The following is a transcript from a talk I gave at the medical device development course, Brigham and Women’s Hospital (Boston, MA) on May 12, 2016.
Due to length, I have broken the talk up into seven parts:
Part 1: Why do this? – I describe the pros and cons of engaging in a translational research venture. It is definitely not for everybody.
Part 2: What you need to do before you start – I assumed that we were interested in pursuing science translation through entrepreneurship and discussed how best to start.
Part 3: Identifying milestones – I discuss the milestones that you need to achieve in order to see a product through to completion.
Part 4: We established a timeline and budget around these milestones, and recruited our team to begin “de-risking” the venture.
Part 5: We recognized the importance of transitioning the research out of your academic lab.
Part 6: Questions and answers 1
Part 7: Questions and answers 2
Questions and Answers, Part 1
Q: You have to prove to investors that your idea is working. At which time do you patent anything? Do you have to?
A: You want to be patenting as soon as possible and you want to be keeping the tech transfer office and your IP group – here at the hospital or institution – abreast of what you’re doing as you’re doing it because the patents need to be filed before any publications happen. And certainly, I’m imagining that this is a competitive landscape and so, definitely before your competitors are patenting possibly similar technology.
Q: In your case, when & how many patents?
A: We have now filed three patents. One is at the international stage, one’s at the PCT stage, one is just a provisional – it’s more recently been filed. I think the first one was filed now, maybe two years ago, three years ago – something like that. It takes a while and also bear in mind that negotiating the intellectual property with the institution will also take you about a year, maybe more.
Q: As a professor and also a founder of a startup, how do you split your time between the two?
A: With a lot of difficulty. I manage a full-time research lab and then I don’t sleep at night and my weekends. You’ve got to make it work – I don’t know how else to say it. There is overlap – I mean, a lot of the early work is the same for both – one of my academic lab projects and the company – and at some point, around the time you found the company and it moves into its private lab space, the two begin to diverge. We were very fortunate that there exists here the B-BIC grant, the BRI grant – these offer a protected space to develop – for commercial applications – academic projects. So, that’s sort of the grey overlap, but it is a difficult question to answer because – at least at this stage – I’m still wearing two hats and I can’t divide myself in two, so how the institution deals with the reality of these sorts of situations is an ever-evolving question. But, in terms of time, you’ve got to make it somehow.
Q: You eluded to this early, but especially given the last question about wearing two hats. In light of the Partners conflict of interest rules that most academic institutions will have, just nitty gritty – how does that work? I mean, at some point you became shareholder in a company with some amount of equity and how is that managed?
A: So, the way it’s managed now is that the conflict is managed and so everyone knows my affiliations with the company and my affiliations with the institution. I have disclosure slides and when I give public talks and in all of my academic publications, I have disclosures. I do have a consulting agreement with the institution and Platelet BioGenesis, which allows me to consult for the company, so it really is a matter of managing the conflict.
I mean, my experience with this, not just from ourselves, but from others, is transparency is always the best way to handle this. Just be brutally honest about what you’re doing in all forms of your life and then people can judge the research coming out of your lab with a grain of salt if they feel it’s biased. But, so long as you disclose.
Q: So, you talked about negotiations with the academic institutions, but what if there are inventors on your patents that are not going to be involved with the startup company in any way. Is there a protocol for following that, do you have to license the patent from them?
A: In our case we had the IP developed by myself, another investigator – Joe, adjacent me, both in the same division here at Harvard Medical School – David Weitz at Harvard University and a postdoc over there in his lab. What the institution does when it’s filing your IP, is it will reach out to all of the groups involved in that IP and they’ll decide amongst themselves who is going to be controlling, or negotiation in favor of all of the inventors.