Filling the void: A scientist’s introduction to commercialization/clinical translation

Author: Holly Wobma, 04/26/17

For anybody who has invested a great deal of time into a research project, you probably feel a certain sense of expertise on the topic. Sure, it is impossible to know a whole field (every answer raises more questions), and lab work is rife with puzzlement and failures, but at the end of the day, you probably still know a lot more about your subject than the general populace.

As an MD-PhD student working on stem cell science, I felt this modicum of expertise on the stem cell therapy I had been working on for the last four years.

That is… until I tried to translate it.

Just like the common phrase “from bench-to-bedside,” my brain had skipped over a very important “B.”

Business.

Fortunately for my project, I participated in a commercialization “bootcamp” at Columbia University, called the Columbia-Coulter Biomedical Accelerator. This program provides seed funding for biomedical technologies spinning out of institutional intellectual property (IP), but first teams must conduct a rigorous evaluation of the business potential of their technology, which is guided by weekly lectures and networking with various business advisors. Here are some of the topics we covered:

  • Unmet Need – what problem is your technology meant to solve? (If it is a platform technology, what is your best beachhead market?)
  • Stakeholder Analysis – who cares about what you are doing and who are your potential partners (patients, providers, insurance companies, distributors…)?
  • Market Validation – who have you talked to who can validate assumptions you make about your business? More = better. Don’t be shy.
  • Business Model – how will your company work? What pains does your product relieve and for whom?
  • Market Landscape – what is your initial total addressable market, and how will this change over time (untapped markets)?
  • Competition – who else is in the space you want to enter and what fraction of the market can you expect to capture? Remember to think about who will be in the space by the time that you get there (future space).
  • Reimbursement and Regulation – what is the path to regulatory approval? Once approved, will it be reimbursed and how?

After exploring these topics over the last four months, I have learned to think about emerging technologies from an investor’s perspective, and my team’s technology has a path-to-market that is far less vague.

Regardless of whether you intend to go down the translational path, I think these exercises are useful, because they paint your science within a much broader landscape, and this “market landscape” can help reinforce the good you are hoping to bring to patients/providers and what you need to do to make this happen.

Now, I am much more hesitant to claim “expertise,” so I will just leave you with some of my final take-aways

  1. The science may be fascinating, but that doesn’t mean something is marketable.
  2. Investors/stakeholders need to be convinced of significant return on investment (real and potential) or your product may not get the financial backing to develop it.
  3. A product can be FDA approved, but that doesn’t mean it will be reimbursed.
  4. While the “customer” for devices/therapies is rarely the patient (often it’s a hospital), it is still possible to have a business mentality that centres on patient well-being.

 (Ed: Holly asked whether similar opportunities exist in Canada to learn about “the business” of regenerative medicine. Her timing is perfect as CCRM and the Rotman School of Management, along with its partners, are hosting The Businesss of Regenerative Medicine: Leadership, Innovation & Entrepreneurship on July 17-19 in Toronto, Canada. Themes include IP, financing, regulatory, reimbursement and manufacturing. Learn more and register here.)

 

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Holly Wobma

Holly Wobma

MD/PhD student at Columbia University
Holly is an MD-PhD student at Columbia University in New York. She recently (2011) completed a Bachelor of Health Sciences Honours Degree from the University of Calgary, where she pursued research related to nanotechnology and regenerative medicine. In addition to research, she enjoys participating in science outreach roles. Previously, she contributed to an award-winning Nanoscience animation produced by the Science Alberta Foundation (“Do You Know What Nano Means?”), and served on the board of directors for the Canadian Institute for Photonic Innovations Student Network. Holly's lab tweets @GVNlab.
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