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What your cro doesn’t
Know could hurt you
How to leverage Canada
for Study Expansion &
Recruitment
What Your CRO Doesn't Know Could Hurt You
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.	
  	
  
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:
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
What Your CRO Doesn't Know Could Hurt You
The	
  Reverse	
  	
  
Feasibility	
  Program	
  Est. 2008
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!	
  	
  
	
  
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…	
  
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.	
  
	
  
Engagement	
  and	
  input	
  from	
  
pa(ent	
  advocacy	
  groups	
  sTEP 1b
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.	
  
	
  
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.	
  
	
  
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.	
  
	
  
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.	
  
	
  
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.	
  
	
  
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	
  
Knowing
investigators
Isn’t enough
What	
   else	
   drives	
   Reverse	
  
Feasibility	
  Performance?	
  	
  
	
  
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	
  
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	
  
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	
  
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.	
  	
  
	
  
What Your CRO Doesn't Know Could Hurt You
Canadian Expansion
Success Stories
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:
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
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
Enrolment Performance
cAse study 1
SITES 33%	
  Canada	
  vs.	
  67%	
  US	
   Patients 55%	
  Canada	
  vs.	
  45%	
  US	
  
CAN US CAN US
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”
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	
  
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	
  
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
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
cAse study 2 Enrolment Performance
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
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  the	
  progress	
  of	
  
ongoing	
  clinical	
  trials.	
  	
  
hDp://www.scimega.com/blog	
  
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.	
  	
  
	
  
Mobilizing an expert canadian
team significantly enhances
study start-up & overall
performance
conclusion
UPDATE ON
Patient 001 – ADC
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.	
  	
  
WHAT OUR CLIENTS ARE SAYING
What Your CRO Doesn't Know Could Hurt You
What Your CRO Doesn't Know Could Hurt You

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What Your CRO Doesn't Know Could Hurt You

  • 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.      
  • 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
  • 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