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Call on Congress 2014 John Marshall, Treatment
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
13. Standard
of
Care
New
Pa>ent
Diagnosis
/
staging
Standard
Chemotherapy
Hope
for
the
best
30%
chance
of
any
response
14.
15.
16. 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.
17. 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
20. 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
21. 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