Security
How innovation and global competition add risk 15
Regional Profile
Quebec partners with Boston and launches new strategy 18
Moments in Time
Dr. Bram Rose establishes allergy and immunology as a specialty 23
july/august 2017
Championing the Business of Biotechnology in Canada
The
Problem with
A pharma perspective on the opioid crisis
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inside
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RISK MANAGEMENT
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REGIONAL PROFILE: QUEBEC
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Protecting the life sciences industry from the hazards of globalization and new technologies.
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OPIOID CRISIS MODE
Understanding the place of pain-relieving opiate medications and their misuse. Where do we go from here?
Championing the Business of Biotechnology in Canada
Industry and government are going hands in their efforts to attract foreign investment to Quebec.
standard Security
How innovation and global competition add risk 15
regional Profile
Quebec partners with Boston and launches new strategy 18
MoMentS in tiMe
Dr. Bram Rose establishes allergy and immunology as a specialty 23
july/august 2017
DaviD Suzuki Research sheds dark light on oil and gas
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Championing the Business of Biotechnology in Canada
Lab ProfiLe The DefiniTive Source for Lab ProDucTS, newS anD DeveLoPmenTS
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July/August 2017
Aerobiology’s 33 sample sites keep tabs on our air
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Bio Genius
The
Problem wiTh
Editor’s note 5 canadian news 6 worldwide news 7 moments in time 23
A pharma perspective on the opioid crisis
Tasnia Nabil’s simulation model could revolutionize cancer nanotherapy
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editor’s note
Publisher & CEO Christopher J. Forbes cforbes@jesmar.com Executive Editor Theresa Rogers trogers@jesmar.com Assistant Editor Hermione Wilson hwilson@jesmar.com CONTRIBUTORS
Frank Goudsmit Kimberley Higgins
art director Katrina Teimo kteimo@dvtail.com graphic designer Houman Hadidi hhadidi@dvtail.com Secretary/Treasurer Susan A. Browne marketing Stephanie Wilson manager swilson@jesmar.com vp of production Roberta Dick robertad@jesmar.com production Stephanie Bellows COORDINATOR sbellows@jesmar.com
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A National Crisis I
n May, the Canadian Medical Association (CMA) released new guidelines for doctors prescribing opioids. Dr. Granger Avery, CMA President, said, “As prescribers, physicians recognize that opioids can be important therapeutic tools in the treatment of pain as well as the fact that we have a fundamental role in helping to ensure their evidence-based use. We take that role very seriously and Canada’s physicians are deeply concerned about the potential harms of opioids.” While opioids have been an essential tool for alleviating patient suffering, there are undeniable problems. Brand new stats from the Canadian Institute for Health Information (CIHI) reveal the number of Canadians affected by the opioid crisis continues to climb. New stats show that an average of 16 Canadians were hospitalized every day between April 1, 2016, and March 31, 2017, due to opioid poisoning. This is a 19% increase from two years ago, when 13 people were hospitalized every day. These numbers do not include people who went to the emergency department (ED) without being admitted or who died before arriving at the hospital. There is no quick fix. Our feature on p. 8 shows pharmas are researching how to accurately measure pain, how to identify people who do not benefit from opioids or are harmed by them, who is prone to misusing the drugs, what kind of tolerance people have to the drugs, and what kind of alternatives can be developed. Citing data of 2,816 apparent opioid-related deaths in Canada in 2016, the federal government says it recognizes this crisis and has identified it as a key priority. It has pledged money, announcing an investment of $7.5 million from the Canadian Institutes of Health Research (CIHR) to support practical research interventions to prevent opioid overdoses, treat those living with opioid dependency, and promote harm reduction. (The government previously announced a new investment of $100 million over 5 years, and $22.7 million ongoing, to support national measures associated with the Canadian Drugs and Substances Strategy, as announced in Budget 2017.) The Canadian Research Initiative in Substance Misuse (CRISM) will use the funding to study how to best integrate evidence-based interventions into practical settings. Research will focus on expanding public health interventions such as safer consumption services and delivery of naloxone; optimizing treatments for opioid use disorder, such as oral and injectable drug treatments; improving the evidence base for managing withdrawal and recovery treatment options; and collaborating with stakeholders to develop new intervention approaches that meet the needs of high-risk populations. The real work is just beginning. The CMA, the federal government and pharma have all called for greater collaboration in the search for solutions. CIHI will release the report, Pan-Canadian Trends in Opioid Prescribing, later this year as part of its ongoing analytical work on this topic. The numbers are sure to get worse, before they get better.
Theresa Rogers
executive Editor
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Championing the Business of Biotechnology in Canada
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canadian news
Newly discovered protein improves heart function
A newly discovered protein called cardiotrophin 1 (CT1) can trick the heart into growing in a healthy way and pumping more blood, just as it does in response to exercise and pregnancy. According to results published in Cell Research, a team made up of researchers from The Ottawa Hospital, the University of Ottawa, the University of Ottawa Heart Institute and Carleton University were able to show that CT1 can repair heart damage and improve blood flow in animal models of heart failure. Heart muscle cells treated with CT1 became longer, healthier fibres, while those treated with a drug called phenylephrine (PE) (known to cause the bad kind of heart growth that leads to heart failure) just grew wider. CT1 causes blood vessels to grow alongside the new heart muscle tissue and increases the heart’s ability to pump blood, while PE does neither.
New technology helps speed up fruit trade
Companies reach funding milestone
Two Canadian biopharmas are being held up as models of success for the industry after completing IPOs this summer. Zymeworks completed its IPO in June and Montreal-based company Clementia Pharmaceuticals completed a US$120 million IPO on the NASDAQ in August. Prior to this, both Clementia and Zymeworks raised more than $200 million in the last 18 months from Canadian and international investors. BDC Capital, the investment arm of BDC, was the flagship investor for both of the companies, a founding investor for Clementia, and led the mezzanine and IPO rounds for Zymeworks.
Biotechnology improves cotton crop yields bio business J U LY/a U G US T 2 0 1 7
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Performance Plants Inc. (PPI), a leading developer of agricultural biotechnologies for crop improvement worldwide, has announced that the company has reached an important crop performance target in the development of drought tolerant and high-yielding cotton for the Bayer Crop Science product development pipeline using PPI’s Yield Protection Technology (YPT). The YPT technology enables crops to maintain maximal yields through protection against yield losses sustained under suboptimal rainfall or periodic drought conditions while showing no yield drag under optimal water conditions. Over the course of three years of field trials under multiple environmental conditions, YPT cotton has shown significant yield advantages over its controls. This positive crop performance data propels the continued advancement of this technology in Bayer’s cotton product development and commercialization pipeline.
The current process that Canadian fruit growers go through in order to export their plants takes an average of three years. The process, which includes the testing and quarantine of fruit plants by the Canadian Food Inspection Agency (CFIA), significantly hampers the speed of trade. Recently, Lawrence MacAulay, Canada’s Minister of Agriculture and Agri-Food, announced that CFIA will lead two projects worth $500,000 that use new DNA-based technologies to reduce quarantine testing time. The first project will dramatically shorten the testing period of seeds, cuttings and bulbs imported into Canada to grow new varieties of plants. With this funding, scientists will use DNA technology to test for all viruses associated with imported plants to get an early indication of any plant diseases present. This approach could reduce the quarantine testing time by up to two-and-a-half years. The second project streamlines the testing of strawberry plants. Traditionally, multiple tests for viruses are required before exporting strawberry plants to foreign markets. This project will test for multiple viruses in one single test, dramatically reducing the time and cost to get plants to market. “Canadian import/export markets will be stronger and more competitive because of these genomics-based tools,” says Catalina Lopez-Correa, Chief Scientific Officer and Vice President at Genome British This project will test for multiple Columbia. “Early detection of viruses in one single test, pathogens and viruses is a vital dramatically reducing the time outcome of genomics and it is being applied across many key and cost to get plants to market. economic sectors.” Funding for these projects is provided through a partnership between the CFIA, Genome British Columbia, Summerland Varieties Corporation, Phyto Diagnostics, the British Columbia Cherry Association, and Vineland Research and Innovations Centre.
worldwide news
MilliporeSigma collaborates on vaccine research
Antifreeze could aid in safe organ transplantation
Researchers from the Department of Chemistry at Warwick Medical School have developed an iron-based synthetic imitation of naturally occurring antifreeze proteins (AFPs), which have been shown to slow the growth of ice crystals. The researchers suggest that these antifreeze properties are a result of the iron complex containing separated regions with water-loving and water-hating characteristics, which mimics the properties observed in AFPs. The ability to prevent the growth of ice crystals could be of huge technological importance across a range of applications, from the protection of aeroplane wings and wind turbines from ice-damage, to making ice cream smoother or safely freezing human tissue for transplantation. The research, “Antifreeze Protein Mimetic Metallohelices with Potent Ice Recrystallization Inhibition Activity” published in the Journal of the American Chemical Society.
Studying fat burning could lead to treatments for diabetes
MilliporeSignma recently announced it would be forming a strategic alliance with Baylor College of Medicine, in Houston, Texas, and its vaccine product development partnership (PDP), Texas Children's Hospital Center for Vaccine Development (Texas Children's CVD), in order to advance vaccine research and development for neglected and emerging infections. The partnership will focus on bringing vaccines through development to commercialization and distribution to populations in need. MilliporeSigma’s experts in process development and formulation are working with Texas Children’s CVD scientists at Baylor College of Medicine in Houston, Texas, to optimize the vaccine manufacturing process to increase vaccine stability and yield. Initially, these activities are targeting schistosomiasis, a deadly parasitic disease that affects millions of people a year in tropical and subtropical regions. The collaboration includes training and exchange of technical know-how in process development and formulation, filling knowledge gaps that exist from research and development to manufacturing, with a focus
MilliporeSigma’s experts in process development and formulation are working with Texas Children’s CVD scientists at Baylor College of Medicine in Houston, Texas, to optimize the vaccine manufacturing process to increase vaccine stability and yield on neglected and emerging diseases. “Our purpose is to solve the toughest problems in life science by collaborating with the global scientific community,” says Udit Batra, CEO of MilliporeSigma. “The alliance with Baylor College of Medicine, one of the premier research universities in the world, is the ideal partnership to advance vaccine development and manufacturing. Together, we will support the fight against infectious diseases.”
What happens and where, when the body’s fat stores are activated? With the support of the Austrian Science Fund FWF, biochemist Ruth Birner-Grünberger investigated the complex interaction of activation and regulation in fat breakdown. After exhausting the fast energy provided by glucose, the body starts burning fat. When we exercise continuously at a low pulse rate, lipolysis starts after about 30 minutes. The same thing happens when we are hungry: the fat cells receive a hormonal signal telling them to make a depot available and break down the stored lipid droplets into fatty acids. The researchers were able to discover the first steps of spatial and chemical interaction on the fat droplets in tissue cells, thus providing a basis for new therapeutic approaches for illnesses such as diabetes or arteriosclerosis.
Scientists use molecular methods to differentiate neurons in the brain
For the first time, scientists at Salk Institute and the University of California San Diego, have profiled chemical modifications of DNA molecules in individual neurons, giving detailed information on what makes one brain cell different from its neighbour. This is a critical step in beginning to identify how many types of neurons exist, which has eluded neuroscientists but could lead to a dramatically better understanding about brain development and dysfunction. Each cell’s methylome – the pattern of chemical markers made up of methyl groups that stud its DNA – gave a distinct readout that helped the Salk team sort neurons into subtypes. The work appeared in the journal Science.
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3-D representation of schistosoma, source of the parasitic disease schistosomaisis, in the bloodstream. Courtesy Millipore Sigma.
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BETWEEN PAIN AND PLEASURE The pharmaceutical industry grapples with the Canadian opioid crisis By hermione wilson
he opioid crisis has dominated the news for the past few years, but it seems to have ramped up in the last few months and every day brings more reports of fatal overdoses. The Public Health Agency of Canada reported an estimated 2,458 opioid-related deaths in 2016 alone, with western Canada experiencing the highest rates. The main culprit is fentanyl, a highly addictive synthetic opioid painkiller, which news sources say started appearing on Canadian streets in 2013. As little as 2 mg of powdered fentanyl (comparable to two grains of salt) can be deadly to a healthy adult. In the midst of this crisis, opioids have become synonymous with death, but this class of drugs has another use; for decades they’ve been an essential part of pain management for patients. For as long as opioids have been in use, however, they have been dogged by concerns that they are being overprescribed and that their addictive nature will enslave vulnerable patients in a cycle of drug abuse. In a recent article, The Globe and Mail quoted figures obtained from IMS Brogan which showed that, in 2015, doctors wrote “one opioid prescription for every two Canadians, making Canada the world’s second-biggest per-capita user of opioids, behind the United States.”
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The Problem of Pain The problem lies with the nature of measuring pain in a clinical setting, says Norman Buckley, Director of the Michael G. DeGroote National Pain Centre and Scientific Director of the Michael G. DeGroote Institute for Pain Research and Care at McMaster University. Sometimes pain arises from obvious sources – an injury or a surgery – but sometimes, as in the case of fibromyalgia for example, there is no physical correlation, he says. Buckley cites a variety of cases where measuring pain in patients is not clear cut: non-verbal patients, neurological injuries, delayed pain onset after a spinal cord injury, phantom limb syndrome. The list goes on. “At the end of the day, pain is a subjective response, so you’re left with your assessment of the patient and the patient’s own report of their sensations in order to decide what sort of problem is leading to the complaint of pain,” Buckley says. “There is not a generally accepted diagnostic measure.” The most common use of opioids includes somatic or acute pain, which is a function of a tissue injury that leads to inflammation and nerve excitation. “It’s often leading to stimulation of the endogenous system for creating opioids, the endorphin and enkephalin system, and that’s where opioids work,” Buckley says. In multi-modal pain therapy clinicians will, for example, combine an anti-inflammatory drug and a small dose of an anti-convulsant with an opioid in an effort to get improved pain management while minimizing the side effects of each of the individual agents, he says. “For many years, clinicians have believed that certain types of pain are more susceptible to opioids or certain opioids are more effective for certain types of pain,” Buckley says. For example, it was thought that opioids were more effective in treating somatic pain experienced post-surgery or caused by conditions like arthritis, than neuropathic pain, he says. “One of the things that I’ve taken away from the work that was done recently to revise the Canadian opioid guideline is that it does not seem to be that clear and it may be that there are people who respond better to opioids rather than conditions,” he says. bio business J U LY/a U G US T 2 0 1 7
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Opiate Addiction Clinical trials have managed to identify people who do not benefit from opioids or are harmed by them, people who may be prone to misusing the drug or whose tolerance is such that they need progressively higher and higher doses, Buckley says. “The mechanisms for how and why people would respond to opioids are fairly clearly described,” he says. “There are opioid receptors in the spinal cord and the brain, so there are clear places for opioids to act. There are a variety of different opioid receptors;
At the end of the day, pain is a subjective response, so you’re left with your assessment of the patient and the patient’s own report of their sensations in order to decide what sort of problem is leading to the complaint of pain. – Norman Buckley, Director, Michael G. DeGroote National Pain Centre, Scientific Director, Michael G. DeGroote Institute for Pain Research and Care at McMaster University
reg Sullivan, Chief Science Office and CEO of U.S.-based G biotech Bridge Therapeutics, and FDA investigator
Alternatives to opiate pain medications that are effective for chronic pain are few and far between.
some of them are associated more with analgesia, some of them are associated more with sedation or mood changes, and different opioids themselves have different characteristics.” As part of a recent study published in Annals of Clinical & Laboratory Science, researchers developed a predictive algorithm to determine opioid addiction risk. The algorithm produced an addiction risk score that is based on 16 single nucleotide polymorphisms, or genetic mutations, in the brain reward pathways, and was developed using 37 patients with prescription opioid or heroin addiction and 30 age- and gender-matched nonaddicted patients. The test, called LifeKit Predict, can identify, with 97 per cent certainty, that an individual has a low likelihood of becoming addicted to opioids, and an 88 per cent likelihood of predicting that an individual has an increased risk for opioid addiction. Regular opiates have an escalating requirement for their use because of their unique activity on pain receptors, says Greg Sullivan, Chief Science Office and CEO of U.S.-based biotech Bridge Therapeutics. “They rapidly cause tolerance in as little as five days,” he says. Once a patient on opioid pain medication has developed a tolerance for the drug, Sullivan says, that tolerance never goes away. He explains that with a patient at this stage, their mu pain receptors become deformed and can no longer be activated by their endorphins. “When a patient then attempts to stop the opioid pain medication, they go through significant psychological and physical withdrawal for six to 10 weeks at a minimum, and then post-acute withdrawal for six months.” Alternatives to opiate pain medications that are effective for chronic pain are few and far between Buckley says. “In some ways, the current front of what’s being investigated in terms of new pain therapies seems to be, at least from a pharmaceutical company standpoint, quite limited,” he says. “There are things like neuromodulation, spinal cord simulators, deep brain stimulation, and things like that, where there is some work being done. There are publications on the role of glutamate, for example, as a neurotransmitter which seems to be generated in certain disease states which are prone to having pain, things like bone pain from metastatic cancer, for example. It seems that it may be associated with an increased production of glutamate.” These studies are in the early stages and have not quite made it to the commercial stage, Buckley says. Other studies, in this era of personalized medicine, focus on characterizing the physiology of patients who have pain and what drugs they might best respond to. “You’re getting into genetic screening of patients, trying to find out if there are particular genetic associations with pain,” he says. At the Michael G. DeGroote National Pain Centre, Buckley says, researchers have adopted the idea that closely examining persistent post-surgical pain
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David Renwick, General Manager, Adapt Pharma Canada
may help them characterize patients who have chronic pain in a way that’s useful.
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Fighting Fire with Fire In the meantime, pharmaceutical companies that produce opiate pain medications have been turning to abuse-deterrent technologies to safeguard their products against tampering by recreational users. After numerous reports of OxyContin abuse, manufacturer Purdue Pharma discontinued the product in 2012 and launched OxyNeo in its place. This new product has the same medicinal ingredient and efficacy as OxyContin “but with certain features intended to discourage misuse,” Purdue Pharma said in a statement. Namely, OxyNeo comes in the form of a crush-proof pill that cannot be snorted, smoked or injected, according to a Maclean’s article. “While products with tamper-resistant properties will not alone address the crisis of illicit and prescription opioid misuse and abuse, they are an important tool to complement other harm-reduction efforts that include increasing awareness of opioid prescribing guidelines and standards,” Purdue Pharma said in a statement. Bridge Therapeutics has gone a different route by developing a drug, BT-205, (which is still awaiting FDA aproval)that combines buprenorphine (an opiate traditionally used to treat opioid addiction) and meloxicam (an anti-inflammatory) to treat chronic pain in “opioid-experienced patients.” “Opiates act differently on the pain receptors
Our own biological endorphins don’t bounce; they bind for approximately eight minutes. Buprenorphine doesn’t bounce and therefore doesn’t cause that euphoric high that’s classic for opioids. Unlike human beta endorphins, it binds for 24 to 46 hours. – Greg Sullivan, Chief Science Office and CEO of U.S.-based biotech Bridge Therapeutics, and FDA investigator.
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than buprenorphine does,” Sullivan says. “Opiates bounce and they bind approximately thirty millionth of a second on the receptor and therefore they disfigure the receptor. Our own biological endorphins don’t bounce; they bind for approximately eight minutes. Buprenorphine doesn’t bounce and therefore doesn’t cause that euphoric high that’s classic for opioids. Unlike human beta endorphins, it binds for 24 to 46 hours.” On the frontlines of the opioid crisis, Adapt Pharma Canada manufactures a naloxone product used as an emergency treatment for opioid overdose. Naloxone is not a new drug – it has been in use for more than 50 years – but Adapt Pharma’s application is unique in that its NARCAN Nasal Spray product is easy to use, needle-free and contains a concentrated dose of naloxone that quickly reverses the effects of opioid overdose. “This product was designed with the broader community in mind,” says David Renwick, General Manager of Adapt Pharma Canada. “Many of the stakeholders agree that we need to find ways to get more naloxone out into the community and make it available to people who may not have extensive medical training.” While Renwick and his company would like to see NARCAN Nasal Spray become as ubiquitous as defibrillators to combat the growing opioid crisis, Craig Landau, President and CEO of Purdue Pharma (Canada), pushes for more research. “We support a research-driven approach to pain that may or may not include available prescription products, in combination with other effective treatments,” Landau says. “At the same time, prescription opioid medicines remain a safe and effective treatment for patients who are appropriately selected and monitored. Effective pain management, even while we face the opioid crisis, requires greater participation by all stakeholders, and taking new and broader actions to support physician decision-making, help patients and protect public health.” BB
Stats
In 2016 at least 2,458 Canadians died due to opioid overdoes
In 2016, 13 Canadians a day were hospitalized for opioid poisoning
According to data from the Canadian Institute for Health Information, seniors have the highest rates of hospitalizations
related to opioid poisoning.
Youth (aged 15-24) have the fastest growth rate in
While Renwick and his company would like to see NARCAN Nasal Spray become as ubiquitous as defibrillators to combat the growing opioid crisis, Craig Landau, President and CEO of Purdue Pharma (Canada), pushes for a more research.
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opioid-related hospitalizations.
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Security
The Price of Doing Good: How Innovation and Global Competition Add Risk to the Life Sciences Industry By Frank Goudsmit and Kimberley Higgins
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Cybersecurity Companies in all sectors are vulnerable to cyber intrusions, but healthcare companies are especially vulnerable to a breach, as they often store personal information, a frequent target for cyber criminals. While life sciences companies may have access to personal information, they hold other sensitive data as well such as intellectual property involving drugs and devices. Cyberattacks to this proprietary data can cause a serious threat to companies, practitioners and patients. Cyber criminals don’t just focus on corporate systems but will target mobile devices as well. Tampering with mobile devices that hold personal data or monitor vital signs can seriously endanger
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he life sciences industry is dedicated to improving health and well-being for individuals around the world. But new technology, innovation and globalization also bring new exposures that companies need to manage in order to protect themselves from loss. Cyber breaches, supply chain interruptions, regulatory hurdles, and M&A liabilities are a few of the exposures that affect the life sciences industry in Canada and worldwide. Solving for all these variables is no small task. Below, we have outlined how life sciences companies in Canada can better understand and mitigate the most pressing threats to their business.
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Security
patients. Cyber vulnerabilities have been identified in some widely used devices such as pacemakers, infusion pumps and insulin pumps. Since consumer trust is so critical in any business, each company needs to vigilantly safeguard its reputation from the lasting damage that such a breach could cause. While cyber-related incidents could be covered in an existing standard property and liability policies, companies are starting to seek out affirmative cyber coverage solutions. These policies not only respond to liability claims for injuries caused by unauthorized access, but also reimburse for first party costs to determine the cause and extent of the breach, notify the affected persons, and restore reputation in the market. Some policies offer pre- and post-incident consulting services to help prevent or mitigate losses. These policies may include expert assessments of a company’s cyber defenses and recommendations on how to strengthen them.
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Companies should look for an insurance carrier that can not only give adequate financial protection, but also provide risk mitigation services to help identify vulnerabilities in their supply chain.
Supply Chain The Canadian government continues to support the life sciences industry through its investment in innovation and research. With the high cost of product development in a heavily regulated industry, many Canadian companies rely on outsourcing with third-party suppliers. Supply chain vulnerability across the globe presents a variety of challenges to life sciences companies. Like cyber criminals, supply chain risks can emerge from anywhere in the world. Life sciences companies should pay close attention to quality control, raw materials and inventory management when assessing their suppliers. Before entering into a contract with any supplier, companies should thoroughly validate the supplier’s raw materials and production methods and conduct rigorous testing before incorporating materials into a final product. Contaminated products can not only taint a company’s supply chain, but its reputation as well. Regarding inventory, companies that rely on just-in-time supplies can experience a costly blow to their sales when a key supplier goes off-line. Where possible, companies should contract with backup suppliers and vet them as thoroughly as their main suppliers to make sure that their manufacturing facilities, procedures and products meet all standards. Companies should look for an insurance carrier that can not only give adequate financial protection, but also provide risk mitigation services to help identify vulnerabilities in their supply chain. Supplier contracts should provide the proper indemnifications to ensure that the supplier assumes the appropriate liabilities for their products.
Security
Regulatory Risk Businesses with global supply chains must also deal with varying legal and regulatory environments in each country where they do business. To develop new drugs and devices, life sciences companies may need to conduct clinical trials in a variety of countries. Each country, however, has its own laws regarding insurance in general along with specific regulations for clinical trials and coverage requirements for those trials. In many countries, a Canada-based policy may not satisfy local admitted insurance requirements. The regulatory challenges also extend to the agreements between and among the trial sponsor, the contract research organization
(CRO), the investigators and the site. Choosing an insurer that has both life sciences expertise and a strong global network can help a company avoid costly trial delays. Insurance and CRO partners can help companies navigate regulatory risks, prequalify sites, and ensure that trial sponsors are using the proper contractual language to protect themselves against any potential risks. Companies considering clinical trials abroad should enlist legal expertise to ensure that their agreements do not violate local laws, regulations, or customs in that country.
Mergers and Acquisitions Once emerging life sciences companies have shown commercial potential, they are likely to be sold to more mature players. Life sciences M&A activity is particularly robust in Canada, known for its innovation and research and development. When larger firms acquire promising companies, they acquire potential liabilities as well. Inheriting the risks of acquired companies takes many forms, and insurance policies in place before the merger do not always carry over to the combined company. Most general liability insurance excludes coverage for events that occur prior to the acquisition. This can leave the successor exposed to a successor liability lawsuit. To identify potential problems in a transaction, acquiring firms should seek to uncover any prior losses and damages at the target firm and to understand its existing insurance arrangements. In addition, they should consider successor liability insurance, which addresses liabilities stemming from an acquired company’s actions before the acquisition,
as well as representations and warranties insurance, which covers financial losses for unintentional breaches of a seller’s assertions in a purchase and sale agreement. Conversely, the acquired company should consider protecting itself from claims that could be reported in the future but would not be picked up by the successor’s policy. It is prudent for companies to buy a supplemental extended reporting period for this type of situation. Conclusion As life sciences companies grow, they are increasingly likely to find themselves in the international arena. The same global viewpoint that embraces development, suppliers, products and sales should extend to insurance as well. As businesses expand across borders, they should seek an insurer that can provide the coverage and services that help make sure their risk management strategy responds to the current and emerging risks they are likely to face. BB
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To identify potential problems in a transaction, acquiring firms should seek to uncover any prior losses and damages at the target firm and to understand its existing insurance arrangements.
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regional profile
OPPORTUNITIES ABOUND Government and industry form partnerships, push for investment in Quebec life sciences sector
By hermione wilson
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round the time of this year’s BIO International Convention in San Diego, several new initiatives designed to promote and improve the Quebec life sciences sector were announced.
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Partnership with Boston BioQuebec, the province’s biotechnology and life sciences industry association, announced in June that it would be signing a cooperation agreement with MassBio, its Massuchusetts counterpart. Anie Perrault, Executive Manager, BioQuebec, stresses this is not an agreement between the province of Quebec and the state of Massachusetts, but rather a partnership between two industry groups. Still, Perrault says she was able, through MassBio President and CEO Robert Coughlin, to introduce Quebec’s Minister of Health and Social Services, Gaétan Barrette, to Massachusetts Governor Charlie Baker at the BIO convention. “There are opportunities for both states to do business together,” she says. “Our Minister of Health [Gaétan Barrette] and Governor Baker had a very good exchange and
I think this is just the beginning of something that’s going to be very interesting for our members in the next few years.” The idea is that BioQuebec and MassBio will collaborate and facilitate networking opportunities for their members. For example, BioQuebec member companies will receive the same discounted registration for certain events MassBio puts together as its own members would receive. Perrault is also working with MassBio to ensure that in 2018, when BIO takes place in Boston, BioQuebec will be front and centre. “The goal here is to facilitate the relationship between our members, organize events that will be of benefit to both of them, and make sure that we host the MassBio membership when they come to Quebec for a visit or a mission,” she says. “If they have any interest in meeting people, we can organize that, and they will be doing the same for us when our members go to Boston.” A partnership between the Quebec and Massachusetts life sciences industries makes sense because of the close connection Quebec companies have to the state, especially Boston. The city is an hour’s flight from Quebec and a five-hour drive, Perrault says. Many BioQuebec member
regional profile
companies are doing business across the border in Boston because it’s such a dynamic hub for life sciences. Governor Baker recently announced a commitment to the biotechnology and life science sector of US$500 million over five years. “We have a lot of CROs (contract research organizations), a lot of researchers that have started their companies and offer their research services on a contract basis,” Perrault says. “We have about 75 of them in the province and, according to the survey we conducted last year, 85 per cent of them were telling us that up to 70 per cent of their business and revenue are coming from the United States and particularly the state of Massachusetts.” Quebec’s New Life Science Strategy In terms of attracting foreign investment to the province of Quebec, most industry insiders interviewed for this piece agreed that playing up the Quebec life sciences sector’s strengths in the area of clinical research is the key. “In Quebec we have a very strong infrastructure,” says Dominique Anglade, Quebec’s Minister of Economy,
BioQuebec, the province’s biotechnology and life sciences industry association, announced in June that it would be signing a cooperation agreement with MassBio, its Massuchusetts counterpart.
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Because we have a public healthcare system, compared to the United States where it’s private, the data that we have can be used to support research at a large scale because we have data on eight million [people]. - Dominique Anglade, Minister of Economy, Quebec
Dominique Anglade, Minister of Economy, Quebec
Alain Denis, Senior Vice-President for Innovation, Fonds de solidarité FTQ
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Anie Perrault, Executive Manager, BioQuebec
Science and Innovation. Anglade speaks of the province’s three university hospitals equipped with clinical trial units: Centre hospitalier universitaire de Montreal (CHUM), Centre universitaire de Santé McGill, and Centre hospitalier universitaire Sainte-Justine. She also points to the access researchers have in Quebec to vast amounts of patient data. “Because we have a public healthcare system, compared to the United States where it’s private, the data that we have can be used to support research at a large scale because we have data on eight million [people],” Anglade says. “We just need to make sure that we can control the access and that it’s used for the right reasons.” The government of Quebec recently released a new life sciences strategy that identified the sector as a key area of growth for the province. Anglade says the goal is to increase foreign direct investment and private sector investment for research and innovation, ensure that existing life sciences companies in Quebec continue to grow, and improve the ability to integrate innovation into the healthcare system. Steps are already being taken to accomplish some of these goals. Anglade points to the creation of an innovation office under the Ministry of Health and paid for by the Ministry of Economy. “The idea is that this innovation office can assess the technology that we have and deploy it in the health ministry,” she says. Clinical Research Initiative There is also CATALIS, an early clinical research initiative introduced by economic development organization Montreal InVivo and its members, with the goal of attracting private investment to clinical trials in Quebec. Non-profit pharmaceutical consortium CQDM will act as host and caretaker to the CATALIS project, by sharing its facilities and supporting its administrative work. “It’s not about doing the clinical trials, it’s about creating the right environment to make sure that we’re going to attract private investment,” says Diane Gosselin, President and CEO of CQDM. The pharma industry is one of the biggest sponsors of clinical trials in life sciences and it is pushing the government to invest in it as well, Gosselin says. The Quebec government announced it would be contributing $5.3 million to the CATALIS initiative at BIO 2017 Convention in San Diego. “We see [the government and the pharmaceutical industry] pushing each other to make sure that they are going to be at the table,” she says. “It is absolutely critical that they build that together and this is what they have done.” Funding Biotech in Quebec In June 2017, Fonds de solidarité FTQ announced its intention to invest US$8.7 million in the launch of Montreal-based biotech Repare. The company was founded by California-based life sciences fund Versant Ventures and is focused on novel cancer medicines that exploit synthetic lethality. The Fonds recently identified the life sciences as a hub of excellence for the Quebec economy
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Québec
Quebec Life Sciences Facts 600 organizations, including 150 research centres, 80 subsidiaries of multinational companies, and 4 universities 27,000 students and 6,300 graduates per year 1,200 researchers 8,500 scientific publications per year 40,000 jobs $5.6 billion contributed to Quebec's GDP *Based on study conducted by Montreal InVivo, 2016.
LIST OF ADVERTISERS & WEBSITES eppendorf Page 2................................................................................www.eppendorf.com bio québec Page 4 ...............................................................................www.bioquebec.com canadian pharmaceutical distribution network Page 14 .........................................................................................www.cpdn.ca VWR Page 24 ........................................................................................ www.vwr.com
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following its strategic planning and intends to increase investment in the sector. The Fonds’ first life sciences investment was in the biotech company BioChem Pharma in 1989, which Didier Leconte, Life Sciences Investment Director, says was a success. Between 2000 and 2015, the Fonds has invested $50 million a year in the life sciences industry. “Life sciences has always been a key area of investment for the Fonds de solidarité,” says Alain Denis, Senior Vice-President for Innovation, Fonds de solidarité FTQ. “In the last 20 years, we’ve invested more than $1.2 billion in this sector. At the Fonds, we decided to keep investing [in the sector] on a constant basis. Today we’re enjoying the benefits of that with our portfolio.” Denis points to a few factors that make Quebec an area ripe for life science innovation. “We have the legacy of that really talented pool of experienced drug development people, so that’s one pillar. A second pillar for Quebec is that it has a great network of infrastructure of research and services. The third pillar is where we really have a vision at the Fonds that we can rebuild that biotechnology economy that we used to have in the late 90s early 2000s.” CQDM’s Gosselin is extremely positive about Quebec’s ability to attract the investment needed to take its life sciences sector to the next level. “I think we have everything from a research point of view and from an infrastructure point of view, we have everything we need to be competitive. What we need to do is really improve our processes and our capacity to recruit patients, but we have the basics.” BB
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moments in time
Founding Father n the 1960s, Dr. Bram Rose was responsible for establishing allergy and clinical immunology as a distinct specialty in Montreal, with his creation of the Division of Immunochemistry and Allergy at McGill University. Together with a team of investigators and fellow faculty members he had recruited, Rose made pioneering research contributions in the areas of histamine, anti-histamines, anti-inflammatory steroids, isolation and synthesis of antibodies and allergens, eosinophil physiology and the mechanisms of auto-immune disease, and the use of ACTH and cortisone in the treatment of asthma and allergic states. Rose was also one of the founding fathers of the Canadian Society of Allergy and Clinical Immunology (CSACI), the recipient of its first Research Award, author of approximately 185 scientific articles, and co-author of several authoritative textbooks in the field of allergy and immunology. By the 1980s, about half of all allergists and immunologists in Canada had been his trainees. BB
Sources http://csaci.ca/csaci-awards www.mcgill.ca/deptmedicine/files/deptmedicine/newsletter_2012mar.pdf
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