41 minute read
THE SPARTAN CUBE REVOLUTIONIZING DNA ANALYSIS
ottawa’s sPartan Bioscience
set to make point-of-care Dna testing a reality
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we live in interesting times, bearing witness to a convergence of accelerated healthcare technologies that are empowering patients to manage their own personal health. Examples include such innovations like home blood glucose meters, pregnancy tests, and various other pointof-care diagnostics. And now, thanks to the efforts of an Ottawa-based firm, Spartan Bioscience, the field of DNA analysis is about to take an exponential leap forward.
It’s all thanks to the invention of a tiny new device called the Spartan Cube. As Paul Lem, CEO and founder of the company explains, the Spartan Cube is on the verge of pushing the power of DNA analysis farther, faster and closer to the end user than ever before. Billed as the world’s smallest DNA analyzer, Lem and his team have constructed a device that not only shrinks the DNA testing process, it takes it out of the hands of lab technicians working with large machines and puts it into those of the consumer. At the same time, it has cut the time it takes to produce DNA analysis results from weeks and months, to as few as 30 minutes. It’s small, roughly the size of a coffee cup, and it packs a powerful punch to accurately diagnose a range of infections.
A former medical doctor with a background in infectious diseases, Lem says his goal was to make DNA testing accessible with the Cube. On this point, he compares the evolution of DNA analysis to that of computer technologies. Specifically, how such technological advances have changed our everyday lives, giving users instant access to information. In much the same way that computer technologies have evolved from cumbersome clunky machines into more personal, faster and portable devices, Lem believes the Cube will do the same for healthcare diagnostics.
He adds that the device has quite a few of the D’s of exponential technology covered. For example, it’s digitized, disruptive, demonetized, and one day, hopefully he says, it will be fully democratized.
“Because it’s small enough to fit into your hand and extremely portable, you can bring it anywhere.” he says.
He expects that the device when approved, will be in every doctor’s office, pharmacies, and eventually in millions of homes, all at a relatively cheap price.
“With the Cube we’re striving to drive the price of DNA analysis down significantly and make it affordable to everyone,” he adds.
This is the evolution of DNA testing that he envisioned when he first launched Spartan Bioscience in 2005. Back then he was a doctor specializing in medical microbiology. As Paul Lem, the man behind the invention, and CEO and founder of the company explains, the Spartan Cube is on the verge of pushing the power of DNA analysis farther, faster and closer to the end user than ever before.
Training to run a diagnostic lab housing mainframe DNA analyzers, he also had a penchant for inventing. He was presented with a problem, one that he believed he could solve.
“We’d see many patients in these labs, and I remember what was so frustrating was that we weren’t able to give patients their results right away,” he recalls. He adds that often patients would have to wait weeks, even months for their results. He felt the anxiety of not knowing and waiting on these results must have been excruciating for these patients. He believed that someone needed to figure out a way to take mainframe DNA analyzers out of the lab and bring them to the bedside. More importantly, he felt that he could be that someone.
“That was the seed that planted the Spartan Cube idea,” he says.
The decision to change careers and become an entrepreneur and inventor was an easy one he recalls. He adds that transitioning was equally about making more of a difference in the world.
“As a doctor, I realized that I was limited to the number of hours I had in my day and the number of patients that I could see. At most maybe, I could see 10 or 20 patients a day. I thought if I could make products like the Spartan Cube, I could scale well beyond this where potentially, I could reach millions of people with these devices or products.”
And yet, there’s a big difference between using such a device and actually inventing one. Likewise, constructing a complex tool like the Spartan Cube required a unique skill set. For most of his peers, it would have been difficult to do so, but not for Lem. An avid tinkerer, Lem says he had always been fascinated by such healthcare tools and wanting to get to the root of how and why they work.
“I would say throughout my undergrad, and even in high school, where I once won a silver medal at a Canada-wide science fair, I have just loved to play with the tools sometimes even building my own.”
According to Lem, everything he has done since leaving medicine has been part of a grand strategy.
“The actual goal is to change the world,” he says.
For Lem, the first significant step on this path was the creation of Spartan’s first generation device, a four-well endpoint PCR instrument called the Spartan DX. This device after years of tinkering eventually evolved into Spartan Bioscience’s first commercial generation Spartan RX platform. The RX, which included a front-end DNA collection plus DNA extraction components all together in one device, was approved by the FDA in 2013 for one test, identifying patients with a mutation of the CYP2C19 gene.
This was important from a pharmacogenetics point of view, Lem explains, as it was used to identify cardiac stent patients that had the mutation and were taking the blood thinner Plavix®. The reason that identifying this mutation is important, is it interferes with the efficacy of the drug. If you have the gene, taking the drug can also lead to serious complications. Likewise, by pre-identifying such patients, cardiologists can instead prescribe other drugs in Plavix’s place.
That first-generation device was roughly the size of a toaster, impressive of course. But Lem knew he and his team could find a way to make it even smaller. With the invention of the Cube, they have done just that, as well as expanding on its applications.
Explaining how the Cube works, Lem says it takes all the steps of DNA analysis and puts it into one small sample-to-result box. “It is a PCR-based system that fully integrates DNA extraction, and analysis, with the results shown on an easy-to-use interfaced wireless tablet.” Lem adds that integrating all these steps makes the Cube a game changer.
The process begins with DNA collection, using a swab that comes with the box. After the user collects the right amount of DNA sample, the swab is then inserted into the box where the DNA extraction is automatic and quick. He adds the cells are broken open through polymerase chain reaction (PCR) and the DNA is released. The machine then uses fluorescence to determine what is present in the DNA.
“There’s a software algorithm that interprets the PCR result and the spits out the actual result that says, for example, whether some-
thing like Strep bacteria is there or it isn’t,” he explains.
Further, the Cube isn’t just for medical applications. Rather, according Lem, because it can do any type of DNA or RNA application, wherever either is present, the device can detect it. This means the device can also be used as a detection tool for certain environmental contaminants on top of its human health applications.
“The way that we think about who can use the device, is that there are three major industry verticals that we want to go after: infectious disease, pharmacogenetic, and finally food and water safety testing.”
Under these verticals, he says the instrument will have tests that can identify Strep A (which is the cause of strep throat) in DNA; it can determine whether a person carries a certain gene tied to the development of Alzheimer’s; and environmentally, it can be used to monitor ventilation systems for Legionella, a bacteria that when inhaled by humans can cause a potentially fatal type of pneumonia called Legionnaires’disease.
Moreover, on the pharmacogenetics front, the company is focusing on the development of two tests – ApoE and the aforementioned CYP2C19. ApoE (apolipoprotein E) genetic mutations increase the risk of developing Alzheimer’s disease, while CYP2C19 mutations affect how people metabolize drugs. And additionally, for food and water safety,, Lem says the Cube could also be used for detection of other bacteria such as E. Coli, Listeria and Salmonella.
The company also has plans to further expand the testing in the other two verticals as well.
“Our hardware team is always hard at work figuring out how we can eventually approach all diagnosis like the old tricorders on Star Trek,” he says. “You simple insert the sample, press go and away you go.”
Regardless of the vertical, Lem also expects users to come from many different types of industries.
“For the healthcare industry, we’re looking at people who work in hospitals, doctor’s offices and pharmacies. For the food and water testing industry, we’re hoping to get it into the hands of building managers and restaurant owners. The ultimate goal is to get this technology to wherever people want it,” he says.
And as alluded to, into people’s homes.
Already the company’s first generation device, the Spartan RX, is selling around the world, giving the company a revenue stream to further develop the Spartan Cube. The RX has been approved by Health Canada, both European and Asian Regulatory Agencies, and most importantly, it has FDA 510(k) approval. Now the company is focused on getting FDA 510 (k) approval for the Cube. Lem adds that fortunately, the company has already learned some valuable lessons from the RX approval pathway that should make the process simpler for the Cube. The company also has a very big player in its corner.
Specifically, Spartan has benefitted from a partnership with consumer product giant Canon Inc., a world leader in the camera and copier market. Through its U.S. arm, Canon BioMedical is helping Spartan in various ways to both develop and market the Cube worldwide. The partnership has also given Spartan access to advanced manufacturing facilities, specifically that scale of manufacturing that makes it possible for Spartan to execute on its vision.
“They have manufacturing expertise at an enormous scale, as well as a massive global network for sales and service,” says Lem. “They also have decades of consumer electronic design expertise, so they know how to design the user interfaces and how to make things easy to use for the average person.”
They also have a huge fleet of technicians at their disposal to service their device.
“I think they have field technicians that are servicing almost every office building in the world because like Canon photocopiers or printers are in every office building, pharmacy and library. So, they already have all these feet on the street which could prove useful if we get the Cube to where we want it to go.”
According to Lem, prior to this partnership, Canon had been developing its own DNA diagnostics division for years, having a very difficult time making a point-of-care device. They decided to look externally for a more user-ready device.
“The sent their business development people all over the world asking key opinion leaders and top scientists for any up and coming companies, and they kept getting referred back to us, and that’s how they found us,” he says.
Lem says it has meant a lot to have such a major player to lean on, and he expects the two sides now are very close to achieving their mutual goals. Likewise, Lem sees a very bright future for the device and for the future Spartan devices to come “It’s amazing to think as little as two decades ago, machines like the Cube took up so much space, even fillingoffices. And here we are today – we’ve built the world’s smallest DNA analyzer and we’re on the verge of making it accessible to millions.”
To see this story online visit www.biotechnologyfocus.ca/spartanbioscience-set-to-make-point-of-care-dnatesting-a-reality/
comBining strengths to fight cancer
BioCanrx supports the translation of key immunotherapy discoveries to the clinic
it’s been nearly 50 years since U.S. President Richard Nixon declared war on cancer. Since then, some battles have been won, others lost. But the traditional weaponry – chemotherapy and radiation – while refined and improved, is still carrying the brunt of battle duty.
In recent years, these two warhorses have been joined by a powerful new weapon. The most promising new approach to cancer to emerge, immunotherapy enlists the patients’ own immune systems to fight their cancer. It’s an exciting field, with new therapeutic approaches being rapidly developed.
BioCanRx was created to build on these discoveries and approaches, to help them reach the clinic, where they can save lives as quickly as possible. In Toronto, for instance, Dr. Pamela Ohashi of the Princess Margaret Cancer Centre has developed a novel method of taking tumour-infiltrating lymphocytes (TILs), a form of T-cells, from patients, growing them in the lab with dendritic cells, another kind of immune cell, and returning them to the patient, where they can attack ovarian cancer tumours. Now, the world’s first clinical trial to use this type of adoptive cell therapy, as it is known, for ovarian cancer is giving women who are no longer responsive to conventional treatment another option.
But there still remain challenges to the widespread implementation of immunotherapy. It is now clear that even within a single patient, cancer is a genetically complex and heterogeneous disease. Its ability to evolve during therapy coupled with its propensity to shroud itself with an immunosuppressive cloak makes metastatic or widespread cancers essentially incurable with the current therapies available to the oncologist. However, our immune systems have the “potential” to evolve in lock-step with the cancer and recognize novel tumor specific antigens as they appear during progression from a normal cell to a malignant cancer. Strategies need to be developed to exploit the ability of our immune systems to recognize foreign cancer antigens while at the same time finding ways to overcome the barriers that tumours set up to block immune cell activity.
Scientists within the BioCanRx Network believe that it is not sufficient to attack each of these barriers on its own. Our approach is to develop novel combination strategies creating a multi-faceted attack on cancer to enable immune recognition and destruction of tumours wherever they hide in the body.
That’s why, today, we are focusing our funding on exactly that – research into combination therapies that together are stronger than the sum of their parts. For example: • Dr. Julian Lum and his colleagues at the BC
Cancer Agency are combining radioactive
Dr. Julian Lum Dr. Marcus Butler Dr. Yonghong Wan Dr. Jonathan Bramson Dr. Raja Ghosh
Dr. Manoj Lalu Dr. Dean Fergusson Dr. Rob Holt
drugs with checkpoint inhibitors so that the immune response generated by the radiation can better infiltrate the cancer tumour.
Their work could provide a new treatment option for metastatic prostate cancer that has become resistant to hormone therapy. • Dr. Marcus Butler of the Princess Margaret
Cancer Centre is conducting the world’s first clinical trial combining an oncolytic vaccine with checkpoint inhibitor antibodies for cancer treatment. The vaccine he is using was developed in Canada and its testing remains exclusive to Canada, as, likely, will its commercialization. The trial will involve patients with advanced solid tumours who already show an anti-cancer immune response and have not responded to conventional therapies. The combination of oncolytic vaccines with checkpoint inhibitors is one of the most exciting prospects in oncology, according to
Dr. Stephen Russell of the Mayo Clinic and a member of the BioCanRx Research Management Committee. • Dr. Yonghong Wan of McMaster University is also using an oncolytic vaccine, this time with adoptive cell therapy, to target cancers already showing an immune response. This exciting combination of therapies has a clear mechanism for working together to kill cancer cells.
This is a key example of the critical role that BioCanRx is playing in the immunotherapy field. Pharmaceutical companies, very justifiably, are focused on developing their own agents. Combining these agents with those of other companies, if it happens at all, generally happens quite a bit later in the process. The development of new therapies as single agents in a “siloed” approach is slow, expensive, ineffective and unlikely to make the rapid progress cancer patients need. We at BioCanRx are investing our funds to make these combinations happen sooner.
The other thing we’ve learned is that we need a better way to select those patients who will benefit most from these promising, but expensive, therapies. The pace of research advances today is so quick that we are missing opportunities to capture the data that results, in particular, from clinical trials. BioCanRx is capturing that data and using it to learn how to best identify those patients who will benefit from specific immunotherapy approaches. This helps to speed up the product development process and ensure that decision-making is strongly rooted in the best possible evidence.
With our funding, we are also helping to develop the foundations and infrastructure to support future immunotherapy discoveries: • Drs. Jonathan Bramson and Raja Ghosh from McMaster University are developing a “bioreactor in a box” to enable the production of T-cells for immunotherapy in a closed system that more closely mimics the body’s production of T-cells, while reducing the costs, lab space and human resources required for current methods of producing T-cells for immunotherapy.
Their work will ensure that the high cost of producing the needed immune-system cells is no longer a barrier for providing immunotherapy in the clinic. • Drs. Manoj Lalu and Dean Fergusson of the Ottawa Hospital Research Institute are leading a multidisciplinary team in developing a template for evaluating future therapeutics and designing clinical trials that are feasible, safe, effective and economical. The team will address issues that most first-in-human/early phase trials encounter and offer a structured method to evaluate available data and design an evidence-informed trial protocol, beginning with CAR-T cell therapy for blood cancers. • Dr. Rob Holt is working with a team at the BC
Cancer Agency and Ottawa Hospital Research
Institute to build the manufacturing capacity to enable CAR-T therapy in Canada. This will bring this necessary, effective and highly publicized therapy to cancer patients for whom conventional treatment has not worked and who are in dire need of a new approach.
The result of our investments is the rapid testing and introduction into the clinic of combination therapies targeted to the patients who will benefit most from them, so that cancer becomes part of their past and not their present. In doing so, we are contributing to a huge improvement in quality of life of people with cancer, lowering healthcare costs by delivering the most effective therapy first and reducing the social and economic toll of this too-often fatal disease.
Dr. Pamela Ohashi Dr. John Bell is Sr. Scientist, Centre for Innovative Cancer Research, Ottawa Hospital Research Institute; Professor, Departments of Medicine and Biochemistry, Microbiology & Immunology, University of Ottawa and Scientific Director, BioCanRx - Biotherapeutics for Cancer Treatment. To see this story online visit www.biotechnologyfocus.ca/combiningstrengths-to-fight-cancer-biocanrx-supportsthe-translation-of-key-immunotherapy-discoveries-to-the-clinic/
reimBursement & market access for innovative canaDian Biotechnologies
reimbursement and market access are critical milestones for commercial success of new biotechnologies, and planning for reimbursement should begin long before regulatory approval. The road to reimbursement is marked by many challenges, not least of which is demonstrating value in terms of both clinical and cost effectiveness. No longer is it sufficient to demonstrate only efficacy, safety and quality (the requirements for regulatory approval). Payers (public and private) now insist on clear evidence of clinical and economic value confirmed through rigorous health technology assessments (HTAs). And budget impact is an additional factor that can limit access even for drugs (eg. Sovaldi (sofosbuvir) for hepatitis C) that have clearly demonstrated both clinical and cost effectiveness.
health Technology assessments (hTas)
Formal HTA reviews are a requirement in most developed countries and Canada has been a leader developing HTA standards and procedures. The Canadian Agency for Drugs and Technology in Health (CADTH)1 and the Institut national d’excellence en santé et en services sociaux (INESSS)2 in Québec conduct assessments of all new prescription drugs and biologics and recommend whether the new technologies should be reimbursed by the federal, provincial and territorial drug benefit plans. Not only are these recommendations critical for public reimbursement, they are increasingly important for private reimbursement as well.
Although the formal CADTH / INESSS HTA review processes commence just before or after market authorization (Notice of Compliance or “NOC” from Health Canada), planning for the HTA review should begin well before and often concurrently with Phase 2 clinical trials, if not earlier. This timing is important because the Phase 3 trials need to be developed with HTA, reimbursement and market access in mind. Trial design (double-blind randomized controlled trial is the gold standard), selection of comparators, primary and secondary outcomes, patient sub-populations, and quality of life measures are important elements that should be considered in the Phase 3 clinical trial program.
For most new drugs and biotechnologies, manufacturers face considerable challenges when it comes to developing and conducting clinical trial programs. For rare (orphan) diseases the barrier is small patient populations that make it difficult to recruit sufficient patients to power statistically significant differences in clinically meaningful outcomes. Moreover, the outcomes may only be surrogate markers and not the clinically relevant outcomes preferred by payers.
Case Study: PCSK9s
For example, approval of the recently launched PCSK9s3 (ie, Praluent (alirocumab), Repatha (evolocumab)), a new class of lipidlowering medications for the treatment of familial hypercholesterolemia, relied primarily on reduction of low-density lipoprotein cholesterol (LDL-C) as the primary outcome. LDL-C is a laboratory measure that often serves as a surrogate marker for cardiovascular events. However, HTA agencies would prefer to see changes in morbidity (e.g., cardiovascular events) and mortality as the primary outcomes in the clinical trials. However, this would have been difficult for the PCSK9s given the small patient population and the extended time horizon necessary to record sufficient morbidity and mortality events to be clinically and statistically meaningful.
Ultimately, HTA agencies accept surrogate markers as proxies for outcomes as long as there is sufficient evidence demonstrating a clear correlation between the surrogate marker and the outcome. Ideally there will be follow-on or extension trials that will help confirm that the new technology truly offers benefits in morbidity and mortality.
early Scientific advice
Leading pharma and biotechnology companies that recognize the challenges in developing clinical trials that are relevant to both regulators and HTA agencies will often seek early scientific advice from HTA agencies (sometimes in conjunction with regulatory agencies). This advice, while non-binding and offered on a fee-for-service basis, can provide valuable insights and suggestions for developing a clinical trial program that address both the requirements of the regulator and the evidence expectations of the HTA agency and payer.
The National Institute for Health and Care Excellence (NICE)4 in the UK was the first HTA agency to develop a scientific advice service, and this type of service is now offered in several countries including by CADTH in Canada which modelled its program on NICE.
Payer engagement
Early scientific advice is but one element of the pre-market activities that are critical to market access success. Payer engagement is important throughout the product life cycle and as such it is about the continuing relationship between the manufacturer and the national and regional decision makers. The objective of payer engagement is to establish professional relationships between manufacturers and payers that maintain clear lines of communication, foster understanding of each others organization and over time develop trust and credibility. Larger pharma companies maintain regional staff that are tasked with maintaining relationships locally whereas smaller firms will have a national person in a senior role with responsibilities for establishing and maintaining relationships with payers and HTA agencies at all levels.
It is important to note that manufacturer – payer relationships are not about becoming “partners” or “friends”, but rather they are about manufacturer representatives establishing credibility with the payers. These relationships will pay dividends when it comes to negotiating risk sharing agreements typically referred to as product listing agreements or “PLAs” negotiated with public payers through the pan Canadian Pharmaceutical Alliance (pCPA)5 process. And this is not because longstanding relationships result in better deals per se, but rather because trust and credibility foster frank and honest negotiations. It is no surprise therefore that the most difficult and protracted negotiations are those led by foreign-based global pricing teams or their equally foreign consultants. Foreign-based global pricing teams are a fixture with large pharma companies, however, the best firms empower their Canadian affiliates (and local consultants) to lead negotiations.
Price regulation, pCPa and PmPrB
The PLAs established through the pCPA process establish (usually) confidential net prices however this is not the only mechanism for limiting prices in Canada. The Patented Medicine Prices Review Board (PMPRB)6 has a mandate to ensure prices of patented medicines in Canada are not excessive. The PMPRB applies to both domestic therapeutic class price comparison and to international price comparisons to limit introductory prices of new patented medicines. Post introduction, prices cannot increase faster than inflation as measured by the consumer price index (CPI) and may never exceed the highest international price among the PMPRB seven reference countries.
The PMPRB and provincial payers (on their own or through pCPA) work independently of each other such that an agreeable price to one may appear excessive to the other. And the confidential rebates paid by manufacturers to provincial payers are typically not included the calculation of the average transaction price that is regulated by the PMPRB. The PMPRB is currently engaged in a comprehensive review of its mandate with an objective of becoming more relevant to payers. New, tougher PMPRB price guidelines are expected in 2018. Meanwhile, the pCPA process continues to evolve. Taken together, it is expected that there will be greater collaboration between PMPRB and pCPA and perhaps even coordination or harmonization at certain levels.
market access is Complex and evolving
While the specific pricing, reimbursement and market access mechanisms described above are unique to Canada, complexity is not. Each country has its own complex systems of national and regional HTA, pricing and reimbursement mechanisms reflecting the underlying health care systems they serve. Although there are many similarities between Canada and other countries in terms of reliance on evidence-based methodologies for assessment, implementation and decision making processes are unique to each country.
Market access is at best a challenging endeavour in Canada (and globally!) that is ever evolving with new regulations, policies and methodologies employed by payers and regulators to assess value. Investors and analysts have become more sophisticated when it comes to market access – no longer are they looking only at regulatory approval but more importantly they need to be convinced that timely reimbursement is both feasible and probable.
Start early!
Above all else it is critical to start early. Too often, small emerging biotechs find out the hard way (and too late) that convincing payers (public and private) to pay for innovative new technologies is a significant challenge. Big Pharma recognized some time ago that regulatory approval and market authorization are only the first step of a long journey and that it is essential that there be careful planning and sufficient resourcing to support strategic planning, model development, dossier preparation and payer engagement.
about the authors
Kaitlyn Proulx (Kaitlyn.Proulx@pdci.ca) is PDCI’s Managing Director with responsibility for managing the firm and leading the team of twenty senior consultants and support staff.
W. Neil Palmer (Neil.Palmer@pdci.ca) founded PDCI in 1996 and serves as principal consultant on many of PDCI’s pricing and reimbursement engagements.
About PDCI Market Access Inc. PDCI is Canada’s leading pricing and reimbursement consultancy featuring senior consultants with clinical, health economic, HTA, pricing and strategic reimbursement expertise. (www.pdci.ca)
references
1 https://cadth.ca/ 2. http://www.inesss.qc.ca/ 3. Proprotein convertase subtilisin/kexin type 9 4. https://www.nice.org.uk/ 5. http://www.pmprovincesterritoires.ca/en/ initiatives/358-pan-canadian-pharmaceutical-alliance 6. http://www.pmprb-cepmb.gc.ca/home
To see this story online visit www.biotechnologyfocus.ca/reimbursement-market-access-for-innovative-canadian-biotechnologies/
the lay of the lanD
for Canadian Government Grants & incentives
to remain competitive globally it is imperative for companies to continue to innovate and grow. For the Canadian life sciences industry, the Globe and Mail reported in April of 20151 that the biotech sector is “ready and eager” for growth but without adequate financing, it will go nowhere. Canada does offer a multitude of government grants and incentives to promote innovation and growth for Canadian businesses.
The federal government as well as all provincial governments offer support in the form of non-repayable grants, favourable loans, and tax credits, with Ontario and Québec having the largest number of programs available. While the other provinces have fewer program offerings, new programs are announced on a monthly basis in an effort to support their regional priorities and compete with the other provinces.
Regardless of the geographic region in the country, government incentive programs are available to companies operating in various industries, including life sciences. The programs available can be broadly grouped into four categories relating to the initiatives they support:
1.Business and Market Expansion 2.Innovation Development 3.People Development 4.Environmental Sustainability
Programs in the Business and Market Expansion category generally support projects that include facility expansions, new product line expansions and expansion to new markets. For Ontario businesses, projects that involve expanding innovation capacity, improving productivity, performance and competitiveness and are proposed be in excess of $10 million in expenditures could be eligible for up to a 20 per cent non-repayable grant contribution. For similar projects that are expected to be less than $10 million, they could be eligible for a 15 per cent non-repayable grant to a maximum of $1.5million if project costs exceed $500,000.
Program offerings in the Innovation Development category generally support all industries, including life science-based projects that require significant R&D investment for new product and technology development; acquisition of new equipment and technology to improve productivity; as well as industry/ university collaboration initiatives.
Canada’s longstanding flagship Scientific Research & Experimental Development (SR&ED) program provides up to a 35 per cent federal credit for SR&ED eligible labour, materials and subcontractor expenditures. In addition to SR&ED, federal programs such as the National Research Council’s (NRC) Industry Research Assistance Program (IRAP) provide R&D project-based non-repayable funding up to $500,000 per project.
The Ontario Centres of Excellence (OCE) AdvancingHealth2 program is designed to bolster innovation in Ontario’s public healthcare sector by matching healthcare needs with innovative products and services through partnerships between public healthcare organizations, companies and academic institutions. The aim of the program is to advance healthcare innovation directed to improved health outcomes, enhanced patient experience and efficient use of resources through investments in collaborative demonstration projects that show clear potential for scaling-up to the system-level and establish a strong case for adoption. Up to $250,000 is available from OCE per demonstration project and applicants can also access two academic vouchers per demonstration project (valued at $50,000) each to support academic researchers and students to work on the demonstration project and/or to assist with adoption.
In many provinces, both federal and provincial assistance is available to help Canadian companies hire and retain staff, improve their effectiveness and train their employees in areas such as advanced technologies or operational processes. Specific programs support initiatives towards hiring of recent university/college graduates; training programs for upskilling staff; training on new technology or equipment installations; and supporting the temporary hiring of co-ops students and interns. Companies looking to hire recent university graduates from science, technology, engineering, and math disciplines can access funding to subsidize 50 per cent of the first year salary for a new hire.
Support for climate change initiatives and technology development projects has also increased in recent years. Grants are available for projects aimed at greenhouse gas reductions, energy conservation, and water conservation and usage reduction. These programs can improve the ROI for a company’s sustainability strategies, including renewable energy investments, energy efficiency improvements, recycling initiatives, advanced manufacturing and green building construction.
Over the past five years, there has been a focused effort by the federal and provincial governments to deliver grants and incentives to Canadian businesses through direct funding mechanisms (i.e., non-repayable cash contributions and favourable loan programs) over indirect funding mechanisms such as tax credits. While these programs have defined eligibility criteria, the majority are discretionary and limited to budget availability. The discretionary nature of the majority of direct funding programs introduces a high level of uncertainty to companies who would otherwise be eligible. In addition, businesses are required to submit their application and receive funding approval before commencing the project. This requires companies to plan ahead and develop a funding strategy to be successful.
Regardless of whether programs are statutory or discretionary, with proper planning and advice, there is significant opportunity for Canadian life science businesses to receive government funding for their upcoming projects.
about the author
Chris Chipman is the Canadian Incentives Leader at EY. He can be reached by email at chris.chipman@ca.ey.com.
references
1. Reguly, Eric, “Why is Canada’s life sciences sector flatlining?,” The Globe and Mail, 23
Apr 2015. http://www.theglobeandmail. com/report-on-business/rob-magazine/ why-is-canadas-life-sciences-sectorflatlining/article24030375/ 2. http://www.oce-ontario.org/programs/commercialization-programs/advancinghealth
To see this story online visit www.biotechnologyfocus.ca/the-layof-the-land-for-canadian-governmentgrants-and-incentives/
Spectrometry IRsweep announces the release of the IRspectrometer, a tabletop frequency dual-comb spectrometer
offering microsecond time resolution, large spectral bandwidth and high spectral resolution. The IRspectrometer can be used in a variety of applications, including biological sample and chemical composition analysis. The device excels where fast time resolution or high throughput and superior brightness is required — including applications that involve a complex background matrix or where multiple similar molecules must be simultaneously quantified. Unique features of the IRspectrometer include: fast time resolution (as low as 1 µs for a full spectrum), the ability to monitor highthroughput applications without relying on techniques like step-scan in FT-IRs and brightness advantages that significantly ease sample preparation for liquid and solid analytes. The device also delivers microsecond resolution at high bandwidths, with center wavelengths between 6 µm (1700 cm-1) and 9.5 µm (1050 cm-1), covering fundamental amid absorption bands, are available. Web: http://irsweep.com
Pipettes Hamilton Company has expanded its pipetting family with the introduction of the ZEUS LT OEM pipetting module. Like the original ZEUS® module, the ZEUS LT is an ideal complement to analytical instruments and clinical diagnostic systems. Unlike the original, the ZEUS LT does not come with an integrated z-axis, but rather offers the option for integrators to custom design the z-axis. More than a simple pipette module, the ZEUS LT also incorporates Hamilton’s intelligent air displacement pipetting technology Qualitative Pipette Monitoring™ (QPM) for monitoring clogged tips or foam aspiration, Anti-Droplet Control (ADC™) for pipetting of volatile liquids, capacitive and pressure based level detection, tip detection and liquid class definitions. Easy mounting hardware enables attachment to an existing XYZ system, or development of an application-specific z-axis to accommodate space constraints or other design considerations. Simple RS-232 or CAN commands combine with pressure and capacitance outputs for simple coordination of the pipette channel and the z-axis for liquid level detection, pipette tip following, and other coordinated movements. Web: www.hamiltoncompany.com
Cell Culture Irvine Scientific, a provider of cell culture media, introduces PRIME-XV® T Cell CDM, a chemically-defined, animal component-free medium for T cell culture.
The new medium has been developed to maximize consistent growth of T cells while maintaining their functionality and therapeutic potential. An increasingly important trend in cell culture media for gene therapies and immunotherapies is the move away from animal-derived and undefined components to serum and animal component-free, chemically-defined culture conditions. When working with T cells the advantage of this is two-fold: animal-derived components are variable between lots; and the naturally occurring cytokines and growth factors in them can result in undesirable effects. For example, cytokines and growth factors have been shown to impact growth, phenotype and the potential of T cells to polarize into therapeutic subtypes. PRIME-XV T Cell CDM removes this variability to provide more consistency between lots. Chemically-defined media also reduces the risk of introducing foreign agents or impurities from undefined components, thereby facilitating scale-up to commercial production and the regulatory submission process. Web: www.irvinesci.com
Pipettes The Eppendorf epMotion 96 is an easy to use bench top system for high precision pipetting in 96- and 384-
well or deep-well plates within life science research, pharmaceutical and industry laboratories. Overcoming the limits of manual multichannel pipetting, the device allows easy, rapid handling with high precision and accuracy compared to multi-channel manual pipettes. Thanks to its ability to dispense into all 96 wells at the same time, users can simultaneously start or stop a biological assay for all wells in a plate. Additionally, the epMotion 96 has a large volume range between 0.5 and 300µL using only one head or system so there is no need to switch pipette heads or employ a second device to achieve all volumes. Workflows benefiting from the epMotion 96 include but are not limited to: solid phase extraction, DNA extractions from blood and tissue, sequencing and PCR clean-up, total RNA isolation, NGS library preparation, distributing reagents and serial dilutions, media change, other cell culture applications and more. Web: www.eppendorf.com
Liquid Handling The BrandTech® Scientific Liquid Handling Station (LHS) pipetting robot reduces repetitive manual pipet-
ting and increases laboratory efficiency and reproducibility through automation. The LHS is an extremely compact benchtop instrument that has seven working positions and five available liquid ends in single channel volumes up to 1000µL and multichannel volumes up to 300µL. With a wide variety of accessories, this flexible system moves liquids between reservoirs, tubes and plates; and is ideal for plate reformatting, ELISA and PCR setup, cherry picking, etc. Web: www.brandtech.com
Hot Plates Torrey Pines Scientific introduces its EchoTherm™ Programmable Corrosion Resistant Digital Stirring Hot Plates for use with aggressive chemicals in environments where other stirring hot plates would be quickly destroyed by vapors or spills. The hot plates are designed to be purged using an inert gas through a fitting on the rear of the chassis. Purging provides a positive pressure inside the unit to prevent corrosive gasses from entering the chassis and attacking the electronics or stirring mechanism. These units feature 10-program memory with 10 steps per program, temperature ramping, RS232 I/O port, membrane keyboard, and full function liquid crystal display where all parameters are continuously visible. Heater tops are 8″ square solid ceramic with 600 watts of power. Temperatures can be set to 450°C. The units are readable and settable to 1°C. Temperature control is by PID software and is controlled to ±1°C or ±1ºF. Stirrer speeds can be set from 100 to 1500 rpm. Temperature ramping can be set from 1ºC/hour to 450ºC/hour in 1ºC increments. The built-in timer is settable to 99 hours and is readable to 1 second. All units are available in 100, 115, and 230 VAC, 50/60 Hz models. Web: www.torreypinesscientific. com
Mixers MilliporeSigma’s Mobius® Power MIX single-use mixing systems are engineered with advanced technology to
effectively handle difficult-to-mix buffers, culture media powders and other pharmaceutical ingredients. The system achieves a strong vortex using an impeller design and motor based on magnetically-coupled NovAseptic® technology-a proven mixing technology in stainless steel tanks. Sterile zero deadleg sampling can be performed directly from the mixing container. A probe port allows for insertion of either a reusable probe for non-aseptic processes or a presterilized, single-use sensor for in-process pH measurement of aseptic processes. The 100, 200 and 500 litre models are available in both jacketed stainless steel and highdensity polyethylene HDPE.
Imaging Solutions Andor Technology (Andor), an Oxford Instruments company, has released its iXon Life Electron Multi-
plying CCD (EMCCD) camera platform for fluorescence microscopy. The iXon Life is available in 1024 x 1024 and 512 x 512 sensor formats, back-illuminated to deliver the highest and broadest QE of any microscopy camera and deep cooled down to -80°C for minimal darkcurrent. Web: www.andor.com/ixon
Mass Spectrometry Mass Spec Ana-
lytical is now shipping its Thermal Extraction Ion Source Sciex™ 3200 Triple Quadrupole Mass Spectrometer and other V-Series models to customers. The TEIS-3200 is ideal for applications where the method requires
a large quantity of sample measurements in a relatively short period of time or where automation is required. When coupled with Mass Spec Analytical’s analysis software, results can be provided in as little as 4 seconds. The TEIS-3200 uses a patented thermal extraction sample introduction device. Compounds amenable to thermal desorption, such as many pesticides, drugs and explosives, can be rapidly analysed in this way without the need for any sample pre-treatment, solvents or glassware. Web: www.msaltd.co.uk
MARCH 2017
March 14-15
Web : http://www.biotech.ca/policy-matters/ health/preventing-disease/
BC Tech Summit Venue: Vancouver, BC Hashtag: #BCTECH Summit new card:Layout 1 1/31/2013 9:09 AM Page 1Email: info@bctechsummit.ca Web: http://bctechsummit.ca/
March 20-22
BIO Europe Spring Venue : Barcelona, Spain Web : https://ebdgroup.knect365.com/ bioeurope-spring/
March 30 May 16-18
LABVOLUTION & BIOTECHNICA Venue: Hanover, Germany Tel: 416 598-7114 Fax: 416 598-1840 Email: info@hf-canada.com Web: http://www.labvolution.de/home Web: http://www.biotechnica.de
May 26-28
Labcon 2017 Venue : Banff, AB Web: https://labcon.csmls.org/
Pharmed CRO 2017 Venue : Montreal, QC Web : http://www.pharmedcanada.ca/
JUNE 2017
June 19-22
Bio International Conference Venue: San Diego, CA Email: convention@bio.org Web: http://convention.bio.org/2017/
June 26-27
WIN 2017 Symposium : Expediting Global Innovation in Precision Cancer Medicine Venue: Paris, France Email: vladimir.lazar@winconsortium.org Web: www.winsymposium.org
SRC101
APRIL 2017
April 3-7
Toronto Health Innovation Week Venue : Toronto, ON Email : info@tohealth.ca Web : http://healthinnovationweek.ca/
April 4
RESI on MaRS 2017 Venue : Toronto, ON Tel: 617-600-0668 Email: RESI@lifesciencenation.com Web : http://www.resiconference.com/
April 20
Pharmed Outsourcing & Biomanufacturing Summit 2017 Venue : Mississauga, ON Web : http://www.pharmedcanada.ca/
MAY 2017
May 1-2
Bloom Burton & Co. Healthcare Investment Conference Venue : Toronto, ON Tel: 416-640-7580 Email: bbloom@bloomburton.com Web : https://www.bloomburton.com/ conference/
May 8-9
World Health Summit North America Venue : Montreal, QC Email : mc.fiset@umontreal.ca Web : https://www.worldhealthsummit.org/
May 10
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The 2017 Canadian Biotech imperative:
remaining Competitive in the Face of Uncertainty
2016 was certainly an active year for the Canadian biotech ecosystem as several early stage Canadian companies including Northern Biologics, Zymeworks, Highland Therapeutics, Cynapsus and Innovative Targeting Solutions all hit milestones and enjoyed significant growth. Moreover, the federal Venture Capital Action Plan investment dollars began to flow into the industry through investments by Teralys, Lumira and CTI Lifesciences. And as 2016 came to a close, Versant Ventures and Bayer AG partnered to launch stem cell focused BlueRock Therapeutics. The momentum was carried over into 2017 as Versant closed its $400M USD healthcare VI fund with Teralys as an LP, and Zymeworks announced more growth with the addition of a new 10,000 square foot lab facility in Vancouver, BC. Commercially, these are all very positive developments which generated considerable buzz at the recent BIOTECanada Investor Summit in Whistler.
From a public policy perspective, the recently released federal Economic Advisory Council on Economic Growth’s report to the Minister of Finance put forward some important conclusions and recommendations in relation to Canada’s biotech sector. Established in March 2016, the Council was mandated to identify policy actions to support the conditions for long-term economic growth.
Importantly, the Report highlighted biotech-heavy sectors, life sciences and agfood, as two of the four “high potential sectors in terms of their economic prospects and their strengths relative to global opportunities.” The Report also provided recommendations on how to move these sectors from just ‘potential’ to ‘commercial reality’, highlighting the importance of developing measures to attract investment capital and talent. It is anticipated that the upcoming Federal Budget (now expected in early March) and the soon to be released Federal Innovation Agenda will begin the process of putting in place a strategy and corresponding measures to support the development and commercialization of life sciences and ag innovation. Yet, while the Canadian industry continues to grow and the government’s policy agenda looks to support that growth, macro economic and political events outside Canada stand to re-define the global industry’s operating environment. In particular, the dramatically changed and unpredictable U.S. political landscape is generating more questions than answers at this point. Questions like what will be the impact of a ‘tweaked’ NAFTA, immigration policy, and ‘buy America’ policy approach be for Canada? How will the Trump administration balance the objectives of supporting biotech innovation while simultaneously trying to reduce drug prices? What will the replacement plan for Obamacare look like and how will it impact the pharmaceutical industry? Depending on the answers, there may be some silver linings for Canada- immigration policies might make it easier to attract and retain top talent and other economic measures and approaches could result in capital migration in our direction.
At a minimum, the shifting sands underscore the importance of Canada ensuring it is globally competitive. The federal Budget and corresponding Innovation Agenda will be important steps towards driving biotech innovation forward. With the right hosting conditions and strategies in place, Canada’s vibrant biotech sector can build on the momentum and success of 2016 to establish itself as a destination of choice for both investors and talent.
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