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June 2014 – by David J. Klein, MD, MBA
Dr. Klein trained in Internal Medicine and Critical Care Medicine at the University of Toronto and completed his MBA at the Kellogg School of Management. Before returning to medicine he was a consultant at McKinsey & Co. where he was a member of the North American Healthcare Practice and served as an advisor in therapeutic area strategy to several large pharmaceutical companies. He has also been involved in medical affairs for the last 15 years for Canadian biotechnology firms and has contributed to clinical trial development, clinical trial oversight, Health Canada and FDA regulatory submissions. Dr. Klein is also active in research in sepsis in critical care as well as health policy and has published and presented his work internationally.
A few weeks ago I attended Gallie Day – an annual celebration of the Surgeon-Scientist Program hosted by the Department of Surgery at the University of Toronto. A major theme was commercialization – a topic that would have been unheard of at the first Gallie Day 40 years ago. A week later, I attended the first annual HealthKick Venture showcase hosted by MaRS – a high profile “pitch event” for 45 of Canada’s most exciting healthcare startup companies. Similar events are on the rise at both traditional “powerhouses” of scientific commercialization like MIT and Stanford, as well as smaller centers in North America, Europe, and even the Middle East. What is clear from these types of events is, in the words of Bob Dylan, “the times they are a changing.” But understanding this brave new world can seem intimidating to even the most experienced clinical investigator or scientist or even company.
One of the key takeaways from the Gallie Day presentations from several successful clinician-scientists who’ve ventured into the world of commercialization is the wide variety of skillsets that are required to take a scientific idea into a commercial venture. These include regulatory affairs, intellectual property and patenting, manufacturing, fundraising, business development, operations, partnering and clinical development strategy. In addition, in most cases the time from idea to marketed commercial product can span 10 to 20 years or more. While this may seem daunting, the rewards can be immense personally and professionally for the individual and for the institution. Consider that in 2007, Royalty Pharma paid Northwestern University in the United States over $700M dollars for Pfizer’s royalty interest in Lyrica – a drug for chronic pain developed in a lab at the University. However, most entrepreneurial ventures from academia do not turn out this way, and many of the panelists at Gallie Day were forthcoming in highlighting that the chances of this kind of success are quite small. Nevertheless, for the clinician-scientist who truly wishes to see his discovery at the bedside as a product that’s widely used and changing patient’s lives, commercialization may represent the ultimate form of knowledge translation.
How can the HUB help? Firstly, the HUB has strong relationships with industry partners in large pharma, local hospital technology transfer offices, MaRS Innovation, venture capitalists and other potential partners who can be helpful in evaluating and accelerating the commercial potential of a discovery. Perhaps more importantly, many members of the HUB have both academic and industry experience and a keen sense of when an idea or discovery might be something that might be commercializable. In a first meeting with us to discuss a clinical trial idea an investigator might get feedback that includes “have you reviewed the investigational product history in the area and thought about filing a patent or an industry partner for funding?” In addition, our experience in running clinical trials and registries includes deep clinical development expertise in what is required to bring a new medical device, drug or other discovery to market. On occasion, where we don’t have the specific expertise needed for a certain area, we can access it very quickly through our networks. To date, the HUB has helped investigators develop everything from a new surgical closure device for trauma surgery, to a natural health product for neurodegenerative disease, to a new topical medication for wound healing. We also enjoy working with companies both small and large in these areas and are often able to provide input into clinical trial strategy, as well as reimbursement and health economic strategy – an increasingly important part of any clinical development plan.
So, while commercialization may seem daunting, the rewards can be immense. We invite you to contact us to see how we can help you along the way.