0
Fighting a Smarter War On Colon Cancer:
John L. Marshall, MD
Value as a new endpoint?
Tel: (202) 444-0275
Fax: (202) 444-1...
Stakeholder	
  Mo-va-on	
  
	
  
Stakeholders	
  
•  FDA	
  
•  CMS/Payers	
  
•  NCI/CTEP	
  
•  PhRMA	
  
•  Community	
...
Stakeholder	
  Mo-va-on	
  
	
  
Stakeholders	
  
•  FDA	
  
•  CMS/Payers	
  
•  NCI/CTEP	
  
•  PhRMA	
  
•  Community	
...
Worldwide	
  Cancers	
  Sta>s>cs	

F.	
  Bray	
  et	
  al,	
  Lancet	
  Oncol	
  2012;	
  13:	
  790–801	
  and	
  h"p://w...
Gastrointestinal (GI) Cancers Facts	

v GI cancers represent the most common and fatal cancers in the world
v 2009: 275,...
Breast Cancer Nation
Why Not Brown?
Value
Safety and
Efficacy
Our Current Model of Colon Cancer
Antoni van Leeuwenhoek
(1632-1723)
Invented the microscope
around 1668
10
The view from 35,000 feet
Everything looks the same from up here
What can we predict?
Standard	
  of	
  
Care	
   New	
  
Pa>ent	
  
Diagnosis	
  /	
  
staging	
  
Standard	
  
Chemotherapy	
  
Hope	
  for	
 ...
Cancer is driven by hyperactive or defective protein circuits
The components of these circuits contain the drug targets
of...
Ruesch	
  Symposia:	
  
•  2010 	
  Biomarkers:	
  Can	
  we	
  measure	
  them?	
  
•  2011 	
  Defining	
  Value	
  in	
 ...
Hypothesis	
  
Prospec>ve	
  incorpora>on	
  of	
  
molecular	
  profiling	
  will	
  
transform	
  global	
  cancer	
  car...
Personalized	
  
Medicine	
  
New	
  
Pa>ent	
  
Diagnosis	
  
/	
  staging	
  
HER2 ↑
TS ↓
TOP1 ↑
KRAS ↑
ERCC1 ↓
SPARC ↑
...
GI	
  Cancer	
  
Pa>ents	
  
Smart Centers
Profile	
  All	
  
Treatment	
  
Outcomes	
  
Unified	
  
CRF/EMR	
  
BioBank	
  ...
Fundamental	
  Shies	
  In	
  Cancer	
  Care	
  
Yesterday	
  
• Consump>on	
  
• Individual	
  Prac>ces	
  
• Rich	
  Cou...
Call on Congress 2014 John Marshall, Treatment
Call on Congress 2014 John Marshall, Treatment
Call on Congress 2014 John Marshall, Treatment
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Call on Congress 2014 John Marshall, Treatment

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Treatment: It’s no longer “one size fits all”
John Marshall, MD, Georgetown University Medical Center

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Transcript of "Call on Congress 2014 John Marshall, Treatment"

  1. 1. Fighting a Smarter War On Colon Cancer: John L. Marshall, MD Value as a new endpoint? Tel: (202) 444-0275 Fax: (202) 444-1229 http://lombardi.georgetown.edu/GI
  2. 2. Stakeholder  Mo-va-on     Stakeholders   •  FDA   •  CMS/Payers   •  NCI/CTEP   •  PhRMA   •  Community  Onc   •  Academic  Onc   •  Pa>ents   Priority/Agenda   •  Safety  and  Efficacy   •  Cost  Control/Value   •  Cure  Cancer   •  Markets,  ROI   •  Efficient/Quality  Care   •  Clinical  Trial  Accrual   •  Cure/Benefit/Altruism  
  3. 3. Stakeholder  Mo-va-on     Stakeholders   •  FDA   •  CMS/Payers   •  NCI/CTEP   •  PhRMA   •  Community  Onc   •  Academic  Onc   •  Pa>ents   Priority/Agenda   •  Safety  and  Efficacy   •  Cost  Control/Value   •  Cure  Cancer   •  Markets,  ROI   •  Efficient/Quality  Care   •  Clinical  Trial  Accrual   •  Cure/Benefit/Altruism  
  4. 4. Worldwide  Cancers  Sta>s>cs F.  Bray  et  al,  Lancet  Oncol  2012;  13:  790–801  and  h"p://www.cancer.org/aboutus/globalhealth.       2030  values  are  es>mated    using  projected  incidence  and  mortality  rates    from  2008  to  2030  and   weigh>ng  for  prevalence  in  developed  compared  to  developing  countries.   GI   2008   0   1000000   2000000   3000000   4000000   5000000   6000000   7000000   0   1000000   2000000   3000000   4000000   5000000   6000000   7000000   2030   Breast   Prostate   Lung   Lung   Prostate   Breast   GI  
  5. 5. Gastrointestinal (GI) Cancers Facts v GI cancers represent the most common and fatal cancers in the world v 2009: 275,720 new diagnosis of GI Cancers and 135,830 deaths in the US alone v Anal Cancer v Colorectal Cancer v Esophageal Cancer v Gallbladder Cancer v Liver Cancer v Pancreatic Cancer v Small Intestine Cancer v Stomach/Gastric Cancer v No two cancers are alike and treatments must be selected based on an individual’s tumor characteristics, by personalized medicine
  6. 6. Breast Cancer Nation
  7. 7. Why Not Brown?
  8. 8. Value Safety and Efficacy
  9. 9. Our Current Model of Colon Cancer
  10. 10. Antoni van Leeuwenhoek (1632-1723) Invented the microscope around 1668 10
  11. 11. The view from 35,000 feet Everything looks the same from up here
  12. 12. What can we predict?
  13. 13. Standard  of   Care   New   Pa>ent   Diagnosis  /   staging   Standard   Chemotherapy   Hope  for   the  best   30%  chance   of    any   response  
  14. 14. Cancer is driven by hyperactive or defective protein circuits The components of these circuits contain the drug targets of the future. Patient A Patient B Each patient’s cancer is different. A drug that works for one patient may not work for another patient with the same cancer.
  15. 15. Ruesch  Symposia:   •  2010  Biomarkers:  Can  we  measure  them?   •  2011  Defining  Value  in  Cancer   •  2012  Clinical  Research:  Engaging  the  97%   •  2013  Molecular  Profiling:Research/ Prac>ce  
  16. 16. Hypothesis   Prospec>ve  incorpora>on  of   molecular  profiling  will   transform  global  cancer  care  
  17. 17. Personalized   Medicine   New   Pa>ent   Diagnosis   /  staging   HER2 ↑ TS ↓ TOP1 ↑ KRAS ↑ ERCC1 ↓ SPARC ↑ B-RAF ↑ PGP ↓ CURE? Targeted   Therapy   Personalized   Therapy   ↑   Response   Molecular-­‐   Tailored   Therapy  
  18. 18. GI  Cancer   Pa>ents   Smart Centers Profile  All   Treatment   Outcomes   Unified   CRF/EMR   BioBank   Team   Central   Imaging   Central   Consent   Data  Cloud:    Shared  &  IP  Protected     Managed  by  DSM,   STATS    HIPPA  compliant,   Regulatory Review Cancer   Centers   Profilers   Pharma  +   Guidelines  
  19. 19. Fundamental  Shies  In  Cancer  Care   Yesterday   • Consump>on   • Individual  Prac>ces   • Rich  Countries   • Microscope   • Safety  and  Efficacy   • Large  trials   • 1.4  months   • QOL   • Pa>ent  as  a  “Subject”   • Chao>c  Data  Collec>on   • Ins>tu>onal  IRBs   • Na>onal  Approvals   Tomorrow   • Outcomes   • Healthcare  Systems   • All  Countries   • Gene  Profile   • Value   • Small  trials   • “Substan>al  Improvement”   • Pa>ent  Reported  Outcomes   • Pa>ent  as  a  “Partner”   • Standard  Data  Collec>on   • Central/Na>onal  IRBs   • Global  Approvals  
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