Scientists aim to develop business plan to guide drug development for potential use in patients

Published on January 24, 2014 at 8:15 AM · No Comments

What if an experimental treatment for an aggressive breast cancer had the potential to save women's lives, but nobody could use it because there was no money to develop and test it? With funding sources for research and development more scarce than in the past, it is not an unusual situation. It's a problem that Sourav Sinha, a Master's degree candidate at Rutgers' Graduate School of Biomedical Sciences, is working to tackle head-on.

Sinha is leading a team entered in the Breast Cancer Startup Challenge, a worldwide competition sponsored by the Avon Foundation, the Center for Advancing Innovation and the National Cancer Institute. The goal is to take a drug that shows promise in the laboratory - a powerful toxin created and patented by scientists at the National Institutes of Health - and develop a business plan to guide its development for potential use in patients.

"We have this unique opportunity to get a powerful treatment to breast cancer patients who desperately need it," says Sinha, who grew up in Holmdel, N.J., and aspires to be a physician as well as a research scientist. "I see this as a new, exciting avenue through which my team and I can make a meaningful contribution to health."

Bringing a drug to market is a much more daunting process than people might realize.

This drug is designed to kill individual cells altered by the HER-2-positive gene mutation that is responsible for as many as 25 percent of all breast cancers. "The toxin is in a very early stage of development right now," says Sinha, "but if it works it will be huge."

That is where the need for a business plan comes in. The drug's inventors have shown it kills cancer cells in the lab, but in order for it to work in people, an intricate transport system is also needed to carry the toxin through patients' bodies and deliver it to diseased cells, while bypassing surrounding healthy cells.

Choosing the right mechanism requires an extensive knowledge of biochemistry. But it also demands business sense: to negotiate financial agreements with biotech companies that have expertise to construct the delivery system. Specialized components include synthetic antibodies that are specifically engineered to seek out HER-2-positive cancer cells, as well as "linkers" that would fuse the toxin to the antibodies - as a space capsule might be attached to a booster rocket - until just the moment when, inside the cell, the toxin detonates.

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