Carmen Wong completed her PhD studies on creating viruses for cancer research. Since then, she has been working with inventors from universities, accelerators, and startup companies to commercialize their innovations. Carmen was a commercialization analyst with CCRM from 2016-2018. In her free time, Carmen is developing her design skills and hopes to incorporate them into science outreach and communication projects.
credit: CCRM
At networking events, the following conversation typically takes place when I meet someone new. They ask me: “What do you do (for your job)?” I typically reply with: “I help bring research to the market.” This usually leads to the question: “Have you worked on anything that I have heard of?”
Sadly, my answer has been, so far, no. It can take years, if not decades, before an idea from a research lab is ready for the public and the timeline to market is even longer for technologies in the regenerative medicine field or life sciences space. What makes commercialization in these industries so difficult?
Every researcher knows that while we can hypothesize what will happen when we test a new drug, biologic or device, we could get an unexpected outcome. The results may not always translate from the dish to an animal or from an animal to a human — after all, we currently cannot account for every interaction or domino effect that occurs when something new is added to a biological system. “Negative” results can lead to the project being shelved, or require a change in project direction before further development.
Let us move ahead and assume there is an innovation that seems to be working. How does the invention fit into the current market? Is there a need for it? Are there any other products like this? Can we protect this innovation with patents, a copyright, or should it be a trade secret?
Often researchers have not considered these questions or may not know how the “bench to bedside” process works at all. The lack of expertise in this area is currently bridged by university and hospital technology transfer offices, patent lawyers, non-profit organizations, and government-funded organizations driven to provide advice, connections or capital in building a business case and/or to establish a company.
Market research can be done through literature searches and talking to end-users or customers to make sure the invention fits into the assumed market and demand exists. While building a business case is required for a new invention in any field, scientific innovations may require additional experiments to satisfy patent application requirements, and optimization or modification before bringing it to industry or investors.
With any investment, there is risk. To reduce risk, investors may ask to see strong results from advanced animal studies or even phase I studies before committing any funds. This could cost up to seven figure amounts for these studies alone, capital that can be difficult for researchers to raise as grant funding is typically restricted for specific uses. Overall, in comparison to consumer products and software, regenerative medicine and life science products require more capital and time to develop and optimize.
Not surprisingly, the lack of funding or investment is the most common challenge faced by researchers trying to get their discoveries to a point where partners may be interested. According to a 2017 Evaluation of Commercialization of Research report, 54 percent of surveyed clients served by federal government’s Centres of Excellence for Commercialization and Research (CECR)-funded centres agreed that funding or investment was a major hurdle.
Moving along the commercialization pathway, manufacturing methods and product distribution are essential steps for getting a product into the hands of patients. These processes require their own development, optimization and other factors such as quality control. While certain types of products (for example, drugs) could have processes built on established platforms or infrastructure, emerging fields such as cell immunotherapies and CRISPR-mediated gene editing, may not share this advantage. Even though the demand for new manufacturing processes or platforms is high, there is a lack of skilled labour in emerging fields to address these problems.
As regenerative medicine and life science-related innovations typically target human health or disease, they need to address regulatory requirements and complete clinical trials — a requirement to ensure the biologic, device, or anything else you may put into the patient is safe and actually does what the inventors claim it can do. It could can take several years, if not more, before the product completes clinical testing and gets approved for market use by the government.
So, what can we do to address these commercialization hurdles?
Academic institutions and organizations with expertise in commercialization should work with researchers at early stages of technology development to provide education on the “bench to bedside” process and help build entrepreneurial skills. This will allow researchers to efficiently plan projects geared towards commercialization and understand the tools and expertise available to them. One such opportunity is the Business of Regenerative Medicine, which has a decade of instructing attendees on what you need to know to commercialize a regenerative medicine-based product or therapy.
Funding organizations should consider additional funding or programs to bridge the gap from research to industry. All parties involved in the long road to commercialization, which includes academia, non-profit organizations, government, angel investors, venture capitalists and industry, should continue to work together to build a strong network and foster an ecosystem where innovations can be brought to those who need them most.
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