<s>
PrecisionFDA	B-Application
(	O
stylized	O
precisionFDA	B-Application
)	O
is	O
a	O
secure	O
,	O
collaborative	O
,	O
high-performance	O
computing	O
platform	O
that	O
has	O
established	O
a	O
growing	O
community	O
of	O
experts	O
around	O
the	O
analysis	O
of	O
biological	O
datasets	O
in	O
order	O
to	O
advance	O
precision	O
medicine	O
,	O
inform	O
regulatory	O
science	O
,	O
and	O
enable	O
improvements	O
in	O
health	O
outcomes	O
.	O
</s>
<s>
This	O
cloud-based	B-Architecture
platform	O
is	O
developed	O
and	O
served	O
by	O
the	O
United	O
States	O
Food	O
and	O
Drug	O
Administration	O
(	O
FDA	O
)	O
.	O
</s>
<s>
PrecisionFDA	B-Application
connects	O
experts	O
,	O
citizen	O
scientists	O
,	O
and	O
scholars	O
from	O
around	O
the	O
world	O
and	O
provides	O
them	O
with	O
a	O
library	O
of	O
computational	O
tools	O
,	O
workflow	O
features	O
,	O
and	O
reference	O
data	O
.	O
</s>
<s>
The	O
platform	O
's	O
code	O
is	O
open	O
source	O
and	O
available	O
on	O
GitHub	B-Application
.	O
</s>
<s>
Globally	O
,	O
precisionFDA	B-Application
has	O
more	O
than	O
5,000	O
users	O
.	O
</s>
<s>
The	O
precisionFDA	B-Application
team	O
collaborates	O
with	O
multiple	O
FDA	O
Centers	O
,	O
the	O
National	O
Institutes	O
of	O
Health	O
,	O
and	O
other	O
government	O
agencies	O
to	O
support	O
the	O
vision	O
and	O
intent	O
of	O
the	O
American	O
Innovation	O
&	O
Competitiveness	O
Act	O
and	O
the	O
21st	O
Century	O
Cures	O
Act	O
.	O
</s>
<s>
In	O
August	O
2015	O
,	O
the	O
FDA	O
announced	O
the	O
launch	O
of	O
precisionFDA	B-Application
as	O
a	O
part	O
of	O
the	O
initiative	O
.	O
</s>
<s>
In	O
February	O
2016	O
,	O
the	O
FDA	O
announced	O
the	O
first	O
precisionFDA	B-Application
challenge	O
,	O
the	O
,	O
which	O
tasked	O
users	O
with	O
testing	O
the	O
reliability	O
and	O
reproducibility	O
of	O
gene	O
mapping	O
and	O
variant	O
calling	O
tools	O
.	O
</s>
<s>
The	O
,	O
run	O
in	O
collaboration	O
with	O
Georgetown	O
University	O
,	O
asked	O
participants	O
to	O
develop	O
machine	O
learning	O
(	O
ML	O
)	O
and	O
artificial	B-Application
intelligence	I-Application
(	O
AI	B-Application
)	O
models	O
to	O
identify	O
biomarkers	O
and	O
predict	O
brain	O
cancer	O
patient	O
outcomes	O
using	O
gene	O
expression	O
,	O
DNA	O
copy	O
number	O
,	O
and	O
clinical	O
data	O
.	O
</s>
<s>
The	O
engaged	O
data	O
scientists	O
to	O
use	O
unsupervised	O
ML	O
and	O
AI	B-Application
techniques	O
to	O
identify	O
anomalies	O
in	O
FDA	O
adverse	O
events	O
,	O
regulated	O
product	O
substances	O
,	O
and	O
clinical	O
trials	O
data	O
,	O
essential	O
for	O
improving	O
the	O
mission	O
of	O
FDA	O
.	O
</s>
<s>
In	O
total	O
,	O
ten	O
community	O
challenges	O
have	O
been	O
completed	O
on	O
precisionFDA	B-Application
,	O
which	O
have	O
generated	O
a	O
total	O
of	O
562	O
responses	O
from	O
240	O
participants	O
.	O
</s>
<s>
PrecisionFDA	B-Application
challenges	O
have	O
led	O
to	O
meaningful	O
regulatory	O
science	O
advancements	O
,	O
including	O
published	O
best	O
practices	O
for	O
benchmarking	O
germline	O
small-variant	O
calls	O
in	O
human	O
genomes	O
.	O
</s>
<s>
In	O
addition	O
to	O
challenges	O
,	O
in-person	O
and	O
virtual	O
app-a-thon	O
events	O
,	O
which	O
promote	O
the	O
development	O
and	O
sharing	O
of	O
apps	O
and	O
tools	O
,	O
are	O
hosted	O
on	O
precisionFDA	B-Application
.	O
</s>
<s>
In	O
August	O
2016	O
,	O
precisionFDA	B-Application
launched	O
,	O
which	O
aimed	O
to	O
encourage	O
the	O
creation	O
and	O
sharing	O
of	O
Next	O
Generation	O
Sequencing	O
(	O
NGS	O
)	O
apps	O
and	O
executable	O
Linux	O
command	O
wrappers	O
.	O
</s>
<s>
Participants	O
were	O
asked	O
to	O
create	O
BioCompute	B-Application
Objects	I-Application
(	O
BCOs	O
)	O
,	O
a	O
standardized	O
schema	O
for	O
reporting	O
computational	O
scientific	O
workflows	O
,	O
and	O
apps	O
to	O
develop	O
BCOs	O
and	O
check	O
their	O
conformance	O
to	O
BioCompute	O
Specifications	O
.	O
</s>
<s>
In	O
April	O
2016	O
,	O
precisionFDA	B-Application
was	O
awarded	O
the	O
top	O
prize	O
in	O
the	O
Informatics	O
category	O
at	O
the	O
Bio	O
IT	O
World	O
Best	O
Practices	O
Awards	O
.	O
</s>
<s>
In	O
2018	O
,	O
the	O
platform	O
,	O
which	O
is	O
leveraged	O
by	O
precisionFDA	B-Application
,	O
was	O
granted	O
(	O
ATO	O
)	O
by	O
Health	O
and	O
Human	O
Services	O
(	O
HHS	O
)	O
for	O
.	O
</s>
<s>
In	O
addition	O
,	O
the	O
precisionFDA	B-Application
team	O
received	O
an	O
FDA	O
Commissioner	O
’s	O
Special	O
Citation	O
Award	O
in	O
2019	O
for	O
outstanding	O
achievements	O
and	O
collaboration	O
in	O
the	O
development	O
of	O
the	O
precisionFDA	B-Application
platform	O
promoting	O
innovative	O
regulatory	O
science	O
research	O
to	O
modernize	O
the	O
regulation	O
of	O
NGS-based	O
genomic	O
tests	O
.	O
</s>
<s>
In	O
2019	O
,	O
precisionFDA	B-Application
received	O
a	O
FedHealthIT	O
Innovation	O
Award	O
and	O
transitioned	O
from	O
a	O
beta	O
to	O
a	O
production	O
release	O
state	O
.	O
</s>
<s>
PrecisionFDA	B-Application
is	O
an	O
open-source	O
,	O
cloud-based	B-Architecture
platform	O
for	O
collaborating	O
and	O
testing	O
bioinformatics	O
pipelines	O
and	O
multi-omics	O
data	O
.	O
</s>
<s>
PrecisionFDA	B-Application
is	O
available	O
to	O
all	O
innovators	O
in	O
the	O
field	O
of	O
multi-omics	O
,	O
including	O
members	O
of	O
the	O
scientific	O
community	O
,	O
diagnostic	O
test	O
providers	O
,	O
pharmaceutical	O
and	O
biotechnology	O
companies	O
,	O
and	O
other	O
constituencies	O
such	O
as	O
advocacy	O
groups	O
and	O
patients	O
.	O
</s>
<s>
The	O
precisionFDA	B-Application
virtual	O
lab	O
environment	O
provides	O
users	O
with	O
their	O
own	O
secure	O
private	O
area	O
to	O
conduct	O
their	O
research	O
,	O
and	O
with	O
configurable	O
shared	O
spaces	O
where	O
the	O
FDA	O
and	O
external	O
parties	O
can	O
share	O
data	O
and	O
tools	O
.	O
</s>
<s>
For	O
challenge	O
sponsors	O
,	O
the	O
precisionFDA	B-Application
platform	O
provides	O
a	O
comprehensive	O
challenge	O
development	O
framework	O
enabling	O
presentation	O
of	O
challenge	O
assets	O
,	O
grading	O
of	O
submissions	O
,	O
and	O
publication	O
of	O
results	O
.	O
</s>
