Innovation with heart
AT SHOCKWAVE MEDICAL, DIVERSITY AND EMPLOYEE CREATIVITY HELP DRIVE THE FUTURE OF CARDIOVASCULAR CARE
Women are persistently underrepresented in cardiology clinical trials, and undertreated for heart conditions such as the buildup of calcium deposits that can narrow and stiffen blood vessels. What’s more, they may also present different symptoms than men, making the identification of heart disease in female patients challenging. As a result, women tend to experience worse long-term cardiovascular healthcare outcomes.
Shockwave Medical aims to change this. The company’s intravascular lithotripsy (IVL) technique breaks up calcium in blood vessels with sound waves generated from a tiny balloon inserted via a catheter. The technology, which is safer and more effective than traditional methods, shatters brittle calcium deposits, helping open blood vessels while leaving soft tissue unharmed.
“We’re committed to making big investments in areas of unmet needs,” says Susan Peterson, senior director, R&D, at Shockwave. “Our patient base is very diverse, and we believe it makes sense that solutions should come from a diverse group of innovators.”
The company’s more representative approach to cardiovascular care and continued efforts to transform patients’ lives through innovation has helped earn Shockwave a spot on Fast Company ’s list of Best Workplaces for Innovators.
A SAFE SPACE FOR NEW IDEAS
Shockwave encourages innovation from the ground up. It does so by fostering employee and company development through internal incubator programs. Employees can pitch ideas outside the purview of existing projects and receive resources to explore them. These incubators essentially become small startups within Shockwave. “They provide a way to look at high-risk, high-reward ideas to which we can dedicate a team budget to really dig in and find out if they’ll be feasible,” Peterson says. “It’s a great way to keep our innovation pipeline growing.”
She adds that the incubator projects also allow employees to have a direct impact on the future of the company: “It’s absolutely motivating to know as an R&D employee that you have a voice and are able to build on ideas to see where they can take you.”
NURTURING COMMUNITY
Shockwave values diversity and connection as a driver of innovation. For example, Peterson is a founding member of an employee resource group at Shockwave called SWAT (Shockwave Women Achieving Together). The group offers technical workshops and mentoring, schedules guest speakers, and provides a forum for sharing information about the various member projects. “It’s a wonderful chance for women from R&D, Quality, and Operations to come together, inspire, and support each other,” Peterson says.
Peterson points out that the culture that gave rise to SWAT is key to driving innovations such as IVL and the company’s upcoming “EMPOWER CAD” study. EMPOWER CAD is an all-female study in coronary interventions, a first in the space, and is led by female investigators, also a first. The study, which began enrolling candidates in May, aims to provide robust long-term outcome data on female heart patients and help determine whether IVL can become a front-line treatment with equal clinical outcomes in men and women.
“Shockwave is a really safe space where you can be creative and push outside the box,” Peterson says. “Employees know that their work matters and directly benefits patients who have no other current treatment options. And that’s a really exciting place to be.”
tag in the tens of thousands of dollars (at least)—would change the company’s fortunes. Moderna’s stock soared more than 25% when initial data from the MRNA-4157 trials was released in December. But it has since lost those gains (and then some), as investors and analysts see a long, complex path to approval.
“The data is encouraging,” says Vinod Balachandran, a surgical oncologist at Memorial Sloan Kettering Cancer Center who has been leading the development of an MRNA vaccine for pancreatic cancer from Biontech and Genentech. But he’d like to see more data on how Moderna’s MRNA-4157 is working—if, and how strongly, immune cells are actually recognizing vaccine targets—which Moderna hasn’t yet released. In addition, FDA regulators might not see an urgent need to fast-track approval for a melanoma therapy, given that multiple treatments are already available. Moderna is also far from alone in developing personalized cancer vaccines.
Other drug candidates advancing through Moderna’s pipeline could be good medicine, if not commercial home runs. The company says it plans to file for FDA approval for its bivalent influenza vaccine, which has had mixed results in Phase 3 trials. It has also launched a Phase 3 study of a vaccine candidate to prevent congenital cytomegalovirus, a leading cause of birth defects in the United States. In addition, Hoge, Moderna’s president, looks forward to getting clinical data later this year on several protein-replacement therapies for rare diseases.
Working across diverse therapeutic areas, though, comes with challenges. Speaking on background, some scientists involved in developing MRNA drugs for other companies argue that the features that make MRNA good for vaccines—short-lived behavior and locally administered—work against it when it comes to treatments. The authors of a 2021 article in the influential journal Nature raised similar concerns, questioning whether MRNA formulations are as effective in therapeutic drugs that target specific organs as they appear to be in vaccines. In other words, Moderna’s MRNA platform may not be as versatile as it seems.
SEVEN YEARS AGO, BANCEL boasted that Moderna would have dozens of drugs on the market by now, not just one. Bancel shrugs it off. “That was the direction, the order of magnitude, not the precise number,” he says. With 36 candidates now in clinical trials, he contends, “I think we’re well on track to that.”
Moderna has a reputation for being secretive and even disingenuous. (A trait, to be fair, that’s shared by many in the industry.) A 2016 editorial in Nature slammed the company for not publishing its science, noting that “other prominent biotechs like Theranos and Kadmon have also chosen stealth over disclosure of data.” This January, FDA advisers chided the company for not sharing key data about rates of infection in recipients of its bivalent COVID-19 booster. And, while Moderna’s COVID-19 vaccine— as well as the one from Biontech and Pfizer—relies on (and pays to use) methods developed by biochemist Katalin Karikó and immunologist Drew Weissman at the University of Pennsylvania, Bancel has fiercely contested patent claims brought by others.
He seems, however, eager to recast his image as an icon of capi
SEVEN YEARS AGO, BANCEL BOASTED THAT MODERNA WOULD HAVE DOZENS OF DRUGS ON THE MARKET BY NOW,
NOT JUST ONE.
talism run amok. In 2022, Bancel earned $19.4 million in base pay and another $398 million in realized gains from exercising stock options. In a March 2023 blog post, he wrote that he donated all his after-tax proceeds from the stock options, $176 million, to philanthropic causes last year. But he’s not apologetic about the 400% increase in the list price of Moderna’s COVID-19 vaccine, arguing that it’s in line with that of similar vaccines. Should the company’s cancer vaccine come to market, it will surely renew the drugpricing conversation.
Moderna is also trying to shake off a reputation as a revolving door for talent. After at least a dozen highly placed executives left the company between 2012 and 2016, Bancel reportedly turned to the HR departments of Google and Netflix for advice on stemming the flow. “Smart people who wanted to stand out and challenge Stéphane’s ideas didn’t last,” says a former employee of this era. “But he was pretty loyal to those who performed for him. And I’ve never met someone as industrious as him.” A more recent ex-employee says that Moderna is “not as toxic as it used to be.” POSTCOVID-19, the company has beefed up HR and implemented well-being perks such as three “Recharge Days” per year and a free subscription to the Calm app.
“I think in the early days I wasn’t clear enough with candidates that this is not a 9-to-5, leave-yourbrain-at-the-door type of company,” Bancel concedes. “This is a place where we believe we can change the lives of millions of people—and that every day that we are late because we didn’t do our best work, people will suffer. Now I tell people, this is who we are.”
What Moderna will be remembered for, however, remains to be seen. Producing a lifesaving vaccine to help stanch a global pandemic might be enough for a regular company. But there’s no indication that Bancel—and his company’s investors—will be satisfied with that.