Transitioning from paper to eCTD for 2253 Submissions? The updated 2253 draft guidelines for Ad Promo submissions, is an example of the FDA encouraging sponsors to adopt practices that will benefit industry as a whole. A step in the right direction. Submitting video, audio and images as DVD media by mail in an age of such impressive computing power at low cost is much too tedious for sponsor and Agency. Modernization. By updating the specification, updating the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.

1. Pyxa
Solu*ons,
LLC
Transi*oning
from
paper
to
eCTD
for
2253
Submissions

2. 2
The
Industry
is
shiAing..
10/6/16
M1
ini*a*ve
The
updated
2253
dra7
guidelines
for
AdPromo
submissions
is
an
example
of
the
FDA
encouraging
sponsors
to
adopt
prac*ces
that
will
benefit
industry
as
a
whole.
A
step
in
the
right
direc*on
SubmiJng
video,
audio
and
images
as
DVD
media
by
mail
in
an
age
of
such
impressive
compu*ng
power
at
low
cost
is
much
too
tedious
for
sponsor
and
Agency.
Moderniza*on
By
upda*ng
the
specifica*on,
upda*ng
the
technology,
and
encouraging
a
rethinking
of
internal
processes,
the
FDA
is
moving
toward
a
more
modern
business
reality.
A
“MORE
MODERN
BUSINESS”
REALITY
FOR
2253’S
..are
you
shiAing
with
it?

3. 3
10/6/16
Quan*fying
the
shi7
in
2253
submissions
from
paper
to
eCTD
Since
the
Office
of
Prescrip*on
Drug
Promo*on
(OPDP)
started
accep*ng
electronic
submissions
in
June
2015
through
the
middle
of
February
2016
(in
the
first
8.5
months),
it
has
received
400
AdPromo
submissions
containing
more
than
1,000
promo*onal
pieces*.
Since
then
(in
the
3
months
that
followed)
these
numbers
have
doubled**.
As
of
now
(end
of
April
2016),
approximately
a
couple
dozen
companies
have
already
made
the
transi*on**.
**Source: Confidential to Pyxa Solutions LLC
** NOTE: The “couple dozen companies” is inclusive of partnerships and subsidiaries.
*Source: presentation from Roberta Szydlo from the ODPD during the DIA Marketing Pharmaceuticals 2016 conference

4. 4
10/6/16
Why
some
Companies
are
deciding
to
shi7
to
eCTD
before
the
dra7
guidance
is
final
and
before
the
mandated
deadline
Proac*vely
shiAing
from
paper
to
eCTD
for
2253
Submissions
Strategic
Considera*ons
Opera*onal
Considera*ons
FDA
Considera*ons
Compliance
Considera*ons

5. 5
10/6/16
Strategic
Considera*ons
Why
companies
are
shi7ing
now…
Reviewers
like
it!
An
overwhelming
#
of
reviewers
in
OPDP
that
review
2253’s
and
associated
promo*onal
materials
like
to
receive
it
in
eCTD
format
Improves
manageability
The
granular
format
of
eCTD
AdPromo
submissions
improves
manageability
and
helps
companies
more
clearly
and
succinctly
organize
their
informa*on
Open
Dialogue
w/
Agency
The
agency
is
seeking
open
dialogue
and
is
providing
some
leeway
for
companies.
They
want
companies
to
no*fy
them
of
formats
that
fall
outside
the
guidance
Influence
Change
Commen*ng
period
is
over,
however
FDA
is
s*ll
taking
comments
on
board
and
may
update
the
guidance
with
clearer
statements
to
remove
ambiguity
Save
*me
and
effort
The
ability
to
submit
grouped
submissions
will
save
*me
and
effort
by
allowing
one
submission
to
mul*ple
applica*ons
that
share
the
same
informa*on.
Beher
insight!
With
AdPromo
being
eCTD,
companies
can
easily
link
to
the
various
applica*ons
in
order
to
have
beher
oversight
and
improved
decision
making.

6. 6
10/6/16
Opera*onal
Considera*ons
Why
companies
are
shi7ing
now…
Submit
high
volume
2253s
Opportunity
for
companies
to
develop
streamlined
processes
to
submit
high
volume
2253s
electronically
over
the
electronic
submission
gateway
(ESG)
Lifecycle
Opera*ons
Take
advantage
of
the
convenience
and
visibility
afforded
when
performing
Lifecycle
opera*ons
in
eCTD.
(e.g.
If
part
of
the
original
submission
is
rejected,
the
sponsor
may
file
an
amendment
with
only
the
missing
or
rejected
component,
instead
of
submiJng
the
en*re
2253)
Reduced
Manual
Effort
Preparing
Ad
Promo
submissions
would
not
require
as
much
manual
effort.
There
would
be
no
coun*ng
of
hard
paper
copies
and
burning
media
to
discs.
Faster
Publishing-­‐Review
Publishing
is
faster
and
cheaper.
Submission
through
the
gateway
allows
reviewers
to
assess
submission
rapidly.
This
process
is
faster
then
Paper.

7. 7
10/6/16
FDA
Considera*ons
Why
companies
are
shi7ing
now…
Alignment
with
Submission
Process
Alignment with submission process for
other submissions in CDER
Improve
processing
efficiency
Due to extensive metadata collection
allows submission information to be
automatically populated into tracking
software to improve processing
efficiency
BeVer
Insights
Electronic search and filtering
capabilities. FDA has more insight, the
FDA can now do searches of the
submission to extract the information
they need.
Faster
and
More
Efficient
Faster and more efficient delivery to the
reviewer - With the new Module 1, the
ability to accept Form 2253
submissions in eCTD format via the
ESG
Ability
to
receive
high
volume
2253’s
Opportunity for streamlined processes
and ability to receive high volume
2253s from companies electronically
over the electronic submission
gateway (ESG)
Availability
for
All
Reviewers
Submission is available for all staff to
see, therefore secondary review and
consultation of other offices is more
efficient
Product
Applica*on
Info
Quickly
Available
Product application information is in
one location, will be quickly available
for all reviewers as needed.
Ability to receive eCTD 2253 and
non-2253 submissions over same
electronic submission gateway (ESG)
Receive
all
Submissions
through
ESG

8. 8
10/6/16
Compliance
Requirements:
FDA
Guidance
&
Landscape
Indicated
by
the
use
of
the
words
MUST
and
REQUIRED,
this
document
is
NOT
subject
to
the
usual
restricAons
in
FDA’s
good
guidance
pracAce
(GCP)
regulaAons
FDA
is
not
including
this
standard
language
in
this
guidance
because
it
is
not
an
accurate
descrip*on
of
all
the
effects
of
this
guidance.
This
guidance
contains
both
binding
and
non-­‐
binding
provisions.
Insofar
as
this
guidance
specifies
the
format
for
electronic
submissions
pursuant
to
sec*on
745A
of
the
FD&C
Act
it
will
have
binding
effect.
FDA
Guidance's
ordinarily
contain
standard
language
explaining
that
guidance's
should
be
reviewed
only
as
recommenda*ons
unless
specific
regulatory
or
statutory
requirements
are
cited.
In
sec*on
745A
of
the
FD&C
Act,
congress
granted
explicit
statutory
authoriza*on
to
FDA
to
specify
in
guidance
the
format
for
the
electronic
submissions
required
under
that
sec*on.

9. 9
10/6/16
Compliance
Requirements:
Upcoming
Requirements
In
OPDP’s
draL
guidance,
FDA
is
proposing
pharmaceuAcal
companies
submit
promoAonal
materials
for
human
prescripAon
drugs
to
OPDP
using
its
electronic
common
technical
document
(eCTD)
format.
OPDP
has
tradi*onally
required
companies
to
submit
promo*onal
materials
to
it
for
review
using
Form
FDA
2253—a
paper-­‐
based
form.
FDA
explains
"As
of
that
date,
paper
hard
copies
will
no
longer
be
accepted
for
such
submissions”.
In
the
mean*me,
firms
are
"strongly
encouraged"
by
FDA
to
begin
submigng
promo*onal
materials
using
the
eCTD
immediately.
This
requirement
is
changing,
eCTD
submissions
for
2253
will
be
required
two
years
aAer
the
guidance
document
is
finalized.

10. 10
10/6/16
Compliance
Requirements:
Risk
of
Non-­‐Compliance
FDA
explains
"As
of
that
date,
paper
hard
copies
will
no
longer
be
accepted
for
such
submissions”.
Not
a
point
for
nego*a*on
with
the
FDA.
Companies
who
do
not
comply
with
the
upcoming
eCTD
requirements
for
submiJng
their
2253s
will
find
themselves
in
a
posi*on
where
their
submissions
will
be
rejected
or
returned
with
comments
(as
would
any
submission
made
to
the
FDA
that
does
not
follow
the
regula*ons).
This
will
result
in
delays
with
FDA
review
and
therefore
use
of
the
materials
in
the
field.

11. 11
10/6/16
Value
Proposi*on
Once
the
guidance
is
final,
there
will
be
NO
other
op*on
but
to
implement
the
eCTD
process
Advance
planning
allows
all
risks
to
be
mi*gated
and
resources
to
be
addressed
prior
to
required
“go-­‐
live”
date
Good
Standing:
Following
FDA’s
strong
recommenda*on
to
begin
submiJng
promo*onal
materials
using
the
eCTD
immediately
Documents
available,
easily
accessible,
traceable
and
reportable
(throughout
the
lifecycle)
Preparing for and implementing (pilot or full go-live) a
2253 eCTD process before it is mandated by FDA
Implemen*ng
the
eCTD
Process
in
advance
will
ensure
the
process
is
implemented
effec*vely
and
efficiently
prior
to
mandated
deadline

12. 12
10/6/16
Risks
that
can
be
avoided
Vendors
not
providing
materials
in
the
correct
format
–
Regulatory
can
take
this
on
Mis-­‐
management
of
life
cycling
of
the
pieces
(and
maintenance
of
lifecycle)
Poor
*meline
management
to
ensure
pieces
are
ready
for
use
Under
es*ma*on
of
resources
/
skills
when
managing
electronic
submissions
As
part
of
the
end-­‐to-­‐end
eCTD
process
ensure
measures
are
put
in
place
to
manage
revised
pieces
or
discon*nua*on
of
a
piece.
As
part
of
the
end-­‐to-­‐end
eCTD
process
ensure
format
and
standards
for
promo*onal
pieces
are
established
and
communicated
to
vendors
–
HAVE
A
BACK
UP
-­‐
if
you
can
not
get
vendors
to
take
this
on
effec*vely
and
efficiently.
As
part
of
the
end-­‐to-­‐end
eCTD
process
ensure
*melines
are
clearly
communicated
to
all
func*ons
involved
in
the
process
and
the
turn-­‐around
*me
for
“re-­‐work”
is
understood
so
that
submissions
are
not
delayed
.
As
part
of
the
end-­‐to-­‐end
eCTD
process
ensure
resources
(people
and
tools)
are
in
place
to
accommodate
the
required
changes
from
paper
to
eCTD.
ConsideraAon:
Eliminate
large
scale
risk
by
implemenAng
a
small
scale
pilot
(for
one
or
more
“not
so
acAve/criAcal”
products
to
ensure
the
process
is
streamlined
and
miAgaAon
plans
are
considered
prior
to
full
scale
implementaAon

13. 13
10/6/16
Industry
Best
Prac*ce
–
How
Pyxa
Can
Support
✓
✓
Establish
a
vendor
guide
to
ensure
all
Vendors
providing
promo*onal
materials
are
following
the
required
format
/
standards
(ONLY
if
Vendors
will
be
managing
this
for
you)
Incorporate
language
in
Vendor
agreements
to
ensure
vendors
are
contractually
obligated
to
abide
by
the
templates
/
standards
guide
provided
to
them
(embed
in
the
process)
-­‐
(ONLY
if
Vendors
will
be
managing
this
for
you)
✓
Ensure
Regulatory
QC
performed
on
materials
received
from
Commercial
is
inclusive
of
checks
for
submission
readiness
(built
within
a
checklist
to
ensure
consistency
with
each
review)
✓ Establish
internal
standards
(e.g.
leaf
*tles
and
file
names;
placement
loca*on
etc.)
–
as
applicable
✓ Establish
a
lifecycle
management
approach
to
maintaining
promo*onal
pieces
Establish
an
end-­‐to-­‐end
cross-­‐funcAonal
2253
eCTD
process
to
ensure
consistent
and
efficient
transiAon
to
meet
the
upcoming
requirements
✓ Implement
a
pilot
(Test
Submission)
to
fine-­‐tune
processes
before
full
implementa*on
✓
Determine
if
Vendors
will
provide
promo*onal
materials
in
the
required
format
or
if
Regulatory
Opera*ons
will
re-­‐format
pieces
to
the
necessary
standards

14. Contact
US
INFO@PYXASOLUTIONS.COM