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Gail Maderis, the Boston Biotech Exec Who Came Home to SF, Seeks to Give Back at BayBio

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that she really enjoyed getting to know the people, the science, and the business of biotech, moreso than other projects she might have worked on. In 1992, Maderis chose to join one of the few hot biotech companies run by a businessman rather than a scientist—Henri Termeer. She joined Genzyme that year in corporate development, and within a year worked her way up to vice president and business manager of the company’s gene therapy program for cystic fibrosis.

This was a fascinating project for anyone from Harvard or Bain. Cystic fibrosis is a genetic disease caused by a single malfunctioning gene, which causes a buildup of thick sticky mucus in patients’ lungs, and usually kills people before the age of 40. Researchers thought that since the specific gene had been identified for cystic fibrosis, it stood to reason that this disease out to be cured by gene therapy. The concept sounded simple—attach a properly functioning copy of the gene to a virus which would efficiently shuttle it inside cells and do its job.

Longtime biotech followers know it wasn’t that simple. There is no cure today for cystic fibrosis, and there is no gene therapy yet approved by the FDA for sale in the U.S.

But there were still fascinating things for Maderis to learn on this project. She had to work on corralling all sorts of intellectual property for the whole gene therapy package, which hadn’t been done before. The business strategy was being crafted at a time when gene therapy was essentially unregulated. If Genzyme was going to be successful in gene therapy, then Maderis needed to learn a lot more than just the dynamics of the market, physicians, pricing models, and the competitive landscape. It forced her to engage with regulators to talk through the issues, to testify before Congress when lawmakers had their inevitable concerns.

“Henri was visionary in saying it’s a new industry, the science is always going to be one step ahead of where the regulation is, and we need to help craft it, and help people understand it, so we can craft an appropriate business climate and regulatory environment to support what is a very dynamic and new industry,” Maderis says.

As the years went by in the late ’90s, the next big thing was genomics and the highly publicized Human Genome Project. Maderis conceived of a division at Genzyme, called Molecular Oncology, which had a tracking stock that went public in 1998 on the idea of using genomic data for cancer. Maderis worked out two dozen partnerships with many of the big names in Big Pharma, oversaw 100 employees, and told the company’s story to Wall Street.

By 2003, Genzyme had given up on the idea of tracking stocks, and consolidated everything under its corporate banner. This was also year after Enron, Worldcom, and other corporate scandals gave rise to the Sarbanes-Oxley Act, generally making it clear to Maderis that life at a public company “had a lot of downsides.”

That was the year she was wooed back to California. Lewis T. “Rusty” Williams, the former head of R&D at Chiron, along with investors at Kleiner Perkins Caufield & Byers, Versant Ventures, and Texas Pacific Group recruited her. The cast of wooers included none other than VC legend Brook Byers himself. The concept was to build a new protein drug discovery engine, based on $70 million of prior R&D from the Japanese government, for a company called Five Prime Therapeutics. Williams and Maderis knew each other “by reputation,” Maderis says, as leaders at fellow big biotech companies. Maderis also wanted to return to the Bay Area to be closer to her mother, who was in failing health. So she said yes to her first experience as a biotech startup CEO, and joined in September 2003, the same time the company raised $12 million in its second round financing.

“It was about the ability to get in on the ground floor in a company with exciting technology, build out the platform, a pipeline, and provide huge value to Big Pharma in partnerships. It was an interesting model,” Maderis says.

Maderis stayed at Five Prime until … Next Page »

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