ON THE FRONT LINES OF THE WAR ON SUPERBUGS

late stage clinical trials, new megacentres such as the ones in Québec will increase the potential to attract clinical trials at earlier stages as well.

The Clinical Trial Asset Map

To put Canada on the international clinical trials map, a collaborative e ort led by the Canadian Clinical Trials Coordinating Centre is underway to better advertise Canadian researchers and their expertise. With the o cial launch date set for this June, the Canadian Clinical Trials Asset Map will be an interactive database of Canadian clinical research capabilities to help sponsors easily identify clinical research sites and investigators.

In a statement to Biotechnology Focus, Alison Sargent, the executive director of Rx&D’s Health Research Foundation, says, “The overall objective for the CCTAM is to provide a comprehensive picture of the breadth and depth of Canada’s clinical research assets. The CCTAM addresses a gap in the Canadian clinical research resources and mainly, a compressive pan-Canadian one-stop shop tool for all Canadian clinical research resources.”

Patient Engagement and Recruitment

Another critical but often overlooked component of the clinical trials process is patient engagement and recruitment. For Canada, the issue is not so much the time for enrollment, but rather the number of patients enrolled.

“There are a signifi cant number of sites that have one, two, fi ve, 10 patients recruited, which means their cost per patient – when you include the site preparation, the monitoring – is very high,” says Soloninka.

At the Clinical Trials Summit, it was speculated that the reasons for poor recruitment in Canada may be due to: • Access • Universal health coverage and perception of good care • Lack of trust and knowledge • Ineffi cient infrastructure • Focus on operational improvements

The Canadian Clinical Trial Summit...Starting the Conversation report states that, “Canada has yet to develop targeted resources and strategies to market, explain, and attract patients and the public to clinical trials. This can further result in recruitment, retention, and compliance problems.”5 Unfortunately, since the Summit, there has been limited activity at the provincial or national levels to address this problem. British Columbia has taken the most progressive steps so far, with a clinical trials participation survey underway that looks at the reasons why people are taking part in clinical trials and, even more importantly, why they are not. The survey recently achieved 600 participants and BCCRIN says it will be presenting the interim results of the survey at the ACRP 2015 Global Conference & Exhibition in Salt Lake City this April.

“We’re very excited about this,” Heather Harris of BCCRIN, says. “This is going to give us some really great insights into what’s going on inside clinical trials participants’ heads, so we can better target our engagement strategies, our protocols and consent forms, and things like our behaviour as we’re bringing patients into clinics and welcoming them. It’s really providing some great information.”

Additionally, BCCRIN has signed an MOU with CTO to work on issues that are important to both organizations, which includes patient recruitment. The two organizations say they will be launching a public opinion poll about clinical trials within the next few months.

To this point, CTO has remained focused on its fi rst strategic priority, which is streamlining the ethics review system in Ontario. Going forward, CTO is turning its attention to patient recruitment and retention. Susan Marlin says the results of this joint survey with BCCRIN will help shape CTO’s patient engagement strategy.

Another key development in Canada in terms of patient engagement includes an evolving collection of Permission to Contact (PTC) databases, where patients agree to share personal data and are receptive to being contacted at a later date about relevant trials. The initiation of PTC databases began in some jurisdictions in British Columbia and has since been taken up by other jurisdictions.

“We have over 80,000 participants in a PTC database in Canada, and over half of those are in BC,” says Harris. “It’s a real area of strength for us, and something that we’re hoping to move forward with and become a provincial program in BC. Hopefully we can connect with some of the other provinces on this.”

PTC databases may play a signifi cant role in mobilizing enrollment processes in the future, especially if stakeholders in Canada can continue to build these databases to include more participants in more areas across the country.

Dr. Albert Friesen notes that while recruit-

“(Priorities are) the quality of the researchers and the quality of infrastructure. The upcoming mega centres, SHUN and McGill are really placing Québec at the forefront, I would say, for the next several years, in terms of the potential to attract investments from pharmaceutical

ment is a signifi cant challenge in Canada, Canadian sites do have their own strengths.

“On average, Canadian sites when selected because of expertise, actually have a higher rate of enrolment than U.S. sites,” he says.

Moving forward, Canada could benefi t from emphasizing recruitment through specialized institutions, creating more PTC databases and acting on the feedback from the surveys that are underway. Nationally, there is clearly a deep need for more action on the clinical trials education and participation front.

Tax Incentives

Although tax incentives are not a priority for sponsors when choosing sites, it is still a factor for consideration. Unfortunately, Canada is lacking compared to other countries in this respect.

KPMG’s 2014 Competitive Alternatives report found: “For research and development operations, many of the countries studied o er signifi cant R&D tax incentives. France, the Netherlands, and Canada o er the lowest e ective tax rates in this subsector.”6

In this regard, the Canadian Scientifi c Research and Experimental Development (SR&ED) tax credit may be helpful for Canadian companies and CROs in attracting clinical trials. However, the credit is limited and often doesn’t refl ect the full scale of a given company’s investment. In terms of attracting foreign investors, the SR&ED credit is often not applicable, unless indirectly through Canadian CROs. However, some provincial credits are fully refundable to all corporations.

Additional tax incentives can vary substantially by province, from 4.5 per cent to 37.5 per cent7 depending on the jurisdiction. Québec is particularly attractive in terms of tax incentives, o ering provincial tax breaks of up to 80 per cent for total eligible R&D expenditures that are incurred in connection with a research contract with a university or eligible research centre. Moreover, Québec o ers tax incentives to attract foreign researchers, o ering them a 100 per cent income tax break for their fi rst two years of living in the province, 75 per cent for the third year, 50 per cent for the fourth year and 25 per cent for the fi fth year.

Canada against the International Playing Field: What Needs to Be Done

Since the 2011 Clinical Trials Summit, the federal government has recognized the value and the need to make Canada a leading jurisdiction for attracting clinical trials. Several initiatives to strengthen the environment for clinical trials in Canada have been undertaken, including the creation of the Canadian Clinical Trials Coordinating Centre. This centre is providing collaborative clinical trials oversight throughout Canada and has generated the Canadian Clinical Trials Asset Map to better advertise Canada’s research strengths. As such, dedicating money to networks and collaborative e orts has been critical in maintaining Canada’s quality of work and should be continued.

However, further steps to support health research at the clinical trials phase would be helpful in attracting more sponsors, such as making the SR&ED tax credit more accessible to Canadian businesses, and o ering more competitive cost incentives to international sponsors.

Je Bacha suggests, “If there are incentives provided in terms of grants available to PIs who are involved in international studies, that helps to reduce the costs overall. Whether that grant comes to the sponsor or the PI as o set, that’s going to be a big driver.”

Canada does have many strengths that make it a desirable location for testing new drugs including a highly trained workforce, experienced investigators, a high standard of medical care and a diverse population. However, the more steps that Canada can take to speed up the time for trials to get started – the number one issue for most sponsors who are holding patents that will expire – will put it in a better position to attract trials.

Model clinical trial agreements that apply to multiple institutions is another area that we could better leverage. The national mCTA being developed by the Canadian Institute of Health Research (CIHR), the Association of Canadian Academic Healthcare Organizations (ACAHO) and Rx&D may be helpful when it is fi nalized; however, how widely it is accepted by sponsors is yet to be seen.

The provincial initiatives to streamline the REB process will likely make some Canadian sites more appealing to sponsors in terms of increasing the e ciency of the approval process; if Canada aims to improve this process even more, additional inter-provincial collaboration is essential.

To regain traction in the global race for clinical trials, Canada needs to remain fl exible and listen to the needs of sponsors. By continuing to improve processes that a ect trial start up time and retain our high quality of research, we may become a leader once again.

References

1. http://www.healthcarecan.ca/wp-content/uploads/2014/07/

Trials-and-Tribulations-Clinical-trials-The-national-efforttoattract-more-investments-to-Canada.pdf 2. http://www.healthcarecan.ca/wp-content/uploads/2014/07/

SPOR-SHRER-Report-Appendix-D-Harmonization-Survey.pdf 3. http://www.healthcarecan.ca/wp-content/uploads/2014/07/

SPOR-SHRER-Report-Appendix-D-Harmonization-Survey.pdf 4. http://csdd.tufts.edu/news/complete_story/pr_ir_jan_ feb_2015 5. http://www.healthcarecan.ca/wp-content/uploads/2014/07/

ClinicalTrialsSummit_Background_Final-posting.pdf 6. http://www.competitivealternatives.com/reports/2014_compalt_report_vol1_en.pdf 7. https://www2.deloitte.com/content/dam/Deloitte/global/

Documents/Tax/dttl-tax-global-rd-survey-aug-2014.pdf

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THE RISE OF THE CORPORATE VENTURE INVESTOR VENTURE INVESTOR

AND THEIR ROLE IN CANADA’S HEALTHCARE INNOVATION ECOSYSTEM HEALTHCARE INNOVATION ECOSYSTEM

Seven years after the global economic downturn began, it is clear the innovation fi nancing ecosystem for Canada’s healthcare sector is fundamentally stronger, but while there has certainly been a re-emergence, it is most defi nitely not the status quo.

At fi rst blush, the most obvious reality is that the number of domestically domiciled venture capital (VC) fi rms in Canada with meaningful mind and management in Canada and a dedicated healthcare focus has been dramatically reduced. While this might not immediately lead one to conclude that the ecosystem is healthier, the simple reality is that for the most part, it is. The management teams of those VC fi rms that remain active and that are thriving in today’s market are dramatically different than those operating fi ve to 10 years ago. For the most part these teams are deeper and more experienced (operationally and fi nancially) and they bring with them far better global connectivity. That new global connectivity in many cases now includes limited partner investors in their funds that go beyond the traditional pension funds, endowments and insurance companies. Instead, many of these funds have been able to attract capital from, and develop more in-depth relationships with, some of the leading corporate healthcare organizations in the world. As a result, these VCs are better able to allocate resources to the truly best-in-class domestic opportunities, are better able to attract capital for their investees from a wide network of alternative sources and are better able to bring unique value added skills and networks to bear in supporting the growth of their portfolio companies.

The engagement of corporate venture investors is of course nothing new, but today it clearly feels different both in scope and magnitude. The role of corporate venture capital investors (CVC), both as investors in funds of independent VCs and as direct investors themselves is evolving rapidly and has signifi cant implications with respect to the funding ecosystem for emerging technology centric companies around the world. While centric companies around the world. While the Canadian data is just starting to emerge, the Canadian data is just starting to emerge, CVCs in the U.S. participated in a surprisingly CVCs in the U.S. participated in a surprisingly high 18 per cent of the 3,617 venture capital high 18 per cent of the 3,617 venture capital deals in 2014, up 25 per cent year-over-year deals in 2014, up 25 per cent year-over-year and up 55 per cent from 2012. That translates and up 55 per cent from 2012. That translates into direct investment participation in 656 into direct investment participation in 656 deals and the investment of some $12.3 billion by CVCs in 2014.

The healthcare sector, despite a more established history of CVC investment, also participated in this upswing, with CVC funding jumping 23 per cent in 2014 vs. 2013. This increase was powered by a particularly strong Q2 2014 which saw a signifi cant number of $40M+ transactions. Year-over-year the increase in healthcare CVC activity was a healthy eight per cent.1

Looking back, historically there was really only one Canadian domiciled healthcare VC with a meaningful corporate relationship. That was of course my legacy fi rm, MDS Capital, but even in that situation, the relationship was more one of providing infrastructure and oversight rather than offering capital and expertise. Today, many of the country’s most active investors have very different and in fact, materially more meaningful relationships with the large corporate players in the ecosystem. For domestically domiciled funds, examples of these relationships include Lumira Capital (Merck), TVM (Lilly), and Teralys Capital (Knight Therapeutics). For funds that are not Canadian centric per se, but that have recently participated in investments in the Canadian ecosystem, examples include Forbion (Knight), Venbio (Amgen, Baxter and PPD), Sanderling (GSK, Mayo Clinic), and Versant Blue Line (Celgene) to name a few. At the same time, Canada enjoys active engagement from a wide variety of captive VC arms of corporations like SROne (GSK), Baxter Ventures, Amgen Ventures, J&J’s Innovation Labs, Pfi zer Ventures and a host of others.

Traditionally the CVC model in healthcare was for the most part a function of the corporate parent allocating some capital in-house, hiring a team (often of internal personnel) and then focusing on investments

Healthcare CVC funding jumped 23% YoY in 2014 behind an array of $40M+ deals in Q2’14. YoY healthcare CVC deals rose 8%.

Figure 1 Corporate VC Investment and Deal Volume in Healthcare

that were almost exclusively tied to existing corporate programs and objectives. In many cases this capital also came with additional strings attached and the CVCs were often willing to sacrifi ce valuation (and fi nancial returns) in exchange for gaining specifi c rights from the portfolio company at the time of the investment. For some CVCs, this model worked extremely well and resulted in substantial growth of their innovation pipelines. For others, it did not. While the reasons for failures are likely many, one often-cited theme was the lack of fi nancial return metrics and objectives2 as part of the core investment thesis and driver for the CVC entity. Given this observation, it is not surprizing that the CVC model has continued to evolve in recent years.

At the in-house or “captive” level, the CVC teams have evolved to include both homegrown and outsiders in the deal teams, and strategically while many still focus on core strategic investments, many others have established internal funds that are relatively autonomous investment entities that continue to leverage their parents core value-adds. This model ultimately gives far more latitude to invest into areas outside of the parent’s core objectives. One of the other fundamental differences of many of the CVCs today is their desire to achieve self-sustainability and the need therefore to focus on fi nancial metrics as well. In parallel with this evolution at the captive CVC level, many corporates have begun to engage more closely and even partner with independent VCs, providing them with direct capital for their venture funds. While the goals for this approach certainly vary, they include: being able to engage “beyond their four walls,” gaining insight into new therapeutic areas; gaining visibility into key trends in regional markets; being able to infl uence and support innovation without all the encumbrances of their inherently large infrastructures; being able to engage earlier or differently from how they might do so via their typical business development initiatives; effi ciently fi nancing interesting but perhaps non-core opportunities off balance sheet; and being able to us capital stranded offshore to support the creation of next generation healthcare solutions globally. Of course other advantages of partnering with independent VCs include the ability to leverage third-party capital for strategic objectives while also being able to ensure that fi nancial metrics are a core part of the investment thesis.

The result of all this has been that while once often referred to as “dumb money,” CVCs are today anything but. Investing directly or via independent VC managers, CVCs have in fact become highly soughtafter syndicate partners. Across the entire VC fi nancial spectrum this resulted in CVCs accounting for 28 per cent of all Series A capital in Q4 2014. In the healthcare sector, the move to participate in earlier stage investments has been very pronounced and in Q4 2014, Series A investments accounted for almost half of all investment activity by healthcare CVCs.3

In Canada there is real evidence of the engagement and importance of CVCs, and their related independent VC partners, particularly with respect to investments in therapeutics companies. The largest healthcare venture backed fi nancing in Canada in 2014 was for Aurinia Pharmaceuticals. Lumira Capital (with Merck as a key LP), led the recapitalization fi nancing for Isotechnika in late 2013 (which supported the merger with private company, Aurinia) and in 2014 was the only Canadian venture fi rm to participate in the $57 million fi nancing led by Venbio (whose LPs, as mentioned above, include Amgen, Baxter and PPD). In Q1 2015 one of the largest biotech fi nancings, if not the largest, was the $21 million round for Thrasos Pharmaceuticals. The new round, which was led by BDC Healthcare Venture Fund, was supported by existing investors that include SROne (GSK), Mitsubishi Tanabe, and Lumira Capital (Merck).

On the medtech side of the equation we have not seen corporates engaging nearly as much in Canada, either directly or via investments in the funds of private VCs, but the recent investment by Canon in Ottawabased Spartan Bioscience is hopefully an encouraging start.

With domestic and global healthcare corporations continuing to invest less and less in domestic Canadian R&D (spending by all patenees was down 9.8 per cent year over year in 2012 and the R&D-to-sales ratio declined to 5.3 per cent in 2012 according to the Patent Medicines Pricing Review Board4) it is clear that despite the changes and improvements in the ecosystem there is still an opportunity for much more to be done. CVC investing is clearly a growing and important global reality. It is also an emerging activity in Canada, but one that still lags comparables in markets like the U.S.

As corporate Canada confronts the realities of a much-debated productivity gap and thinning innovative product pipelines, governments worry about the hollowingout of industries, research and development spending in Canada continues to lag that of global leaders, and as corporate balance sheets grow heavy with idle and unproductive cash, now could be the perfect time for even more corporations – domestic and foreign – to seize the CVC opportunity. By investing directly themselves, or as a limited partner in an existing VC fund, these corporations can access Canada’s phenomenal healthcare innovation ecosystem, generate enhanced returns on idle cash and further strategic objectives. That sounds a lot like a win-win situation.

References

1. CB Insights, The 2014 US Corporate Venture Capital Review, February 2015 2. Financial Metrics in Corporate Venture

Capital: Enhancing Strategic Value by Focusing on Financial Goals, Kauffman Press 3. CB Insights, The 2014 US Corporate Venture Capital Review, February 2015 4. http://www.pmprb-cepmb.gc.ca/home

Peter van der Velden is Managing General Partner at Toronto-based Lumira Capital and the Past President of Canada’s Venture Capital & Private Equity Association (CVCA).

To see this story online visit http://biotechnologyfocus. ca/the-rise-of-the-corporateventure-investor

GREATER PRIVATE AND PUBLIC SECTOR SUPPORT NEEDED TO DRIVE GROWTH IN THE BIOTECH SECTOR

After years of fl ying under the radar, venture capital in Canada is maturing as an industry, and with it opportunities in life sciences and biotechnology are growing. And yet, venture capital remains chronically underfunded – a stubbornly persistent trend that will negatively impact the future of life sciences in Canada at a time when greater economic diversifi cation is needed most.

Without higher levels of investment we risk stifl ing innovation in biotechnology and losing out on all the socioeconomic benefi ts that come with supporting a sector that adds high paying jobs to Canada’s economy – the engineers, scientists and researchers that propel this industry forward, while minimizing breakthroughs in medicine that improve quality of life for all Canadians.

The good news is that we don’t need to panic – yet. Canadian venture capital fi rms and its managers bring a wealth of experience that wasn’t as prevalent 10 to 15 years ago. The reality is that outside the U.S., every country had to bump and grind its way into developing a vibrant venture capital community. It was new territory, and simply emulating what was going on in Silicon Valley wasn’t easy to do – they had such a large head start. Our understanding of the mechanisms that make a successful venture capital market is far more advanced now.

For instance, we know that more niche and sector specifi c investment mandates serve us better. We are now seeing very targeted venture capital funds set up in all fi elds, whether it be health and life sciences, information and technology or others. This has obvious advantages of access to the cutting edge of a fi eld, and opportunities for in-depth due diligence on any potential acquisitions. As a result, we are also seeing venture capital funds steering away from hiring generalist analysts and towards hiring people with direct fi eld experience (i.e. doctors and IT entrepreneurs).

As a country, we also now understand the vital role that government can play in venture capital. This isn’t a weakness by any stretch. Governments everywhere have recognized that venture capital is a smart investment to make. In fact, that bastion of capitalism and venture capital, Silicon Valley, got its start with public money too – government was directly involved and still is in the U.S. in a big way and producing big results.

That’s why the Canadian federal government’s relatively new Venture Capital Action Plan (VCAP) is so important. VCAP is a $400 million strategy to help increase private sec-

tor investments in early-stage risk capital. It includes a commitment to fund private sector-led funds with matching funds from other private sector investors and interested provinces.

One of them, the Teralys Capital Innovation Fund, has a specific healthcare team which guarantees capital for life science start-ups. Recently, Teralys Capital and the Harbourvest Funds of Funds both received capital commitments for Knight Pharmaceuticals. This creates massive leverage economics. It is common for follow on investment that multiplies the original by three or more. The initial spark by government is foundational capital that enables Canadian VC funds to attract outside investment. That’s VCAP’s objective, and it is being fulfilled.

This is all coming together to create a more robust VC framework that creates big advantages for Canada. According to our 2013 report1 with Industry Canada, over a five year period, VC backed companies have almost 2.5 times higher sales growth, almost 50 per cent greater employee growth, invest over three times more in R&D and have 15 per cent higher survival rates.

Venture capital deal and investment volume continues to grow in Canada, and life sciences reliably captures a high percentage of VC investment. In 2014 alone, life sciences secured almost a quarter of total VC investment dollars, and 18 per cent of all deal activity with $423 million invested over 68 deals.

Moreover, biotechnology had a commanding share of life science venture capital deals in 2014 accounting for $201 million, or almost half of available investment dollars, and 40 per cent of all life sciences deal activity.

What’s particular to life sciences is how many of us benefit from strong performance in this sector. Investors are getting great returns for their money. Aquinox and Xenon Pharmaceuticals both exited by way of initial public offerings in 2014 combining for almost $100 million ($51 and $47 million respectively). But what really stands out is that investment in this space spurs advances in medicine, truly game-changing alternatives are surfacing that are having a real impact on people’s lives. Thrasos Therapeutics, a clinical-stage biotherapeutics company focused on delivering new solutions to individuals affected with kidney disease, raised CDN $60 million from Canadian and U.S. investors including Lumira Capital, SR One, Pappas Ventures and Mitsubishi Tanabe Pharma America, and more recently raised $21 million led by BDC Capital. Canadian investors are helping to lead science through strategic funding, connections and entrepreneurial know-how.

However, resting on our laurels now is not an option. When compared to what’s going on south of the border it’s clear that Canada has more to accomplish. According to data from the MoneyTree Report from PricewaterhouseCoopers (PwC) LLP and the National Venture Capital Association (NVCA), Biotechnology captured $6 billion of total VC investment in the U.S. last year. If we use the typical 10x model to compare the economics vis-à-vis Canada and the U.S., Canada’s $201 million would translate to roughly $2 billion in the U.S. – not the $6 billion that is actually invested south of the border. Just a third of where it should be to be comparable.

So, the venture capital community in Canada has matured and is set up for success. The government understands its vital role and is playing it well so far. Yet we are still chronically underfunded. What’s left to be done?

We would argue more of the same and to continue on this path. Private venture capital must continue to play its role in nurturing life sciences. It must continue to mature and refine its offering, but venture capital is not a panacea. There is room for government to expand its support and there are other vehicles of funding, such as corporate Canada that should be more active for its shareholders.

On top of increasing existing financial commitments, government can also act as a large customer and create a procurement model that favours Canadian innovation. This is particularly true in medtech, digital health and the IT sectors. This tactic is frequently applied in other markets and yet Canadian governments both provincial and federal, have been reticent to deploy. It is vital – often an entrepreneur’s first big contract outside of Canada is with government. In fact, we have many examples of Canadianborn innovations in health and life sciences gaining traction with governments outside of Canada before even securing domestic approval and adoption. This needs to change. Australia, Finland, Germany, Sweden, the United Kingdom and European Commission stress public procurement as a means to drive innovation. Even with NAFTA in place the U.S. has a well-documented “Buy America” agenda while we sit on the sidelines hiding behind NAFTA provisions.

Too often government is only interested in the cheapest option instead of the best option to serve Canadian citizens. By prioritizing emerging Canadian biotechnology solutions for investment, the government can address pressing health issues, while having an amplifying effect on innovation.

And finally, as mentioned, more activity from corporate Canada in venture capital should be encouraged. While it is common in the U.S., few Canadian corporations take advantage of investment in the start-up community. There are four main reasons to consider this option. Strategic investment in aligned sectors can give a company access to new intellectual property and patents, help identify star candidates for recruitment, stay on the cutting edge of their industry, all while providing a hefty return on investment.

There are examples of this in the life science space - Novartis, Johnson & Johnson, GlaxoSmithKline, Merck and others have all demonstrated the value of CVC. Yet we pale in numbers compared to the U.S. in corporate venture activity. It is time for more bold action on this front, and corporate Canada should seize the opportunity.

We have been talking about innovation and productivity gaps in Canada for decades. Yet at a time when the Canadian economy really needs innovation as traditional manufacturing on the decline and oil and gas suffers from substantial and lasting price shocks, we are lacking the necessary funding. By working together, biotechnology can flourish in Canada, but it will take a coordinated effort, and political will. This combination of public and private sector support can lay the foundation in which to build many new economies in Canada – life sciences is no exception.

Reference

1. http://www.bdc.ca/en/bdc-capital/ venture-capital/newsroom/pages/ impact-vc-on-busin.aspx

Mike Woollatt is the CEO of the Canadian Venture Capital & Private Equity Association (CVCA). Prior to joining the CVCA, he co-founded Beaconsfield Group, a successful management consulting and public affairs firm. Mike has held senior executive roles at various major Canadian corporations, including Bell Canada, CTVglobemedia, and Canwest Global Communications. Before entering the private sector, Mike worked for the Government of Canada, both as an economist in the bureaucracy and as a political advisor at the Department of Finance. He has also worked overseas as an economist on international development projects. Mike has both a B.A. and M.A. in Economics from the University of British Columbia.

To see this story online visit www.biotechnologyfocus.ca/ greater-private-and-public-sectorsupport-need-to-drive-growth-inthe-biotech-sector

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C86 Buying Influence C87 Which products are used in your lab?

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On the front lines of WARTHE

ONSUPERBUGS

When 150 of the world’s leading scientists gathered in California this spring to map out new approaches to fi ght antibiotic resistance, McMaster University experts were at the forefront of the scientifi c discussions focused on tackling this crisis. Infection-fi ghting antibiotics are the workhorses of modern day medicine, enabling everything from successful cancer chemotherapies and organ transplants, to joint replacements and preterm infant care. But antibiotics, once considered a sure-fi re way to cure and control a host of infectious diseases, are in a fi erce battle as microbes – bacteria, viruses, fungi and parasites – develop resistance to the drugs faster than new treatments are delivered to the clinic.

As antibiotic resistance is at an all-time high and expected to worsen, McMaster lead scientist Gerry Wright and his team at the Michael G. DeGroote Institute for Infectious Disease Research in Hamilton, ON, are collaborating with more than 60 McMaster researchers including engineers, chemists, health scientists, doctors, mathematicians and anthropologists to address this critical problem. Working across fi elds of study, this team of internationally respected researchers is investigating at a break-neck pace, building on more than two decades of research momentum and efforts to improve human health in the escalating global challenge of infectious diseases and antibiotic resistance.

“Resistance to antibiotics is a challenge of global proportion,” says Wright, Canada Research Chair in Antibiotic Biochemistry and the institute’s scientifi c director. “It is considered one of the greatest global crises of our time and if left unchecked, the world could soon face 10 million deaths per year because antibiotics used to treat infections no longer work.”

The staggering estimate, released late last year by the British government, is from one of many recent reports by the world’s public health leaders demonstrating the real and pressing need for solutions. Already, 23,000 people die yearly from antibiotic-resistant bacteria in the U.S. and more than two million fall ill, according to the U.S.-based Centers for Disease Control. In Canada, up to 12,000 Canadians are dying each year from antibiotic-resistant infections. Health Canada reported in March that drug-resistant microbes or “superbugs” have cost Canadians $1 billion in medical care.

Canada has joined the global call to arms to fi ght deadly drug-resistance infections with the federal government unveiling a new action plan that includes several steps to address the problem, as well as funding for a study on antimicrobial resistance’s impact on the economy. Wright says Canada’s plan aligns well with similar efforts in the U.S. and Europe.

The dilemma, explains Wright, is almost all bacteria have developed some form of resistance, making antibiotics less effective at treating serious infections. And while movement is being seen in public health surveillance data, global management of antibiotic delivery in the clinic and agriculture, innovation in infection control and diagnostics, new antimicrobial therapies, new drug discovery has stalled, magnifying the problem. No new antibiotic drug classes have been discovered for more than 30 years and activity in the pharmaceutical industry is at a low not seen since the pre-antibiotic era 75 years ago. In 1990 there were 18 large drug companies searching for new antibiotics and now there are no more than four.

“The antibiotic discovery pipeline is dry,” Wright says. “The reasons for this are complex, including economic and regulatory hurdles, but principal among them is that traditional target-based or cell killing screening approaches have failed to deliver new drug candidates over the past 20 years and ‘big pharma’ has moved to more tractable areas of drug discovery.” McMaster infectious disease experts Eric Brown and Gerry Wright. Wright is the scientifi c director of the Michael G. DeGroote Institute for Infectious Disease Research (IIDR) at McMaster University.

Wright says universities like McMaster and its team of experts are perfectly positioned to assume some of the roles pharma used to play and to deliver tangible solutions that will help make Canada a leader in the fi eld. Working collaboratively, and with colleagues from institutions nationally and internationally, the university’s researchers are fi nding candidates for drug development for new antibiotics along with alternatives to traditional antibiotics and new diagnostic tools by developing creative approaches to address the drug-resistance threat.

“Our critical mass of researchers expertly cross the boundaries of science, engineering and health sciences. Using their extensive knowledge and experience, combined with access to our state-of-the-art and unique combination of research facilities and screening technologies, they are priming the discovery pump in this fi eld,” he says. “We have already made substantial inroads and have already generated new molecules that have commercial potential. This new intellectual property can lead to new medicines and also new start-up companies that can exploit new business opportunities and create jobs for highly qualifi ed employees.”

McMaster’s approach is unique, he adds. Not only is it multidisciplinary, it thrives on creativity and breaking through traditional thinking about how to fi nd new solutions: • Unlike traditional academic-driven discovery that is typically dominated by solitary analy-

sis of narrowly defined systems, McMaster researchers are performing a variety of largescale chemical screens across a number of innovative targets with a goal of providing lead compounds that can be explored in preclinical and eventually clinical studies. • New screening methodologies such as the combination of bioactive compounds with antibiotics to preserve the activity of legacy antibiotics are delivering results. Recent work by the team demonstrated that a combination of the cephalosporin cefuroxime and the anti-platelet drug ticlopidine were highly effective in selectively targeting

MRSA (methicillin resistant Staphylococcus aureus). • In an effort to contribute fresh directions for new antibacterial therapeutics, McMaster researcher Eric Brown, with others, studies new antibiotic targets in Gram-negative bacteria, a problem of resistance that is acute. Brown’s group has found that starving bacteria under conditions typically found in infections makes these bacteria particularly vulnerable to antibiotics. • A potentially revolutionary treatment of infectious diseases exists in targeting bacterial virulence factors, the proteins involved in host colonization, immune avoidance and transmission. McMaster researchers Brian

Coombes, Mike Surette and Lori Burrows, world leaders in this field, study pathogenic bacteria. In particular, the researchers look at the interface between the host and the pathogen and countermeasures those pathogens have evolved to defend themselves and withstand the human immune system’s attempts to kill them off. McMaster is also tackling resistance by finding ways to boost the immune system to better treat infections. A rise in the elderly population as well as an increase in the average number of days spent in hospital has contributed to rising severity and incidence of hospital-acquired infections. This has prompted researcher Dawn Bowdish to investigate why the elderly are particularly susceptible to pneumonia and is developing new therapies that bolster the body’s own natural defense mechanisms.

Other researchers are working out in the field, locating samples from unusual environments including the sediment of the Great Lakes, muskeg swamps of Northern Ontario and, with collaborators, Cuban marine and coastal environments and a variety of locations in Nigeria to revive the historical collections of pharmaceutical companies.

Wright’s lab recently made strides in this area after discovering a fungus living in the soils of Nova Scotia. The lab screened the fungus using its state-of-the-art infrastructure and screening methodology, and discovered that the molecule’s properties targets and rapidly disarms one of the most dangerous antibiotic-resistance genes currently in existence. Called NDM-1, officials have referred to the gene as a nightmare since it is capable of overpowering nearly every drug from the penicillin class of antibiotics. The compound is currently in pre-clinical assessment and under evaluation by the U.S. National Institutes of Health. Wright’s team is also in the process of licensing the drug to a potential spin-off company.

Wright’s team also works in tandem with researchers such as John Brennan, director of McMaster’s Biointerfaces Institute where researchers are focused on creating new approaches for the detection of infectious diseases. For example, Brennan’s team is developing new ways to use an ordinary office inkjet printer to print paper biosensors, simplifying the diagnosis of infections like E. coli, salmonella and C. difficile. Knowing what bacteria are causing disease enables doctors to more accurately prescribe the right antibiotics and lessen the chance of developing resistance.

As the world enters a new medical era, McMaster is meeting the urgent global need to prevent, detect, treat and use an evidencebased approach for drug-resistant infections and infectious disease research, says Wright. “McMaster is finding creative and innovative solutions to ensure we do not revert to pre-antibiotic times, when infections that we now routinely cure are again life threatening,” he says. “We have seized the opportunity to advance how we discover new drugs and rethink drug use and drug combinations. We are confident McMaster will help Canadians can enjoy better health through new technologies and innovations in this important battle against superbugs and antibiotic resistance.”

Michael G. DeGroote Institute for Infectious Disease Research By the Numbers

• 37 principal investigators, including eight medical doctors and 29

PhD students • Researchers from three Faculties (Health Sciences, Sciences and

Engineering) and eight departments, including Biochemistry &

Biomedical Sciences, Medicine,

Pathology & Molecular Medicine,

Chemistry, Biology, Mathematics & Statistics, Anthropology, Geography & Earth Sciences • 400 graduate students, post-doctoral fellows and clinical fellows • More than $83 million in research funding acquired since the institute was established in 2007 • Unique supporting infrastructure, including: • Centre for Microbial Chemical

Biology – early stage drug discovery, natural products • Robert E. Fitzhenry Vector Laboratory – GMP manufacturing for vaccine candidates • Farncombe Family Axenic-

Gnotobiotic Facility – microbiome investigations • McMaster Genomics Lab –high-throughput sequencing, 454, MySeq • Renovated BSL3 Suite – HIV, Mtb, animals

To see this story online visit www.biotechnologyfocus.ca/ on-the-front-lines-of-the-war-onsuperbugs

By David Young

TAIWAN REAPING REWARDS

dr. david Young, Md

is the current CEO of Actium and is the founding Chairman of OBIO.

from strategic pivot to build sustainable biotech industry

Can it happen in Ontario?

Ontario has a deep respect for science, research and education. The thread that winds through human health, universal healthcare, and life science research joins the tapestry that is Ontario’s diversity of strengths, placing the province at the cross-roads of a signifi cant economic opportunity.

Ontario’s commitment to education is at a historic high, producing signifi cant results: high school graduation rates are at 90 per cent, university graduation rates are at 30 per cent and tertiary education is widely available through colleges and the 23 universities in the province. The large network of research universities means the province has a solid base of trained people, discovery capabilities, infrastructure and a repository of knowledge in the life sciences. Ontario has consistently funded basic research in life sciences which puts it in a good position to buffer against the rapidly changing economic environment by converting that investment into commercial opportunities.

The shifting economic sand that threatens Ontario is free trade and the expanding network of global trade agreements being forged.

Ontario’s economic engine has been to this point the auto sector, which accounts for more than one-third of its exports, primarily to the U.S. The Canada-U.S. Auto Pact signed in 1965 was abolished in 2001; Canada’s auto sector peaked in 1999 when it was the fourth largest auto maker in the world, now it is 10th. As an indication of the future softening of the auto sector’s importance to Ontario, global car companies are not investing in Ontario - of the US$24 billion being spent on growing capacity by the world’s car makers this year none of it is being invested in Canada. The second leg being sawed off in Ontario’s economy is due to the cyclical erosion of commodity prices since commodities provide a further 10 per cent of Ontario’s exports. The trifecta of an economic downturn, the need to service the current debt of C$267 billion and interest rate increases can trigger a calamity in Ontario.

The provincial government can create policy to af-

fect the fi rst, which has a knock on effect on the second but it has no control over the third. The exigencies of government budgets can curtail freedom of action but the spending side of the ledger is where a government can exert the most control. Development and investment decisions for future growth are the tools by which governments can bend the revenue and expenditure curves to an intersection. These can be long cycles but the payoffs are not only big, but vital to the health of a jurisdiction. This is especially true as global forces erode a jurisdiction’s economic base. Ontario is living this dynamic now; are there lessons to be learned from other jurisdictions confronting the same issues?

Lessons to be learned, fi nding a comparable

Taiwan has striking parallels to Ontario and faces a similar crisis in its economy. Taiwan and Ontario have similar GDPs, C$631.8 vs. C$695.7, respectively assuming an 80 cent Canadian dollar. Like Ontario, Taiwan relies on one industry for the bulk of its exports - with electronics comprising about 40 per cent of Taiwan’s exports, in the same ballpark as the auto sector for Ontario. Taiwan sells about C$25 billion of oil a year, and together with electronics these two sectors make up about 45 per cent of its exports; in Ontario auto and commodities make up about the same fraction of exports. Taiwan’s largest trading partner is also a behemoth - China receives almost 40 per cent of its exports; Ontario exports almost 80 per cent of its goods to the U.S. Since martial law was lifted in Taiwan in 1987 the country has been governed by the main opposition party, the DPP, for eight years and the current governing party, the KMT, for the remainder. In Ontario, the current main opposition party, the PC’s, has governed for eight years, and the current governing party, the Liberals, have been in power for 14 of the remaining 27 years. Like Ontario, Taiwan is seeing fundamental shifts in its economy because manufacturing has migrated to jurisdictions with lower labour costs like China and other Asian countries. Like Ontario, Taiwan’s exposure to oil subjects it to broader commodity trends.

How Taiwan is dealing with these pressing issues is a useful case study in harnessing innovation to pivot an economy from an impending weakness to a future strength.

Like many jurisdictions that recognize the manifold global demographic shifts, Taiwan, through successive generations of government, acted on the insight that healthcare is increasing in its importance to both governments and consumers. This is not only because of the aging of the baby boomers but also because of the emerging middle class globally. For example, China’s middle class can ultimately increase to 500 million people.

The Taiwanese government launched successive waves of plans, policies, funding and reforms over the last two decades culminating in a transformation of its life science sector over the last fi ve years. Astonishingly, the combined market capitalization for Taiwanese life science companies increased from US$3 billion to US$30 billion over fi ve years.

There is a robust, deep and liquid public market for biotech companies in Taiwan. Investor participation is wide from retail investors, to traditional venture capital, and private equity, to family offi ces, as well as corporate and conglomerate investors. Valuations are generous, and amount of capital raised is comparable to U.S. biotech companies at the same stage. The Taiwan Biotechnology & Pharmaceutical Industries Promotion Offi ce estimates there are 840 biopharmaceutical or biotech companies operating in Taiwan. By comparison the Canadian life science landscape has remained stagnant at about US$3.6 billion combined market cap for the same universe of companies. The workforce in biopharma in Taiwan increased from 42,000 people in 2008 to about 71,000 currently while Industry Canada estimates that 27,000 people work in the industry in Canada. Scaling the Canadian metrics

Table 1

ONTARIO (in C$ billions, 2014)

Exports Imports Trade balance GDP

TOP FIVE INTERNATIONAL EXPORTS, 2014 (%)

Motor vehicles & parts Precious metals & stones Mechanical equipment Plastic products Electrical machinery 353.29 350.10 3.19 695.71

33.9 11.2 9.2 3.7 3.6

TOP FIVE INTERNATIONAL EXPORT MARKETS, 2014 (%)

United States United Kingdom Hong Kong China Mexico 79.3 6.4 1.8 1.2 1.2

TAIWAN

Electronic equipment Machines, engines, pumps Plastics Medical, technical equipment Oil $391.50 342.25 49.25 631.82

39.3 10 6.8 6.6 6.4

China Hong Kong United States Singapore Japan 26.2 13.6 11.1 6.5 6.3

THE LAsT Word

Chi-Huey Wong, a prize winning chemist at the Scripps Research Institute and a co-founder of Optimer Pharmaceuticals, was convinced to return to Taiwan and head up Academia Sinica. @

to Ontario makes the comparisons stand out even more.

What is striking about Taiwan’s development plan for biotech is the persistence of its government’s vision, and the resources it was willing to devote to it. Perhaps it was through the success of guiding the country through many iterations of economic development from low value add products like textiles and petrochemicals in the 1960s and 1970s, to the transformation of the island into the leading tech manufacturer in the 1980s and 1990s that created the belief that another “economic miracle” was possible.

In 2009 the “Diamond Action Plan for Taiwan Biotech Takeoff” helped coalesce the many elements at play to catalyze the growth of the sector. Prior to the plan that sparked the transformation, the government was diligent at tweaking all the factors that went into such a central initiative including bringing in key leaders to advise, and ultimately to champion the cause.

In 2006 Chi-Huey Wong, a prize winning chemist at the Scripps Research Institute and a co-founder of Optimer Pharmaceuticals, was convinced to return to Taiwan and head up Academia Sinica by its prior president, the Nobel Laureate Yuan Tseh Lee. Dr. Wong helped to get the Biotechnology and New Pharmaceutical Development Act passed which had provisions similar to the Bayh-Dole Act in the U.S. and a 35 per cent tax exemption on investments in biotech research. Perhaps more significant was the accompanying creation of a US$2 billion venture fund, a new Food and Drug Administration and expanded infrastructure support for the sector to pave the way for turning the sector into a pillar of Taiwan’s economy.

Taiwan’s Diamond Action Plan is notable for being multi-faceted and trying to cover all aspects of the ecosystem. This includes core science and development functions like creating a Supra Incubator that integrates the physical resources of the four life science parks on the island, as well as providing new infrastructure. The regulatory regime works hand-in-hand with establishing best-in-class practices and aiding industrial development. The coordination function spans both fundamental and translational research to commercialization and capital formation.

Financial regulatory changes that facilitated listing of biotech companies happened to coincide with government efforts and the shift in investor sentiment that made biotech investing widespread. This redirection of private risk capital fueled the growth of the industry beyond the direct government investment that would not have been sustainable or desirable. The general tax regime and some specific incentives also tilted investment into biotech. Taiwan’s corporate tax rate is 17 per cent, and the capital gains tax can be as low as 7.5 per cent if the shares are held for more than a year. There are many biotech specific tax credit and tax deferral mechanisms, such as a 35 per cent corporate tax credit for training and a 20 per cent tax deduction for corporate shareholders that provide further incentives for biotech investment. Got something to say? There are also direct subsidies that blunt the risk and capital intensity Please send your comments/letters to inherent in research and development to make biotech mainstream biotechnology_focus@promotive.net

in Taiwan, such as funding for up to 49 per cent of the cost of a clinical trial and direct research grants to biotech companies. There has been talk of a biotech bubble in Taiwan, and in recent months there has been some retraction in the GreTai Biotechnology and Medical Care sub-index. However, the underlying premise and fundamentals of the Taiwan biotech sector are still valid. The aging society is not going away. The march of medical and healthcare innovation is not stopping soon. The importance of health to the individual is only going to become more important as people around the world become more affluent. The conversation on the balance of private vs. public payment in healthcare is only going to become more urgent as public healthcare budgets are being reigned in.

These global trends are as germane in Ontario as in Taiwan. Are there any lessons to be gleaned from Taiwan’s success in biotech that are applicable to a similar jurisdiction such as Ontario? The principles of investment, persistence, coordination, objective decision making, getting the best people to help, long term planning, effective tax policies, incentives for broad private sector capital mobilization, clearly stated goals, and public promotion have worked over many economic cycles in Taiwan. It should not escape any but the most casual observer that this kind of behavior has kept the governing party in power for 19 of the last 27 years; long term planning and staying the course in creating economic expansion has rewarded the KMT with longevity. Rather than viewing economic pivots as impossible tasks that could lead to political wilderness, both main parties in Taiwan see it as an essential tool to win electoral mandates - after all jobs and prosperity matter to everyone.

Taiwan’s success in biotech is based on a big bet. Ontario has made big bets before; funding the auto sector created 50 years of prosperity. To be successful in biotech Ontario has to put significant capital into the ecosystem to make a difference - like Taiwan, $2 billion of risk capital may be what is needed. Ontario has to use its policy levers, like creating a capital gains holiday for life science investments, to mobilize private capital; it has to recruit champions with track records of objective and relevant success to lead the charge; it has to concentrate its attention into a few efforts so that there is clarity in mission and accountability; and it has to have the political will to make it a top three priority for the province so that everyone will know what the big bet is.

Perhaps at first these actions seem bold, but, upon reflection, end up being necessary. The pivot to a biotech economy in Ontario can change the future prospects for the province as much as it does for Taiwan. Dr. David Young, MD, is the current CEO of Actium and is the founding Chairman of OBIO, a biotech industry group; a director of MabNet, a NSERC Strategic Network and a director of the St. Michael’s Hospital Foundation. He was the Founder, CSO and CEO of ARIUS, a biotechnology company which was publicly traded on the TSX until its sale to F. Hoffman-La Roche and the BIOTECanada Biotech Company of the Year in 2009. He is a recognized entrepreneur and received the Entrepreneur of the Year award from the Association of Chinese Canadian Entrepreneurs.

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