When we interviewed Amy Jenkins, a student at Clarkson University, 02 ( chemistry and biomolecular sciences) in the spring of 2020, he was working on an antibody therapy that acts as a "temporary vaccine" to prevent infection in people exposed to COVID-19. The antibody, which would create immunity that would last for several months, was still in the production stage.
Jenkins is a program manager in the Agency's Office of Biological Technologies Defense Advanced Research Projects (DARPA), a research and development agency of the US Department of Defense. There he manages three programs that focus on medical countermeasures, both vaccines and therapeutic, and how to develop and manufacture them more quickly to combat infectious disease threats.
We recently met again with Amy.
What's the latest about antibody treatment you were working on in the spring 2020? Did it come into use?
Yes. We are very excited to report that two of the products in the portfolio I manage are now in clinical trials late stage or have emergency use authorization (US) and are being used. These were the first tracks that came out of this show and I think they are in record development time.
The first is bamlanivimab from Eli Lilly / AbCellera. That antibody, as it stands now, has an indication for the treatment of patients who are at a very early stage in the evolution of COVID disease. So while the use of monoclonal antibodies can prevent disease, an app we're absolutely interested in within the Department of Defense, Eli Lilly was involved in those studies to see if they could use it to treat COVID patients and got a use for emergency. authorization to do so. It is now being distributed and used nationwide to prevent infected and symptomatic people from progressing to serious illness and needing to be admitted to the hospital.
The second product, AZD7442, is a combination of products. This cocktail of monoclonal antibodies (two antibodies that are used in one product) is in late-stage clinical trials with AstraZeneca. This antibody was fully discovered, characterized, and developed as part of DARPA's P3 (Pandemic Prevention Platform) program and went on to receive additional funding from the US government to conduct late-stage clinical trials. They are currently in a phase three clinical study with two arms.
The first takes healthy people and sees if this can act as a preventive, what we call pre-exposure prophylaxis. You are walking, you know that you have not been exposed to COVID and you try to prevent that, similar to a vaccine.
The second is a clinical trial in a post-exposure prophylaxis setting. So you may not have symptoms, but you know you have been exposed, you can sign up for this trial. It seeks to see why people do not have symptoms of COVID disease and the prevention of the disease in that environment where people know they have been exposed.
What is your role in these two products?
The companies and academic groups we work with – we call them performers – did all this amazing work. Of course, I was there with them on the phone many times, but they do the hard work of finding the antibodies. But what we do as program managers is visualize what we think is necessary: establish if we ever encountered this kind of situation, how would we solve this problem?
We try to visualize the types of technology investments that must be made for this to be a reality. And that's what I've been handling. Invest in those. Pushing these groups. Keeping them focused. Have many technical calls to make sure they are making the progress we anticipate. And if they're not making progress, we brainstorm what we can do to fix it.
And then also on the much less exciting side, but absolutely necessary: making sure that we are doing everything up from the perspective of the United States government taxpayer dollar.
Are you working on a new project?
I am very excited that we have recently been able to launch a follow-up program. The goal of the NOW (Nucleic Acids on Demand Worldwide) program is to create the ability to manufacture nucleic acid-based vaccines and countermeasures (think Moderna's mRNA vaccine) in a distributed environment.
So instead of having to manufacture things in a big building in one place in the country and then ship the vaccines all over the country, imagine a situation where you could have a fairly small manufacturing device: think of devices or rooms the size of a tractor-trailer or half a tractor-trailer. And you could have this device on site that essentially produces thousands of doses of antibodies every other day.
When we designed the program, we thought heavily about the Ebola crisis in both West Africa and the Democratic Republic of the Congo, and how helpful it would be to be able to have On-Site Manufacturing in some of these advanced remote environments. But I think that even in the context of the current COVID response, if we didn't have to ship and we didn't have all the logistics and distribution that centralized manufacturing entails, and we could make things where we need them, it could ease some of the pressure on the system.
DARPA is always very interested in pursuing high-risk, high-reward technologies. Another program I run is called PREPARE (Preventive Expression of Protective Alleles and Response Elements). It is a very early and very high risk R&D effort to develop a completely new modality to combat infectious diseases and viruses using the newly emerging CRISPR-Cas technology.
These are enzymes that can cut DNA very specifically, and versions of this have recently been discovered that are enzymes that can very specifically cut RNA. The idea was that if you had an enzyme that could cut an RNA very specifically, could we engineer it to very specifically cut RNA from, say, the coronavirus or influenza virus, and essentially shred that virus before make us sick?
This is a very early stage R&D program. Right now we are only doing laboratory experiments, but it is promising in the early stages that it could also use these new emerging modalities to combat infectious diseases.
Did Clarkson play a role in your success today?
Absolutely. It really set me up for success in grad school. I came to Clarkson as a first generation college student. He didn't even know how to get a Ph.D. I had professors and advisers at Clarkson who helped guide me through that process. I would credit Clarkson 100 percent as the foundation of my success.
I was able to move between chemistry and biomolecular science and had daily conversations with professors and consultants about my interests. They helped me think about taking classes like medical microbiology and classes that I think traditional chemistry students don't take.
It allowed me to obtain a very interdisciplinary training. That's one of the reasons DARPA is so successful – we bring people from such diverse backgrounds together to solve problems and I think it helps when you have that different background.
Professors Phil Christiansen and Jim Peploski were truly instrumental in helping me prepare to think critically as part of a PhD. Program. They said, "You're smart, use your brain and think about it. You'll find out. That's what graduate students do." And I used what they told me many times. Use rational thinking and that is your job as a graduate student. I give them a lot of credit for giving me that advice.
Any advice for Clarkson's current students?
Clarkson has a very recognized program and the opportunities are there. Take advantage of them and use them to get where you want. And if you don't know how to get where you want to go, ask people. Because there are people who help you and can take you there.