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 2
Q: So you’ve eluded to this throughout your talk and you’re presenting the time frame very thoughtfully, but I wanted to really expressly understand – what triggered BioGenesis to spin out as an independent research as well as development entity separate from your lab?
A: Yea, that’s probably the key question. What did it was a frustration with the fact that we had gotten to a place in this field where all of the pieces – or I felt – all of the pieces for development of this technology – which is the reason I got into science in the first place – were finally there, but they were existing as separate entities at different academic institutions. And allowing them to continue just as academic research projects would mean it would probably be another 15 to 20 years before we could ever realize a donor independent platelet unit. What we needed was some entity to piece together the key pieces of technology, put them in process, translate them over to cGMP, do the preclinical work for investigational new drug approval, and take them through the regulatory processes. It was the only way it was going to happen and this being so young a thing, there did not exist any large companies that were willing to gamble on this and so, when we started this, the first sort of gut feeling was: well, we’ll just license the technology to Amgen and let them figure it out, but Amgen had no interest in touching this, Baxter had no interest in touching this. Too risky, right? And so, it was either going to take 15 years and no one was going to do it or someone was going to do it and the only person that was at all interested in doing it was me, so I just bit the bullet and am trying to do it.
Q: Other than the time management issues that you’ve raised, in terms of having far more than 40 hours of work a week, do you find that the work related to the development of the company is in any way deleterious in the development of your academic career?
A: No, I would actually say it’s the opposite. That network that you establish, taking a research project through commercial development, the people you meet, the skill set you develop – all of these things have made me a far better scientist than I was and allow me to ask more critical questions in my own academic research projects. It has also expanded the network, so in terms of finding partners to co-develop other projects in the lab, finding alternative sources of funding for academic research projects, understanding the legal landscape so that I even know when I’ve got something that we should file IP on and when we should file IP – all of that has come from my own experiences taking this through. So, I would say it actually benefit – it did not hurt at all.
Q: Are there any circumstances in which you’d consider leaving academia to go full-time into the company and if someone were to do that, do you think that closes the door on academic research in the future?
A: So, to answer your second question first – no, I don’t think it closes the door at all – and I know a lot of people that actually made careers bouncing back and forth, so no, that’s a myth. The first question – yes. The limitation now in our hands is the amount of financing the company has. It makes a lot more sense to invest money in a young research scientist to develop the company goals than to pay my salary. At some point, if we do well, the company is going to have the resources to bring me over. I’m under incredible pressure to go over to the company and it’s probably something I’m going to do. It’s just a matter of timing.
Q: Being a professor at Brigham and CEO of a company, is it allowed that you can apply for an SBIR grant in your name?
A: No. I’m not the principal investigator on the SBIR grant. I was a consultant for the SBIR grant and I helped shape it and direct how it was formulated. STTR grants, I think are different. STTR grants are shared between the company and the institution, so if we had filed an STTR grant, I probably could have been the PI on that.
Q: But if not you, can anybody from the company apply for the SBIR grant?
A: Yea, it’s interesting. We filed two SBIRs. The first SBIR was actually led by our finance officer, so he was not even a scientist, but that didn’t matter because we had a very strong scientific consulting team that we had hired for the company, and we had consultants from other academic institutions, so we filled that niche. The second SBIR, we’ve just recently filed – actually Lea, our principal research scientist is the PI on that.