 "Photo: Aysha Jamali / Contributing Photographer")
Global researchers dedicated to the search for new drugs find issues like proper dosages, time, facilities and most of all — money — that keep them from becoming a reality.
According to Dr. Fazlul H. Sarkar, a professor in the department of pathology at the School of Medicine and at the Barbara Ann Karmanos Cancer Institute, the Food and Drug Administration requires a phase one clinical investigation of correct dosage before any product can be approved for human use. Sarkar is researching the dietary agent B-DIM for pancreatic cancer treatment.
“For any drug, you have to test whether 100 mg is good, 200 mg is good or 400 mg is good. You test how much you can give before you see toxicity,” Sarkar said.
However, it often costs a lot of time and money to get these clinical tests done. Few in academia have that kind of money.
It usually takes 10 years for a drug company to get a drug through, according to Lawrence Lum, a professor of medicine and immunology and microbiology at Karmanos and SOM.
Lum has been working on breast cancer treatment with antibody-targeted T cells. He worked with the Roger Williams Medical Center, which now owns the start-up company founded by Lum, TransTarget Inc.
Lum is leading ongoing clinical trials at Karmanos where researchers use T cells to treat metastatic breast cancer in patients.
This need for more skill and advanced facilities is always growing, which creates the need for more funding.
“We try to convince the National Institute of Health to support our clinical trials,” Lum said.
According to the NIH Web site, it invests over $30.5 billion annually in medical research for the American people, but the NIH can’t fund everything even.
The other option for drug development is taking the clinical product to a pharmaceutical company that will hopefully pick up the tab.
“It usually costs $40 million to $160 million to get a drug all the way through the phases for the FDA to approve it,” Lum said. “And that’s making the assumption that it works.”
Bringing new drugs to the market
Drug companies like all-for-profit enterprises are in the business of making money. But because their business requires a great deal of time and investment in clinical testing, and that often requires a huge risk. It gives them a reputation for supporting only those products that will make large and fast profits. Something like $1.5 billion in the first three years, Lum said.
If the drug is promising, then major drug companies like Bristol Meyers Squib, Johnson & Johnson and Pfizer will show interest and offer to provide venture-capital money.
According to Lum, they want about a 100 percent profit in less than three years, looking to double their money because of the risk in investing.
Making big bucks like that is possible, Lum said. Just with FDA approval, a start-up company could be worth from $5 million to $10 million. With completion of a few clinical trials, the company could be worth from $60 million to $80 million.
After a definitive phase three trial, Lum said the company would be worth $200 million to $250 million.
The drug company’s next move is to buy the start-up company and back it with a much larger clinical trial, which only increases its value.
“So what’s the profit margin?” Lum said. “From $180 million to $1.5 billion.”
This is the only “guaranteed” way a start-up drug company could make it. Lum said that between 1-in-20 and 1-in-10 good start-up companies survive, although now it’s even less because of the economic situation.
“I have a company and all it’s doing is focusing on vaccinating patients with these targeted T cells for cancer,” Lum said.
Lum has received grants from the Department of Defense, NIH, Leukemia & Lymphoma Society and Susan G. Komen for the Cure to advance his drug research.
“Without FDA approval, you can’t charge for your product,” he said.
Procedural protocals
According to Lum, there are 140 procedural protocols that are reviewed by the FDA. For example, every time an adjustment is made in the drug’s production it must be sent to the FDA.
“The FDA, at any time, can make a phone call and say, ‘You’re now on clinical hold,’” Lum said.
Sarkar said it took him almost two years to get the FDA’s Investigational New Drug application, or IND, for his drug. Lum’s IND took about a year.
The NIH grants process can take 10 months, from the application receipt to the peer review process to the negotiation and to the award, according to its Web site. Sarkar and other researchers want to see steady progress in their studies.
“I want to get the whole thing done by this year, so I can do a phase one essentially,” he said.
According to Dr. Daniel Walz, an associate dean for research at the SOM, the pressure for funding is intense. Just within the SOM, he said, federal funding is in excess of $52 million to $54 million a year.
“Our total research investment is somewhere approaching $110 million a year,” Walz said. “And we’re a mid-level institution.”
Walz said in the last 10 years about one or two start-up companies have come out of the SOM annually, but some of them no longer exist.
“We do not have a big success story that everyone could point to,” Walz said.
According to Lum, it’s because of the SOM’s poor success rate that people don’t want to gamble their companies on it.
“Why would I risk a company valued at $80 million or $160 million?” Lum said.
Michigan’s higher education is going to be severely challenged for the next several years, according to Walz. How WSU invests funding will be compromised for the next couple of years, which means more obstacles for researchers.
“So, I have a drug that might help cure breast cancer,” Lum said, “but it’s a pain in the neck.”
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