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Helping life-changing technologies leave the nest

Researchers discuss what it takes to advance an innovation towards commercialization while remaining at the Wyss Institute

By Jessica Leff 

Helping life-changing technologies leave the nest
Nina Donghia poses with one of the technologies she helped to develop – wearable freeze-dried cell-free that can be incorporated into clothing or face masks. Credit: Wyss Institute at Harvard University

At the Wyss, we know that breakthrough discoveries can’t change the world if they don’t leave the lab. People often equate scientific research leaving the lab with people leaving too. Sometimes that is the case, as with our Lumineers who launch and lead companies based on work they’ve done at the Wyss. However, startup formation is not the only way to ensure maximum impact.    

Many members of our community have a proven track record of developing and de-risking innovations to the point of commercialization and choose to stay at the Wyss. It could be that their technology’s best path forward is being licensed to an existing company, or the person might feel they can make a bigger impact by continuing to mentor young scientists who can then make their own mark on the world. Whatever the case may be, these valuable inventors make up an important part of our ecosystem and are essential to our mission to transform healthcare and sustainability.  

We sat down with some of these individuals – Nina Donghia, James Niemi, M.S., Sasha Stafford, Jenny Tam, Ph.D., and Jeffrey Way, Ph.D., to learn more about their technology development work and motivations for continuing to innovate at the Wyss.  

What are some of the technologies you’ve worked on and where are they now? 

Donghia: Right now, my role is to help validate technologies in vivo. I contributed to our instrument-free molecular diagnostics, which is now part of the 2024 Faculty Focus list. I’m also part of the team that worked on the COVID-19 diagnostic face mask. Elite Bio is another project I’ve worked on that’s exciting to me. It is an Institute Project, so it’s really preparing for commercialization.   

Helping life-changing technologies leave the nest
Jim Niemi presenting on some of his early Wyss work at the Retreat in 2013. Credit; Wyss Institute at Harvard University

Niemi: Early on in my time at the Wyss, I was involved in developing a series of stochastic resonance stimulation devices for a variety of potential applications. One of those, vibrating shoe insoles for balance and gait improvements, was licensed to a large company. A related innovation applied this stimulation to wearables for improved sensory and motor performance. This formed the technology base for the startup Accelera. Finally, one of our major efforts was developing innovations for improving infant cardiorespiratory function. This resulted in the formation of the startup Prapela, and additionally some components of the program were licensed to MediCollector, an existing company. Since that time, I have been involved in several other efforts at a technical level.  

Stafford: I initially came on to support the analytic aspects of a clinical trial we did over at Dana-Farber for a melanoma cancer vaccine. It was actually the first ever Institute Project and was licensed to Novartis. Another configuration of that cancer immunization using tumor lysates was licensed to Attivare, a Wyss startup.  

We’ve also done a lot of work making hydrogels. A company has an option on one of these innovations. Alkem Laboratories licensed another related technology to treat ischemic injury and vascular disease 

Tam: Right now, my primary focus is on the CircaVent project, where we’ve developed a platform for discovering and screening drug candidates for bipolar disorder. We have filed patents for some of these discoveries, and some of these efforts are part of active discussions for licensing.  But part of my role is also mentoring researchers throughout the Platform, providing scientific feedback, and shepherding projects through the technology development pipeline. Recently, Dyno Therapeutics, Manifold Bio, EnPlusOne Biosciences, and Rejuvenate Bio all spun out and licensed IP that originated with the Synthetic Biology Platform.  

Helping life-changing technologies leave the nest
Jeffrey Way has mentored numerous researchers over the years, for example Marika Ziesack who spun out Circe Biosciences. Credit: Wyss Institute at Harvard University

Way: Aside from the work that led to the founding of General Biologics, a Wyss startup at which I spend about 20% of my time, many other innovations I’ve contributed to have spun out. For example, I mentored Marika Ziesack starting when she was a master’s student in the Silver Lab and continuing on through her Ph.D. and postdoctoral fellowship. She founded a startup, Circe Bioscience, based around technology developed at the Wyss. I also worked on the technology that became the basis of 64x Bio, now run by Lex Rovner. Now, I’m working on a protein therapeutic for pancreatitis, a devastating disease where patients are in such horrible pain that sometimes it cannot even be controlled by opiates. The team has a product that works, and we’re hoping that can be commercialized soon. 

What does it take to advance a technology to commercialization? 

Donghia: It is important to assemble a team of people from different backgrounds and fields that work well together. You also need to emphasize on technical validation. 

Niemi: Every technology is different, but my experience with MedTech programs indicates that you have to significantly de-risk technologies before they are attractive enough to either secure a license or warrant the creation of a startup company. I think MedTech is an especially demanding space for academic innovation. For our successful programs, we had to advance each to the point where we had an industry-level, high-quality, prototype with documentation, published clinical results on human participants, an established intellectual property position, as well as a preliminary market analysis. 

Stafford: You must make sure that your work is robust and reproducible. That goes a long way towards translation and satisfying regulatory agencies, like the FDA.  

Tam: It takes a team with good communication and a complementary division of skills that’s creative and flexible.  

Way: Overall, I’d say the most important thing is to have someone championing the technology who is willing to withstand the tough times until you can truly have an impact. 

What motivates you to continue to develop cutting-edge technologies? 

Donghia: Our group has an incredible body of work. I’ve been here for ten years, and it’s completely different now from how it was when I started. Jim Collins’ lab, and the Wyss at large, can scan the landscape and sense where science is going, then pivot our focus and iterate until we come up with something impactful. That ability comes from the marriage of academic work and a focus on translation. It’s fascinating to see the intersection of the computational side and the technology development side, and how we can validate that work in the lab.

Niemi: I am motivated to work on these technologies because I believe they will positively impact people’s health and well-being once commercialized. I enjoy working on challenging, early-stage, high-risk, high-reward technologies. Many have to be created from scratch then advanced and then de-risked before being ready for industry investment, scale-up, and commercialization. I enjoy addressing each of those challenges. 

Stafford: That ah-hah moment! There’s a lot of intellectual curiosity that’s satisfied through invention and exploring new ways of doing things. I get a kick out of pushing the limits of technologies to figure out new applications. 

Helping life-changing technologies leave the nest
Jenny Tam presenting at the 2023 Wyss Retreat on her work on the CircaVent project. Credit: Wyss Institute at Harvard University

Tam: This process uses a lot of creativity and is driven by finding solutions. Sometimes problems are really difficult, and you have to find a solution that doesn’t exist yet. I find that interesting.  

Way: The patients! There are so many things in life that are not fair, and one major form of inequity that isn’t discussed as often is health inequity. If you have a chronic illness for which no cure has been invented, that’s a real challenge. I’m particularly interested in working on diseases where there is some sort of social stigma or misunderstanding. General Biologics’ lead indication is Chronic Obstructive Pulmonary Disease or COPD. In the United States, this is primarily caused by cigarette smoking, and because of that many people don’t have sympathy for these patients. However, in most of the world, COPD comes from air pollution. Respiratory disease is the third leading cause of death worldwide.  

Another example is pancreatitis – a good percentage of cases result from alcohol consumption, often in combination with a genetic predisposition. Again, some people judge these patients, but I understand that there are many reasons why people drink alcohol to excess. It doesn’t mean that people don’t need our help. Their stories motivate me.  

What is the difference between advancing a technology internally and going out with a startup? 

Niemi: You can only advance a technology so far internally before you are faced with challenges like corporate fundraising, design for manufacturing, scale-up, certification and testing, clinical trials for regulatory approval, and regulatory submissions. These later activities need to be handled by companies and not academic institutions. Conversely, some of the earlier activities around prototype development, proof of concept, and early clinical studies are risky and cannot always be explored effectively by startups or existing companies. This is especially true for new disruptive technologies, leading them to be best explored by innovative experienced groups such as the Wyss Institute. 

Helping life-changing technologies leave the nest
Sasha Stafford enjoys working on the early-stage aspects of multiple technologies. Credit: Wyss Institute at Harvard University

Stafford: The advantage of being at the Wyss is we can work on the early-stage aspects of a technology to further expand it in both indication and capability. We can also keep a lot of balls in the air, whereas industry and startups are very focused. 

Tam: The Wyss provides a lot more support and services than what you have at a young company. Depending on where you go, one challenge of a startup is you really have to do everything, from administrative duties to operations to sometimes even serving as the janitor. Leaders in young companies need to balance the operational side while pushing science forward and fundraising, which can be very daunting.  There are places like the Blavatnik Accelerator and Lab Central that have some infrastructure to meet these challenges, but at the Wyss there’s additional scaffolding, including business development, to help a company or technology be successful.  

What drives you to keep innovating at the Wyss? 

Donghia: It’s such a dynamic environment – our research goals are shifting and changing. I’m not doing the same thing each day, or even from one year to the next, and that’s why I love being here. Hopefully this flexibility allows my efforts to be meaningful and impactful. 

Niemi: When I first arrived at the Wyss, with primarily industry experience, I imagined staying here a handful of years while working on a technology and then spinning out with it. The first successful program that I had a significant role in here was licensed, so there was not an opportunity to spin out with it. This was the best outcome for advancing the technology further to commercialization, so we were happy with the end result. At the time I had already begun to work on other technologies that were of strong interest to me, and I was motivated to stay and move them forward. Then the opportunity came to take on additional responsibilities here, staying and helping to mentor and assist other entrepreneurs rather than always being directly involved myself. This opened new growth challenges that I was, and still, am excited to tackle. 

Stafford: The Wyss allows us to not only innovate technologically, but also to form new models of collaboration, like the Brain Targeting Program. Startups are more subject to market forces and timing, but staying at the Wyss allows me to keep developing and de-risking technologies to ultimately help people.  

Tam: At the Wyss, there’s a constant generation of fresh approaches to grand challenges. I don’t think we have the solutions for all of them quite yet, but I like continuing to work on these complex problems and collaborating with different scientists and researchers.   

Way: I feel a responsibility to the projects that I’ve started – I want to see them advance to commercialization. I want to continue to mentor young scientists so they can see their visions realized.  

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