Donna Christopher

With the recent reporting that three of the COVID-19 vaccines currently in development are highly effective, it’s easy to jump right to the question of “when will we get it?” While it is impossible to know that at present, we can shed some light on how we got to the point where asking that question is even possible. And for that answer, we need to look to those who worked tirelessly this summer to fast-track the global clinical trials that have delivered the much-needed good news.

Ohio Northern University alumna Donna Christopher, BSPh ’87, is a global vice president of operations for Almac Clinical Services, a division of the Almac Group. Almac Clinical Services currently provides services to more than 600 pharmaceutical and biotech companies worldwide within the niche and complex market of clinical trial supply. Christopher’s team has been working with BioNtech and Pfizer on their COVID-19 vaccine clinical trial since June, providing the supply chain support necessary to get the vaccine to approximately 30,000 patients at 120 phase III trial sites in six countries across the globe.

Clinical trials are painstakingly regimented affairs. Every minute detail is recorded and analyzed. Consistency and accuracy determine success or failure. Almac’s job was to transform bulk quantities of the vaccine into thousands of individually packaged and labeled vials that could be administered to patients at the clinical trial sites.

“August and September were terribly busy months. We were working basically 20 hours a day, seven days a week,” says Christopher. “It takes a lot to get a phase III clinical trial up and running, so a lot of people worked very, very hard during the summer to get the drug labeled and shipped out to the patients.”

For an added degree of difficulty, because it is 2020, the vaccine must be kept at -70 degrees Celsius. That means that from the moment of its manufacturing in Europe, to its arrival at Almac’s Pennsylvania facility, to its delivery at sites all over the world, each dose of vaccine has to be precisely maintained at a temperature that is just a few ticks warmer than the coldest temperature ever recorded on planet Earth. Should the vaccine be approved, it will be the first time a commercial drug has ever required such a cold environment. Fortunately, Almac is also a world leader in temperature-controlled packaging.

“Three years ago, we developed the Almac Pod™, which is a reusable phase-change shipper. All shipments of the vaccine went out in Pods containing dry ice to reach -70. They can hold temperatures as low as -90. Things are definitely getting colder in the pharmaceutical industry,” says Christopher.

Almac, working with pharma clients, has supported more than two-thirds of recently approved drugs in the U.S., but the effectiveness of the new vaccines in development (the Pfizer/BioNtech, Moderna and Oxford-AstraZeneca vaccines are all above 90 percent) has amazed even Christopher. For context, the yearly flu vaccine is around 40 to 50 percent effective.

“It’s extraordinary that it all worked, because it really is a crapshoot whenever something comes out of the lab. Even here at Almac, where we see ourselves as significant in our support of R&D it is rare to see a drug make it all the way to licensure. This success is beyond anyone’s wildest dreams,” she says.

In addition to working on the Pfizer vaccine trial, the Almac Group has participated in nearly 100 COVID-19 studies since March. Christopher has been awed by her team’s commitment to their work in really difficult times.

“What’s really interesting, and I think reaffirming, is that is easy to get people to work hard on these types of studies. We all know how important this is,” she says. “It’s been the thrill and honor of a lifetime to be working on this.”