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Beyond Aspirin:
The next era of pharmaceutical manufacturing is here
By Karen Tiano

Your head is pounding, so you head to the medicine cabinet in search of aspirin. The bottle says, "Take as directed," so you pop two, followed by a few gulps of water, and wait the 15 to 20 minutes for them to take effect. You, like millions of others, presume the tablets are safe and effective, manufactured under the strictest regulations. Rarely have any of us thought about what it took to make aspirin or any other prescription medicine. The simple answer: it takes a lot.

Developing a new drug takes between 10 to 15 years and $2.6 billion, as estimated by the Tufts Center for the Study of Drug Development, to get from conception to store shelves. The process involves thousands of steps and input from scientists working in a range of areas, including chemistry, biology, pharmacology and medicine. The three main stages progress from the discovery of a new candidate to investigations showing if and how that would take effect to, finally, the development of a suitable production method. It's a painstaking process with a lot of failure along the way. In fact, some 86 percent of all drugs fail in clinical trials, according to a recent MIT study. Scientists then have to go back to the drawing board.

Today, we are looking at ways to speed up drug development. New technologies promise to reduce the footprint and cost of making drugs — a disruption that, over the next 15 years, could lead to the availability of therapies that tackle illnesses and rare diseases once elusive to the scientific community. Thousands of new medicines are in development by traditional pharmaceutical companies globally and new players in biotech across the U.S., Europe and China. And biosimilars — biologics that are coming off patent — will become available to more people in the next few years. Still, research and development as well as drug manufacturing remain slow, inefficient and expensive.

Scientists are working to discover, develop and manufacture drugs in dramatically different ways. Advancements in artificial intelligence have allowed us to go from screening millions of compounds to tens or hundreds of millions. Genomics allow us to understand the pathways that cause disease and find which drug will elicit a patient response. New technologies let us test how a drug works and what side effects it has before a drug candidate ever reaches users. These changes are transforming the research and development side of drug development.

Changes are also underway in manufacturing. In the past, drug batches were processed in huge, stainless-steel bioreactors and processing a new batch required time-consuming regulatory validation. Today, drug material can be produced in smaller batches using disposable, single-use bioreactors, cutting manufacturing time from weeks to days. Safety testing will likely go online, speeding the final drug product to pharmacy shelves and, ultimately, to patients.

While we continue to collaborate with the global scientific community to accelerate access to better health for people everywhere, the full benefit of these advancements will become even more evident as the decade unfolds.