The document discusses the challenges of recruiting patients for oncology clinical trials in Canada and outlines a reverse feasibility program established by Scimega to address these issues. It highlights the importance of understanding investigator motivations, improving start-up times, and fostering connections between sponsors and Canadian sites to enhance trial participation. Success stories underscore the program's effectiveness, achieving significantly faster start-up times and better patient recruitment in Canada.

1. What your cro doesn’t
Know could hurt you
How to leverage Canada
for Study Expansion &
Recruitment

3. Patient 001 – ADC
This
pa(ent
was
diagnosed
with
Mul(ple
Myeloma
in
2002.
A
pharmacist
by
training,
he
was
highly
educated
and
well
aware
of
his
chances
for
survival
and
the
limited
treatment
op(ons
that
were
available
at
the
(me.
He
asked
his
oncologist
about
par(cipa(ng
in
a
clinical
trial
but
was
informed
there
was
only
one
available.
He
eagerly
signed
on,
but
was
randomized
to
the
control
arm.

4. It’s
stories
like
these
that
give
meaning
to
what
we
do
and
why
we
are
so
passionate
about
our
mission,
which
is
to
aDract
cu$ng-­‐edge
oncology
trials
to
Canada
and
to
connect
sponsors
with
a
network
of
highly
mo(vated
inves(gators
and
their
pa(ents.
Scimega’s mission:

5. A
Look
Under
The
Hood
of
the
Reverse
Feasibility
Program
-­‐
REB
Strategy
-­‐
Site
Contract
Execu(on
-­‐
Regulatory
Strategy
Keys
to
AcceleraAng
Site
Performance
Real-­‐life
Canadian
Expansion
Success
Stories
&
Results
summary

7. The
Reverse
Feasibility
Program
Est. 2008

8. What are
investigators
looking for?
The
ques(ons
we
seek
to
answer
oMen
revolve
around
how
we
can
help
aDract
more
oncology
trials
that
would
be
successful
in
Canada.
Selling
the
idea
of
a
niche
CRO
that
is
100%
dedicated
to
oncology
is
not
the
hard
part.
Everyone
can
understand
the
value
in
that.
The
true
challenge
lies
in
how
to
sell
Canada
-­‐
a
region
well
known
for
its
data
quality,
but
not
usually
recognized
for
its
speed.
The
key
has
been
to
understand
what
drives
enrolment.
In
other
words,
to
understand
what
inves(gators
are
looking
for!

9. Why
some
trials
just
seem
to
run
by
themselves?
?
Why
some
inves(gators
just
seem
to
“get
the
science”
and
grasp
the
urgency
of
one
program
but
not
another?
?
To do so we need
To understand:
Meanwhile:
Others
just
go
through
the
mo(ons
and
don't
seem
very
mo(vated…

10. sTEP 1a
Con(nuous
survey
of
Canadian
inves(gator
needs
and
interests
We
start
by
reaching
out
to
our
Reverse
Feasibility
Champions
and
asking
them
to
provide
us
with
their
preferences
in
terms
of
compounds,
indica(ons
and
lines
of
therapy.
We
do
this
on
a
regular
basis.

11. Engagement
and
input
from
pa(ent
advocacy
groups
sTEP 1b

12. 1csTEP Find
U.S.
biotech
sponsors
in
need
of
oncology
study
expansion.
Once
we
have
an
idea
of
what
is
needed,
we
ac(vely
aDend
key
oncology
events
like
AACR,
ASCO
and
ASH
in
an
effort
to
meet
with
sponsors
developing
in
the
key
indica(ons
Canadian
sites
are
in
need
of
for
their
pa(ents.

13. 2sTEP Sponsor
compounds/studies
matched
to
needs
of
Canadian
sites
Once
a
match
is
found,
we
offer
to
help
the
sponsor
enhance
their
recruitment
by
expanding
their
trial
to
the
right
sites
in
Canada.

14. 3sTEP Approach
select
sites
with
summary
of
criteria
We
execute
a
mutual
CDA
with
the
sponsor
and
request
that
they
allow
us
to
use
our
CDA
template
to
share
info
with
the
sites.
Having
been
around
since
1997
means
the
sites
know,
like
and
trust
us.
We
help
accelerate
the
process
with
the
help
of
pre-­‐approved
templates.

15. 4sTEP
Introduce
sponsor
to
sites
and
discuss
viability
&
feasibility
Once
we
have
confirmed
interest
we
coordinate
a
conference
call
with
each
Inves(gator
so
the
sponsor
can
assess
the
sites’
level
of
engagement
for
themselves.

16. 5sTEP Iden(fy
best
fit
sites
We
typically
iden(fy
more
sites
than
are
required
so
the
sponsor
has
the
privilege
of
cherry-­‐picking
the
best
sites
for
their
program.

17. 6sTEP Start-­‐up
&
FPI
(first
pa(ent-­‐in)
The
proof
is
in
the
start-­‐up
and
the
Reverse
Feasibility
approach
has
resulted
in
start-­‐up
(mes
that
are
rou(nely
up
to
50%
faster
than
the
industry
average.

18. 18

19. Knowing
investigators
Isn’t enough
What
else
drives
Reverse
Feasibility
Performance?

20. REB
Strategy
sTart-up strategy
Unlike
centers
in
the
U.S.,
Canadian
ins(tu(ons
do
not
have
private
Central
Ethics
Boards.
Provincial
review
boards
propose
that
sites
iden(fy
a
“lead
site”
to
coordinate
with
all
other
par(cipa(ng
sites.
As
you
can
see
by
these
flowcharts
it’s
a
complex
process.
That’s
why
it’s
so
cri(cal
to
have
the
right
team
on
the
ground
to
help
you
navigate
the
system
and
expedite
start-­‐up.

21. 21
Site
Contract
Strategy
sTart-up strategy
Scimega
model
Clinical
Trial
Agreement
Process
Our
model
CTA
is
US
biotech
friendly
(addressing
all
key
issues
such
as
IP,
indemnity,
ownership
and
obliga(ons),
and
it
has
been
nego(ated
and
approved
with
all
the
top
cancer
centers
in
Canada.
This
alleviates
the
administra(ve
burden
on
the
sites
and
removes
the
contract
signing
boDleneck,
thereby
expedi(ng
start-­‐up
which
leads
to
faster
FSO
and
First
Pa(ent
In.

22. 22
sTart-up strategy
Regulatory
Strategy
• Parallel
REB
/
Health
Canada
Review
(Ame
to
prepare
a
CTA:
1-­‐2
weeks)
• Having
the
right
contacts
at
Health
Canada
(official
/
unofficial
discussions)
• Knowing
when
to
hold
a
pre-­‐CTA
meeAng
and
when
to
avoid
it

23. Average
Site
Start-­‐Up
(me
in
Canada
36 weeks
Scimega
Site
Start-­‐Up
(me
using
Reverse
Feasibility
14 weeks
»
»
Why
do
some
trials
take
forever
to
start-­‐up
and
then
lag
behind
in
recruitment,
while
other
trials
just
seem
to
take
off?
We
found
that
what
truly
mo(vates
them
is
not
a
monetary
incen(ve,
but
rather
the
chance
to
par(cipate
in
cuing-­‐edge
science,
that
has
academic
merit
and
publica(on
opportuni(es.

25. Canadian Expansion
Success Stories

26. Phase
1
dose
finding
HER2+
BrCa
study
looking
at
oral
HER2
inhibitor
in
combina(on
with
T-­‐DM1
Trial
had
been
ongoing
for
6
months
at
7
sites
in
the
U.S.
Target
end
of
recruitment
by
July
2015
cAse study 1
Situation:

27. challenge reason Action taken
Slow
Enrolment
0.1
pts/month
Scarcity
of
comparator
arm
naïve
subjects
(comparator
drug
in
wide
use
in
US)
3x
Repeat
customer:
Came
to
Canada
aMer
last
study
was
completed
3
months
ahead
of
schedule
cAse study 1

28. Introduced
Sponsor
to
select
Reverse
Feasibility
Champions
Confirmed
Inves(gator
Interest
(comparator
arm
approved
but
not
yet
covered
for
2nd
line)
results
Iden(fied
5
sites
in
less
than
two
weeks
Selected
4
sites
Average
Start-­‐Up:
14
weeks
from
CPS
to
SI
Study
closed
to
enrolment
in
April
2015
1
2
3
cAse study 1 START-UP METRICS
4

29. Enrolment Performance
cAse study 1
SITES 33%
Canada
vs.
67%
US
Patients 55%
Canada
vs.
45%
US
CAN US CAN US

30. Thanks
to
the
Reverse
Feasibility
Program
and
Scimega’s
ability
to
aCract
perEnent
clinical
trials
to
Canada,
several
of
my
paEents
were
able
to
LIVE
significantly
longer.”
Dr. Cristiano ferrario
Montreal Jewish General hospital
“2015 reverse feasibility champion”

31. cAse study 2
Situation:
Sophis(cated
Phase
III
Immuno-­‐Oncology
study
in
mRCC
Global
trial
ongoing
for
14
months
Recruitment
at
risk
Minimize
logis(cal
complexity

32. challenge reason Action taken
cAse study 2
Slow
Enrolment
L o g i s ( c a l
C o m p l e x i t y
(required
fresh
tumor
sample
collec(on
and
access
to
leukapheresis
lab)
Site
Expansion
:
Were
told
by
exis(ng
CRO
that
Europe
was
the
op(on;
not
Canada
due
to
lack
of
PI
interest
&
sites
with
limited
capabili(es

33. Introduced
Sponsor
to
select
Reverse
Feasibility
Champions
Confirmed
Inves(gator
Interest
(comparator
arm
approved
but
not
yet
covered
for
2nd
line)
results
cAse study 2
Within
2
weeks
we
had
confirmed
6
sites
Sponsor
selected
top
5
sites
to
add
to
exisAng
four;
In
the
end
we
doubled
the
#
of
sites
in
Canada
Average
Start-­‐Up:
9.3
weeks
from
CPS
to
SIV
1
2
3
4
START-UP METRICS

34. Introduced
Sponsor
to
select
Reverse
Feasibility
Champions
Confirmed
Inves(gator
Interest
(comparator
arm
approved
but
not
yet
covered
for
2nd
line)
results
cAse study 2
Scimega
ExisAng
CRO
in
Canada
IRB
TYPE
Local
Local
#
sites
5
4
Time
from
CPS
–
IRBapp
7.8
weeks
14.1
weeks
Time
from
IRBapp
–
SIV
1.5
weeks
total:
9.3
weeks
18.7
weeks
total
:
32.8
weeks
START-UP METRICS

35. cAse study 2 Enrolment Performance

36. Scimega
managed
to
expedite
EC/IRB
regulatory
submissions
at
the
site
level,
and
did
it
much
faster
than
our
global
CRO.
They
are
nimble,
aDen(ve
and
have
an
experienced
oncology
team
that
can
handle
all
aspects
of
study
opera(ons
and
site
level
needs”
VP, Clinical and medical affairs

37. Subscribe to
our blog
to
follow
the
progress
of
ongoing
clinical
trials.
hDp://www.scimega.com/blog

38. disclaimer
While
some
ini(al
resistance
from
the
exis(ng
CROs
is
to
be
expected
it
is
nice
to
see
how
fast
their
study
teams
mesh
with
ours
and
how
quickly
they
appreciate
that
our
success
means
the
trial’s
success,
which
ul(mately
translates
into
their
own
success.
NO
U.S.
CROs
WERE
HARMED
DURING
THE
CONDUCT
OF
THESE
TRIALS.

39. Mobilizing an expert canadian
team significantly enhances
study start-up & overall
performance
conclusion

40. UPDATE ON
Patient 001 – ADC

41. PATIENT A.D.C
ALDO
DEL COL
Since
being
diagnosed
with
Mul(ple
Myeloma
in
2002,
Mr.
Del
Col
co-­‐founded
Myeloma
Canada,
the
only
non-­‐profit
organiza(on
uniquely
focused
on
the
needs
of
the
Canadian
myeloma
community.
Myeloma
Canada
works
with
regional
support
groups,
key
myeloma
experts
and
other
pa(ent
organiza(ons.
Their
Scien(fic
Advisory
Board
brings
together
Canada’s
leading
myeloma
inves(gators
and
clinicians
and
is
the
founda(on
of
the
Myeloma
Canada
Research
Network
(MCRN),
a
myeloma
study
group
that
ac(vated
its
first
clinical
trial
early
in
2012.

42. WHAT OUR CLIENTS ARE SAYING