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 value-add 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 Canada. 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 business-friendly, 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.

For example, it ought to be axiomatic that focus, scale, and depth of research 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.  

Gordon C. McCauley is President & CEO of The Centre for Drug Research & Development in Vancouver.