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What your cro doesn’t
Know could hurt you
How to leverage Canada
for Study Expansion &
Recruitment
Patient 001 – ADC
This	
  pa(ent	
  was	
  diagnosed	
  with	
  Mul(ple	
  
Myeloma	
  in	
  2002.	
  A	
  pharmacist	
  b...
It’s	
  stories	
  like	
  these	
  that	
  give	
  meaning	
  to	
  what	
  we	
  do	
  and	
  why	
  we	
  are	
  
so	
 ...
A	
  Look	
  Under	
  The	
  Hood	
  of	
  the	
  
Reverse	
  Feasibility	
  Program	
  
	
  	
  -­‐	
  REB	
  Strategy	
 ...
The	
  Reverse	
  	
  
Feasibility	
  Program	
  Est. 2008
What are
investigators
looking for?
The	
  ques(ons	
  we	
  seek	
  to	
  answer	
  oMen	
  revolve	
  around	
  how	
  w...
Why	
  some	
  trials	
  just	
  seem	
  to	
  run	
  
by	
  themselves?	
  
	
  ?
Why	
  some	
  inves(gators	
  just	
  ...
sTEP 1a
Con(nuous	
  survey	
  of	
  Canadian	
  
inves(gator	
  needs	
  and	
  interests	
  
	
  
	
  
We	
  start	
  by...
Engagement	
  and	
  input	
  from	
  
pa(ent	
  advocacy	
  groups	
  sTEP 1b
1csTEP Find	
  U.S.	
  biotech	
  sponsors	
  in	
  need	
  
of	
  oncology	
  study	
  expansion.	
  
	
  	
  
	
  
Once	...
2sTEP Sponsor	
  compounds/studies	
  
matched	
  to	
  needs	
  of	
  Canadian	
  sites	
  
	
  
	
  
Once	
  a	
  match	...
3sTEP Approach	
  select	
  sites	
  with	
  summary	
  
of	
  criteria	
  
	
  
	
  
We	
  execute	
  a	
  mutual	
  CDA	...
4sTEP
Introduce	
  sponsor	
  to	
  sites	
  and	
  
discuss	
  viability	
  &	
  feasibility	
  
	
  
	
  
Once	
  we	
  ...
5sTEP Iden(fy	
  best	
  fit	
  sites	
  
	
  
	
  
We	
  typically	
  iden(fy	
  more	
  sites	
  than	
  
are	
  required...
6sTEP Start-­‐up	
  &	
  FPI	
  (first	
  pa(ent-­‐in)	
  
	
  
	
  
The	
  proof	
  is	
  in	
  the	
  start-­‐up	
  and	
...
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	
  ha...
21	
  
Site	
  Contract	
  Strategy	
  
sTart-up strategy
Scimega	
  model	
  Clinical	
  Trial	
  Agreement	
  Process	
 ...
22	
  
sTart-up strategy
Regulatory	
  Strategy	
   •  Parallel	
  REB	
  /	
  Health	
  Canada	
  Review	
  
(Ame	
  to	
...
Average	
  Site	
  Start-­‐Up	
  
(me	
  in	
  Canada	
  
36 weeks
Scimega	
  Site	
  Start-­‐Up	
  (me	
  
using	
  Rever...
Canadian Expansion
Success Stories
Phase	
  1	
  dose	
  finding	
  HER2+	
  BrCa	
  study	
  looking	
  at	
  oral	
  
HER2	
  inhibitor	
  in	
  combina(on	...
challenge reason Action taken
Slow	
  Enrolment	
  
0.1	
  pts/month	
  
Scarcity	
  of	
  comparator	
  
arm	
  naïve	
  ...
Introduced	
  Sponsor	
  to	
  select	
  Reverse	
  Feasibility	
  Champions	
  
	
  
Confirmed	
  Inves(gator	
  Interest	...
Enrolment Performance
cAse study 1
SITES 33%	
  Canada	
  vs.	
  67%	
  US	
   Patients 55%	
  Canada	
  vs.	
  45%	
  US	...
Thanks	
  to	
  the	
  Reverse	
  Feasibility	
  
Program	
  and	
  Scimega’s	
  ability	
  to	
  
aCract	
  perEnent	
  c...
cAse study 2
Situation:
Sophis(cated	
  Phase	
  III	
  Immuno-­‐Oncology	
  study	
  in	
  mRCC	
  
	
  
Global	
  trial	...
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	
...
Introduced	
  Sponsor	
  to	
  select	
  Reverse	
  Feasibility	
  Champions	
  
	
  
Confirmed	
  Inves(gator	
  Interest	...
Introduced	
  Sponsor	
  to	
  select	
  Reverse	
  Feasibility	
  Champions	
  
	
  
Confirmed	
  Inves(gator	
  Interest	...
cAse study 2 Enrolment Performance
Scimega	
  managed	
  to	
  expedite	
  
EC/IRB	
  regulatory	
  submissions	
  at	
  
the	
  site	
  level,	
  and	
  did...
Subscribe to
our blog
to	
  follow	
  the	
  progress	
  of	
  
ongoing	
  clinical	
  trials.	
  	
  
hDp://www.scimega.c...
disclaimer
While	
  some	
  ini(al	
  resistance	
  from	
  the	
  
exis(ng	
  CROs	
  is	
  to	
  be	
  expected	
  it	
 ...
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	...
WHAT OUR CLIENTS ARE SAYING
What Your CRO Doesn't Know Could Hurt You
What Your CRO Doesn't Know Could Hurt You
What Your CRO Doesn't Know Could Hurt You
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

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In this presentation, you'll get answers to these important questions that are having a big impact on improving oncology clinical trial performance in Canada. You will also see some real life stories about how the Reverse Feasibility Program is impacting patient outcomes:

1. How knowledge & relationships at Health Canada can remove bottlenecks and speed up the regulatory process;
2. How you can navigate ethics review boards more efficiently;
3. How a Master CTA template is speeding up site contract negotiations

Published in: Health & Medicine

What Your CRO Doesn't Know Could Hurt You

  1. 1. What your cro doesn’t Know could hurt you How to leverage Canada for Study Expansion & Recruitment
  2. 2. 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.    
  3. 3. 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:
  4. 4. 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
  5. 5. The  Reverse     Feasibility  Program  Est. 2008
  6. 6. 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!      
  7. 7. 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…  
  8. 8. 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.    
  9. 9. Engagement  and  input  from   pa(ent  advocacy  groups  sTEP 1b
  10. 10. 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.    
  11. 11. 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.    
  12. 12. 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.    
  13. 13. 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.    
  14. 14. 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.    
  15. 15. 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.      
  16. 16. 18  
  17. 17. Knowing investigators Isn’t enough What   else   drives   Reverse   Feasibility  Performance?      
  18. 18. 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.    
  19. 19. 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.        
  20. 20. 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  
  21. 21. 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.      
  22. 22. Canadian Expansion Success Stories
  23. 23. 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:
  24. 24. 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
  25. 25. 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
  26. 26. Enrolment Performance cAse study 1 SITES 33%  Canada  vs.  67%  US   Patients 55%  Canada  vs.  45%  US   CAN US CAN US
  27. 27. 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”
  28. 28. 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  
  29. 29. 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  
  30. 30. 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
  31. 31. 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
  32. 32. cAse study 2 Enrolment Performance
  33. 33. 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
  34. 34. Subscribe to our blog to  follow  the  progress  of   ongoing  clinical  trials.     hDp://www.scimega.com/blog  
  35. 35. 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.      
  36. 36. Mobilizing an expert canadian team significantly enhances study start-up & overall performance conclusion
  37. 37. UPDATE ON Patient 001 – ADC
  38. 38. 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.    
  39. 39. WHAT OUR CLIENTS ARE SAYING

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