewed Canadian Minister of State for Science and Technology Ed Holder and National Research Council of Canada (NRC) president John R. McDougall, President of the National Research Council of Canada (NRC) have announced the renewal of the Genomics Research and Development Initiative (GRDI).

The GRDI was first implemented in 1999 and is now in its sixth funding cycle. At the beginning of each funding phase, departments and agencies strategically review their research priorities and hold peer-reviewed competitions for the allocation of funds to new projects.

The renewal of the GRDI funding for another five years is a measure of the scientific successes of the initiative to date, which range from the identification of tumour-specific antibodies for use in cancer treatment to genomics-based diagnosis of invasive and damaging species such as the fungus causing sudden oak death.

The Feds are committing $99.5 million to the initiative over the next five years to continue research in agriculture, environment, fisheries, forestry, and health. Genomics is the science that studies DNA sequences and the complex interactions of genes found in living organisms.

As part of the announcement, two projects that were launched in 2012 will receive two years of additional funding: • The Quarantine and Invasive Species project aims at developing diagnostic tools based on DNA barcoding for the early detection, surveillance and management of hundreds of species, focusing on those that are of quarantine concern. (Project name: Protection of Canadian biodiversity and trade from the impacts of global change through improved ability to monitor invasive alien and quarantine species) • The Food and Water Safety project aims at developing increased speed and reduced cost of genomicsbased methods for pathogen isolation, detection and characterization.

It also intends to develop a federally integrated database to manage,

Dr. Pascal Chartrand

Roche and Montreal-based venture capital firm AmorChem L.P. have entered into a collaboration to discover novel small molecule diseasemodifying therapies for the treatment of myotonic muscular dystrophy 1, or Steinert’s disease.

Myotonic dystrophy is a progressive degenerative disease that affects an estimated 130,000 people in US, EU and Japan. There is currently no approved treatment available to slow or stop disease progression.

The collaboration will focus on the development of novel small molecules

Researchers use DNA to build tool that may shine light on cancer

Roche Pharma Research and Early Development. “The partnership with AmorChem fits well into our discovery externalization strategy, which aims to leverage external scientific excellence and experienced entrepreneurs to complement our internal portfolio of innovative drug programs.”

“We are very pleased to be working together with Roche to pursue this project. Not only is it a testament to the value of our ongoing collaboration with Dr. Chartrand and his team, but it also highlights the contributions made by our affiliate, NuChem Therapeutics,” said Inès Holzbaur, general partner at AmorChem.

Under the terms of the agreement, Roche will have the option to acquire an exclusive, worldwide license at the end of the collaboration. AmorChem may earn up to $107 million in total, based on developmental and commercial milestones, and single-digit tiered royalties.

The researchers’ nanosensor measures pH variations at the nanoscale determining how acidic (a higher pH level) or alkaline (a lower pH level) it is.

Many biomolecules such as enzymes and proteins are strongly regulated by small pH changes. These changes affect in turn biological activities such as enzyme catalysis, protein assembly, membrane function and cell death.

There is also a strong relation between cancer and pH. Cancer cells often display a lower pH compared to normal cells: the pH level inside cancer cells is higher than it is outside. “In living organisms, these small pH changes typically occur in tiny areas measuring only few hundred nanometers,” says senior author and professor, Chemistry Department of the University of Rome, Tor Vergata Francesco Ricci.

“Developing sensors or nanomachines that can measure pH changes at this scale should prove useful in the fields of in-vivo imaging, clinical diagnostics and drug-delivery.”

“DNA represents an ideal material to build sensors or nanomachines at the nanometer scale” adds co-senior author Alexis Vallée-Bélisle, a professor at the University of Montréal’s Department of Chemistry and Department of Biochemistry. “By taking advantage of a specific DNA sequences that form pH-sensitive triple helix, we have designed a versatile nanosensor that can be programmed to fluoresce only at specific pH values.”

Fluorescence is the emission of radiation, including visible light, caused by an exchange of energy.

“This programming ability represents a key feature for clinical applications –we can design a specific sensor to send a fluorescent signal only when the pH reaches a specific value which is, for example, characteristic of a specific disease,” adds first author Andrea Idili.

In the future, this recently patented nanotechnology may also find applications in the development of novel drug-delivery platforms that release chemiotherapeutic drugs only in the vicinity of tumour cells.

The research was supported by the European Research Council and the Natural Sciences and Engineering Research Council of Canada.

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store and provide access to genomic data and related information from food and waterborne pathogens, focusing on Escherichia coli and Salmonella Enteritidis.

The GRDI coordinates eight federal science departments and agencies in the field of genomics research: the National Research Council of Canada, Agriculture and Agri-Food Canada, Health Canada, Fisheries and Oceans, the Canada Food Inspection Agency, Environment Canada, Natural Resources Canada, and the Public Health Agency of Canada.

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Roche and AmorChem announce alliance focused on myotonic muscular dystrophy 1 capable of correcting the consequences of the splicing deficit caused by the myotonic dystrophy 1 gene mutation. Through this approach, some of the molecular alterations caused by the disease process may be corrected and the progression of disease may be curtailed. The enabling technology was developed by Dr. Pascal Chartrand, a principal investigator at University of Montreal, and licensed to AmorChem by Univalor, the University’s technology transfer group. Discovery will take place at AmorChem’s medicinal chemistry incubator, NuChem Therapeutics, and in Dr. Chartrand’s laboratory. Roche will provide scientific support and will contribute R&D funding together with AmorChem.

“By targeting the molecular consequences of the genetic mutation that causes myotonic dystrophy, we aim to slow down or stop the progression of this currently untreatable, chronic and slowly progressing musclewasting disease,” said Luca Santarelli, global head of neuroscience, ophthalmology and rare diseases at

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aPPointments ing cash flow until he can hire a business development officer in the next six to eight months.

Michel Perron

The Canadian Institutes of Health Research (CIHR) announces the appointment of Michel Perron to the position of vice-president, external affairs and business development. Since 1999, Perron has served as CEO of the Canadian Centre on Substance Abuse (CCSA) where he championed a national, collaborative approach to preventing and addressing the impacts of substance abuse. Among his many accomplishments, Perron spearheaded the creation of a national action plan on substance abuse and initiated the development and implementation of national strategies to address such issues as prescription drug and alcohol abuse. In addition to his role as CEO of CCSA, Perron also chaired the Vienna Non-Governmental Organization Committee on Drugs, which brings together not-forprofit organizations involved in drug policy, strategy and control, in order to advise the United Nations on international drug policy.

He is a graduate of the University of Winnipeg and of the Harvard Business School.

In an effort to help the business attract more venture capital, MRM Proteomics, a biotech spinoff from Genome B.C. and the University of Victoria, has enlisted Gary Kruppa as its new CEO. The New Jersey native joined the company July 7 and will continue working from his office in Boston. Kruppa, who has a PhD in chemical physics, said his main plan is to focus on building the customer base and increas-

Ron Dizy has been named managing director of MaRS Discovery District’s Advanced Energy Centre (AEC). The Advanced Energy Centre is a public-private partnership focused on innovative energy technologies in Ontario and Canada and fostering international market opportunities. The creation of the centre was announced by Ontario Premier Kathleen Wynne at the Canadian Energy Innovation Summit at MaRS in February. In his new role, Dizy will work closely with Paul Murphy, the former president and CEO of Ontario’s Independent Electricity System Operator (IESO) and founding chair of the centre’s advisory board.

Dizy joins MaRS after seven years leading ENBALA, where he was responsible for strategy, recruiting the executive leadership team, financing, establishing corporate direction and business development.

Prior to ENBALA, Dizy spent seven years as a Partner at Celtic House Venture Partners, where he opened its Toronto office, helped raise two venture capital funds (over $500M) and was responsible for all aspects of sourcing, selecting, negotiating and managing investments.

Zenith Epigenetics Corp. announces it has appointed Dr. Julie Cherrington as president and CEO. Her employment record includes past positions such as CEO of Pathway Therapeutics Inc., president of Phenomix Corporation, vice president, preclinical research and exploratory development SUGEN/Pharmacia/Pfizer, and director, Virology at Gilead Sciences. Notably, she was a key contributor to the successful development of multiple FDA approved products including anti-virals (Vistide™, Viread™, Hepsera™) and anti-cancer agents (SUTENT™, Palladia™). Donald J. McCaffrey, founding CEO, will assume the title of chairman and Dr. Peter Johann will act as lead director for the company.

Cipher Pharmaceuticals appoints Shawn Patrick O’Brien as its new CEO. O’Brien has spent the past 30 years in the pharmaceutical and

biotechnology sectors providing global executive leadership. He is one of the three founders of AltheRx Pharmaceuticals and served as president and CEO, where he built the business and secured funding to acquire and develop a mid-stage asset from GlaxoSmithKline Inc. Previous roles include president and CEO of Profectus BioSciences Inc., where he secured two rounds of equity financing and a major vaccine licensing deal with Wyeth, as well as president and CEO of Solstice Neurosciences, Inc., which was spun out of Elan Pharmaceuticals. At Solstice, he built a fully integrated organization of more than 150 employees and raised $125 million in private financing prior to the sale of the business.

Previously, he spent 17 years with AstraZeneca Pharmaceuticals, where he held multiple senior-level positions in Canada and the U.S., most recently as vice president of commercial operations for emerging brands.

Dr. B. Mario Pinto has been named the new president of the Natural Sciences and Engineering Research Council of Canada (NSERC), effective fall 2014. Currently, Dr. Pinto is completing his second term as vice-president, research at Simon Fraser University, where he is a professor of chemistry and also served as chair of the Department of Chemistry from 1999 until 2004. He completed his post-doctoral work at the Centre national de la recherche scienti-

Dr. b. Mario Pinto

fique in France and the National Research Council of Canada in Ottawa before joining Simon Fraser University in 1983. Considered one of Canada’s leading chemical biologists, he is a member of several organizations, including the Chemical Institute of Canada, the Royal Society of Canada, the American Chemical Society and the American Society for Microbiology.

He is also a Fellow of the Chemical Institute of Canada and the Academy of Sciences of the Royal Society of Canada. Some of his past honours include receiving the Horace S. Isbell Award of the American Chemical Society in 1992, the Merck Frosst Award of the Canadian Society for Chemistry (CSC) in 1993, the Bernard Belleau Award of the CSC in 2002, the Frontiers in Research Award of the British Columbia Innovation Council in 2005, the R.U. Lemieux Award of the CSC in 2012, the Alfred Bader Award of the CSC in 2013 and the Montréal Medal of the Chemical Institute of Canada in 2014.

Anie Perrault has been named the new executive manager of BIOQuébec, effective immediately.

Perrault comes to BIOQuébec with more than 20 years of professional experience in both the public and private sectors. A member of several boards notably, that of Loto-Québec, Perrault is currently City Councellor for the City of Bromont and serves on the research and ethics committee for Génome Québec. She held the position of vice president of communications at Génome Canada from 2001 to 2006 and prior to this, she was national communications director for Canada’s Research-Based Pharmaceutical Companies (Rx&D). In addition to these past roles, she has solid knowledge of the political and media environment, having acted as consultant to several federal elected officials over the course of her career, among them, Joe Clark.

Anie earned the designation of Administrateur de sociétés certifié (ASC) from Collège des administrateurs de sociétés de l’Université Laval. She completed her legal training at the École du Barreau du Québec in 1993 after having obtained her Bachelor of Civil Law from the University of Ottawa.

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Laboratory Focus August/September 2014

Pharma notes OncoGenex Pharmaceuticals, Inc. (Vancouver, BC) says that its Cedar™ clinical trial, an investigatorsponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer is now open for enrollment. Apatorsen is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells’ defenses and overcome treatment resistance. Approximately 140 patients with previously untreated stage IV or recurrent squamous cell lung cancers or stage IIIB squamous cell cancers that are not amenable to radiochemotherapy will be randomized to receive either apatorsen plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone.

The primary objective of the study is progression-free survival (PFS), with secondary objectives to evaluate tumour response rates, overall survival, safety, tolerability and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on Hsp27 levels and to explore potential biomarkers that may help predict response to treatment.

Biosign Technologies Inc. (Thornhill, ON) has completed its acquisition of 51 per cent of issued and outstanding shares of Meck Medical GmbH (MECK). In connection with the acquisition, the company has agreed to provide MECK a loan to fund its operations of up to 100,000 Euros per month to a maximum of 2.4 million Euros in the aggregate.

Specialty pharmaceutical company Medicure Inc. (Winnipeg, MB) through its newly formed subsidiary, Medicure U.S.A. Inc. has acquired a minority interest in pharmaceutical manufacturing business Apicore (Somerset, NJ). In all, Medicure and Medicure USA have acquired a 6.09 per cent equity interest (5.33 per

cent on a fully-diluted basis) in two newly formed holding companies of which Apicore LLC and Apicore US LLC will be wholly owned operating subsidiaries. Medicure has also received an option to acquire all of the remaining issued shares of Apicore LLC and the holding company of Apicore US LLC, within the next three years.

Eventi Capital Partners, a Toronto-based growth capital investment firm specializing in high growth technologies in the IT and healthcare sectors, has sold Visualase Inc. (Houston,TX) to Medtronic Inc. in a deal valuing the company at approximately US$105 million. Visualase develops and sells a laser system for minimally invasive neurosurgery. The Visualase technology has been used to treat more than 800 neurosurgical patients.

Eventi Capital Partners made its initial investment in Visualase in February 2009 with a follow-on round of financing made in May 2012. The all-cash transaction of up to US$105 million includes an initial payment of US$70 million to Visualase’s shareholders plus the potential for an additional US$35 million in incremental revenue-based earn out payments. Leerink Partners LLC served as financial advisor and Miller, Egan, Molter & Nelson LLP served as legal advisor in the transaction.

Privately owned Canadian pharmaceutical services provider Dalton Pharma Services (Toronto, ON) has entered into a manufacturing services agreement with GLyPharma Therapeutics Inc., a Montréal-based company developing clinical therapies for chemotherapyinduced intestinal mucositis. Under the terms of the service agreement Dalton Pharma Services will provide aseptic fill/finish services and analytical support under cGMP for FE 203799, a long-acting GLP-2 receptor agonist under development

by GLyPharma as a therapy for supportive care in oncology for patients receiving chemotherapy.

Laval-based KLOX Technologies has struck a license and joint venture agreement deal with dermatology company LEO Pharma to further develop and commercialize KLOX’s BioPhotonic technology platform in dermatology, which includes the LumiCleanse System.

The worldwide license and joint venture agreement, excludes Canada where KLOX’s solution is commercialized

by Sandoz Canada. Additionally, as part of the agreement LEO Pharma says it will also make an equity investment in KLOX. Toronto, ON-based Lorus Therapeutics says the FDA has completed its review and cleared the company’s

investigational-new-drug application of LOR-253 for the treatment of hematologic malignancies, including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Clearance of the IND allows Lorus to initiate a Phase 1b, multicenter, open-label, clinical study of LOR-253 in patients with relapsed or refractory hematologic malignancies.

The Phase 1b trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamic responses and efficacy of LOR-253 as a single agent.

The trial is expected to enroll 45-to-60 patients as part of a dose-escalation program and two separate disease-specific single-agent expansion cohorts. Lorus believes that LOR-253 may represent a targeted therapeutic solution for a very difficult-to-treat cancer. It works by inducing the KLF4 gene, which has been reported as a key transforming event in AML and high-risk MDS. Amorfix Life Sciences (Mississauga, ON) has been issued a broad patent covering antibodies that target misfolded SOD1 (mSOD1) for the treatment of ALS. The patent has issued as US 8,778,885. SOD1 is a protein which is highly expressed in the motor nerve cells which degenerate in ALS. While normally a protector of cells, under certain conditions it can “misfold” – its

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three-dimensional structure becomes distorted – and it then becomes toxic for cells, as well as triggering propagated misfolding of normal SOD1. This mechanism of disease onset and progression scould support mSOD1 as a target for the development of therapeutics for the treatment of ALS. ProMetic Life Sciences Inc. (Laval, QC) reports that it has successfully completed its PBI-4050 Phase 1 clinical trial in 40 healthy volunteers and that PBI-4050 was found to be safe and very well tolerated without any serious adverse events reported in any of the five cohorts tested. The objectives of the oral, double blind, placebo controlled, single ascending dose study were to demonstrate the safety and tolerability of PBI-4050 and to establish the pharmacokinetic profile of the drug candidate at different doses. The study design also included a component looking at food effect on drug absorption.

The trial was conducted in five cohorts of eight subjects.

In each cohort, six subjects received PBI-4050 and two subjects received matching placebo. ProMetic added that PBI-4050 is now set to move into clinical development in diabetic patients with kidney diseases, as well as other orphan medical conditions where diabetes and/or fibrosis is affecting key organs such as liver, kidney, heart and lungs.

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August/September 2014 Laboratory Focus www.laboratoryfocus.ca

Feature

Caring for Canada’s Most Vulnerable Citizens through a National Plan for

Rare

Disorders B y: B y Durha ne W ong - Rieger a nd Christine Beya ert

E

very year, hundreds of Canadians with severe or lifethreatening disorders do not get access to the medicines they need. What do these patients have in common? They all have rare disorders. It’s almost unbelievable but true. With a public health system that is the envy of much of the world, Canada sadly lags behind almost all other developed nations, including the U.S., the EU, Japan and Australia, in our care and treatment for rare disorders. We’ve made progress over the past few years but it’s time for Canada to stop making excuses and bring in a comprehensive plan that will give Canadians with rare disorders the same treatment as those with common ones.

A rare disorder is defined as a disorder that affects less than one in 2,000 Canadians. Many are severe, progressive, and/or life threatening conditions, with high mortality rates and devastating impacts on patients, families and society. Although individually rare, collectively, they affect one in 12 persons or 2.8 million Canadians. There are no effective treatments for many of these disorders.

However, for many others, if infants or children are diagnosed and treated early enough, they can avoid physical disability or cognitive delays and live nearly normal lives.

Rare disorders present unique public health challenges. Few physicians are familiar with diagnosing and treating these conditions, which means most patients are undiagnosed, misdiagnosed, or delayed in

diagnosis, so they do not get timely access to treatments even when therapies exist.

There are relatively few therapeutic options - between 7,000 and 8,000 rare disorders have been identified, but there are only 400 effective drug treatments. This situation is expected to change dramatically with hundreds of new therapies in development and coming to market over the next decade. But without change in our rare disease environment, many of these therapies will not be accessible for Canadian patients.

Currently, Canadians tend not to be included in clinical trials and companies are reluctant to bring their drugs to Canada. Approximately half of the rare disease drugs available to patients in the U.S. or Europe have been approved in Canada and only half of these are funded through public drug plans.

Currently, Canada’s regulatory and reimbursement systems present significant challenges to researchers and developers of drugs for rare diseases, also known as orphan drugs.

On the federal regulatory side, the review process is about to change.

In October 2012, Health Canada announced their intention to implement an Orphan Drug Regulatory Framework, a review process for orphan drugs that is similar to those of the U.S. and the European Union. Health Canada has indicated that this framework will include tools to improve the quality of knowledge used by provincial and territorial decision-makers and healthcare

professionals, provide the opportunity for patient input, encourage transparency and sharing information, and support international collaboration. By harmonizing Canada’s orphan drug regulatory process with those of the U.S. and the EU, companies will be able to set up clinical trials and to apply to Canada for market approval at about the same time as they do in these other jurisdictions, ultimately reducing delays and increasing the number of new drugs available to Canadians with rare diseases.

Unfortunately, a federal regulatory framework will not assure equal access across all provinces. Under Canada’s federated model, screening, diagnosis, care and treatment are the responsibility of individual provinces. With an aging population, there is an inevitable increase in both incidence and prevalence of chronic disease, which translates into greater demand for healthcare and greater use of medications. Provinces challenged by healthcare costs that are increasing, on average by seven percent each year, and drug costs that are proportionately rising even faster, have placed more controls on drug prices and restricted access to new drugs.

To those ends, all provinces (except Quebec) have agreed to collaborate on a Common Drug Review (CDR) to assess the comparative effectiveness and cost-effectiveness of new drugs and the pan-Canadian Oncology Drug Review (pCODR) for oncology drugs. Both will soon by operated under one umbrella, the Canadian Agency for Drugs and Technologies in Health (CADTH). Their mandate is to make recommendations to the public drug plans on which drugs to reimburse, under what conditions and, often, at what price. Intended to reduce duplication and improve consistency across formulary listings, the common evaluation methods used by the processes have disadvantaged certain types of drugs resulting in more negative recommendations. These include drugs for small patient

populations, first-in-class drugs without comparators, early-market entry drugs for severe or life-threatening conditions, or drugs that primarily impact quality of life, such as pain management or psychological conditions. What is needed is an orphan drug access framework designed specifically to provide access to drugs for unmet needs as soon as they are approved by Health Canada. Known as managed access schemes, risk-sharing schemes, or evidence building schemes, they provide appropriate patients reimbursed access to drugs with a monitoring plan that accumulates evidence of safety, effectiveness, and cost-effectiveness over time.

Such schemes are already being used in Canada and most other countries, and are much more appropriate to rare disease drugs than the CDR or pCODR. A new step in the process is the pan-Canadian Pricing Alliance (PCPA), which negotiates a single price and listing conditions for a new drug, on behalf of all participating provinces. The final decision about reimbursement, however, is still made by each provincial or territorial government, ostensibly on the basis of budget impact and other factors. Because the latter two steps are not transparent – the basis for the negotiated price and the reimbursement decision are not publicly available – it is not clear how different jurisdictions arrive at their respective decisions. It remains to be seen whether the PCPA will reduce delays and improve consistency of access to rare disease drugs.

Finally, many drugs for rare diseases fall outside of the established regulatory and reimbursement pathways, so patient access is evaluated on a case-by-case basis. These include

www.laboratoryfocus.ca drugs that are not approved in Canada, are used off-label for a rare condition, or are not listed on the drug formulary. Access may be requested through Health Canada’s Special Access Programme only for the named patient and the patient may additionally need to apply to the provincial compassionate or exceptional access programme.

These processes are inefficient, costly and time-consuming, for both the patient and the health care system.

Designed for urgent, one-off situations, they are not viable mechanisms to ensure Canadians with rare disorders have sustainable access to appropriate therapy in a monitored and timely fashion.

As importantly, getting drug reimbursement and access right for rare diseases will have big payoffs as we move into the era of personalized medicine for more common conditions. Our knowledge about genetic bases for individual differences in large population disorders such as breast or prostate cancer, diabetes, circulatory conditions, and psychiatric disorders such as schizophrenia will result in identification of subgroups defined by genotype. What we are learning and pioneering in drug development and access for rare diseases will someday benefit all patients.

Over the past few years, Canada has made remarkable progress in the care and treatment of patients with rare diseases but, frankly, we still lag far behind most developed countries. The implementation of the Orphan Drug Regulatory Framework will have significant impact, but it still lacks some of the provisions that will ensure pharmaceutical and biotech companies bring research and clinical trials to Canada, including a period of market exclusivity for innovative drugs and tax incentives.

Moreover, in order to realize the benefits of a regulatory framework, we need to follow the lead of the 27 EU countries in bringing in a national plan for rare diseases.

The Canadian Organization for Rare Disorders (CORD) in collaboration with the Canadian Institutes for Health Research, Genome Canada, BIOTECanada, and Rx&D are developing the framework for a Canadian Strategy for

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Laboratory Focus August/September 2014

Rare Diseases that will address the definition of rare diseases, research, diagnosis, care and support, and access to treatment. This strategy allows us to consider rare disorders in the context of a broader public health approach and builds upon existing infrastructure, expertise, and programmes.

Although Canada has come late to the game, there is an opportunity for us build on existing international experience and knowledge.

Canadians with rare diseases have a right to the same health care as those with more common conditions. A Canadian strategy for rare diseases will help

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Durhane Wong-Rieger is President and CEO, Canadian Organization for Rare Disorders. Christine Beyaert is Manager, Corporate Communications, Ontario Genomics Institute.

feature To see this story online visit http://biotechnologyfocus.ca/ caring-for-canadasmost-vulnerablecitizens-through-anational-plan-for-raredisorders/

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August/September 2014 Laboratory Focus www.laboratoryfocus.ca

feature

Rethinking

Liquid Chromatography by fraser mcleod themes that boiled down to three main categories: • Performance (more resolution, sensitivity) • Productivity (more throughput, ruggedness, sample capacity) • Usability (easier and less method development, familiar software, simpler operation)

L

iquid chromatography is one of the most competitive categories in the scientific instrument industry, with the major players continually increasing pressures, adjusting flow rates and generally waging a never-ending battle of specifications. How do you go beyond making incremental improvements to deliver a new kind of value for research laboratories?

Our existing UHPLC product family has a very loyal customer base, but another set of customers have indicated their desire to take chromatography to the next level. Here’s how we set out to meet their needs.

We asked our R&D, marketing, manufacturing and executive teams how we could create a new generation of UHPLC, but the answer didn’t come easily. Actually, the answer didn’t come from within the company at all, it came from the greater community of chromatography users. We asked a large number of customers, basically, what they would want to see in a new UHPLC system.

As you might imagine, there were plenty of differing responses, but there were also some recurring

Following much debate, we realized that an upgrade to an existing platform would not deliver the additional value that customers were looking for, nor the competitive edge that we sought. We decided to take the big step of creating a completely new UHPLC platform from scratch, based on current and future customer needs rather than evolution.

This gave us the opportunity to actually begin by developing new column technology and then designing the rest of the platform around it. This way they complement each other with additional performance.

It’s like beginning with a set of high performance tires and designing a sports car around them so they all work in harmony.

We knew that the new system would need to work at very high pressure to deliver the performance we sought, and we developed Thermo Scientific Accucore Vanquish UHPLC columns for 1500 bar (22,000 psi), the maximum pressure rating for the new Thermo Scientific Vanquish UHPLC system. The new columns feature 1.5 µm solid core particles utilizing Core Enhanced Technology to take full advantage of this pressure

at a flow rate of 5mL/min. for ultrashort diffusion path lengths and high resolving power.

High pressures tend to be tough on hardware, but since we had the luxury of designing the system from scratch, we were able to mitigate wear and tear. The clean, monolithic design of the Vanquish system features very short, strong connections between the modules, contributing to the platform’s exceptional ruggedness. Because the modules easily slide in and out, the Vanquish system combines the flexibility and ease of maintenance of a modular system with the ruggedness of an integrated one. Eliminating accidental void volumes and dispersion effects contribute to this performance and ruggedness, as do unique zero-dead-volume Viper fingertight fittings.

We were also able to include hard carbon-coated ceramic injection valve and pump pistons, designed for very consistent performance for 200,000 injections between the need for maintenance. After this interval, they can be easily swapped out, further enhancing productivity and uptime.

The column compartment can be positioned on either the right hand or left hand side of the Vanquish system, to keep the flow-path short regardless of how the benchtop workflow is set up. Because we were starting from with a clean slate and a clear focus on what we wanted this system to achieve, the list of features that enhance performance, productivity and ease-of-use is long.

“Form follows function” is a very

basic but comprehensive principle in architecture and design. We kept this in mind from the beginning when we started to discuss our new generation UHPLC. The result is the completely new industrial design of the Vanquish system providing new levels of performance, productivity and usability without compromising flexibility. One obvious example how design supports functionality are the doors: they open widely to allow excellent access for setting up fluidic connections, but when closed there is a clean appearance. Rather than simple LED indicators, we use LED bars that efficiently display the relevant information on instrument status. The lean design concept is also applied to details like a drawer for consumables and drawer-accessible Vanquish modules to make maintenance easy to perform.

Many people consider liquid chromatography a fairly mature technology. We believe that, with the right approach, substantial advances are not only possible, but achievable. We offer the new Vanquish system as proof.

Fraser McLeod is Vice President and General Manager, HPLC, with Thermo Fisher Scientific

To see this story online visit http://www. laboratoryfocus. ca/?p=2518

www.laboratoryfocus.ca

11

Laboratory Focus August/September 2014

feature

Measuring Safety Performance b y : g e n e m a ri e s he m at e k

M

ost laboratories expect that work will be performed safely and that all proper precautions are taken to ensure all aspects of the work – accuracy, efficiency, safety – are considered and all standards are met. While many laboratories monitor and measure accuracy (errors) and efficiency (tests conducted over time), not many laboratories monitor or measure safety. The old adage “what gets measured gets done” is often borne out in laboratories, where worker safety may take a backseat to productivity. So, how is worker safety measured in a laboratory?

There are two major categories of health and safety performance metrics. The most commonly used measures are “lagging indicators.” This means that they are “after-the-fact” and represent data related to adverse effects that have already occurred.

Examples of lagging indicators are: • Number of time loss accidents • Types of injuries that occur • Cost of time loss accidents • Number of days absent due to injury/illness • Number of incidents that required medical aid, but did not include time loss • Number of fires, spills or other safety emergencies • Number of exposures to chemicals or biological hazards While we can learn something about the types and frequency of injuries from this data, we do not often identify what needs to be done to prevent the incidents.

“Leading indicators” are measures of activities done to prevent incidents from occurring. Leading indicators are often considered “proactive” measures of safety performance. Examples of leading indicators are: • Per cent of laboratory inspections conducted as per schedule • Per cent of hazards identified in in-

in the Laboratory

spections that have been corrected • Per cent of tasks on which a formal risk assessment has been conducted • Per cent of scheduled health and safety committee meetings that occurred • Per cent of incidents that were properly investigated to find and correct root causes • Per cent of required emergency response drills conducted • Per cent of workers using proper personal protective equipment • Per cent of newly hired workers who received orientation within the first week of work • Per cent of workers who attended refresher training Laboratories often develop a false sense of security because they do not have many time loss incidents. Workers compensation costs are often low, and property damage from worker incidents is captured as “equipment breakdown” and not associated with the incident.

Does this mean laboratories are safe places to work? Not necessarily.

Many laboratory workers have had “close calls” or “near misses” or have witnessed them. Under slightly different circumstances, these close calls may result in serious injuries. Chemical or biological exposures may go unnoticed if there are no acute effects. Musculoskeletal injuries are often attributed to factors outside the work environment.

To ensure that the laboratory is on a continual improvement path, performance measures should focus on leading indicators (in addition to proving data related to lagging indicators). This helps promote the important safety activities that should be carried out in the laboratory and allows the lab to track trends and identify weak areas.

When we identify leading indicators as a percentage of activities that should occur (such as the per cent of required laboratory inspections con-

ducted), we are comparing the actual occurrences with a desired or established standard. For example, if a laboratory requires monthly lab inspections, and they are conducted nine times in one year, that means that they have a 75 per cent compliance rate with the standard. If this improves each year, the trend can be tracked. On the other hand, if one of these activities starts to be neglected, that is picked up as a negative trend.

One of the most effective ways to measure health and safety is to involve all lab workers in the process.

While labs commonly post information related to quality control issues, lab errors, and workload statistics, most laboratories do not have posted laboratory safety metrics. Make laboratory workers more aware of safety standards and enlist their help in tracking performance. Consider placing progress charts of health and safety activity measures on the bulletin boards and having employees fill them in. Set and publicize goals relat-

ed to health and safety performance.

The key to continual improvement in health and safety lies in awareness of prevention activities and documentation of their performance.

Keep in mind that old adage “what gets measured gets done.”

About the Author: Gene Marie Shematek, MSc, CIH, ROH is a safety advisor to the Canadian Society for Medical Laboratory Science.

This article first appeared in the Canadian Journal of Medical Laboratory Science and was reprinted with their permission.

To see this story online visit http://www. laboratoryfocus. ca/?p=2522

12

August/September 2014 Laboratory Focus www.laboratoryfocus.ca

Feature

By Jeffrey A. Duchemin

Laboratory Equipment: Making Decisions About What to Purchase and Why The task of buying equipment for a modern laboratory requires innovative, original thinking on a number of fronts.

I

n today’s fast-changing working environment within the life sciences, it is vital that you, as the manager of the laboratory, establish answers to several important questions. These questions include: What kind of equipment can I afford?

What specific equipment will be useful? And what should I look for in an equipment seller? Just as best practices in the lab are constantly evolving, so are the answers to these questions.

As the CEO of a life science supply company that is attuned to the 21st century marketplace, I have some insights to share that might help with these decisions.

To begin with, if your lab depends on funding from the National Institutes of Health, the National Research Council of Canada, The Canadian Institutes of Health Research or some other funding body, you are already aware that the question of

what equipment you can afford can change as funding levels vary considerably from year to year. Although it is hard not to be pleased with the $1 billion increase that was built for example into the 2014 NIH budget, it is also not clear what lies ahead for biomedical research enterprises in the coming years. Of course I do not know your individual funding situation, but generally speaking, it is critical to keep abreast of funding bodies budget negotiations and study the final budget to evaluate your purchasing options.

On a related note, a recent study conducted by Frost & Sullivan on behalf of the Laboratory Products Association (LPA) asked researchers to identify the most important factors involved in choosing new lab instrumentation. Respondents uniformly chose four items: lower purchase costs, lower operating costs, increased accuracy and easier-to-oper-

ate capabilities. Such considerations are likely to grow in importance in the next few years; according to the LPA study, overall growth in the lab product market is expected to grow 2.1 per cent in 2014 to $39.4 billion and 2.7 per cent in 2015 to $40.5 billion. The U.S. lab product market is expected to grow 1.3 per cent in 2014 to $15.2 billion and 2.6 per cent in 2015 to $15.6 billion.

Turning to specific purchasing decisions, your individual needs will of course vary; but certain trends are clear today in 2014. Products particularly in demand in the modern lab these days include devices for protein electrophoresis and nucleic acid electroporation, and electroporation. Another area of in-demand equipment is spectrophotometers.

The rise of Big Data within the life sciences is influencing equipment purchases as well. Specifically, I am seeing a general uptick in interest in

DNA/RNA separation equipment, as well as equipment designed to facilitate cell-based therapeutics. There is a growing sentiment that treating patients with cells might one day become as common as it is now to treat the sick with drugs made from engineered proteins, antibodies or smaller chemicals, and I believe that purchasing decisions will evolve in the coming years to mirror these endeavors.

Aside from questions of what equipment to buy, there is a separate trend influencing lab purchases in 2014: more than ever, lab buyers are learning that the particular companies with whom they do business matters a great deal. In the U.S., the vast majority of life science products that researchers receive come from a very small roster of manufacturers. As a result, these customers might not be getting the best value possible in terms of service, prices and information. In the future, I believe customers

www.laboratoryfocus.ca

13

Laboratory Focus August/September 2014

feature

t:

will not only be seeking to purchase products alone; they will be looking for greater value in terms of more personal customer service and guidance.

In turn, equipment manufacturers should aim to help each and every one of their customers to become more efficient in their work and fulfill their specific objectives. Customers are not merely looking for a box to show up on their doorstep with the products they have ordered; they expect to receive a more personalized level of support.

The customer wants to see reasonable prices and good value; good suppliers have always provided these, but great suppliers go beyond this.

The best companies don’t just offer good products at competitive prices but also offer support to their customers before, during and after the purchase.

Going forward, value and price will

remain important in equipment purchasing decisions, but the ability to provide client-on-demand consultation, specific advice based on clients’ need to boost productivity, and personalized support, will reign supreme. The best suppliers will employ salespeople who have specific knowledge of the features and benefits of the products they sell, and who are willing to visit your lab to demonstrate its operation. It is definitely worth inquiring whether a supplier offers this level of service prior to making a purchasing decision.

Likewise, the skill levels of the clinical diagnosticians using the lab equipment should be given some serious thought before making a significant purchase. Will the end-users require additional training on how to properly operate the equipment or how to optimize results, and is training provided online or offline and at what cost? Will the end-users

have unlimited access to online usage, maintenance and vendor performance reports and will those reports be provided at no cost?

An additional consideration if one purchases new equipment is whether to buy a service contract. A service contract can include many services beyond a general warranty, such as software updates, calibration, certification, preventative maintenance, priority service and/or additional discounts on upgrades. Service contracts can be costly, and one can either discuss options with colleagues or make one’s own informed decision.

In the end, your due diligence regarding the above criteria will help determine what considerations coincide with how to best serve a laboratory. It is important to choose wisely when making such a significant purchase; do not rush things. The final purchase will ultimately come down to the right piece of lab equipment

that meets the majority of your wish list needs and is the most beneficial to everyone involved. The perfect solution for purchasing lab equipment for a lab is out there; one just needs to do the necessary homework to find it.

Jeffrey A. Duchemin is Chief Executive Officer of Harvard Bioscience, a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science.

To see this story online visit http://www. laboratoryfocus. ca/?p=2524

14

August/September 2014 Laboratory Focus www.laboratoryfocus.ca

neW Products Automated Sample Storage Systems Compact, high-density automated systems designed to fit into existing laboratories that require ultra-low-temperature storage of sensitive biological samples. These systems ensure the viability of 100,000 to over one million long-term samples. The BiOS M and L are ideal for forensic applications, and mediumsized research and clinical repositories. Samples are held in labware that is both tracked and picked automatically without human intervention, thus avoiding the risk of inadvertent warming and degraded sample integrity. The original BiOS and largest system, BiOS XL, is designed for very large biological sample collections, such as large clinical biorepositories and population-based biobanks, and holds 250,000 to more than 10 million samples. All samples within BiOS systems are stored in -80° C chest freezer compartments to maintain temperature stability. All internal workflows, including sample picking, are optimized to keep samples at ultra-low temperatures at all times. System parts are easily accessible for service and maintenance, while 1-D and 2-D barcode reading and sample tracking provide complete chain-of-custody documentation, with software tools to support 21 CFR Part 11 compliance. Multiple backup systems ensure that samples stay at -80° C even in emergencies. BiOS systems can store and process multiple labware types, and they integrate with Hamilton liquid handling robotics for additional tracking and hands-free, high-throughput sample preparation.

System for Advanced Protein Structure Analysis Malvern Instruments Zetasizer Helix combines dynamic light scattering and Raman spectroscopy for advanced protein structure analysis. It is a tool for early stage biopharmaceutical development that enables the detailed study of mechanisms of protein aggregation. This system combines Zetasizer dynamic light scattering (DLS) technology, for sizing of proteins and other biomolecules, with Raman spectroscopy. The combination of DLS and Raman spectroscopy allows measurement of protein size and structure from a single small volume sample, providing unique insight into protein folding, unfolding, aggregation, agglomeration and oligomerization.

Raman spectroscopy delivers information on protein unfolding by monitoring the variations in molecular vibrations that result from changes in secondary and tertiary protein structure. The combination of dynamic light scattering with Raman spectroscopy characterizes a wealth of chemical, structural, and physical parameters of biotherapeutic proteins under formulation conditions - at high concentrations up to 100 mg/ml and using a wide range of buffers and excipients.

web: www.malvern.com

Sample Handling Seward Ltd has expanded its range of Simplette(r) pipetting straws to fit a variety of variable-volume pipette handsets. Disposable Simplettes are designed specifically to transfer prepared samples from the bottom of a Stomacher(r) bag without risk of cross contamination. Available with an internal diameter of 3.6-3.7mm, as well as 4.1-4.2mm, Simplette straws will fit pipette handsets from a number of companies, including Barky and Socorex. Pipetting volumes of between 0.1 to 2 mL, Simplettes are also available in both 170 and 250mm lengths. Irradiated sterile, Simplettes are available in quantities, either in bulk boxes of 1000 and 2000, or in sachets of 25 or 50. The narrower gauge Simplettes are available as well.

www.seward.co.uk

Plate Reader The DynaPro Plate Reader II is capable of running high-throughput, automated HTS-DLS analyses to characterize PPI in standard microwell plates, under multiple conditions in reduced time frame.

The onset points of aggregation or melting may be obtained in the DynaPro via temperature ramps or chemical denaturing, to assess additional SIPs for conformational stability, making the DynaPro DLS plate reader the tool for developability and formulation screening.

Techniques for determining protein stability are debated amongst researchers, and a combination of stability-indicating parameters must be weighed to get a complete picture, explains Dr. Daniel Some, Director of Marketing and Principal Scientist at Wyatt Technology, Optimization of screening processes to reduce time and resources spent on ensuring long-term viability is a key consideration in the drug development process. The DynaPro Plate Reader II ensures comprehensive testing, over a range of conditions in minimal time, and eliminates the need for additional laboratory apparatus when screening the stability-indicating parameters of high concentration protein formulations.

web: www.wyatt.com

HPLC Columns Waters Corporation has expanded its family of CORTECS Columns with the 2.7 micron silica-based, solid-core particle columns. The new set of columns is an addition to the Waters CORTECS family of columns. Designed for analytical scientists who need to maximize performance on their existing LC systems, CORTECS 2.7 micron Columns run at lower pressures while delivering high efficiencies. This gives the scientist the flexibility to use longer column lengths to improve resolution or higher flow rates to speed instrument analysis times and increase throughput. CORTECS 2.7 micron Columns are scalable to CORTECS 1.6 micron Columns. CORTECS C18+ columns deliver peak shapes for basic compounds and impart selectivity while being a formic acid-friendly option for LC/MS applications.

CORTECS C18 Columns are RP columns offering balanced retention of acids, bases, and neutrals at low and mid-range pH. CORTECS HILIC Columns are designed for the retention of extremely polar analytes utilizing hydrophilic interaction chromatography (HILIC).

web: www.waters.com

RTD Sensor Omega introduces its new PR-21 series of RTD sensors with M12 connector which features an all welded 316L stainless steel housing, an integral 4-pin M12 connector for easy connection, a fast response time and a temperature range of -50 to 250 degrees Celsius. The PR-21 series is ideal for process control and test and measurement applications. These sensors can be used in any 2, 3 or 4-wire application by selecting one of the two available wiring arrangements and using only those wires needed for your connection. This allows for simplified, trouble free installation with any existing application. This also allows the PR-21 series sensor to be used for a wide variety of replacement applications since it can be connected as-is with just about any measurement or control equipment available when combined with a 4-pin female M12 connector extension or patch cable.

web: www.omega.com

www.laboratoryfocus.ca

Laboratory Focus August/September 2014

Columns Tosoh Bioscience introduces its new line of MiniChrom Columns for TOYOPEARL® and TSKgel® resins. Designed as 8 mm ID × 10 cm (5 mL) columns for optimal resin screening, MiniChrom Columns ensure consistent experimental results when it comes to method optimization, parameter screening and/or small scale purifications. These preparative resins can be used for sample analysis as well as purifying proteins and nucleic acids for medical purposes.

Web: www.tosohbioscience.com

Sequencing Kits The NEXTflex Cell Free DNA-Seq Kit is the newest product from BIOO Scientific, and is optimized for library prep solution for ctDNA and cfDNA. The technology allows NGS library construction from circulating tumour DNA (ctDNA) cell free fetal DNA (cffDNA) isolated from cell free fluids. Delivering high coverage quality and reduced bias, the Illumina-compatible libraries can be created quickly and painlessly: it only requires one ng of DNA – the lowest amount yet – and construction occurs in under two hours, with flexible multiplexing options. The kit is equipped with enhanced adapter ligation technology, which offers improved ligation efficiency, resulting in library preps with a larger number of unique sequencing reads.

The SEQBOT™ NGS Library Prep Automation Platform, the Beckman Biomek® Laboratory Automation Workstations and the Sciclone NGS Workstation also include automated protocols to optimize the kit’s safe and efficient usage.

Web: www.biooscientific.com

Spectroscopy Good news for all those seeking a smaller and more simplistic approach to Raman Spectroscopy – the new NRS-4100 Series Laser Raman Spectrometer from JASCO delivers the same performance and features as its larger counterparts – and then some.

The spectrometer measures just 24” tall, 22” wide and 24” , and weighs in at only 120 lbs. Delivering all the brains without the bulk, the system comes with a three-laser system at 457nm, 532nm and 785nmm and a spectrograph resolution down to 0.7cm-1/pixel. These three internally mounted lasers deliver up to nine different wavelengths (405 to 1064mm) with the standard measurement range being between 8000 to 50 cm-1 (532nm laser with edge filter). The spectrometer features two imaging-lenses with high and low power objectives for better quality imaging of the laser spot on the sample, and the Raman light path can be auto-aligned when switching between lasers. The options for manual and automated X-Y-Z stages, with temperature control stages for high temperature measurement, provide the icing atop the proverbial cake. These features – and JASCO’s highest resolution CMOS observation camera – make the NRS4100 ideal for work in R&D, forensics and QC.

Web: www.jascoinc.com

New Products Fluid Extractor Supercritical Fluid Technologies (SFT) has just released its latest product in its top supercritical fluid extractor (SFE) line, the SFT-110XW. The extractor comes with a restrictor valve, redesigned for more precise flow control, as well as a completely removable oven lid and side panel for access to the high pressure vessel(s). It’s applications include process development, food, flavours and fragrance extraction, chemical and polymer synthesis, and natural product extraction. The SFT-110XW features a variety of precautionary features to avoid misuse or damage, such as an indicator light on the pump module to guide the users through operation of the Peltier pre-cooler and a robust outlet to prevent damage to the outlet tube. With process parameters developed in the laboratory, dual sapphire syringe pump technology, integrated pre-heaters, and precise flow control, the SFT-110XW provides the control of temperature, pressure, and flow rate necessary for both research and process development applications.

Web: www.supercriticalfluids.com

Company & Advertiser Index COMPANY

Page

Website

Air Science....................................... 16.......................... www.airscience.com Amorfix Life Sciences.......................... 5............................... www.amorfix.com Biosign Technologies Inc...................... 5................................www.biosign.com BIOQuebec......................................... 6.......................www.bioquebec.com/en BIOTECanada...................................... 4..................................www.biotech.ca Caledon Labs.................................... 5......................www.caledonlabs.com Canadian Institutes of Health Research.6...........www.cihr-irsc.gc.ca/e/193.html Ceapro Inc......................................... 4................................www.ceapro.com Centre for Commercialization.......................................................................... of Regenerative Medicine.................... 3.....................................www.ccrm.ca Centre for Drug Research and........................................................................

Development...................................... 3......................................www.cdrd.ca Chemical Institute of Canada............. 4....................... www.cheminst.ca/cct Children’s Miracle Network............ 17... www.childrensmiraclenetwork.ca Dalton Pharma Services...................... 5.................................www.dalton.com Denville Scientific............................... 16................. www.denvillescientific.com Eppendorf........................................ 20............ www.eppendorf.ca/nexusX2 Harvard Apparatus............................ 16...............www.harvardapparatus.com Lorus Therapeutics............................. 5...........................www.lorusthera.com Mandel............................................. 9................................www.mandel.ca MaRS Innovation................................ 3....................www.marsinnovation.com Medicure Inc...................................... 5............................ www.medicure.com McGill University................................ 3.................................... www.mcgill.ca Natural Sciences and Engineering ...................................................................

Research Council of Canada................. 6.......................www.nserc-crsng.gc.ca OncoGenex Pharma............................ 5.......................... www.oncogenex.com Sanofi Group Inc................................. 4....................................www.sanofi.ca Supercritical Fluid Technologies........... 16............... www.supercriticalfluids.com Trillium Therapeutics........................... 4..............www.trilliumtherapeutics.com Versant Ventures................................ 2..................www.versantventures.com VWR................................................. 2.................................. www.vwr.com

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August/September 2014 Laboratory Focus www.laboratoryfocus.ca

New Products

Pumps

Harvard Apparatus has launched its new Pump 11 Elite Glucose Clamp Infusion System, a time-efficient syringe pump designed for academic euglycemic or hyperglycemic glucose clamp studies. The pump aims to simplify glucose clamp studies by offering animal weight, concentration, and dose rate programming as well as the ability to change dose rates during infusion. The pump requires minimal set-up using touch-screen display and reduces the margin for error by providing the most accurate fluid delivery available.

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Web: www.harvardapparatus.com

Cabinets

II Type A2 Biosafety Cabinet, it is designed to protect individuals, the environment and products from a variety of biological particulates. To prevent contaminants from escaping the work area, Purair BIO uses an HEPA filtration system that scours 70% of the incoming room air to protect products, and filters the remaining 30% of exhausted air by a second HEPA filter. Furthermore, the Purair BIO minimizes Biosafety Level 1-3 agents by maintaining negative pressure inside the cabinet during operation. Environmentally sound and efficiently designed, the Purair BIO runs off of low energy consumption and provides ample workspace.

Air Science’s introduces its Purair BIO as part of its new line of biological safety cabinets. A Class

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Web: www.airscience.com

Kits Harvard Apparatus now offers surgical instrument kits, configured from its surgical tool line.

These kits provide a variety of tools and popular surgical applications, with a significant cost savings over purchasing the pieces individually.

These pieces include the Rodent Microsurgical Kit, Rodent Microdialysis Surgical Kit, Rat/Guinea Pig Isolated Heart Surgical Kit, Mouse Isolated Heart Surgical Kit, Rat/Guinea Pig Isolated Organ Surgical Kit, Mouse Isolated Organ Surgical Kit, Rat General Surgical Kit, Mouse General Surgical Kit, Minor Surgical Kit and the Deluxe Major Surgical Kit. Surgical instruments are also available individually to supplement any of the kits, and can be made from German Stainless Steel, Tungsten Carbide, and Titanium. Additional instruments include diamond-coated tweezers and UltraEdge scissors.

Web: www.harvardapparatus.com

Test Tubes Denville Scientifics now offers a complete range of Culture Tubes, made from Type 1, Class A Borosilicate Glass that reduces both pH changes and leached contaminants. The tubes are produced in an ISO 9001 certified factory before being shrink wrapped in boxes of 250, designed to fit into standard test tube dispensers. The tubes meet ASTM E890 specification, type 1 requirements and conform to USP Type 1 standards. In addition to being chemically inert, the tubes are tissue culture and blood bank compatible. Fire-polished rims and well-rounded bottoms contribute to both the functionality and aesthetic of the tubes.

Web: www.denvillescientific.com

www.laboratoryfocus.ca Laboratory Focus

SEPTEMBER 2014 September 7-10 128th AOAC Annual Meeting & Exposition Venue: Boca Raton, FL Tel: 301-924-7077 Email: aoac@aoac.org Web:http://www.aoac.org/ imis15_prod/AOAC/Meetings___ Events/14AM_Annual_Meeting/ About/AOAC_Member/Meetings___Events/14AM/14Ann_Mtg. aspx?hkey=58bf83e9-c881-47a5a678-dd394512bc33

August/September 2014

Calendar

Tel: (613) 634-2022, ext. 141 Email: bdavis@kpm.ca Web: http://web.cim.org/ com2014/index.cfm

OCTOBER 2014 October 3-5 BCSLS Congress 2014 Venue: Whistler, BC Tel: 604-714-1760 Email: bcsls@telus.net Web: www.bcsls.net

October 5-8 ABIC 2014 Venue: Saskatoon, SK Tel: 306-668-2650 Email: abic2014@agwest.sk.ca Web: www.abic.ca/abic2014/

October 5-10 ECS Fall Meeting

17

Venue: Cancun, Mexico Tel: 609-737-1902 Email: meetings@electrochem.org Web: www.electrochem.org

October 8-12 ID Week Venue: Philadelphia, PA Tel: (703) 740-4961 Web: http://www.idweek.org/

September 16-17 North American Cold Spray 2014 Venue: Bromont, QC Tel: 440-338-5151 Email: memberservicecenter@ asminternational.org Web: http://www.asminternational. org/conferences/main/-/journal_content/56/10192/1645865/EVENT

September 17-20 World Molecular Imaging Congress 2014 Venue: Seoul, Korea Tel: 310-215-9730 Email: ami@ami-imaging.org Web: www.ami-imaging.org

September 17-19 HI TEMP Conference 2014 Venue: Santa Fe, New Mexico Tel: 781-472-5353 Email: hitemp2011@netzsch.com Web: www.hitemp2014.com 2014 OSMT Conference and Trade Show Venue: Kingston, ON Tel: 1-800-461-6768 Email: dbrooks@osmt.org Web: www.osmt.org

September 24-25 Biofuels International Conference 2014 Venue: Ghent, Belgium Tel: +44 (0)20 8687 4138 Email: tracy@horseshoemedia.com Web: http://www.biofuels-news. com/conference/index.php

September 25-26 Banff Venture Forum Venue: Banff, AB Tel: (403) 819-0383 Email: marc@criticalpathgroup.com Web: http://www.banffventureforum. com/

CritiCal priority needs for

14

Children’s

hospitals

aCross Canada

eaCh day, there are

4,900

Children

September 19-21

Children’s MiraCle network funds

who rely on the support of Children’s MiraCle network

MeMber hospitals in Canada

What is Children’s Miracle Network?

Children’s Miracle Network® raises funds for 170 children’s hospitals in North America, 14 of which are in Canada. These hospitals, in turn, use the money where it’s needed the most.

When a donation is given, it stays in the community, ensuring that every dollar is helping local kids.

These donations have gone to support critical research and training, purchase life-saving equipment, and ensure excellence in care - all in support of our mission to save and improve the lives of children.

September 25-27 Santorini Conference Biologie Prospective Venue: Santorini, Greece Tel: 33 3 83 44 51 41 Email: brigitte.hiegel@univ-lorraine.fr Web: http://www.santorini2014.org

September 28-October 1 COM 2014 Venue: Vancouver, BC

Learn more at: ChildrensMiracleNetwork.ca

18

Laboratory Focus August/September 2014 www.laboratoryfocus.ca

Canadian scientists facing a funding shortage?; And our annual Readers Choice Awards!

It’s always exciting to hear about the exciting discoveries made by Canadian scientists and researchers on a day-to-day basis. For example, researchers from McGill University and the Génome Québec Innovation Centre this past month achieved a technical breakthrough that could result in the quicker diagnosis of cancer and various pre-natal conditions.

The discovery relates to a new tool developed by professors Sabrina Leslie and Walter Reisner of McGill’s Physics Department and their collaborator Dr. Rob Sladek of the Génome Québec Innovation Centre. The tool, called a “Convex Lens-Induced Confinement” (CLIC) allows researchers to load long strands of DNA into a tunable nanoscale imaging chamber in ways that maintain their structural identity and under conditions that are similar to those found in the human body.

And yet, these types of discoveries are also thanks in large part to not just the exceptional Canadian talent, but also the funding provided through federal and provincial granting councils. In the case of the above research project, the financial backers included the National Research and Engineering Council of Canada (NSERC), the Canadian Institute for Health Research (CIHR) and the Canadian Foundation for Innovation (CFI).

A recent study from Thomson Reuters ranking the world’s most influential scientists for 2014 (based on peer citations) reported that mong the 3,200-odd names on the global list, 89 were Canadians, not a bad number at all given our size. So, we have to be doing something right.

However, you also read stories in the news like Subash Sad’s commentary in the Ottawa Citizen that there’s stagnation in funding for fundamental research and that researchers at Canadian universities are suffering. Specifically, that out of every 100 scientists who apply for funding from the federal or provincial granting councils, approximately 10 to 15 per cent actually are successful at finding it. Meaning that roughly 90 per cent of all funding grant applications are an exercise in futility.

That’s a huge number!

It makes you wonder, how many great ideas, or amazing discoveries will never get off the ground simply because the funds just aren’t there.

On an entirely different note, I should make mention that it’s that time of year again where we turn to you, our readers, to learn about the tools you use and the brands you trust for your daily lab research activities.

Running now till Oct. 1, our annual Reader’s Choice Awards Survey will be open on our website. The questions are pretty straight forward, and it shouldn’t take more than five minutes of your time. Check out the survey at http://info.biotechnologyfocus.ca/Laboratory-Focus-ReadersChoice-2014.

app review

NeuroMind

From Pieter Kubben, MD, PhD https://itunes.apple.com/ca/app/neuromind/id353386909?mt=8 https://play.google.com/store/apps/details?id=eu.dign.

NeuroMind&hl=en Available free on the Apple Store, Android Market and Windows Store, the NeuroMind app offers interactive clinical decision support with over one hundred medical classifications and grading systems. NeuroMind is ranked as the number one product for neurology and neurosurgery apps in the App Store, and is supported officially by both Surgical Neurology International and the European Association of Neurosurgical Soccieties (EANS). The app provides a variety of pathologies with their relevant calculators and scoring tools, as well as well-researched information and criteria regarding clinical conditions and anatomical images and diagrams. Although the user-interface is disappointingly mediocre, the old adage “It’s what’s on the inside that counts” proves true for NeuroMind – organization and functionality makes this app a must-have for both students and practicing neurosurgeons and neurologists.

iPharmacy - Drug Guide & Pill Identifier

By SigmaPhone LLC https://itunes.apple.com/ca/app/ipharmacy-drug-guide-pill/ id368679506?mt=8 https://play.google.com/store/apps/details?id=com.sigmaphone. topmedfree&hl=en The iPharmacy app will revolutionize the way patients manage and consume their medications – particularly if they lack the discipline or organization needed to safely and effectively take their medications. This app helps users manage their prescriptions by setting reminders, accessing dosage, and having direct access to all the latest drug news, such as FDA recalls and safety alerts. The app also has a built-in pill identifier based on the pill’s shape, colour, score and imprint. Furthermore, iPharmacy goes above and beyond, with discount codes and coupons, wellness information from Berkeley University, and price comparisons at all major US pharmacies. And the price tag? Free. iPharmacy is understandably consumer targeted; therefore, the information is simplified, and as a result it is not recommended for healthcare professionals to use as a committed monograph. However, the app’s accessibility and userfriendliness make it a great tool for patients and doctors alike to have on-hand.

IS HOSTING

ITS ANNUAL READERS’ CHOICE

AWARDS

AND WANTS YOUR OPINION ON WHAT PRODUCTS AND SERVICES ARE VALUABLE TO YOU. HERE IS YOUR OPPORTUNITY TO VOICE YOUR OPINION IN PRINT Enter your nomination in each of the 11 categories listed on our website.

Encourage your colleagues to vote for their favourites as well.

Look for the finalists to be announced in the November issue.

TO PARTICIPATE, VISIT

http://info.biotechnologyfocus.ca/ Laboratory-Focus-Readers-Choice-2014

Perfect Asymmetry The Mastercycler® nexus X2 with two totally independent blocks Two independent blocks of different size provide ultimate flexibility.

Combine up to 3 units for higher throughput.

The Mastercycler nexus X2 will impress any user with its low noise, low power consumption and an intuitive graphic software.

> 64-well block for larger assays— 32-well block for smaller assays > Universal block for strips, 0.2 mL and 0.5 mL PCR tubes > Intuitive graphic programming > Optional gradient for PCR optimization on the 64-well block > Email notification

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