So I left Bristol-Myers Squibb in 1995 and came to Genentech,
which was the first biotech company and founded
in 1976 based on recombinant DNA technology.
Which was co-discovered at UCSF and Stanford.
So that discovery of recombinant DNA technology started an industry.
And I was thrilled when I got to Genentech to find
out that it could be possible to treat cancer patients
potentially without the side effects of nausea,
vomiting, hair loss and bone marrow suppression,
trying to use biology to treat cancer instead
of chemistry to treat cancer like Taxol.
So, the development of Herceptin was an extremely innovative project.
And let me tell you three ways in which Herceptin
was fundamentally different than anything I had
ever been able to bring to cancer patients.
First and foremost, Herceptin was the first
time ever that a monoclonal antibody,
a human-like monoclonal antibody-like we all make in our immune system-could
be brought in large amounts to patients with a solid tumor.
A very, very scary disease,
fast growing and likely to kill the patient.
Now, at the time monoclonal antibodies,
being natural, being humanlike,
were thought to be gentler treatments.
And in fact people use to have a slogan,
"Could you have a kinder, gentler treatment for cancer?"
And I was a little puzzled by that.
Having seen so many cancer patients,
I didn't want to be kind and gentle when
it came to the therapy of cancer.
I wanted to wallop that cancer without causing side effects.
But this monoclonal antibody therapy,
for the most difficult to treat breast cancer,
was completely innovative.
And we were relatively pessimistic about it.
One of the things I learned from that experience is
don't be afraid to take risk and try something,
even if everyone's skeptical. And every one was.
The second thing that was innovative about
Herceptin and now it seems routine,
but at that time, it was incredibly innovative.
Could you treat only the breast cancers
that were driven by an oncogene,
a growth factor for that cancer called HER2.
Only one in five of the patients with breast cancer had that driver.
Therefore, we would only treat that one patient out of five
whose cancer was dependent on HER2 to drive its growth.
Personalized medicine, targeted therapy-now popular,
while not routine, definitely the best way
to treat patients but incredible novel.
What that meant for the regular trade path is we
had to go to FDA and ask for approval for the therapeutic
and the diagnostic at the same time. Extremely hard, and very novel.
And the third thing that was so special
about this is that the engineers,
in manufacturing, had to be ready with the biotech process for
making this antibody reliably using Chinese hamster ovary cells
at the same time we were ready with the therapeutic.
So you had to work in teams effectively,
with a large team that could go to FDA.
The experience of working in biotechnology to make
the first antibody that had been approved for use
in breast cancer was an amazing experience for me.
And in the end taught me not just all those technical things,
which we were able to overcome and obtained approval in 1998,
but much more importantly, not to underestimate what was possible.
I always thought that you had to be in discovery,
that you had to have that sort of test tube in
one hand and light bulb going off over your head
in the other hand to do something innovative.
And as a clinician, I didn't see myself as an innovator.
But that opportunity to take what have been made
in the labs and bring it into clinical trials,
use all those things I had learned about inference
and proof in showing that Herceptin was good for
patients with HER2-driven breast cancer, I could be an innovator.
A big breakthrough for me,
personally, and something that my group, who were the
"D" of R&D at Genentech, could take great pride in.
So a very focused product-driven innovation to bring
something through the Food and Drug Administration,
to patients and other regulatory agencies,
to bring this product to market worldwide.