When Joseph Paul Eder, MD, Director of
Experimental Therapeutics and the Phase I Research
Group, came to Yale in the summer of 2012, only a few
Phase I clinical trials were underway. A more robust
Phase I program was important to achieve Yale’s mission.
Eighteen months later, 10 Phase I trials are open, and
by the end of 2014 Dr. Eder expects that number to be
somewhere between 15 and 18.
Among the most exciting trials now underway, he says,
are five using “checkpoint inhibitor” immunotherapies
that activate the immune system and shrink tumors.
The targets are melanoma, kidney cancer, lung
cancer, and others. These trials have built Yale Cancer
Center’s reputation as an innovator in immune-based
therapies. Three additional trials will soon open.
“These are complicated new treatments,” Dr. Eder said.
“The pharmaceutical companies want to bring their
trials to the people with experience and expertise
with these novel agents and their unique effects, good
and bad.”
He gives several reasons why it’s important that
these early clinical trials of new cancer therapies have
started coming to Yale: “We urgently need new and
better treatments for our patients who have run out of
other treatment options. Many of the therapies we use
in cancer medicine are not good therapies – they are
just the best we have. These agents and trials allow us
to look for new causes for drug effectiveness or drug
resistance. The trials bring in additional resources
for the work that needs to be done by our scientists.
They establish us as a place that can get additional
funding to help basic scientists explore new areas –
the NIH is more likely to send funds your way if you
are doing work that intersects with clinical medicine.
Patients are certainly interested in research that
translates into some sort of clinical impact. So are
pharmaceutical companies.”
Previously, these companies did not often think of
Yale as a place to conduct trials of their experimental
drugs. Since her arrival at Yale in May, Juliane
Juergensmeier, PhD, Research Scientist, Developmental
and Experimental Therapeutics, has been in discussion
with large and small pharmaceutical companies to
explain that Yale Cancer Center can handle their trials,
no matter how difficult or complicated.
“They can see that we are building an outstanding
center of clinical and scientific excellence here, and are
interested not just in accruing patients to their trials but
in also progressing scientific understanding of the disease
and treatment.” All companies have been receptive to
Dr. Juergensmeier’s approach. Over the last six months,
a number of them visited Yale for portfolio presentations
and smaller detailed discussions with scientists.
Like Dr. Eder, Dr. Juergensmeier has many years
of experience in both academia and industry, and
understands the needs of both. “We know what Pharma
needs,” Dr. Eder said. “We know how to put together a
message that will resonate with all the different levels
– not just the scientists but the people who control
resources, who see that we can help them get to their
next milestone of drug development.”
Phase I trials also may come to Yale Cancer Center
from other avenues, such as the industry contacts of
veteran Yale investigators. Dr. Eder spent much of his
time in 2013 working to get Yale into the clinical trials
network of the National Cancer Institute.
The fourth potential source of trials is scientific
hypotheses developed at Yale and then brought into the
clinic. That takes longer, explained Dr. Eder, “because
you don’t have Pharma handing you a protocol and a
budget.” But he expects such trials soon, possibly in the
area of therapy utilizing nanoparticles. Drs. Eder and
Juergensmeier work closely with Dr. Roy Herbst and Dr.
Karen Anderson, the co-leaders of the Developmental
Therapeutics Research Program and at Yale Cancer
Center to bring new agents from the labs at Yale into
the clinics.
Perhaps the group most pleased about the influx of
Phase I trials are patients. Many of them come to Smilow
Cancer Hospital at Yale-New Haven with advanced
tumors. Existing therapies have failed them and they are
looking for options. “That’s where clinical trials come
into cancer medicine,” Dr. Eder said. “They offer the
hope that patients and providers want.”