Here’s one pathway to a nationwide drug shortage: Start with a rapidly aging population, add increasing costs from new technologies and advancing health care, toss in supply chain chaos thanks to a global pandemic or geopolitical fallout and you’ve arrived.
Japan is dealing with this exact situation right now, and, in the U.S., we aren’t too far behind. Unraveling this frightening issue is a top priority in both countries. Japan’s government has approached drugmakers and insisted they increase throughput, but has yet to offer solutions or subsidies to help.
Here in the U.S. we have a similar approach, with some members of Congress insisting we hold the pharma industry accountable for shortages. But most pharma companies are doing everything they can and the FDA is already stretched too thin.
We desperately need more productive discussion about how the industry can safely and reasonably increase throughput and reliable yield. Here are important steps U.S. pharma manufacturers can take now.
Lean on technology
Right now, the big tech question pharma companies are asking is: How do we leverage AI? Fortunately, there are many positive use cases.
Pharma manufacturers rely on people pouring through quality and manufacturing data to figure out the parameters that will lead to the maximum yield with the minimum amount of waste and errors. Searching for this so-called ‘golden batch’ typically takes an army of people weeks or months.
Using AI, companies can process clean, digitized data in near-real time, identifying processing improvements, finding problems before they occur and sorting issues into actionable insights. This requires only a handful of skilled technicians, freeing up personnel for more critical tasks.
Leveraging technology is increasingly critical for pharma manufacturers as they seek to increase potential throughput. Using modern tools to help build a bigger pipeline is the first step in alleviating the looming shortage problems.
Maintain consistent quality
Of course, it doesn’t matter the size of the pipeline if companies can’t deliver consistent quality to the end user. Creating yields as high as possible comes from building quality into manufacturing, which should be table stakes for pharma. Failed batches and product recalls can be incredibly costly, in every possible way.
As tech tools become more ubiquitous and important, our focus on quality needs to extend to how they are used. Right now, the industry struggles from a lack of standardized data models. In order to gain the full benefit of next-gen technology, we need an industry consortium or a standards body to help create and provide those models.
Making data more universal would allow for greater understanding across the industry and give manufacturers powerful tools to control quality. It would also allow companies to share critical safety information without having to reinvent the wheel every time.
Collaborate across the chain
Speaking of sharing through technology, opening collaboration across companies will play a major role in helping avoid dangerous shortages.
The pandemic showed us the weak spots in our supply chains. Many pharma companies were unable to produce at any volume because shipments from other countries — where the raw materials were produced — suddenly stopped.
Ensuring the robustness of your supply chain all the way from the raw materials to packaged products has become a critical conversation. Many are proposing challenging and politically charged solutions, including repatriating the supply chain.
Whatever comes of those efforts, it’s clear that when companies within the chain can work together, they see better outcomes. Creating that level of collaboration is a tall task, as companies generally operate on different systems and can be adversarial due to competitive situations. But we must cultivate a spirit of partnership and a willingness to share necessary data.
Increasing throughput while maintaining quality at the same or lesser cost is where pharma companies need to focus on in the next few years. Embracing technology, cementing the principles of safety within the process and fostering collaboration are steps that will help get us there.
