Innovators' Dilemmas: Genentech's Susan Desmond-Hellman on the FDA, Regulations in Europe, and the Inability to Predict Outcomes

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Susan Desmond-Hellman is president for product development at Genentech. A former practicing oncologist, she joined the pioneering biotechnology company as a clinical scientist in 1995.

Tell us about Genentech.

Genentech is the first biotechnology company. We're 32 years old this year and we use the technical science called biotechnology to make medicines. The mission of the company is to meet unmet medical needs. We go after the really hard problems in medicine--things like cancer, cystic fibrosis, rheumatoid arthritis, systemic lupus--and increasingly focus on diseases that many baby boomers are worried about, such as Alzheimer's disease.

What does it mean to be the first biotechnology company?

In the mid-'70s, recombinant DNA technology was co-discovered by Herb Boyer, one of the co-founders of Genentech, who was a biochemist at the University of California, and Stanley Cohen, who was at Stanford. This technology was thought to allow a company to be able to take living cells and make them into factories to produce medicines.

Genentech was started in 1976 based on this new technology, and the first product the company worked on and brought to market using this recombinant technology was human growth hormone.

So you use biological products as factories to produce treatments for human ailments?

That's exactly right. One of the most exciting products that we have now is a medicine called Avastin, which is a cancer medicine. Avastin is anti-VEGF (anti-vascular endothelial growth factor), which basically blocks cancer cells' ability to form new blood vessels. We use biotechnology to make the antibody that is anti-VEGF. Because that antibody is like what you and I would make, it isn't rejected by the body. The science of biotechnology enables us to do things in medicine that weren't possible using chemistry.

What are your biggest obstacles to innovation?

One of the big challenges is our ability to predict the outcomes. If you make a discovery in research and it's at a very basic level, it is not at all easy to predict how that discovery translates into a medicine for human beings that is safe and effective. The balance in a company like Genentech is to make something that people can trust, to really innovate, and to take enough risks so that we can do something substantially better for patients. One of the most important things in allowing a company like Genentech to innovate is having a really strong, transparent Food and Drug Administration as well as the European equivalent of the FDA. Innovation in a highly regulated environment is a particular challenge for a company like Genentech.

How is the biotech industry different today than it was at its inception?

I think first and foremost there's a greater confidence in the medicines that we are able to produce using biotechnology. When we first launched recombinant human growth hormone, Nutropin, in the mid-'80s, there was a lot of worry about the use of a recombinant product in children, the population you worry about most.

Genentech did something incredibly innovative at that time: we started a patient registry. We enrolled every child ever treated with Genentech's growth hormone to make sure that we didn't have any surprises on safety. That registry's been in place now for 25 years. We feel very confident that we understand the safety of recombinant human growth hormone for children. Now when I say to a cancer patient or a physician that Genentech's going to bring out a new product using biotechnology, there's enormous confidence that biotech's a reliable, safe approach to making human medicines.

The other thing is that some biotech companies--Genentech, Gilead, Amgen, Biogen Idec, Genzyme, to name a few--are now profitable. In the early days of biotechnology, there was a lot of promise that you could make a business out of biotechnology, and the business model is now established--although it's important to note that most biotechnology companies don't actually make money. …