Bio Business November/December 2016

regional profile Ideas without limits in Israel 14

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TPP and CETA impact life sciences 19

moments in time

Canada develops first Ebola vaccine 23

november/december 2016

Championing the Business of Biotechnology in Canada

Virus

Taking a bite out of Zika

Warfare

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Virus Warfare

Canadian researchers are at the forefront of the Zika response.

The Start-Up Nation

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Championing the Business of Biotechnology in Canada

Israel has a strong entrepreneurship gene and one of the world’s highest per capita ratios of bioscientists.

Canada’s Trading Future

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TPP and CETA’s ongoing influence on Canada’s life science industry.

standard regional profile Ideas without limits in Israel 14

laW

TPP and CETA impact life sciences 19

moments in time

Canada develops first Ebola vaccine 23

novEmBEr/dECEmBEr 2016

Virus

BIOPROCESSING

DavID SuzukI Maintaining the carbon dioxide balance

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Championing the Business of Biotechnology in Canada

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Taking a bite out of Zika

Warfare

Editor’s note 5 canadian news 6 worldwide news 7 moments in time 23

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Burying Monsanto could give GMO science a new lease on life

By Sylvain Charlebois

P

utting Monsanto out of its misery could mean future debate about geneticallymodified crops will be based on facts rather than emotion.

Monsanto is arguably the most detested company in the world. But now, Bayer’s acquisition of St. Louis-based Monsanto will likely mean the latter (or at least its brand) will slowly disappear.

Many suspect Monsanto intended to kill its brand and leave environmentalists looking for a new foe.

We have seen several acquisitions in the agrifood sector in recent months but this one is different. Germany-based Bayer AG and Monsanto Co. recently announced the acquisition at nearly US$130 a share, more than US$65 billion in total. The deal comes after months of discussions between the two companies.

The combined companies are an agricultural behemoth that will be the market leader on the three largest continents: North America, Europe and Asia.

From a business perspective, the acquisition makes sense. New markets can be developed for Monsanto’s products while Bayer gains access to considerable intellectual property in crop science and seeds. Bayer also gains a comprehensive portfolio of chemicals and products to help farmers increase yields.

Bayer’s brands will likely dominate the portfolio of products and it’s difficult to see how the Monsanto brand will survive over the long term.

A backdrop to all of this was the ever-increasing public outcry against Monsanto’s tactics. For years, company leaders seemed to think their sciencebased approach validated their goals. But they failed to properly engage the public until it was much too late.

Worldwide gatherings aimed to raise awareness about genetically-modified seeds, labelling and potential health risks caused by the use of unwanted herbicides. With the help of social media, the opposition gained steam. The state of Vermont, for example, made GMO labelling mandatory this summer and other states are considering following suit.

However, there is compelling science showing that genetically-modified crops are safe. So the anti-Monsanto movement seems less about GMOs than about the company itself.

Monsanto felt so confident about its science-based approach in a sciencedominated corporate culture that social optics were never really seriously considered.

Monsanto employs thousands of PhDs and researchers, and science has always been king. By having science on its side, the company seemed to believe there was no need to answer public concerns.

But adversaries of Monsanto’s business model have successfully exploited the fact that trust actually has more currency than science. That’s the golden rule when it comes to communicating about potential risk, and they ignored it.

Much too late, Monsanto recognized it had lost control over public perceptions and gaining social licence was impossible. The company had inadvertently polarized the two sides in the debate over genetically modified crops, to its own detriment.

Monsanto’s end will be met with delight from many environmentalists. But now it’s time for a rational conversation about biotechnologies.

Troy Media columnist Sylvain Charlebois is dean of the Faculty of Management and professor in the Faculty of Agriculture at Dalhousie University. © 2016 Distributed

by Troy Media

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Championing the Business of Biotechnology in Canada

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canadian news

New U of T Technique Pinpoints Cancer Cells

A research group led by Shana Kelley of the University of Toronto has developed a new method of characterizing circulating tumour cells (CTCs) that may help cancer biologists and clinicians understand how to use these cells to provide better treatment. CTCs are cells released by tumours and are often the source of metastatic tumours, tumours which spread and form in distant locations in the body. The technique Kelley and her group developed uses a high-resolution microfluidic device to separate cells into 100 different capture zones. A profile is generated that provides phenotypic information related to metastatic potential. Using this approach and monitoring cells generated in animal models of cancer and in samples collected from prostate cancer patients, the properties of CTCs were shown to evolve and become more aggressive as tumours became more advanced.

New HR Strategy for PEI Bioscience Sector

Mississauga Mayor Officially Welcomes CPDN

Employees of BioVectra, the largest bioscience employer in PEI.

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Sav DiPasquale, President, Canadian Pharmaceutical Distriubtion Network (CPDN), welcomed more than 50 guests to the organization’s 2016 AGM and open house event October 17 at its new corporate offices in Mississauga, ON. In attendance were member manufacturers, strategic partners, third party service providers, industry associations and special guest, Her Worship, Bonnie Crombie, Mayor of Mississauga. The mayor, in addition to extending a warm welcome to CPDN, spoke of her commitment to the growing life sciences sector in Mississauga, a leadership position the city holds as one of the top biopharmaceutical hubs in North America.

Award for Hep C Pill

Gilead Sciences Canada has received the 2016 Prix Galien Canada – Innovative Product Award for its Havroni tablet. It is the first daily single tablet regimen for the treatment of chronic genotype 1 hepatitis C virus infection in adults. Since its approval in 2014, 13,000 patients in Canada have been treated with Havroni. Prix Galien Canada’s Innovative Product Award is presented to a company that has developed and launched a drug product in the Canadian market, and has made the most significant overall contribution to patient care in Canada in terms of innovation, efficacy, safety and therapeutic benefits.

The PEI BioAlliance has unveiled a new HR strategy for the province’s bioscience sector, focusing on actions to maintain a high level of recruitment and retention success, HR support for companies, skills development, and community outreach.

Prince Edward Island’s 47 bioscience companies have added almost 1,000 jobs over the past decade, with over $200 million in export sales, and the sector currently employs over 1,400 people. These companies work in the development and commercialization of products ranging from functional food ingredients to pharmaceuticals, animal and fish health products, and diagnostics.

“Bright minds have many career opportunities. Whether they are PEI graduates in science or business, or skilled individuals from another part of the world, we want our employers to be able to attract and retain the best talent possible,” says Vivian Beer, the BioAlliance HR Prince Edward Island’s 47 bioscience Strategy Manager. companies have added almost 1,000 jobs “That’s what this strategy is all about.” over the past decade, with over $200 Beer says there million in export sales, and the sector is a high level of currently employs over 1,400 people. collaboration within the PEI bioscience sector and HR is a team effort. “Holland College, UPEI, our federal and provincial government partners, our PEI network of employers – everyone works together to support students and job seekers, as well as companies’ recruitment and training requirements.” The BioAlliance also has a partnership with BioTalent Canada, providing access to national compensation data to ensure PEI is offering competitive compensation and benefits packages.

The new HR strategy will support other strategic priorities laid out in the cluster’s 2020 strategy for growth, including new incubation and manufacturing scale-up facilities, business attraction, strengthening business-academic collaborations, and achieving national recognition as an important element of Canada’s innovation ecosystem.

worldwide news

Growing Rice in Salty Conditions

Identifying Genetic Markers

An international team of researchers have analyzed the genomes of 41,000 people in an attempt to isolate the genetic variations that increase risk for schizophrenia. The study, which was led by Jonathan Sebat of the University of California San Diego School of Medicine and involved over 260 researchers from around the world, is the largest genome-wide study of its kind to date. It revealed several regions of the genome where mutations increase schizophrenia risk between four- and 60-fold. These mutations, known as copy number variants, are deletions or duplications of the DNA sequence. A copy number variant may affect dozens of genes, or it can disrupt or duplicate a single gene. This type of variation can cause significant alterations to the genome and lead to psychiatric disorders.

Sebat and others had previously discovered that relatively large copy number variants occur more frequently in people with schizophrenia than in the general population.

Researchers Study Tiny Hunters

Zika Studies Reinforce Link Between Virus and Birth Defects

Three new studies reporting on the effects of the Zika virus outbreak in Brazil were recently presented at the annual meeting of the Radiological Society of North America (RSNA). The first study looked at CT findings of the central nervous system in 16 newborn babies with congenital Zika virus infection confirmed by tests in cerebral spinal fluid. Another study analyzed the imaging results of three target groups affected by Zika: adults who developed acute neurological syndrome, newborns with vertical infection with neurological disorders, and pregnant women with rash outbreaks suggestive of Zika. In the third study, ultrasound and fetal MRI were performed on pregnant patients with Zika virus infection at different gestational ages. The researchers then created 3-D virtual and physical models of the skulls of babies once they were born and found that more than half of them had microcephaly, brain calcifications and loss of brain tissue volume, along with other structural changes. Zika appears to be most dangerous when transmitted from a pregnant mother to her fetus during the first trimester of pregnancy.

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A state-of-the-art plant research facility in Australia is helping develop effective crop production strategies across the globe. The Plant Accelerator in Adelaide, Australia, studies the physical biochemical traits of various plants and has automated processes that allow it to do those studies quickly and monitor thousands of plants a day. The Plant Accelerator consists of several kilometres of conveyor belts where plants sit in little carts and travel around to be photographed and measured. The facility studies up to 2,400 plants a day and uses a range of different cameras to measure temperature, water absorption, colour, shoot mass, size, health and physical traits of plants.

The facility has allowed outside access for international organizations and one such group took them up on the invitation. A team of researchers led by King Abdullah University of Science and Technology (KAUST) in Saudi Arabia recently used the Plant Accelerator to discover a rice gene that helps it grow in salty conditions. A number of researchers from the University of Adelaide and University of South Australia were also involved in the study.

The Plant Accelerator in Bettina Berger, Scientific Adelaide, Australia, studies the Director at the Plant physical biochemical traits of Accelerator, says the various plants and has automated discovery of the gene means it has the potential processes that allow it to do be extracted and those studies quickly and monitor to transferred to other thousands of plants a day. varieties.

“Having the Plant Accelerator means we don’t have to kill the plants, cut them off, put them on scales and weigh them, which is what traditionally you had to do,” she says. “We grew over 500 genotypes of rice for this study and looked at the one that grew best under salt, ultimately finding the gene that was more salt-tolerant.”

The study still needs to conduct field trials, but Berger anticipates it should be possible to use rice as a model plant for other cereal plants such as wheat and barley, and see whether the same gene is present there and if it has the same effect.

Diplonemids are the ocean’s tiniest predators. The singlecelled microbes are the most abundant protozoa in the ocean. Despite their abundance, they have never been captured or observed directly in the ocean. A team of scientists from the University of British Columbia and the Canadian Institute for Advanced Research (CIFAR) sailed from the Monterey Bay Aquarium Research Institute in California to a well-studied part of the ocean known as Line 67. There, they were able to photograph organisms from deep-water samples and use technology to sequence the genomes of the diplonemids. Their research showed that diplonemids are a diverse group of species of many different shapes and sizes, and that they hunt both bacteria and larger algae.

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regional profile

The Start-Up

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regional profile

With a strong entrepreneurship gene and one of the world’s highest per capita ratios of scientists in life sciences, ideas know no limits By hermione wilson

f asked to describe the Israeli life science sector in one word, one would probably choose “entrepreneurial”.

In a country that is slightly smaller than the state of New Jersey, there are more than 1,000 life science start-ups. According to Teva, a major Israeli pharmaceutical company, Israel ranks first in the world for gross domestic expenditure on R&D and leads globally in venture capital (VC) investment per capita.

Israel also has among the largest number of companies listed on the NASDAQ, behind the U.S. and China.

“Almost 50 per cent of the industrial export of Israel is derived from the technology [industry] - high-tech and life science,” says Karin Mayer Rubinstein, CEO of Israel Advanced Technology Industries (IATI), an umbrella organization for the technology and life science industries.

“There is a lot of innovation going on in Israel,” she says. There is a culture of entrepreneurship in Israel, she says. “[It’s a] culture of ‘It’s OK to fail.’”

Rubinstein relates that entrepreneurial spirit to Israel’s military culture, pointing to the fact that the Israel Defence Force’s medical unit was recently ranked number one in the world by the United Nations despite the country’s location in the turbulent Middle East.

“We are the only democracy in the Middle East and I always say that the constant threat looming [encourages] a higher awareness,” Rubinstein says, “We always think, how can we develop? How can we invent? How can we have more innovation?”

IATI has a mandate to expand and promote the technology and life science industries in Israel and worldwide. It works closely with the government, and supports life science start-ups and mature companies, as well as the

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regional profile

Above top and right: Researchers at Pluristem in Haifa, Israel.

Middle and bottom: Life science events held by Ramot.

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technology transfer entities at academic institutions and hospitals.

“One of our main goals is to facilitate bringing multinational life science companies to Israel,” Rubinstein says. “We have 300 high-tech multinationals… but when we’re talking about life science multinationals, their R&D activities are not in Israel.” Multinationals in Israel mainly scout life science start-ups for opportunities for investment and collaboration, she says.

IATI has more than 700 member companies in Israel, including entrepreneurs, start-ups, incubators, accelerators, R&D centers, multinationals, VC funds, private investors, technology transfer organizations (TTOs), and service providers.

Pluristem is one of those members, an Israeli biotech company that is developing stem cell therapies derived from placental cells. The cells in placenta obtained after full delivery has the ability to treat a variety of conditions in patients, according to President and COO Yaky Yanay.

“The placenta contains very young and very potent cells in very high numbers,” Yanay says. “We were able to demonstrate that once we inject our cells into the patient’s body, we started to see that our cells were getting signals from the body… and based on these signals, the cells start to secrete a variety of different proteins… that are helping the body toward recovery.”

Pluristem currently has three indications in phase III clinical trials based on placental cells: an indication for critical limb ischemia (CLI); another for older patients who are prone to falls, for which Yanay says phase II studies showed promising results in terms of muscle force and volume; and a third for treating acute radiation syndrome in the event of a nuclear catastrophe. The U.S. government is stockpiling Pluristem’s cells in case of such an event.

regional profile

I’m seeing more and more companies trying to move to the next level… to become real biotech companies. Ten years ago none of the Israeli companies – other than Teva, for example – did phase III studies. But today my company alone is launching three phase III studies and I see a good number of my colleagues doing the same thing.

– Yaky Yanay, President and COO of Pluristem of respiratory, oncology and women’s health. Along with being a major player in Israel, the company is also strongly established in Canada. It has offices in Ontario and Quebec and more than 120 million Teva prescriptions are filled in Canada annually.

Bridging the gap between life science innovation at the academic and early-stage level and well-established life science companies are Israel’s commercialization companies, or TTOs. Ramot is one such company, based at the prestigious Tel Aviv University.

The company, which is a fully owned subsidiary of Tel Aviv University, is able offer from $50,000 to $1 million worth of support to entrepreneurs and academics at the university, as well as resources such as project management, IP consulting, business development. All this is made possible by the company’s own full profit fund, which it runs like a VC, as well as government support and the financial backing of multinationals Tata and Temasek, acting as anchor investors.

“Essentially, if you’re a scientist at Tel Aviv University, you have a continuum of support,” says Shlomo Nimrodi, CEO of Ramot. Not all assets make it to the $1 million investment, he says, but along the way Ramot decides to either license the asset to a multinational corporation or establish a start-up company in Israel.

Nimrodi estimates they sign between 30 to 40 licensing deals (not all are life science related) about 25 to 30 per cent of those become Israeli start-ups.

“What’s unique about what we’re doing at Tel Aviv University, compared to other universities… we basically take very seriously our early stage innovations and we handpick those that have the most promising future,” Nimrodi says. “We invest within the boundaries of the campus of the university; we invest in enhancing the value of these assets.”

Yaky Yanay, President and COO of Pluristem.

Karin Mayer Rubinstein, CEO of Israel Advanced Technology Industries (IATI).

Shlomo Nimrodi, CEO of Ramot at Tel Aviv University.

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Pluristem is being funded by the U.S. government for that last indication, and the company is collaborating with the National Institutes of Health (NIH).

Pluristem eventually wants to adapt a treatment to help cancer patients undergoing chemotherapy.

As a member of the IATI, Pluristem President Yaky Yanay says he sees it as his job to help promote the life science industry in Israel. “I believe that Israel in a very unique position... switching from being a start-up nation and my role is to help Israel become a biotech nation,” he says. “I think that we have a huge potential to provide a lot of good technology to the world in order to [increase] quality of life.”

“I’m seeing more and more companies trying to move to the next level… to become real biotech companies,” Yanay says. “Ten years ago none of the Israeli companies – other than Teva, for example – did phase III studies. But today my company alone is launching three phase III studies and I see a good number of my colleagues doing the same thing.”

There is certainly no speaking of the life science sector in Israel without discussing Teva’s role in the Israeli pharmaceutical sector. The company was founded in Jerusalem in 1901 as a small wholesale drug business that distributed imported medications to the local population and later began to produce them. Today, Teva is one of the top 10 pharmaceutical companies in the world, serving more than 200 million patients per year and holding a top three position in 40 of the markets in which it operates.

Teva is known for its speciality pharmaceuticals used to treat central nervous system conditions such as multiple sclerosis, pain, migraines, movement disorders and neurodegenerative diseases. It also has a strong commercial presence in the areas

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regional profile

Recently, Ramot announced the establishment of an “Internet of Things” initiative to be based on the Tel Aviv University campus, which will undoubtedly have implications for health innovation.

More Israeli life science facts…

The life sciences represent about 60 per cent of all academic research publications in Israel, originating from the country’s seven universities, 10 research institutions, 5 medical schools and many cutting-edge medical centres.

Israel has one of the world’s highest per capita ratios of scientists in life sciences, with 1 out of every 3 Israeli scientists specializing in this area.

Israel has 6 Nobel Prize winners in the last decade, including 4 in chemistry.

Teva’s plant in Jerusalem, Israel.

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Among the assets Ramot has fostered are a blood test used to diagnose breast and lung cancer, a company that analyzes patients’ DNA sequence in order to advise them on lifestyle and health choices, and a technology that could see in vitro fertilization become an automated and more accurate process.

Recently, Ramot announced the establishment of an “Internet of Things” initiative to be based on the Tel Aviv University campus, which will undoubtedly have implications for health innovation, Nimrodi says.

“Just imagine if you were wearing a shirt and the shirt could continuously send a signal on your vital indicators like heart [rate], blood pressure, et cetera,” he says. “God forbid something goes wrong, your physician or loved ones will get a message saying, ‘Hey, better check on so-and-so.’”

The initiative will involve an investment fund comprised of five multinationals including GE, Microsoft, QualComm, Tata, and China’s HNA. Tel Aviv University and Pitango Veture Capital, Israel's leading Venture Capital fund, are also supporting the fund. So far,

the investors have raised $20 million, which will be followed up by in-kind contributions to entrepreneurs.

“It will allow us to actually offer Tel Aviv [University] students that are seeking to innovate... an investment of up to $1 million, but more importantly, we will offer them access to the multinationals so that can get to market much faster, which means lower risk and a higher probability of success,” Nimrodi says, adding that the initiative will be open to students outside of the university as well.

“Everybody is very opportunistic here and if they see a good idea, they jump on it,” says Tamir Gedo, CEO of BOL Pharma. The company supplies medical cannabis and active pharmaceutical ingredients derived from cannabis to companies and research organizations.

“The entrepreneurship gene here is very strong... the ideas are boundless,” Gedo says. “I couldn’t find some specialization that is leading the biotech sector [in Israel]. I would say actually it’s very fragmented. This is the beauty and at the same time the weakness of the Israeli system.” BB

Israel has a high concentration of engineers and scientists, as well as quality academic research.

The country has 4 universities with computer science programs ranked in the top 30 globally.

Courtesy of Teva

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Canadian researchers at forefront of Zika response By hermione wilson

s with Ebola, Canadian researchers have once again stepped up to the plate, developing new and innovative ways to prevent, treat and vaccinate against the Zika virus. Although Zika may never reach Canadian shores, there has been a movement in the life science sector to rise to the challenge and provide help to countries that are struggling to contain it.

“We feel an obligation to mobilize in emerging infectious disease issues like Zika, because we can,” says Rick Galli, Chief Technical Officer at bioLytical. The British Columbia-based company is developing two new Zika detection methods, for which it has filed patents in the U.S. The Zika test is based on the company’s INSTI platform, which is geared to the detection of HIV. BioLytical’s INSTI is an immunofiltration platform that is able to produce on-thespot results in about 60 seconds. For the Zika virus, the company has developed two approaches: the first is a standard screening test that is sensitive to Zika but may also have some cross reactivity to other flaviviruses like Dengue, Galli says. That makes it ideal for populations who have never been exposed to the disease, he says, such as the U.S. For areas in South America and the Caribbean where Zika and other flaviviruses have been prevalent for some time, a broad test doesn’t work as well, Galli says. That’s where the second approach comes in. “The second iteration [of the test] is to look for a specific IgM [Immunoglobulin M] marker which is present only in the acute phase of infection, so it’s more of a diagnostic tool as opposed to a screening tool,” he explains.

Dealing with the Ebola outbreak in 2013 and the ensuing scramble to develop an effective vaccine proved to be an instructive experience for regulatory bodies around the world. They have made sure that more funding opportunities and support are available this time around. In the U.S., the FDA has developed an emergency use regulatory process designed to prioritize Zika treatments, which Galli says bioLytical is aiming for. The World Health Organization has a similar process, called The WHO Emergency Use Assessment and Listing (EUAL) procedure.

The U.S. Health and Human Services’ Biomedical Advanced Research Development Authority (BARDA), as well as groups associated with the National Institutes of Health (NIH), have allocated priority funding to assist in the development of Zika treatments, Galli says.

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In Canada, the Canadian Institutes for Health Research (CIHR), in partnership with the International Development Research Centre (IDRC), set up the Canada-Latin AmericaCaribbean Zika Virus Program in order to invest in groups developing diagnostics for the virus, researching the pathology of the virus, and working to prevent Zika’s transmission.

Grand Challenges Canada, an organization that is fully funded by the government of Canada, teamed up with the Consortium for Affordable Medical Technologies (CAMTech) for a competition designed to accelerate the development and commercialization of innovations addressing the Zika crisis.

In May 2016, Grand Challenges Canada and CAMTech presented the Zika Innovation Awards, which recognized six innovative projects with a prize of $25,000 each. One of those recipients was Dr. Alex Brolo of the University of Victoria, for his low-cost biosensor for Zika screening. Brolo’s device uses nanoparticles of gold to detect the presence of the Zika virus in saliva.

“We basically prepare these gold nanoparticles, we immobilize them in glass, and then we coat the particles with a protein that is related to the Zika virus,” he says. “When you expose that strip... to the saliva of someone that is [infected], the antibodies that the person has in their saliva is going to attach to the surface. When this happens, there is a small colour change on the strip that we detect with a reader.”

“Every year in Brazil is the same thing,” says Brolo, who grew up in Sao Paulo. “Summer starts, you start to see the

Top: Alex Brolo has developed a cheap, easily administered Zika screening test for health workers in Brazil.

Bottom: Gary Kobinger speaks at the University of Laval.

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Original Zika virus papers found in University of Glasgow Archive

Original research documents belonging to Alexander Haddow, who was a key member of an investigative team that first identified the Zika virus in the forests of Uganda in 1948. Top: Images of monkeys drawn by Haddow; Middle: Haddow and his colleagues under a tower used to capture mosquito data; Bottom: Handwritten graph of mosquito distribution in relation to the tower. Courtesy of the University of Glasgow’s Alexander Haddow Zika Collection.

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news about the mosquitoes and it’s always the same thing going on over and over again.” He remembers health workers going from house to house looking for mosquitoes and handing out educational brochures.

“These diseases like Zika and Dengue and this kind of stuff, there is no specific treatment or vaccine or anything like that, so the solution for those things is to kill the mosquitoes,” he says. “That’s what people do and having been doing for the last 500 years.”

Brolo contemplated how he could make health workers’ jobs easier and improve the response time of the Brazilian government to these types of outbreaks. “These guys who go door to door... are not nurses or medical doctors or anything like that, so they cannot handle blood,” Brolo says. He knew he had to make his detection test easy to administer and give health workers the ability to get fast results. Using saliva instead of blood was one way of doing that; adding a geolocation feature to the device was another.

“The idea in the end is to do the reading of the result of the test on-site and hopefully get that connected to a cell phone, for example, that can upload the result in real-time... to generate a real-time map of the infection [and] how it is spreading,” he says.

The $25,000 grant from Grand Challenges Canada and CAMTech allowed Brolo and his team to develop a proof of concept, but their financial needs did not end there. They used that proof of concept to attract partners and investors who would help them reach the next stage of development, Brolo says. They hope to have Zika screening strips ready to send to Brazil for initial testing by the end of 2016.

Brolo and his group at the University of Victoria are also working with a group in the U.S. to develop a simple way to detect mosquito larvae, again incorporating a way to geolocate the position of mosquito breeding grounds. The detection method would involve taking a picture of standing water and using recognition software to identify what type of mosquito larvae were present. They received a separate Grand Challenges Canada grant for this project.

For Gary Kobinger, Director of the Infectious Disease Research Centre (IDRC) at Université Laval and leader of the first group to conduct human clinical trials on a Zika vaccine, the hardest part of developing a vaccine hasn’t been the clinical work, but the paperwork.

“The clinical protocol is a massive amount of information to assemble and submit to regulatory agencies," Kobinger says.

While Kobinger’s team was preparing the clinical protocol for both the FDA and Health Canada for the phase I human clinical trial, partners at the University of Pennsylvania were securing a strain of the virus through a pipeline they developed in Philadelphia, born out of their experience with West Nile Virus.

“On our side, we were advancing the animal model, knowing that at one point we would need to do what’s called a challenge experiment where we vaccinate the animal and then we expose them and infect them, and we can see if they’re protected or not,” Kobinger says of his team at Laval.

The Zika vaccine the Laval group is working on is being sponsored by Inovio Pharmaceuticals and GeneOne Life Science. Two other sites, at the University of Pennsylvania

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and the University of Miami, will also be conducting human clinical trials.

It was Kobinger and his colleague David Weiner of the University of Pennsylvania who first had the idea of developing a Zika vaccine. They started to seriously look into a vaccine in the fall of 2015, hoping to get something in the works before it became a problem in South America and the southern U.S. “The vaccine is based on DNA that expresses only... a unit or part of the virus of interest,” Kobinger says. “[Weiner’s team] knew from West Nile studies which part of the virus was the most likely or promising in terms of making a vaccine.”

After three months of working separately on different aspects of the vaccine, the animal models were ready to go and they knew that the vaccine was immunogenic, meaning it generated an immune response, though they did not yet know whether it was protective or not. In the meantime, their clinical timeline was moving on schedule. Kobinger says they were able to accomplish all this, and get approval from the FDA and Health Canada, in about eight months. All in all, the process was smooth and rapid.

“What takes time is to assemble this package to submit our hundreds and hundreds of pages,” Kobinger says. “To assemble all the information related to a vaccine that is to be tested in humans is very demanding.”

He also notes that they weren’t able to get much financial support from agencies in Canada or the U.S. because of how early they started. In the U.S. there was an open call for Zika vaccines, Kobinger says, but the open call for vaccines in Canada came too late.

“I don’t mean this as a criticism,” he says. “Those funding opportunities take time for funding agencies to assemble.”

Kobinger and his colleagues ended up organizing the three project sites in Quebec, Philadelphia and Miami with Inovio and GeneOne, without the help of any government agencies.

Their commercial sponsors will bear the brunt of the vaccine development costs.

The response to calls for Zika treatments and vaccines

The vaccine is based on DNA that expresses only... a unit or part of the virus of interest.

[Weiner’s team] knew from West Nile studies which part of the virus was the most likely or promising in terms of making a vaccine.

– Gary Kobinger, Director of Infectious Disease Research Centre (IDRC) at Université Laval

has highlighted the work pharmaceutical and biotechnology companies are doing to support innovation in this area. This work isn’t always necessarily tied to a company’s bottom line, says Elizabeth Bailey, Director of CAMTech at the Massachusetts General Hospital Center for Global Health, but they do reap rewards in the form of reputation and greater relationships with stakeholders.

“They really recognize that they have an important role to play, partly in providing funding but also in providing engagement and expertise,” Bailey says of CAMTech’s commercial partners in the life science sector. “It’s been encouraging to see them take a more active role in things that don’t necessarily impact their business per se, but because they sit in the healthcare space, they want to be seen as being part of this broader coalition trying to make a difference and trying to address these different types of public health crises.” BB

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Canada’s Trading TPP and CETA’s impact on Canada’s life science industry

By Scott Foster and John Norman

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Future

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n the Fall of 2016, significant global political issues affected the future of two important treaties for Canada: the TransPacific Partnership Treaty and the Canada-European Union Comprehensive Economic and Trade Agreement.

Both the TPP and CETA included significant changes to pharmaceutical and patent laws in Canada. In the January/ February and March/April editions of Bio Business, we discussed the opportunities that TPP and CETA respectively afforded to Canada and biotech related industries in Canada.

However, recent events in Europe and the United States have had an impact on both of these treaties and so it is helpful to look at the progress of CETA and TPP since the earlier articles and to re-evaluate how they may impact Canada going forward.

Canada-European Union Comprehensive Economic and Trade Agreement

CETA was signed by both Canada and the European Union in October 2016. Many readers will recall the high profile last minute objections raised by the parliament of Wallonia (a region of Belgium). Fortunately, last-minute negotiations convinced Wallonia to withdraw its objections and Belgium approved the Council of the European Union to sign CETA. On October 30, 2016, Prime Minister Justin Trudeau, Donald Tusk, President of the European Council, and Jean-Claude Juncker, President of the European Commission, officially signed CETA in Brussels.

CETA is likely to lead to changes to the laws of Canada that will have a beneficial impact on biotech-related industries in Canada. These may include: • Restoration of the duration of patents covering pharmaceutical products where “unreasonable curtailment” of the patent term occurs during the marketing approval process of the pharmaceutical products. The objective is to provide additional patent protection to permit the patentee to recover some of the expensive research and development costs associated with developing pharmaceutical products; and • Replacement of the current dual-track system of patent litigation for pharmaceuticals where summary proceedings under the Patented Medicine (Notice of Compliance) Regulations are often followed by actions for patent infringement. Under CETA, it is likely PMNOC proceedings will be replaced with full actions that will result in a final determination of patent infringement and validity including an opportunity for innovator companies to appeal a negative decision.

Trans-Pacific Partnership Treaty

The TPP involves 12 countries: Canada, the United States, Japan, Malaysia, Vietnam, Singapore, Brunei, Australia, New Zealand, Mexico, Chile and Peru. It would create a freetrade zone around the Pacific Ocean. On October 5, 2015, the

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parties to the TPP announced the conclusion of negotiations on the TPP and on February 4, 2016, the parties signed the TPP Agreement in New Zealand.

The January/February 2016 edition of Bio Business outlined the opportunities that the TPP, if ratified, might provide to biotech related industries in Canada. Some of the provisions in TPP are similar if not identical to the provisions of CETA. However, TPP included some unique provisions not in CETA such as:

tireless perseverance to negotiate and sign CETA despite the length of time it took and the last-minute obstacles is something that ought to be applauded. The implementation of CETA in Canada is likely to be a benefit for biotech-related industries in Canada which is welcome news. In contrast, the potential death of TPP is unfortunate, and its ratification would have been a further benefit for biotech-related industries in Canada. BB

(i) an extension to the term of patents where “unreasonable” delays occur in issuing the patent by the Canadian Intellectual Property Office; and

John Norman, is Partner, Life Sciences Industry Group Leader, Gowling WLG (Ottawa). He can be reached at John.norman@gowlingwlg.com. Scott Foster is Partner, Gowling WLG (Vancouver). He can be reached at Scott.foster@gowlingwlg.com.

(ii) a new data protection period of a minimum of three years for new clinical information submitted for new formulations, indications, or method of administration, of approved pharmaceutical products.

However, since the election of Donald Trump as the next president of the United States, the future of TPP is in doubt. Trump ran on an anti-free trade agenda that publicly promised to block the TPP. As such, the United States may not approve the TPP and without the backing of the U.S. it will not be ratified. Accordingly, the provisions that are in TPP and not in CETA are therefore likely to not end up, for the time being anyway, being implemented in Canada. This is unfortunate as the benefits to research and development in Canada derived from patent term restoration and enhanced data protection regimes are well understood both in the United States and Europe where similar laws are already in place.

CETA took approximately seven years from the start of negotiations to the signing of the agreement in 2016. Canada’s

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The implementation of CETA in Canada is likely to be a benefit for biotech-related industries in Canada which is welcome news. In contrast, the potential death of TPP is unfortunate, and its ratification would have been a further benefit for biotech-related industries in Canada.

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n July 31, 2015, Dr. Marie-Paule Kieny, the Assistant Director General of Health Systems and Innovation at the World Health Organization (WHO), presented the interim results of a VSV-ZEBOV clinical trial at a press conference.

A single dose of the experimental Ebola vaccine, which was developed by NewLink Genetics and Merck Vaccines USA in collaboration with the Public Health Agency of Canada, was shown to be 100 per cent protective against Ebola after 10 days in a study published in the Lancet. “We believe that the world is on the verge of an efficacious Ebola vaccine,” Kieny said in 2015. A bold statement, but then VSV-ZEBOV, nicknamed “the Canadian vaccine”, has earned that distinction after the success of its initial clinical trials, conducted in the field in Guinea during the height of the Ebola crisis. Although international regulatory bodies still need to be convinced of the VSV-ZEBOV’s safety, the development of the first vaccine against Ebola is an unprecedented development and one in which Canada can take great pride. BB

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