With a pounding head, an exhausted individual plods to the medicine cabinet in search of aspirin. The bottle says, “Take as directed,” so they pop two, followed by a few gulps of water, and wait the 15 to 20 minutes to feel some relief. The headache sufferer, like millions of others, presume the tablets are safe and effective, manufactured under the strictest regulations. Rarely does anyone think 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, the life science industry is 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 improved therapies that tackle illnesses and rare diseases once inaccessible to the larger 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 them to go from screening millions of compounds to tens or hundreds of millions. Genomics allow them to understand the pathways that cause disease and find which drug will elicit a patient response. New technologies let them 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 MilliporeSigma continues 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.
The next era of pharmaceutical manufacturing is here — what role can you play in its advancement?
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