Transcript MD Anderson: Innovation in the Current Environment

Personalized Medicine/
Diagnostics/ ChemicalComplex Ecosystems
Produce Various Strategies
Connecting IP with Products
and Services
AIPLA Mid-Winter Institute
January 31, 2013
Natalie Wright Curley, JD
Managing Director,
Office of Technology Commercialization
MD ANDERSON BACKGROUND
• Established in 1941 by the Texas State Legislature and
matching funds from Monroe Dunaway Anderson.
• One of the nation’s original three comprehensive
cancer centers designated by the National Cancer Act
of 1971.
• One of 41 National Cancer Institute-designated
comprehensive cancer centers .
• In 2011, MD Anderson marked its 70-year anniversary
and welcomed Ronald DePinho, M.D., as the fourth
full-time president in the institution's history.
• Ranked as the best hospital in the nation for cancer care
8 out of the past 10 years by US News and World
Report.
• Currently employs more than 19,000 people, including
1,600 faculty.
Our Mission
To eliminate cancer in Texas, the nation and the world through
outstanding programs that integrate patient care, research and
prevention, and through education for undergraduate and graduate
students, trainees, professionals, employees and
the public.
Patient Care • FY 2012
*115,000 patients seen, nearly 1/3 new patients
Hospital admissions
26,726
Hospital patient days
191,735
Average number of operating beds
Outpatient clinic visits, treatments and procedures
Pathology and laboratory medicine procedures
Diagnostic imaging procedures
Surgery hours
Active clinical research protocols
616
1,281,489
11,619,591
497,660
66,241
1,078
MD Anderson Locations
MD Anderson Cancer
Center Main Campus,
Houston, TX
Centro Oncológico MD Anderson
International España (Madrid, Spain)
MD Anderson Radiation
Treatment Center at
Presbyterian Kaseman
Hospital (Albuquerque,
NM)
Banner MD Anderson
Cancer Center (Gilbert, AZ)
MD Anderson Cancer
Center-Orlando (FL)
MD Anderson Radiation Treatment Center
in Istanbul at American Hospital (Turkey)
TEXAS
•
In addition to MD Anderson’s main campus in
the Texas Medical Center in Houston, multiple
regional care centers:
 Regional Care Center in the Bay Area
(Nassau Bay)
 Regional Care Center in Katy
 Regional Care Center in Sugar Land
 Regional Care Center in The Woodlands
• Two research campuses in Bastrop County,
Texas
Research funding • FY 2011
Federal grants and contracts
Private industry grants and contracts
$196,753,104
$68,413,794
Philanthropy and foundations
$100,794,491
Internal funding
$241,560,330
State funding
Total research funding
$40,019,178
$647,540,897
Of MD Anderson’s total revenue of $3.7 billion
in FY12, only 4.6% was general revenue
appropriated by the State of Texas.
Net Patient Revenue
Auxillary income
Other Income
Investment and other non-operating income
State-appropriated general revenue
Restricted grants and contracts, philanthropy
Sources of Revenue (in millions)
Office of Technology Commercialization
• Obtain invention disclosures from faculty;
• Evaluate for patentability and commercial
potential;
• Oversee patent drafting and prosecution;
• Out license discoveries for commercial
development and sale;
• Create new companies to commercialize
university technologies;
• Goal: generate revenue to contribute back to
mission!
Diagnostics on the Scene!
• Patient demand;
• Shorter time to market (especially compared to
those difficult therapeutic approvals!!!);
• Better technologies at cheaper costs;
• Money easy to get;
• Patient samples available.
Personalized Medicine!
As a result, we saw a surge in “diagnostic discoveries.”
Invention Disclosures (average 134/year)
Before 2010
After 2010
Therapeutics
Diagnostics
and Devices
Other
Therapeutics
Diagnostics
and Devices
Other
Hmmm….Diagnostic “Market” Issues
There is a need, BUT….
• Markers are changing and under debate.
• If new/better biomarkers are identified, how can these be validated
and included on an existing panel? Cost? Regulatory approval?
• Tests often stratified by disease type; diagnostic; prognostic;
predictive…not a one size fits all market.
• Regulatory uncertainty—not clear what the FDA will require.
• Patentability issue…Supreme Court ruling on Prometheus has cast
a cloud over the patentability of diagnostics in general; Myriad to be
heard by SC.
• Potential infringement of previously issued patents/FTO.
• Reimbursement not certain.
• Indicated course of treatment may still not be clear.
• Funding is difficult.
Diagnostic “Technology” Issues
CURRENT PRACTICE
Patient treated based on original biopsy
CHALLENGE
Patient outcome is determined by metastatic tumor
Does the primary tumor represent metastatic or
recurrent tumor?
Are there subclones in the primary tumor?
Are they selected by the metastatic process?
Does it matter?
Heterogeneity and Molecular Evolution
Primary
Assay
PTEN
PIK3CA
marked change
ER (38)
PR
HER2
Loss
10% (5/46)
8% (4/21)
8% (4/21)
7% (4/38)
12% (7/38)
2% (1/12)
Metastasis
Gain
15% (8/46)
8% (4/21)
12% (6/21)
0% (0/38)
3% (2/38)
2% (1/12)
*n=51 tumors and 56 metastases
Ana Gonzalez; Funda Meric; Kat Hale
Discordance
25%
16%
20%
7%
15%
4%
HETEROGENEITY: DO DIFFERENT SUBLCONES
METASTASIZE TO DIFFERENT SITES
Breast Cancer
PIK3CA (Exon 9/20 only)
48% discordance between
primary and metastasis
Example
Primary WT
Metastasis #1 H1047R
Metastasis #2 E542K
Deep sequencing of
primary tumor may
identify mutations
Jensen et al. 2011
E542K
Functionality
WHAT CLONE FREQUENCY MATTERS FOR PATIENT
OUTCOMES????
Drivers and passengers: Specific mutation matters
Functional genomics program
• How do we know which mutations are functional
drivers and which ones are noise? (More of a
problem as more genes are examined and we
expand to whole exome sequencing.)
• Current offerings only tell us which genes are
mutated, not which ones are functional.
Opportunities
HOW CAN WE DEVELOP A MODEL
THAT ADDRESSES THESE
ISSUES?????
•
•
•
•
•
Panels;
Functional information;
Better biopsy technologies;
Improved certainty from regulatory and legal/PTO landscape;
Reimbursement criteria/economics.