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A Shot in the Arm

Ryan

Moderna Senior Vice President Shaun Ryan ’91 on managing risk and helping the company scale up to take on COVID-19.

BY ANDREW WICKENDEN ’09

Since early 2020, Shaun Ryan ’91 has been operating at warp speed. The senior vice president and deputy general counsel at Moderna says, “For better or worse, we’ve always been a lean legal team,” and when COVID-19 emerged, he was the lawyer responsible for working with governments and negotiating research and manufacturing contracts. Ryan says he wouldn’t want to relive the stresses of the pandemic or the whirlwind production of the vaccine, but he’s also “probably learned more in the past 20 months than I have in the past 20 years of practicing law.”

Moderna — founded in 2010 as ModeRNA Therapeutics — is a pioneer in messenger RNA biotech, still an emerging field in pharmaceutical research. The )rst successful mRNA transfection was recorded only 32 years ago, and with the pace of standard testing protocols, most mRNA drugs are in their nascency (most of Moderna’s products are either in Phase 1 trials or preclinical development). When the pandemic hit, Moderna was a clinical stage company, still about two years away from running large-scale Phase 3 studies, let alone distributing significant quantities of mRNA medicines.

For Moderna scientists, creating “the COVID-19 vaccine took a matter of days,” Ryan says, “because of the 10 years prior spent developing the mRNA platform.” But the company now had to account for preclinical research and large-scale clinical trials alike, while navigating an uncertain regulatory landscape, building out supply chain operations and expanding manufacturing capacity (and raising the capital to do so) — on top of coordinating with government agencies and negotiating international agreements. Going from a development-stage biotech operation to a global pharmaceutical company practically overnight introduced another order of complexity, Ryan says, “in part because we were doing all of these things simultaneously…all well before we knew whether the vaccine would even work. There wasn’t a lot of precedent.”

With a vaccine candidate in hand, Moderna researchers raced to start testing. In partnership with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, Moderna completed clinical trials and won FDA approval in just shy of a year. Meanwhile, Ryan and the company’s legal team were coordinating trial protocols, allocating materials, managing logistics and hashing out contract terms with government officials.

In some ways, the frenzy helped gauge the company’s priorities. Among other duties, in-house counsel manage risk, but “there was no way to manage for all the risks we were taking on,” Ryan says. “The most important part of managing a crisis of this scale is to figure out the two or three things you need to get right… and solve for those.”

With the pandemic raging, there wasn’t time to roleplay negotiations and game out different scenarios. Typical sticking points — like which party covers delivery costs — became minor concerns compared to issues like manufacturing capacity, the vaccine’s efficacy and liability.

“Administering hundreds of millions of doses of vaccine around the world, essentially simultaneously…the risk of liability is huge,” Ryan says. Convincing governments to accept a share was crucial. “In a normal situation, a company should, and would, be 100 percent liable for its products. Here, we all agreed that we needed to move fast, so we had to make sure we were all sharing that liability — that it wasn’t all borne by one small company.”

Ryan, who studied English at HWS, says “the introduction to a broad range of ideas and ideologies proved immensely useful” in thinking through the potential legal, ethical and financial consequences of Moderna’s decisions. “Learning how to read carefully, think critically and make cogent arguments has been invaluable for what I do now,” he says.

These days, Ryan still spends about half his time on COVID issues, including efforts to deliver vaccine to underserved parts of the world. “So far,” he says, “almost 50 million doses of Moderna vaccine have been delivered to [the international vaccine alliance] Gavi/Covax for distribution to low and low-middle income countries, but we have a long way to go.”

And while getting beyond this pandemic remains a priority, Moderna is also readying for the next one. Until now, Ryan says, there’s been little political appetite for a dedicated pandemic response facility, which requires vast resources to maintain, possibly for decades, without being used. As governments and NGOs revisit the idea, Ryan has a seat at the (still virtual) table, helping his bureaucratic counterparts think through practical challenges “to ensure the world is better prepared for the next pandemic, whenever that may come.”