November 2020 Newsletter

WWW.MHCE.US Monthly Newsletter | 15
Remdesivir was originally created in 2009
by Gilead Sciences, a large American
biopharmaceutical company, to combat
hepatitis C and respiratory syncytial virus
(RSV), but it proved to be ineffective against
both.
With the help of the Defense Threat
Reduction Agency's Joint Science and
Technology Office in Fort Belvoir, Virginia,
and USAMRIID on Fort Detrick, remdesivir
was repurposed for use against other viruses,
such as Ebola and Marburg.
In 2015, preclinical trials at USAMRIID
showed that remdesivir blocked Ebola
in Rhesus monkeys, paving the way for
it to eventually be used in human trials.
Remdesivir was used to help curb the Ebola
outbreak in West Africa in 2016.
Doctors, scientists and lab technicians at
Fort Detrick continued to study the possible
effects of remdesivir against a family of
related viruses, known as filoviruses.
When the call arrived in early 2020 about
the novel coronavirus, they sprang into
action, poring over 500-plus pages of highly
technical medical papers in search of ways to
combat it.
"It was daunting," Eckmeier said. "I think
that's the right word for it."
The digging produced a previously published
entry in an academic journal that showed
remdesivir had some in-vitro effectiveness
against other coronaviruses.
Word of the discovery quickly spread through
other government agencies, such as the
National Institutes of Health, and eventually
made its way back to Gilead.
"Gilead was already moving in that direction,"
Eckmeier said. "It was their product. So, they
knew about the academic journal [entry].
They were watching the unfolding events as
the rest of the world was."
With a long-term partnership already
established, the U.S. government and Gilead
began working frenetically to get remdesivir
approved to help fight COVID-19.
"Just absolute huge amounts of work to get
this effort [approved]," Eckmeier said. "It
was a lot of facilitation and linking folks up,
making sure the right people were talking
to the right people to move this forward
quickly. It was a frenzy, and a lot of the effort
is still ongoing. The fact that we have agile
acquisition systems and vehicles through
multiple partnerships allows us to go out and
do these things much quicker."
The speed doesn't have much precedent.
"Normally it takes 10-15 years and a billion
dollars or more to develop vaccines or drugs
all the way to licensing," Eckmeier said. "For
one thing, it's hard."
With the onset of COVID-19, the government
has put a lot of the development and approval
processes on parallel instead of successive
tracks, which has enabled the process to
move faster, according to Dr. Dye.
"It's been impressive, the speed at which
things are happening while keeping in mind
the safety component," he said. "We are
doing this in a compacted time frame with
no less of an emphasis on safety and efficacy.
Those standards are being maintained."
Prior to receiving full approval last week,
remdesivir was approved for emergency use
in severely ill coronavirus patients back in
May. In August, the approval was expanded
to treat mild to severe cases.
"It's a great first step," Dye said. "It's not a
cure, not a fix-all. But it gets us one more step
closer to winning this battle. There are more
steps to get there and more battles along the
way. But it's a great first step."
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