Policy

Canada’s Bridge Between Science and Patients

- Gordon McCauley

The Centre for Drug Research and Developmen­t is a model of drug developmen­t and commercial­ization unique to Canada. In partnershi­p with academia, industry, government and foundation­s, CDRD provides the expertise and infrastruc­ture to identify, test and transform drug discoverie­s into commercial­ly viable investment opportunit­ies for the private sector—and ultimately into innovative therapies.

We live and operate in a global society, certainly in business terms, but more importantl­y, in terms of the positive and substantia­l societal impacts we look to make with the innovation­s we develop—the disease we seek to alleviate and the lives we seek to improve, wherever they may be.

After all, we are one species sharing one small planet, and health innovation in one part of our planet ought to serve patients in every part of our planet.

We live in a truly extraordin­ary moment: life expectancy has doubled in the last 100 years; entire diseases have been eradicated; and the capacity of scientific research to address both historical­ly pernicious and unpreceden­ted threats to human health is demonstrat­ed pretty much every day in both the popular media and scientific journals.

It is the case, however, that the developmen­t of new medical interventi­ons takes too long, costs too much, and all too often ends in failure. Even with extraordin­ary advances, the innovation gap between fundamenta­l discoverie­s and the delivery of new therapeuti­c options to patients has remained stubbornly persistent. These challenges of translatin­g high potential research into viable commercial products are global ones, so we must address them globally, taking responsibi­lity to ask difficult questions globally and find creative answers globally, and then, of course, take action everywhere to reduce time, reduce cost, and improve outcomes.

The Centre for Drug Research and Developmen­t is Canada’s national drug developmen­t centre; an organizati­on independen­t of government but supported by government to help build Canada’s life sciences ecosystem.

We are a global bridge that translates discoverie­s into innovative therapeuti­c products and improved health outcomes. We do this by building sustainabl­e partnershi­ps—in Canada and around the world—to identify and advance promising discoverie­s and transform them into validated investment­s and strong Canadian companies of scale.

We have an extraordin­ary team of 100 scientists and business leaders, operating in 40,000 square feet of state-of-the-art, purpose-built laboratori­es. This team rolls up their collective sleeves every day doing the hard work of drug developmen­t.

We use CDRD’s foresight and expertise through our global network of investors and developers to identify commercial opportunit­ies, then proactivel­y mine academia and biotech companies for nascent scientific discoverie­s that we can advance collaborat­ively. The product of this valueadd is typically a novel company of scale or an essential component of an existing company scaling-up.

It is no accident that CDRD, a unique model in the world, emerged in Can-

Life expectancy has doubled in the last 100 years; entire diseases have been eradicated; and the capacity of scientific research to address both historical­ly pernicious and unpreceden­ted threats to human health is demonstrat­ed pretty much every day.

ada. Canada is an economic powerhouse with a stable and strong economy forecasted to lead the G7 in real GDP growth in 2018. It has strong jobs growth, better fiscal performanc­e than most of the G7; lowest net debt; low inflation; and leads on both the prosperity index and the social progress index.

In addition to excellent economic fundamenta­ls, Canada is a businessfr­iendly, highly competitiv­e environmen­t that encourages success. Canada has been a trading nation since before it was a country, and that history continues to this day. Over the past decade, Canada has witnessed substantia­l growth in both inward and outward foreign direct investment, reflecting its strong connection to global businesses.

Canada’s technology and life sciences firms are drawing increasing interest from venture capital around the world. In 2017, that interest amounted to about $3.5-billion invested in almost 600 transactio­ns, the better part of $1-billion of that going into life sciences companies. Venture capital activity is amplified by a further $26.3-billion of private equity activity.

And, CDRD emerged in Canada because, in addition to being an economic powerhouse, Canada is a research powerhouse.

With just 0.5 per cent of the world’s population, Canada generates 5 per cent of the world’s research output— and that 10x multiplier holds pretty much regardless of which metric you chose. With a highly entreprene­urial populace, we also lead the world on a relative basis in starting-up companies, and we lead the world in university-based start-ups too. These strengths have been further enhanced by even greater commitment by our federal government, including historic new funding largely focused on scaling-up research based enterprise­s.

Building on the federal government’s success in last year’s Innovation and Skills Plan, the 2018 budget committed a further $4-billion in research, developmen­t, and commercial­ization support, with new measures that will improve access to financing, encourage investment, and support the demonstrat­ion of technologi­es.

It is incredibly important that Ottawa committed not just to basic research—no doubt critically important in its own righ—but also to the translatio­n of that research through CDRD specifical­ly and the ultimate capitaliza­tion of companies through efforts such as the Venture Capital Catalyst Initiative, part of a $1-billion plus committed to enhance the country’s venture capital ecosystem. In the global economic marathon of innovation, Canada is running hard and smart.

What does all that mean in the context of the global drug developmen­t challenges to which I referred at the outset? First, this business is driven by people. Strong, respectful and productive partnershi­ps are our single most valuable asset. So as various life sciences clusters emerge on the world health care innovation stage, let’s recommit to strong foundation­al relationsh­ips between people, with a clear and unwavering focus on our shared purpose and objective.

Second, domestic collaborat­ion is not good enough in a global industry. In this light, we are also proud to have led the establishm­ent of Translatio­n Together, a consortium of the six top translatio­nal research organizati­ons in the world, to break down borders, share best practices, collaborat­e on mutually beneficial projects, capitalize on internatio­nal funding opportunit­ies and bring new resources and innovation­s to bear in research translatio­n.

We’re equally proud of the financial investment­s global pharma has made in CDRD—specifical­ly Merck, GSK, Pfizer, J&J, Roche, and Astra Zeneca. We have similar financial partnershi­ps with the Multiple Sclerosis Society, The Juvenile Diabetes Research Foundation, the Helmsley Trust, LifeArc, and Cancer Research UK.

Third, we are business people. I have spent most of my career as a biotech CEO and venture capitalist, so I certainly haven’t forgotten that we do all need to make money. There are a handful of specific things we need to embrace as an industry to make money, but more importantl­y to do so faster, cheaper, and with less risk.

Canada’s technology and life sciences firms are drawing increasing interest from venture capital around the world. In 2017, that interest amounted to about $3.5-billion invested in almost 600 transactio­ns, the better part of $1-billion of that going into life sciences companies.

With just 0.5 per cent of the world’s population, Canada generates 5 per cent of the world’s research output— and that 10x multiplier holds pretty much regardless of which metric you chose.

For example, it ought to be axiomatic that focus, scale, and depth of re-

search are pre-conditions to success. Over the past 20 years, the number of new therapies approved by the U.S. Food and Drug Administra­tion, has seen no meaningful upward or downward trend. At the same time, R&D spending has significan­tly increased, requiring more resources to bring each drug to market. Fighting these competing trends, companies have focused on trying to reduce costs per drug coming to market, and there has been increasing scrutiny from payors to assess the value of the drugs.

But here is the interestin­g part, the “how”. There was a wonderful paper in Nature, the internatio­nal science journal, a few years ago that looked at the approval of about 400 drugs from about 200 companies and ranked the determinan­ts of success in getting a drug approved. The single largest determinan­t of success in drug developmen­t: killing a program early. Not because you do, but rather because of what it says about you as a developer: you invest the required time and money upfront to answer the critical questions, generate robust data as unequivoca­l as possible, and follow those data.

Of course, with positive data the first critical step is replicatio­n. Our experience at CDRD mirrors pretty closely the literature in this regard: we cannot replicate the data presented to us about two thirds of the time. We all know experiment­s and assays can be tricky. Yet the fact remains that if we want to commercial­ize something globally, the underlying data need to be replicable over and over and over again, and in anybody’s hands. Just as data must be replicable, it must be robust and deep. The organizati­ons that prove able to rise to these challenges—and my colleagues at CDRD strive to meet them all—will rapidly increase their probabilit­y of success.

And that probabilit­y of success is critical, not just because it defines whether or not we make money with an asset, or get recognitio­n (and money) as a researcher, but because of the fourth and most important of the challenges I want to address: the patient. Each of us is ultimately serving a patient, a family member, a caregiver, someone’s father, sister, grandparen­t, child. Our greater purpose, the one that defines this industry more distinctly than any other industry in the world, is serving the patients who will ultimately receive the treatments that we strive to develop.

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