Kiran Mazumdar-Shaw - FierceBiotech's 2011 Women in Biotech

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Kiran Mazumdar-Shaw
Chairman and Founder, Biocon

India's Kiran Mazumdar-Shaw knows what it takes to beat the odds in biotech.

Starting out as an Australian-trained brewer, she launched her company in a garage and it went on to become an industrial enzymes powerhouse. Her company has earned a reputation as the largest insulin maker in Asia while growing into the biggest biotech in the subcontinent.

Each step was hard, says Mazumdar-Shaw, but it helped her gain confidence for the next challenge ahead. And among the many challenges on the horizon, one of the biggest will be to continue to grow the drug development side of the business.

"Trying to build a very integrated biopharmaceutical business, it's a huge challenge when you're trying to develop novel drugs," she says. "It's much more complex and more challenging to take new molecules to the marketplace. I'm really very keen to see one of our novel drugs make it to the market."

"You tend to be very biased about programs," she adds, noting that she's become "emotionally committed to our oral insulin program. If oral insulin works out, that will completely transform us as a company."

Just last week, the Biocon chief told Reuters that she's in late-stage discussions with a possible deep-pocket pharma partner for the oral insulin program, despite the failure of IN-105 in a late-stage trial this year.

Other top development programs include an anti-CD6 antibody treatment for psoriasis, now being tested in 200 patients. A hybrid peptide drug is in co-development, and she's spun off her growing contract drug research business, Syngene, and put it on a path to a public offering.

"I really believe this is an interesting hybrid model for drug innovation," says Mazumdar-Shaw, taking the "low-cost base in India and marrying it with the discovery skills in the U.S. and seeing if you can reduce the cost and time for drug development. We do what we do best in India and they do what they do best in the U.S."

That approach helped pave the way to a deal to develop biosimilar insulin products with Pfizer that paid $200 million upfront and offered up to $150 million in milestones plus royalties. The Biocon chief expects the company to double in size in the next five years as it sustains a blistering annual growth rate that has broken the 20% mark.

Last year, Mazumdar-Shaw was included as one of Time magazine's 100 most influential people. Her success has extended far beyond Biocon. India's entire biotech industry has benefited from the entrepreneur's drive and determination.