By
Jim Nicholson
Biologics are the future of medicine. Instead of a pill, which
is a chemical composition, a biologic is made from a biological
system. It comes from protein derived from a living system.
Most biologics are made from mammalian cells. Others are derived
from yeast, bacteria, plants and animals. They are rapidly changing
medicine worldwide and, befitting its position as the heart
of the BioBelt, St. Louis is the center of Biologic development
in the United States.
At Chlorogen, the focus is on pioneering a drug designed to
fight ovarian cancer, which is produced from its transformed
tobacco cell technology. According to David Duncan, president
and CEO, many plants including duckweed, alfalfa, safflower,
corn, rice and tobacco have already been utilized in biologic
research because “plants may be able to produce biologics more
economically. If (we) can load enough protein into (plant) cells,
we will have an efficient economically produced biologic.” Efficiency,
capacity and economics are big concerns with biologics, which,
simply stated, do not come cheap.
Chlorogen’s motto of the moment, “Imagine: a cure for cancer
from tobacco” seeks to turn irony into medical miracle. The
drug, with a target application of women’s reproductive cancers,
is expected to enter Phase 1 clinical trials in 2009 and conclude
the FDA approval process by 2013, is a member of the mammalian
TGF-Beta super family (a group of unique cell-cycle modulators
which regulate the fate of the cell). The venture needs the
backing of a partner with obviously deep pockets and a strong
sense of the proposed drug’s potential.
This is strong validation for a company founded on venture capital
reliant on a small (twelve total) team of people in St. Louis
who only four years ago initiated commercialization of the platform
technology developed in Florida. Already, it has received major
awards including the National Outstanding Incubation Client
Award in 2006. In April, it was featured on The Discovery Channel.
As Dr. Duncan states with a knowing smile, “Certain important
biologics cannot be produced by any other means except in plants.”
According to Larry Shapiro, executive vice chancellor for medical
affairs and dean of Washington University’s School of Medicine,
the University is “really intent on pushing translational (medical)
research linking discovery science more closely with outcomes
beneficial to people” through its BioMed 21 program.
Building upon several core platforms of strength within the
School of Medicine, BioMed 21 links the Center for Genome Science,
the Center for Imaging Sciences and the new Institute of Clinical
Sciences. The University’s goals are in alignment with the “roadmap”
initiatives of the National Institute of Health with the result
that the University has received substantial NIH funding to
pursue BioMed 21.
The Clinical Imaging Center, for instance, will house advanced
imaging equipment dedicated to research. Usually, such equipment
is hospital-owned (and ultimately paid for via patient medical
costs) and any research must be done after hospital hours and
only with hospital approval concerning changing of equipment
settings, et cetera. Here, the equipment will be owned by the
Center and the research will be full time. Dean Shapiro modestly
points out “there’s no comparable facility anywhere in the country.”
Shapiro states that in BioMed 21 interdisciplinary teams will
focus on “important clinical problems” and will “create research
space without intellectual boundaries” while working with industry
to achieve its goals.
On a beautiful tree-laden, 200-acre campus situated in Chesterfield,
Mo. sits the Pfizer St Louis Laboratories, home to the Biologics
(protein-based medicines) Center of Emphasis for Pfizer, the
world’s leading research-based pharmaceutical company.
Dr. Daniel P. Getman, vice president of Pfizer Global Research
and Development and director of the St. Louis Laboratories (home
to approximately 1,200 employees in St. Louis) explains that
Biotherapeutics is a growing part of the company’s research
and development pipeline. Scientists in St Louis work closely
with other Pfizer scientists, throughout the world, to provide
technical expertise to discovery teams selecting the final drug
candidates to enter human clinical trials. But prior to being
available to patients, a major part of the development of these
potential medicines will occur in Chesterfield. “Through a combination
of our people’s expertise, new technology and state-of-the art
facilities, we have the capability to produce these complex
proteins, then carefully characterize them and develop formulations
for human clinical trials.”
Biotherapeutics offer unique treatment options for serious diseases
affecting millions of patients. “Our research touches all areas
of medicine, including cancer, arthritis and cardiovascular
disease. There are some exciting potential new medicines currently
in mid- to late-stage clinical trials for cancer that offer
great promise and hope for patients suffering from this disease,”
says Getman.
“Nothing motivates our scientists more than bringing forward
a new drug candidate that could make a difference in people’s
lives,” says Getman. “Many colleagues will share personal stories
of friends and relatives who suffer from various diseases; through
our work, we hope to help future patients.”
Biologics are already being used for treatments of arthritis,
Crohn’s disease and psoriasis. New ways to treat various cancers,
cardiovascular diseases and multiple sclerosis are in the offing.
The potential is enormous and the impact for people suffering
from or prone to such diseases will be vast. Thanks to its position
as heart of the BioBelt, St. Louis will give birth to a new
wave of medicines, which will be making medical headlines for
years to come.
