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1 NCI Director’s Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy, M.D. March 25, 2019

NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

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Page 1: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

1

NCI Director’sUpdateBoard of Scientific Advisors

Norman E. Sharpless, M.D.

Douglas R. Lowy, M.D.

March 25, 2019

Page 2: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

2

By SexAll Races (includes Hispanic), All Ages

Female Male

By Race/EthnicityBoth Sexes, All Ages

Black (includes Hispanic)

White (includes Hispanic)

Source: NCI Surveillance, Epidemiology, and End Results Program

(1975 – 2015)

Long-Term Trends in U.S. Mortality Rates - All Cancer Sites Combined

Page 3: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

3

Late-stage pipeline composition by therapeutic area, 2010-18 – original cohort

Clinical cycle time by therapy area(selected therapy areas only), 2016-18

Source: Deloitte Center for Health Solutions, 2018

Page 4: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

4From Blumenthal and Pazdur, Nat Rev Clin Oncol, 2019

Cancer drug approvals in 2018

Page 5: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

0

5

10

15

20

25

30

2000 2003 2006 2009 2012 2015

Rate

per

100,0

00

Year of diagnosis

Melanoma of the skin

SEER incidence rates

0

0.5

1

1.5

2

2.5

3

2000 2003 2006 2009 2012 2016

Rate

per

100,0

00

Year of death

Melanoma of the skin

US mortality rates

NivolumabCTLA4

Incidence has increased by ~2% per year

2000-2015 Mortality has decreased by ~5% per year

2012-2016

Vemurafenib

Melanoma incidence & mortality

Page 6: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

6

Key Focus Areas

Fully realize the power of clinical trials

through innovative design,

administration, and analyses

C L I N I C AL T R I AL S

Support the cancer research enterprise

by focusing on the workforce of cancer

investigators

W O R K F O R C E D E V E L O P M E N T

Reaffirm our commitment to basic

science to drive novel approaches and

technologies

B AS I C S C I E N C E

Increase data aggregation and

interpretation to speed our work across

the cancer enterprise

B I G D ATA

Page 7: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

7

Key Focus Areas

Fully realize the power of clinical trials

through innovative design,

administration, and analyses

C L I N I C AL T R I AL S

Support the cancer research enterprise

by focusing on the workforce of cancer

investigators

W O R K F O R C E D E V E L O P M E N T

Increase data aggregation and

interpretation to speed our work across

the cancer enterprise

B I G D ATA

Reaffirm our commitment to basic

science to drive novel approaches

and technologies

B AS I C S C I E N C E

Page 8: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

8

Workforce Development

MERITR37

Method to Extend

Research in Time

ESI

PAYLINE

14th

PERCENTILE

Page 9: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

9

Key Focus Areas

Fully realize the power of clinical trials

through innovative design,

administration, and analyses

C L I N I C AL T R I AL S

Support the cancer research enterprise

by focusing on the workforce of cancer

investigators

W O R K F O R C E D E V E L O P M E N T

Increase data aggregation and

interpretation to speed our work across

the cancer enterprise

B I G D ATA

Reaffirm our commitment to basic

science to drive novel approaches

and technologies

B AS I C S C I E N C E

Page 10: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

10

FY 2018

RPG POOL

+ $170M over

FY 2017Largest increase

since FY 2003

FY 2019

RPG POOL

˃$100MILLION

Page 11: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

11

Key Focus Areas

Fully realize the power of clinical trials

through innovative design,

administration, and analyses

C L I N I C AL T R I AL S

Support the cancer research enterprise

by focusing on the workforce of cancer

investigators

W O R K F O R C E D E V E L O P M E N T

Reaffirm our commitment to basic

science to drive novel approaches and

technologies

B AS I C S C I E N C E

Increase data aggregation and

interpretation to speed our work across

the cancer enterprise

B I G D ATA

Page 12: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

12

Modernizing Clinical Trials

January 23, 2019

Page 13: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

13

Key Focus Areas

Fully realize the power of clinical trials

through innovative design,

administration, and analyses

C L I N I C AL T R I AL S

Support the cancer research enterprise

by focusing on the workforce of cancer

investigators

W O R K F O R C E D E V E L O P M E N T

Reaffirm our commitment to basic

science to drive novel approaches and

technologies

B AS I C S C I E N C E

Increase data aggregation and

interpretation to speed our work across

the cancer enterprise

B I G D ATA

Page 14: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

14

Childhood Cancer Data Initiative

• Data infrastructure

and inter-operability

• Data acquisition

• Extramural grants

Page 15: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

15

Key Focus Areas

Fully realize the power of clinical trials

through innovative design,

administration, and analyses

C L I N I C AL T R I AL S

Support the cancer research enterprise

by focusing on the workforce of cancer

investigators

W O R K F O R C E D E V E L O P M E N T

Reaffirm our commitment to basic

science to drive novel approaches and

technologies

B AS I C S C I E N C E

Increase data aggregation and

interpretation to speed our work across

the cancer enterprise

B I G D ATA

Page 16: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

16

Cancer Moonshot Funding Authorized Under the 21st Century Cures Act (dollars in millions)

300 300

400

195 195 194 216

00

50

100

150

200

250

300

350

400

450

FY 2017 FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 FY 2023 FY 2024

Page 17: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

17

21st Century Cures Act

funding shown in orange

$4,950$5,215

$5,389$5,665 $5,744

$5,055

$0

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 President’s 2020 Budget Proposal

$5,689$300

$300

$5,965$400

$6,144

NCI Appropriations FY 2013 - 2019 (in millions)

$5,250

$195

Page 18: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

18

NCI/NIH BUDGET PROCESS FOR REGULAR APPROPRIATION

White House OMB

coordinates with

federal agencies

to formulate the

President’s budget

proposal

Congressional

appropriations

committees

consider

President’s

proposal &

prepare legislation

Congress

reconciles &

finalizes

appropriations

legislation & sends

to the President

President signs

the appropriations

bill into law

making funds

available for

NIH & NCI

STEP 1 STEP 2 STEP 3 STEP 4

FY 2019

FY 2020

Page 19: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

19

• Director, Center for Global Health (CGH)

• Director, Center for Bioinformatics and Information

Technology (CBIIT)

• Director, Cancer Therapy Evaluation Program

(CTEP)

• Director, Division of Cancer Prevention (DCP)

Leadership transitions

Page 20: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

20

Associate Director, NCI at Frederick

• Cancer Research Technology Program, Frederick

National Laboratory for Cancer Research

• NCI’s Office of Cancer Nanotechnology Research

• Research Associate, University of Virginia Health

Sciences Center, Department of Biochemistry and

Molecular Genetics

• Post-doctoral Fellowship, Fred Hutchinson Cancer

Research Center, Division of Basic Sciences

• Ph.D. in Pharmacology, Duke University Medical

Center in 1999Sara Hook, Ph.D.

Page 21: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

21

NCI @ AACR 2019

• 15 NCI-sponsored sessions

• > 25 additional

presentations by NCI staff

• 40 Meet-the-Experts

sessions at the NCI Exhibit

• 80 poster sessionsOpening

Ceremony

Sunday, March 31

9:00 AM

Page 22: NCI Director’s Update · 2019-12-12 · Update Board of Scientific Advisors Norman E. Sharpless, M.D. Douglas R. Lowy ... White (includes Hispanic) Source: NCI Surveillance, Epidemiology,

www.cancer.gov

www.cancer.gov/espanol