FY05 Annual Report

Sponsored Research Executive Summary ......................................................................1

Funding History by sponsor Type – FY01 to FY05 Figure 1 Funding History by Sponsor Type.............................................................2 Table 1 Funding History by Sponsor Type.............................................................2 Figure 2 Federal Funding........................................................................................3 Figure 3 % Growth in Fed. Science & Eng. Obligations, 1995 to 2003...................3 Figure 4 State, Local, & International Government Funding ...................................4 Figure 5 Private Industry Funding...........................................................................4

Funding History by School – FY01 to FY05 Figure 6 Arts & Sciences ........................................................................................5 Figure 7 Engineering ..............................................................................................5 Figure 8 Social Work ..............................................................................................5 Figure 9 Medicine ...................................................................................................5 Table 2 ..................................................................................................................5

Award Dollars by School and Cost Category

Table 3 Direct Costs vs. F&A Costs – FY05 & FY04 .............................................6

Award Dollars by Project Type – FY05 & FY04 Table 4 Award Dollars by School and Project Type...............................................7 Figure 10 Award Summary by Sponsor Type ...........................................................8

Award Summary by Sponsor Type – FY05 & FY04 Table 5 Direct and Indirect Dollars ........................................................................9 Table 6 Award Dollars by Sponsor & Cost Category ...........................................10 Table 6a Award Dollars by Sponsor and Direct/Sub Award Category ...................11 Table 7 Federal Award Dollars by School & Sponsor – FY05 .............................12 Table 8 Award Dollars by School and Sponsor Type ..........................................13 Table 9 School of Arts & Sciences – Award Dollars by Department....................14 Table 10 School of Engineering – Award Dollars by Department ..........................15 Table 11 School of Medicine – Award Dollars by Department...............................16

Washington University Rankings Table 12 WU Rank among Research Universities Receiving Federal Support .....17 Table 13 WU Rank among Private Universities Receiving Federal Support .........18 Table 14 WU Rank among Medical Schools Receiving NIH Support ....................19

Office of Technology Management Executive Summary ............................................20

Invention Disclosures by School Table 15 Invention Disclosure by School – FY00 to FY05.....................................26 Figure 11 Invention Disclosure by School – FY00 to FY05.....................................26 Table 16 Invention Disclosure by Department – FY00 to FY05.............................27

Patent Applications by School Table 17 US Patent Applications by School – FY00 to FY05 ................................28 Figure 12 US Patent Applications by School – FY00 to FY05 ................................28 Table 18 US Patent Applications by Department – FY03 to FY05.........................29

Table of Contents

Licenses by School Figure 13 Licenses by School – FY00 to FY05.......................................................30 Table 19 Licenses by School – FY00 to FY05.......................................................31 Figure 14 Percent of Licenses by School ...............................................................31 Table 20 Licenses by Department – FY03 to FY05 ...............................................32 Table 21 License Type by School..........................................................................33

License Revenue by School – FY01 to FY05 Table 22 License Revenue....................................................................................34 Figure 15 License Revenue by School ...................................................................34 Table 23 License Revenue by School ...................................................................35

License Revenue – FY01 to FY05 Table 24 License Revenue....................................................................................36

Industry Sponsored Research Agreements – FY05 Table 25 Industry Sponsored Agreements by School............................................37 Figure 16 Industry Sponsored Agreements by School............................................37 Table 26 Industry Sponsored Agreements by Departments. .................................38

Other Agreements – FY05 Table 27 Other Agreements by School..................................................................39

Material Transfer Agreements – FY05 Table 28 Material Transfer Agreements by Departments ......................................40

Sponsored Research Expense Executive Summary....................................................41 Direct and F&A Expenditures – FY04 to FY05

Table 1 By Sponsor Type ....................................................................................46 Table 2 By School and Cost Category.................................................................47 Table 3 By School and Project Type ...................................................................48

Fiscal Year 2005 Expenditures Table 4 By Sponsor and Agreement Type – FY05 ..............................................49 Table 4a Graphs by Sponsor Type – FY01 to FY05..............................................50 Table 5 By Sponsor and Project Type .................................................................51 Table 5a Graphs by Sponsor Type – FY01 to FY05..............................................52 Table 6 By Sponsor and School ..........................................................................53 Table 7 By Detailed Cost Category and Sponsor ................................................54 Table 8 By Detailed Cost Category and School...................................................55 Table 8a Graph of Detailed Cost Category and School FY01 to FY05..................56

F&A Expenditures (Recovery) FY04 to FY05 Table 9 By Sponsor and F&A Rate......................................................................57 Table 10 By Sponsor and Agreement Type...........................................................58 Table 11 By School Federal Agency and School...................................................59 Table 12 By Detailed Cost Category and School...................................................60

Industry Sponsored Clinical Trials...................................................................................61 Figure 1 School of Medicine: by Department ........................................................64 Figure 2 Internal Medicine: by Division .................................................................65 Figure 3 New Contracts Completed FY03 to FY05.............................................66

Appendix one ........................................................................................................................67

1

This report presents an overview of external funding for sponsored projects at Washington University during the fiscal year of 2005 (FY05). The awards reported are those with start dates on or between July 1, 2004 and June 30, 2005 and the associated funds represent new money only. Beginning in 2005, business rules for reporting were changed to avoid including dollars approved by sponsors to be carried over from the previous award period. For a full explanation, please refer to Appendix 1. Five year trends tables have been adjusted accordingly. Federal Agency Funding Down Slightly Funding for Washington University’s sponsored programs totaled $516.7 million in FY 05, an increase of 1.3% over FY 04. Federal award dollars decreased by 1 % or about $4.5 M during FY05. Only two schools increased federal obligations for research during FY05, the School of Engineering and the School of Social Work (Center for Mental Health Development and Electrical Engineering). Direct dollars from numerous federal agencies dove by an average of 34% over FY04, with only the National Aeronautics and Space Administration (NASA) standing out, awarding a million dollars more in FY05. Regardless of difficult times in Washington, federal agency support continues to be the University’s leading source of award dollars, constituting 84% of total sponsored funding this year. Increase in Non—Profit Sponsor Support A significant rise in funding from private, non-profit sources cushioned the impact of the federal decreases on the overall total of Washington University dollars for research. Private non-profit dollars increased by 26%, almost $11M, during FY05. Approximately 60% of those funds were awarded to the School of Medicine, perhaps the largest increases in support coming from the American Cancer Society and the Barnes-Jewish Foundation. A key award contributing to Danforth Campus initiatives was Monsanto’s support for Science on the Move, with the Ewing Marion Kauffman Foundation and the Ford Foundation also making a significant impact in the private sponsor column. Key Federal Research Sponsors NIH awarded $399.6M, up about 2% in dollars over the previous fiscal year. This amount represents 77% of WU’s total sponsored project funding and 92% of its federal dollars. NSF remains the number two sponsor of University research with $15.2 million, though dollars decreased 38% from last year. NASA, on a happier note, increased support of WU researchers by 24% to $6M direct dollars and another $1.7 million through subawards. Tables 6 and 6a illustrate the rankings of the different sponsoring agencies by dollar volume. Washington University’s National Ranking NSF’s most recent nationwide comparison of universities with federal research support reflects Fiscal Year 2003. Using those numbers from the past, Washington University ranked 9th in receiving federal research funding, fourth when compared only to other private universities. In addition, according to the website of the National Institutes of Health, the School of Medicine ranks 4th out of all medical schools in the United States in the amount of funding it received from the NIH for federal FY04. (Table 14)

Sponsored Research Executive Summary

2

$0$100,000$200,000$300,000$400,000$500,000$600,000

FY01 FY02 FY03 FY04 FY05

Federal State/Local/Int'l Private

The following graphs illustrate Washington University’s funding history over the past five years. Figure 1 illustrates the total dollars summarized in table 1 received each year, sorted by three broad sponsor types: 1) federal, 2) state, local and international governments, and 3) private sector, which includes industry and nonprofit sponsors. Figures 2-5 address the same sponsor data in greater detail. Finally, 5-year trends are compared in figures 6-9 and table 2 among the four research-intensive units of the university: the School of Arts and Sciences, the School of Engineering and Applied Science, the School of Medicine, and the George Warren Brown School of Social work.

Figure 1

Funding History FY01 to FY05 by Sponsor Type† (000s)

Table 1 (000s)

FY01 FY02 FY03 FY04 FY05Federal 324,824 352,731 397,375 437,230 432,779State/Local/Int'l 8,100 12,305 14,953 17,301 17,133Private 56,326 46,501 51,085 55,685 66,821TOTAL 389,250 411,537 463,413 510,216 516,733

†Data from past years have been revised to reflect new money only. (See Appendix One)

Funding History

3

As figure 2 illustrates, the University has demonstrated cumulative growth in federal research funding from 2001 to 2005. Figure 3 illustrates that Washington University has continued to outpace the growth in federal science and engineering obligations made to the top 100 universities and colleges receiving these dollars1.

Figure 2 Federal Funding – FY01 to F05

(000s)

Figure 3 Percent Growth in Federal Science and Engineering Obligations

1995 to 2003

1National Science Foundation (SRS), “Survey of Federal Support to Universities, Colleges and Nonprofit Institutions: Fiscal Year 2003” (Arlington, VA) 2005.

Funding History by Sponsor Type

Federal Support to Washington University

0%

10% 20% 30% 40% 50% 60% 70% 80% 90%

100%

1995 1996 1997 1998 1999 2000 2001 2002 2003

Federal Support to Washington University

Federal Science & Engineering Obligations to Top 1001

$0

$100,000

$200,000

$300,000

$400,000

$500,000


Federal

4

Figure 5 Private Industry Funding – FY01 to FY05

(000s)

Funding History by Sponsor Type

State/Local/Int'l

Figure 4 State, Local and International Government Funding - FY01 to FY05

(000s)

$0

$5,000

$10,000

$15,000

$20,000


$0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000 $70,000 $80,000


Private

5

Figure 6 Figure 7 School of Arts and Sciences School of Engineering Figure 8 Figure 9

School of Social Work School of Medicine

Table 2 (000s)

FY01 FY02 FY03 FY04 FY05 Arts & Sciences 29,693 30,175 38,353 43,102 42,693Engineering 8,401 15,351 14,166 16,433 17,722Medicine 345,844 357,391 402,973 433,557 447,727Social work 9,065 6,037 6,421 5,423 6,580Other (839) 1,909 1,534 1,700 2,011Total 392,164 410,863 463,447 510,216 516,733


$0

$5,000

$10,000


Funding History by School FY01 – FY05†

$500,000 $400,000 $300,000 $200,000 $100,000

$0


$0 $5,000

$10,000 $15,000 $20,000


$0

$20,000

$40,000

$60,000


6

The following table compares FY05 award dollars with the prior year, broken out by direct and facility/administrative cost for each school The percent of change from one fiscal year to the next is tracked in the far right column. It should be noted that when a school receives one very large award or regularly receives a small number of awards, the data could lead to skewed or even misleading interpretations.

Table 3 Direct Costs vs. F & A Costs

FY05 and FY04† (000s)

FY05 FY04 Change

Schools

Award Count

DirectCosts

F&A Costs

Total

AwardCount

Direct Costs

F&A Costs

Total $$ %

Arts & Sciences 263

32,015

10,678

42,693

258

33,151

9,951

43,102

(409) -1.0%

Business 8

503

92

595

4

542

135

677

(82) -13.8%

Engineering 132

12,605

5,117

17,722

117

12,093

4,341

16,434

1,288 7.3%

Law 4

217

30

247

3

339

-

339

(92) -37.2%

Medicine 1,496

326,811

120,916

447,727

1,636

323,624

119,933

443,557

4,170 0.9%

Social Work 36

5,263

1,317

6,580

38

4,203

1,220

5,423

1,157 17.6%

Other Schools 16

1,048

121

1,169

11

559

124

683

486 41.6%

TOTAL 1,955

378,462

138,271

516,733

2,067

374,511

135,704

510,216

6,518 1.3% †Data from past years have been revised to reflect new money only. (See Appendix One)

Award Dollars by School and Cost Category

7

The term “project type” refers to the distinct types of awards received by the University. Types chosen for this table are Research, Research Training and Other Sponsored Activities. Research projects are those activities whose principal focus is the discovery, verification, or even evaluation of new knowledge. Research training includes individual and institutional awards for the support of pre and postdoctoral trainees and fellows plus institutional awards for graduate education. Other Sponsored Activities include projects such as scholarly conferences, equipment grants and community outreach programs.

Table 4 Award Dollars by School and Project Type

FY05 and FY04† (000s)

Research Research Training Other Sponsored Activities TOTAL

Schools FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04 Administration 391 298 648 383 1,039 681 Art 128 2 2 130 2 Arts & Sciences 38,038 39,640 3,088 1,906 1,566 1,556 42,692 43,102 Business 552 678 43 595 677 Engineering 16,961 14,744 611 577 150 1,112 17,722 16,434 Law 115 30 132 309 247 339 Medicine 419,105 416,261 19,185 20,904 9,437 6,392 447,727 443,557 Social Work 4,300 3,246 605 737 1,675 1,439 6,580 5,423 TOTAL 479,591 474,897 23,489 24,124 13,653 11,193 516,733 510,216


Award Summary by Project Type

8

The graphs and tables in this section attempt to answer many questions.

• From what sources does the University receive funding? • From which sectors – government, industry, and not for profit – does the University receive most funding? • Which federal agencies provide the most support to the individual schools? • Which sponsors have stepped up or scaled down their investments in University research over the past fiscal year?

Figure 10 Award Summary by Sponsor Type

FY05 and FY04† (000s)


FY04

24,701

21,48717,301

14,918 40,767

391,042

Award Summary by Sponsor Type

FY05

17,07215,254 51,567

399,60917,922

15,240

Other Gov’t. Industry Non ProfitNIH NSF Other Fed

9

Sponsor types in the following tables are broadly defined as Federal, Other Government, Industry, and Not for Profit. The Federal sponsor type refers to the large number of federal agencies who provide 84% of total University award dollars for FY05. The Other Government category most often includes state universities whose subcontracts to WU are funded from their federal grants. Industry denotes for-profit or corporate entities that fund research agreements. Not for Profit includes foundations, professional societies and volunteer health organizations.

Table 5 Direct and F&A Award Dollars by Sponsor Type

FY05 and FY04† (000s)

FY05 FY04

% % % % Direct Total F&A Total % Direct Total F&A Total %

Sponsor Costs Direct Costs F&A Total Total Costs Direct Costs F&A Total Total Federal 309,599 81.8% 123,180 89.1% 432,779 83.8% 316,301 84.5% 120,928 89.1% 437,230 85.7% Other Govt. 12,279 3.2% 4,853 3.5% 17,133 3.3% 12,198 3.3% 5,103 3.8% 17,301 3.4% Total Govt. 321,878 85% 128,033 92.6% 449,911 87.1% 328,499 87.7% 126,031 92.9% 454,531 89.1% Nonprofit 45,660 12.1% 5,907 4.3% 51,567 10% 35,450 9.5% 5,317 3.9% 40,767 8.0% Industry 10,924 2.9% 4,330 3.1% 15,254 3.0 10,561 2.8% 4,356 3.2% 14,918 2.9% Total Private 56,583 15.0% 10,238 7.4% 66,821 12.9% 46,011 12.3% 9,673 7.1% 55,685 10.9% GRAND TOTAL 378,462 100% 138,271 100% 516,733 100% 374,511 100% 135,704 100% 510,216 100% †Data from past years have been revised to reflect new money only. (See Appendix One)


10

Table 6 Award Dollars by Sponsor and Cost Category

FY05 and FY04† (000s)

FY05 FY04 Direct F&A Direct F&A Change

Category Source Costs Costs Total Costs Costs Total $$$ % FEDERAL AGENCIES NIH 285,712 113,905 399,617 280,968 110,073 391,041 8,576 2.2% NSF 10,657 4,583 15,240 19,148 5,553 24,701 (9,461) -38.3% NASA 4,127 1,916 6,044 3,311 1,552 4,863 1,181 24.3% DOD 1,701 638 2,339 3,242 844 4,086 (1,747) -42.8% EPA 91 44 135 (71) 112 41 94 229.3% EDUC 1,217 60 1,277 1,561 197 1,758 (481) -27.4% DOE 2,263 895 3,158 1,951 898 2,849 309 10.8% DHHS HRSA 1,394 351 1,745 1,414 393 1,808 (63) -3.5% LABOR 1,357 519 1,875 2,017 928 2,945 (1,070 -36.3% USDA 243 69 312 1,548 166 1,714 (1,402) -81.8% OTHER 836 201 1,037 1,212 212 1,424 (387) -27.2%TOTAL FEDERAL 309,598 123,181 432,779 316,301 120,928 437,230 (4,451) -1.0%OTHER GOVERNMENT Missouri 741 128 869 831 130 960 (152) -15.8% State- All Other 10,725 4,650 15,375 10,532 4,922 15,455 (80) -0.5% Other Gov’t. 813 76 889 834 50 885 4 0.5%TOTAL OTHER 12,279 4,854 17,133 12,197 5,102 17,301 (167) -1.0%PRIVATE SOURCES Industry 10,924 4,330 15,254 10,561 4,356 14,918 336 2.3% Non Profits 45,660 5,907 51,567 35,450 5,317 40,767 10,800 26.5%TOTAL PRIVATE 56,584 10,237 66,821 46,011 9,673 55,685 11,137 20%GRAND TOTAL 378,461 138,272 516,733 374,509 135,703 510,216 6517 1.3% †Data from past years have been revised to reflect new money only. (See Appendix One)

Award summary by Sponsor Type

11

Washington University receives a considerable amount of research funding from other institutions and corporations, commonly referred to as “sub-awards”. The following table shows the original source of the award dollars, including sub-award dollars, rather than attributing the funds to the awarding entity. The effect increases the Federal total and decreases the Private and State totals.

Table 6a Award Dollars by Sponsor and Direct/Sub Award Category

FY05 and FY04† (000s)

FY05 FY04 Direct Sub Direct Sub Change

Category Source Awards Awards Total Awards Awards Total $$$ % FEDERAL AGENCIES NIH

NSF NASA DOD EPA ED DOE DHHS HRSA LABOR USDA OTHER

396,12215,173

5,6942,184

1351,2772,9901,7451,875

312941

25,6592,5052,026

921387

731,176

872

1,070

421,78517,679

7,7203,105

5211,3494,1662,6171,8751,382

941

389,72324,701

4,8633,486

411,7582,8481,8082,9451,7141,399

25,7132,2302,4861,853

368173216876101

709

415,43726,931

7,3495,339

4091,9303,0652,6843,0461,7142,108

6,348 (9,252)

371(2,234)

112(581)1,101

(67)(1,171)

(333)(1,167)

1.5%-34.4%

5.0%-41.8%27.4%

-30.1%35.9%-2.5%

-38.4%-19.4%-55.4%

TOTAL FEDERAL 428,448 34,689 463,137 435,286 34,725 470,012 (6,872) -1.5%OTHER GOVERNMENT Missouri

State – All Other Other Gov’t.

511412

90

372525

57

883937147

520489

52

235185

44

755674

96

128263151

17.0%39.0%53.1%

TOTAL OTHER 1,013 954 1,967 1,061 464 1,525 442 29.0%PRIVATE SOURCES Industry 11,305 291 11,597 11,328 0 11,328 268 2.4% Non Profits 36,094 3,939 40,033 25,378 1,971 27,350 12,683 46.4%TOTAL PRIVATE 47,399 4,230 51,629 36,706 1,971 38,678 12,951 33.5%GRAND TOTAL 476,860 39,873 516,733 473,053 37,160 510,216 6,375 1.3% †Data from past years have been revised to reflect new money only. (See Appendix One)


12

Table 7 Federal Award Dollars by School and Sponsor FY05†

(000s)

Arts &

Sciences Engineering Medicine Social Work Other Schools Total University

FY05

% of Change

From FY04† FY05

% of Change

From FY04† FY05

% of Change

From FY04†

FY05

% of Change

From FY04†

FY05

% of Change

From FY04† FY05

% of Change

From FY04†

NIH 14,526 22.2% 4,968 127.6% 375,904 0.7% 3,538 21.3% 681 14.4% 399,617 2.2%NSF 8,684 -45.9% 5,268 -7.1% 1,098 -62.3% 100 100% 90 22.9% 15,240 -38.3%NASA 4,516 23.5% 617 108.2% 910 10.0% 6,044 24.3%DOD 545 9.2% 1,378 -31.9% 416 -73.4% 2,339 -42.8%EPA 11 110.3% 124 242.4% 135 229.3%ED 712 -37.7% 126 100% 215 -28.3% 225 -28.9% 1,277 -27.4%DOE 1,521 30.6% 200 -21.4% 1,438 60.0% 3,158 10.8%DHHS HRSA 1,745 -3.5% 1,745 17.1%LABOR 1,875 -36.3% 1,875 -36.3%USDA -100.0% 312 100% -100.0% 312 -81.8%OTHER 350 69.0% 156 2313.0% 366 -40.5% -100.0% 165 -45.2% 1,037 -27.2%

TOTAL

30,864 -11.9%

13,149 25.6%

383,967 -0.8%

3,638 13.3%

1,160 -9.7%

432,779 -1.0%



13

Table 8 Award Dollars by School and Sponsor Type

FY05 and FY04† (000s)

Government Private Federal Other Gov’t. Industry Nonprofit Total

Schools FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04 Administration

786 615 28 48

225 19 1,040 682

Art

2 2

128 130 2

Arts & Sciences

30,864 35,024 896 1,136 3,596

3,121 7,336 3,822 42,693 43,103

Business

285 370

310 309 595 678

Engineering

13,149 10,469 1,117 1,127 1,811

2,393 1,645 2,443 17,722 16,433

Law

90 300

9 157 30 247 339

Medicine

383,967 387,241 15,080 14,950 9,882

8,974 38,798 32,391 447,727 443,556

Social Work

3,638 3,211 10 37 (35)

421 2,967 1,753 6,580 5,423

Total

432,779 437,230 17,133 17,300 15,254

14,918 51,567 40,767 516,733 510,216



14

Table 9 School of Arts and Sciences

Award Dollars by Department and Sponsor Type FY05 and FY04†

(000s)

Government Private Total Department Federal Other Gov’t. Industry Nonprofit FY05 FY04Anthropology Arts & Sciences Biology Career Center Chemistry Classics Earth & Planetary Science Education English Graduate School Mathematics Philosophy Physics Psychology The Center For Humanities Weidenbaum

164

6,14411

6,36529

2,5392,450

532994

405,8095,361

223204

374

113

310

1184

3

2,136

382

923

156

10841

4,493

265

522

3964

769940

95

27241

13,14711

7,12529

4,2942,450

7271,058

406,5896,385

321204

50441

16,08913

6,79365

4,5052425

959673113

6,7196,192

10377

TOTAL 30,864 896 3,596 7,336 42,693 43,103 †Data from past years have been revised to reflect new money only. (See Appendix One)


15

Table 10 School of Engineering


(000s)

Government Private Total Federal Other Gov’t Industry Nonprofit FY05 FY04

Biomedical Engineering

Chemical Engineering

Civil Engineering

Computer Science & Engineering

Electrical & Systems Engineering

Environmental Engineering

Mechanical & Aerospace Engineering

Other

2,077

595

279

3,874

4,094

1,235

607

387

86

510

195

158

122

46

-50

446

1,267

148

27

112

230

801

537

-78

15

2,141

1,663

279

5,566

5,044

1,931

651

447

3,081

982

982

6,475

1,586

832

1,991

503

TOTAL 13,149 1,117 1,811 1,645 17,722 16,433 †Data from past years have been revised to reflect new money only. (See Appendix One)


16

Table 11 School of Medicine


(000s) Government Private FY05 FY04

Departments FederalOther Gov't

Industry Non-profit Total Total

Anatomy & Neurobiology 12,679 371 1,187 14,237 13,519Biochemistry & Molecular Biophysics 6,016 15 140 179 6,350 6,572Cell Biology & Physiology 9,471 218 454 885 11,029 10,174Genetics 49,625 2,210 203 1,312 53,350 66,162Molecular Biology & Pharmacology 11,802 119 636 2,384 14,940 11,881Molecular Microbiology 11,823 212 468 661 13,164 12,521Subtotal Preclinical 101,417 3,146 1,901 6,607 113,070 120,829Anesthesiology 5,261 69 71 398 5,799 6,127Internal Medicine 83,571 1,457 3,031 11,798 99,856 95,123Neurological Surgery 1,096 88 23 145 1,351 2,486Neurology 19,109 1,682 25 2,339 23,154 25,913Obstetrics & Gynecology 3,304 403 3,707 2,251Ophthalmology & Visual Sciences 11,590 24 751 583 12,949 13,977Orthopedic Surgery 2,659 (3) 309 961 3,926 4,424Otolaryngology 6,750 325 32 167 7,274 8,123Pathology & Immunology 23,666 38 1,460 2,974 28,139 25,923Pediatrics 19,478 3,202 930 3,440 27,051 33,082Psychiatry 33,933 2,796 113 1,492 38,331 40,112Radiation Oncology 5,552 - 445 509 6,507 4,599Radiology 26,898 313 442 1,202 28,855 24,036Surgery 14,565 884 269 3,581 19,298 19,088Subtotal Clinical 257,429 10,875 7,900 29,993 306,197 305,264Administration* 7,540 (68) 125 7,596 1,544Biology/Biomedical Sciences 4,194 4 (54) 4,143 4,307Biostatistics 5,172 602 90 662 6,526 5,142Center For Clinical Studies 73 73 123Center For Health Behavior Research 1,925 898 2,823 2,095Center For Study Of Health Policy 149 149 Div Of Comparative Medicine 19 19 Emergency Medicine 15 15 138Medical Library 108 108 181Occupational Therapy 705 197 5 140 1,047 1,797Physical Therapy 1,193 55 20 1,268 721Proteomics Core Lab 521 40 562 9Siteman Cancer Center 3,852 280 4,132 1,405Subtotal Other 25,120 1,059 82 2,198 28,460 17,462Total 383,967 15,080 9,882 38,798 447,727 443,556

*Administration: Clinical Research Faculty, Division of Comparative Medicine, Experimental Neurol/Neuro Surgery, Facilities Management, Health Administration Program, Human Studies Committee, New Parking Garage, Student Affairs, Medical School Administration, MBP-Protein Neucleic Acid Chemia, Neurotrophic Factors. †Data from past years have been revised to reflect new money only. (See Appendix One)


17

Each year, the National Science Foundation produces a ranking of the top 100 research universities receiving federal research support. The most recent federal fiscal year data reported by NSF is for FY03. Washington University ranked 9th in federal funding (table 12). Compared to other private institutions during the same time period, Washington University ranked fourth (table 13).

Table 12

Washington University Ranking in the Top 100 Universities Receiving Federal Support

FY2003

Source: National Science Foundation (SRS), “Survey of Federal Support to Universities,

Colleges and Nonprofit Institutions: Fiscal Year 2003” (Arlington, VA) 2005.

Washington University Rankings

Rank InstitutionAll Federal Obligations

1 Johns Hopkins University 1,137.42 University of Washington 631.1 3 University of Michigan 520.8 4 University of Pennsylvania 495.3 5 U. CA - Los Angeles 475.7 6 Stanford University 467.2 7 U. CA - San Diego 466.5 8 U. WI-Madison 422.1 9 Washington University St. Louis 419.0 10 Columbia University New York 412.7 11 Duke University 412.1 12 U. Pittsburgh 394.7 13 U. CA -San Francisco 393.114 Harvard University 384.915 U. Colorado 367.916 Yale University 349.617 Boston University 347.218 PA State U. - University Park 345.919 U. Minnesota 345.820 U. North Carolina- Chapel Hill 344.6

18

Table 13 Washington University Ranking Among Private Universities

Receiving Federal Support FY2003

Rank Institution All Federal

Obligations 1 Johns Hopkins University 1,137.4 2 University of Pennsylvania 495.3 3 Stanford University 467.2 4 Washington University in St. Louis 419.0 5 Columbia University- New York 412.7 6 Duke University 412.0 7 Pittsburgh- all campuses 394.7 8 Harvard University 384.9 9 Yale University 349.6 10 Boston University 347.2 11 Cornell University- all campuses 334.1 12 Baylor College of Medicine 297.3 13 Massachusetts Institute of Technology 291.9 14 University of Southern California 279.4 15 Vanderbilt University 263.8 17 Emory University 215.0 18 Northwestern University 213.6 19 Scripps Research Institute, The 209.9 20 University of Chicago 208.1

Source: National Science Foundation (SRS), “Survey of Federal Support to Universities, Colleges and Nonprofit Institutions: Fiscal Year 2003” (Arlington, VA) 2005.


19

The most recent data reported by NIH is for federal fiscal year 2004. Washington University Medical School ranked 4th among all medical schools receiving NIH funding.

Table 14

National Institute of Health (NIH) Ranking of Medical Schools

Receiving Federal NIH Support FY2004

Source: “NIH Awards to All Medical School by Rank, Fiscal Year 2004,” from Award Trends, NIH Office of Extramural Research (OER) web page.


Rank Medical School Number Awards Amount 1 Johns Hopkins University School of Medicine 991 $449,470,7822 U. of Pennsylvania School of Medicine 947 $393,623,6713 U. of CA San Francisco School of Medicine 836 $379,851,6084 Washington University School of Medicine 820 $371,719,4725 University Washington School of Medicine 689 $307,873,0696 Duke University School of Medicine 662 $304,740,6677 Yale University School of Medicine 741 $287,811,3258 UCLA School of Medicine 683 $285,852,7209 University Pittsburgh School of Medicine 726 $270,642,80210 Stanford University School of Medicine 611 $265,499,85811 Baylor College of Medicine 558 $248,451,31312 U. of Michigan Medical School 651 $245,342,43313 Case Western Reserve School of Medicine 606 $232,074,07014 U. of CA San Diego School of Medicine 467 $231,023,20915 Vanderbilt University School of Medicine 554 $226,826,14216 Columbia U. College of Physicians & Surgeons 557 $226,575,84817 U. of North Carolina School of Medicine 532 $212,868,56518 U. of Alabama School of Medicine 457 $207,078,63719 Emory University School of Medicine 472 $178,147,06920 U. of Colorado HLTH Sci School of Medicine 445 $172,322,57721 U. of Texas SW Medical Center/Dallas 433 $172,246,99522 Albert Einstein College of Med Yeshiva U. 372 $170,228,59623 Oregon HLTH Sci U. School of Medicine 444 $162,756,28224 Harvard Medical School 368 $161,450,32825 Mt. Sinai School of Medicine NYU 393 $153,194,929

20

During Fiscal Year 2005, the Office of Technology Management received 124 new invention disclosures. Of these disclosures, 71% originated in the School of Medicine, 6% from the School of Engineering and Applied Sciences, and the remainder from the School of Arts & Sciences and the School of Social Work. The Office handled 22 % more disclosures than the prior year. The University filed 97 new United States patent applications. The Patent Office issued 20 patents on behalf of the University. Foreign offices issued 34 patents on behalf of the University. The University generated $11.7M in total technology transfer revenue. This amount exceeds the previous fiscal year by 22%. The University entered into a total of 43 revenue generating license agreements during the year, down 23% from the previous year. Of the new license agreements, 74% were non-exclusive. Open source software licenses—most involving gene sequencing and related topics—numbered 2,074. Licensing related distributions to individual inventors, Washington University Schools and third parties totaled $9.3M. Legal expenses totaled $1.9M, of which $0.9M was reimbursed by licensees. Technology transfer revenues generated by each School were as follows: School of Medicine $10.2M School of Engineering and Applied Sciences $1.0M School of Arts and Sciences $0.4M School of Social Work $0.002M

OTM continues its community involvement through such organizations as RCGA, BioGenerator, Danforth Plant Sciences Center Alliance, Coalition for Plant and Life Sciences, Missouri Venture Forum, Midwest Research Universities Network and the Research Alliance of Missouri. Involvement with these various organizations extends to local, state and regional levels. In its relationships with these organizations, OTM works to build the economy and to develop channels for commercializing Washington University technologies. OTM staff members work continuously with the Business School’s entrepreneurship program and the larger Kaufmann Foundation entrepreneurship undertaking. The work by the students contributes to the assessment of ideas within a commercial context—whether in a start-up situation or the licensing of ideas to large, established companies. Most of the students involved have—or are pursuing—advanced technical degrees in the life sciences, chemistry, math, physics or computer sciences. The Bear Cub Fund has matured into a well-recognized arm of the University’s commitment to technology development and community growth. During this fiscal period at least two local start-up companies have benefited from Bear Cub proof of concept work. The fund maintains its pace of allotting approximately $250,000 per year to about five award winners in amounts ranging from $20,000 to $50,000. The fund has proved useful in enabling investigators to conduct proof of concept experiments in areas where commercial promise exists. During the fiscal year, 21 projects were reviewed—16 from the Medical School and 5 from Engineering. Of these, 8 projects were awarded funding, with total outlays amounting to $275,000. The awardees are listed below. Six awardees are from the School of Medicine and two are from the School of Engineering. OTM received no applications from the School of Arts and Sciences or School of Social Work.

Technology Management Executive Summary

21

Bear Cub Fund Awardees Jeff Mumm and Stephen Johnson Department of Genetics and Anatomy and Neurobiology Feasibility study to use genetically engineered Zebra fish as a vertebrate cellular regeneration disease model for the identification of targets and therapeutics. David Zar Computer Science and Engineering Development of a prototype crystal controlled clock that controls very high speed computing in large integrated circuits. This technique blends clockless with clocked subsystems to prevent synchronizer failure. Arthur Neufeld Ophthalmology and Visual Sciences, Molecular Biology and Pharmacology Studies to support the confirmation of the epidermal growth factor receptor kinase as a new therapeutic target to treat glaucoma and to prevent nitric oxide toxicity of the retinal ganglion cells. Thomas Baranski and Ross Cagan Internal Medicine, Molecular Biology and Pharmacology Development and use of a high throughput developmental screen to select and identify small molecule drug candidates which block the sensitivity to high glucose in an intact organism. The screen identifies both vascular and neuroendocrine targets that participate. John Heuser Cell Biology Completion of a prototype “freezing machine” which allows one to fix tissues for ultra structural studies that retain all of their insitu subcellular detail. The technology, which is of great interest to electron microscopy machine manufacturers, exploits freezing samples under very high pressure to prevent ice crystal damage. Eric Leuthardt, Dennis Rivet and Guy Genin Mechanical Engineering, Neurosurgery and Radiology Completion of a prototype “HaLOW” device which tethers the head of spinal cord injury patients to a base mounted like a back pack on the individual. This replaces the clam shell devices which have not been improved for 40 years and affords the patient better support and quality of life. This invention came out of the Biomedical Engineering senior design course. Richard Todd Department of Psychiatry Funds will be used to complete a genetic correlation screen to prove the correlation between genetic polymorphisms and the tendency to use nicotine (smoking). If confirmed, this increases the size of genetic screening for nicotine use to about 50% of the world population. Jaime Landman Department of Urology and Minimally Invasive Surgery The funds are being used to develop a “bloodless” scalpel, or parenchymal transecting device, for expanding minimally invasive surgical procedures. The bipolar electrodes use an external controller to cauterize tissue without heat that expands the procedures available for laparoscopic surgery.


22

Technology Highlights for Fiscal Year 2005 Profound effect of microbiota on fat storage and metabolism Studies using combinations of gnotobiotic normal and genetically modified mice reveal that the gut microbiota exerts a profound effect on fat storage and metabolism. This control of metabolism appears to work through a pathway that involves microbial regulation of a circulating lipoprotein lipase inhibitor. Jeffrey Gordon, Fredrick Backhed, Justin Sonnenburg, John Rawls, and Lora Hooper. Molecular Biology & Pharmacology. Novel uses of perfluorocarbon nanoparticles Nanoparticles have been developed which offer a variety of novel approaches to the detection and treatment of vascular disease and other disorders. These perfluorocarbon nanoparticles have unique properties that make them highly sensitive for imaging disease or following the course of therapy. Novel uses of both targeted and nontargeted particles have been described. Sam Wickline and Greg Lanza. Internal Medicine. Method for Noninvasive Electrocardiographic Imaging Over 7 million people worldwide die annually from rhythm disorders of the heart and many more are disabled. Despite this alarming statistics, there is no noninvasive imaging modality (similar to CT or MRI) for cardiac arrhythmias to identify patients at risk of sudden death, or to provide specific diagnoses and guide therapeutic intervention. Electrocardiographic Imaging (ECGI) is such a novel imaging modality. The present invention improves this approach so that it can be used on complex geometries (e.g. the atria; diseased ventricles), increases its accuracy, and accelerates its application so that it can be used interactively during a medical episode or intervention (an extremely important property for clinical application). The new technology is the novel application of a mathematical method and computer algorithm for a new noninvasive imaging modality for diagnosis and treatment of cardiac arrhythmias. Yoram Rudy, Yong Wang. Biomedical Engineering. Electrode Array Device for array chip stability This is a process for performing an isolated Pd (O) catalyzed reaction electrochemically on an electrode array device. This chemical process can be used for building chip-based molecular libraries and is the first example of a transition metal catalyst being used at selected electrodes on an addressable semi-conducting chip. The invention shows that the use of a confining agent to the solution above the chip can keep the catalyst from migrating to undesired sites on the chip. Kevin Moeller, Jun Tian, Eden Tesfu, Karl Maurer. Chemistry Department.


23

Process for performing an isolated Pd (II)-mediated oxidation reaction This invention allows for the spatial isolation of Pd (II) oxidant to pre-selected sites on a semi-conducting chip. It is the first example of a transition metal oxidation, particularly Pd (II), being conducted at selected electrodes on the addressable semi-conducting chips. The invention shows that the use of a reductant in the solution over the chip (namely ethyl vinyl ether) serves as an effective means for confining the Pd (II) generated on the chip to selected electrodes. Kevin Moeller, Eden Tesfu, Karl Maurer, Steve Ragsdale. Chemistry Department. Methanobrevibacter smithi, a mesophilic methanogenic Archeon isolated from the human intestine Obesity is a worldwide health problem with an estimated 500 million adults being over weight and 250 million classified as obese. This invention relates to the use of mesophilic methanogenic archaea to modulate nutrient harvesting in the gut of individuals. In particular, the invention provides methods that use archaea to modulate the nutrient harvesting functions of the microbiota in a subject’s gastrointestinal tract. Jeffrey Gordon, Samuel Sparrow. Molecular Biology and Pharmacology. D.O.C.S. (Dobbs clubfoot orthotic system) Clubfoot is one of the most common serious congenital deformities of the musculoskeletal system. Once the deformity is corrected, a brace is required to keep the deformity from recurring. This brace must be worn for up to 4 years. Compliance with foot abduction bracing is essential to prevent relapse of the clubfoot deformity. If the brace is not worn, recurrence is inevitable and the child is faced with major reconstructive foot surgery to correct the clubfoot. It was shown that those children that have the major surgery suffer stiffness, pain, and arthritis in early adulthood. It was also shown that the main reason for noncompliance with bracing is the formation of blisters on the back of heels caused by rubbing in the traditional brace. This has led to the improved design of D.O.C.S. - a brace that would fit the children better and therefore prevent blister formation. Matthew Dobbs. Orthopaedic Surgery. Low-voltage defibrillation by unpinning anatomical reentry During cardiac arrhythmias determining the precise moment when a defibrillation shock will be most effective, the voltage required for the defibrillation can be much lower – estimated to be about 90% lower – than is presently used. Since higher defibrillation voltages can have undesirable side effects, a lower, more precise, the defibrillation voltage should be better for the patient. This low-voltage defibrillation system is now being tested in large-animal model studies. Igor Efimov, Vladimir Nikolski, Alain Pumir, Valentin Krinski. Biomedical Engineering. Upflow Microbial Fuel Cell (UMFC) The microbial fuel cells currently in wide use for waste water treatment are net energy consumers. The UMFC is a new design that in small scale lab models has proven to be a net energy producer. A Bear Cub grant has been awarded to Dr Angenent to develop a large scale model. Largus Angenent, Zhen He. Chemical Engineering.


24

Wrong Site Procedure Prevention Method Current procedures in most hospitals are for the surgeon, the patient and the operating room nurse to meet immediately prior to surgery to agree on the site of surgery. For many reasons, but primarily time pressures, these procedures are sometimes not followed, and surgery to the wrong side of body part occasionally ensues. The system developed at WUSTL requires a positive action to turn off an inexpensive alarm system prior to surgery. If not turned off, an alarm sounds as the patient enters the operating room. The system has been licensed to CheckSite Medical Systems, a startup company based in St Louis, and is now in clinical trials in local hospitals. Richard Chole. Otolaryngology. Osteogenic Screw System Using Variable Anodized Screws Screws have long been used to hold bones together while healing. This new design allows a low voltage current to be passed through the screw and delivered to specific locations in the bone. This current from an external power source drastically speeds up the bone regeneration and healing process. The process is being tested in small mammals for use in spinal surgery. Eric Leuthardt, Daniel Moran. Neurosurgery, Biomedical Engineering. Biochemical Diagnosis of Sleep Deprivation A biological marker for quantitating sleep deprivation in humans has been identified. This marker could eventually be used in clinical labs to help treat sleep conditions and abnormalities or as a measure of efficacy for sleep therapeutics. The marker might even be used for the consumer market to test sleep deprivation in drivers and long-shift workers. Paul Shaw. Anatomy & Neurobiology. In vitro-reconstituted mammalian NAD biosynthesis system This in vitro assay system can be used to screen therapeutic candidates for use in treating diabetes. It includes pathway information, cell assay systems and mouse models. In addition, several potential therapeutic molecules have been identified using this assay and are currently being examined in further studies. Shin-ichiro Imai, Javier Revollo, Andrew Grimm. Molecular Biology & Pharmacology. Plaque purified MNV-1 strains A novel virus has been discovered that appears to be endemic in mouse colonies. Several institutions are already using assays to detect the presence of the virus in barrier mouse colonies. In some types of knock-out mice the virus is correlated with high morbidity and possibly mortality. Herbert Virgin IV. Pathology & Immunology. Monoclonal and polyclonal antibody against MNV-1 capsid Biological reagents have been generated which are required for identifying mice exposed to the new norovirus discovered by Virgin. They are also useful in determining strain variants. Herbert Virgin IV. Pathology & Immunology.


25

Plasmid containing MNV-1 This plasmid can serve as a template and source of information for designing confirmatory PCR primers for detection of MNV in mouse tissues. The plasmid can also be used as a positive control. Herbert Virgin IV. Pathology & Immunology. Treatment of cancer with stimulators of apoptosis Naturally occurring compounds have demonstrated to exhibit significant apoptotic effects on cancer cells in culture and in mouse models. These molecules might be used as an effective single or combination therapeutic in certain cancer types. Shrikant Anant, Arun Balakrishnan. Internal Medicine. Novel function of the mammalian NAD-dependent protein deacetylase A new therapeutic target and compound that may promote insulin secretion from pancreatic beta cells. Shin-ichiro Imai, Marshall Permutt, Kathryn Moynihan. Molecular Biology & Pharmacology, Endocrinology Diabetes & Metabolism Division Cytoplasmic Factor that Protects Injured Neurons This technology describes a molecule, or a class of molecules, that can be used to protect neurons that have suffered injury. Studies show that increasing the NAD (nicotinamide adenine dinucleotide) concentration by overexpression of Nmnat1 (nicotinamide nucleotide adenylyltransferase), the enzyme that converts nicotinamide mononucleotide (NMN) to NAD, in neurons can protect against axonal degeneration secondary to axotomy or toxic injury. Jeffrey Milbrandt. Pathology & Immunology. Use of rapamycic and rapamycin analogs for the treatment of neurofibromatosis 1-associated tumors Currently, no effective biologically-active therapies exist for treating NF1 tumors. Rapamycin, rapamycin analogs and other novel compounds have been found to be effective in treating NF1 tumors in mice. These compounds act on the mTOR pathway and restore normal growth in NF1 deficient cells. David Gutmann, Jason Weber. Neurology, Internal Medicine. Inhibition of DKK1 binding to Wnt signaling receptors LRP5 and LRP6 peptides This technology may be a novel treatment for osteoporosis and alter bone mass diseases. A certain protein and shortened variations have demonstrated promising results in cell culture. Guojun Bu, Yonghe Li. Pediatrics Department, Internal Medicine Treatment of cancers with purified phytochemicals from the plant Phyllanthus amarus. Studies have revealed that a novel cancer treatment method and protection against reoccurrence can be achieved with selected natural molecules. Shrikant Anant, Sripathi Sureban, Brian Dieckgraefe. Internal Medicine. Interleukin-10 (IL-10) and IL-10 receptor as Therapeutic targets for Anti-Angiogenic Therapy The present invention generally describes novel methods for treatment of neovascularization in various tissues of a patient’s eye. Rajendra Apte, Thomas Ferguson. Ophthalmology & Visual Sciences.


26

FY00 FY01 FY02 FY03 FY04 FY05Arts & Sciences 8 5 10 7 6 28Engineering 4 8 10 12 9 8Medicine 70 63 62 71 86 79Social Work 1 1 0 0 0 0Inventions Across Disciplines 1 1 9Total 83 77 82 91 102 124

84

70

1

58

63

1

10

10

62

0

7

12

71

01

69

86

01

28

8

79

09

0

20

40

60

80

100

120

140

FY00 FY01 FY02 FY03 FY04 FY05

Arts & Sciences Engineering

Medicine Social Work

Inventions Across Disciplines

Under the University IP Policy, creators are required to disclose to OTM inventions made using significant University resources. OTM evaluates each new “disclosure” to determine:

• accuracy of the disclosure; • potential commercial value; • to protect the intellectual property; • the best mode for its commercialization; and • whether the University wishes to retain title to invention

Table 15

Figure 11

Invention Disclosures by School

27

Disclosures by Department

Disclosures by Department FY03 FY04 FY05Total new disclosures for FY 91 102 124

Department FY03 FY04 FY05Arts & Sciences

Biology 3 1 22Chemistry 0 1 4Earth & Planetary Sciences 1 2 0Physics 2 0 0Psychology 1 2 1

0 0 1

Arts & Sciences Total 7 6 28Engineering & Applied Science

Biomedical Engineering 0 3Chemical Engineering 1 0 1Computer Science 5 5 3Electrical Engineering 6 2 0Mechanical & Civil Engineering 0 0 0Mechanical Engineering 0 2 1System Science & Mathematics 0 0 0

Engineering & Applied Science Total 12 9 8Medicine

Anatomy & Neurobiology 1 2 1Anesthesiology 2 2 0Biochemistry & Molecular Biophysics 0 0 1Bioorganic Chemistry & Molecular Pharmacology 0 6 0Cell Biology & Physiology 3 3 4Comparative Medicine 0 0 0Genetics 2 3 0Institute of Biological Computing 0 0 0Internal Medicine 18 21 20Molecular Biology & Pharmacology 4 3 5Molecular Microbiology 3 1 2Neurology 2 3 3Neurosurgery 1 3 0Obstetrics & Gynecology 0 1 0Occupational Therapy 1 0 0Ophthalmology & Visual Sciences 1 1 6Orthopedic Surgery 0 0 1Otolaryngology 0 1 4Pathology & Immunology 6 11 13Pediatrics 10 3 7Psychiatry 2 1 3Radiation Oncology 3 2 0Radiology 11 9 5Siteman Cancer Center 1 0 0Surgery 0 10 4

Medicine Total 71 86 79Social Work

Social Work 0 0 0

Social Work Total 0 0 0

Internal Medicine / Molecular Biology & Pharmacology 0 0 3Internal Medicine / Pathology & Immunology 0 0 1Surgery / Pathology & Immunology 0 0 1Internal Medicine / Biostatistics 0 0 1Internal Medicine / Neurology 0 0 1Surgery / Electrical Engineering/Genetics 0 0 1Neurosurgery / Biomedical Engineering 0 0 1

1 0 00 1 0

Joint Disclosure Total 1 1 9Total 91 102 124

Inventions Across Disciplines

Electrical Engineering / Computer SciencePhysics/Biochemistry / Molecular Biophysics

Mathematics

Table 16

28

FY00 FY01 FY02 FY03 FY04 FY05Arts & Sciences 6 2 5 6 8 9Engineering 4 3 9 7 11 7Medicine 62 52 31 52 91 70Social Work 0 0 0 0 0 0US Patents- Joint 0 7 11Total 72 57 45 65 117 97

64

62

23

52

59

31

67

52

0

8

11

91

7

97

70

11

0

20

40

60

80

100

120


Arts & Sciences Engineering Medicine

Social Work US Patents- Joint

US Patent OTM filed a total of 97 U.S. provisional and non-provisional patent applications. Patent applications are filed on inventions that have potential commercial value as well as social value. Frequently, the first step is to file for a provisional patent. This filing is not actually examined by the Patent Office, but rather serves to establish a filing date and “patent pending” status for a year. Provisional filings, because of their relative ease and speed, are particularly useful for managing the sometimes conflicting demands between publication and commercialization. OTM will later file for a non-provisional patent that will be examined by the patent office before it is granted. Patent protection strengthens the University’s position with respect to potential licensees, particularly in a field such as pharmaceuticals where the investment to bring a product to market can be large. OTM will seek foreign patents if warranted.

Table 17

Figure 12

US Patent Applications by School

29

Department FY03 FY04 FY05Total US Patent Applications for FY 65 117 97


Biology 6 6 6Chemistry 0 1 3Earth & Planetary Sciences 0 0 0Physics 0 0 0Psychology 0 1 0

Arts & Sciences Total 6 8 9Engineering & Applied Science

Biomedical Engineering 0 0 2Chemical Engineering 0 0 1Computer Science 4 6 4Electrical Engineering 2 5 0Mechanical Engineering 0 0 0Mechanical & Civil Engineering 1 0 0Systems Science & Mathematics 0 0 0

Engineering & Applied Science Total 7 11 7Medicine

Anatomy & Neurobiology 3 2 0Anesthesiology 2 3 2Biochemistry & Molecular Biophysics 1 2 0Bioorganic Chemistry & Molecular Pharmacology 0 7 6Cell Biology & Physiology 0 3 2Comparative Medicine 0 0 0Genetics 1 6 1Inst. For Biomedical Computing 0 0 0Internal Medicine 11 11 8Molecular Biology & Pharmacology 4 8 16Molecular Microbiology 3 6 0Neurology 5 2 2Neurosurgery 0 3 2Obstetrics & Gynecology 0 0 0Ophthalmology & Visual Sciences 2 0 5Orthopedic Surgery 0 0 0Otolaryngology 0 1 1Pathology & Immunology 6 18 7Pediatrics 3 5 3Psychiatry 1 1 0Radiology 8 7 11Radiation Oncology 1 3 1Renal Division 1 1 0Surgery 0 2 3


Social Work 0 0 0Social Work Total 0 0 0

US Patents filed on Joint Inventions0 1 10 1 00 3 40 1 0

Neurology / Internal Medicine 0 1 2Surgery / Biomedical Engineering 0 0 1Neurosurgery / Biomedical Engineering 0 0 1Pathology & Immunology / Moleculary Biology & Pharmacology 0 0 2

Joint US Disclosures Total 0 7 11Total 65 117 97

Internal Medicine / Molecular Biology & PharmacologyBioorganic Chemistry / Molecular Pharm. / Internal Medicine

Computer Science / Electrical EngineeringAnesthesiology / Pediatrics

Table 18

US Patent Applications by Department

30

4

44

80

1

56

59

0

45

26

3

53

34

4

29

20

1

33

8

0

20

40

60

80

100

120

140


Arts & Sciences Engineering Medicine Social Work

Patented and unpatented inventions are transferred to industry through a variety of licensing arrangements. The rights to a license are defined by the allowed field of use and by the exclusivity of the license. Payment terms are also highly varied including one or a combination of license fees due on signing, maintenance fees, milestone payment and earned royalties on sales. Defined here are major categories used in this report. Exclusive: A fee-and royalty-bearing exclusive license grants a license the sole right to commercialize a technology (may include sublicensing rights). Non-Exclusive:

• Fee-and royalty-bearing license: grants of rights to commercialize the technology; may be granted to multiple licenses,

• Paid-up license: a non-exclusive license granted in return for a one-time, up-front license fee without subsequent fees or royalties,

• No-fee license: rights are granted to a third-party (usually another non-profit educational institution) to use a technology (frequently computer software) that is generally licensed to others for a fee.

License Modifications:

• Amendment: an agreement modifying the terms of an existing license. • Assignment: a reassignment of rights caused by a change in ownership of

the license through merger or acquisition. The majority of licenses granted by the University are to existing commercial companies located in the United States, with a smaller number to foreign entities. The University is also beginning to focus more on partnerships with Missouri and St. Louis companies and is actively supporting and encouraging the creation of new business ventures. Licensing technology to start-up companies can provide the best mode of commercialization for early-state platform technologies.

Figure 13

Licenses by School

31

FY00 FY01 FY02 FY03 FY04 FY05Arts & Sciences 1 1 1 2 3 1Engineering 4 1 0 3 4 1Medicine 44 56 45 53 29 33Social Work 80 59 26 34 20 8

TOTAL 129 117 72 92 56 43

Arts & Sciences

2%

Engineering2%

Social Work19%

Medicine77%

Table 19

Figure 14 Percent of Licenses by School

Licenses by School

32

Department FY03 FY04 FY05

Total Licenses for FY 92 56 43


Biology 2 3 0Earth & Planetary Sciences 0 0 1Psychiatry 0 0 0

Arts & Sciences Total 2 3 1

Engineering & Applied ScienceBiomedical Engineering 0 0 0Computer Science 0 0 1Electrical Engineering 2 4 0Mechanical Engineering 1 0 0

Engineering & Applied Science Total 3 4 1

MedicineAnatomy & Neurobiology 0 2 1Biochemistry & Molecular Biophysics 0 1 1Cell Biology & Physiology 4 1 0Dermatology 0 0 0Genetics 11 4 5Institute of Biological Computing 0 1 3Internal Medicine 9 5 5Molecular Biology & Pharmacology 4 2 2Molecular Microbiology 3 3 1Neurology 1 0 2Ophthalmology & Visual Sciences 3 1 0Otolaryngology 3 0 2Pathology & Immunology 8 6 6Pediatrics 3 0 3Psychiatry 0 0 0Radiology 4 1 2Surgery 0 2 0


Social Work 34 20 8Social Work Total 34 20 8

Subtotal 92 56 43

No Fee Licenses 147 679 2074

Total Licenses 239 735 2117

Table 20

Licenses by Department

33

Non-ExclusiveDepartment Exclusive Roy. Bearing Paid-up No Fee

Arts & SciencesBiology 0 0 0 0Earth & Planetary Sciences 1 0 0 0Psychiatry 0 0 0 0

Arts & Sciences Total 1 0 0 0

Engineering & Applied ScienceBiomedical Engineering 0 0 0 0Computer Science 1 0 0 1Electrical Engineering 0 0 0 0Mechanical Engineering 0 0 0 0

Engineering & Applied Science Total 1 0 0 1

MedicineAnatomy & Neurobiology 0 1 0 0Biochemistry & Molecular Biophysics 0 1 0 0Cell Biology & Physiology 0 0 0 0Dermatology 0 0 0 0Genetics 1 4 0 2056Institute of Biological Computing 0 3 0 10Internal Medicine 1 4 0 3Molecular Biology & Pharmacology 1 1 0 0Molecular Microbiology 0 1 0 0Neurology 1 1 0 0Ophthalmology & Visual Sciences 0 0 0 0Otolaryngology 1 0 1 0Pathology & Immunology 3 3 0 0Pediatrics 0 3 0 0Psychiatry 0 0 0 1Radiology 1 1 0 0Surgery 0 0 0 0

Medicine Total 9 23 1 2070

Social WorkSocial Work 0 0 8 3

Social Work Total 0 0 8 3

Total 11 23 9 2074

Total Licenses by Department 2117

Table 21

License Type by School

34

FY01 FY02 FY03 FY04 FY05Arts & Sciences 223,286$ 171,433$ 810,051$ 91,445$ 458,213$ Engineering 840,410$ 861,541$ 70,634$ 764,034$ 961,856$ Medicine 7,938,441$ 6,997,028$ 937,343$ 8,689,587$ 10,233,584$ Social Work 182,055$ 100,070$ 12,508,499$ 36,520$ 1,710$

TOTALS 9,184,192$ 8,130,072$ 14,326,527$ 9,581,586$ 11,655,363$

$-

$2,000,000

$4,000,000

$6,000,000

$8,000,000

$10,000,000

$12,000,000

$14,000,000

$16,000,000


Arts & Sciences Engineering Medicine Social Work

Under most licenses, OTM receives gross licensing income in the form of license fees, maintenance fees, milestone payments, and earned royalties against product sales. In addition, the University collects patent expense reimbursement from some licensees, particularly when the license is exclusive. Legal expenses represent the amounts paid out to external law firms engaged in the preparation and prosecution of patents. Other expenses may include specific out-of-pocket costs incurred as part of technology licensing (e.g. consulting fees, marketing fees) or non-patent legal costs.

Licensing Income Distribution

Disclosed between Agreement Signed Disclosed Prior to 7/1/98 7/1/98 and 6/30/05 After 7/1/05 Inventors: 50% 45% 35% School: 45% 40% 40% OTM: 5% 15% 25%

Table 22

Figure 15

License Revenue

35

Arts & Sciences Engineering Medicine Social Work Total

IncomeLicensing Income 451,419$ 691,573$ 8,824,125$ 1,200$ 9,968,317$

Expense Reimbursements OTM Current FY (External) -$ 192,946$ 804,901$ -$ 997,848$ Expense Reimbursements OTM Prior FY (External) -$ (3,735)$ 1,286$ -$ (2,449)$ Expense Reimbursements for Dept. (External) -$ -$ -$ -$ -$ Expense Credits 6,794$ 81,072$ 603,272$ -$ 691,138$ Other -$ -$ -$ 510$ 510$ Subtotal Income 458,213$ 961,856$ 10,233,584$ 1,710$ 11,655,363$

ExpensesLegal 107,690$ 304,047$ 1,569,402$ -$ 1,981,139$ Other 57$ 37$ 487$ -$ 581$ Subtotal Expenses 107,747$ 304,084$ 1,569,889$ -$ 1,981,720$

Distributions (1)Distribution to Inventors 126,651$ 327,807$ 4,074,997$ 600$ 4,530,055$ Distribution to Schools (Lic. Income) 155,103$ 298,694$ 3,527,913$ 540$ 3,982,250$ Distribution to Schools (Other Income) -$ -$ -$ 510$ 510$ Distribution to Third Parties 67,121$ 23,686$ 654,500$ -$ 745,307$

Expense Payback to 3rd Parties from License Revenue -$ -$ 4,930$ -$ 4,930$ Expense Payback to Dept. from License Revenue -$ -$ 268$ -$ 268$ Expense Reimbursement for Dept. (External) -$ -$ -$ -$ -$ Carry Forward - - Expenses Held/Paid in Advance -$ -$ -$ -$ -$ CFU Legal expense recovery -$ -$ -$ -$ -$ Transfer to reserve -$ -$ -$ -$ -$ Patent expense held in advance -$ -$ -$ -$ -$ Patent expense adjustment -$ -$ -$ -$ -$

Subtotal Distributions 348,874$ 650,187$ 8,262,609$ 1,650$ 9,263,320$

Contributions to OTM Operations $ 1,592 $ 7,584 $ 401,086 $ 60 410,322$

Fiscal Year 05

Table 23

License Revenue – By School

36

01 02 03 04 05

IncomeLicensing Income 7,687,256$ 6,546,707$ 12,815,429$ 8,174,816$ 9,968,317$ Expense reimbursements OTM Current FY (External) 1,080,046$ 992,793$ 800,900$ 719,325$ 997,848$ Expense reimbursements OTM Prior FY (External) -$ -$ 91,349$ (8,041)$ (2,449)$

Expense reimbursements for Dept. (External) -$ 20,503$ 15,227$ 49,266$ -$ Expense Credits 367,503$ 547,298$ 592,687$ 638,601$ 691,138$ Other 49,390$ 22,770$ 10,934$ 7,620$ 510$

Subtotal Income 9,184,195$ 8,130,071$ 14,326,526$ 9,581,586$ 11,655,363$

ExpensesLegal 1,758,822$ 1,696,924$ 1,585,941$ 1,555,481$ 1,981,139$ Other 44,165$ (105)$ 4,284$ 3,561$ 581$

Subtotal Expenses 1,802,987$ 1,696,819$ 1,590,225$ 1,559,042$ 1,981,720$

DistributionsDistribution to inventors 3,534,864$ 2,954,063$ 5,625,302$ 3,742,581$ 4,530,055$ Distribution to schools (Lic. Income) 3,147,532$ 2,542,439$ 5,062,039$ 3,276,202$ 3,982,250$ Distribution to schools (Other Income) -$ 22,770$ 10,934$ 7,620$ 510$ Distribution to third parties 501,508$ 579,395$ 889,129$ 554,331$ 745,307$

Expense Payback to Third Parties from Lic. Rev. -$ 10,807$ 608$ 1,500$ 4,930$ Expense Payback to Dept. from Lic. Rev. 4,887$ 8,019$ 75,376$ 41,107$ 268$

Expense Reimbursements for Dept. (External) -$ 20,503$ 83,089$ 49,266$ -$ Expense Reimbursement OTM fromDistribution -$ -$ 65,281$ 52,043$ -$

Carry forward - - Expenses Held/Paid in Advance -$ 11,240$ 8,827$ -$ -$ CFU legal expense recovery -$ -$ -$ -$ -$ Transfer to reserve -$ -$ -$ -$ -$ Patent Expenses held in advance -$ (4,615)$ - -$ -$ Patent expense adjustment -$ -$ -$ -$ -$

Subtotal Distributions 7,188,792$ 6,144,621$ 11,820,585$ 7,724,650$ 9,263,320$

Contribution to OTM operations 192,416$ 288,631$ 980,997$ 349,937$ 410,322$

Fiscal Year

Table 24

License Revenue – 5 Years

37

NewArts & Sciences 3Engineering & Applied Science 13Medicine 34Social Work 0

Total 50

Arts & Sciences

6%

Engineering & Applied Science

26%

Medicine68%

Social Work0%

Arts & Sciences

Engineering & AppliedScienceMedicine

Social Work

OTM handles all sponsored research agreements where the sponsor is a for-profit entity and the research does not involve human subjects (i.e. not a clinical trial). “Research” is defined primarily as laboratory activity that may result in the discovery of new intellectual property.

Table 25

Figure 16

Industry Sponsored Research Agreements – FY 05

38

FY04 FY05

Total Research Agreements for FY 31 50

Department FY04 FY05

Arts & SciencesBiology 1 0Chemistry 0 3Earth & Planetary Sciences 0 0Physics 0 0Psychology 0 0

Arts & Sciences Total 1 3Engineering & Applied Science

Biomedical Engineering 0 1Chemical Engineering 3 7Civil Engineering 0 0Computer Science 5 4Electrical Engineering 3 0Mechanical & Civil Engineering 0 0Mechanical Engineering 0 1System Science & Mathematics 0 0

Engineering & Applied Science 11 13Medicine

Anatomy & Neurobiology 0 0Anesthesiology 0 0Biochemistry & Molecular Biophysics 3 2Biostatistics 1 0Cell Biology & Physiology 0 4Comparative Medicine 0 0Genetics 1 1Institute of Biological Computing 0 0Internal Medicine 6 9Molecular Biology & Pharmacology 0 0Molecular Microbiology 0 1Neurology 1 4Neurosurgery 1 0Obstetrics & Gynecology 0 1Occupational Therapy 0 0Ophthalmology & Visual Sciences 0 2Orthopedic Surgery 0 3Otolaryngology 0 0Pathology & Immunology 1 0Pediatrics 0 2Psychiatry 0 1Radiation Oncology 0 2Radiology 1 2Surgery 4 0

Medicine Total 19 34Social Work

Social Work 0 0Social Work Total 0 0

Total 31 50

Table 26

Research Agreements by Department – FY 05

39

Confidentiality Evaluation & Option Interinstitutional Service

Agreement Other

Total Other Agreements for FY 72 7 7 40 10

Department Confidentiality Evaluation & Option Interinstitutional Service

Agreement Other

Arts & SciencesBiology 2 1 0 1 1Chemistry 0 0 0 2 0Earth & Planetary Sciences 0 0 0 0 0Physics 0 0 0 0 0Psychology

Arts & Sciences Total 2 1 0 3 1

Engineering & Applied ScienceBiomedical Engineering 4 0 0 0 0Chemical Engineering 0 0 0 1 0Computer Science 1 0 0 0 0Electrical Engineering 0 0 0 3 0Engineering & Applied Science 0 0 0 0 0Mechanical & Civil Engineering 6 0 0 0 0Mechanical Engineering 0 0 0 0 0System Science & Mathematics 0 0 0 0 0

Engineering & Applied Science Total 11 0 0 4 0

MedicineAnatomy & Neurobiology 0 0 0 0 0Anesthesiology 2 1 0 1 0Biochemistry & Molecular Biophysics 0 0 0 1 0Cell Biology & Physiology 0 0 0 1 0Comparative Medicine 0 0 0 0 0Genetics 0 0 0 0 1Institute of Biological Computing 0 0 0 0 0Internal Medicine 12 1 3 12 2Molecular Biology & Pharmacology 5 1 0 0 0Molecular Microbiology 3 0 1 0 0Neurology 1 0 0 1 1Neurosurgery 1 0 1 0 0Obstetrics & Gynecology 1 0 0 0 0Occupational Therapy 0 0 0 0 0Ophthalmology & Visual Sciences 8 0 0 0 1Orthopedic Surgery 0 0 0 2 0Otolaryngology 0 0 0 0 0Pathology & Immunology 8 3 2 4 2Pediatrics 3 0 0 4 0Psychiatry 1 0 0 1 1Radiation Oncology 2 0 0 0 0Radiology 8 0 0 3 0Siteman 1 0 0 0 0Surgery 3 0 0 3 1

Medicine Total 59 6 7 33 9

Social WorkSocial Work 0 0 0 0 0

Social Work Total 0 0 0 0 0

Total 72 7 7 40 10

OTM processes service contracts-limited laboratory research activities frequently involving the testing of another party’s proprietary material or device. OTM manages confidentiality agreements, evaluation and option, Interinstitutional, service agreements and other various contracts involving for-profit companies. These agreements play a key role in laying the foundation for better industry relationships and potential future license agreements. Interinstitutional agreements play an increasingly important role as collaboration becomes a more significant element in advanced research.

Table 27

Other Agreements – FY 05

40

Total Material Transfer Agreements for FY

Department Incoming Outgoing

Arts & SciencesBiology 12 18Chemistry 0 0Earth & Planetary Sciences 0 0Physics 0 0Psychology 0 1

Arts & Sciences Total 12 19

Engineering & Applied ScienceBiomedical Engineering 3 1Chemical Engineering 0 0Computer Science 0 0Electrical Engineering 0 0Mechanical & Civil Engineering 0 0Mechanical Engineering 0 0System Science & Mathematics 0 0

Engineering & Applied Science Total 3 1

MedicineAnatomy & Neurobiology 9 0Anesthesiology 8 4Biochemistry & Molecular Biophysics 2 0Bioorganic Chemistry & Molecular Pharmacology 0 2Cardiology 0 0Cell Biology & Physiology 15 9Comparative Medicine 0 0Genetics 4 0Institute of Biological Computing 0 0Internal Medicine 93 111Molecular Biology & Pharmacology 22 65Molecular Microbiology 19 18Neurology 14 20Neurosurgery 2 0Obstetrics & Gynecology 2 0Occupational Therapy 0 0Ophthalmology & Visual Sciences 11 13Orthopedic Surgery 8 0Otolaryngology 8 1Pathology & Immunology 43 42Pediatrics 16 15Psychiatry 3 6Radiation Oncology 9 2Radiology 13 16Surgery 15 2

Medicine Total 316 326

Social WorkSocial Work 0 0

Social Work Total 0 0

Total 331 346

677

When transferring proprietary materials in and out of the University to support research activities, the University requires execution of material transfer agreements (MTA). Incoming MTAs are no-fee agreements used when the material is received from another non-profit institution or from a commercial third party. Many of these materials are highly valuable research tools deemed essential to our research activities. Outgoing MTAs are used to distribute our materials (patented and unpatented) without charge to other non-profit institutions so that researchers can use them in their research activities. The nature of materials agreements involving transfer to for-profit companies depends on whether the use of the material will be restricted to internal research purposes.

Table 28

Material Transfer Agreements by Departments – FY 05

Sponsored Research Expense Executive Summary

41


This report presents an overview of expenditure activity for sponsored research projects at Washington University during the fiscal year of 2005 (FY05). The expense dollars reported are for all transactions that occur on or between July 1, 2004 and June 30, 2005.

Data Sources The data presented in this report was obtained from the Washington University’s Financial Information System (FIS) and it reflects the expenditure activity incurred during the performance of sponsored projects. Excluded from these figures are expenses associated with projects supported by gifts, sales and service agreements and clinical trials. Additionally, the figures in this report include expenses related to training and the U.S. Department of Education’s College Work-Study Program; however, theses activities represent only a very small fraction of total expenditures. Expenditure Activity The University’s total research expenditures for FY05 amounted to $504 million, an increase of 7% over FY04. This percentage increase is driven primarily from additional dollars ($28.5 million) from the National Institutes for Health (NIH). The NIH continues to provide the single largest funding stream, thus the costs for those projects represent 80% of total expenditures during the fiscal year. In addition to the NIH, several large projects funded by the National Science Foundation contributed to the rise in the expenditure level ($2.5 million). The University maintained a strong position in sponsored research during FY05. Detailed schedules regarding this activity have been compiled this data in several formats, see Tables 1 – 12. Noted below are definitions and descriptions of the key expenditure categories.

Sponsor / Sponsor Type Federal Direct Agreements Expenditures incurred under sponsored agreements

awarded by a Federal agency directly to the University.

DHHS - Department of Health and Human Services (Agencies other than HRSA and NIH)

DOD - Department of Defense (Includes Air Force,

Army, Navy, DARPA, and ARPA)

DOE - Department of Energy

EPA - Environmental Protection Agency

HRSA - Health Resources and Services Administration (A division of DHHS)


42


NASA - National Aeronautics and Space Administration

NIH - National Institutes of Health (A division of

DHHS)

NSF - National Science Foundation

USDA - United States Department of Agriculture

USDE - United States Department of Education Federal Subagreements Expenditures incurred under a subagreement from another

entity (usually another university) that has received an award directly from a Federal agency. The University is considered a subrecipient of federal funds.

Total Federal Expenditures incurred under direct agreements with Federal

agencies and subagreements with other entities (that have received a direct award from a Federal agency). The figure(s) is the total of the Federal and Federal Subagreements categories noted above.

Other Government Expenditures incurred under sponsored agreements with

other city, county, state and international government agencies.

Private Sources Expenditures incurred under sponsored agreements from

industry, foundations and trusts, voluntary health agencies and other entities.

Industry – Typically commercial (for-profit) entities

that fund hardware, software, fabrication and clinical device projects. Entities would include companies such as Monsanto, Lockheed Martin and Hoffman La Rouche.

Foundations & Trusts – Sponsored agreements from non-profit entities such as; the James S. McDonnell Foundation, Robert Wood Johnson Foundation and the Juvenile Diabetes Foundation.

Voluntary Health - Sponsored agreements from non-profit health/disease specific agencies such as; American Heart Association, American Cancer Society and the National Multiple Sclerosis Society.

Other – Sponsored agreements and subagreements (excluding federal pass-thru funding) from other non-


43


profit agencies such as: Schriners Hospital for Children, Howard Hughes Medical Institute and the St. Louis Zoo.

Project Type Research Projects and activities that discover new scientific areas,

procedures and devices. Research Training Support provided to pre/postdoctoral students and fellows involved

in research training programs. Other Sponsored Activities Other activities such as public service, patient service, conference

grants, community outreach programs and student aid.

Schools School of Medicine

School of Arts & Sciences

School of Engineering and Applied Science

George Warren Brown School of Social Work

Other

School of Architecture John M. Olin School of Business School of Art School of Law

Cost Category Direct Costs Expenditures incurred that can be specifically identified to a

particular sponsored agreement/project. Costs of this nature would include those such as; faculty & staff salaries (and applicable fringe benefits), consultants, consumable supplies, travel, subagreements and equipment. Direct costs are booked to the general ledger on a daily basis.

F&A Costs Abbreviated term for Facilities and Administrative (F&A) Costs

(also known as indirect/overhead costs). F&A costs are defined as expenditures incurred for common or joint objectives which cannot be specifically identified with a particular agreement/project.


44


Costs of this nature would include: utilities and building services, building and equipment depreciation, university/school/ department administration, research administration and the library. The University has negotiated F&A rates with our cognizant federal agency (the Department of Health and Human Services). The F&A costs are posted to the general ledger monthly, based upon the project’s direct or modified direct (excludes capital equipment, subcontract expenses > $25,000, patient care costs, tuition, and off-campus rent) costs and the applicable F&A rate.

Cost Sharing Defined as costs incurred under a specific cost objective which are

not supported by the sponsoring agency. Cost sharing can be described as the dollar amount the University provides to support a sponsored project. The University will commit resources to support a project under the following conditions:

Mandatory Cost Sharing: Certain sponsoring agencies, and

programs within those agencies, may require the University to contribute resources towards the project as a condition of the award. Typically, the agency will state in the sponsored agreement the minimum dollar amount or percentage of project costs that the University must contribute as cost sharing.

Voluntary Cost Sharing: The University will voluntarily pledge

resources towards the project.

The University monitors and maintains cost sharing expenditures by establishing separate accounts/funds in the general ledger. For each sponsored project, a specific cost sharing account will be established based upon the terms and conditions of the award. See Table 11 for a summary of the University’s cost sharing contributions.

Facilities and Administrative (F&A) Rates Sponsored projects awarded to the University provide funding for direct and F&A costs (see above). A percentage rate is applied to the direct costs in order to determine the F&A funding/expenses for the project. The Federal F&A rate for on-campus research can change at the start of a fiscal year, based upon our current rate agreement. Federal F&A rates are applied based on the competitive start date of the project. Non-federal sponsors will also provide funding for F&A costs, but the rates can vary based upon the internal policies of the sponsor. Noted below is a brief description of the major F&A rates.


45


56% Federal on-campus research rate for projects awarded on or before

6/30/98. Applied to modified total direct costs.

54.5% Federal on-campus research rate for projects awarded during the period 7/1/00 – 6/30/01. Applied to modified total direct costs.

54% Federal on-campus research rate for projects awarded during the period

7/1/01 – 6/30/02. Applied to modified total direct costs.

53% Federal on-campus research rate for projects awarded during the period 7/1/02 – 6/30/05. Applied to modified total direct costs.

50% Base rate for non-federal sponsors. Applied to total direct costs.

26% Federal off-campus research rate.

8% Federal rate for research training and fellowship projects.

Other Includes various rates from federal, private and other government

sponsors. Sponsored Projects Accounting The mission of Sponsored Projects Accounting (SPA) is to provide consistent and high quality financial stewardship, policy interpretation and compliance assurance to the University's research community and the sponsoring agencies. Members of the department strive to perform accurate and timely transaction approvals, financial analysis and reporting of costs incurred for sponsored projects. We monitor and maintain the accounting structure involved with revenue, expense and receivable transactions for sponsored projects so that these amounts are properly stated in the University's financial statements. In conjunction with Grants and Contracts and the Research Office, SPA develops a coordinated and consistent approach on institutional issues involving sponsored projects. The office of Sponsored Projects Accounting reports to Barbara Feiner, Vice Chancellor for Finance and Chief Financial Officer. This report and other data is available of on the SPA website, see http://www.spa.wustl.edu/.

46

Sponsors Direct Costs

% Total Direct

F&A Costs

% Total F&A Total % Total

Direct Costs

% Total Direct

F&A Costs

% Total F&A % TotalTotal

Federal $332.960 89% $123,563 96% $458,523 91% $310,321 90% $117,069 96% $427,390 91%

Private Sources 39,198 11% 5,464 4% 44,662 9% 35,679 10% 4,971 4% 40,650 9%

Other Government 565 0% 105 0% 670 0% 582 0% 121 0% 703 0%

TOTAL $372,723 100% $131,132 100% $503,855 $346,582 100% $122,161 100% $468,743 100%

FY05 FY04

100%

TABLE 1 DIRECT AND F&A EXPENDITURES

BY SPONSOR TYPE (in thousands)

47

SCHOOLSDIRECT COSTS

F&A COSTS TOTAL

DIRECT COSTS

F&A COSTS TOTAL $$ %

MEDICINE $317,717 $113,904 $431,621 $295,767 $106,215 $401,982 $29,639 7%

ARTS & SCIENCES 31,025 10,715 41,740 28,123 10,091 38,214 3,526 9%

ENGINEERING 14,183 4,647 18,830 13,633 4,097 17,730 1,100 6%

SOCIAL WORK 5,018 1,310 6,328 4,634 1,309 5,943 385 6%

OTHER 4,780 556 5,336 4,425 449 4,874 462 9%

TOTAL $372,723 $131,132 $503,855 $346,582 $122,161 $468,743 $35,112 7%

FY05 FY04 CHANGE

TABLE 2 DIRECT AND F&A EXPENDITURES

BY SCHOOL AND COST CATEGORY FY 05 and FY 04

(in thousands)

48

SCHOOLS FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04

MEDICINE $389,168 $363,702 $34,046 $32,896 $8,407 $5,384 $431,621 $401,982

ARTS & SCIENCES 36,387 33,265 1,771 1,854 3,582 3,095 41,740 38,214

ENGINEERING 17,028 16,087 786 787 1,016 856 18,830 17,730

SOCIAL WORK 3,788 3,189 921 814 1,619 1,940 6,328 5,943

OTHER 1,288 880 60 52 3,988 3,942 5,336 4,874

TOTAL $447,659 $417,123 $37,584 $36,403 $18,612 $15,217 $503,855 $468,743

Research Research Training Other Sponsored Activities Total

TABLE 3 DIRECT AND F&A EXPENDITURES BY SCHOOL AND PROJECT TYPE

FY 05 and FY 04 (in thousands)

49

DIRECT AGREEMENTS

SUB AGREEMENTS TOTAL

DIRECT AGREEMENTS

SUB AGREEMENTS TOTAL $$ %

FEDERAL AGENCIESNIH $383,170 $19,353 $402,523 $356,620 $17,398 $374,018 $28,505 8%NSF 18,172 2,219 20,391 15,371 2,557 17,928 2,463 14%USDE 6,186 89 6,275 5,679 142 5,821 454 8%NASA 5,943 2,070 8,013 4,760 2,378 7,138 875 12%DOD 4,023 1,449 5,472 4,971 1,277 6,248 (776) -12%EPA 1,989 551 2,540 3,260 354 3,614 (1,074) -30%DHHS OTHER 4,208 968 5,176 4,134 964 5,098 78 2%DOE 3,398 78 3,476 2,962 172 3,134 342 11%DHHS HRSA 1,804 885 2,689 1,676 669 2,345 344 15%USDA 773 233 1,006 598 - 598 408 68%OTHER 626 336 962 570 878 1,448 (486) -34%

TOTAL FEDERAL 430,292 28,231 458,523 400,601 26,789 427,390 31,133 7%

OTHER GOVERNMENT 670 - 670 703 - 703 (33) -5%

PRIVATE SOURCESINDUSTRY 11,180 - 11,180 11,107 - 11,107 73 1%FOUNDATIONS & TRUSTS 20,953 - 20,953 15,867 - 15,867 5,086 32%VOL HEALTH 8,107 - 8,107 8,735 - 8,735 (628) -7%OTHER 4,422 - 4,422 4,941 - 4,941 (519) -11%

TOTAL PRIVATE 44,662 - 44,662 40,650 - 40,650 4,012 10%

TOTAL $475,624 $28,231 $503,855 $441,954 $26,789 $468,743 $35,112 7%

FY05 FY04 CHANGE

TABLE 4 FISCAL YEAR 2005 EXPENDITURES

BY SPONSOR AND AGREEMENT TYPE (in thousands)

50

FEDERAL FUNDING

-

75,000

150,000

225,000

300,000

375,000

450,000

525,000

Dol

lars

(in

thou

sand

s

Federal 326,976 348,953 409,801 427,390 458,523


OTHER GOV'T FUNDING

-

300

600

900

1,200

1,500

Dol

lars

(in

thou

sand

Other Gov't 1,283 820 741 703 670


PRIVATE FUNDING

-

10,000

20,000

30,000

40,000

50,000

60,000

Dol

lars

(in

thou

sand

Private 49,155 42,221 40,372 40,650 44,662


TABLE 4A FISCAL YEAR 2005 EXPENDITURES

GRAPHS BY SPONSOR

51

FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04FEDERAL AGENCIESNIH $373,587 $346,673 $28,438 $26,654 $498 $691 $402,523 $374,018NSF 19,093 16,510 1,279 1,406 19 12 20,391 17,928 USDE 89 142 - - 6,186 5,679 6,275 5,821 NASA 7,844 7,047 169 91 - - 8,013 7,138 DOD 5,319 6,159 153 89 - - 5,472 6,248 EPA 2,534 3,609 6 5 - - 2,540 3,614 DHHS OTHER 4,436 4,165 193 314 547 619 5,176 5,098 DOE 3,476 3,134 - - - - 3,476 3,134 DHHS HRSA 160 46 20 21 2,509 2,278 2,689 2,345 USDA 1,006 598 - - - - 1,006 598 OTHER 622 1,217 78 3 262 228 962 1,448

TOTAL FEDERAL 418,166 389,300 30,336 28,583 10,021 9,507 458,523 427,390

OTHER GOVERNMENT 263 312 - 8 407 383 670 703

PRIVATE SOURCESINDUSTRY 10,174 9,741 558 650 448 716 11,180 11,107 FOUNDATIONS & TRUSTS 11,512 9,753 2,816 2,587 6,625 3,527 20,953 15,867 VOL HEALTH 4,759 4,984 3,285 3,677 63 74 8,107 8,735 OTHER 2,785 3,033 589 898 1,048 1,010 4,422 4,941

TOTAL PRIVATE 29,230 27,511 7,248 7,812 8,184 5,327 44,662 40,650

TOTAL $447,659 $417,123 $37,584 $36,403 $18,612 $15,217 $503,855 $468,743

Research Research Training Other Sponsored Activities Total

TABLE 5 FISCAL YEAR 2005 EXPENDITURES BY SPONSOR AND PROJECT TYPE

(in thousands)

52

RESEARCH TRAINING

-

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Dol

lars

(in

thou

sand

s

Research Training 26,531 30,577 32,724 36,403 37,584


SPONSORED RESEARCH

-

75,000

150,000

225,000

300,000

375,000

450,000

525,000

Dol

lars

(in

thou

sand

s

Research 339,391 348,014 402,974 417,123 447,659


OTHER SPONSORED ACTIVITIES

-

5,000

10,000

15,000

20,000

Dol

lars

(in

thou

sand

s

Other SponsoredActivities

11,492 13,403 15,216 15,217 18,612



GRAPHS BY SPONSOR TYPE

53

FY05$ Change

from FY04 FY05$ Change




from FY04 FY05$ Change from

FY04

TOTAL FEDERAL $397,442 $26,855 $36,758 $3,174 $15,955 $728 $3,848 $19 $4,520 $357 $458,523 $31,133

OTHER GOVERNMENT 605 (3) 5 (20) 17 (23) - 1 43 12 670 (33)

PRIVATE SOURCES Industry 7,532 (117) 2,291 199 1,177 119 153 (138) 27 10 11,180 73

Foundations & Trusts 15,255 4,233 1,492 147 1,208 99 2,303 541 695 66 20,953 5,086

Vol Health 7,886 (672) 34 (143) 187 187 - - - - 8,107 (628)

Other 2,901 (657) 1,160 169 286 (10) 24 (38) 51 17 4,422 (519) TOTAL PRIVATE 33,574 2,787 4,977 372 2,858 395 2,480 365 773 93 44,662 4,012

TOTAL ALL SOURCES $431,621 $29,639 $41,740 $3,526 $18,830 $1,100 $6,328 $385 $5,336 $462 $503,855 $35,112

Other Schools Total UniversitySchool of Medicine Arts & SciencesSchool of Engineering &

Applied Science GWB School of Social Work


BY SPONSOR AND SCHOOL

54

DETAILED COST CATEGORY FY05 FY04

% Of Change

from FY 04 FY05 FY04

% Of Change


% Of Change


% Of Change

from FY 04

Academic Salaries $64,492 $59,710 8% $49 $79 -38% $7,141 $6,379 12% $71,682 $66,168 8%Staff Salaries 79,530 75,033 6% 336 349 -4% 9,108 9,030 1% 88,974 84,412 5%Grad Assistant 8,978 8,307 8% - - 0% 1,250 1,210 3% 10,228 9,517 7%Subtotal Salaries 153,000 143,050 7% 385 428 -10% 17,499 16,619 5% 170,884 160,097 7%

Fringe Benefits 32,073 28,049 14% 86 94 -9% 3,806 3,428 11% 35,965 31,571 14%Stipends/Health Allowance 14,334 14,028 2% - - 0% 3,240 3,176 2% 17,574 17,204 2%Consultants 1,206 1,308 -8% 20 19 5% 577 310 86% 1,803 1,637 10%Consumable Supplies 38,818 38,458 1% 24 13 85% 5,773 5,304 9% 44,615 43,775 2%Other 36,702 35,921 2% 42 21 100% 4,880 4,450 10% 41,624 40,392 3%Travel 4,473 4,533 -1% 4 7 -43% 913 827 10% 5,390 5,367 0%Subcontracts 27,533 24,160 14% 1 - 0% 1,370 829 65% 28,904 24,989 16%Equipment 24,821 20,814 19% 3 - 0% 1,140 736 55% 25,964 21,550 20%

TOTAL DIRECT COSTS 332,960 310,321 7% 565 582 -3% 39,198 35,679 10% 372,723 346,582 8%

F&A Costs 125,563 117,069 7% 105 121 -13% 5,464 4,971 10% 131,132 122,161 7%

TOTAL $458,523 $427,390 7% $670 $703 -5% $44,662 $40,650 10% $503,855 $468,743 7%

FEDERAL OTHER GOVERNMENT PRIVATE SOURCES TOTAL


BY DETAILED COST CATEGORY AND SPONSOR (in thousands)

55

DETAILED COST CATEGORY FY05

$ Change from FY04 FY05





$ Change from FY04

Academic Salaries $58,143 $4,418 $8,600 $413 $3,750 $547 $958 $26 $231 $110 $71,682 $5,514Staff Salaries 81,920 4,653 3,745 69 533 65 1,501 (111) 1,275 (114) 88,974 4,562 Grad Assistant 3,907 (99) 3,367 349 2,801 399 40 40 113 22 10,228 711 Subtotal Salaries 143,970 8,972 15,712 831 7,084 1,011 2,499 (45) 1,619 18 170,884 10,787

Fringe Benefits 31,947 3,977 2,732 296 752 85 442 9 92 27 35,965 4,394 Stipends/Health Allowance 14,506 (20) 1,753 190 827 36 488 164 - - 17,574 370 Consultants 792 (92) 379 55 111 19 326 56 195 128 1,803 166 Consumable Supplies 41,060 272 2,345 90 1,044 481 124 (16) 42 13 44,615 840 Other 35,720 763 2,336 79 776 222 591 128 2,201 40 41,624 1,232 Travel 3,452 (45) 1,239 82 407 39 265 (58) 27 5 5,390 23 Subcontracts 23,183 4,384 2,398 505 2,436 (1,244) 283 146 604 124 28,904 3,915 Equipment 23,087 3,739 2,131 774 746 (99) - - - - 25,964 4,414

TOTAL DIRECT COSTS 317,717 21,950 31,025 2,902 14,183 550 5,018 384 4,780 355 372,723 26,141

F&A Costs 113,904 7,689 10,715 624 4,647 550 1,310 1 556 107 131,132 8,971

TOTAL $431,621 $29,639 $41,740 $3,526 $18,830 $1,100 $6,328 $385 $5,336 $462 $503,855 $35,112




BY DETAILED COST CATEGORY AND SCHOOL (in thousands)

56

HILLTOP SCHOOLS

-6,000

12,00018,00024,00030,00036,00042,000

Dol

lars

(in

thou

sand

A&S 27,749 30,118 32,919 38,214 41,740

Engineering 14,134 14,377 15,970 17,730 18,830

Other 4,225 4,847 5,262 4,874 5,336

Social Work 6,409 6,873 6,312 5,943 6,328


SCHOOL OF MEDICINE

-

75,000

150,000

225,000

300,000

375,000

450,000

Dol

lars

(in

thou

sand

School of Medicine 324,897 335,779 390,451 401,982 431,621



GRAPHS BY SCHOOL

57

FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04 FY05 FY04FEDERAL AGENCIESNIH $106,239 $99,139 $10 $0 $3,463 $3,210 $1,733 $1,588 $571 $418 $112,016 $104,355NSF 5,400 4,602 - - 78 93 3 5 87 115 5,568 4,815 USDE 83 67 - - 44 43 25 29 292 259 444 398 NASA 2,369 2,120 - - 27 91 - - - - 2,396 2,211 DOD 1,540 1,700 - - 88 35 7 5 - - 1,635 1,740 EPA 319 486 - - 30 31 - - - - 349 517 DHHS OTHER 862 813 - - 341 344 33 26 74 57 1,310 1,240 DOE 917 839 - - 93 85 - - 3 24 1,013 948 DHHS HRSA 45 15 - - 283 281 1 4 119 74 448 374 USDA 15 - - - - - - - 182 102 197 102 OTHER 137 300 - - 19 51 - - 31 18 187 369

TOTAL FEDERAL 117,926 110,081 10 - 4,466 4,264 1,802 1,657 1,359 1,067 125,563 117,069

OTHER GOVERNMENT 5 - - - - 8 1 1 99 112 105 121

PRIVATE SOURCESINDUSTRY 480 348 2,575 2,645 9 1 20 14 160 158 3,244 3,166 FOUNDATIONS & TRUSTS 111 56 33 13 - - 64 50 1,210 940 1,418 1,059 VOL HEALTH - - 14 55 - - 22 28 500 461 536 544 OTHER 133 41 66 84 2 16 35 44 30 17 266 202

TOTAL PRIVATE 724 445 2,688 2,797 11 17 141 136 1,900 1,576 5,464 4,971

TOTAL $118,655 $110,526 $2,698 $2,797 $4,477 $4,289 $1,944 $1,794 $3,358 $2,755 $131,132 $122,161

F&A RATE PERCENTAGES54% / 53% * 50% 26% 8% OTHER Total F&A Costs

TABLE 9

F&A EXPENDITURES (RECOVERY) BY SPONSOR AND F&A RATE

(in thousands)

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DIRECT AGREEMENTS

SUB AGREEMENTS TOTAL

DIRECT AGREEMENTS

SUB AGREEMENTS TOTAL $$ %

FEDERAL AGENCIESNIH $106,071 $5,945 $112,016 $99,103 $5,252 $104,355 $7,661 7%NSF 4,928 640 5,568 4,082 733 4,815 753 16%USDE 433 11 444 374 24 398 46 12%NASA 1,852 544 2,396 1,519 692 2,211 185 8%DOD 990 645 1,635 1,329 411 1,740 (105) -6%EPA 187 162 349 407 110 517 (168) -32%DHHS OTHER 1,155 155 1,310 1,109 131 1,240 70 6%DOE 989 24 1,013 904 44 948 65 7%DHHS HRSA 362 86 448 339 35 374 74 20%USDA 153 44 197 102 - 102 95 93%OTHER 80 107 187 102 267 369 (182) -49%

TOTAL FEDERAL 117,200 8,363 125,563 109,370 7,699 117,069 8,494 7%

OTHER GOVERNMENT 105 - 105 121 - 121 (16) -13%

PRIVATE SOURCESINDUSTRY 3,244 - 3,244 3,166 - 3,166 78 2%FOUNDATIONS & TRUSTS 1,418 - 1,418 1,059 - 1,059 359 34%VOL HEALTH 536 - 536 544 - 544 (8) -1%OTHER 266 - 266 202 - 202 64 32%

TOTAL PRIVATE 5,464 - 5,464 4,971 - 4,971 493 10%

TOTAL $122,769 $8,363 $131,132 $114,462 $7,699 $122,161 $8,971 7%

FY05 FY04 CHANGE

TABLE 10 F&A EXPENDITURES (RECOVERY)

BY SPONSOR AND AGREEMENT TYPE (in thousands)

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FEDERAL AGENCIES

FY05$ Change





from FY04 FY05$ Change from

FY04

NIH $380,599 $25,258 $13,147 $1,193 $4,747 $1,763 $3,556 $76 $474 $215 $402,523 $28,505

NSF 2,112 45 12,692 694 5,333 1,567 62 10 192 147 20,391 2,463

USDE 572 (45) 1,762 478 112 69 115 11 3,714 (59) 6,275 454

NASA 780 61 6,729 677 504 137 - - - - 8,013 875

DOD 2,756 745 409 74 2,307 (1,595) - - - - 5,472 (776)

EPA - - 5 - 2,535 (1,074) - - - - 2,540 (1,074)

DHHS OTHER 5,084 109 32 (9) - - 60 (22) - - 5,176 78

DOE 1,660 320 1,525 259 291 (237) - - - - 3,476 342

DHHS HRSA 2,689 349 - - - - - (5) - - 2,689 344

USDA 817 568 146 (203) 43 43 - - - - 1,006 408

OTHER 373 (555) 311 11 83 55 55 (51) 140 54 962 (486)

TOTAL FEDERAL $397,442 $26,855 $36,758 $3,174 $15,955 $728 $3,848 $19 $4,520 $357 $458,523 $31,133



TABLE 11 FISCAL YEAR 2005 FEDERAL EXPENDITURES

BY FEDERAL AGENCY AND SCHOOL (in thousands)

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DETAILED COST CATEGORY FY05






$ Change from FY04

Academic Salaries $9,790 $636 $1,498 ($97) $103 ($34) $23 $8 $52 $20 $11,466 $533Staff Salaries 941 289 49 15 27 5 6 3 93 (6) 1,116 306 Grad Assistant 158 65 57 - 1 (2) - - - - 216 63 Subtotal Salaries 10,889 990 1,604 (82) 131 (31) 29 11 145 14 12,798 902

Fringe Benefits 1,871 480 312 4 20 (8) 7 3 25 5 2,235 484 Stipends/Health Allowance 73 62 - (45) - (4) - - - - 73 13 Consultants 2 (5) 2 - - - - - - - 4 (5) Consumable Supplies 840 563 48 22 2 (4) - (2) - - 890 579 Other 1,261 819 333 147 2,604 2,504 4 3 - - 4,202 3,473 Travel - (23) 9 - 6 - - (2) 1 1 16 (24) Subcontracts - - - - 7 7 - - - - 7 7 Equipment 544 531 94 (50) 9 (11) - - - - 647 470

TOTAL DIRECT COSTS 15,480 3,417 2,402 (4) 2,779 2,453 40 13 171 20 20,872 5,899

F&A Costs 5,142 830 666 157 125 30 29 10 43 24 6,005 1,051

TOTAL $20,622 $4,247 $3,068 $153 $2,904 $2,483 $69 $23 $214 $44 $26,877 $6,950



TABLE 12 FISCAL YEAR 2005 COST SHARING EXPENDITURES

BY DETAILED COST CATEGORY AND SCHOOL (in thousands)

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Fiscal Years 2005 - 2003 Industry Sponsored Clinical Trials performed at Washington University have gone through a period of steady growth over the last three fiscal years. Over that period, the numbers of clinical trials performed at the institution have increased 9% from 1,191 trials in fiscal year 2003 to 1,294 trials in fiscal year 2005. During that same time, the cash receipts from those trials have increased by 20% from $17.8 million in 2003 to $21.4 million in 2005. For a break-down of clinical trials by department of the School of Medicine please refer to Figure 1. Of the total trials performed at the School of Medicine in 2005, 628 out of 1,294 or 48% were performed in the Department of Internal Medicine. In dollar terms this represents 58% of the total clinical trial dollars for FY 2005. For a break-down of clinical trials by Division of the School of Medicine’s Department of Internal Medicine, please refer to Figure 2. Also, during the period FY 2003 to 2005 the number of new clinical trial contracts has increased by 30% as is shown in Figure 3. The industry sponsored trials highlighted in this report are performed by numerous faculty throughout the School of Medicine. There are also a number of Centers dedicated to supporting clinical trials across the school of Medicine. These Centers have been highlighted below:

The Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis is an international leader in patient care, cancer research, prevention, education and

community outreach and a National Cancer Institute-designated Comprehensive Cancer Center. The Siteman Cancer Center offers many different types of clinical trials. At any given time, Siteman has more than 350 trials open. There are different types of clinical trials performed at Siteman. Therapeutic trials involve some type of treatment, such as a new drug, combination of new and/or existing drugs or a new combination of therapies (for example, changing the schedule of the chemotherapy and radiation therapy). They are aimed at patients who have already been diagnosed with cancer. Other trials are designed to prevent cancer in healthy people or control cancer in people who have had curative treatment.

The Center for Clinical Studies (CCS), at Washington University Medical School in St. Louis-MO, supports the effective, efficient, and reliable evaluation of new pharmaceuticals and medical devices

in collaboration with sponsoring organizations (industry and/or government). CCS

Industry Sponsored Clinical Trials

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supports Wash U. faculty with industry contract negotiation and clinical trial referrals, a full spectrum of services for planning and conducting clinical trials, and programs to streamline relevant Medical Center-wide processes. CCS also provides sponsoring organizations with access to top-quality investigators, study coordinators, and participants for the conduct of clinical trials and other ancillary resources. CCS is the department responsible for negotiating all clinical trial contracts performed at Washington University, Barnes-Jewish Hospital and St. Louis Children’s Hospital. The department has a staff of 11 nurse/coordinators that can be utilized to complete clinical trials. CCS also provides assistance to create clinical trial budgets, opens clinical trial accounts, deposits funds from industry sponsors, and provides other forms administrative support. In addition, CCS has 5,400 square feet of outpatient research space on the 11th floor of the Center for Advanced Medicine Building that can be utilized to conduct clinical trials. This fully staffed and dedicated clinical trial space has six patient exam rooms, phlebotomy room, consultation room, 2 long-term lounges for extended visits, portable ECG machine, IV infusion pumps, laboratory specimen processing and packaging area. Currently CCS provides clinical trial support services for 1 out of 6 clinical trials performed at the institution.

In order to improve patient accrual in clinical trials, CCS has instituted a program called Volunteer for HealthTM (VFH). This innovative program seeks to develop a patient registry of potential study candidates and improve recruitment efficiency. Currently, the registry of volunteers exceeds 21,000 individuals.

Working with the Washington University Institutional Review Board, VFH also assists Wash U. faculty place advertisements seeking clinical trial volunteers. As of FY 2005 VHF placed more than 900 advertisements in all forms of media (radio, newspaper, posters & flyers, etc.).

The Washington University AIDS Clinical Trials Unit (ACTU) was established in 1987 to conduct clinical research and participate in clinical trials for persons with HIV-associated disease. Since its inception, 3,000 HIV-infected persons have been seen at the unit and more than 1,300 have been enrolled in clinical trials of new agents for primary HIV infection or for its associated opportunistic infections. Many patients have volunteered to participate in other clinical research protocols at this unit.

Studies of anti-retroviral agents and immunomodulators have been conducted in patients with asymptomatic HIV disease, symptomatic infection and AIDS. In addition, the unit has participated in collaborative trials investigating the treatment and prevention of most


63

of the opportunistic infections associated with AIDS. Unit oncologists perform studies in AIDS-related malignancies. The ACTU has a neurology clinical core to participate in specific neurologic protocols and to perform more detailed neurologic sub-studies of patients actively enrolled in other ACTU protocols. In addition, we have recently established a metabolic clinical core to perform more detailed metabolic sub-studies of patients with HIV disease as these become a greater problem in infected individuals. The unit has two clinics: the main unit at the Washington University Medical Center and a second at St. Louis ConnectCare. The latter, located at the only municipally supported public clinic in St. Louis, was specifically developed to increase access to clinical trials for minorities, drug abusers and other individuals underrepresented in clinical research. We direct a substantial effort toward making the goals and successes of clinical research known to the community, especially health care workers. An immunology laboratory and a virology laboratory serve the ACTU. Since 1988, the Washington University ACTU has screened approximately 3,000 HIV-infected individuals for possible participation in clinical trials. As of December 1, 2000, 1,363 HIV-positive persons have participated in studies offered at our site.

Patient Oriented Research Unit (Pediatrics): The Patient Oriented Research Unit (PORU) has dedicated space on the 11th floor of the MPRB and serves as an academic base for the interaction and collaboration of clinical investigators within the Department of Pediatrics. Administrative members of the PORU assist members of the Department with submission of human studies protocols to the Internal Review Board (IRB) and with preparation of clinical research grants and contracts. PORU investigators are studying a variety of clinical topics, including diabetes, asthma, sickle cell disease, hypertension, cancer predisposition, organ transplantation, smoking cessation and many others. Beyond physicians, participants in these studies include psychologists, epidemiologists, and biostatisticians.


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Figure 1:

Industry Sponsored Clinical Trials by Dept. of the School of Medicine

Note 1: The majority of industry sponsored clinical trials for the Siteman Cancer Center are accounted for in other departments.

Note 2: The dollar totals contained in this chart are based on cash receipts from industry sponsors.

Department #'s $ #'s $ #'s $ #'s $Internal Medicine 628 12,279,318 599 10,372,727 540 9,134,760 16% 34%Surgery 147 1,778,660 159 1,802,762 109 1,453,802 35% 22%Pediatrics 108 1,072,408 69 1,121,084 92 792,500 17% 35%Neurology 101 1,253,842 145 1,467,898 114 1,218,686 -11% 3%Radiology 69 1,100,496 79 1,347,717 89 1,131,701 -22% -3%Pathology & Immunology 47 463,307 54 450,094 43 306,571 9% 51%Psychiatry 42 1,684,310 40 1,617,200 44 1,465,251 -5% 15%Anesthesiology 29 317,958 29 299,394 36 314,230 -19% 1%Obstetrics & Gynecology 28 470,295 32 475,838 28 459,571 0% 2%Orthopedic Surgery 19 218,849 17 242,975 17 137,778 12% 59%Emergency Medicine 15 223,006 13 141,113 12 119,044 25% 87%Radiation Oncology 11 186,150 16 345,792 12 317,880 -8% -41%Siteman Cancer Center (NOTE 1) 10 204,934 14 296,311 12 234,089 -17% -12%Ophthalmology & Visual Sciences 9 55,330 7 21,762 6 117,763 50% -53%Neurological Surgery 8 94,449 14 38,228 13 229,209 -38% -59%Otolaryngology 5 70,133 4 62,583 4 82,688 25% -15%Molecular Biology & Pharmacology 4 30,258 3 57,542 2 2,850 100% 962%Health Administration 4 (200,256) 6 325,000 5 45,000 -20% -545%Genetics 3 7,569 2 1,510 2 77,181 50% -90%Molecular Microbiology 2 25,756 4 13,600 3 12,750 -33% 102%Occupational Therapy 2 5,900 2 35,047 2 47,674 0% -88%Biochemistry & Molecular Biophysics 1 20,000 1 20,000 2 27,350 -50% -27%Div of Comparative Medicine 1 2,554 2 (84,624) 2 6,792 -50% -62%Cell Biology & Physiology 1 0 1 0 1 36,750 0% -100%Physical Therapy 0 0 0 0 1 1,970 -100% -100%Total 1,294 21,365,225 1,312 20,471,553 1,191 17,773,837 9% 20%

FY 2003FY 2004FY 2005% Inc / (Dec)FY 03 - FY05


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Figure 2:

Industry Sponsored Clinical Trials by Div. of the Dept. of Internal Medicine

Note: The dollar totals contained in this chart are based on cash receipts from industry sponsors.

Divisions of Internal Medicine #'s $ #'s $ #'s $ #'s $Medical Oncology 168 3,000,685 140 2,563,944 90 1,838,425 87% 63%Cardiology 104 1,119,505 98 1,036,212 92 1,044,851 13% 7%Endocrine / Metabolism 47 916,493 51 764,320 49 1,131,756 -4% -19%Chrom Kidney Center 38 606,794 35 395,984 32 487,658 19% 24%AIDS Clinical Trial Unit 37 92,262 28 63,283 - - 100% 100%Pulmonary 35 878,367 29 730,422 30 468,162 17% 88%Renal 35 794,602 25 419,117 26 605,607 35% 31%Gastroenterology 33 427,258 34 352,208 36 274,653 -8% 56%Dermatology 30 465,100 36 595,686 23 657,326 30% -29%Infectious Diseases 21 111,888 24 130,910 60 426,117 -65% -74%Lipid Research 18 3,012,183 47 2,565,175 58 1,342,440 -69% 124%Rheumatology 16 224,543 20 154,955 16 124,034 0% 81%Center for Human Nutrition 14 440,108 9 178,368 11 430,333 27% 2%Bone & Mineral Diseases 8 73,431 2 34,259 - - 100% 100%Bone Marrow Transplant 6 31,500 8 13,322 5 161,345 20% -80%Immunology 5 15,164 5 49,624 5 41,427 0% -63%Medical Education 5 14,259 4 8,732 4 84,791 25% -83%Hematology 4 35,896 1 3,500 - - 100% 100%Geriatrics / Gerontology 3 19,280 2 312,707 1 15,836 200% 22%Applied Physiology 1 0 1 0 1 0 - -Medical Informatics 0 0 0 0 1 0 - -Total 628 12,279,318 599 10,372,727 540 9,134,760 16% 34%

% Inc / (Dec)FY 2005 FY 2004 FY 2003 FY 03 - FY05


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Figure 3: New Contracts Completed FY 2005, 2004 & 2003

FY05 FY04 FY03 Inc/DecClinical Studies 355 231 251 29%Confidentiality Agreements 88 61 68 29%Amendments (all types) 183 201 182 0%Other (lab, animal, data analysis) 37 43 46 (20%)

TOTAL 663 536 547 21%


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Appendix One

Changes in Business Rules and Historical Trend Data in Fiscal Year 2005 Report A recent analysis of the “new award” data provided in past years have actually contained totals for both new fiscal year dollars awarded and carried forward award money from the prior fiscal year. Essentially, this has resulted in a report of dollars that are actually ‘available award dollars’ rather than newly awarded money for each of the fiscal years. The difference is about $16M and primarily impacts the School of Medicine; particularly the Department of Genetics and the Genome Sequencing Center. The impact on the other schools is minimal. The FY05 Annual Report will reflect the following changes:

1) Modified business rules that include only ‘new money’ used to generate the award dollars

2) The 5-year history (FY01 - FY05), rather than the previously published ten

year history, will present the modified historical trend data (Figure 1 and Table 1)

3) Modified tables 2-11 reflecting only ‘new money’

a. Table 2 – Funding History by School – Five years b. Table 3 – Direct Costs vs. F & A Costs FY05 and FY04 c. Table 4 – Award Dollars by School and Project Type FY05 and FY04 d. Table 5 – Direct and F & A Award Dollars by Sponsor type FY05 and

FY04 e. Table 7 – Federal Award Dollars by School and Sponsor FY05 f. Table 8 – Award Dollars by School and Sponsor Type FY05 and

FY04 g. Table 9 – School of Arts & Sciences – Award Dollars by Department

and Sponsor Type h. Table 10 – School of Engineering – Award Dollars by Department and

Sponsor Type i. Table 11 – School of Medicine – Award Dollars by Department and

Sponsor Type

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FY05 Annual Report

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