FY05 Annual Report by Office of the Vice Chancellor for Research

Table of Contents 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

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

Sponsored Research Executive Summary 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)

Funding History 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)

$600,000 $500,000 $400,000 $300,000 $200,000 $100,000 $0 FY01

FY02 Federal

FY03

FY04

State/Local/Int'l

FY05

Private

Table 1 (000s)

Federal State/Local/Int'l Private TOTAL

FY01 324,824 8,100 56,326 389,250

FY02 352,731 12,305 46,501 411,537

FY03 397,375 14,953 51,085 463,413

FY04 437,230 17,301 55,685 510,216

FY05 432,779 17,133 66,821 516,733

†

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

Funding History by Sponsor Type 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) $500,000 $400,000 $300,000 $200,000 $100,000 $0 FY01

FY02

FY03

FY04

FY05

Federal

Figure 3 Percent Growth in Federal Science and Engineering Obligations 1995 to 2003 100% 90% 80% 70%

Federal Support to Washington University Federal Support to Washington University

60% 50% 40% 30% 20% 10%

Federal Science & Engineering Obligations to Top 100

0% 1995

1996

1997

1998

1999

2000

2001

2002

2003

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

Funding History by Sponsor Type Figure 4 State, Local and International Government Funding - FY01 to FY05 (000s) $20,000 $15,000 $10,000 $5,000 $0 FY01

FY02

FY03

FY04

FY05

State/Local/Int'l

Figure 5 Private Industry Funding â&#x20AC;&#x201C; FY01 to FY05 (000s) $80,000 $70,000 $60,000 $50,000 $40,000 $30,000 $20,000 $10,000 $0 FY01

FY02

FY03

FY04

FY05

Private

Funding History by School FY01 – FY05†

Figure 6 School of Arts and Sciences

Figure 7 School of Engineering $20,000 $15,000 $10,000 $5,000 $0

$60,000 $40,000 $20,000

$0 FY01

FY02

FY03

FY04

FY01

FY05

Figure 8 School of Social Work

$0 FY03

FY04

FY05

FY01

Arts & Sciences Engineering Medicine Social work Other Total

FY04

FY05

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

$5,000

FY02

FY03

Figure 9 School of Medicine

$10,000

FY01

FY02

FY01 29,693 8,401 345,844 9,065 (839) 392,164

Table 2 (000s) FY02 30,175 15,351 357,391 6,037 1,909 410,863

FY03 38,353 14,166 402,973 6,421 1,534 463,447

FY02

FY04 43,102 16,433 433,557 5,423 1,700 510,216

FY03

FY04

FY05

FY05 42,693 17,722 447,727 6,580 2,011 516,733

†

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

Award Dollars by School and Cost Category 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 FY04â&#x20AC; (000s) FY05

FY04

Change

Award Count

Direct Costs

F&A Costs

Total

Award Count

Direct Costs

F&A Costs

Total

263

32,015

10,678

42,693

258

33,151

9,951

43,102

(409)

-1.0%

503

595

542

135

677

(82)

-13.8%

132

12,605

5,117

17,722

117

12,093

4,341

16,434

1,288

7.3%

217

247

339

(92)

-37.2%

1,496

326,811

120,916

447,727

1,636

323,624

119,933

443,557

4,170

0.9%

Social Work

5,263

1,317

6,580

4,203

1,220

5,423

1,157

17.6%

Other Schools

1,048

121

1,169

559

124

683

486

41.6%

1,955

378,462

138,271

516,733

2,067

374,511

135,704

510,216

6,518

1.3%

Schools Arts & Sciences Business Engineering Law Medicine

TOTAL

â&#x20AC;

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

Award Summary by Project Type

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 Schools

FY05

Administration Art Arts & Sciences Business Engineering Law Medicine Social Work TOTAL

391 128 38,038 552 16,961 115 419,105 4,300 479,591

Research Training

FY04

FY05

FY04

298 39,640 678 14,744 30 416,261 3,246 474,897

3,088

1,906

611

577

19,185 605 23,489

20,904 737 24,124

Other Sponsored Activities FY05 FY04 648 2 1,566 43 150 132 9,437 1,675 13,653

383 2 1,556 1,112 309 6,392 1,439 11,193

TOTAL FY05

FY04

1,039 130 42,692 595 17,722 247 447,727 6,580 516,733

681 2 43,102 677 16,434 339 443,557 5,423 510,216

†

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

Award Summary by Sponsor Type

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)

FY05

15,254 17,072

51,567

FY04

14,918 17,301

40,767

21,487

17,922 399,609

15,240

NIH

NSF

Other Fed

391,042

24,701

Other Gov’t.

Industry

Non Profit

†

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

Award Summary by Sponsor Type

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 FY04â&#x20AC; (000s) FY05

Sponsor

Direct Costs

% Total Direct

Federal

309,599

Other Govt. Total Govt.

FY04

F&A Costs

% Total F&A

Total

% Total

Direct Costs

% Total Direct

81.8%

123,180

89.1%

432,779

83.8%

316,301

84.5% 120,928

12,279

3.2%

4,853

3.5%

17,133

3.3%

12,198

321,878

85%

128,033

92.6%

449,911

87.1%

328,499

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%

378,462

100%

138,271

100%

516,733

100%

374,511

100% 510,216

100%

GRAND TOTAL

3.3%

F&A Costs 5,103

87.7% 126,031

100% 135,704

% Total F&A

Total

% Total

89.1% 437,230 3.8%

85.7%

17,301

3.4%

92.9% 454,531

89.1%

â&#x20AC;

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

Award summary by Sponsor Type

Table 6 Award Dollars by Sponsor and Cost Category FY05 and FY04† (000s) FY05 Category FEDERAL AGENCIES

Source NIH NSF NASA DOD EPA EDUC DOE DHHS HRSA LABOR USDA OTHER

TOTAL FEDERAL OTHER GOVERNMENT

TOTAL OTHER PRIVATE SOURCES TOTAL PRIVATE GRAND TOTAL

Missouri State- All Other Other Gov’t. Industry Non Profits

Direct Costs 285,712 10,657 4,127 1,701 91 1,217 2,263 1,394 1,357 243 836

F&A Costs 113,905 4,583 1,916 638 44 60 895 351 519 69 201

309,598

FY04 Total 399,617 15,240 6,044 2,339 135 1,277 3,158 1,745 1,875 312 1,037

Direct Costs 280,968 19,148 3,311 3,242 (71) 1,561 1,951 1,414 2,017 1,548 1,212

F&A Costs 110,073 5,553 1,552 844 112 197 898 393 928 166 212

Total 391,041 24,701 4,863 4,086 41 1,758 2,849 1,808 2,945 1,714 1,424

Change $$$ % 8,576 2.2% (9,461) -38.3% 1,181 24.3% (1,747) -42.8% 94 229.3% (481) -27.4% 309 10.8% (63) -3.5% (1,070 -36.3% (1,402) -81.8% (387) -27.2%

123,181

432,779

316,301

120,928

437,230

(4,451)

-1.0%

741 10,725 813 12,279 10,924 45,660 56,584

128 4,650 76 4,854 4,330 5,907 10,237

869 15,375 889 17,133 15,254 51,567 66,821

831 10,532 834 12,197 10,561 35,450 46,011

130 4,922 50 5,102 4,356 5,317 9,673

960 15,455 885 17,301 14,918 40,767 55,685

(152) (80) 4 (167) 336 10,800 11,137

-15.8% -0.5% 0.5% -1.0% 2.3% 26.5% 20%

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 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 Category FEDERAL AGENCIES

TOTAL FEDERAL OTHER GOVERNMENT

TOTAL OTHER PRIVATE SOURCES TOTAL PRIVATE GRAND TOTAL

Source NIH NSF NASA DOD EPA ED DOE DHHS HRSA LABOR USDA OTHER Missouri State – All Other Other Gov’t. Industry Non Profits

Direct Awards 396,122 15,173 5,694 2,184 135 1,277 2,990 1,745 1,875 312 941 428,448

Sub Awards 25,659 2,505 2,026 921 387 73 1,176 872

FY04 Sub Awards 25,713 2,230 2,486 1,853 368 173 216 876 101

34,689

Total 421,785 17,679 7,720 3,105 521 1,349 4,166 2,617 1,875 1,382 941 463,137

Direct Awards 389,723 24,701 4,863 3,486 41 1,758 2,848 1,808 2,945 1,714 1,399 435,286

709 34,725

Total 415,437 26,931 7,349 5,339 409 1,930 3,065 2,684 3,046 1,714 2,108 470,012

511 412 90 1,013 11,305 36,094 47,399

372 525 57 954 291 3,939 4,230

883 937 147 1,967 11,597 40,033 51,629

520 489 52 1,061 11,328 25,378 36,706

235 185 44 464 0 1,971 1,971

755 674 96 1,525 11,328 27,350 38,678

128 263 151 442 268 12,683 12,951

17.0% 39.0% 53.1% 29.0% 2.4% 46.4% 33.5%

476,860

39,873

516,733

473,053

37,160

510,216

6,375

1.3%

1,070

Change $$$ % 1.5% 6,348 -34.4% (9,252) 5.0% 371 -41.8% (2,234) 27.4% 112 -30.1% (581) 35.9% 1,101 -2.5% (67) -38.4% (1,171) -19.4% (333) -55.4% (1,167) (6,872) -1.5%

†

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

Award Summary by Sponsor Type Table 7 Federal Award Dollars by School and Sponsor FY05† (000s) Arts & Sciences

NIH NSF NASA DOD EPA ED DOE DHHS HRSA LABOR USDA OTHER TOTAL

Engineering

FY05 14,526 8,684 4,516 545 11 712 1,521

% of Change From FY04† 22.2% -45.9% 23.5% 9.2% 110.3% -37.7% 30.6%

FY05 4,968 5,268 617 1,378 124 126 200

350

-100.0% 69.0%

312 156

30,864

-11.9% 13,149

Medicine

Social Work

% of % of % of Change Change Change From From From FY04† FY05 FY04† FY05 FY04† 127.6% 375,904 0.7% 3,538 21.3% -7.1% 1,098 -62.3% 100 100% 108.2% 910 10.0% -31.9% 416 -73.4% 242.4% 100% 215 -28.3% -21.4% 1,438 60.0% 1,745 -3.5% 1,875 -36.3% 100% -100.0% 2313.0% 366 -40.5% -100.0% 25.6% 383,967

-0.8% 3,638

Other Schools

Total University

% of % of Change Change From From FY05 FY04† FY05 FY04† 681 14.4% 399,617 2.2% 90 22.9% 15,240 -38.3% 6,044 24.3% 2,339 -42.8% 135 229.3% 225 -28.9% 1,277 -27.4% 3,158 10.8% 1,745 17.1% 1,875 -36.3% 312 -81.8% 165 -45.2% 1,037 -27.2%

13.3% 1,160

-9.7% 432,779

-1.0%

†

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

Award Summary by Sponsor Type Table 8 Award Dollars by School and Sponsor Type FY05 and FY04† (000s) Government Schools Administration

Federal FY05 FY04 786

615

Art Arts & Sciences Business Engineering Law Medicine Social Work Total

Private

Other Gov’t. FY05 FY04

Industry FY05 FY04

Nonprofit FY05 FY04

225

128

896

1,136

30,864

35,024

285

370

13,149

10,469

300

383,967

387,241

15,080

14,950

3,638

3,211

432,779

437,230

17,133

1,117

FY04

1,040

682

130

3,822

42,693

43,103

310

309

595

678

2,393

1,645

2,443

17,722

16,433

157

247

339

9,882

8,974

38,798

32,391

447,727

443,556

(35)

421

2,967

1,753

6,580

5,423

17,300

15,254

14,918

51,567

40,767

516,733

510,216

1,811

3,121

FY05

7,336

1,127

3,596

Total

†

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

Award Summary by Sponsor Type Table 9 School of Arts and Sciences Award Dollars by Department and Sponsor Type FY05 and FY04† (000s) Government Department Anthropology Arts & Sciences Biology Career Center Chemistry Classics Earth & Planetary Science Education English Graduate School Mathematics Philosophy Physics Psychology The Center For Humanities Weidenbaum TOTAL

Private

Total

Federal 164

Other Gov’t.

Industry

6,144 11 6,365 29 2,539 2,450

374

2,136

Nonprofit 108 41 4,493

113

382

265

310

923

522

156

39 64

532 994 40 5,809 5,361 223 204 30,864

769 940 95

11 84 3 896

3,596

7,336

FY05 272 41 13,147 11 7,125 29 4,294 2,450 727 1,058 40 6,589 6,385 321 204

FY04 504 41 16,089 13 6,793 65 4,505 24 25 959 673 113 6,719 6,192 10 377

42,693

43,103

†

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

Award Summary by Sponsor Type

Table 10 School of Engineering Award Dollars by Department and Sponsor Type FY05 and FY04† (000s) Government

Private

Total

Federal 2,077

Other Gov’t 86

Industry -50

Nonprofit 27

FY05 2,141

FY04 3,081

Chemical Engineering

595

510

446

112

1,663

982

Civil Engineering

279

982

Biomedical Engineering

Computer Science & Engineering

3,874

Electrical & Systems Engineering

4,094

Environmental Engineering

1,235

Mechanical & Aerospace Engineering Other TOTAL

195

1,267

230

5,566

6,475

148

801

5,044

1,586

158

537

1,931

832

607

122

-78

651

1,991

387

447

503

13,149

1,117

1,645

17,722

16,433

1,811

†

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

Award Summary by Sponsor Type Table 11 School of Medicine Award Dollars by Department and Sponsor Type FY05 and FY04â&#x20AC; (000s) Government Private Other Industry NonDepartments Federal Gov't profit Anatomy & Neurobiology 12,679 371 1,187 Biochemistry & Molecular Biophysics 6,016 15 140 179 Cell Biology & Physiology 9,471 218 454 885 Genetics 49,625 2,210 203 1,312 Molecular Biology & Pharmacology 11,802 119 636 2,384 Molecular Microbiology 11,823 212 468 661 Subtotal Preclinical 101,417 3,146 1,901 6,607 Anesthesiology 5,261 69 71 398 Internal Medicine 83,571 1,457 3,031 11,798 Neurological Surgery 1,096 88 23 145 Neurology 19,109 1,682 25 2,339 Obstetrics & Gynecology 3,304 403 Ophthalmology & Visual Sciences 11,590 24 751 583 Orthopedic Surgery 2,659 (3) 309 961 Otolaryngology 6,750 325 32 167 Pathology & Immunology 23,666 38 1,460 2,974 Pediatrics 19,478 3,202 930 3,440 Psychiatry 33,933 2,796 113 1,492 Radiation Oncology 5,552 445 509 Radiology 26,898 313 442 1,202 Surgery 14,565 884 269 3,581 Subtotal Clinical 257,429 10,875 7,900 29,993 Administration* 7,540 (68) 125 Biology/Biomedical Sciences 4,194 4 (54) Biostatistics 5,172 602 90 662 Center For Clinical Studies 73 Center For Health Behavior Research 1,925 898 Center For Study Of Health Policy 149 Div Of Comparative Medicine 19 Emergency Medicine 15 Medical Library 108 Occupational Therapy 705 197 5 140 Physical Therapy 1,193 55 20 Proteomics Core Lab 521 40 Siteman Cancer Center 3,852 280

FY05

FY04

Total 14,237 6,350 11,029 53,350 14,940 13,164 113,070 5,799 99,856 1,351 23,154 3,707 12,949 3,926 7,274 28,139 27,051 38,331 6,507 28,855 19,298 306,197 7,596 4,143 6,526 73 2,823 149 19 15 108 1,047 1,268 562 4,132

Total 13,519 6,572 10,174 66,162 11,881 12,521 120,829 6,127 95,123 2,486 25,913 2,251 13,977 4,424 8,123 25,923 33,082 40,112 4,599 24,036 19,088 305,264 1,544 4,307 5,142 123 2,095

Subtotal Other Total

28,460 447,727

17,462 443,556

25,120 383,967

1,059 15,080

82 9,882

2,198 38,798

138 181 1,797 721 9 1,405

*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. â&#x20AC;

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

Washington University Rankings

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

Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

All Federal Obligations Institution Johns Hopkins University 1,137.4 University of Washington 631.1 University of Michigan 520.8 University of Pennsylvania 495.3 U. CA - Los Angeles 475.7 Stanford University 467.2 U. CA - San Diego 466.5 U. WI-Madison 422.1 Washington University St. Louis 419.0 Columbia University New York 412.7 Duke University 412.1 U. Pittsburgh 394.7 U. CA -San Francisco Harvard University U. Colorado Yale University Boston University PA State U. - University Park U. Minnesota U. North Carolina- Chapel Hill

393.1 384.9 367.9 349.6 347.2 345.9 345.8 344.6

Source: National Science Foundation (SRS), â&#x20AC;&#x153;Survey of Federal Support to Universities, Colleges and Nonprofit Institutions: Fiscal Year 2003â&#x20AC;? (Arlington, VA) 2005.

Washington University Rankings

Table 13 Washington University Ranking Among Private Universities Receiving Federal Support FY2003

All Federal Obligations 1,137.4 495.3 467.2

Rank 1 2 3

Institution Johns Hopkins University University of Pennsylvania Stanford University

Washington University in St. Louis

419.0

5 6 7 8 9 10 11 12 13 14 15 17 18 19 20

Columbia University- New York Duke University Pittsburgh- all campuses Harvard University Yale University Boston University Cornell University- all campuses Baylor College of Medicine Massachusetts Institute of Technology University of Southern California Vanderbilt University Emory University Northwestern University Scripps Research Institute, The University of Chicago

412.7 412.0 394.7 384.9 349.6 347.2 334.1 297.3 291.9 279.4 263.8 215.0 213.6 209.9 208.1

Source: National Science Foundation (SRS), â&#x20AC;&#x153;Survey of Federal Support to Universities, Colleges and Nonprofit Institutions: Fiscal Year 2003â&#x20AC;? (Arlington, VA) 2005.

Washington University Rankings 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 Rank

Medical School

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Johns Hopkins University School of Medicine U. of Pennsylvania School of Medicine U. of CA San Francisco School of Medicine Washington University School of Medicine University Washington School of Medicine Duke University School of Medicine Yale University School of Medicine UCLA School of Medicine University Pittsburgh School of Medicine Stanford University School of Medicine Baylor College of Medicine U. of Michigan Medical School Case Western Reserve School of Medicine U. of CA San Diego School of Medicine Vanderbilt University School of Medicine Columbia U. College of Physicians & Surgeons U. of North Carolina School of Medicine U. of Alabama School of Medicine Emory University School of Medicine U. of Colorado HLTH Sci School of Medicine U. of Texas SW Medical Center/Dallas Albert Einstein College of Med Yeshiva U. Oregon HLTH Sci U. School of Medicine Harvard Medical School Mt. Sinai School of Medicine NYU

Source:

Number Awards 991 947 836 820 689 662 741 683 726 611 558 651 606 467 554 557 532 457 472 445 433 372 444 368 393

Amount $449,470,782 $393,623,671 $379,851,608 $371,719,472 $307,873,069 $304,740,667 $287,811,325 $285,852,720 $270,642,802 $265,499,858 $248,451,313 $245,342,433 $232,074,070 $231,023,209 $226,826,142 $226,575,848 $212,868,565 $207,078,637 $178,147,069 $172,322,577 $172,246,995 $170,228,596 $162,756,282 $161,450,328 $153,194,929

â&#x20AC;&#x153;NIH Awards to All Medical School by Rank, Fiscal Year 2004,â&#x20AC;? from Award Trends, NIH Office of Extramural Research (OER) web page.

Technology Management Executive Summary 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 startup 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

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.

Technology Management Executive Summary 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 chipbased 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.

Technology Management Executive Summary

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 subjectâ&#x20AC;&#x2122;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 â&#x20AC;&#x201C; estimated to be about 90% lower â&#x20AC;&#x201C; 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.

Technology Management Executive Summary

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.

Technology Management Executive Summary

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 AntiAngiogenic Therapy The present invention generally describes novel methods for treatment of neovascularization in various tissues of a patientâ&#x20AC;&#x2122;s eye. Rajendra Apte, Thomas Ferguson. Ophthalmology & Visual Sciences.

Invention Disclosures by School 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

Arts & Sciences Engineering Medicine Social Work Inventions Across Disciplines Total

FY00 8 4 70 1

FY01 5 8 63 1

FY02 10 10 62 0

FY03 7 12 71 0 1 91

FY04 6 9 86 0 1 102

FY05 28 8 79 0 9 124

Figure 11 140

9 0

120 1 0

100 1 0 1 80

0 1

60 70

40 8 20 4 8

8 5

0 FY00

FY01

FY02

FY03

FY04

Arts & Sciences

Engineering

Medicine

Social Work

FY05

Inventions Across Disciplines

Disclosures by Department Table 16 Disclosures by Department Total new disclosures for FY

Department

FY03

FY04

FY05

102

124

FY03

FY04

FY05

3 0 1 2 1 0

1 1 2 0 2 0

22 4 0 0 1 1

1 5 6 0 0 0

0 5 2 0 2 0

1 3 0 0 1 0

1 2 0 0 3 0 2 0 18 4 3 2 1 0 1 1 0 0 6 10 2 3 11 1 0

2 2 0 6 3 0 3 0 21 3 1 3 3 1 0 1 0 1 11 3 1 2 9 0 10

1 0 1 0 4 0 0 0 20 5 2 3 0 0 0 6 1 4 13 7 3 0 5 0 4

Arts & Sciences Biology Chemistry Earth & Planetary Sciences Physics Psychology Mathematics

Arts & Sciences Total Engineering & Applied Science Biomedical Engineering Chemical Engineering Computer Science Electrical Engineering Mechanical & Civil Engineering Mechanical Engineering System Science & Mathematics

Engineering & Applied Science Total Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Bioorganic Chemistry & Molecular Pharmacology Cell Biology & Physiology Comparative Medicine Genetics Institute of Biological Computing Internal Medicine Molecular Biology & Pharmacology Molecular Microbiology Neurology Neurosurgery Obstetrics & Gynecology Occupational Therapy Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiation Oncology Radiology Siteman Cancer Center Surgery

Medicine Total Social Work Social Work

Internal Medicine / Molecular Biology & Pharmacology

Internal Medicine / Pathology & Immunology

Surgery / Pathology & Immunology

Social Work Total Inventions Across Disciplines

Internal Medicine / Biostatistics

Internal Medicine / Neurology

Surgery / Electrical Engineering/Genetics

Neurosurgery / Biomedical Engineering

Electrical Engineering / Computer Science

Physics/Biochemistry / Molecular Biophysics

1 91

1 102

9 124

Joint Disclosure Total

Total

US Patent by School US Patent Applications

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

Arts & Sciences Engineering Medicine Social Work US Patents- Joint

FY00 6 4 62 0

FY01 2 3 52 0

FY02 5 9 31 0

Total

FY03 6 7 52 0 0 65

FY04 8 11 91 0 7 117

FY05 9 7 70 0 11 97

Figure 12 120

100 11 80 0

60 70 40

52 52

3 2

9 5

4 6 FY00

FY01

FY02

7 6 FY03

Arts & Sciences

Engineering

Social Work

US Patents- Joint

FY04

FY05

Medicine

US Patent Applications by Department Table 18 Department

FY03

FY04

117

FY03

FY04

FY05

Arts & Sciences Total

6 0 0 0 0 6

6 1 0 0 1 8

6 3 0 0 0 9

Engineering & Applied Science Total

0 0 4 2 0 1 0 7

0 0 6 5 0 0 0 11

2 1 4 0 0 0 0 7

Medicine Total

3 2 1 0 0 0 1 0 11 4 3 5 0 0 2 0 0 6 3 1 8 1 1 0 52

2 3 2 7 3 0 6 0 11 8 6 2 3 0 0 0 1 18 5 1 7 3 1 2 91

0 2 0 6 2 0 1 0 8 16 0 2 2 0 5 0 1 7 3 0 11 1 0 3 70

Social Work Total

0 0

0 0 0 0 0 0 0 0 0

1 1 3 1 1 0 0 0 7

1 0 4 0 2 1 1 2 11

117

Total US Patent Applications for FY

Department Arts & Sciences Biology Chemistry Earth & Planetary Sciences Physics Psychology

FY05

Engineering & Applied Science Biomedical Engineering Chemical Engineering Computer Science Electrical Engineering Mechanical Engineering Mechanical & Civil Engineering Systems Science & Mathematics

Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Bioorganic Chemistry & Molecular Pharmacology Cell Biology & Physiology Comparative Medicine Genetics Inst. For Biomedical Computing Internal Medicine Molecular Biology & Pharmacology Molecular Microbiology Neurology Neurosurgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiology Radiation Oncology Renal Division Surgery

Social Work Social Work

US Patents filed on Joint Inventions Computer Science / Electrical Engineering Anesthesiology / Pediatrics Internal Medicine / Molecular Biology & Pharmacology Bioorganic Chemistry / Molecular Pharm. / Internal Medicine Neurology / Internal Medicine Surgery / Biomedical Engineering Neurosurgery / Biomedical Engineering Pathology & Immunology / Moleculary Biology & Pharmacology

Joint US Disclosures Total

Total

Licenses by School 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 nonprofit 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 13 140

120

100 80

34 26

20 8

40 44

56 45

20 4 0 FY00

1 FY01

Arts & Sciences

0 FY02 Engineering

3 FY03

FY04

Medicine

33 1 FY05

Social Work

Licenses by School Table 19

Arts & Sciences Engineering Medicine Social Work TOTAL

FY00 1 4 44 80 129

FY01 1 1 56 59 117

FY02 1 0 45 26 72

FY03 2 3 53 34 92

FY04 3 4 29 20 56

FY05 1 1 33 8 43

Figure 14 Percent of Licenses by School Social Work 19% Arts & Sciences 2% Engineering 2%

Medicine 77%

Licenses by Department Table 20

Department

FY03

FY04

FY05

FY03

FY04

FY05

Arts & Sciences Total

2 0 0 2

3 0 0 3

0 1 0 1

Biomedical Engineering Computer Science Electrical Engineering Mechanical Engineering Engineering & Applied Science Total

0 0 2 1 3

0 0 4 0 4

0 1 0 0 1

0 0 4 0 11 0 9 4 3 1 3 3 8 3 0 4 0

2 1 1 0 4 1 5 2 3 0 1 0 6 0 0 1 2

1 1 0 0 5 3 5 2 1 2 0 2 6 3 0 2 0

Medicine Total

Social Work Total

34 34

20 20

8 8

No Fee Licenses

147

679

2074

Total Licenses

239

735

2117

Total Licenses for FY

Department Arts & Sciences Biology Earth & Planetary Sciences Psychiatry

Engineering & Applied Science

Medicine Anatomy & Neurobiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Dermatology Genetics Institute of Biological Computing Internal Medicine Molecular Biology & Pharmacology Molecular Microbiology Neurology Ophthalmology & Visual Sciences Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiology Surgery

Social Work Social Work

Subtotal

License Type by School Table 21 Non-Exclusive

Department

Exclusive Roy. Bearing Paid-up No Fee

Arts & Sciences Biology Earth & Planetary Sciences Psychiatry Arts & Sciences Total

0 1 0 1

0 0 0 0

0 1 0 0 1

0 0 0 0 0

0 1 0 0 1

0 0 0 0 1 0 1 1 0 1 0 1 3 0 0 1 0 9

1 1 0 0 4 3 4 1 1 1 0 0 3 3 0 1 0 23

0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1

0 0 0 0 2056 10 3 0 0 0 0 0 0 0 1 0 0 2070

0 0

8 8

3 3

2074

Engineering & Applied Science Biomedical Engineering Computer Science Electrical Engineering Mechanical Engineering Engineering & Applied Science Total

Social Work Social Work Social Work Total

Total Total Licenses by Department

2117 33

License Revenue 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-ofpocket costs incurred as part of technology licensing (e.g. consulting fees, marketing fees) or non-patent legal costs. Licensing Income Distribution Disclosed Prior to 7/1/98

Disclosed between 7/1/98 and 6/30/05

Agreement Signed After 7/1/05

50% 45% 5%

45% 40% 15%

35% 40% 25%

Inventors: School: OTM:

Table 22 Arts & Sciences Engineering Medicine Social Work

FY01 $ 223,286 $ 840,410 $ 7,938,441 $ 182,055

FY02 $ 171,433 $ 861,541 $ 6,997,028 $ 100,070

FY03 $ 810,051 $ 70,634 $ 937,343 $ 12,508,499

$ $ $ $

FY04 91,445 764,034 8,689,587 36,520

FY05 $ 458,213 $ 961,856 $ 10,233,584 $ 1,710

TOTALS

$ 9,184,192

$ 8,130,072

$ 14,326,527

9,581,586

$ 11,655,363

Figure 15 $16,000,000 $14,000,000 $12,000,000 $10,000,000 $8,000,000 $6,000,000 $4,000,000 $2,000,000 $FY01

Arts & Sciences

FY02

FY03

Engineering

FY04

Medicine

FY05

Social Work

License Revenue â&#x20AC;&#x201C; By School Table 23

Fiscal Year 05 Arts & Sciences

Engineering

Medicine

Social Work

Total

Income Licensing Income

451,419

691,573

8,824,125

1,200

Expense Reimbursements OTM Current FY (External)

$ $ $ $ $

6,794 -

$ $ $ $ $

192,946 (3,735) 81,072 -

$ $ $ $ $

804,901 1,286 603,272 -

$ $ $ $ $

510

$ $ $ $ $

$ 458,213

961,856

$ 10,233,584

1,710

$ $

107,690 57

$ $

304,047 37

$ $

1,569,402 487

$ $

$ 107,747

304,084

1,569,889

$ 1,981,720

$ $ $ $

327,807 298,694 23,686

$ $ $ $

4,074,997 3,527,913 654,500

$ $ $ $

600 540 510 -

$ $ $ $

4,530,055 3,982,250 510 745,307

$ $ $ $ $ $ $ $

4,930 268 -

$ $ $ $ $ $ $ $

4,930 268 -

8,262,609

1,650

Expense Reimbursements OTM Prior FY (External) Expense Reimbursements for Dept. (External) Expense Credits Other

Subtotal Income

9,968,317 997,848 (2,449) 691,138 510

$ 11,655,363

Expenses Legal Other

Subtotal Expenses

1,981,139 581

Distributions (1) Distribution to Inventors Distribution to Schools (Lic. Income) Distribution to Schools (Other Income) Distribution to Third Parties Expense Payback to 3rd Parties from License Revenue Expense Payback to Dept. from License Revenue 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

$ $ $ $ $ $ $ $

126,651 155,103 67,121 -

$ $ $ $ $ $ $ $

Subtotal Distributions

$ 348,874

Contributions to OTM Operations

1,592

650,187

7,584 $

401,086 $

$ 9,263,320

60 $

410,322

License Revenue â&#x20AC;&#x201C; 5 Years Table 24

Fiscal Year 02

Income Licensing 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

$ $ $

15,227 592,687 10,934

$ $ $

Expense reimbursements for Dept. (External) Expense Credits Other

Subtotal Income

$ $ $

367,503 49,390

$ 9,184,195

$ $ $ $

20,503 547,298 22,770

$ 8,130,071

$ 14,326,526

(8,041) $ 49,266 638,601 7,620

$ 9,581,586

$ $ $

(2,449) 691,138 510

$ 11,655,363

Expenses Legal Other

Subtotal Expenses

$ $

1,758,822 44,165

$ 1,802,987

$ $

1,696,924 $ (105) $

1,585,941 4,284

$ $

1,555,481 3,561

$ $

1,981,139 581

$ 1,696,819

$ 1,590,225

$ 1,559,042

$ 1,981,720

Distributions Distribution to inventors Distribution to schools (Lic. Income) Distribution to schools (Other Income) Distribution to third parties

$ $ $ $

3,534,864 3,147,532 501,508

$ $ $ $

2,954,063 2,542,439 22,770 579,395

$ $ $ $

5,625,302 5,062,039 10,934 889,129

$ $ $ $

3,742,581 3,276,202 7,620 554,331

$ $ $ $

4,530,055 3,982,250 510 745,307

Expense Payback to Third Parties from Lic. Rev. $ Expense Payback to Dept. from Lic. Rev. $

4,887

$ $

10,807 8,019

$ $

608 75,376

$ $

1,500 41,107

$ $

4,930 268

Expense Reimbursements for Dept. (External)

20,503

83,089

49,266

Expense Reimbursement OTM from Distribution

65,281

52,043

Carry forward - - Expenses Held/Paid in Advance $ $ $ $ $

$ $ $ $ $

11,240 (4,615) -

$ $ $ $

8,827 -

$ $ $ $ $

CFU legal expense recovery Transfer to reserve Patent Expenses held in advance Patent expense adjustment

Subtotal Distributions Contribution to OTM operations

$ 7,188,792

$ 6,144,621

$ 11,820,585

$ 7,724,650

$ 9,263,320

$ 192,416

288,631

980,997

349,937

410,322

Industry Sponsored Research Agreements – FY 05

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

Arts & Sciences Engineering & Applied Science Medicine Social Work Total

New 3 13 34 0 50

Figure 16

Social Work 0% Arts & Sciences 6% Engineering & Applied Science 26%

Arts & Sciences Engineering & Applied Science Medicine

Medicine 68%

Social Work

Research Agreements by Department â&#x20AC;&#x201C; FY 05 Table 26

Total Research Agreements for FY

Department

FY04

FY05

FY04

FY05

1 0 0 0 0 1

0 3 0 0 0 3

0 3 0 5 3 0 0 0 11

1 7 0 4 0 0 1 0 13

0 0 3 1 0 0 1 0 6 0 0 1 1 0 0 0 0 0 1 0 0 0 1 4

0 0 2 0 4 0 1 0 9 0 1 4 0 1 0 2 3 0 0 2 1 2 2 0

Arts & Sciences Biology Chemistry Earth & Planetary Sciences Physics Psychology Arts & Sciences Total

Engineering & Applied Science Biomedical Engineering Chemical Engineering Civil Engineering Computer Science Electrical Engineering Mechanical & Civil Engineering Mechanical Engineering System Science & Mathematics Engineering & Applied Science

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

Social Work Social Work Social Work Total

Total

Other Agreements â&#x20AC;&#x201C; FY 05 OTM processes service contracts-limited laboratory research activities frequently involving the testing of another partyâ&#x20AC;&#x2122;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

Total Other Agreements for FY

Department

Confidentiality

Evaluation & Option

Interinstitutional

Service Agreement

Other

Confidentiality

Evaluation & Option

Interinstitutional

Service Agreement

Other

2 0 0 0

1 0 0 0

0 0 0 0

1 2 0 0

1 0 0 0

4 0 1 0 0 6 0 0 11

0 0 0 0 0 0 0 0 0

0 1 0 3 0 0 0 0 4

0 0 0 0 0 0 0 0 0

0 2 0 0 0 0 0 12 5 3 1 1 1 0 8 0 0 8 3 1 2 8 1 3 59

0 1 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 6

0 0 0 0 0 0 0 3 0 1 0 1 0 0 0 0 0 2 0 0 0 0 0 0 7

0 1 1 1 0 0 0 12 0 0 1 0 0 0 0 2 0 4 4 1 0 3 0 3 33

0 0 0 0 0 1 0 2 0 0 1 0 0 0 1 0 0 2 0 1 0 0 0 1 9

0 0

Arts & Sciences Biology Chemistry Earth & Planetary Sciences Physics Psychology Arts & Sciences Total

Engineering & Applied Science Biomedical Engineering Chemical Engineering Computer Science Electrical Engineering Engineering & Applied Science Mechanical & Civil Engineering Mechanical Engineering System Science & Mathematics Engineering & Applied Science Total

Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Comparative Medicine Genetics Institute of Biological Computing Internal Medicine Molecular Biology & Pharmacology Molecular Microbiology Neurology Neurosurgery Obstetrics & Gynecology Occupational Therapy Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiation Oncology Radiology Siteman Surgery Medicine Total

Social Work Social Work Social Work Total

Total

Material Transfer Agreements by Departments â&#x20AC;&#x201C; FY 05 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 28 677

Total Material Transfer Agreements for FY

Department

Incoming

Outgoing

12 0 0 0 0

18 0 0 0 1

3 0 0 0 0 0 0

1 0 0 0 0 0 0

9 8 2 0 0 15 0 4 0 93 22 19 14 2 2 0 11 8 8 43 16 3 9 13 15

0 4 0 2 0 9 0 0 0 111 65 18 20 0 0 0 13 0 1 42 15 6 2 16 2

316

326

0 0

331

346

Arts & Sciences Biology Chemistry Earth & Planetary Sciences Physics Psychology Arts & Sciences Total

Engineering & Applied Science Biomedical Engineering Chemical Engineering Computer Science Electrical Engineering Mechanical & Civil Engineering Mechanical Engineering System Science & Mathematics Engineering & Applied Science Total

Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Bioorganic Chemistry & Molecular Pharmacology Cardiology Cell Biology & Physiology Comparative Medicine Genetics Institute of Biological Computing Internal Medicine Molecular Biology & Pharmacology Molecular Microbiology Neurology Neurosurgery Obstetrics & Gynecology Occupational Therapy Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiation Oncology Radiology Surgery Medicine Total

Social Work Social Work Social Work Total

Total

Sponsored Research Research Expense Expense Executive Executive Summary Summary Sponsored 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)

Sponsored Research Research Expense Expense Executive Executive Summary Summary Sponsored

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 nonprofit 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-

Sponsored Research Research Expense Expense Executive Executive Summary Summary Sponsored 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 School of Art

John M. Olin School of Business 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.

Sponsored Research Research Expense Expense Executive Executive Summary Summary Sponsored 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 projectâ&#x20AC;&#x2122;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 Universityâ&#x20AC;&#x2122;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.

Sponsored Research Research Expense Expense Executive Executive Summary Summary Sponsored

56%

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.

Federal rate for research training and fellowship projects.

Other Includes various rates from federal, private and other government sponsors.

Federal on-campus research rate for projects awarded on or before 6/30/98. Applied to modified total direct costs.

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/.

TABLE 1 DIRECT AND F&A EXPENDITURES BY SPONSOR TYPE (in thousands)

Sponsors

FY05 Direct % Total F&A % Total Total Costs Direct Costs F&A

Federal

$332.960

Private Sources Other Government

TOTAL

89% $123,563

96% $458,523

FY04 Direct % Total F&A % Total Total % Total Costs Direct Costs F&A 91% $310,321

90% $117,069

96% $427,390

% Total 91%

39,198

11%

5,464

44,662

35,679

10%

4,971

40,650

565

105

670

582

121

703

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

TABLE 2 DIRECT AND F&A EXPENDITURES BY SCHOOL AND COST CATEGORY FY 05 and FY 04 (in thousands)

FY05 DIRECT COSTS

SCHOOLS MEDICINE

F&A COSTS

FY04 TOTAL

DIRECT COSTS

F&A COSTS

CHANGE TOTAL

$317,717

$113,904

$431,621

$295,767

$106,215

$401,982

$29,639

ARTS & SCIENCES

31,025

10,715

41,740

28,123

10,091

38,214

3,526

ENGINEERING

14,183

4,647

18,830

13,633

4,097

17,730

1,100

SOCIAL WORK

5,018

1,310

6,328

4,634

1,309

5,943

385

OTHER

4,780

556

5,336

4,425

449

4,874

462

$372,723

$131,132

$503,855

$346,582

$122,161

$468,743

$35,112

TOTAL

TABLE 3 DIRECT AND F&A EXPENDITURES BY SCHOOL AND PROJECT TYPE FY 05 and FY 04 (in thousands)

Research FY05

SCHOOLS MEDICINE

FY04

Research Training FY05 FY04

Other Sponsored Activities FY05 FY04

Total FY05

FY04

$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

3,988

3,942

5,336

4,874

$18,612

$15,217

TOTAL

$447,659

$417,123

$37,584

$36,403

$503,855

$468,743

TABLE 4 FISCAL YEAR 2005 EXPENDITURES BY SPONSOR AND AGREEMENT TYPE (in thousands)

FY05

FEDERAL AGENCIES NIH NSF USDE NASA DOD EPA DHHS OTHER DOE DHHS HRSA USDA OTHER TOTAL FEDERAL OTHER GOVERNMENT PRIVATE SOURCES INDUSTRY FOUNDATIONS & TRUSTS VOL HEALTH OTHER TOTAL PRIVATE

TOTAL

FY04

DIRECT AGREEMENTS

SUB AGREEMENTS

$383,170 18,172 6,186 5,943 4,023 1,989 4,208 3,398 1,804 773 626 430,292

$19,353 2,219 89 2,070 1,449 551 968 78 885 233 336 28,231

TOTAL $402,523 20,391 6,275 8,013 5,472 2,540 5,176 3,476 2,689 1,006 962 458,523

CHANGE

DIRECT AGREEMENTS

SUB AGREEMENTS

$356,620 15,371 5,679 4,760 4,971 3,260 4,134 2,962 1,676 598 570 400,601

$17,398 2,557 142 2,378 1,277 354 964 172 669 878 26,789

TOTAL $374,018 17,928 5,821 7,138 6,248 3,614 5,098 3,134 2,345 598 1,448 427,390

$28,505 2,463 454 875 (776) (1,074) 78 342 344 408 (486) 31,133

8% 14% 8% 12% -12% -30% 2% 11% 15% 68% -34% 7%

670

703

(33)

-5%

11,180 20,953 8,107 4,422 44,662

11,107 15,867 8,735 4,941 40,650

73 5,086 (628) (519) 4,012

1% 32% -7% -11% 10%

$475,624

$28,231

$503,855

$441,954

$26,789

$468,743

$35,112

TABLE 4A FISCAL YEAR 2005 EXPENDITURES GRAPHS BY SPONSOR FEDERAL FUNDING

OTHER GOV'T FUNDING 1,500 Dollars (in thousand

450,000 375,000 300,000 225,000 150,000 75,000 FY01 Federal 326,976

FY02

FY03

FY04

FY05

348,953

409,801

427,390

458,523

1,200 900 600 300 -

Other Gov't

FY01

FY02

FY03

FY04

FY05

1,283

820

741

703

670

PRIVATE FUNDING 60,000 Dollars (in thousand

Dollars (in thousands

525,000

50,000 40,000 30,000 20,000 10,000 Private

FY01

FY02

FY03

FY04

FY05

49,155

42,221

40,372

40,650

44,662

TABLE 5 FISCAL YEAR 2005 EXPENDITURES BY SPONSOR AND PROJECT TYPE (in thousands)

Research

FY05 FEDERAL AGENCIES NIH NSF USDE NASA DOD EPA DHHS OTHER DOE DHHS HRSA USDA OTHER TOTAL FEDERAL OTHER GOVERNMENT PRIVATE SOURCES INDUSTRY FOUNDATIONS & TRUSTS VOL HEALTH OTHER TOTAL PRIVATE

TOTAL

$373,587 19,093 89 7,844 5,319 2,534 4,436 3,476 160 1,006 622 418,166

Research Training

FY04 $346,673 16,510 142 7,047 6,159 3,609 4,165 3,134 46 598 1,217 389,300

FY05 $28,438 1,279 169 153 6 193 20 78 30,336 -

Other Sponsored Activities

FY04

FY05

$26,654 1,406 91 89 5 314 21 3 28,583

FY04

Total

FY05

FY04

$498 19 6,186 547 2,509 262 10,021

$691 12 5,679 619 2,278 228 9,507

$402,523 20,391 6,275 8,013 5,472 2,540 5,176 3,476 2,689 1,006 962 458,523

$374,018 17,928 5,821 7,138 6,248 3,614 5,098 3,134 2,345 598 1,448 427,390

407

383

670

703

263

312

10,174 11,512 4,759 2,785 29,230

9,741 9,753 4,984 3,033 27,511

558 2,816 3,285 589 7,248

650 2,587 3,677 898 7,812

448 6,625 63 1,048 8,184

716 3,527 74 1,010 5,327

11,180 20,953 8,107 4,422 44,662

11,107 15,867 8,735 4,941 40,650

$447,659

$417,123

$37,584

$36,403

$18,612

$15,217

$503,855

$468,743

TABLE 5A FISCAL YEAR 2005 EXPENDITURES GRAPHS BY SPONSOR TYPE RESEARCH TRAINING

SPONSORED RESEARCH 40,000 Dollars (in thousands

450,000 375,000 300,000 225,000 150,000 75,000

35,000 30,000 25,000 20,000 15,000 10,000 5,000

Research

FY01

FY02

FY03

FY04

FY05

339,391

348,014

402,974

417,123

447,659

Research Training

FY01

FY02

FY03

FY04

FY05

26,531

30,577

32,724

36,403

37,584

OTHER SPONSORED ACTIVITIES 20,000 Dollars (in thousands

Dollars (in thousands

525,000

15,000

10,000

5,000

Other Sponsored Activities

FY01

FY02

FY03

FY04

FY05

11,492

13,403

15,216

15,217

18,612

TABLE 6 FISCAL YEAR 2005 EXPENDITURES BY SPONSOR AND SCHOOL

School of Medicine FY05 TOTAL FEDERAL OTHER GOVERNMENT PRIVATE SOURCES Industry Foundations & Trusts Vol Health Other TOTAL PRIVATE

TOTAL ALL SOURCES

School of Engineering & Applied Science

Arts & Sciences

$ Change from FY04

FY05

$ Change from FY04

FY05

GWB School of Social Work $ Change from FY04

FY05

$397,442

$26,855

$36,758

$3,174

$15,955

$728

$3,848

605

(3)

(20)

(23)

7,532

(117)

2,291

199

1,177

119

15,255

4,233

1,492

147

1,208

7,886

(672)

(143)

2,901 33,574

(657) 2,787

1,160 4,977

$431,621

$29,639

$41,740

Other Schools

Total University

$ Change from FY04

FY05

$ Change from FY04

$19

$4,520

$357

$458,523

$31,133

670

(33)

153

(138)

11,180

2,303

541

695

20,953

5,086

187

8,107

(628)

169 372

286 2,858

(10) 395

24 2,480

(38) 365

51 773

17 93

4,422 44,662

(519) 4,012

$3,526

$18,830

$1,100

$6,328

$385

$5,336

$462

$503,855

$35,112

TABLE 7 FISCAL YEAR 2005 EXPENDITURES BY DETAILED COST CATEGORY AND SPONSOR (in thousands)

FEDERAL

DETAILED COST CATEGORY

FY05

FY04

OTHER GOVERNMENT % Of Change from FY 04

FY05

FY04

PRIVATE SOURCES

% Of Change from FY 04

FY05

FY04

TOTAL

% Of Change from FY 04

FY05

FY04

% Of Change from FY 04

Academic Salaries Staff Salaries Grad Assistant Subtotal Salaries

$64,492 79,530 8,978 153,000

$59,710 75,033 8,307 143,050

8% 6% 8% 7%

$49 336 385

$79 349 428

-38% -4% 0% -10%

$7,141 9,108 1,250 17,499

$6,379 9,030 1,210 16,619

12% 1% 3% 5%

$71,682 88,974 10,228 170,884

$66,168 84,412 9,517 160,097

8% 5% 7% 7%

Fringe Benefits Stipends/Health Allowance Consultants Consumable Supplies Other Travel Subcontracts Equipment TOTAL DIRECT COSTS

32,073 14,334 1,206 38,818 36,702 4,473 27,533 24,821 332,960

28,049 14,028 1,308 38,458 35,921 4,533 24,160 20,814 310,321

14% 2% -8% 1% 2% -1% 14% 19% 7%

86 20 24 42 4 1 3 565

94 19 13 21 7 582

-9% 0% 5% 85% 100% -43% 0% 0% -3%

3,806 3,240 577 5,773 4,880 913 1,370 1,140 39,198

3,428 3,176 310 5,304 4,450 827 829 736 35,679

11% 2% 86% 9% 10% 10% 65% 55% 10%

35,965 17,574 1,803 44,615 41,624 5,390 28,904 25,964 372,723

31,571 17,204 1,637 43,775 40,392 5,367 24,989 21,550 346,582

14% 2% 10% 2% 3% 0% 16% 20% 8%

F&A Costs

125,563

117,069

105

121

-13%

5,464

4,971

10%

131,132

122,161

$458,523

$427,390

$670

$703

-5%

$44,662

$40,650

10%

$503,855

$468,743

TOTAL

TABLE 8 FISCAL YEAR 2005 EXPENDITURES BY DETAILED COST CATEGORY AND SCHOOL (in thousands)

School of Medicine DETAILED COST CATEGORY

FY05

$ Change from FY04

School of Engineering & Applied Science

Arts & Sciences FY05

$ Change from FY04

FY05

$ Change from FY04

GWB School of Social Work FY05

$ Change from FY04

Other Schools FY05

Total University

$ Change from FY04

FY05

$ Change from FY04

Academic Salaries Staff Salaries Grad Assistant Subtotal Salaries

$58,143 81,920 3,907 143,970

$4,418 4,653 (99) 8,972

$8,600 3,745 3,367 15,712

$413 69 349 831

$3,750 533 2,801 7,084

$547 65 399 1,011

$958 1,501 40 2,499

$26 (111) 40 (45)

$231 1,275 113 1,619

$110 (114) 22 18

$71,682 88,974 10,228 170,884

$5,514 4,562 711 10,787

Fringe Benefits Stipends/Health Allowance Consultants Consumable Supplies Other Travel Subcontracts Equipment TOTAL DIRECT COSTS

31,947 14,506 792 41,060 35,720 3,452 23,183 23,087 317,717

3,977 (20) (92) 272 763 (45) 4,384 3,739 21,950

2,732 1,753 379 2,345 2,336 1,239 2,398 2,131 31,025

296 190 55 90 79 82 505 774 2,902

752 827 111 1,044 776 407 2,436 746 14,183

85 36 19 481 222 39 (1,244) (99) 550

442 488 326 124 591 265 283 5,018

9 164 56 (16) 128 (58) 146 384

92 195 42 2,201 27 604 4,780

27 128 13 40 5 124 355

35,965 17,574 1,803 44,615 41,624 5,390 28,904 25,964 372,723

4,394 370 166 840 1,232 23 3,915 4,414 26,141

F&A Costs

113,904

7,689

10,715

624

4,647

550

1,310

556

107

131,132

8,971

$431,621

$29,639

$41,740

$3,526

$18,830

$1,100

$6,328

$385

$5,336

$462

$503,855

$35,112

TOTAL

TABLE 8A FISCAL YEAR 2005 EXPENDITURES GRAPHS BY SCHOOL SCHOOL OF MEDICINE

Dollars (in thousand

450,000 375,000 300,000 225,000 150,000 75,000 School of Medicine

FY01

FY02

FY03

FY04

FY05

324,897

335,779

390,451

401,982

431,621

Dollars (in thousand

HILLTOP SCHOOLS 42,000 36,000 30,000 24,000 18,000 12,000 6,000 -

FY01

FY02

FY03

FY04

FY05

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

TABLE 9 F&A EXPENDITURES (RECOVERY) BY SPONSOR AND F&A RATE (in thousands)

54% / 53% * FY05 FY04 FEDERAL AGENCIES NIH NSF USDE NASA DOD EPA DHHS OTHER DOE DHHS HRSA USDA OTHER TOTAL FEDERAL

$106,239 5,400 83 2,369 1,540 319 862 917 45 15 137 117,926 5

OTHER GOVERNMENT PRIVATE SOURCES INDUSTRY FOUNDATIONS & TRUSTS VOL HEALTH OTHER TOTAL PRIVATE

TOTAL

480 111 133 724 $118,655

F&A RATE PERCENTAGES 26% 8% FY05 FY04 FY05 FY04

50% FY05 FY04

$99,139 4,602 67 2,120 1,700 486 813 839 15 300 110,081 -

348 56 41 445 $110,526

$10 10

$3,463 78 44 27 88 30 341 93 283 19 4,466

2,575 33 14 66 2,688

2,645 13 55 84 2,797

$2,698

$2,797

9 2 11 $4,477

$3,210 93 43 91 35 31 344 85 281 51 4,264

$1,733 3 25 7 33 1 1,802

FY05

$1,588 5 29 5 26 4 1,657

OTHER FY04

$571 87 292 74 3 119 182 31 1,359

$418 115 259 57 24 74 102 18 1,067

Total F&A Costs FY05 FY04 $112,016 5,568 444 2,396 1,635 349 1,310 1,013 448 197 187 125,563

$104,355 4,815 398 2,211 1,740 517 1,240 948 374 102 369 117,069

112

105

121

1 16 17

20 64 22 35 141

14 50 28 44 136

160 1,210 500 30 1,900

158 940 461 17 1,576

3,244 1,418 536 266 5,464

3,166 1,059 544 202 4,971

$1,944

$1,794

$3,358

$2,755

$4,289

$131,132

$122,161

TABLE 10 F&A EXPENDITURES (RECOVERY) BY SPONSOR AND AGREEMENT TYPE (in thousands)

FY05

FEDERAL AGENCIES NIH NSF USDE NASA DOD EPA DHHS OTHER DOE DHHS HRSA USDA OTHER TOTAL FEDERAL OTHER GOVERNMENT PRIVATE SOURCES INDUSTRY FOUNDATIONS & TRUSTS VOL HEALTH OTHER TOTAL PRIVATE

TOTAL

FY04

DIRECT AGREEMENTS

SUB AGREEMENTS

$106,071 4,928 433 1,852 990 187 1,155 989 362 153 80 117,200

$5,945 640 11 544 645 162 155 24 86 44 107 8,363

TOTAL $112,016 5,568 444 2,396 1,635 349 1,310 1,013 448 197 187 125,563

CHANGE

DIRECT AGREEMENTS

SUB AGREEMENTS

$99,103 4,082 374 1,519 1,329 407 1,109 904 339 102 102 109,370

$5,252 733 24 692 411 110 131 44 35 267 7,699

TOTAL $104,355 4,815 398 2,211 1,740 517 1,240 948 374 102 369 117,069

% $7,661 753 46 185 (105) (168) 70 65 74 95 (182) 8,494

7% 16% 12% 8% -6% -32% 6% 7% 20% 93% -49% 7%

105

121

(16)

-13%

3,244 1,418 536 266 5,464

3,166 1,059 544 202 4,971

78 359 (8) 64 493

2% 34% -1% 32% 10%

$8,971

$122,769

$8,363

$131,132

$114,462

$7,699

$122,161

TABLE 11 FISCAL YEAR 2005 FEDERAL EXPENDITURES BY FEDERAL AGENCY AND SCHOOL (in thousands)

FEDERAL AGENCIES

School of Medicine $ Change from FY04

FY05 NIH

$380,599

NSF

2,112

School of Engineering & Applied Science

Arts & Sciences

$25,258

$ Change from FY04

FY05

$ Change from FY04

FY05

$13,147

$1,193

$4,747

$1,763

12,692

694

5,333

1,567

USDE

572

(45)

1,762

478

112

NASA

780

6,729

677

504

137

DOD

2,756

745

409

2,307

EPA

FY05

$ Change from FY04

$76

$474

$215

$402,523

$28,505

192

147

20,391

2,463

115

3,714

(59)

6,275

454

8,013

875

(1,595)

5,472

(776)

2,535

(1,074)

2,540

(1,074)

(22)

5,176

3,476

342

2,689

344

1,006

408

(51)

140

$19

$4,520

$357

DOE

1,660

320

1,525

DHHS HRSA

2,689

349

USDA

817

568

146

(203)

OTHER

373

(555)

311

259

291

$3,174

FY05

$36,758

$3,556

Total University

$ Change from FY04

109

$26,855

FY05

Other Schools

5,084

$397,442

$ Change from FY04

DHHS OTHER

TOTAL FEDERAL

(9)

GWB School of Social Work

$15,955

(237) -

$728

60 55 $3,848

(5)

962 $458,523

(486) $31,133

TABLE 12 FISCAL YEAR 2005 COST SHARING EXPENDITURES BY DETAILED COST CATEGORY AND SCHOOL (in thousands)

School of Medicine DETAILED COST CATEGORY

FY05

School of Engineering & Applied Science

Arts & Sciences

$ Change from FY04

FY05

$ Change from FY04

FY05

$ Change from FY04

Academic Salaries Staff Salaries Grad Assistant Subtotal Salaries

$9,790 941 158 10,889

$636 289 65 990

$1,498 49 57 1,604

($97) 15 (82)

$103 27 1 131

($34) 5 (2) (31)

Fringe Benefits Stipends/Health Allowance Consultants Consumable Supplies Other Travel Subcontracts Equipment TOTAL DIRECT COSTS

1,871 73 2 840 1,261 544 15,480

480 62 (5) 563 819 (23) 531 3,417

312 2 48 333 9 94 2,402

4 (45) 22 147 (50) (4)

20 2 2,604 6 7 9 2,779

(8) (4)

5,142

830

666

157

125

$20,622

$4,247

$3,068

$153

$2,904

F&A Costs TOTAL

GWB School of Social Work $ Change from FY04

FY05 $23 6 29

Other Schools FY05

$8 3 11

$52 93 145

$20 (6) 14

FY05

$ Change from FY04

$11,466 1,116 216 12,798

$533 306 63 902

1 20

2,235 73 4 890 4,202 16 7 647 20,872

484 13 (5) 579 3,473 (24) 7 470 5,899

25 1 171

6,005

1,051

$2,483

$69

$23

$214

$44

$26,877

$6,950

(4) 2,504 7 (11) 2,453

Total University

$ Change from FY04

(2) 3 (2)

5 -

Industry Sponsored Clinical Trials 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 Medicineâ&#x20AC;&#x2122;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

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 Childrenâ&#x20AC;&#x2122;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

Industry Sponsored Clinical Trials

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.

Industry Sponsored Clinical Trials

Figure 1: Industry Sponsored Clinical Trials by Dept. of the School of Medicine

FY 2005 Department Internal Medicine Surgery Pediatrics Neurology Radiology Pathology & Immunology Psychiatry Anesthesiology Obstetrics & Gynecology Orthopedic Surgery Emergency Medicine Radiation Oncology Siteman Cancer Center (NOTE 1) Ophthalmology & Visual Sciences Neurological Surgery Otolaryngology Molecular Biology & Pharmacology Health Administration Genetics Molecular Microbiology Occupational Therapy Biochemistry & Molecular Biophysics Div of Comparative Medicine Cell Biology & Physiology Physical Therapy Total

#'s 628 147 108 101 69 47 42 29 28 19 15 11 10 9 8 5 4 4 3 2 2 1 1 1 0 1,294

$ 12,279,318 1,778,660 1,072,408 1,253,842 1,100,496 463,307 1,684,310 317,958 470,295 218,849 223,006 186,150 204,934 55,330 94,449 70,133 30,258 (200,256) 7,569 25,756 5,900 20,000 2,554 0 0 21,365,225

FY 2004 #'s 599 159 69 145 79 54 40 29 32 17 13 16 14 7 14 4 3 6 2 4 2 1 2 1 0 1,312

$ 10,372,727 1,802,762 1,121,084 1,467,898 1,347,717 450,094 1,617,200 299,394 475,838 242,975 141,113 345,792 296,311 21,762 38,228 62,583 57,542 325,000 1,510 13,600 35,047 20,000 (84,624) 0 0 20,471,553

FY 2003 #'s 540 109 92 114 89 43 44 36 28 17 12 12 12 6 13 4 2 5 2 3 2 2 2 1 1 1,191

$ 9,134,760 1,453,802 792,500 1,218,686 1,131,701 306,571 1,465,251 314,230 459,571 137,778 119,044 317,880 234,089 117,763 229,209 82,688 2,850 45,000 77,181 12,750 47,674 27,350 6,792 36,750 1,970 17,773,837

%Inc / (Dec) FY 03 - FY05 #'s $ 16% 34% 35% 22% 17% 35% -11% 3% -22% -3% 9% 51% -5% 15% -19% 1% 0% 2% 12% 59% 25% 87% -8% -41% -17% -12% 50% -53% -38% -59% 25% -15% 100% 962% -20% -545% 50% -90% -33% 102% 0% -88% -50% -27% -50% -62% 0% -100% -100% -100% 9% 20%

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.

Industry Sponsored Clinical Trials

Figure 2: Industry Sponsored Clinical Trials by Div. of the Dept. of Internal Medicine

FY 2005 Divisions of Internal Medicine Medical Oncology Cardiology Endocrine / Metabolism Chrom Kidney Center AIDS Clinical Trial Unit Pulmonary Renal Gastroenterology Dermatology Infectious Diseases Lipid Research Rheumatology Center for Human Nutrition Bone & Mineral Diseases Bone Marrow Transplant Immunology Medical Education Hematology Geriatrics / Gerontology Applied Physiology Medical Informatics Total

#'s 168 104 47 38 37 35 35 33 30 21 18 16 14 8 6 5 5 4 3 1 0 628

$ 3,000,685 1,119,505 916,493 606,794 92,262 878,367 794,602 427,258 465,100 111,888 3,012,183 224,543 440,108 73,431 31,500 15,164 14,259 35,896 19,280 0 0 12,279,318

FY 2004 #'s 140 98 51 35 28 29 25 34 36 24 47 20 9 2 8 5 4 1 2 1 0 599

$ 2,563,944 1,036,212 764,320 395,984 63,283 730,422 419,117 352,208 595,686 130,910 2,565,175 154,955 178,368 34,259 13,322 49,624 8,732 3,500 312,707 0 0 10,372,727

FY 2003 #'s 90 92 49 32 30 26 36 23 60 58 16 11 5 5 4 1 1 1 540

$ 1,838,425 1,044,851 1,131,756 487,658 468,162 605,607 274,653 657,326 426,117 1,342,440 124,034 430,333 161,345 41,427 84,791 15,836 0 0 9,134,760

%Inc / (Dec) FY 03 - FY05 $ #'s 87% 63% 13% 7% -4% -19% 19% 24% 100% 100% 17% 88% 35% 31% -8% 56% 30% -29% -65% -74% -69% 124% 0% 81% 27% 2% 100% 100% 20% -80% 0% -63% 25% -83% 100% 100% 200% 22% 16% 34%

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

Industry Sponsored Clinical Trials

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

Clinical Studies Confidentiality Agreements Amendments (all types) Other (lab, animal, data analysis)

FY05 355 88 183 37

FY04 231 61 201 43

FY03 251 68 182 46

TOTAL

663

536

547

Inc/Dec 29% 29% 0% (20%) 21%

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. b. c. d. e. f. g. h. i.

Table 2 – Table 3 – Table 4 – Table 5 –

Funding History by School – Five years Direct Costs vs. F & A Costs FY05 and FY04 Award Dollars by School and Project Type FY05 and FY04 Direct and F & A Award Dollars by Sponsor type FY05 and FY04 Table 7 – Federal Award Dollars by School and Sponsor FY05 Table 8 – Award Dollars by School and Sponsor Type FY05 and FY04 Table 9 – School of Arts & Sciences – Award Dollars by Department and Sponsor Type Table 10 – School of Engineering – Award Dollars by Department and Sponsor Type Table 11 – School of Medicine – Award Dollars by Department and Sponsor Type