throbber
100
`
`90
`
`80
`
`70
`
`60
`
`50
`
`40
`
`30
`
`20
`
`10
`
`0
`
`100
`
`92
`
`78
`
`55
`
`30
`
`0
`
`10
`
`0
`
`20
`
`0
`
`10
`
`30
`
`10
`
`20
`
`40
`
`20
`
`30
`
`50
`
`30
`
`40
`
`60
`
`40
`
`50
`
`70
`
`50
`
`60
`
`80
`
`60
`
`70
`
`90 100
`70
`
`80
`
`80
`90 100
`
`90 100
`
`2005 Fact Book
`
`National Cancer Institute
`
`U.S. DEPARTMENT
`OF HEALTH AND
`HUMAN SERVICES
`National Institutes
`of Health
`
`NOVARTIS EXHIBIT 2110
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`

`2005 Fact Book
`
`National Cancer Institute
`
`U.S. DEPARTMENT
`OF HEALTH AND
`HUMAN SERVICES
`National Institutes
`of Health
`
`NOVARTIS EXHIBIT 2110
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`

`

`The information set forth in this publication is
`compiled and amended annually by the financial
`management staff of the National Cancer Institute
`and is intended primarily for use by members of the
`Institute, principal advisory groups to the Institute
`and others involved in the administration and
`management of the National Cancer Program.
`Questions regarding any of the information contained
`herein may be directed to the Financial Management
`Branch, National Cancer Institute, 9000 Rockville
`Pike, Bethesda, Maryland, 20892.
`
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`
`Executive Summary
`
`Organization
`
`
`
`
`
`Cancer Statistics
`
`
`
`
`
`
`Budget Data
`
`TABLE OF CONTENTS
`Fiscal Year 2005 Annual Report.......................................................iii
`
`
`
`Director's Biography...................................................................... O-1
`Former Directors of the NCI.......................................................... O-2
`National Cancer Advisory Board................................................... O-3
`Boards of Scientific Counselors and Advisors .............................. O-7
`President's Cancer Panel ............................................................. O-8
`Executive Committee Members.................................................... O-8
`NCI Director’s Consumer Liaison Group....................................... O-9
`Organization Charts:
`National Cancer Institute ......................................................... .O-10
`Office of the Director................................................................. O-11
` OD I: Office of Management .................................................. O-12
` OD II: Office of the Deputy Director ........................................ O-13
` OD II: Center for Strategic Scientific Initiatives....................... O-13
` OD II: Office of Education and Special Initiatives ................... O-13
` OD III: Office of Centers, Training and Resources ................. O-14
` OD IV: Center to Reduce Cancer Health Disparities .............. O-15
` OD IV: Office of Budget and Financial Management.............. O-15
` OD IV: Office of Science Planning and Assessment .............. O-15
` OD IV: Office of Communication………………………………...O-15
` Center for Cancer Research……………………………………... O-16
` Division of Cancer Epidemiology and Genetics........................ O-18
`Division of Cancer Prevention................................................... O-19
`Division of Cancer Control and Population Sciences................ O-20
`Division of Cancer Treatment and Diagnosis............................ O-21
`Division of Cancer Biology........................................................ O-22
`Division of Extramural Activities................................................ O-23
`
`Number of Deaths for the Five Leading Cancer Sites .................. C-1
`Relationship of Cancer to the Leading Causes of Death
` in the U.S.. .................................................................................. C-1
`Estimated New Cancer Cases and Deaths................................... C-2
`The Cost of Cancer....................................................................... C-3
`Average Years of Life Lost Per Person Dying of Cancer.............. C-4
`Five-Year Relative Survival Rates by Cancer Site........................ C-5
`Cancer Incidence Rates ............................................................... C-6
`Cancer Mortality Rates Changes from 1992 to 2003.................... C-7
`Cancer Incidence Rates by Race ................................................. C-8
`Cancer Mortality Rates by Race ................................................... C-9
`The Prevalence of Cancer .......................................................... C-10
`
`NCI Budget ....................................................................................B-1
`Program Structure .........................................................................B-2
`Extramural Funds ..........................................................................B-3
`NCI Obligations by Mechanism......................................................B-4
`Division Obligations by Mechanism ...............................................B-5
`NIH Management Fund, Service & Supply Fund and GSA Rent...B-6
`Special Sources of Funds..............................................................B-7
`
`
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`Funding for Various Research Areas.............................................B-8
`Extramural Programs Research Project Grants:
`Number of Awards .......................................................................E-1
`Requested, Awarded ...................................................................E-2
`Awards by Activity Code ..............................................................E-3
`Activity Code Descriptions ...........................................................E-4
`Cancer Centers
`By State .......................................................................................E-5
`Specialized Programs of Research Excellence (SPORE) ...........E-6
`National Research Service Awards – Pre and Post Doctoral
` Trainees.......................................................................................E-7
`Construction/Renovation Funding..................................................E-8
`Grant and Contract Awards by State .............................................E-9
`Grant and Contract Awards by Country.......................................E-10
`Institutions Receiving More than $15,000,000 in NCI Support ....E-11
`
`Appropriations of the NCI ............................................................. H-1
`Bypass Budget Requests ............................................................. H-2
`Comparison of Bypass Requests and Appropriations of the NCI . H-3
`Comparison of Dollars, Positions and Space................................ H-4
`Personnel Resources ................................................................... H-5
`AIDS Funding History ................................................................... H-6
`
`
`
`
`
`
`Historical Trends
`
`
`
`This publication may be viewed on the World Wide Web by pointing a browser to the Financial
`Management Branch homepage on the National Cancer Institute’s website: www.nci.nih.gov or
`www.cancer.gov.
`
`
`
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`
`Executive Summary
`
`
`
`
`
`Fiscal Year 2005 Annual Report
`
`BUDGET IN REVIEW
`
`
`This report provides a summary of the distribution of the Fiscal Year 2005 budget among the various
`National Cancer Institute (NCI) research programs and funding mechanisms, funding policies
`influencing grant awards, and comparisons with prior year allocations. Additional information on the
`NCI budget is accessible from the NCI Home Page (http://www.cancer.gov).
`
`Summary
`Funds available to the NCI in FY 2005 totaled over $4.795 billion, reflecting an increase of 1.5% and
`$71 million over the previous fiscal year.
`
`Fiscal highlights from FY 2005 include:
`• Of the total NCI budget, 46% of the funds were allocated for Research Project Grants.
`• The total number of Research Project Grants (RPGs) funded was 5,412.
`• One-fifth of the RPGs awarded were new (Type 1) or competing renewal (Type 2) awards.
`• 1,292 competing RPG’s were funded.
`• Approximately 32% of the total NCI budget supported ongoing non-competing (Type 5) RPGs.
`• R01 grants were funded to the 16th percentile.
`• 265 grants – totaling nearly $98 million – were funded as Small Business Innovation Research
`(SBIR) and Small Business Technology Transfer (STTR) awards.
`Intramural Research was just under 15% of the total NCI budget in FY 2005.
`•
`• $532 million – over 11% of the total NCI budget – was allocated for Cancer Prevention &
`Control.
`
`
`
`
`
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`
`Distribution of the Budget by Funding Mechanism for FY 2004 and FY 2005
`
`
`Summary Points
`
`Of the $71 million increase:
`• Nearly all of the increase – or $67 million – was allocated for the Research Grants budget
`mechanisms.
`• $29 million – or 39% of the increase – was provided to the Research Project Grant (RPG)
`category.
`• Within the RPG category, competing grants and administrative supplemental grants decreased
`by $58 million and the non-competing grants increased by $87 million.
`• Funds for training and career development of current and future research scientists through
`Research Career Awards grew by 3%; Career Education funding increased by 7%.
`• The total budget for Cancer Centers, Specialized Centers (U54) and SPOREs increased by
`11%.
`• Specialized cancer centers include two new programs for FY2005. The Transdisciplinary
`Research on Energetics and Cancer (TREC) and the Nanotechnology Alliance.
`• Clinical Cooperative Groups and R&D contracts decreased by 8% and 3%, respectively.
`• During FY 2005, NIH and DHHS Assessments increased a total of $19 million, including a $11
`million increase for Program Evaluation, a $10 million increase for the Management Fund, a $3
`million reduction in other assessments including ORS Security, and a $1 million increase for IT
`Assessments.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`NCI Dollars by Mechanism for FY 2004 and 2005
`(in thousands)
`
`Research Project Grants:
`Noncompeting
`Admin Supplements
`Competing
`
`Subtotal, RPG
`
`SBIR/STTR
`
`Total, RPG
`
`Cancer Centers
`Specialized Cancer Centers (U54)
`SPOREs
` Total: Centers, Spec Ctrs, U54s & SPOREs
`Research Career Program
`Cancer Education
`Clinical Cooperative Groups
`Other Grants
`
` Subtotal, Other
` Total, Research Grants
`National Research Service Awards
`R&D Contracts
`Intramural Research
`Research Management & Support
`Cancer Prevention & Control
`Construction
`Buildings and Facilities
`
` Total, NCI
`AIDS research included above
`
`2004
`
`2005
`
`$1,513,234
`54,543
`494,003
`2,061,780
`99,579
`2,161,359
`245,761
`28,640
`134,887
`409,288
`74,207
`32,214
`154,357
`54,138
`314,916
`2,885,563
`66,264
`361,569
`708,939
`171,578
`529,980
`0
`0
`4,723,893 *
`[$263,442]
`
`$1,600,585
`50,655
`439,870
`2,091,110
`97,775
`2,188,885
`255,263
`65,964
`133,025
`454,252
`76,652
`34,581
`142,847
`54,891
`308,971
`2,952,108
`67,299
`351,056
`711,009
`173,702
`531,634
`0
`7,936
`4,794,744 *
`[$265,907]
`
`Change '04-05
`Am't
`
`%
`
`$87,351
`-3,888
`-54,133
`29,330
`-1,804
`27,526
`9,502
`37,324
`-1,862
`44,964
`2,445
`2,367
`-11,510
`753
`-5,945
`66,545
`1,035
`-10,513
`2,070
`2,124
`1,654
`0
`7,936
`70,851
`[$2,465]
`
`5.8%
`-7.1%
`-11.0%
`1.4%
`-1.8%
`1.3%
`3.9%
`130.3%
`-1.4%
`11.0%
`3.3%
`7.3%
`-7.5%
`1.4%
`-1.9%
`2.3%
`1.6%
`-2.9%
`0.3%
`1.2%
`0.3%
`0.0%
`
`1.5%
`0.9%
`
`* Does not include $3.5 million in FY2004 and $2.9 million in FY2005 obligated by the NCI from funds collected thru the sale of the Breast
`Stamp by the U.S. Postal Service.
`
`
`
`
`
`
`
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`

`Summary Points
`
`
`Percent Share of Total NCI Dollars
`
`
`
`
`
`
`
`
`
`
`
`• The mechanism shares of the total budget have remained relatively stable from FY 2001 to FY
`2005.
`Intramural Research has dropped to under 15% of total NCI dollars.
`
`•
`
`
`Research Project Grants
`Cancer Centers
`Specialized Centers
`SPOREs
`Clinical Cooperative Groups
`Intramural Research
`R&D Contracts
`Cancer Prevention & Control
`Other Mechanisms
`
`Percent Share of Total NCI Dollars
`2005
`2004
`2001
`2002
`2003
`45.2% 45.3% 44.8% 45.8% 45.6%
`5.1% 5.0% 5.1% 5.2% 5.3%
`0.3% 0.4% 0.4% 0.6% 1.4%
`2.0% 2.3% 2.7% 2.9% 2.8%
`4.1% 3.9% 3.5% 3.3% 3.0%
`15.1% 15.3% 15.1% 15.0% 14.8%
`7.6% 7.1% 8.1% 7.7% 7.3%
`12.2% 12.0% 11.6% 11.2% 11.1%
`8.4% 8.7% 8.6% 8.3% 8.7%
`
`National Cancer Institute
`FY 2005
`Actual Obligations by Mechanism
`$4,794,744
`($'s in Millions)
`
`Cancer Prevention & Control
`$531.6
`
`Other Mechanisms
`$164.7
`
`Research Management &
`Support
`$173.7
`
`Intramural Research
`$711.0
`
`R&D Contracts
`$351.1
`
`Research Project Grants
`$2,188.9
`
`Clinical Cooperative Groups
`$142.8
`
`Research Career Program
`$76.7
`
`Cancer Centers, Spec Ctrs, and
`SPOREs
`$454.3
`
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`
`Summary Points
`
`
`
`Funding Trends
`
`
`
`
`
`
`
`• The NCI budget has increased by $1.04 billion – or 28% – since FY 2001.
`All mechanisms, except for Research Project Grants, Intramural Research, Clinical
`Cooperative Groups, and Cancer Prevention & Control have experienced percentage
`increases greater than the total NCI growth since FY 2001.
`
`Historical Funding Trends
`(Dollars in Millions)
`2005
`2004
`2003
`2001
`2002
`$3,753.7 $4,176.7 $4,592.3 $4,723.9 $4,794.8
`1,696.6
`1,893.2
`2,058.7
`2,161.4
`2,188.9
`567.3
`637.6
`693.1
`708.9
`711.0
`192.1
`208.0
`235.8
`245.7
`255.3
`10.7
`16.8
`19.2
`14.2
`66.0
`76.8
`94.9
`123.1
`149.4
`133.0
`154.3
`163.8
`158.7
`154.3
`142.8
`459.5
`501.2
`533.2
`530.0
`531.6
`284.0
`298.2
`370.8
`361.6
`351.1
`312.3
`363.0
`399.7
`398.4
`415.1
`
`
`Total NCI
`Research Project Grants
`Intramural Research
`Cancer Centers
`Specialized Centers
`SPOREs
`Clinical Cooperative Groups
`Cancer Prevention & Control
`R&D Contracts
`Other Mechanisms
`
`
`
`
`Total NCI
`Research Project Grants
`Intramural Research
`Cancer Centers
`Specialized Centers
`SPOREs
`Clinical Cooperative Groups
`Cancer Prevention & Control
`R&D Contracts
`Other Mechanisms
`
`% Growth by Mechanism
`
`
`
`2002 to
`2001 to
`2003
`2002
`11.3% 10.0%
`11.6%
`8.7%
`12.4%
`8.7%
`8.3% 13.4%
`57.0% 13.7%
`23.4% 29.9%
`6.2%
`-3.1%
`9.1%
`6.4%
`5.0% 24.3%
`16.2% 10.1%
`
`
`
`2003 to 2004 to 2001 to
`2004
`2005
`2005
`2.9%
`1.5%
`27.7%
`5.0%
`1.4%
`29.0%
`2.3%
`0.3%
`25.3%
`4.2%
`3.9%
`32.9%
`-26.0% 365.0%
`516.8%
`9.5%
`-1.4%
`73.2%
`-2.7%
`-7.5%
`-7.5%
`-0.6%
`0.3%
`15.7%
`-2.5%
`-2.9%
`23.6%
`-0.4%
`2.2%
`32.9%
`
`
`
`
`
`
`
`
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`

`Summary Points
`
`
`Research Project Grants
`
`
`• 89% of competing dollars supported grants awarded within the established payline; 11%
`supported grants as an exception to the payline.
`• RFA funds, which increased from the FY 2004 dollar level, accounted for 10% of FY 2005
`competing dollars.
`• Research Project Grant applications submitted to NCI increased by approximately 3%.
`• 1,292 competing RPG’s were funded.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Research Project Grants
`(Dollars in Thousands)
`
`
`
`2004*
`Amount
`No.
`5,467 $2,161,359
`397
`$99,579
`5,070 $2,061,780
`3,578 $1,454,513
`1,492
`$494,003
`$54,543
`$58,721
`
`
`
`
`1,375
`886
`33
`67
`
`118
`
`
`
`
`
`
`
`
`
`
`
`
`6,148 $2,279,782
`24.30%
`20th
`
`
`
`
`
`
`
`
`Total funding for RPGs
`
`SBIR/STTR
`
`Funding for RPGs without SBIR/STTR Program
`
`Continuation or noncompeting grants funded
`
`Competing grants funded
`
`Administrative Supplements
`
`Partial assessment for DHHS Program Evaluation
`
`
`
`Funds set aside within competing dollars for:
`
`$448,654
`Grants within Paylines:
`
`$290,361
` Traditional R01
`
`$52,049
` Program Projects (P01)
`
`$41,848
` RFA Grants
`8.47%
` Share of competing grant funds
`$45,349
`
`Exception Grants
`9.18%
` Share of competing grant funds
`
`
`
`6,325 $2,489,515
`
`Competing Application Requests
` 20.40%
`
`Funding Success Rate
` 16th
`
`Percentile funding for R01 grants
`
`
`$331
`
`Average Cost-Competing
`-15%
`
`Average Reduction from recommended/requested levels
`
`
`
`
`
`
`
`
`
`
`*Does not include $3.5 million received by the NCI from the US Postal Service’s sale of the Breast Cancer Stamp.
`**Does not include $2.9 million received by the NCI from the US Postal Service’s sale of the Breast Cancer Stamp.
`
`
`2005**
`Amount
`No.
`5,412 $2,188,885
`265
`$97,775
`5,147 $2,091,110
`3,855 $1,651,239
`1,292
`$439,871
`292
`$50,655
`$58,721
`
`
`
`
`1,154
`704
`38
`92
`
`138
`
`$392,692
`$226,797
`$65,273
`$44,568
`10.13%
`$47,179
`10.73%
`
`
`
`
`
`
`
`
`
`
`
`
`$340
`-22%
`
`
`
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`
`
`
`
`
`
`
`
`Grant Funding Paylines
`
`
`
`
`
`
`
`
` 2005
`RPG Mechanisms:
`
`
`R01 Traditional Grants
` 16th
` percentile
`
`P01 Program Projects
` N/A*
` priority score
`
`R03 Small Grants
` 210
` priority score
`
`R21 Exploratory Phase I
` 175
` priority score
`R33 Exploratory Phase II
` 160
` priority score
`
`R41/R42 STTR
` 185
` priority score
`
`R43/R44 SBIR
` 190
` priority score
`
`
`
`
`
`
`
`* Formal paylines for P01 grants are determined by the Executive Committee
`
`2004
`20th
`N/A*
`225
`166
`155
`232
`220/210
`
`National Cancer Institute
`FY 2005
`% Share of Total RPG Funds
`
`Program
`Evaluation,
`2.7%
`
`Other, 3.4%
`
`SBIR/STTR,
`4.6%
`
`R33, 2.0%
`R21, 3.6%
`R03, 0.8%
`
`RFA, 7.8%
`
`P01, 15.9%
`
`R01, 59.2%
`
`
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`
`
`
`
`
`
`
`
`National Cancer Institute
`Extramural vs. Inhouse Funding
`($'s in millions)
`
`Extramural
`2005
`2004
`2003
`2002
`2001
`$1,696.60 $1,893.20 $2,058.70 $2,161.40 $2,188.90
`192.1
`208
`235.8
`245.7
`255.3
`10.7
`16.8
`19.1
`14.1
`66
`76.8
`94.8
`123.1
`134.8
`133
`269.2
`304.1
`320.3
`314.9
`309
`57.9
`63.7
`65.9
`66.2
`67.3
`284
`298.2
`370.8
`361.6
`351.1
`183.7
`208.2
`221.6
`220
`232
`126.1
`135.9
`160
`153
`145.8
`3
`5
`5
`0
`0
`0
`0
`0
`0
`7.9
`2,900.10
`3,227.90
`3,580.30
`3,671.70
`3,756.30
`
`
`Inhouse
`2002
`$637.60
`154
`157.1
`948.7
`
`2001
`$567.30
`136.5
`149.7
`853.5
`
`2003
`$693.10
`167.3
`151.5
`1,011.90
`
`2004
`$708.90
`171.6
`157
`1,037.50
`
`2005
`$711.00
`173.7
`154
`1,038.70
`
`
`
`3,753.60
`
`
`
`4,176.60
`
`
`
`4,592.20
`
`
`
`4,709.20
`
`
`
`4,795.00
`
`
`
`National Cancer Institute
`Extramural vs. Inhouse Funding
`2001 - 2005
`
`
`
`01-05%
`chg.
`29.0%
`32.9%
`516.8%
`73.2%
`14.8%
`16.2%
`23.6%
`26.3%
`15.6%
`-100.0%
`0%
`590.9%
`
`01-05%
`chg.
`25.3%
`27.3%
`2.9%
`21.7%
`
`27.7%
`
`
`
`Mechanism
`Research Project Grants
`Cancer Centers
`Specialized Centers
`SPOREs
`Other Research Grants
`NRSA
`R&D Contracts
`Cancer Control Grants
`Cancer Control Contracts
`Construction
`Buildings & Facilities
`Total Extramural Funds
`
`
`Mechanism
`Intramural Research
`RMS
`Control Inhouse
`Total Inhouse Funds
`
`Total NCI
`
`2005
`2004
`2003
`2002
`2001
`
`Fiscal Year
`
`$3,800
`$3,600
`$3,400
`$3,200
`$3,000
`$2,800
`$2,600
`$2,400
`$2,200
`$2,000
`$1,800
`$1,600
`$1,400
`$1,200
`$1,000
`$800
`$600
`$400
`$200
`$0
`
`Funding
`(in millions)
`
`x
`
`Inhouse
`
`Extramural
`
`
`
`
`
`
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 13 of 74
`
`

`

`
`
`
`
`Summary Points
`
`
`
`
`
`
`
`
`Research Career Awards – “K” Program
`
`• The Research Career Award mechanism grew by 3% in FY 2005.
`• The number of Research Career Awards increased by 37 in FY 2005 from FY 2004.
`• NCI’s funding in FY 2005 for the K30 Institutional Curriculum Awards, which are administered
`by the National Heart, Lung, and Blood Institute, was $1.1 million.
`
`
`(Dollars in Thousands)
`
`
`
`
`
`2004
`Amount
`$10,485
`5,285
`15,770
`2,396
`11,393
`17,243
`8,791
`5,333
`7,911
`3,061
`
`No.
`72
`41
`113
`19
`88
`131
`17
`35
`61
`25
`
`5
`494
`0
`494
`
`712
`72,610
`1,597
`74,207
`
`
`
`
`
`
`
`
`2005
`Amount
`$11,897
`5,837
`17,734
`2,554
`13,529
`17,841
`7,436
`5,344
`7,533
`2,306
`
`No.
`82
`45
`127
`20
`110
`141
`13
`35
`60
`16
`
`9
`531
`0
`531
`
`1,227
`75,505
`1,147
`76,652
`
`
`
`
`
`
`
`K01 Temin Awards
`K01 Minority Mentored Career Development Award
`
` Subtotal, K01s
`K05 Research Scientist Award
`K07 Preventive Oncology
`K08 Clinical Investigator
`K12
`Institutional Clinical Oncology Research
`K22 Transition Career Development
`K23 Patient-Oriented Career
`K24 Patient-Oriented Career -- Mid Career
`Mentored Quantitative Research Career Development
`Award
`
`Institutional Curriculum Awards -- Administered by NHLBI
` Total Research Career Program
`
`K25
`
`K30
`
`
`xi
`
`
`
`
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 14 of 74
`
`

`

`National Cancer Institute
`FY 2005
`% of Total Research Career Award Funds
`
`K30-Institutional
`Curriculum Awards
`1.4%
`
`K01-Temin Awards
`15.5%
`
`K01-Minority
`Mentored Career
`Development Awards
`7.6%
`
`K05-Research
`Scientist Awards
`3.3%
`
`K07-Preventive
`Oncology
`17.6%
`
`
`
`K25-Mentored
`Quantitative Research
`Career Development
`Awards
`1.6%
`
`K24-Patient Oriented
`Career -- Mid Career
`3.0%
`
`K23-Patient Oriented
`Career
`9.8%
`
`K22-Transition Career
`Development
`6.9%
`
`K12-Institutional
`Clinical Oncology
`Research
`9.7%
`
`K08-Clinical
`Investigator
`23.2%
`
`
`
`
`
`
`
`
`
`
`
`xii
`
`
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 15 of 74
`
`

`

`Research Dollars by Various Cancers
`
`
`Summary Points
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`• Funding for various cancers listed below may overlap
`• Funding for cancers listed below do not represent the entire NCI budget
`
`
`
`
`
`Total NCI
`AIDS
`Brain & Central Nervous System
`Breast Cancer
`Cervical Cancer
`Clinical Trials
`Colorectal Cancer
`Head and Neck
`Hodgkin's Disease
`Leukemia
`Liver Cancer
`Lung Cancer
`Melanoma
`Multiple Myeloma
`Non Hodgkin's Lymphoma
`Ovarian Cancer
`Pancreatic Cancer
`Prostate Cancer
`Stomach Cancer
`Uterine Cancer
`
`Research Dollars by Various Cancers
`(Dollars in Millions)
`
`
`
`
`
`2005
`2004
`2003
`2001
`2002
`$3,753.70 $4,176.70 $4,592.30 $4,723.90 $4,794.70
`237.8
`254.4
`263.4
`267
`265.9
`80.7
`95.2
`111.5
`132.3
`124.9
`475.2
`522.6
`548.7
`566.2
`560.1
`72.6
`67.6
`79
`79
`81.7
`648.6
`702.1
`799.5
`800
`781.8
`207.4
`245
`261.6
`262
`253.1
`50
`58.9
`77.7
`88.2
`89.5
`10.2
`11.8
`16.5
`17.4
`17.2
`154
`177.2
`200.9
`214.7
`220.6
`54.5
`62.5
`63.7
`63
`60.5
`206.5
`237.5
`273.5
`276.5
`266.1
`71.8
`82.3
`90.7
`94.9
`102.9
`19.7
`20.8
`26.3
`23.9
`28.2
`79.5
`85.6
`95.2
`99.6
`107
`76.9
`93.5
`99.4
`99.5
`97.7
`21.8
`33.1
`42.3
`52.7
`66.7
`258
`278.4
`305.2
`308.5
`309
`9
`11.4
`13.4
`11.6
`11
`18.8
`23.1
`25.5
`27
`31.1
`
`xiii
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 16 of 74
`
`

`

`National Cancer Institute
`
`
`Director=s Biography
`Andrew C. von Eschenbach, M.D.
`
`Andrew C. von Eschenbach, M.D. became the 12th Director of the National Cancer
`Institute in January 2002. In September 2005, he was also appointed as the Acting
`Commissioner of the Food and Drug Administration and currently holds both positions.
`He is a nationally recognized urologic surgeon who formerly directed the Genitourinary
`Cancer Center and the Prostate Cancer Research Program at The University of Texas
`M.D. Anderson Cancer Center in Houston, Texas. He also served as special assistant
`for external affairs to M.D. Anderson’s president and held the Roy M. and Phyllis Gough
`Huffington Clinical Research Distinguished Chair in Urologic Oncology.
`
` A
`
` native of Philadelphia, Dr. von Eschenbach received his medical degree from
`Georgetown University Medical School in 1967. He completed residencies in general
`surgery and urology at Pennsylvania Hospital in Philadelphia, then was an instructor in
`urology at the University of Pennsylvania School of Medicine. He served as a
`Lieutenant Commander in the U.S. Navy Medical Corps.
`
`In 1976, Dr. von Eschenbach went to M.D. Anderson Cancer Center for a fellowship in
`urologic oncology and was invited to join the faculty the following year. From 1983 to
`1996, he was Chairman of the Department of Urology and, since 1985, has also been a
`Consulting Professor in the Department of Cancer Biology.
`
`In 1996, Dr. von Eschenbach was named the founding director of M.D. Anderson’s
`Prostate Cancer Research Program, comprised of over 60 scientists and clinicians
`collaborating on integrated translational research in the biology, treatment,
`epidemiology and prevention of the disease. From 1997 to 1999, he also served as
`Vice President for Academic Affairs and then as Executive Vice President and Chief
`Academic Officer, leading a faculty of almost 1,000 cancer researchers and clinicians.
`
`He was a founding member of C-Change and, prior to his accepting the position as NCI
`Director, he was President-elect of the American Cancer Society. Dr. von Eschenbach
`has contributed more than 200 articles, books and chapters to the scientific literature.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`O-1
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 17 of 74
`
`

`

`Former Directors of
`the National Cancer Institute
`
`
`
`
`Richard D. Klausner, M.D.
`Dr. Klausner was appointed as the Director of the National Cancer
`Institute (NCI) on August 1, 1995. From 1984 until 1997 he was Chief
`August 1995 – September 2001
`
`of the Cell Biology and Metabolism Branch of the National Institute of
`Child Health & Human Development. Dr. Klausner is well known for
`
`his contributions to multiple aspects of cell and molecular biology. Dr.
`
`Klausner=s research has illuminated the genetics and biochemistry of
`
`metals as essential but toxic nutrients for virtually all forms of life, has
`
`illuminated the pathways by which molecules traffic and speak to each
`
`other within the cell, and has described novel mechanisms by which
`
`tumor suppressor genes function.
`
`
`
`
`
`Dr. Broder joined NCI in 1972 as a Clinical Associate in the
`Samuel Broder, M.D.
`Metabolism Branch. In 1981, he became Associate Director for NCI’s
`December 1988 – March 1995
`Clinical Oncology Program. In 1985 he led the laboratory team that
`
`discovered the therapeutic effects of AZT and other drugs now
`
`approved for the treatment of AIDS including DDI and DDC.
`
`
`Vincent T. DeVita, Jr., M.D.
`January 1980 – June 1980 (Acting)
`July 1980 – August 1988
`
`Dr. DeVita joined NCI in 1963 as a Clinical Associate in the Laboratory
`of Chemical Pharmacology. He served NCI as head of the Solid
`Tumor Service, Chief of the Medicine Branch, Director of the Division
`of Cancer Treatment and Clinical Director prior to his appointment as
`Director of NCI.
`
`Prior to his tenure as NCI Director, Dr. Upton served as Dean of the
`School of Basic Health Sciences at the State University of New York at
`Stony Brook.
`
`Dr. Rauscher served as Scientific Director for Etiology, NCI, prior to his
`appointment as Director of NCI in 1972.
`
`During his tenure with PHS, Dr. Baker served as Scientific Director for
`Etiology, NCI, and as Acting Director of NCI prior to his appointment
`as Director in July 1970.
`
`Dr. Endicott served as Chief of the Cancer Chemotherapy National
`Service Center, PHS, and as Associate Director, NIH, prior to being
`appointed Director of NCI in July 1960.
`
`Dr. Heller joined PHS in 1934 and became Chief of the Venereal
`Disease Division prior to his appointment as Director of NCI in 1948.
`
`Dr. Scheele served in various capacities during his tenure with PHS
`prior to his appointment as Assistant Chief and, subsequently, Director
`of NCI in July 1947.
`
`Dr. Spencer became NCI's first Assistant Chief and, subsequently,
`was appointed Director of the Institute in 1943.
`
`Dr. Voegtlin served as Professor of Pharmacology and Chief of the
`Division of Pharmacy at the Hygienic Laboratory prior to becoming the
`first Director of NCI in 1938.
`
`Arthur Canfield Upton, M.D.
`July 1977 – December 1979
`
`Frank Joseph Rauscher, Jr., Ph.D.
`May 1972 – October 1976
`
`Carl Gwin Baker, M.D.
`November 1969 – July 1970 (Acting)
`July 1970 – April 1972
`
`Kenneth Milo Endicott, M.D.
`July 1960 – November 1969
`
`
`
`John Roderick Heller, M.D.
`May 1948 – June 1960
`
`Leonard Andrew Scheele, M.D.
`July 1947 – April 1948
`
`
`
`Roscoe Roy Spencer, M.D.
`August 1943 – July 1947
`
`Carl Voegtlin, Ph.D.
`January 1938 – July 1943
`
`
`
`
`
`O-2
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 18 of 74
`
`

`

`National Cancer Advisory Board
`Membership and Term
`
`2010 Acting Chairperson
`Daniel D. Von Hoff, M.D., F.A.C.P
`Translational Genomics Research Institute
`Phoenix, AZ 85004
`
`2006 Samir Abu-Ghazaleh, M.D.
`Avera Cancer Institute
`Sioux Falls, SD 57105
`
`2006 James O. Armitage, M.D.
`College of Medicine
`University of Nebraska Medical Center
`Omaha, NE 68198
`
`2008 Moon Shao-Chuang Chen, Jr., Ph.D., M.P.H.
`University of California
`Davis Cancer Center
`Sacramento, CA 95817
`
`2006 Eric S. Lander, Ph.D.
`The Broad Institute of MIT and Harvard
`MIT and Harvard Medical School
`The Whitehead Institute for Biomedical Research
`Cambridge, MA 02141
`
`2010 Diana M. Lopez, Ph.D.
`Department of Microbiology & Immunology
`University of Miami School of Medicine
`Miami, FL 33136
`
`2006 Arthur W. Nienhuis, M.D.
`St. Jude Children's Research Hospital
`Memphis, TN 38101
`
`2008 Ms. Marlys Popma
`IHS Consulting
`Colfax, IA 50054
`
`2008 Kenneth H. Cowan, M.D., Ph.D.
`University of Nebraska Medical Center
`Eppley Institute for Cancer Research
`Omaha, NE 68198
`
`2008 Franklyn G. Prendergast, M.D., Ph.D.
`Mayo Clinic Cancer Center
`Mayo Foundation
`Rochester, MN 55905
`
`2008 Jean B. deKernion, M.D.
`Department of Urology
`UCLA School of Medicine
`Los Angeles, CA 90095
`
`2006 Ralph S. Freedman, M.B.B.Ch., Ph.D.
`Department of Gynecologic Oncology
`University of Texas
`Houston, TX 77030
`
`2006 James H. French , M.D.
`The Center for Plastic Surgery
`Annandale, VA 22003
`
`2010 Kathryn Giusti, M.B.A.
`Multiple Myeloma Research Foundation, Inc.
`New Canann, CT 06840
`
`2010 David H. Koch
`Koch Industries
`New York , NY 10021
`
`2010 Carolyn D. Runowicz, M.D.
`The Carol and Ray Neag Comprehensive
`Cancer Center
`University of Connecticut Health Center
`Farmington, CT 06030
`
`2008 Lydia G. Ryan, M.S.N., P.N.P.
`Children's Healthcare of Atlanta
`AFLAC Cancer Center
`Atlanta, GA 30322
`
`Executive Secretary
`Paulette S. Gray, Ph.D.
`
`Committee Management Officer
`Ms. Claire L. Harris
`
`O-3
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 19 of 74
`
`

`

`National Cancer Advisory Board (Continued)
`Ex Officio Members
`
`The Honorable Elaine Chao, M.B.A.
`Secretary of Labor
`Washington, DC 20210
`
`Andrew C. von Eschenbach, M.D.
`Acting Commissioner
`Food and Drug Administration
`Rockville, MD 20857
`
`John Howard, M.D., M.P.H., J.D., LL.M.
`Director
`National Institute for Occupational Safety and
`Health (NIOSH)
`Washington, DC 20857
`
`Mr. Stephen L. Johnson
`Administrator
`Environmental Protection Agency
`Washington, DC
`
`The Honorable Michael O. Leavitt
`Secretary
`Department of Health and Human Services
`Washington, DC 20201
`
`John H. Marburger, III
`Science Advisor to the President
`Director
`Office of Science and Technology Policy
`Executive Office of the President
`Washington, DC 20502
`
`Ari Patrinos, Ph.D.
`Associate Director
`Office of Biological and Environmental Research
`U.S. Department of Energy
`Washington, DC 20585
`
`The Honorable Dr. Jonathan Perlin
`Under Secretary for Health
`Veterans Health Administration
`Department of Veterans Affairs
`Washington, DC 20420
`
`David A. Schwartz, M.D.
`Director
`National Institute of Environmental Health Sciences
`National Institutes of Health
`Research Triangle Park, NC 27709
`
`Mr. Hal Stratton
`Chairman
`Consumer Product Safety Commission
`Bethesda, MD 20814
`
`The Honorable Dr. William Windwerder, Jr.
`Assistant Secretary of Defense for Health Affairs
`Washington, DC 20301-1200
`
`Elias A. Zerhouni, M.D.
`Director
`National Institutes of Health
`Bethesda, MD 20892
`
`O-4
`
`NOVARTIS EXHIBIT 2110
`Par v. Novartis, IPR 2016-01479
`Page 20 of 74
`
`

`

`National Cancer Advisory Board (Continued)
`Alternates to Ex Officio Members
`
`Richard Pazdur, M.D.
`Division Director
`Division of Oncology Drugs
`Food and Drug Administration
`Rockville, MD 20857
`(Andrew C. von Eschenbach, M.D. - FDA)
`
`John F. Potter, M.D.
`Director
`United States Military Cancer Institute
`Walter Reed Army Medical Center
`Washington D.C. 20307
`(The Honorable Dr. William Winkwerder, Jr. - DOD)
`
`R. Julian Preston, Ph.D.
`Director
`Environmental Carcinogenesis Division
`U.S. Environmental Protection Agency
`Research Triangel Park, NC 27703
`(Mr. Stephen L. Johnson - EPA)
`
`Anita L. Schill, Ph.D., M.P.H., M.A., R.N., COHN-S
`Senior Scientist
`Office of the Director
`National Institute for Occupational Safety
` and Health
`Washington, DC 20201
`(John Howard, M.D., M.P.H., J.D., LL.M. - NIOSH)
`
`Donald J. Wright, M.D. MPH
`Director
`Office of Occupational Medicine
`Department of Labor, OSH

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