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W&M alumna oversees quality control for Pfizer’s COVID-19 vaccine development

  • Colleen Gorman
    A sense of urgency:   While working on clinical trials for Pfizer's vaccine, Gorman was facing a health challenge of her own that made her even more mindful of the pressing need for medical therapies from a patient’s perspective.  Courtesy photo
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Editor’s note: This article previews a feature in the Winter 2022 issue of W&M Alumni Magazine about alumni who have been involved in developing the COVID-19 vaccines produced by Pfizer, Moderna and Johnson & Johnson.  

As the world anxiously awaited the first COVID-19 vaccine, Colleen Gorman ’95 played a crucial role at Pfizer in ensuring that correct practices were being followed during clinical trials and preventing any issues that arose from being repeated.

Gorman was facing a health challenge of her own in 2020 that made her even more mindful of the urgency of medical therapies from a patient’s perspective. She had been diagnosed with breast cancer after the onset of the pandemic and was undergoing treatment as clinical trials for the vaccine progressed.

“Those two experiences paralleled each other,” she says. “It made me very aware that patients are waiting for these innovations and medicines that we're bringing to the market. So, when I go to work now, I’m a little more conscious of how critical our timelines are, and how being able to shorten the timeline really does have a meaningful impact to a patient on the other end.”

After producing the first vaccine to receive emergency use authorization from the Food and Drug Administration (FDA) in December 2020 (and then full approval in August 2021), Pfizer and BioNTech received emergency use approval in May 2021 for their vaccine among adolescents between 12 and 15 years old. The FDA then amended the Pfizer-BioNTech emergency use authorization on Sept. 22 to allow a COVID-19 booster shot.

A few days later, Pfizer submitted to the agency initial results for clinical trials of its vaccine among children ages 5-11. After an FDA panel considers emergency use authorization on Oct. 26, the Pfizer-BioNTech vaccine could become available for children in that age range in November.

The head of quality events and investigation for global product development at Pfizer,  Gorman leads a team that conducts investigations when problems emerge and proposes corrective actions. A quality event, she explains, is an incident that occurs while a trial is being conducted that could affect the integrity of the data or infringe on a participant’s rights, such as an error in dosing or an incorrect version of an informed consent being signed.

“We promptly investigate and perform root-cause analysis on these errors so that we can remediate the single instance and also ensure it is addressed more broadly to prevent recurrence at other sites or with other participants,” she says. 

For each incident, Gorman’s team analyzes the situation and develops corrective and preventive actions (known as CAPAs) and tracks them to completion. Given the fast pace of patient enrollment during the COVID-19 vaccine trials, it was especially important to intervene quickly and prevent any issues from reoccurring and having a bigger impact on the integrity of the trial or on patient safety, she says. For the COVID-19 trials, the timeline for managing a quality event was shortened from the typical 75 days to within 35 days. 

“Because so many subjects were enrolling so quickly, we wanted to make sure if there was an issue we identified it, resolved it and tried to prevent it before there were a lot more subjects enrolling in this study,” Gorman says. “So we modified our process to be as efficient as possible.”

In addition to the COVID-19 vaccine, her team works on clinical trials for a variety of products in development, including therapies such as Palbociclib for breast cancer. But because of the size of the COVID-19 trials — involving over 44,000 patients at sites around the world — and the importance of working quickly, Pfizer assigned a group to focus solely on the vaccine.

“It allowed them to get really familiar with the study and be able to move through their work much more quickly than if they were learning lots of different protocols,” she says. “People worked night and day on this program, especially leading up to the emergency use authorization, to get the studies finished as quickly as possible.”

One challenge was to maintain the necessary quality controls during such a large trial in a compressed time frame. 

“As much as we were being very, very efficient and trying to look for opportunities to go faster and to do things in parallel, we also had to be careful not to cut corners in places that would jeopardize the safety of the subjects in the trial or the reliability of the results, so it was a fine line,” Gorman says.

While working on the COVID-19 vaccine trials, Gorman took part in a clinical trial of her own related to her breast cancer treatment at Memorial Sloan Kettering Cancer Center. Coincidentally, Gorman had worked on managing clinical trials related to breast cancer as a research assistant at MSKCC after graduating from William & Mary in 1995.

“It was an unusual coming full circle,” she says. “For me to be on the other side of it as a patient was also unique, since I'd always been on the side of managing the trial from the institution’s perspective.”

Because Gorman has worked on clinical trials for most of her career, she had decided that if she ever had a chance to enroll in a trial as a patient and saw a potential benefit, she would do it.

“It was a nice opportunity to see it from the other side and feel like you are getting access to the newest care, while also providing information that will be valuable for future patients,” she says.

As she underwent surgery and radiation, Gorman was out on medical leave for some of the time when Pfizer’s COVID-19 studies were being finalized in the fall of 2020.

“Fortunately, the team was in a good position in terms of having processes in place and I had colleagues that were willing to step up for me,” she says.

Because of restrictions related to the pandemic, Gorman was not able to have visitors when she was in the hospital for surgery. She now has completed active treatment and will be on oral therapy for the next five years.

“My friends and family were great about supporting me from afar in any way they could, including lots of my friends from William & Mary that I’m still very close with,” she says. “They checked on me on a regular basis and really sustained me.”

Among Gorman’s closest friends are women she met in her freshman dorm, Yates Hall, and members of her sorority, Gamma Phi Beta.

“Even though I left Williamsburg and came back to New York and have been in New York ever since, I still feel like that experience was so formative and that these people I met are still so much a part of my life,” she says. 

Gorman, who is from New York City’s Queens borough, says that when she was deciding where to apply to college, she wanted to go somewhere very different from the urban environment where she grew up. She was drawn to William & Mary’s beautiful, relatively small campus and top-notch academic reputation. She majored in biology and English, a combination that has served her well.

“Certainly the biology major prepares you for the hard science component of going into a career in health care, but health care is also about how you interact with people, how you communicate and how you solve problems,” she says. “I think that the liberal arts education background at William & Mary lends itself well to those kinds of skills.”

Gorman went on to earn a master of public health in health policy and management from Columbia University’s Mailman School of Public Health. She began her career at Pfizer in 1998 as a clinical study manager and took on roles of increasing responsibility in study management and clinical operations. After leaving for a little over a year in 2007 to join PricewaterhouseCoopers as a management consultant in pharmaceutical research and development, she returned to Pfizer as a clinical protocol manager. She’s been in her current position since 2016.

Her advice to students majoring in biology or another science field is to think outside of a traditional career path such as working in a laboratory.

“There are lots of different ways that you can work within science and apply your skills,” she says. “As a biology major, I didn’t know that this world of clinical trials existed. I sort of fell into it through a summer job that I had at Sloan Kettering. I also think that having a liberal arts degree allows you to flex and apply those skills in different places.”

Since graduating from William & Mary, Gorman has remained connected to her alma mater through the New York City Alumni Network, including serving a term as a board member. On June 30, Gorman participated in a panel discussion about vaccine development, boosters and preparing children for the school year and beyond with Dr. Lee Savio Beers ’92, president of the American Academy of Pediatrics, and Melissa J. Moore ’84, chief scientific officer of platform research at Moderna Inc. Dr. David Dafashy, medical director and staff physician at the W&M Student Health Center, moderated the discussion.

Asked what lasting lessons can be learned from the pandemic, Gorman says, “I hope it has taught us that we have to be more prepared. In the beginning, it seemed like there was a lack of preparedness, which created a lot of challenges for us as we were trying as a nation to figure out how to navigate this. I think it has strengthened a respect for science and a respect for the contributions that science can make.”