Is U.S. Vaccine Development Ready for the Race?

Covid-19 has placed global scrutiny on how exactly the pharmaceutical industry approaches vaccine development. What has drawn the most attention is the typical timeline, which using an albeit simplified definition includes steps such as discovery, preclinical and clinical trials, regulatory approvals, facility build-out and distribution.

Why is the timeline drawing attention? Simply put, it's not the process, it's the amount of time it takes to go through the phases. Historically, the average timeframe to bring a vaccine to market is measured in years (often ranging between 10 to 16 years) not months. And, with Covid-19, the global population is putting pressure on the industry to buck the system and create a market-ready vaccine in 18 months or less.

To a large extent, government funding has provided much needed fuel for companies to work towards compressing each stage, often conducting sequential stages in parallel. For instance, running phase two and three trials simultaneously, while also building out manufacturing lines in existing facilities to be able to produce vaccines while they are still in clinical trials.

Take a moment to let that sink in.

“It's usually all done in phases because no company would invest the money or the time unless it clears the first stage hurdle. Even after getting through phase 3, most companies would not build the production line until after receiving FDA approval with a viable drug that's ready for the market,” says Jim Nyquist, group president at Emerson. “So far it has been about picking the best potential vaccines and building a big inventory as soon as one passes clinical phase three. It's an example of everyone (manufacturers, FDA, etc.) working collaboratively, while breaking the conventional norms to get a vaccine to the market as quickly as possible.”

Dangerous curves

In many ways the focus on compressing the vaccine development process – and getting populations back to some sort of normal – has resulted in a frantic race type environment where companies (and countries) are pushing their way to the finish line, in hopes of being the one with the winning vaccine. “Going through the process of compressing vaccine development for Covid-19 is helping the industry rethink all the regulations,” says Nyquist. “Obviously, we have to produce safe drugs, but we need to do it faster.”

Of course, going too fast can be dangerous, especially when people’s lives are on the line.

As recent news reports have shown, there are real challenges in rushing a vaccine through the various phases. Although early results of the AstraZeneca vaccine development effort showed encouraging results, the program was put on hold September 8 while in phase 3, after it was revealed one of the trial participants exhibited a “potentially unexplained illness.”

According to an AstraZeneca statement, "In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials."

The fact that AstraZeneca has pressed pause reinforces a recent industry pledge to avoid releasing a vaccine until it is ready for mass distribution.

Time for transformation?

When developing new drugs and getting them into the market, it can be challenging to understand how to first develop something in the lab, carry all the knowledge through to clinical trials and ultimately enable the company to scale up into production level. At the same time creating a batch is a very time-consuming process, so consistency is crucial in ensuring that manufacturers avoid losing batches to deviation.

In many ways, automation has surfaced as a savior here as organizations work to avoid costly issues. “The technology has evolved fast enough over the past decade that we can develop the sequencing and recipe logic to automate the batch,” says Nyquist. “Further connecting this logic to a digital twin allows manufacturers to visualize processes and learn before building the plant or production line.”

Seeking maturity

When it comes to digital transformation, achieving maturity is as challenging in life sciences as in any other industry, in a large part because of the investment. Additionally, companies cannot dramatically change existing facilities because the production approaches already have validation. After all, changing processes often means revalidating.

As manufacturers digitally transform, enabling flexible operations takes center stage. Using Covid-19 as an example, as the virus mutates, manufacturers need to be able to quickly bring new drugs online using those same production lines. “Automated batch processing and automated recipe management are crucial because they allow manufacturers to change and have a very adaptable and flexible plant,” he says. “Also, the digital twin can play a big role because while you're modifying the plant itself, you can model changing the logic, changing the recipes and training operators so that as soon as the new drug receives clinical trial approval, the plant can begin production. Automating the recipes and automating facility is key to replicating the golden batch.”

A few milestones exist as pharmaceutical firms go through the process of transforming and realizing digital maturity:

Realizing operational automation. This includes automating workflows, recipe management and leveraging digital twins to understand how to make changes. This is key to optimizing operations in a way that eliminates bottlenecks and provides flexibility needed to adjust as virus mutations dictate the need for vaccine modifications.
Providing decision support. There needs to be a focus on digitally providing better information, so that everyone involved in development and release can work quickly to make good decisions. For instance, it historically took days or even weeks to satisfy FDA requirements and release a batch. By digitally collecting all the information all in one place, manufacturers can literally release a batch within hours of its completion.
Strengthening workforce. As manufacturers put all the digital tools in place, there is a growing need to up-skill the workforce – ensuring team members have the skills necessary to fully utilize the tools. This is a huge opportunity for companies to reach the next level.
Maximizing mobility. Manufacturers need to provide access to mobile tools, empowering key personnel with information that is available wherever they are and whenever they need it. The importance here has intensified as more businesses have embraced operating remotely.

Beyond simply deploying the technologies, realizing this next level of digital maturity is really about the people and getting them to embrace and ultimately drive the change throughout the organization, explains Nyquist. “The industry is very focused on transforming itself, using all the digital tools to move itself forward quickly, getting drugs to market faster to produce them in the most optimized way. And then to meet all the regulatory requirements that are necessary to make sure we produce safe and effective medications and vaccines.”