Meeting the Crisis Head-On

Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Pharmaceutical Executive, Pharmaceutical Executive-06-01-2021, Volume 41, Issue 6

Past lessons, strong resolve, and complex coordination propel J&J’s vaccine efforts.

Janssen/Johnson & Johnson made the decision to jump into COVID-19 vaccine development as soon as the first virus sequence was available. From then on, says Macaya Douoguih, MD, MPH, head, Janssen clinical development and medical affairs, vaccines, it was an adrenaline-laden process. “We didn’t know at the time how the pandemic would evolve, but seeing what it has become today…this was the most unprecedented timeline for getting a regulatory status for any vaccine,” she told Pharm Exec.

No stranger to vaccine development, Janssen’s Ebola vaccine, like its COVID-19 vaccine, is based on the J&J AdVac technology. Douoguih says, “Because [Ebola] was accelerated in a similar manner, it laid the groundwork for this pandemic preparedness, however, not quite to the global scale that we’ve seen for the COVID-19 pandemic. But it was the same way of thinking—ignore the turnaround times for reviews and have open discussions to move things ahead.”

As Douoguih explains, the vaccine development process is typically sequential. Information that is needed for the next step is validated in the previous step. Processes that are conducted in parallel risk potential failure, which can lead to a loss of time, resources, and money. During these pandemic timelines, however, processes were conducted in parallel and in unprecedented ways, says Douoguih. “There were risks (manufacturing and nonclinical), and, fortunately, they panned out.”

Collaborating with the federal government and FDA was also key to crunching clinical development timelines. There were many open discussions with the regulators, at all times of the day. Many uncertainties had to be managed to ensure that J&J could move swiftly into the efficacy evaluation of its vaccine; on how the pandemic would evolve epidemiologically, and thus the need for predictive modeling to identify the geographic areas for the trial, especially regions that had the hotspots.

“It was the most exciting and challenging thing I’ve had to oversee and execute,” remarks Douoguih.

Douoguih was keenly aware of the importance and criticality of their work. “Just living and experiencing all the new restrictions for the pandemic and knowing that what we were doing was going to hopefully change the outlook in the future, couldn’t have been more important for me or for the company,” says Douoguih. “For everyone at J&J, no matter what their level of seniority in the organization, they were willing to roll up their sleeves, and work on this and get things done. It reflects how we care about the world, and that we were committed to contributing to improve health and finding a solution for this pandemic.”

Even while immersed in vaccine development and getting only a “few minutes of sunlight now and then,” she felt the pressures of the external world at large—the COVID restrictions, job insecurity, colleagues that were homeschooling. “I’m just amazed at how people have dealt with all of this over time,” she says.

Moving forward, Douoguih reflects on the processes and technologies that were incredibly helpful during the pandemic; for example, how important partnerships are to achieving goals and how consortiums connecting on critical issues and making decisions can be effective. Other specific clinical trials processes include electronic informed consents and virtual visits. “There are more digital tools that have been piloted with smaller numbers, but now that we were able to deploy on a larger scale, I think that’s something we should continue, and it will also help toward our goal of removing barriers to participation in clinical research,” says Douoguih.

While there is still planned and ongoing work with the COVID vaccine that needs to be carried out, and with the goal to make J&J’s vaccine available globally, Douoguih’s overall workload has stabilized. It also means she can give more attention to the rest of the portfolio, given COVID tapped leadership in terms of focus. “We are working on other vaccines that are very important and will make great contributions, we hope, in the near future,” she says.

Personally, Douoguih maintained an attitude of gratitude during COVID, and that attitude is moving with her post-pandemic. She was able to visit some of her family during the crisis, she was grateful for the times she could get outside to exercise or appreciate the outdoors, and she appreciates what the loosening of the pandemic restrictions brings.

“If I can take time to do things that I’ve put aside for a very long time, I appreciate it. I see now that life will return to what it was, and I can be patient,” says Douoguih.

“My job is as meaningful as it’s ever been,” she adds of the experience. “It was an honor to be able to be part of one of the many solutions that are available to people to combat this pandemic. That just makes me really happy.”

Lisa Henderson is Pharm Exec’s Editor-in-Chief. She can be reached at lhenderson@mjhlifesciences.com.

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