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Call on Congress 2014 John Marshall, Treatment

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Treatment: It’s no longer “one size fits all” …

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

Published in: Health & Medicine

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  • 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. 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. 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. 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. 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. Breast Cancer Nation
  • 7. Why Not Brown?
  • 8. Value Safety and Efficacy
  • 9. Our Current Model of Colon Cancer
  • 10. Antoni van Leeuwenhoek (1632-1723) Invented the microscope around 1668 10
  • 11. The view from 35,000 feet Everything looks the same from up here
  • 12. What can we predict?
  • 13. Standard  of   Care   New   Pa>ent   Diagnosis  /   staging   Standard   Chemotherapy   Hope  for   the  best   30%  chance   of    any   response  
  • 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. 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. Hypothesis   Prospec>ve  incorpora>on  of   molecular  profiling  will   transform  global  cancer  care  
  • 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. 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. 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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