From Idea To Cure: Moving Ideas to Market at MSU
The discovery of a new drug is exhilarating. It’s also a long, frustrating path, fraught with obstacles and constantly in need of attention and funding.
And getting a new drug to market has its own unique set of challenges and timelines.
So, the 40th anniversary of the FDA’s approval of the cancer drug cisplatin is undoubtedly cause for celebration.
When Dr. Barnett Rosenberg emerged from his research lab at Michigan State University in 1965, proclaiming to a group of grad students that he’d just cured cancer, it would be another 13 years before the FDA cleared cisplatin for treatment in cancer patients.
“At the time, MSU didn’t have a technology transfer office like ours,” said Dr. Richard Chylla, executive director of MSU Technologies, which facilitates the commercial development and public use of technologies and copyrightable materials developed by MSU faculty and staff.
There was no office of intellectual property either, which wasn’t unusual at the time. But a company called Research Corporation Technologies out of Tucson, Arizona, was cruising the halls at universities back then, looking for things that had the potential to be commercialized.
RCT connected with Rosenberg and his team and assisted MSU in the commercialization and eventual licensing of cisplatin.
The path to market
“When things are invented at Michigan State, they’re at a very early stage. They’re far away from being a commercial product,” Chylla explained. “Our researchers may have invented a better way of doing something, a method, a device, but it’s far away from something someone would be willing to buy or use as a product.”
The challenge at the university is finding companies that would be interested in the technology or the discovery and developing it into a viable product for purchase by a company or consumers. These discoveries need a lot of investment behind them to move out of the labs and into the market.
“Companies have to be willing to take something at a very early stage, knowing they will have to invest hundreds of thousands or millions of dollars to actually make a product out of it,” Chylla said.
Even once a discovery is acquired by a company, the odds of it being commercialized are still small.
“Even though we license somewhere between 20 to 30 percent of the technologies that come into our office, only a small percentage ever get commercialized, and even a smaller percentage will ever make money,” he said.
“These are home runs that happen very rarely.”
Most universities don’t have any “home runs” on the level of cisplatin in their history. “We’re lucky enough to have one at Michigan State,” Chylla said.
The approval process
Pharmaceuticals present an even bigger challenge in the path to commercialization. Drug discoveries travel the same path as any other technology discoveries, but they have an added layer of complexity.
“Even when you have a molecule that shows efficacy against tumors, that’s just the first step,” Chylla said. “You have to go through all the clinical trials and FDA approval before it’s allowed for sale. Those trials cost hundreds of millions of dollars, so by the time a drug goes from a university setting to being sold to consumers, easily $800 million to $1 billion may have been spent.”
In the United States, drugs go through a five-step development process:
- Step 1: Discovery and development – Research for a new drug begins in the laboratory.
- Step 2: Preclinical research – Drugs undergo laboratory and animal testing to answer basic questions about safety.
- Step 3: Clinical research – Drugs are tested on people to make sure they are safe and effective.
- Step 4: FDA review – FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
- Step 5: FDA post-market safety monitoring – FDA monitors all drug and device safety once products are available for use by the public.
The discovery, patenting and FDA approval of cisplatin was a 13-year process. It’s a rarity in the research world.
“This is one of those handful of success stories where the impact of its discovery is far more important than the money the discovery made,” Chylla said. “Cisplatin has had a huge impact on society. It’s a cancer workhorse.”
Resources earned from sales of cisplatin and its derivative, carboplatin, fuel the work and investments by the MSU Foundation, through offices such as MSU Technologies.
“The fact that I work in an office that is the legacy of something like this is huge,” he said. “That’s the way I think about it. The royalties allowed us to build capacity, fund research, do a lot of things, but when we look at the success of our office, we’re looking at what kind of impact we have. This discovery has literally saved millions of lives.”