From The Editor | March 8, 2024

Debra Weiss, RN: Big Impact In Small, Non-Profit Bio


By Matthew Pillar, Editor, Bioprocess Online

Debra Weiss, RN, MSN, Chief Operating Officer, Gates Medical Research Institute

I know a handful of nurses, all of them female, and every one of them driven, confident, and capable. These nurses I know put off a complete control kind of vibe. I’m in control of my situation, that vibe tells me. If need be, I can take control of yours, too.

This vibe gives me a sense of comfortable confidence when I’m around my nurse friends. Confidence that come what may, I’m a little more protected.

I’m starting to think this “nurse vibe” is universal, because my newest nurse friend, Debra Weiss, RN, MSN, puts it off too. I think that’s why people trust her, why they follow her lead, and, ultimately, I think it’s what propelled her to the Chief Operating Officer’s chair at the Bill and Melinda Gates Medical Research Institute (Gates MRI). She exudes control of her own destiny, and in a comforting nurse kind of way, acceptance of responsibility for the people around her, too.

All that said, not even Debra Weiss saw this coming.

A Small Organization With A Big Global Impact

For the unaware, Gates MRI is a multinational, not-for-profit biopharmaceutical company with a pipeline of early-to-late-stage therapeutic candidates in tuberculosis, malaria,  diarrheal diseases, and maternal, newborn, and child illnesses. Its mission is to reduce the burden of these diseases – diseases that don’t offer giant incentives to address – in low- and middle-income countries.

Gates MRI employes about 160 associates and is led by an all-star team of life sciences professionals. Emilio A. Emini, Ph.D., FCPP, FAAM leads the team. A pioneer in antiretroviral therapy and HPV and rotavirus vaccines, he’s a guy who knows how to solve big health problems. He’s backed by Chief Medical Officer and Head of Development Michael Dunne M.D., FIDSA, whose work on several antibacterial, antifungal, antiviral, and HIV therapeutics while at Merck, and subsequent startup biotech experience, helps guide the company. The entire C-Suite at Gates MRI is what you would expect of a Gates Foundation-backed organization – a who’s-who of industry heavyweights.

During her practicing RN days at the University of Pennsylvania and Hahnemann University Hospitals, had you asked Debra Weiss where she’d be in 20 or so years, serving among those heavyweights as COO at Gates MRI wouldn’t have been on her bingo card. But looking back on her career from the vantage point she’s now held since 2020, she isn’t surprised at all. She’ll admit that she didn’t plan it, but she’ll acknowledge that, in retrospect, she was certainly in control of it.

Kicking Down Doors In Big Bio

Working as an RN in a university hospital allowed Weiss to do what she intended upon earning her MSN from the University of Pennsylvania. “I went into nursing because I cared about the patients. I wanted to make a daily connection with them,” she says. Running clinical research trials as Sr. Research Coordinator at Penn scratched that itch.

In an early illustration of her insatiable appetite to learn and expand her influence, Weiss became a member of Penn’s FDA-recognized Institutional Review Board (IRB). That was something of a coup. While not unheard of for a master’s-level RN, IRB positions at research universities are more typically held for Ph.D.-level physical and biological research scientists.

At the time, she didn’t even know what a curriculum vitae was, much less that she was beginning to build one.

Running clinical research in a major university hospital setting also exposed Weiss to Big Pharma, or what some of her colleagues in academia referred to as “the dark side.” When you’re doing great work in academia, industry tends to notice. Ten years into her university work, that’s exactly what happened. Merck came calling to recruit Weiss into a trial monitor role.

“Some of the university physicians I worked with dissuaded me. They said, ‘we’re academics. Don’t enter the big, bad, pharma world,’” she recalls. But when a particular physician confided to her that Merck was the best of the best, she took the leap.

At Merck, Weiss became a sponge, absorbing as much as she could. “My 10 years there were amazing, because they really understood how to do clinical trials right, and how to protect patients and do what’s right for them,” she says.  She began her stay there as a Medical Research Coordinator. Nearly nine years and several promotions later, she was Merck’s Manager of Quality Assurance.

Weiss’ ascension at Merck gave her access to new intelligence at every turn, and she took full advantage. “I didn’t view those experiences and that exposure as boxes to check off,” she says. “I looked at them as opportunities to learn more. I'm a big believer in experiences, building a toolbox and putting as much into it as you possibly can.”

With a master’s degree, 11 years doing academic research in the clinic, an IRB appointment, and nearly ten years at Merck, her toolbox was filling right up. Industry continued to take notice.

In 2004, Shire came calling. Weiss was hesitant to leave Merck, but that insatiable appetite to learn, grow, and expand took over. “Merck gave me a great foundation to build on my training. I loved it there, but it was the Merck way,” she says. “The opportunity at Shire would give me a lot more exposure to folks from different pharma companies and biotechs. Merck had a great way of interpreting the regulations, but there are other ways to do that.”

Weiss took the job at Shire and spent a little more than 11 years there, starting as Director of R&D and Quality Assurance and climbing her way to Group Vice President, R&D and QA. More importantly, she added another tray or two of shelves to her growing toolbox.

A Journey Back To The Patient

With a decade of academic research experience and more than 20 years of leadership in industry, the writing of Weiss’ next chapter began when Big Pharma circumstances intervened. She’d spent her career in the Philly area and built a life there, but Shire was relocating to Boston. The company’s sale to Takeda was imminent. It was once again time to exercise control of her own destiny.

Weiss left Shire to take a turn at a gig that resonates with many experienced life sciences executives; she became an independent consultant. Providing quality and compliance guidance and solutions to pharmaceutical companies, and implementing strategies for ensuring GCP, GLP, and GMP inspection readiness, were in the dead center of her wheelhouse. Why not?

But this was a short chapter. Adept as she was, pieces were missing.

“I consulted for two years, long enough to realize that’s not what I wanted to be,” she says. “I wanted to be deeply involved in the organization, and I wanted to be closer to the patient.”

In 2017, Weiss was approached with an opportunity that came with a map back to leadership and patient centricity. The Bill and Melinda Gates Foundation was setting up a not-for-profit pharmaceutical company aimed at developing medicines for the most urgent healthcare needs in low- and middle-income regions. The Bill and Melinda Gates Medical Research Institute (Gates MRI), as it would be called, wanted Weiss to serve as its Head of Quality Assurance. She would be employee number two.

“I thought, wow, these past 20 years of experience in industry have been invaluable, but they’ve taken me away from the patient. This opportunity would take me closer to my nursing days, when I felt like I had the greatest patient impact.”

Even during her time in big pharma, the patient-centric mantra never left Weiss. In 2005, while at Shire, she began teaching a graduate course on good clinical practices (GCPs) at Temple University. Nearly 20 years later, she’s still teaching that GCP class. “I teach my classes about the Declaration of Helsinki. I teach them about the Nuremberg Code. Why? Because they set the groundwork for the guidance of our behavior to protect patients,” she explains. “And if we don’t have patients willing to be in studies and willing to take on risk, which there will always be despite our best attempts to minimize it, we won’t be able to bring our good work forward.”

Servant Leadership Doesn’t Require The Smartest Person In The Room

In June 2020, Weiss was appointed Chief Operating Officer at Gates MRI. Turns out, the North Star that led her into patient care is the same guiding light that drew her into leadership. It’s that aforementioned nurse’s mentality: I will take care of me, and I will take care of you, too. She’s leaned into team building, taking care of her teams, and counting on them to take care of the organization.

Don’t be mistaken, Weiss has no reservations about making risk-based decisions. In fact, application of the “decision-by-committee” approach, to even the simplest problems, was one of the things that irked her most about working in Big Pharma. But she’s quick to admit that leadership decision making isn’t about what you know. Once upon a time, that was a hard lesson for her to swallow.

“For a time, while I was at Merck, I felt like I needed to know everything there was to know about the  technical aspects of the job,” she says. “When I moved to Shire, I was exposed to some amazing female leaders, like Denise Hudson (SVP, Supply Chain). She wanted me to move into the Group VP, Global QA role, and I was hesitant. I asked her what she saw in me that I didn’t see in myself. She told me she saw an ability to think strategically and pull teams together. She taught me that you don’t have to know everything, because you can’t possibly know everything,” says Weiss. “I don’t need to be the smartest person in the room, and in fact, I don’t want to be the smartest person in the room. I want to bring the smartest people to the room and learn from them.”

Exercising Leadership At Gates MRI

Naturally, when Weiss joined Gates MRI as Head of QA in 2018, her charge was to build the startup’s QA function. As the organization rapidly grew, so did her responsibilities. Weiss embraced them. “When you’re on a team, you’re not just there for your function,” she says. Penny Heaton, M.D., Gates MRI CEO at the time, drove that lesson home to leadership teams, too. “Penny instilled the philosophy that the challenges we face are the institute’s problem, not a specific person or function’s problem,” says Weiss. Speaking of Dr. Heaton, while Weiss recognizes the value that strong female executives have contributed to her career, she also suggests that she’s not a gender equity hawk. “There are inequities, and I recognize that. But I’ve never focused on ‘male’ or ‘female,’ just as I’ve never focused on title or status. I’ve focused on opportunities to fill my toolbox, which is something I have control of.”

At Gates MRI, the tools in that toolbox earned Weiss a reputation as a “fixer,” in the most positive sense of the word. Gradually, she took on procurement, IT, facilities, HR ,and finance. True to her word, whatever she didn’t know, she supplemented by hiring. “In a quarterly board meeting I said, ‘please don’t expect me to understand everything about finance. I didn’t grow up in that space, but I will commit to you that I will find the best finance leader, ever,” she recalls. That she found in Mahendra Pattni, a Shire colleague who she recruited to team Gates MRI, from which he recently retired.  “The higher your career takes you, the less it becomes about you and your expertise, and the more it becomes about the organization and how you’re solving its problems,” she says.

That’s the expectation of all leaders at Gates MRI. “We attract some amazing talent, people who are interested in the mission-driven work we do,” says Weiss. “We need very experienced folks, we need subject matter experts, and we need leaders who are willing to roll up their sleeves and wear multiple hats.” That, she says, has been a challenge. Leaders coming from big pharma are accustomed to delegation; one department handles this, another handles that. “We’re very clear with candidates when we tell them, ‘yeah, that would be you doing that,’” Weiss says. Dirtying hands at Gates MRI might not be a cultural match for the majority of biopharma leaders, but she wouldn’t ask it of anyone else if she hadn’t accepted it for herself.

The game of responsibility whack-a-mole Weiss plays in her COO role at Gates MRI won’t slow down, at least not in the short term. The Institute is simultaneously entering its tuberculosis vaccine candidate into phase 3 clinical trials (where it will join an ongoing phase 3 B. Infantis program), progressing TB therapeutics in a phase 2b trial, shigella vaccine, and malaria candidates through the clinic, and searching for its next CEO (Dr. Emini has announced his intent to retire). “We’re working on version 3.0 of Gates MRI,” she says, “And in this version, we’ll prove that we can do the work, that we can run the studies, and that we can do something we didn’t actually intend to do from the outset.”

Version 3.0 of Gates MRI sounds an awful lot like Debra Weiss.

Learn more about Gates MRI at