everybody will be using Amphora.”
Amphora also puts decision-making power squarely in the
hands of women. The gel can be discreetly inserted, via an
applicator that looks like a small tampon, up to an hour before
sex. A woman’s partner can be as involved—or not—as she
wishes. “This is for an empowered woman,” says Pelletier,
emphasizing she doesn’t just mean in the U.S. Her plan, if she
wins FDA approval, is to distribute Amphora in the develop-
ing world on a philanthropic basis.
The drug development regime in the U.S. puts entrepreneurs such as Pelletier in limbo for a terribly long time. The
cost of bringing a new drug to market has been estimated at
anywhere from $648 million to $2.6 billion, and the timeline
can easily stretch to 10 years. Development of Amphora began
in the mid-1990s, and the results of its frst clinical trial were
published in 1999. Pelletier is in what should be the very last
stages of this particular form of sufering, and hopes Evofem
can bring Amphora to market in 2019. But there is no guarantee it will make the cut.
If and when the FDA does approve Amphora, there is
always a chance that women won’t fock to it. If that happens,
signifcant modifcations to Amphora are pretty much out of
the question. In the world of new drugs, startup mantras such
as “Iterate” and “Move fast and break things” sound silly. A
drug needs to be approved by the FDA, and after that happens,
there’s not much room for change. Some drugs get just one
shot. Amphora is already on its second.
W HEN PELLE TIER was in frst grade, her mother started sending her to school in the kid version of a suit: blue trousers and a blue button-up collared shirt with contrasting trim, with her lunch in a small briefcase.
Pelletier begged for a lunch pail, like what the other kids had,
but her mother told her, “Saundra, school is not about eating.”
Her mother’s singular mission was to get her daughter
out of Caribou, Maine, population 7,736. Pelletier was plenty
motivated to leave. Her grandparents had outdoor plumbing,
and her family was sometimes on food stamps.
Pelletier went to Husson University in Bangor, and then
got a job in sales in the women’s health division at G.D. Searle,
selling its birth control pills. On Sundays, she would map out
the coming week—studying doctors’ schedules, composing
messages, and choosing treats for the doctors’ stafs. “I had
this level of discipline that was like, here’s the goal, here’s
how we’re going to accomplish it,” she recalls. She was
awarded a top salesperson distinction, and rose quickly
through the ranks. When a colleague told her she would have
to stay in her post for three years before she could be pro-
moted, she corrected him: “Maybe you have to stay in your
job for three years,” she said. “I don’t.” She got promoted after
two years. By the time she was 34, she was a vice president.
But then came the mini midlife crisis. Earlier in her
career, she had gone on a safari in Africa with a girlfriend.
When the guide asked if there was anything else Pelletier
wanted to see, she mentioned health clinics. “I kept remem-
bering all these poor women,” she says. “If they’re given an
opportunity to have access to contraception, they don’t have
to be poor. It was a very big reality check.” She didn’t think
that her colleagues in women’s health necessarily had inter-
nalized what women around the world were dealing with.
“Even in big pharma, it didn’t seem that we understood the
gravitas of it—when women can make the right decisions for
themselves and their families and how it impacted everyone
they touched,” says Pelletier. “We wanted to sell product.”
Pelletier quit her job and became an executive coach.
“I had this fantasy that all my clients would be women,” she
says. “Of course, all my clients were men. Women just don’t
HOW TO SURVIVE THE FDA
Entrepreneurs in drug development succeed or fail at the hands of the FDA.
The long road to approval requires uncommon levels of patience, fortitude—and cash.
Once a promising substance
has been identifed, it needs
to be tested either in animals
or in human cells. After
that testing is complete, the
developer asks the FDA
for permission to begin
testing the drug in humans.
This is the end of the line for
many drug candidates.
The substance is
then tested on 20 to
100 healthy people
to determine if it’s
likely to be safe.
The substance is tested for
safety and efcacy, often
with double-blind studies, so
neither the doctors nor the
patients know who is getting
the drug or the placebo.
These can involve several
hundred to several thousand
patients, and can take anywhere from a few months to
a few years.
This phase continues
testing for safety and
efcacy, and can take
several years and involve
thousands of patients.
Once complete, the
company or research
the drug can fnally apply
for FDA approval.
90 - INC. - NOVEMBER 2017