St. Mike’s people join in the push for a COVID-19 vaccine

Craig Duffy ’06, a Saint Michael’s Spanish graduate and liberal arts enthusiast who became a supply-chain logistics specialist across varied industries, landed in January with the major Boston-area pharmaceutical firm Moderna, and since early spring has been supporting one of the most promising clinical trials for a safe and effective vaccine for COVID-19.

Craig Duffy during “Purple and Gold Day” for alumni to show their St. Mike’s spirit in 2019.

“I support the clinical trial leads and make sure they have enough drugs to supply those studies,” said Duffy, who helps direct the efficient transfer to labeling, packaging and distribution from external-partner manufacturers of drugs that are being used in Moderna’s COVID-vaccine trial studies at different sites.

The fast-tracked work is an expanding enterprise: Researchers design clinical trials to answer specific research questions related to a drug candidate, and clinical trials follow a rigorous series from early, small-scale, Phase I studies to late-stage, large scale, Phase III studies. If a treatment is successful in one phase, it moves on to the next phase.

Phase I of Moderna’s COVID-19 vaccine study started last winter at just two sites; Phase II was at 10 sites with more volunteers, Duffy said in anticipation of the still wider-scale Phase III studies, which were on track to begin in July.

Such a timeline is more rapid than is typical in drug development and testing, given the urgency of this mission in potentially saving lives on a large scale, Duffy said. “I had never seen drug development move at this speed – it normally takes years and years to get where we have in months,” he said. “But then, I have never worked on a vaccine in a pandemic.”

Moderna has been in the headlines since the pandemic started for the company’s promising work on a potential COVID-19 vaccine. Among the several companies working on a possible vaccine, Duffy describes a mutually-supportive and friendly competition, given the nature of the mission.

“There’s definitely competition to be the first out there because we certainly feel an obligation to the world to try to do whatever we can in our capacity to find some sort of solution,” he said.  “It goes without saying, if you know the pharmaceutical industry well, that Moderna is playing with the big boys – Pfizer, AstraZeneca – but we operate on different technology from theirs … ours is a little different method of a vaccine. I wish them all the success in the world and hope they are successful too. There won’t be just one vaccine out there to meet worldwide demand. – we hope everybody does well in it.”

He said Moderna, founded in 2011 and based in Cambridge, MA, is considered a medium-size biotech with nearly 1,000 employees. Duffy said he found his niche in the biotech industry right around in 2011, although he first worked at two other biotech firms before coming to Moderna in January 2020.

Right out of Saint Michael’s, Duffy worked for “a small third-party logistics company” that served major clients such as Ocean Spray and Gillette. There he learned about supply logistics and eventually went to work for the large sportswear manufacturer Adidas for 4-plus years. While working at Adidas he completed an MBA at Assumption College, taking part-time night classes.

Making alumni connections

As the immediate past president of the St. Mike’s Alumni Association’s Board of Directors, Duffy just finished the first year of his two-year term on the Board of Trustees, after Annie Rosello ’94 stepped down early to take a job with the College in Institutional Advancement.

Craig Duffy ’06 is helping hold the Alumni Association banner on the left side in this file photo of the group during one of its meetings from recent years, taken on campus in the Pomerleau Alumni Center.

Duffy said he soon discovered that he is far from the only Saint Michael’s graduate behind the scenes at Moderna as the company is poised to possibly make history. “After I started here, I did a Linked-In search and saw eight other Saint Mike’s grads so I emailed them all to try and connect,” Duffy said.

Angela Armour in the Alumni office reports that graduates she knows at the firm in a wide variety of roles from her records are Zach Minior ’17, Kristen Cowens ‘12, Christopher Pepin ’08, Julia Hughes ’17, Meredith Wolfrom ’00, and Molly McGovern ‘14. The latter was the only one from that group whom Duffy had met earlier before coming to Moderna: “I met her at a St. Mike’s career symposium a few years ago and stayed in touch,” he said, adding that McGovern “is a scientist who has been able to work from home during the pandemic, while Zach Minior works at our manufacture facility in Norwood.”

Said Duffy, “It goes to show that Saint Mike’s graduates are everywhere and we’re doing important work out there. I think this industry sometimes gets a bad reputation, but at the heart and soul of it, we’re just trying to solve health problems, as I see it …and this is where a St. Mike’s liberal arts education really broadens my world view and makes me comfortable in a high pressure situation, where every minute of the day counts because time is of critical essence.”

What they’re doing

In May, widespread news reports noted how Moderna, which describes itself in publicity as “a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients,” announced “positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).” In standard clinical trial protocols, Phase I basically determines if a drug is safe, Phase II determines with a larger study group whether it is effective and Phase III explores effectiveness on a still wider scale.

Phase II trials began around February with Moderna’s potential COVID-19 vaccine, and now a June 12 report from Clinical Trials stated that “Moderna has finalized the protocol for the Phase III clinical trial of its Covid-19 vaccine candidate, mRNA-1273, based on feedback from the U.S Food and Drug Administration (FDA). The trial is set to be performed in partnership with the U.S. National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID). It will enroll about 30,000 participants in the US. The primary endpoint of the Phase III trial is the prevention of symptomatic Covid-19 disease while key secondary endpoints include the prevention of severe Covid-19 and SARS-CoV-2 infection.”

Duffy explained that it was about January when “everybody started hearing about coronavirus” just as he was starting at Moderna, and it was “probably the end of February when the floodgate started to open for us.” He said his role is in “demand planning” — namely, “how much drug needs to be manufactured to support clinical trials, and then I manage the labeling, packaging and distribution of the drugs.”

All this is keeping Duffy and his colleagues very busy as the study enters Phase III. “I’ve definitely gone from the traditional 8 or 9 hour work day to 12 hours easily, and I know people I work with who do 16 hours every single day on it,” he said. “It’s a lot of work to do, but it’s like we feel a sense of obligation and urgency to do this, not necessarily driven by the business but by trying to stay with the world and what people need.” He’s been working from home since the middle of March with the pandemic.

Liberal Arts: A Universal language

Originally from Franklin, MA, Duffy now lives in Andover. He remembers visiting St. Mike’s as a high school senior and immediately knowing it was where he wanted to attend college, even though he is not a person who likes the cold. He joked that this might well have been a reason as a Spanish major that he chose to spend a full year rather than the typical semester studying abroad in Spain (Salamacca), as a junior. “I loved being there and was really immersed in the language and culture,” said Duffy, who also, when back in Vermont, was involved as Founder’s Society Tour Guide and active in Edmundite Campus Ministry, while taking a service/study trip to El Salvador as a sophomore.

Craig Duffy gets a photo during Commencement ceremonies with his academic adviser and favorite professor at St. Mike’s, Carolyn Lukens-Olson of the Spanish faculty.

“I truly am so grateful every single day for having a liberal arts background,” Duffy said. “It really makes you have the ability to think about complex issues, makes you a better writer and thinker and gives you critical thinking skills.” While allowing how his personal career path “didn’t follow what you might expect for a Spanish major to maybe be a teacher, I try to use the international travel and global mindset to take my humanities insights and bring that into business” – though he never took a Saint Michael’s business course.

A favorite academic memory for him is a seminar on the Spanish poet Lorca that he took with his adviser Carolyn Lukens-Olson of the Spanish faculty. “It was a tight-knit and close group of students and I think of that class frequently,” he said. “We still stay in touch.”

As to his continued involvement to benefit the College, Duffy said, “I just feel like I got so much out of my Saint Michael’s experience that if I’m able to help even one student, whether making an annual gift or being a resource in their career searches, that makes me feel like I’m able to give back at least part of what I got out of Saint Michael’s. I feel that, for all they gave me, it’s the least I can do.’