Getting a cancer drug to patients takes both scientific and business smarts

January 23, 2014

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 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 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.

If the product ultimately works, each of these companies will see a share of what could be substantial profits. Those financial details, and many others, are essential parts of the , and need to be worked out now. Sinha and his team would then take the completed plan to venture capitalists and large foundations – which he hopes he and his team can convince to put up the capital needed to fund both the manufacturing process and the all-important human clinical trials that would follow.

Attacking HER-2-positive breast cancer may be just the start. If, as Sinha expects, the toxin can also be combined with different antibodies that seek out other cancers, Sinha says the drug has "nearly endless" cancer fighting potential.

"He is a very impressive young man," says Joseph Bertino, chief scientific officer at the Rutgers Cancer Institute of New Jersey and a professor of medicine and pharmacology at Rutgers Robert Wood Johnson Medical School.

Bertino, whose own research focuses on targeted cancer therapies, is one of several Rutgers faculty members who have advised Sinha. "He has collaborators lined up," Bertino adds, "and I think he has a real shot at it." Sinha and his team have formed a company, OncoLinx LLC, to help advance their plans.

Sinha's foray into the business side of drug development is a sign of rapidly changing times. In the past, nearly all who earned doctorates in the stayed in academia. But now, Bertino notes, "some of our best scientists are working with biotech companies and big pharma. It's important for them to understand what industry is all about, so we at Rutgers are trying to make sure it's part of their education."

Explore further: Drug delivery system successfully treats deadly ovarian cancer in mice

Related Stories

Drug delivery system successfully treats deadly ovarian cancer in mice

December 6, 2013
(Medical Xpress)—Scientists at Rutgers University have developed a targeted drug delivery system that they believe could make ovarian cancer more treatable and increase survival rates for the most deadly gynecological cancer ...

Lactation protein suppresses tumors and metastasis in breast cancer, scientists discover

October 24, 2012
A protein that is necessary for lactation in mammals inhibits the critical cellular transition that is an early indicator of breast cancer and metastasis, according to research conducted at the University at Buffalo and Princeton ...

Study finds potential to match tumors with known cancer drugs

February 5, 2013
When it comes to gene sequencing and personalized medicine for cancer, spotting an aberrant kinase is a home run. The proteins are relatively easy to target with drugs and plenty of kinase inhibitors already exist.

Zebrafish shown to be useful tool in prostate cancer stem cell research

November 7, 2013
(Medical Xpress)—Research from Rutgers Cancer Institute of New Jersey demonstrates that using zebrafish to identify self-renewing tumor stem cells in prostate cancers may be more beneficial than using traditional experimental ...

Engineered anti-toxin antibodies improve efficacy

January 9, 2014
The effectiveness of toxin-neutralizing antibodies is considered to be mediated through the interaction of the variable region of the antibody and the toxin; however, recent studies suggest that the constant region (Fc) of ...

Scientists propose a breast cancer drug for bladder cancer patients

January 22, 2014
Researchers at Mayo Clinic have found amplification of HER2, a known driver of some breast cancers, in a type of bladder cancer called micropapillary urothelial carcinoma (MPUC) and have shown that the presence of HER2 amplification ...

Recommended for you

Anti-cancer chemotherapeutic agent inhibits glioblastoma growth and radiation resistance

July 24, 2017
Glioblastoma is a primary brain tumor with dismal survival rates, even after treatment with surgery, chemotherapy and radiation. A small subpopulation of tumor cells—glioma stem cells—is responsible for glioblastoma's ...

New therapeutic approach for difficult-to-treat subtype of ovarian cancer identified

July 24, 2017
A potential new therapeutic strategy for a difficult-to-treat form of ovarian cancer has been discovered by Wistar scientists. The findings were published online in Nature Cell Biology.

Immune cells the missing ingredient in new bladder cancer treatment

July 24, 2017
New research offers a possible explanation for why a new type of cancer treatment hasn't been working as expected against bladder cancer.

Shooting the achilles heel of nervous system cancers

July 20, 2017
Virtually all cancer treatments used today also damage normal cells, causing the toxic side effects associated with cancer treatment. A cooperative research team led by researchers at Dartmouth's Norris Cotton Cancer Center ...

Molecular changes with age in normal breast tissue are linked to cancer-related changes

July 20, 2017
Several known factors are associated with a higher risk of breast cancer including increasing age, being overweight after menopause, alcohol intake, and family history. However, the underlying biologic mechanisms through ...

Immune-cell numbers predict response to combination immunotherapy in melanoma

July 20, 2017
Whether a melanoma patient will better respond to a single immunotherapy drug or two in combination depends on the abundance of certain white blood cells within their tumors, according to a new study conducted by UC San Francisco ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.