IF SOMEONE COULD PLUG INTO THE ENERGY
Dr.Victoria Hale exudes, it would drive a car across the
continent and back, and still show a full tank. An ex-
FDA, ex-Genentech expert on drug review, Hale now
runs her own non-profit firm: the Institute for
OneWorld Health (IOWH) out of San Francisco.The Bill and
Melinda Gates Foundation recently granted her nascent firm
$1.4 million towards fine-tuning a possible drug for visceral
leishmaniais.Vis…what?

The U.S. FDA decrees that a disease, afflicting less than
200,000 people within the continent, is an “orphan” disease.
Not many drug-developing companies invest in finding out
cures for such “orphans.” One such disease is visceral
leishmaniais. Less known, yet still lethal and contagious,
visceral leishmaniais is known better in the eastern parts of
India—Bihar specifically—as kala azar, or the dreaded black
fever. Apparently, visceral leishmaniais afflicts over 12 million
people worldwide with 500,000 new cases annually. In an
exciting breakthrough, Hale and her team are developing
paromomycin, an aminoglycoside as a new drug therapy.The
lead to this drug was from a formula that was shelved by an
Italian drug firm, which had given it to the World Health
Organization, (WHO) who subsequently passed it on to
IOWH. Hale is excited about the new funds from the Gates
foundation, which helped her conduct the phase 3 clinical
trials. She is now working with research firms in India to
obtain approvals, and will subsequently work with drug
companies in there to develop the drug for large-scale
applications.

Why would somebody who worked with the FDA and
Genentech want to do something like this on her own—that
too, for no profit? “At the FDA, I have reviewed many drugs
that could extend to curing many other illnesses, just by some
more extension work. But the drug company would not be
interested in it, as it would bring them no profit.This sparked
off an idea within me. If I could get ahold of these halfdeveloped
compounds and tweak them around to solving
some large-spread diseases, it would become a win-win for all
of us.That was when I started putting IOWH on paper,” says
Hale. Her persistent work for more than two years has paid
off. She recently secured rights from Cerent Genomics to
develop a drug, CRA-3316, that could possibly become a cure
for the Chagas disease in Latin America.

Hale takes up “formulas-on-shelf,” drugs that a company
has shelved for some reason, and explores possibilities of
working with it to look for cures for parasitic diseases.
“Companies are interested in vaccines and treatment drugs
for non-contagious ills like cancer. Parasitic diseases don’t
normally respond well to current vaccines or drugs.Thus the
interest levels are low or none in these sectors,” explains
Hale. She then works with teams of similar-minded drug
developers and pharma companies to take the drug through
the three phases of development, and then finally to the
regulatory bodies concerned. Paromomycin and CRA-3316
are her first two victories.

“There are many such less-to-unknown diseases afflicting
regions of the world. I exploit my past experience to pick
some shelved compounds. The big companies are willing to
grant or give these compounds away, if they can get some
good mileage out of the final development. If we crack the
drug, the authorities in the countries world over are happy to
help us in approval. And finally, vast numbers of people are
cured…win, win, win all the way!” exults Hale. “And there
are numerous such drugs sitting with universities, the Army,
smaller companies that went bankrupt and in some cases,
where the patent on the drug expired.We capitalize on these.
If you look at a big company’s development process, there are
at least five-dozen products in the pipeline. If they hit a
stumbling block with one, they promptly abandon it, since it
will cost them at least a year’s time to retrace and rectify a
block.We try to trace such near-success failures, as they are
in an advanced state of development and testing, and will not
cost us much time or money to take it further.”

But isn’t Hale appalled by the cost of bringing a drug even

at this state out of the door? “There are some important
reasons why these drugs fail. About 20 percent of the time a
drug doesn’t work! And for the other 80 percent of the time,
there are wrong doses, wrong endpoints measured, or such
a diverse patient population tested that the tests don’t prove
anything.We simply need to focus on the core issues and
bring our costs down…which we feel is very possible,” says
Hale. “If we work with good compounds that are in an
advanced state of development, and collaborate with good
drug development experts, our costs will come down
drastically.”

Currently, IOWH works with a skeleton team in this
tedious process.With the infusion of funds, Hale hopes to
expand her team to include a development team. Hale is
open to smart contributions. While she does not turn away
money, she sees time and effort donations by pharmacists
and drug developers as more effective, smart contributions.
Even her current funding from the Gates foundation came
with a recommendation: to establish an independent unit in
Bihar where the paromomycin could be developed and lead
to further such discoveries. Eventually, this will be the case,
where teams work in specific locations on specific diseases.
“I took up visceral leishmaniais because it is within my current
abilities. Malaria is too vast. I want to deliver effective
solutions, in tangible time-frames,” says Hale. “Malaria’s
time will come.”

Her sense of entrepreneurship is admirable. No venture
capital, no profits at the end of the process, and no particular
path to success. Yet this woman has made tremendous
inroads in the drug industry. What would she expect from
the vast IT Indian immigrant populace in the U.S., where the
pockets run deep and plenty? “From development, we
would like to step backwards, eventually to diagnosis,
research and analysis. This is definitely a platform for these
bright, smart English-savvy people to participate.We will
need help when we progress from parasitic diseases to issues
like contraception, low-cost medical devices and
compound-tracing processes,” says Hale.

Right now, Hale’s focus is on short-term goals, but
eventually, she would like IOWH to work constantly on at
least half a dozen pipeline products. “We may experiment
with new business models at that time, but for now we are
more than content in working with one or two diseases and
find solutions for them, that will be effective and affordable
for the people who can’t afford them now. Not-for-profit
doesn’t mean we shouldn’t be accountable for our time or
other people’s money. A drug solution is an accountable,
tangible answer from us…whether it is a big or small
solution is not the issue,” says a firm Hale. Focused,
tenacious and ever optimistic, Hale is the true entrepreneur
who works smartly to deliver hope and life to needy people
around the world.