FY11 Annual Report by Office of the Vice Chancellor for Research

LEADERSHIP SUPPORT SERVICE INTEGRITY I N N O VAT I O N OPPORTUNITY PA R T N E R S H I P QUALITY ENTREPRENEURSHIP OUTREACH ETHICS COMPLIANCE INVENTION E D U C AT I O N RESEARCH KNOWLEDGE

ANNUALREPORT

Letter from the Vice Chancellor for Research

Like any Annual Report, this year’s Summary of Sponsored Research contains retrospective data, summary reflections, and forward-looking statements. In a year of continued economic challenge, funding uncertainties, and constant change, we have nonetheless seen an unwavering constant. That constant is the passion and excellence of our faculty, staff, and trainees -- for inquiry, the creation of new knowledge, and the dissemination of that knowledge for public good. Our position as a leader in research continues to benefit the world, long after the research is concluded and results published, and our students have become alumni. Fiscal year 2011 realized the anticipated waning of the funding “bolus” which was infused into the nation’s research enterprise by the American Recovery and Reinvestment Act of 2009. Washington University’s ARRA funding was $47M in FY11, compared to $105M in the ARRA apex year of FY10. Nonetheless, total FY11 research funding of nearly $618M evidenced the overall health and competitiveness of the University research enterprise, and the strength of our faculty in competing successfully for increasingly sought-after funding. As in previous years, Washington University in FY11 received the majority of its extramural research funding from the federal government. Federal agency support accounted for nearly 76% of total research funding. The majority of that support derived from the National Institutes of Health, which provided almost 68% of total University sponsored project dollars and more than 89% of the federal support. The unwinding of ARRA, which saw a 12% decrease in overall federal research spending, from FY10 to FY11, was mirrored in a 13% decrease in total Washington University research support. Our faculty, like the American research community, will be challenged going forward, to maintain and grow their individual research enterprises. Increased competition for federal research support has and will continue to necessitate greater numbers of federal research applications by faculty and diversification of funding sources, such as foundations and the private sector. Washington University faculty, who currently enjoy greater-than-average success rates in federal funding, have already responded to these realities. From FY06 to FY11, research funding from private sources grew 63%.

Private providers of research funding, in the form of sponsored laboratory and clinical research grants, and philanthropy, from industry, corporations foundations, and disease advocacy organizations, continue to provide substantial benefit to Washington University. Moreover, industry-sponsored research agreements represent the types of partnerships that Washington University can forge with the private sector in moving research advancements through development, toward commercialization, and, ultimately, to improve the lives of people all over the world. The overall Washington University goal to “Enhance our global leadership today to benefit the world tomorrow” took a new direction in FY11, with a University-wide initiative of Innovation and Entrepreneurship. In March, Chancellor Mark Wrighton provided an address to the University community on this theme, and I followed with a presentation on Innovation, Intellectual Property, Commercialization, and Entrepreneurship in Research. These presentations may be viewed on the Office of the Vice Chancellor for Research (OVCR) website, at http://research.wustl.edu/Pages/default.aspx. Together we set forth an ambitious goal, to expand the University research culture and to enhance the role of WU in commercializable innovation -- creating intellectual property and advancing the fruits of research for the greatest public benefit. The coming year will see the implementation of our ambitious plans to realize these goals. New initiatives have not been limited to the agenda of innovation and entrepreneurship. FY11 saw the debut, and phenomenal success, of a new pilot grant program sponsored by the OVCR, designed to stimulate and support new collaborative research. Termed the University Research Strategic Alliance (“URSA”, Latin for Bear, the Washington University mascot), it requires that applications represent a new collaboration between faculty from different disciplines working together in a new area of research or approaching a problem in an innovative way. The goal is to promote new collaborations that build on different scientific and scholarly backgrounds to facilitate breakthroughs in solving challenging research questions in a collaborative manner. The program attracted over forty applications, most from teams of investigators from different Washington University Schools. The applications were outstanding in their quality and novelty of collaborations, and six were funded with the resources available. Hopefully many if not all of the new collaborations, funded and unfunded by URSA, will persist and succeed. The URSA Program will return annually. This Annual Report presents funding and expenditure data and accounts of innovative research and technology from the past year. As we strive to attract the best faculty and students, and support them in their research endeavors, next year will entail revising and strengthening our operational and regulatory infrastructure, establishing and maintaining entrepreneurial partnerships, and supporting and encouraging innovative faculty and alumni, to help guarantee Washington University’s place as a global leader well into the future. Evan D. Kharasch, MD PhD Vice Chancellor for Research

Table of Contents Page Sponsored Research Funding Sponsored Research Funding Executive Summary ........................................................................ 1 Funding History by Sponsor Type .................................................................................................... 9 Funding History by School............................................................................................................... 16 Funding by Sponsor .......................................................................................................................... 23 Funding by Sponsor and School...................................................................................................... 28 Funding – School of Arts & Sciences Departments..................................................................... 32 Funding – School of Engineering Departments ........................................................................... 34 Funding – School of Medicine Departments ................................................................................ 36 Technology Management and Intellectual Property Technology Management and Intellectual Property Executive Summary................................. 39 Technology Highlights – FY11 ........................................................................................................ 41 Bear Cub Fund ................................................................................................................................... 51 Invention Disclosures ....................................................................................................................... 53 Patent Portfolio .................................................................................................................................. 55 Licenses ............................................................................................................................................... 57 License Revenue................................................................................................................................. 59 Industry Sponsored Research Agreements by School .................................................................. 61 Other Agreements by Department.................................................................................................. 63 Material Transfer Agreements by Department.............................................................................. 65 Social and Financial Impact .............................................................................................................. 66

Clinical Trials â&#x20AC;&#x201C; Industry Sponsored Industry Sponsored Clinical Trials Executive Summary .............................................................. 68 Industry Sponsored Clinical Trials (School of Medicine) ............................................................ 71 Industry Sponsored Clinical Trials (Department of Internal Medicine) .................................... 72 New Contracts.................................................................................................................................... 73 Sponsored Research Expense Sponsored Research Expense Executive Summary ...................................................................... 75 Expenditures ....................................................................................................................................... 80

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Sponsored Research Funding Executive Summary The Washington University in St. Louis (WU) research program had another successful year in fiscal year 2011 (FY11), receiving $617.7M of sponsored research awards. This amount of funding continues to demonstrate the strength of the WU research program and faculty engaged in research, a particularly successful achievement in light of a struggling national economy, intense scrutiny of government spending, and the end of the American Recovery and Reinvestment Act (ARRA) of 2009. Funding History Funding growth over five years (FY06-FY11) was a healthy 13.2%, largely due to the boom year of FY10, which was also the peak year for ARRA funding. As expected, the ARRA awards dropped in FY11 since most agencies completed awarding their ARRA funds in FY10. As explained later in this Executive Summary, ARRA was a one-time, unique occurrence in the research funding environment that all academic institutions experienced. WU certainly benefited from this unusual funding opportunity, but ARRA funding decreased as expected, from $105M in FY10 to $47.4M in FY11 (54.9%). More importantly, however, WU faculty managed to soften the effect of the ending of ARRA funding by acquiring $570.3M of nonARRA funding, so that total funding in FY11 ($617.7M) decreased from FY10 ($706.3M) by much less (12.6%) than expected. Removing the ARRA funds from the total funding picture for the sake of comparative analysis, the total funding in FY11 was 5.2% less than FY10, but grew 1.2% over two years and 4.4% over five years. Total ($M) Total (with ARRA) Total (w/out ARRA)

Growth

FY06

FY07

FY08

FY09

FY10

FY11

5-yr

4-yr

2-yr

1-yr

546

537

548

567

706

618

13.2%

15.1%

9.0%

-12.6%

546

537

548

563

601

570

4.4%

6.1%

1.2%

-5.2%

The percentages of funding per major sponsor type related to total funding of $617.7M were similar or the same as for the prior year. Federal support accounted for 75.8% of total funding; state, local, and international for 4.2%; and private for 20.1%. Federal Agency Funding Federal agency support at $468M is by far the leading source of research award dollars for the University, accounting for 75.8% of the total ($617.7M) for FY11. Federal dollars in FY11 accounted for the same percentage of the total in FY10, a sign that University faculty remained competitive for important federal support, particularly from the National Institutes of Health (NIH). The decrease in total federal funding dollars (12.5%) closely mirrors that of the total funding decrease (12.6%).

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding The amount of federal direct costs received decreased by about $54M (13.6%) in FY11, and federal Facilities & Administrative (F&A) costs received decreased by $13.0M (9.4%). For more details on direct and F&A costs, see Tables 5 through 6A on pages 25 through 27, and the Sponsored Projects Expense section of this report. Key Federal Research Sponsors The number one federal sponsor of University research is the NIH. Its total award obligation of $418.1M to WU (13.5% less than the previous fiscal year) represents 67.7% of WUâ&#x20AC;&#x2122;s total sponsored project funding and 89.3% of its federal dollars. NIH was also the primary contributor of NIH is the primary ARRA funding in the amount of $42.6M, which accounted contributor of both total for 89.9% of total ARRA funding, 10.2% of total NIH funding and ARRA dollars, and 6.9% of total funding to WU in FY11. NIH funding to the University. ARRA funding to WU saw a 53.9% decrease from FY10 to Subsequently, all Schools FY11, correlating with the decrease in total ARRA funding receiving NIH funding (54.9%). saw decreases in support

from that federal agency School of Medicine NIH award dollars in FY11 ($390.5M) in FY11compared to decreased by $57.1M (12.8%) compared to FY10 FY10. ($447.6M). The decrease in NIH funding to the School of Medicine ($57.1M) was 87.3% of the total NIH decrease of $65.4M, 85.2% of the total federal dollar decrease of $67M, and 64.9% of the total funding decrease for the University ($88M). The Medical School and University continue to be competitive for NIH dollars, however. The Blue Ridge Institute for Medical Research (BRIMR) ranks WU fourth among medical schools for NIH funding provided during the governmentâ&#x20AC;&#x2122;s FY2011. 1

Total NIH dollars awarded to the School of Engineering in FY11 ($9.7M) decreased by 19.2% from the previous year. NIH award dollars in FY11 to the George Warren Brown School of Social Work decreased by $3.5M (32.7%), bringing it to just above the FY09 funding level. Arts & Sciences experienced a similar decline to that of FY10, receiving 17.5% fewer NIH dollars in FY11. The National Science Foundation (NSF) remains the second largest contributor of federal dollars to University research with obligations of $14.8M for FY11, a 36.8% decrease from the prior year. The University received no ARRA funding directly from NSF in FY11. The Schools of Arts & Sciences and Engineering typically receive the majority of NSF funding to WU. Engineering received $6.2M (a decrease of 17.3% from FY10), and Arts & Sciences received $6.8M (a decrease of 49.3% from FY10). As with prior years, increases and decreases in Arts & Sciences are due not from the loss or gain of one single grant but multiple grants spread across the departments within the School. NSF funding to the School of Medicine decreased by $483,000 (a decrease of 22.7% compared to the prior year). The School of Social Work, which typically receives little or no funding from NSF each year, received no funding from NSF in FY11. 1

The Blue Ridge Institute for Medical Research (BRIMR). www.brimr.org.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

Department of Energy (DOE) total funding to WU decreased 13.8% ($1.3M) from FY10 ($9.5M) to FY11 ($8.1M). The International Center for Advanced Renewable Energy and Sustainability (I-CARES) received a DOE grant for nearly $1.5M in FY11. Tables 6 and 6A (page 26 and 27) list the different sponsoring agencies with dollar volume and change from FY10 to FY11. Tables 7 and 7A (pages 28 and 29) further break out agency funding by School. Award data are often affected by unusual events such as large, multi-year private awards in which all funds are provided at the beginning of the project. Though the work on these projects is spread over the course of several years, the amount of the total award is registered entirely in one year. For that reason, annual award levels may vary significantly year to year and do not necessarily reflect the amount of funding available for use in any given fiscal year. In addition, the receipt or completion of a single significant award may have a dramatic affect on percentages shown in this report. The award data picture over the last two years has been uniquely affected by the one-time implementation of the ARRA program. American Recovery & Reinvestment Act (ARRA) The ARRA program enacted in 2009 provided WU and other institutions a unique and positive opportunity to conduct research on certain eligible programs in a short-two year window. This national reinvestment program was designed to help the U.S. economy recover from a deep recession by funding programs that would sustain or create new jobs. As a result of this program, WU faculty benefited significantly from the new and additional funds supporting their research. Through FY11, WU received more than $157M in stimulus funding provided by the federal government under ARRA. In FY11, $47.4M in ARRA funding was received by WU, a 54.9% decrease from the peak year of FY10. After a remarkable FY10, wherein already-healthy research funding levels were supplemented by more than $105M in ARRA obligations, the federal government’s spending under the stimulus program slowed. Three factors are important to remember when comparing ARRA funding in FY11 to FY10. •

Activity peaked in the first full year of ARRA funding, FY10 ($105M), as expected due to the U.S. government’s stipulation that funds be distributed and expended within a narrow window of time. ARRA dollars received during FY11 were largely those awarded to new proposals for stimulus funding, whereas in FY10, ARRA funding came not only from new proposals but also supplements to existing awards and proposals that previously had been declined due to lack of money rather than lack of worthiness.

•

Although ARRA funding was originally provided by federal agencies, in FY10 and FY11 the University also benefited from funding that originally went to other institutions and agencies. Stimulus funding was received from local and state governments, international organizations, and private donors as a result of their receiving federal ARRA funds and passing them through to the University.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

â&#x20AC;˘

All universities that received ARRA funding will see a similar peak-and-valley picture of their research funds as the ARRA program comes to a close.

The table below shows the stimulus dollars received each year since the reinvestment and recovery program began in FY09. The total of $47.4M in ARRA funding for FY11 represents 7.7% of total sponsored research funding to WU ($617.7M).

Sponsor Type Federal

ARRA (000s) FY10

FY09

FY11

$4,730

$98,530

$43,130

State/Local/Int'l

2,344

1,065

Private

4,159

3,188

TOTAL

$4,730

$105,033

$47,383

Private Sources: Industry and Non-Profit Sponsor Support WU has experienced a trend of increased funding from private (industry and non-profit) sources, playing an important role in filling the gap left by declining federal support. Growth in this sector reached 63.2% over a five-year-period, and increased 11.7% from FY09. While funding from FY10 to FY11 declined 15.7%, part of the decrease can be attributed to a lack of large, multi-year grants from non-profits and industry, which also experienced a negative effect from the U.S. economic troubles. Industry funding of $19.3M was 24.3% ($6.2M) less than in FY10, and non-profit funding of $104.6M was 13.5% ($16.4M) less than in FY10. Federal ARRA dollars flowing through non-federal sources to WU had a negligible influence on private sources, accounting for just 2.6% of the total private funding received in FY11 (compared to 14.9% in FY10). The School of Medicine received three notable grants totaling more than $17M in FY11, from non-profit entities. Of note also are two contracts totaling nearly $7M from industry sponsors to the School of Medicine. The School of Arts & Sciences received a $1M award from a corporate foundation, and an $800,000 award from a not-for-profit institute. The Effect of ARRA ARRA was an historic infusion of funding into research institution programs. Its effect on funding cannot be emphasized enough when discussing the total sponsored research funding for multiple fiscal years. The importance of the ARRA funding era is particularly evident when viewing federal funding levels across fiscal years 2006 through 2011.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding As the table and figure below show, ARRA greatly enhances the picture of federal funding growth over several years. Although the University showed overall growth in total federal research funding from FY06 to FY11 (3.5%) and from FY09 to FY11 (7.1%), those figures include ARRA funding. Without stimulus dollars, as the second line in the table below shows, federal funding for FY06 to FY11 would have decreased by 6.0%, and decreased by 1.8% for the period FY09 to FY11. Total ($M) FY06 FY07 FY08 FY09 FY10

FY11

Growth 5-yr 4-yr 2-yr

Federal (with ARRA)

452

444

440

437

535

468

3.5%

5.4%

7.1%

Federal (w/out ARRA)

452

444

440

433

437

425

-6.0%

-4.3%

-1.8%

The following graph clearly shows the peak for ARRA in FY10. Funding provided by ARRA in FY10 accounted for 18.4% of federal funding to WU. If no ARRA funding had been received, federal funding would have been flat over the last six years.

Federal Funding

ARRA Rec'd in FY09-FY11

600

If No ARRA Rec'd in FY09-FY11

500

Dollars ($M)

400 ARRA rec’d: 7.1% FY09-FY11 5.4% FY07-FY11 3.5% FY06-FY11

300 200

No ARRA rec’d: -1.8% FY09-FY11 -4.3% FY07-FY11 -6.0% FY06-FY11

100 0 FY06

FY07

FY08

FY09

FY10

FY11

While ARRA funding received directly from federal agencies decreased 56.2% from FY10 ($98.5M) to FY11 ($43.1M), total federal funding decreased by a much lesser degree – 12.5% ($468.0M in FY11 versus $535.0M in FY10) – and when discounting ARRA dollars altogether, federal funding in FY11 at $424.9M decreased by an even lesser amount – 2.7% – from FY10 ($436.5M). 5

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding The effect on total funding by ARRA directly correlates with that on federal funding. Total funding decreased 12.6% and federal funding decreased 12.5% from the prior year. When funding is examined without taking ARRA dollars into account, it becomes clear that the University remained competitive in total funding. While total ARRA funding decreased 54.9% from FY10 to FY11, and direct federal ARRA funding decreased 56.2%, total research funding at $617.6M decreased from FY10 ($706.3M) by a lesser degree – 12.6% ($88.6M) – and when discounting ARRA dollars altogether, total funding at $570.3M decreased by an even lesser amount – 5.2% ($31.0M) – from FY10 ($601.3M). Although the University showed overall growth in total research funding from FY06 to FY11 (13.2%) and from FY09 to FY11 (9.0%), those figures include ARRA funding. Without stimulus dollars, funding for FY06 to FY11 would have increased by 4.4%, and increased by 1.2% for the period FY09 to FY11.

Total ($M) Total (with ARRA) Total (w/out ARRA)

Growth

FY06

FY07

FY08

FY09

FY10

FY11

5-yr

4-yr

2-yr

1-yr

546

537

548

567

706

618

13.2%

15.1%

9.0%

-12.5%

546

537

548

563

601

570

4.4%

6.1%

1.2%

-5.2%

Total Funding

ARRA Rec'd in FY09-FY11

800 700

If No ARRA Rec'd in FY09-FY11

Dollars ($M)

600 500

ARRA rec’d: 9.0% FY09-FY11 15.1% FY07-FY11 13.2% FY06-FY11

400 300

No ARRA rec’d: 1.2% FY09-FY11 6.1% FY07-FY11 4.4% FY06-FY11

200 100 0 FY06

FY07

FY08

FY09

FY10

FY11

While ARRA had a positive, short-term impact on WU, it is important to remember that the core of the WU research program remained strong, as demonstrated by the growth of non-ARRA funding between FY09 and FY11 of 1.2%.

The completion of the ARRA stimulus era may coincide with an historic shift in the way the federal government, particularly NIH, views its investment in research. There has already been an effort to concentrate a greater proportion of funding toward centers and other collaborative efforts as the continued economic strain forces federal agencies to consider ways to stretch their funding dollars further. Other research institutions may also find increased competition for federal dollars; all will be looking for new strategies. The spending of ARRA funds nationally can be monitored through the federal government’s website: www.recovery.gov. Fiscal Year 2010 It is important to note FY10’s uniqueness in that it was also the peak for non-ARRA funding, a testament to the efforts of WU faculty to remain competitive in a struggling economy and changing funding environment. Non-ARRA funding highlights of FY10 included $12M from private industry for energy research, $19M from NIH toward the Human Microbiome Project, a $20M grant from a nonprofit entity for children’s medical research, $5M from a foundation toward eliminating tropical diseases, and nearly $8M for the first year of a DOE grant to establish an Energy Frontier Research Center. The approximately $64M in non-ARRA funding provided by just these examples accounted for nearly 46% of the $139M increase in total funding from FY09 ($567M) to FY10 ($706M). Even without that infusion of non-ARRA funding, total FY10 funding would have increased by approximately 13.2% over FY09. Large Center Funding As predicted previously by several observers of the research funding environment, NIH is targeting collaborative multi-institutional, multi-disciplinary initiatives. Two of the largest grants received by WU researchers in FY11 were to multi-institution projects: one with five institutions and the other with nine. Because the University has long recognized that Centers and Institutes are integral to a healthy research environment and successful funding acquisition, it has established many innovative, vibrant, and thriving collaborative centers, and will continue to do so.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Funding to centers can come from any source, whether governmental or private. The objective of the large multidisciplinary and/or multi-institutional center is to concentrate applicable expertise and knowledge in specific areas of research. A list of centers at WU can be found at http://www.wustl.edu/academics/centers-institutes.html. A Top American Research University In its 2010 Annual Report, The Center for Measuring University Performance (published by Arizona State University) ranked WU twentieth (20) among top American research universities in total research expenditures and fourteenth (14) in federal research expenditures. Among top private research universities, the University was ranked sixth (6) in total research expenditures and seventh (7) in federal research expenditures. The rankings in the report are based on a number of factors, and rankings for other categories – such as number of faculty who are National Academy Members and doctorates granted – are also shown. 2 In a ranking conducted by the Blue Ridge Institute for Medical Research (BRIMR) 3 in Horse Shoe, North Carolina, WU is ranked fourth (4) in NIH Funding to U.S. Medical Schools for the federal fiscal year 2011. Additional data regarding NIH funding to U.S. Medical Schools can be found by visiting www.brimr.org/NIH_Awards/2011/NIH_Awards_2011.htm. Overview and Details of FY11 Sponsored Research Funding The following Sponsored Research Funding section of the Annual Report presents an overview of external funding for sponsored projects at WU during the University’s fiscal year of 2011 (FY11). In addition to the information provided here in the Executive Summary, it includes details of funding broken down into sponsor type among the various Schools for both ARRA and non-ARRA funding. All references within Tables and Figures to “Fiscal Year” are to WU’s fiscal year, which begins on July 1 and ends on June 30 of the following year. The awards reported within are those with start dates on or between July 1, 2010, and June 30, 2011, and the associated funds represent new money only (i.e., no carry-over funds from year to year for the same grant award are included).

The Top American Research Universities, 2010 Annual Report. The Center for Measuring University Performance. Arizona State University. Capaldi, E, Lombardi, J., Abbey, C., Craig, D. http://mup.asu.edu. 3 The Blue Ridge Institute for Medical Research (BRIMR) is a 501(c)(3) non-profit organization. www.brimr.org.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Funding History

The figures and tables in this section present WU’s funding history for five years, including three years – FY09, FY10, and FY11 – in which ARRA stimulus dollars benefited funding totals. In addition to direct federal ARRA funding, stimulus dollars were received from non-federal organizations that passed federal stimulus dollars through to the University in FY10 and FY11. Figure 1 and Table 1 break down the total dollars received by three broad sponsor types: (1) Federal, (2) State/Local/International, and (3) Private. The totals for FY09, FY10, and FY11 include ARRA stimulus funding. Total sponsored research funding for FY11 reached $617.7M, a decrease of 12.6% from FY10. Federal State/Local/Int'l Private TOTAL

FY07 444,018 16,765 76,691 $537,474

FY08 439,551 21,389 87,411 $548,351

FY09 437,435 18,662 111,285 $567,383

FY10 535,043 24,805 146,439 $706,288

FY11 467,981 25,791 123,873 $617,646

Table 1 Funding History by Sponsor Type – FY07 to FY11 (000s)

800 700

Dollars ($M)

600

Federal State/Local/Int'l

500

535

400 300

444

440

437

200 100

17 77

21 87

468

19 111

25 146

Private

26 124

0 FY07

FY08

FY09

FY10

FY11

Figure 1 Funding History by Sponsor Type – FY07 to FY11

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding A decrease in research funding from FY10 to FY11, including a correlative decrease in federal funding, was expected as ARRA awards dwindled after the peak year of FY10. Total funding decreased 12.6%, and federal funding decreased 12.5% from the prior year. State, Local, and International (“other government”) awards increased by 4.0% from FY10, a result of federal ARRA flow-through dollars. Without ARRA funding, this category would have experienced a 0.3% decrease. Private industry and non-profit funding in total decreased 15.4% from prior year FY10, but was 11.7% higher than FY09. Without ARRA the total funding for FY11 would have been 5.2% less than for FY10 and only 1.2% more than FY09. Figure 1A illustrates the effect of ARRA on total sponsored research, especially in FY10, the peak year for both ARRA and non-ARRA funding. Over a period of five years (FY06-FY11) WU funding grew 13.2%, and over a period of two years (FY09-FY11) grew 9.0%, due to ARRA funding.

Total Funding

ARRA Rec'd in FY09-FY11

800 700

If No ARRA Rec'd in FY09-FY11

Dollars ($M)

600 500

ARRA rec’d: 9.0% FY09-FY11 15.1% FY07-FY11 13.2% FY06-FY11

400 300

No ARRA rec’d: 1.2% FY09-FY11 6.1% FY07-FY11 4.4% FY06-FY11

200 100 0 FY06

FY07

FY08

FY09

FY10

FY11

Figure 1A Growth (with ARRA vs. without ARRA) – FY06 to FY11

Another way of illustrating ARRA’s importance on research funding at WU is to compare averages over a period of time, with and without ARRA funding. For the period FY06-FY11, the average per year with ARRA funding is $587M, while without ARRA funding it is $561M, a difference of $26M average per year. For the period FY09-FY11, with ARRA dollars the average per year is $630M, while the average for the same period without ARRA funding is $578M, a difference of $52M average per year. ARRA is not the only unique factor affecting the total funding for FY11 ($617.6M) versus FY10 ($706M). The FY10 non-ARRA total included $12M from private industry for energy research, $19M from NIH toward the Human Microbiome Project, a $20M grant from a nonprofit entity for children’s medical research, $5M from a foundation toward eliminating 10

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding tropical diseases, and nearly $8M for the first year of a DOE grant to establish an Energy Frontier Research Center. The approximately $64M in non-ARRA funding provided by these examples accounted for nearly 46% of the $139M increase in total funding from FY09 ($567M) to FY10 ($706M). Note in Table 1A that ARRA stimulus funding in FY11 was received not only directly from federal agencies but also from non-federal agencies that received federal ARRA funding and passed it through to the University.

Sponsor Type Federal

ARRA (000s) FY10

FY09

FY11

$4,730

$98,530

$43,130

State/Local/Int'l

2,344

1,065

Private

4,159

3,188

TOTAL

$4,730

$105,033

$47,383

Table 1A ARRA Funding by Sponsor Type (000s) Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Federal Research Funding Federal research funding refers to the dollars awarded by federal agencies directly to WU for use in its sponsored research programs. Federal funding accounted for 75.8% of total University award dollars in FY11 (the same percentage as in FY10). Figure 2 shows the effect that ARRA had on FY11 compared to years FY09 and FY10. In FY10, funding provided by the stimulus program was at its peak, accounting for 18.4% of the federal funding received by the University. In FY11, as less new stimulus funding was available and existing stimulus-funded projects came to an end, ARRA funding accounted for only 9.2% of WU’s federal funding.

550 500

Dollars ($M)

450 400 350 300 250

535 444

440

433

FY07

FY08

FY09

437

468

437

425

200 150 100 50 0

Federal (without ARRA)

FY10

FY11

Federal (with ARRA)

Figure 2 Federal Funding (000s) – FY07 to FY11

FY11 Table 2 Federal ARRA Funding – FY11 (000s)

Total Federal

ARRA from Direct Federal Sources

Federal ARRA as % of Total Federal

$467,981

$43,130

9.2%

When federal funding is examined even without taking ARRA dollars into account, it becomes clear that the University remained competitive. While ARRA funding itself decreased 54.9% ($57.7M) from FY10 to FY11, total federal funding decreased by a lesser degree – 12.5% ($67.1M) – and when discounting ARRA dollars total federal funding decreased by an even lesser amount – 2.7% ($11.6M). 12

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Additionally, while the overall growth in total federal funding from FY07 through FY11 (5.4%) was much lower than the growth for the period of FY06 through FY10 (18.4%), without taking ARRA dollars into account the growth delta is slim. Growth from FY07 through FY11 would have been -4.3%, compared to -3.3% for years FY06 through FY10. Not surprisingly, since ARRA funding originated with the federal government and federal funding is the major sponsor of WU research funding, the decrease in total federal funding dollars (12.5%) closely mirrors that of the total funding decrease (12.6%). Figure 1B shows, when discounting stimulus dollars, federal funding decreased 1.8% over the last two years and 6.0% over the last five years.

ARRA Rec'd in FY09-FY11

Federal Funding 600

If No ARRA Rec'd in FY09FY11

500

Dollars ($M)

400

ARRA rec’d: 7.1% FY09-FY11 5.4% FY07-FY11 3.5% FY06-FY11

300 200

No ARRA rec’d: -1.8% FY09-FY11 -4.3% FY07-FY11 -6.0% FY06-FY11

100 0 FY06

FY07

FY08

FY09

FY10

FY11

Figure 1B Federal Growth (with ARRA vs. without ARRA) – FY06 to FY11

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

State, Local, and International (“Other Government”) Funding

Commonly referred to as “Other Government”, this category most often includes state universities that subcontract to WU after receiving federal funding. It also includes funding from other U.S. States, international government agencies, and local entities such as the State of Missouri, St. Louis City, and St. Louis County. Of the $25.8M received in FY11, $1.1M was a result of other institutions receiving federal ARRA funding and subcontracting it to WU. While federal funding’s overall growth from FY07 to FY11 declined by 5.4%, overall growth for the State, Local, and International category increased over the same period by 53.8%, with a negligible effect from ARRA dollars.

Dollars ($M)

25 20 15 10

25 21 17

26 23

5 0 FY07

FY08

FY09

State, Local, & Int'l. (with ARRA)

FY10

FY11

State, Local, & Int'l. (without ARRA)

Figure 3 State/Local/International – FY07 to FY11

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Private Funding

Private funding received from companies and organizations fall into two main categories: Industry and Non-Profit. In FY11 this category included federal ARRA funding passed through to the University by non-federal entities. As in FY10, Private funding accounted for approximately 20% of total University funding. Industry typically includes commercial (for-profit) entities such as Ameren, Arch Coal, Peabody Energy, Pfizer, and Monsanto. Non-Profit includes foundations and trusts, such as charitable organizations established by family foundations or employees of a company, and voluntary health-specific or diseasespecific agencies such as the American Heart Association or the American Cancer Society. Other non-profit entities may include hospitals, individuals, institutes, and organizations such as The Foundation for Barnes-Jewish Hospital, the Howard Hughes Medical Institute, and NFL Charities. Figure 4 illustrates how the two main components of private funding – industry and nonprofit – compare to each other in dollars. The University experienced a sizable decrease (15.4%) in total private funding from FY10 to FY11. Although both industry and non-profit funding decreased from the prior year (24% and 13.2% respectively), it should be noted that funding in FY10 benefited uniquely from two large, one-time receipts: $12M from industry and $20M from a non-profit entity. Even without similar instances in FY11, the total private dollars were strong enough to represent an 11.3% increase over two years from FY09.

160 140

124

105

112

FY07

FY08

FY09

FY10

121

146

100

Dollars ($M)

120

Industry

Non-Profit

FY11

Total Private

Figure 4 Private Funding – FY07 to FY11 (000s)

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Funding by School

Research is a university-wide endeavor at WU. As collaborative and interdisciplinary research increases, a single prime award may fund projects at multiple Schools. The numbers for each School in the following table and figures most likely include dollars allocated to them by other Schools. Although much of the decrease in federal dollars is due to the “downhill” activity of the ARRA stimulus program, decreases in any fiscal year numbers can be attributed to the expiration of a large grant or contract, the timing of a sizable award near fiscal year end, or continuing work on a multiyear grant or contract for which the funding was awarded up front but for which research continues. The following table and figures show a five-year history of funding to the four most researchintensive Schools. “Administration & Other” in Table 2A includes central fiscal units (CFUs), Schools not listed here, and some Centers. Data for all Schools is shown in Table 3. FY07

FY08

FY09

FY10

FY11

Administration & Other

$1,099

$3,470

$1,798

$14,986

$1,623

Arts & Sciences

44,007

41,278

42,924

46,993

33,482

Engineering

22,103

23,480

24,010

28,624

23,284

464,444

471,753

483,915

596,130

545,158

5,820

8,370

14,735

19,555

14,099

$537,474

$548,351

$567,383

$706,288

$617,646

Medicine Social Work Total

Table 2A Funding History by School – FY07 to FY11 (000s) Note: Due to rounding, detail may not add up to total.

The School of Arts & Sciences received 28.7% fewer total research dollars in FY11 than in FY10. This includes a 29.2% decrease in federal dollars from FY10 to FY11.

Figure 5 – School of Arts and Sciences

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

The School of Engineering received 18.7% fewer total research dollars in FY11 than in FY10, closely reflecting the 19.7% decrease in federal dollars from FY10 to FY11.

Figure 6 – School of Engineering

The School of Medicine received 8.6% fewer total research dollars in FY11 than in FY10, including a 10.4% decrease in federal dollars.

Figure 7 – School of Medicine

The School of Social Work received 27.9% fewer total research dollars in FY11 than in FY10, mirrored by a decrease of 31.1% in federal funding for the same period.

Figure 8 – School of Social Work

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Table 2B below illustrates the breakdown of total and ARRA award dollars between Schools and the effect of ARRA on the total funding for FY11. As expected, ARRA funding was less of a factor in research funding compared to FY10, when ARRA made up for 14.9% of the Universityâ&#x20AC;&#x2122;s total research funding. In FY11, ARRA stimulus funding represented only 7.7% of total external research funding.

FY11 Total

School

Administration & Other Arts & Sciences Engineering Medicine Social Work TOTAL

FY11 ARRA

ARRA as % of Total

$1,623

$257

15.8%

33,482 23,284 545,158 14,099

831 548 45,586 162

2.5% 2.4% 8.4% 1.1%

$617,646

$47,384

7.7%

Table 2B ARRA Funding by School â&#x20AC;&#x201C; FY11 (000s)

Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs), Schools not listed, and some Centers.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding The following table compares FY11 award dollars with the prior year, broken out by Direct and F&A costs for each School. Change from one fiscal year to the next is tracked in the far right column of Table 3, expressed in dollars and percentage. The 92.6% decrease in Administration & Other from FY10 to FY11 is due mainly to a single receipt in FY10 of $12M to a Center. FY10 School Administration & Other

Direct Costs

FY11

F&A Costs

Total

Direct Costs

Change

F&A Costs

Total

$13,571

$522

$14,094

$566

$483

$1,050

($13,044)

-92.6%

34,764

12,230

46,993

24,585

8,897

33,482

(13,511)

-28.8%

Business

235

115

349

147

206

(143)

-41.0%

Design & Visual Arts

191

273

(192)

-70.3%

21,223

7,401

28,624

16,711

6,574

23,284

(5,339)

-18.7%

211

270

257

287

6.0%

458,613

137,516

596,130

411,849

133,308

545,158

(50,972)

-8.6%

15,356

4,199

19,555

11,216

2,883

14,100

(5,456)

-27.9%

$544,163 $162,124

$706,288

$465,405 $152,241 $617,646

($88,642)

-12.6%

Arts & Sciences

Engineering Law Medicine Social Work TOTAL

Table 3 Award Dollars by School and Cost Category FY10 and FY11 (000s) Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs) and some Centers. In FY10 it included the $12M award to the International Center for Advanced Renewable Energy Sustainability (I-CARES).

Table 3A on the next page further breaks down the FY11 awards to show how ARRA funding affected each School. 19

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

FY11 TOTAL

School

Administration & Other Arts & Sciences Business Design & Visual Arts Engineering Law Medicine Social Work TOTAL

Direct Costs

F&A Costs

FY11 ARRA Dollars

Direct Costs

F&A Costs

ARRA as % of Total Dollars

Dollars

$566

$483

$1,050

$34

$17

$51

4.9%

24,585

8,897

33,482

550

281

831

2.5%

147

206

111

168

81.6%

0.0%

16,711

6,574

23,284

360

187

548

2.4%

257

287

13.2%

411,849

133,308

545,158

33,273

12,313

45,586

8.4%

11,216

2,883

14,099

110

162

1.1%

$465,405

$152,241

$617,646

$34,462

$12,921

$47,383

7.7%

Table 3A ARRA Award Dollars by School and Cost Category â&#x20AC;&#x201C; FY11 (000s)

Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs) and some Centers.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding The term “Project Type” refers to the distinct types of awards received by the University. Table 4 breaks award dollars into three projecttype categories: 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), and Other Sponsored Activities (such as public service, patient service, conference grants, community outreach programs, and student aid). While viewing Table 4, it should be kept in mind that the bulk of ARRA funding occurred in FY10. Research

Other Sponsored Activities

Research Training

School / Department FY10 Administration & Other

FY11

FY10

FY11

FY10

TOTAL

FY11

FY10

FY11

$13,157

($151)

$10

$263

$927

$937

$14,094

$1,050

43,797

28,753

2,020

3,180

1,176

1,549

46,993

33,482

Business

330

171

349

206

Design & Visual Arts

248

273

26,892

22,354

1,631

208

101

722

28,624

23,284

135

128

237

270

287

540,407

497,607

22,013

23,951

33,710

23,601

596,130

545,158

17,297

12,717

692

653

1,566

728

19,555

14,100

$642,264

$561496

$26,383

$28,273

$37,641

$27,876

$706,288

$617,646

Arts & Sciences

Engineering Law Medicine Social Work TOTAL

Table 4 Award Dollars by School or Department and Project Type – FY10 and FY11 (000s)

Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs) and some Centers. In FY10 it included the $12M award to the International Center for Advanced Renewable Energy Sustainability (I-CARES).

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Table 4A shows the effect that ARRA stimulus funding had on the different project-type categories for the Schools in FY11. Note that, as expected, the total ARRA funding for FY11 ($47.4M) was substantially less than that received in FY10 ($105M), a decrease of 54.9%. The influence of the change, however, was partially mitigated by the fact that non-ARRA funding decreased by only 5.2% from FY10 ($601M) to FY11 ($570M).

Research School / Department

Administration & Other Arts & Sciences Business Design & Visual Arts Engineering Law Medicine Social Work TOTAL

Research Training

FY11 ARRA

FY11

FY11 ARRA

FY11

Other Sponsored Activities

Totals

FY11 ARRA

FY11

ARRA as % of Total

FY11 ARRA

FY11

($151)

$51

$263

$937

$1,050

$51

4.9%

28,753

831

3,180

1,549

33,482

831

2.5%

171

168

206

168

81.6%

22,354

548

208

722

23,284

548

2.4%

237

287

13.3%

497,607

45,122

23,951

147

23,601

317

545,158

45,586

8.4%

12,717

162

653

728

14,100

162

1.1%

$561,496 $46,919

$28,273

$147

$27,876

$317

$617,646

$47,383

7.7%

Table 4A ARRA Award Dollars by School or Department and Project Type â&#x20AC;&#x201C; FY11 (000s)

Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs) and some Centers. A negative figure indicates that amount was allocated to another School or Department.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Funding by Sponsor

The graphs and tables in this section provide information about the sources of sponsored projects funding to the University, including: • • • •

All sources from which the University receives sponsored projects funding The sectors from which the University receives the most funding: government, industry, and non-profit The federal agencies that provide the most support to the individual schools within the University The sponsors that have increased or decreased their investments in University research over the past fiscal year

25,469

120,971

418,135

25,791

24,805 28,158

35,047

23,430

NIH

104,600

19,274

483,455

14,800

NSF

Other Fed

Other Gov't

Industry

Non-Profit

NIH

NSF

Other Fed

FY10

Other Gov't

Industry

Non-Profit

FY11 Figure 9 Award Summary by Sponsor Type – FY10 and FY11 (000s)

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Figure 9A breaks out FY11 ARRA funding by sponsor type, dollars, and percentage. Note that in FY11, as with FY10, ARRA funding was received from various sponsor types, unlike in FY09 when all ARRA funding was received from only federal sponsors NIH and NSF. (WU received no direct ARRA funding from NSF in FY11.) Figure 9B shows the relationship of ARRA funding to the total amount of research funding WU received in FY11. Of the $617.7M in total research funding awarded to WU in FY11, ARRA funding accounted for 7.7% ($47.4M). Tables 5 and 5A on the following page further break down funding among sponsor types by Direct and F&A costs.

530 1.1%

1,065 2.2%

305 0.6%

2,884 6.1%

47,384 7.7% 570,263 92.3%

42,600 89.9%

NIH

Other Fed

Other (Non-Federal) Gov't

Industry

Figure 9A ARRA Awards by Sponsor Type – FY11 (000s)

Non-Profit

ARRA

Non-ARRA

Figure 9B ARRA and Non-ARRA Awards – FY11 (000s)

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding FY10

Sponsor Type Direct Costs Federal

% of Total Direct

FY11 % of Total F&A

F&A Costs

% Total

Total

% of Total Direct

Direct Costs

F&A Costs

% of Total F&A

Total

% Total

$397,717

73.1%

$137,327

84.7%

$535,043

75.8%

$343,615

73.8%

$124,366

81.7%

$467,981

75.8%

Other Gov’t.

17,683

3.2%

7,122

4.4%

24,805

3.5%

18,591

4.0%

7,200

4.7%

25,791

4.2%

Total Gov’t.

415,400

76.3%

144,448

89.1%

559,848

79.3%

362,207

77.8%

131,566

86.4%

493,773

79.9%

107,100

19.7%

13,871

8.6%

120,971

17.1%

12,535

2.7%

6,740

4.4%

19.274

3.1%

21,663

4.0%

3,805

2.3%

25,469

3.6%

90,663

19.5%

13,936

9.2%

104,600

16.9%

128,763

23.7%

17,676

10.9%

146,439

20.7%

103,198

22.2%

20,675

13.6%

123,873

20.1%

$544,163

100.0%

$162,124

100.0%

$706,288

100.0%

$465,405

100.0%

$152,241

100.0%

$617,646

100.0%

Industry Non-Profit Total Private

TOTAL

Table 5 Award Dollars by Sponsor Type and Cost Category FY10 and FY11 (000s)

Sponsor Type Federal

Direct Costs

FY11 ARRA F&A Costs

Total

$31,560

$11,570

$43,130

Other Gov’t.

715

350

1,065

Industry

219

305

1,968

916

2,884

$34,462

$12,921

$47,383

Non-Profit

TOTAL

Table 5A ARRA Award Dollars by Sponsor Type and Cost Category – FY11 (000s)

Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

FY10 Sponsor

Federal Agencies

NIH NSF NASA DOD EPA DOEd DOE DHHS HRSA LABOR USDA Other

Total Federal Other Government

Missouri Other States Other Govâ&#x20AC;&#x2122;t.

Total Other Government Industry Private Sources Non-Profit Total Private GRAND TOTAL

Direct Costs $359,121 17,257 6,100 560 156 756 7,371 2,675 1,849 24 1,848 397,717 2,113 14,819 751 17,683 21,663 107,100 128,763 $544,163

Note: Due to rounding, detail may not add up to total.

F&A Costs $124,334 6,174 2,485 269 81 22 2,084 599 797 7 474 137,327 392 6,664 66 7,122 3,805 13,871 17,676 $162,124

FY11 Total $483,455 23,431 8,585 829 237 779 9,455 3,274 2,645 31 2,322 535,043 2,506 21,483 816

24,805 25,469 120,971 146,439 $706,288

Direct Costs $307,174 10,308 4,354 1,026 34 1,536 6,489 2,594 7,024 141 2,935 343,615 1,205 15,204 2,183 18,591 12,535 90,633 103,198 $465,405

F&A Costs $110,962 4,491 1,688 320 0 217 1,657 651 3,495 11 875 124,366 311 6,539 350 7,200 6,740 13,936 20,675 $152,241

Change in Total Total

Dollars

$418,135 14,800 6,042 1,346 34 1,753 8,146 3,244 10,519 152 3,810 467,981 1,516 21,742 2,533

($65,320) (8,631) (2,543) 517 (203) 974 (1,309) (30) 7,874 121 1,488 (67,062) (990) 259 1,717

-13.5% -36.8% -29.6% 62.4% -85.7% 125.0% 13.8% -0.9% 297.7% 390.3% 64.1% -12.5% -39.5% 1.2% 210.4%

25,791 19,274 104,600 123,873 $617,646

986 (6,195) (16,371) (22,566) ($88,642)

4.0% -24.3% -13.5% -15.4% -12.6%

Table 6 Award Dollars by Sponsor Type and Cost Category FY10 and FY11 (000s)

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Table 6A extracts FY11 ARRA funding from the total funding in Table 6 and separates it into categories of Direct and F&A costs. Stimulus funding in FY11 was received from all the main sponsor types: Federal, Other Government, Industry, and Non-Profit. The makeup of ARRA funding in FY11 is different from that in both FY09 and FY10. In FY09, stimulus funding came from only NIH and NSF, while in FY10 stimulus funding was received from not only NIH and NSF but from Other Government and Private sources. In FY11, no stimulus funding was received from NSF. As in the two prior years, NIH was the largest contributor of ARRA funding to the University (89.9%) in FY11. FY11 ARRA Sponsor Type

Federal Agencies

$11,420

$42,600

89.9%

NSF

0.0%

DOE

0.1%

326

150

476

1.0%

31,560

11,570

43,130

91.0%

0.1%

685

330

1,015

2.1%

715

350

1,065

2.2%

219

305

0.6%

1,968

916

2,884

6.1%

2,187

1,001

3,188

6.7%

$34,462

$12,921

$47,383

100.0%

Missouri Other States

Total Other Govâ&#x20AC;&#x2122;t. Industry Non-Profit

Total Private GRAND TOTAL

% of ARRA Total

Total

$31,180

Total Federal

Private Sources

F&A Costs

NIH

Other

Other Government

Direct Costs

Table 6A ARRA Award Dollars by Sponsor Type and Cost Category â&#x20AC;&#x201C; FY11 (000s) Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

Arts & Sciences Change From FY10

Sponsor FY11

Engineering

Medicine

Change From FY10

FY11

Social Work

Change From FY10

FY11

Change From FY10

Other Schools Change From FY10

FY11

Total Federal Change From FY10

FY11

NIH

$10,370

-17.4%

9,659

-19.4%

390,510

-12.8%

$7,220

-32.5%

$376

-33.3%

$418,135

-13.5%

NSF

6,833

-49.3%

6,231

-17.3%

1,645

-22.7%

100%

-55.6%

14,800

-36.8%

NASA

5,791

-25.3%

167

-67.8%

-60.6%

n/a

6,042

-29.6%

DOD

170

-17.1%

591

-0.2%

585

1672.7%

n/a

1,346

62.4%

EPA

-92.8%

n/a

-85.7%

549

74.8%

n/a

750

n/a

454

-2.4%

1,753

125.0%

3,466

-7.8%

250

-50.0%

1,352

-46.8%

n/a

3,078

16.0%

8,146

13.8%

n/a

3,244

-0.9%

n/a

3,244

0.9%

LABOR

166

-51.5%

n/a

10,276

346.2%

n/a

10,519

297.7%

USDA

n/a

177.4%

n/a

152

390.3%

554

-36.2%

140.0%

3,014

194.3%

124

n/a

-86.2%

3,810

64.1%

$27,961

-29.2%

$16,994

-19.7%

$411,548

-10.4%

$7,422

-31.1%

$4,057

-5.7%

$467,981

-12.5%

DOEd DOE DHHS HRSA

OTHER TOTAL

Table 7 Federal Award Dollars by Sponsor and School â&#x20AC;&#x201C; FY11 (000s) Notes: 1. Due to rounding, detail may not add up to total. 2. No federal funding was received by Administration.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Tables 7A and 7B show the Schools that received ARRA funding from federal sponsors in FY11. Of note is the lack of new NSF stimulus funding in FY11. (The numbers shown on the NSF line in Table 7A represent allocations to and from the Schools of Arts & Sciences, Engineering, and Medicine. They are shown here to further detail the effect of federal ARRA funding on each School.) FY11 Federal ARRA Sponsor

NIH NSF DOE Other Federal TOTAL

Arts & Sciences

Engineering

Medicine

Social Work

Other Schools

Total University

$849 (72) 54 0

$351 8 0 0

$41,019 64 0 476

$162 0 0 0

$219 0 0 0

$42,600 0 54 476

$831

$359

$42,600

$162

$219

$43,130

Table 7A Federal ARRA Award Dollars by Sponsor and School â&#x20AC;&#x201C; FY11 (000s)

FY11 Federal ARRA School Federal Total Table 7B Federal ARRA Award Dollars by Sponsor and School â&#x20AC;&#x201C; FY11 (000s)

Arts & Sciences Engineering Medicine Social Work Other Schools TOTAL

Federal ARRA

ARRA as % of Federal Total

$27,961 16,994 411,548 7,422 4,056

$831 359 41,560 162 219

3.0% 2.1% 10.1% 2.2% 5.4%

$467,981

$43,130

9.2%

Notes: 1. Due to rounding, detail may not add up to total. 2. No federal funding was received by Administration.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Government School/Dept.

Federal FY10

Private

Other Govâ&#x20AC;&#x2122;t.

FY11

FY10

Industry

FY11

FY10

Total

Non-profit

FY11

FY10

FY11

FY10

FY11

Administration & Other

$3,569

$3,739

$99

$62

$10,363

($3,747)

$62

$996

$14,094

$1,050

Arts & Sciences

39,518

27,961

1,246

1,260

1,073

760

5,157

3,501

46,993

33,482

Business

330

171

349

206

Design & Visual Arts

224

273

21,160

16,994

1,679

1,458

3,220

2,998

2,565

1,835

28,624

23,284

168

114

102

163

270

287

459,299

411,548

20,249

22,258

10,748

19,248

105,833

92,104

596,130

545,158

10,775

7,422

1,531

730

7,185

5,941

19,555

14,100

$535,043

$467,981

$24,805

$25,791

$25,469

$19,274

$120,971

$104,599

$706,288

$617,646

Engineering Law Medicine Social Work Total

Table 8 Award Dollars by School or Department and Sponsor Type FY10 and FY11 (000s) Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs) and some Centers. In FY10 it included the $12M award to the International Center for Advanced Renewable Energy Sustainability (I-CARES).

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

ARRA Schools/Dept.

Government

Private

FY11 ARRA

FY11 Total

ARRA as % of Total

Federal

Other Gov’t.

Administration & Other

$51

$1,050

4.9%

Arts & Sciences

831

33,482

2.5%

Business

168

206

81.6%

n/a

359

548

23,284

2.4%

287

13.3%

41,560

1,015

230

2,782

45,586

545,158

8.4%

162

14,100

1.1%

$43,130

$1,065

$305

$2,884

$47,383

$617,646

7.7%

Design & Visual Arts Engineering Law Medicine Social Work Total

Industry

Non-profit

Table 8A ARRA Award Dollars (All Sources) by School or Department and Sponsor Type – FY11 (000s)

Notes: 1. Due to rounding, detail may not add up to total. 2. "Administration & Other" includes central fiscal units (CFUs) and some Centers.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

Department

(1)

Anthropology Applied Statistics Art History & Archaeology (2) Arts & Sciences Asian & Near Eastern Languages & Lit. Biology Center for New Institutional Social Sciences Chemistry Dean – College of Arts & Sciences Earth & Planetary Science East Asian Studies Economics Education (2) English Film and Media Studies Graduate School History International Studies Mathematics Office of Undergraduate Research Performing Arts Philosophy Physics Political Sciences Psychology Romance Languages The Center For Humanities The Center for Joint Projects The Center for Materials Innovation The Center for Study of Human Values Weidenbaum Center Women Gender & Sexuality Studies

Total

FY11 Government Private Other NonFederal Industry Gov’t. profit

Total FY10

FY11

183 68 0 0 0 4,917 0 4,813 0 5,180 0 0 0 0 0 713 96 0 316 238 0 160 5,755 312 4,620 -4 225 0 0 0 252 118

0 0 0 0 0 420 19 0 0 268 0 0 0 0 2 0 0 100 4 0 0 0 111 241 87 0 9 0 0 0 0 0

0 0 0 0 0 180 0 185 0 80 0 0 0 0 0 0 0 0 0 0 0 0 65 0 250 0 0 0 0 0 0 0

111 0 0 0 38 1,621 0 49 6 930 2 0 28 0 0 0 46 159 0 0 0 7 266 65 73 7 0 0 0 0 93 0

633 3 -259 100 137 11,405 0 6,064 0 6,557 n/a 438 -32 45 0 492 28 150 550 246 14 123 10,855 0 8,473 47 234 185 262 55 188 n/a

294 68 0 0 38 7,138 19 5,047 6 6,458 2 0 28 0 2 713 142 259 320 238 0 167 6,198 617 5,030 2 234 0 0 0 344 118

$27,961

$1,260

$760

$3,501

$46,993

$33,482

Table 9 School of Arts & Sciences – Award Dollars by Department and Sponsor Type (000s) – FY11

Only departments receiving awards in FY10 and/or FY11 are listed. As a result, some departments listed in the FY10 Annual Report may not be listed in FY11. Negative numbers are due to Department transferring funds to another Department or School. Note: Due to rounding, detail may not add up to total.

(1) (2)

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding Table 9A shows the distribution of ARRA money to Arts & Sciences departments, and ARRA funding as a percentage of each department’s total funding and as a percentage of total funding to the School of Arts & Sciences.

FY11 Department

Anthropology

Total Department Awards

ARRA Awards

ARRA as % of Department Total

ARRA as % of School Total

$294

$22

7.5%

0.1%

Biology

7,138

(93)

(1.3%)

(0.4%)

Earth & Planetary Science

6,458

0.2%

0.1%

320

15.6%

0.2%

6,198

1.3%

0.3%

617

14.3%

2.8%

5,030

719

14.3%

2.8%

$26,055

$831

N/A

3.2%

Mathematics Physics Political Science Psychology Total (for departments receiving ARRA funds)

Table 9A School of Arts & Sciences – ARRA Award Dollars by Department – FY11 (000s)

Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

FY11 Government

Department

Federal

Biomedical Engineering

Private

Other Gov’t

Industry

Total

Non-profit

FY10

FY11

$9,179

$418

$404

$255

$13,693

$10,256

Computer Science & Engineering

4,633

215

604

6,472

5,506

Electrical & Systems Engineering

1,865

2,156

2,045

Environmental, Energy & Chemical Engineering

644

561

2,151

920

6,111

4,276

Mechanical Engineering & Materials Science(1)

669

342

186

192

1,197

$16,994

$1,458

$2,998

$1,835

$28,624

$23,284

Other TOTAL

Table 10 School of Engineering – Award Dollars by Department and Sponsor Type FY10 and FY11 (000s)

(1) In

FY10, listed as “Mechanical, Aerospace & Structural Engineering”

Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

Table 10A shows the departments in the School of Engineering that received ARRA funding, and ARRA funding as a percentage of each department’s total funding and as a percentage of total funding to the School.

FY11 Department

Biomedical Engineering

Total Department Awards

ARRA Awards

ARRA as % of Department Total

ARRA as % of School Total

$10,256

$10

0.1%

0.0%

Computer Science & Engineering

5,506

329

6.0%

1.4%

Environmental, Energy & Chemical Engineering

2,045

189

4.4%

0.8%

Mechanical Engineering & Materials Science

1,197

1.7%

0.1%

$23,284

$548

N/A

2.4%

Total School

Table 10A School of Engineering – ARRA Award Dollars by Department – FY11 (000s)

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding FY11 Departments

Government Other Federal Gov't

Private NonIndustry profit

Total FY10

FY11

Anatomy & Neurobiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Developmental Biology Genetics Molecular Microbiology

$16,679 3,941 8,568 7,047 16,455 10,972

$17 95 34 25 1,123 304

$68 106 0 423 708 23

$714 452 1,236 1,161 815 684

$15,104 6,921 9,090 8,803 88,614 15,361

$17,478 4,593 9,838 8,656 19,101 11,983

Subtotal Preclinical

63,662

1,598

1,327

5,062

143,983

71,649

Anesthesiology Internal Medicine Neurological Surgery Neurology Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopaedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiation Oncology Radiology (1) Surgery

7,425 103,962 1,349 25,151 3,597 8,296 5,625 7,163 28,442 18,798 32,813 5,546 39,090 11,305

14 4,226 643 759 197 0 13 257 989 3,420 5,016 521 1,997 573

219 3,720 8 2,647 0 135 382 26 5,258 934 755 357 2,464 570

837 17,405 521 4,270 6,251 1,353 2,377 167 9,826 10,210 2,830 421 4,810 6,800

9,731 138,005 1,713 30,041 7,879 12,735 7,403 6,732 47,957 37,010 48,053 9,378 31,861 29,524

8,495 129,312 2,521 32,828 10,044 9,784 8,398 7,614 44,515 33,363 41,404 6,845 48,362 19,249

298,563

18,627

17,465

68,078

418,023

402,733

164

356

11,328

597

4,724 4,011 139 1,039 0 0 439 27,781 5 0 939 1,940 4,909

0 533 8 189 0 0 110 777 0 0 373 44 0

0 28 0 0 0 0 73 0 0 0 0 0 0

201 407 0 17 25 0 11 16,031 3 0 897 539 694

4,992 4,520 359 2,069 0 10 361 0 177 75 2,589 2,443 4,963

4,926 4,979 1 1,245 25 0 633 44,590 8 0 2,209 2,523 5,603

Subtotal Clinical Administration

(2)

Biology/Biomedical Sciences Biostatistics Center for Clinical Studies Center For Health Behavior Research Center For Study Of Health Policy Div Of Comparative Medicine Emergency Medicine The Genome Institute Medical Library Microarray Facility Occupational Therapy Physical Therapy Siteman Cancer Center Subtotal Other Admin/Academic Grand Total

49,322

2,033

457

18,963

34,214

70,776

$411,548

$22,258

$19,248

$92,104

$596,130

$545,158

Table 11 School of Medicine â&#x20AC;&#x201C; Award Dollars by Department and Sponsor Type FY10 and FY11 (000s) (1) Radiology includes Research Imaging Facilities (2) Administration includes: Continuing Medical Education, Student Support, and Medical School Administration. (3) The Genome Institute was part of the Department of Genetics until FY11. Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Sponsored Research Funding

FY11 Departments

Anatomy & Neurobiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Developmental Biology Genetics Molecular Microbiology Subtotal Preclinical Anesthesiology Internal Medicine Neurological Surgery Neurology Ophthalmology & Visual Sciences Orthopaedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiation Oncology Radiology (1) Surgery

Subtotal Clinical Biostatistics Biology/Biomedical Sciences Center for Clinical Studies Center for Healthy Behavior Research Emergency Medicine The Genome Institute Medical Library Occupational Therapy Physical Therapy Siteman Cancer Center Subtotal Other Admin/Academic Grand Total

Total Awards

ARRA

ARRA as % of Total Awards

$17,478 4,593 9,838 8,656 19,101 11,983 71,649 8,495 129,312 2,521 32,828 9,784 8,398 7,614 44,515 33,363 41,404 6,845 48,362 19,249 402,733 4,979 4,926 147 1,245 633 44,590 8 2,209 2,523 5,603 70,776

$1,221 217 632 500 1,064 827 4,460 337 17,187 74 4,657 207 572 447 3,651 934 5,164 925 1,545 1,698 37,398 886 93 8 4 230 1,728 (4) 2 629 152 3,728

7.0% 4.7% 6.4% 5.8% 5.6% 6.9% 6.2% 4.0% 13.3% 2.9% 14.2% 2.1% 6.8% 5.9% 8.2% 2.8% 12.5% 13.5% 3.2% 8.8% 9.3% 17.8% 1.9% 5.2% 0.3% 36.4% 3.9% (44.6%) 0.1% 24.9% 2.7% 5.3%

$545,158

$45,586

8.4%

Table 11A School of Medicine ARRA Award Dollars by Department â&#x20AC;&#x201C; FY11 (000s) (1) Radiology includes Research Imaging Facilities. (2) The Genome Institute was part of the Department of Genetics until FY11. Note: Due to rounding, detail may not add up to total.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Technology Management and Intellectual Property This section of the Annual Report is provided by the Office of Technology Management. For questions regarding information within this section, please contact Brad Castanho, Director, at bjcastanho@wustl.edu.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Technology Management and Intellectual Property Executive Summary The mission of the Office of Technology Management (OTM) is to promote the public utilization of University innovations created by faculty and employees through the formation and management of commercial partnerships. OTM strives to be a “full service” technology management office by providing the following activities and services: processing and review of invention disclosures; protection of intellectual property and management of the WUSTL patent portfolio; licensing of intellectual property and distribution of licensing revenue; material transfer management; negotiation of industry sponsored research agreements confidentiality agreements and inter-institutional agreements. Fiscal Year 2011 (FY11) saw disclosures, patent filings, and license agreements up from FY10 (Table 1). Revenue for FY11 has remained about the same as in FY10. Invention Disclosures US/PCT Patents Filed License Agreements MTAs -Academic -Industry Revenue Industry Sponsored Research

FY11 136 83 48 700 95 $6.3M 51

FY10 104 76 41 718 61 $6.4M 41

FY09 FY08 FY07 125 98 101 106 94 75 44 42 45 817 674 749 62 51 55 $7.9M $17.0M $12.0M 53 72 60

Table 1 OTM Statistics – FY11 through FY07 The OTM staff consists of 20 full-time employees. As in years past, this year OTM continued its technology transfer trainee program designed for advanced-degree WU students to acquire a hands-on experience in technology transfer. Six candidates have completed the program and one is currently participating. OTM remains active in the community through its involvement through such organizations as the St. Louis Regional Chamber and Growth Association, BioGenerator, Donald Danforth Plant Sciences Center Alliance, Center of Research, Technology & Entrepreneurial Exchange, Coalition for Plant and Life Sciences, Nidus Center for Scientific Enterprise, Center for Emerging Technologies, MO Bio Laboratories, Inc., Missouri Venture Forum, Midwest Research Universities Network and the Research Alliance of Missouri. Involvement with these various organizations extends the mission of WU to local, state and regional levels. In its relationships with these organizations, OTM works to build the economy and to develop channels for commercializing WU technologies. In FY11 WU technology was licensed to two start-up companies which are currently located in the St. Louis area.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property OTM staff members work continuously with the Business Schoolâ&#x20AC;&#x2122;s entrepreneurship program and the larger Kaufmann Foundation (e.g., iBridge) entrepreneurship undertaking. OTM, working with the Small Business Association in Missouri, sponsored another FastTrac training program for WU faculty. Nine faculty attended the eight week program and in the last five years nearly fifty faculty have been through this entrepreneurial training program developed by the Kaufmann Foundation. OTM also continued its administration of the Bear Cub Fund grant program that WU reinstated in FY08. The fund supports innovative translational research not normally backed by federal grants. Any WU faculty member, post-doctoral fellow, graduate student or employee can apply. During fiscal year 2011, WU awarded six Bear Cub Fund grants totaling $240,000 to support innovative research projects that could be attractive for licensing by commercial entities or serve as the foundation for a start-up company. The grants were awarded to: Scott Hultgren, PhD, the Helen L. Stoever Professor of Molecular Microbiology, and Bradley Ford, MD, PhD, a postdoctoral research associate; David Haslam, MD, Associate Professor of Pediatrics and Molecular Microbiology; Enrique W. Izaguirre, PhD, Assistant Professor of Radiation Oncology and of Biomedical Engineering; Kelle Moley, MD, the James Crane Professor of Obstetrics and Gynecology; and Daniel Moran, PhD, Associate Professor of Biomedical Engineering, and Matthew MacEwan, MD, PhD, a graduate research assistant in Biomedical Engineering, and Phillip Tarr, MD, Melvin E. Carnahan Professor Pediatrics.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Technology Highlights for Fiscal Year 2011 Cardiac Imaging By using new analysis and computation techniques, coupled with existing Magnetic Resonance Imaging (MRI) techniques, a clear picture of the expansion and contraction of the heart can be made. The resulting precise image can be used clinically by cardiologists and surgeons to determine the proper type of treatment. Primary Investigator: Michael Pasque, Surgery. This technology has been exclusively licensed to a St. Louis startup company: CardioWise, Inc. BarIC Probe Cerebral shunt malfunction is a life threatening problem which can be often very difficult to diagnose and treat. Each year, approximately 40,000 shunt related operations are performed and 40% of shunts fail during the first year after implantation. Symptoms of shunt malfunction are ambiguous and often lead to costly evaluations and hospital admissions. The most direct way to determine shunt malfunction and hydrocephalus is measuring intracranial pressure (ICP) through a surgical procedure. Delays in diagnosis/treatment may cause health and cognitive problems. A noninvasive ICP monitoring process is not currently available. BarICProbe is an implantable intracranial pressure monitor that can be easily and non-invasively interrogated by external ultrasound. The device is consistent with shunt implantation techniques and can be implanted concurrently. The BarICProbe is small, MRI-compatible, and bio-compatible. The ease of use and chronic ability of BarICProbe will improve patient outcomes through its ability to diagnose problems in an ambulatory setting, more appropriate timing of surgery, and the avoidance of unnecessary admissions and tests. Primary Investigator: Eric Leuthardt, Neurosurgery. The BarIC Probe has been exclusively licensed to a Boston-area startup company: Allied Minds Devices, LLC. High Throughput Liquid Film Electrospray Existing atomization and electrospray techniques permit only one or two grams of material an hour due to the design of the capillaries. For example, electrostatic atomization of food additives, such as coloring agents, stabilizers and alcohols, cannot be achieved in the volumes required with existing techniques. This invention is a new design of an atomization head that permits pounds of material per hour deposition and should be able to be scaled up considerably. Primary Investigator: Da-Ren Chen A Process for Making Copper Nanostructures Below 24nm Size The wires made with this process are ~ one-half the diameter of the thinnest Cu nanowire made in commercial processes today. Although gold and silver, inter alia, can be made in the 24nm range, this is the first process to show the ability to make Cu (a much cheaper material) in such sizes with the ability to scale up to commercial production rates. Cu nanowires are excellent conductors of electricity, and as the wires get smaller, many more transistors can be put on a single microprocessor â&#x20AC;&#x201C; speeding up and enhancing computer capability. Cu nanowires can also be used as catalysts, in displays, heat pipes and solar cells, and to make smaller LEDs and LCDs. Primary Investigator: Younan Xia

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Dichromic Fluorescent Compounds It has been discovered that structural asymmetry of chromic compounds results in the generation of dichromic emissions that have distinct lifetimes. Because the fluorescent lifetimes of the two peaks are distinct, the information content may be multiplexed. The dichromic fluorescent compounds may advantageously be utilized for several applications including imaging, diagnostics, to monitor biological events, and for detecting and monitoring molecular processes. Primary Investigator: Samuel Achilefu, Radiology. Fluorescent Polymethine Cyanine Dyes The present invention provides compounds that possess a robust C-C bond containing near infrared chromophore as optical antenna. The C-C bond allows the development of stable dyes for imaging and monitoring biological events such as disease-associated enzymatic activity. This novel molecular design offers superior chemical stability for biomedical and analytical applications. Because of the biological stability, changes in spectral properties can be attributed accurately to target biological processes such as monitoring disease-associated enzymatic activity. The C-C coupled dyes also allows for extended pi-bond conjugation, thereby enabling the use of new designs to obtain diagnostically useful spectral information such as pH-sensitive response in solid tumors. Primary Investigator: Samuel Achilefu, Radiology. Compounds Having Rd Targeting Motifs The present invention provides compounds that have motifs that target the compounds to cells that express integrins. In particular, the compound shave peptides with one or more RD motifs conjugated to an agent selected from an imaging agent and a targeting agent. These compounds may be used to detect, monitor, and treat a variety of integrin-mediated biological processes, including the progression of disease states such as diabetes, cardiovascular disease, inflammation and cancer. Primary Investigator: Samuel Achilefu, Radiology Effective Anti-integrin Antitumor Reagent for Chrondrosarcoma Chondrosarcoma is a difficult musculoskeletal tumor to treat. Chemotherapy is only somewhat effective in mesenchymal chondrosarcoma and is of uncertain value in dedifferentiated chondrosarcoma. Surgical excision is the only tumor treatment, but it leads to severe disability with high rate of local recurrence, often at a higher grade, and can thus be life threatening. Radiation and adjuvant therapy are not effective in differentiated chondrosarcoma. More effective antitumor reagents for chondrosarcoma are needed. The present invention utilizes an anti-integrin reagent which has chondrosarcoma tumor cell killing activity in vitro. Promising animal data indicates that this is also true in vivo. Primary Investigator: Linda Sandell, Orthopaedic Surgery Methods of Prevention snd Treatment of Ischemic Damage The present invention in various embodiments provides methods of treating stroke and conferring protection on a population of cells associated with ischemia in a subject following an ischemic event, comprising: (a) providing an estrogen compound; and (b) administering the effective amount of the compound over a course that includes at least one dose within a time that is effectively proximate to the ischemic event, so as to confer protection on the population 42

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property of cells. Novel methods are provided for the delivery of an estrogen compound. Examples of ischemic events treatable according to the invention are cerebrovascular disease or stroke, subarachnoid subhemorrhage, myocardial infarct, surgery and trauma. A method of treating ischemic damage utilizing hormones that are non-sex hormones is also provided. A method of treating stroke with ent-17.beta.-estradiol, and a method of synthesis, and compounds produced from the synthesis are provided. Primary Investigator: Doug Covey, Developmental Biology Combined Drug Therapy to Ameliorate Hearing Loss Noise-induced hearing loss (NIHL) is the second most common form of sensorineural hearing deficit, after age-related hearing loss. There are approximately 30 million people in the US alone that are exposed to hazardous levels of noise on a regular basis; however there is no effective medication to prevent NIHL. This is a novel combination drug therapy approach to ameliorate hearing loss. Primary Investigators: Jianxin Bao, Otolaryngology and Richard Chole, Otolaryngology Novel Steroid Anesthetic Agents The technology is directed to novel steroids. having utility as an anesthetic and/or in the treatment of disorders relating to GABA function and activity. A shortâ&#x20AC;?acting, steroidal anesthetic could offer a significant clinical and practical advantage as a continuous infusion sedative for various nonâ&#x20AC;?surgical procedures. Primary Investigator: Doug Covey, Developmental Biology Novel Therapies to Treat Cancer Researchers at Washington University have identified several agents (antibodies and/or peptides) targeted to radiation inducible antigens. This is a new paradigm in therapeutic antibody development. The principle of inducible antigens is that ionizing radiation induces the translocation of protein from the intracellular reservoirs to the cancer cell surface. The proteins are over expressed in cancer cells but not in the normal tissue which allows antibodies to opsonize cancer cells after x-ray irradiation in a specific manner. Efforts are underway to optimize and test these agents in a clinical setting for therapeutic and imaging purposes. Primary Investigator: Dennis Hallahan, Radiation Oncology Biomarker for Alzheimer's Disease and Human Brain Injury Biomarker such as VILIP-1 (Visinin-like protein-1) is an important prognostic and diagnostic tool in providing an early indication of brain injury such as Alzheimer's disease, stroke and other related disease indications. VILIP-1 is a neuronal calcium-sensor protein that had been identified as a potential marker of neuronal injury in large-scale gene-array analyses and confirmed in brain injury models. VILIP-1 in combination with other markers is an excellent tool for prediction, progression, risk stratification, and monitoring of the disease in patients with suspected or established brain injury, stroke and Alzheimerâ&#x20AC;&#x2122;s disease. Primary Investigator: Jack Ladenson, Pathology and Immunology.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Method of Treating Pruritus Itch, or pruritus, is an unpleasant sensation that causes the desire to scratch, associated with many conditions such as liver disease or kidney dialysis, can find no relief for the problem. Pruritus is also a serious condition experienced by animals. The present invention provides methods for treating pruritus by providing methods of substantially inhibiting the activation of bombesin receptors or by killing GRPR specific neurons in the spinal cord. Mitigation of itch through either of these mechanisms does not affect motor or sensory functions. Primary Investigator: Zhou-Feng Chen, Anesthesiology. Novel Genetic Risk Factor for Alzheimer’s Disease Progression Researchers at Washington University have identified a novel genetic variant that strongly correlates with Alzheimer’s disease progression. Dr. Alison Goate and collaborators used an established biomarker for the decline of AD patients (cerebrospinal fluid tau phosphorylated at threonine 181, ptau181) to find genetic variants that influence levels of ptau181 in the cerebrospinal fluid. The study found a highly significant association between ptau181levels and the rs1868402 SNP located within a regulatory subunit of PPP3R1 (calcineurin B), a gene previously linked to AD pathogenesis. Carriers of the rs1868402 risk allele showed a 6-fold faster rate of disease progression than AD patients without the variant. Direct examination of brain samples from AD cases and controls revealed that rs1868402is in fact associated with reduced PPP3R1 mRNA levels and increased tangle formation, providing biological validation for the genome-wide association study and further implicating PPP3R1 in disease pathology. As the first genetic variant associated with rate of AD progression to be reported, its use in clinical trial design and patient care will translate into a significant benefit to patients. Primary Investigator: Alison Goate, Psychiatry Blood A Production and Clearance Measurements as a Diagnostic Test for Amyloidosis and Alzheimer's Disease Previous work from the Bateman and Holtzman labs have demonstrated clinical utility in measuring the synthesis and clearance rates of the amyloid-beta (Aβ) protein as a biomarker for efficacy of candidate Alzheimer’s drugs that target the protein. In a completely distinct invention, the labs have demonstrated the ability to detect changes in Aβ in blood plasma, an assay that has utility for assessing drug candidates as well as diagnostic applications. Primary Investigator: Randy Bateman, Neurology, and Dave Holtzman, Neurology Novel Antithrombin Nanoceutical for Preventing Blood Clots The current invention comprises a first-in-class nanoparticulate antithrombotic that features a potent dual antithrombin/antiplatelet compound linked to a nanoparticle to function as a single unit or drug. Advantages of this novel agent include (1) prolonged activity of drug at the nanoparticle surface and only at the site of active clotting, (2) potential for image-based detection and tracking of the agent and the acute thrombotic process, (3) the elimination of harmful side effects after systemic delivery through the use of smaller drug amounts featuring site-specific thrombin targeting and action, (4) well defined pharmacokinetics that are driven by the nanoparticle itself and are independent of a subject’s genetics, and (5) the ability to multiplex any other anticoagulant that is already on the market or in development for combination 44

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property therapeutics. Studies indicate the nanoceutical outperforms standard heparin treatment, by increasing the time to total occlusion by more than 40%. Primary Investigator: Samuel Wickline, Internal Medicine, Cardiovascular Division. Non-Steroidal Intra-Uterine Contraception Inhibitors of the pentose phosphate pathway (PPP) have utility in contraception and pregnancy prevention and provide an alternative to current progesterone-based contraception. Our research suggests that local administration, in the form of intrauterine devices (IUD), is the most effective method to deliver PPP inhibitors for contraceptive use. Mice treated with the steroid PPP inhibitor dehydroepiandrosterone, DHEA, did not develop uterine deciduomas in response to a mechanical decidual stimulus applied to the hormone-primed endometrium. Further, studies that implanted slow release pellets of DHEA or 6-aminonicotinamide (6-AN) in the uterine horn of mice showed efficacy in preventing pregnancy. Primary Investigator: Kelle Moley, Obstetrics and Gynecology. Novel Catheter for Delivering Anesthetic Nerve Blocks Peripheral nerve blocks are given to patients as a regional or local anesthetic or for chronic pain relief. The current peripheral nerve block is a two-step process that is technically challenging and has other drawbacks, including anesthetic leakage and needle displacement. The current invention describes a novel catheter device for delivering anesthetic nerve blocks in a single step process that will avoid anesthetic leakage and enable accurate placement of the catheter. The device incorporates an echogenic feature within an echogenic catheter for accurate positioning and continued monitoring by ultrasound. The echogenic feature is removable without resulting in anesthetic leakage. Primary Investigators: Stephen Hsu, Anesthesiology and Chris Lee, Anesthesiology. Anti-HIV/Contraceptive Nanoparticles Researchers have designed new nanoparticle decoys that survey the vaginal compartment for HIV or sperm. Designed to distinctly fuse with HIV or sperm, these particles kill the target virus or cell by releasing melittin, a toxin found in bee venom, after the fusion event. The fusion event ensures specific targeting of the melittin only to the virus or sperm, leaving other cells in the vaginal compartment unharmed. In vitro studies demonstrate that melittin delivered from anti-HIV nanoparticles ablates virus infectivity. Primary Investigator: Samuel Wickline, Internal Medicine, Cardiovascular Division. Inhibition of Morphine-Induced Itch Intractable itch can be a serious and incurable side effect of many opioid drugs prescribed to mitigate pain, including morphine. For the first time, researchers have teased apart the pain and itch pathway showing that morphineâ&#x20AC;&#x2122;s effects are mediated by different isoforms of the mu receptor. As demonstrated through siRNA knockdown experiments in mice, MOR1 governs the analgesic response, whereas MOR1D specifically interacts with gastrin-releasing peptide receptor (GRPR) to mediate morphine-induced itch. The technology further describes a peptide that in vitro specifically disrupts the interaction between MOR1D and GRPR thereby preventing

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property morphine induced itch. Importantly, the analgesic effects of morphine in mice treated with the peptide therapy were unaffected. Primary Investigator: Zhou-Feng Chen, Anesthesiology. Breast Cancer Prognostic Screen Methods for deriving a minimal "intrinsic" gene set for making biological classifications of breast cancer and using "intrinsic" genes in a real-time qRT-PCR assay for breast cancer classification, prognosis and/or treatment. A Start-up company, BioClassifier (formerly known as University Geneomics), has been founded on this technology. A larger corporate partner has sublicensed this technology and is developing it for prognostic applications. Primary Investigator: Matthew Ellis, Oncology/Endocrinology Surgery. Neurturin, a Novel Molecule to Treat Parkinsonâ&#x20AC;&#x2122;s Disease. This is an older technology that has been licensed for gene therapy treatment for Parkinsonâ&#x20AC;&#x2122;s Disease. The licensee took this technology forward to clinical phase 2. The results showed little difference at 12 months between blinded sham controls and treated patients. However, the 18 month unblinded results showed a clear distinction between the two groups. A new successful phase 1 trial was run using a two-site injection protocol. Currently a phase 2b trial is in progress. Primary investigators: Eugene Johnson, Neurology, and Jeffrey Milbrandt, Genetics. Novel Murine Norovirus (MNV) This technology has continued to gain traction in mouse diagnostics and is currently being used as a surrogate virus for testing commercial disinfectants. To date, five patents have been issued for detection of MNV and a virus culture system. Several licenses have been issued. Primary Investigator: Herbert Virgin, Immunobiology. Limiting CD47 or Blocking Thrombospondin-1 Reverses the Detrimental Effects on Tissue Healing and Blood Flow This technology has demonstrated that certain monoclonal antibodies and possibly other compounds allow for more effective wound healing and graft survival in animal models. A new company, Vasculox was founded around this technology by the inventor. Primary Investigator: William Frazier, Biochemistry and Molecular Biophysics. Neimann Pick C Disease Marker A novel marker to detect Neimann Pick C (NPC), a fatal neurodegenerative disease, has been discovered. This discovery demonstrates the first and only plasma biomarker that has been discovered for this orphan disease. Certain NPC organizations in Europe have shown interest in this technology and a series of non-exclusive licenses are in process. A commercial partner is coordinating the European institutions. Primary Investigator: Daniel Ory, Internal Medicine, Cardiovascular Division.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Natriuretic Peptide-Mediated Imaging and/or Treatment of Atherosclerotic Plaque This invention includes a functionalized peptide that preferentially binds to unstable plaque. Imaging of unstable plaque may identify areas of imminent plaque rupture so that corrective action can be taken before a catastrophic event occurs. A large corporate partner is exploring a research partnership using this technology. Primary Investigator: Pamela Woodard, Radiology. Novel Virus Discovery Program Several nucleic acid fragments of novel viruses have been discovered in disease samples of unknown etiology. Over the next few years, the study of these novel fragments should result in nearly complete genome and protein characterizations of several novel human viral pathogens. The novel sequences may be used in diagnostic tests or vaccines production. This technology is expanding into other departments and is resulting in new molecular approaches to discoveries. Primary Investigator: Herbert Virgin, David Wang, Pathology. Dnmt3a, Novel Prognostic Markers for Acute Myeloid Leukemia Twenty two percent of AML patients have a mutation in the Dnmt3a gene. These novel mutations predict which form of AML will require intensive therapy for best outcomes. Several companies are exploring this marker for licensing and implementation onto a diagnostic platform. Primary Investigator: Timothy Ley, Internal Medicine; John Dipersio, Internal Medicine; Richard Wilson, Genetics; Li Ding, Genetics; and Elaine Mardis, Genetics. The Novel Effects of NAD-Related Compounds (Nicotinamide, Nicotinamide Mononucleotide & NAD) on Blood Glucose Levels NMN has been shown to be an effective molecule to regulate blood glucose levels in animal models. A US patent has been issued for this technology. Currently a large sponsored research agreement is in place with a small molecule manufacturing company to test NMN on a widescale for blood glucose regulation. Primary Investigator: Shin-ichiro Imai, Molecular Biology. Novel Biomarkers for the Early Detection of Renal Cell Carcinoma Two novel biomarkers can be detected in urine indicating renal cell carcinoma via non-invasive techniques. The technology has developed from west blotting techniques to quantitative ELISA assays making this technology more attractive to and compatible with diagnostic companiesâ&#x20AC;&#x2122; clinical platforms. Although a few start-up companies have evaluated this technology, it should be ready for licensing to large corporations early in 2012. Primary Investigators: Evan Kharasch, Anesthesiology, and Jeremiah Morrissey, Anesthesiology. Effective Anti-integrin Antitumor Reagent for Chrondrosarcoma Chondrosarcoma is a difficult musculoskeletal tumor to treat. Chemotherapy is only somewhat effective in mesenchymal chondrosarcoma and is of uncertain value in dedifferentiated chondrosarcoma. Surgical excision is the only tumor treatment, but it leads to severe disability with high rate of local recurrence, often at a higher grade, and can thus be life threatening.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Radiation and adjuvant therapy are not effective in differentiated chondrosarcoma. More effective antitumor reagents for chondrosarcoma are needed. The present invention utilizes an anti-integrin reagent which has chondrosarcoma tumor cell killing activity in vitro. Promising animal data indicates that this is also true in vivo.Primary Investigator: Linda Sandell, Orthopaedic Surgery Anticonvulsant and Anxiolytic Lactam and Thiolactam Derivatives This invention relates to lactam and thiolactam derivatives having useful anticonvulsant and anxiolytic activity, pharmaceutical compositions containing these compounds and therapeutic applications using such compositions. Convulsant seizures occur in various chronic central nervous system (CNS) disorders, particularly epilepsies. These seizures are generally correlated with abnormal and excessive EEG (electroencephalogram) discharges. A variety of drugs have been used for treatment of these seizures. The compounds covered under this patent significantly enhance GABA neuronal inhibition and are more active anticonvulsant and anxiolytic agents than prior art lactones and thiolactones. Further, these lactams and thiolactams have been found to have relatively low toxicity and low sedative activity. Primary Investigator: Doug Covey, Developmental Biology Methods of Prevention and Treatment of Ischemic Damage The present invention in various embodiments provides methods of treating stroke and conferring protection on a population of cells associated with ischemia in a subject following an ischemic event, comprising: (a) providing an estrogen compound; and (b) administering the effective amount of the compound over a course that includes at least one dose within a time that is effectively proximate to the ischemic event, so as to confer protection on the population of cells. Novel methods are provided for the delivery of an estrogen compound. Examples of ischemic events treatable according to the invention are cerebrovascular disease or stroke, subarachnoid subhemorrhage, myocardial infarct, surgery and trauma. A method of treating ischemic damage utilizing hormones that are non-sex hormones is also provided. A method of treating stroke with ent-17.beta.-estradiol, and a method of synthesis, and compounds produced from the synthesis are provided. Primary Investigator: Doug Covey, Developmental Biology Neuroactive 13, 24-Cyclo-18, 21-Dinorcholanes and Structurally Related Pentacyclic Steroids The present invention is directed to novel pentacyclic steroids and novel pentacyclic Dhomosteroids that have utility as anesthetics and in the treatment of disorders relating to GABA function and activity. In addition to anesthetic properties, neuroactive steroids may be used to treat disorders related to GABA function. For example, neuroactive steroids may be used as sedative-hypnotics e.g. insomnia, mood disorders, convulsive disorders, anxiety, or symptoms of ethanol withdrawal. These agents act by enhancing GABA.sub.A receptor desensitization and display different degrees of enantioselectivity. These compounds may be useful as memory enhancers and in reversing the anesthetic effects of compounds that potentiate GABA at GABA.sub.A receptors. Primary Investigator: Doug Covey, Developmental Biology

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Novel Genetic Risk Factor for Alzheimer’s Disease Progression Researchers at Washington University have identified a novel genetic variant that strongly correlates with Alzheimer’s disease progression. Dr. Alison Goate and collaborators used an established biomarker for the decline of AD patients (cerebrospinal fluid tau phosphorylated at threonine 181, ptau181) to find genetic variants that influence levels of ptau181 in the cerebrospinal fluid. The study found a highly significant association between ptau181levels and the rs1868402 SNP located within a regulatory subunit of PPP3R1 (calcineurin B), a gene previously linked to AD pathogenesis. Carriers of the rs1868402 risk allele showed a 6-fold faster rate of disease progression than AD patients without the variant. Direct examination of brain samples from AD cases and controls revealed that rs1868402is in fact associated with reduced PPP3R1 mRNA levels and increased tangle formation, providing biological validation for the genome-wide association study and further implicating PPP3R1 in disease pathology. As the first genetic variant associated with rate of AD progression to be reported, its use in clinical trial design and patient care will translate into a significant benefit to patients. Primary Investigator: Alison Goate, Psychiatry Blood A production and Clearance Measurements as a Diagnostic Test for Amyloidosis and Alzheimer's Disease Previous work from the Bateman and Holtzman labs have demonstrated clinical utility in measuring the synthesis and clearance rates of the amyloid-beta (Aβ) protein as a biomarker for efficacy of candidate Alzheimer’s drugs that target the protein. In a completely distinct invention, the labs have demonstrated the ability to detect changes in Aβ in blood plasma, an assay that has utility for assessing drug candidates as well as diagnostic applications. Primary Investigator: Randy Bateman, Neurology, and Dave Holtzman, Neurology Novel Antithrombin Nanoceutical for Preventing Blood Clots The current invention comprises a first-in-class nanoparticulate antithrombotic that features a potent dual antithrombin/antiplatelet compound linked to a nanoparticle to function as a single unit or drug. Advantages of this novel agent include (1) prolonged activity of drug at the nanoparticle surface and only at the site of active clotting, (2) potential for image-based detection and tracking of the agent and the acute thrombotic process, (3) the elimination of harmful side effects after systemic delivery through the use of smaller drug amounts featuring site-specific thrombin targeting and action, (4) well defined pharmacokinetics that are driven by the nanoparticle itself and are independent of a subject’s genetics, and (5) the ability to multiplex any other anticoagulant that is already on the market or in development for combination therapeutics. Studies indicate the nanoceutical outperforms standard heparin treatment, by increasing the time to total occlusion by more than 40%. Primary Investigator: Samuel Wickline, Internal Medicine, Cardiovascular Division. Novel Compounds to Treat Urinary Tract Infection Urinary tract infections (UTI) affect a large proportion of the population and account for significant morbidity and high medical costs. Uropathogenic Escherichia coli (UPEC) is responsible for up to 85% of infections and a large percentage of recurrent UTI are caused by the same strain of bacteria as the initial UTI despite the antibiotic regimen; the current gold 49

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property standard. The annual UTI incidence rate is 12.1% in women and 3% among men. Recurrence rates are high with women having a 25% to 44% chance of developing a second episode within 6 months of the initial UTI. Treatment of UTI like other microbial infections is exacerbated by increasing antimicrobial resistance and there is a huge unmet need for alternative therapies. Novel patented compounds such as Pilicides and Mannosides disrupt pili biogenesis and hostpathogen interaction to effectively block disease progression. Primary Investigators: Scott Hultgren, Molecular Microbiology and James Janetka, Biochemistry Macrocyclic Molecular Beacons The cyclization of fluorescent probes through bioactive molecules creates new compounds with a rigid structural framework. This agent retains the binding properties of the peptide while the photophysical characteristics of the optical probe may be altered. The constrained conformation of the peptide conjugate modifies the selectivity of the receptor. Use of this agent can lend insight into biological activities and facilitate the creation of disease-specific drugs. The current invention describes novel bioactive near infrared (NIR) macrocyclic optical compounds whose biological and spectral properties can be enhanced through bioactive peptide-mediated cyclization. Primary Investigator: Samuel Achilefu, Radiology Fluorescent Polymethine Cyanine Dyes The present invention provides compounds that possess a robust C-C bond containing near infrared chromophore as optical antenna. The C-C bond allows the development of stable dyes for imaging and monitoring biological events such as disease-associated enzymatic activity. This novel molecular design offers superior chemical stability for biomedical and analytical applications. Because of the biological stability, changes in spectral properties can be attributed accurately to target biological processes such as monitoring disease-associated enzymatic activity. The C-C coupled dyes also allows for extended pi-bond conjugation, thereby enabling the use of new designs to obtain diagnostically useful spectral information such as pH-sensitive response in solid tumors. Primary Investigator : Samuel Achilefu, Radiology Compounds Having Rd Targeting Motifs The present invention provides compounds that have motifs that target the compounds to cells that express integrins. In particular, the compound shave peptides with one or more RD motifs conjugated to an agent selected from an imaging agent and a targeting agent. These compounds may be used to detect, monitor, and treat a variety of integrin-mediated biological processes, including the progression of disease states such as diabetes, cardiovascular disease, inflammation and cancer. Primary Investigator : Samuel Achilefu, Radiology

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Bear Cub Fund During fiscal year 2011, WUSTL awarded six Bear Cub Fund grants totaling $240,000 to support innovative research projects that could be attractive for licensing by commercial entities or serve as the foundation for a start-up company. The grants were awarded to: Scott Hultgren, PhD, the Helen L. Stoever Professor of Molecular Microbiology, and Bradley Ford, MD, PhD, a postdoctoral research associate; David Haslam, MD, associate professor of pediatrics and molecular microbiology; Enrique W. Izaguirre, PhD, assistant professor of radiation oncology and of biomedical engineering; Kelle Moley, MD, the James Crane Professor of Obstetrics and Gynecology; Daniel Moran, PhD, associate professor of biomedical engineering, and Matthew MacEwan, MD, PhD, a graduate research assistant in biomedical engineering; and Phillip Tarr, MD, Melvin E. Carnahan Professor of Pediatrics. David Haslam is taking a novel approach to fighting Clostridium difficile infection, a severe intestinal illness that affects about 500,000 Americans annually. Rather than target the bacteria, he is focused on blocking the C. difficile toxins as a means to control the infection. Toxins released by the bacterium are responsible for damage to intestinal cells and cause massive inflammation. Haslam has identified small-molecule inhibitors of C. difficile toxins and will evaluate their effectiveness in animal models. Scott Hultgren and Bradley Ford are developing a new class of antibiotics that specifically target urinary tract infections caused by the bacterium Escherchia coli. Recurrent and drug-resistant infections caused by E. coli are a significant and increasing problem for women. Their research has suggested that new antibiotics called mannosides that target a bacterial component essential to bladder adherence can prevent urinary tract infections caused by E. coli. They now plan to evaluate whether the drugs can cure an existing infection, circumvent antibiotic resistance and prevent recurrence in a mouse model of urinary tract infection. Enrique Izaguirre is developing a device to measure the actual dose of radiation delivered to cancer patients in â&#x20AC;&#x153;real time.â&#x20AC;? External-beam radiation therapy is used to treat about 50 percent of cancer patients in the United States. This imaging dosimeter would allow clinicians and medical physicists to verify the radiation dose delivered to patients during the course of treatment, enhancing the safety and accuracy of the therapy. Kelle Moley is investigating a new type of intrauterine device for contraception that does not rely on hormones to prevent pregnancy. IUDs currently on the market use forms of the hormones estrogen and progesterone to prevent pregnancy. But the hormones can cause numerous side effects, including breakthrough bleeding, heavy bleeding, headaches, nausea, weight gain and cardiovascular problems. Moley is investigating an IUD that releases an inhibitor of the pentose phosphate pathway. Activating this pathway is necessary for pregnancy to occur. Two non-hormonal inhibitors of the pathway will be evaluated as contraceptives in animal models, and the researchers also plan to identify additional inhibitors of the pathway.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Daniel Moran and Matthew MacEwan have developed a new type of resorbable, lightweight mesh for use during surgery to repair abdominal hernias. Surgeons routinely place a piece of synthetic mesh over the internal sutures to reinforce the abdominal wall. The mesh developed by Moran and MacEwan is constructed of nanofibers and is expected to promote tissue regeneration and wound healing without promoting excessive scar tissue, like other types of mesh. They will evaluate the mesh in animal models and compare their outcomes to results using commercially available hernia repair meshes. Since 2008, Bear Cub has reviewed 79 projects and funded 21. Total funding over this period has been $937,000. More information about the Bear Cub grants can be found at http://research.wustl.edu/Offices_Committees/OTM/faculty/Pages/TranslationalResearch.asp x#bear_cub

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Invention Disclosures Under the Universityâ&#x20AC;&#x2122;s Intellectual Property (IP) policy, creators are required to disclose to OTM inventions made using significant University resources and/or pursuant to a research project funded through corporate, federal, or other external sponsors. OTM evaluates each new disclosure for its potential commercial value and for the best modes of intellectual property protection and commercialization. For some disclosures copyright protection is most appropriate, such as computer software or questionnaires, for others patent protection is sought and still others may be commercialized without filing for a patent. For recording-keeping purposes, OTM tracks disclosures as either copyright or inventions. During Fiscal Year 2011 (FY11), OTM received 136 new disclosures from 24 different departments. This was an increase of 30% from FY10. Of these disclosures, 73% originated in the School of Medicine, 22% from the School of Engineering and Applied Science, and 5% from the School of Arts & Sciences. Table 2 below shows invention disclosures by school and Table 3 below shows invention disclosures by department.

Arts & Sciences Engineering Medicine Architecture Law School Total

FY11 7 30 99 0 0 136

FY10 4 18 82 0 0 104

FY09 9 17 96 3 0 125

FY08 6 13 79 0 0 98

FY07 6 13 81 0 1 101

Table 2 Invention Disclosures by School â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Department Arts & Sciences Biology Chemistry Earth & Planetary Sciences Mathematics Physics Psychology Arts & Sciences Total School of Engineering Biomedical Engineering Computer Science & Engineering Electrical & Systems Engineering Energy, Environmental & Chemical Engineering Mechanical, Aerospace & Structural Engineering Engineering Total School of Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Biostatistics Cell Biology & Physiology Developmental Biology Genetics Internal Medicine Molecular Microbiology Neurology Neurological Surgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Physical Therapy Psychiatry Radiation Oncology Radiology Siteman Cancer Center Surgery Medicine Total School of Architecture Architecture Architecture Total School of Law Law Law Total Total

FY11

FY10

FY09

FY08

FY07

4 3 0 0 0 0 7

2 1 0 0 1 0 4

6 2 0 0 1 0 9

4 0 0 1 0 1 6

3 0 1 0 2 0 6

13 5 3 4 5 30

11 2 2 3 0 18

10 1 0 4 2 17

9 0 0 0 4 13

2 3 1 5 2 13

1 6 1 0 0 3 3 18 0 2 3 3 1 1 4 9 6 0 2 22 12 1 1 99

3 5 4 1 0 2 0 18 4 6 7 1 4 1 1 3 5 1 1 4 6 0 5 82

0 7 2 0 0 4 3 17 3 8 3 1 1 0 4 13 4 0 0 7 13 0 6 96

0 4 4 0 0 5 2 24 0 5 1 0 3 1 1 7 2 0 3 2 10 0 5 79

0 3 3 0 1 7 2 22 3 6 2 0 4 2 1 3 1 2 2 0 5 0 12 81

0 0

3 3

0 0

0 0 136

0 0 104

0 0 125

0 0 98

1 1 101

Table 3 Invention Disclosures by Department â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Patent Portfolio When OTM decides to pursue patent protection for an invention, a U.S. provisional patent application is usually filed. 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. OTM filed provisional patent applications for 39 of the 136 invention disclosures received in FY11. After the one year provisional period, OTM will have the opportunity to file or convert the provisional application into a non-provisional application that will be examined by the patent office before being granted. A non-provisional application can be filed in the U.S., with the World Intellectual Property Organization as a PCT international application and/or in individual foreign countries. The decision of when and where to file such applications are a part of OTM’s management of the University’s IP portfolio. During FY11, OTM filed 28 non-provisional patent applications. OTM’s management of the University’s patent portfolio also includes ongoing communication with external patent counsel and patent office staff while an application is being examined, maintenance of issued patents, and payment of required fees. To date the OTM manages a portfolio of 621 pending patent applications and 917 issued patents (442 US patents and 475 foreign patents). In FY11 the University had 49 patents issued, 26 issued by the US patent office and 23 issued by foreign patent offices. In total, OTM invested close to $2M in the management of the University patent portfolio in FY11.

Arts & Sciences Engineering Medicine Total

FY11 10 15 58 83

FY10 7 15 54 76

FY09 4 20 82 106

FY08 3 7 84 94

FY07 3 13 59 75

Table 4 U.S. Patent Applications by School – FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Department Arts & Sciences Biology Chemistry Earth & Planetary Sciences Mathematics Physics Psychology Arts & Sciences Total School of Engineering Biomedical Engineering Computer Science & Engineering Electrical & Systems Engineering Energy, Environmental & Chemical Engineering Mechanical, Aerospace & Structural Engineering Engineering Total School of Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Developmental Biology Genetics Internal Medicine Molecular Microbiology Neurology Neurological Surgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Physical Therapy Psychiatry Radiation Oncology Radiology Siteman Cancer Center Surgery Medicine Total Total

FY11

FY10

FY09

FY08

FY07

2 4 0 1 3 0 10

2 2 0 1 2 0 7

2 0 0 1 0 1 4

3 0 0 0 0 0 3

9 0 1 3 2 15

13 0 1 0 1 15

15 0 0 3 2 20

5 2 0 0 0 7

3 4 1 2 3 13

0 2 5 0 4 1 9 1 5 6 1 2 1 0 5 1 0 1 2 9 0 3 58 83

0 2 3 0 5 2 13 1 3 3 0 0 0 0 2 2 1 1 1 11 0 4 54 76

1 3 4 0 8 2 21 2 11 2 0 1 0 0 8 1 1 3 1 9 0 4 82 106

2 1 6 2 9 1 18 4 8 7 0 3 1 0 3 5 0 2 0 9 0 3 84 94

0 2 6 0 1 3 18 5 2 2 0 1 1 1 1 0 1 2 0 10 0 3 59 75

Table 5 U.S. Patent Applications by Department â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Licenses OTM seeks to put the University’s inventions and discoveries into the hands of the public. Sometimes this means sharing our inventions with other non-profit organizations for free and other times this means licensing them out to corporate entities in exchange for fees and/or royalties. Patented and unpatented inventions are transferred to industry through a variety of licensing arrangements. Some of the licensing or license-related arrangements OTM enters into are as follows: Evaluation & Option Agreement: • Gives a company a time-limited (generally six months to a year) “preview” of the invention for the purpose of deciding whether to take a license. Non-Exclusive License Agreement: • Fee- and royalty-bearing license: rights are granted to commercialize the technology, may be granted to multiple licensees. • Paid-up license: a non-exclusive license granted for a one-time, up-front license fee without subsequent fees or royalties. • No-fee license: rights are granted to a third party (usually another non-profit educational institution) to use a technology that is generally licensed to commercial entities for a fee. Exclusive License Agreement: • A fee- and royalty-bearing exclusive license; grants a licensee the sole right to commercialize a technology (may include sublicensing rights). License agreements may be limited to a particular field of use or geographic area. They also often vary in terms of amount of fees and royalties due, milestones to be achieved by the company, and length of the agreement. While the majority of licenses granted by the University are to existing commercial companies, the University is also actively supporting and encouraging the creation of new business ventures in St. Louis by licensing technology to start-up companies. In FY11 the University entered into 12 Evaluation and Option Agreements. This year the University also granted a total of 48 revenue-generating licenses, 15 exclusive and 33 nonexclusive. The table below shows the number of revenue-generating licenses by School. This result is remarkable considering the downturn in the global economy and continuation of company mergers and downsizing. FY11

FY10

FY09

FY08

FY07

Arts & Sciences

Engineering

Medicine Law Social Work Total

Table 6 Licenses by School – FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Department Arts & Sciences Biology Chemistry Earth & Planetary Sciences Mathematics Physics Psychology Arts & Sciences Total School of Engineering Biomedical Engineering Computer Science & Engineering Electrical & Systems Engineering Energy, Environmental & Chemical Engineering Mechanical, Aerospace & Structural Engineering Engineering Total School of Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Biostatistics Cell Biology & Physiology Developmental Biology Genetics Internal Medicine Molecular Microbiology Neurology Neurological Surgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Psychiatry Radiation Oncology Radiology Siteman Cancer Center Surgery Medicine Total School of Law Law Law Total School of Social Work Social Work Social Work Total Total Licenses

FY11

FY10

FY09

FY08

FY07

0 0 0 0 0 0 0

1 0 0 2 0 3

2 0 0 1 0 3

2 0 0 0 0 2

0 2 0 0 1 3

0 0 0 0 0 0

0 1 1 0 2 4 1 11 2 3 0 0 3 0 1 6 2 0 4 1 1 2 45

2 0 1 2 2 0 6 4 1 8 0 0 1 0 2 2 1 1 3 1 0 1 38

1 0 0 0 0 2 0 4 1 4 1 0 1 0 5 14 1 1 2 2 0 2 41

2 0 0 0 0 0 0 6 0 5 0 0 0 1 6 15 0 1 0 1 0 1 38

1 0 1 0 1 4 1 8 0 3 0 0 0 0 2 17 2 2 0 0 0 3 45

0 0

1 1

0 0

0 0 48

0 0 41

1 1 44

0 0 42

0 0 45

Table 7 Licenses by Department â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property License Revenue The OTM staff manages a total of 1873 active license agreements. This includes monitoring the licensee’s business development and compliance of performance milestones, coordinating patent prosecution, processing license income and distributing revenue according to the University’s IP policy. Under most revenue-generating licenses, OTM receives gross licensing income in the form of license fees, maintenance fees, milestone payments, and earned royalties on sales of products or services. In addition, the University collects patent expense reimbursement from some licensees, particularly when the license is exclusive. The University received $6.3M in total licensing revenue in FY11. Revenues generated by each school were as follows: School of Medicine: $4.9M School of Engineering and Applied Sciences: $1.04M School of Arts and Sciences: $0.3M

Arts & Sciences Engineering Law Medicine Social Work TOTALS

FY11 $307,503 1,043,137 0 4,922,705 0 $6,273,345

FY10 $326,470 1,134,545 0 4,891,770 0 $6,352,784

FY09 $437,028 1,064,222 0 6,419,449 0 $7,920,699

FY08 $1,762,509 1,291,326 8,568 13,952,595 0 $17,014,998

FY07 $312,773 1,054,607 0 10,642,473 0 $12,009,853

Table 8 License Revenue by School – FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Fiscal Year 11 Arts & Sciences

Engineering

Medicine

Total

Income Licensing Income

$260,670

$833,399

$4,277,149

$5,371,218

57,994

210,309

663,630

931,933

Expense Reimbursements OTM Current FY (External)

(11,162)

Expense Reimbursements OTM Prior FY (External)

Subtotal Income Expenses

(571)

(18,074)

(29,806)

307,503

1,043,137

4,922,705

6,273,345

Legal

78,745

341,020

1,513,791

1,933,556

Other

171

216

78,745

341,065

1,513,963

1,933,772

Distribution to Inventors

83,357

396,408

1,893,957

2,373,722

Distribution to Schools (Lic. Income)

99,955

320,445

1,741,809

2,162,209

Distribution to Third Parties

42,500

154,238

Subtotal Expenses Distributions

Subtotal Distributions Contributions to OTM Operations

225,813 $2,945

716,854 ($14,781)

196,738

3,790,003 ($381,261)

4,732,670 ($393,097)

Table 9 Technology Transfer Activity by School â&#x20AC;&#x201C; FY11

FY11

FY10

FY09

FY08

FY07

Income Licensing Income

$5,371,218

$5,028,595

$6,301,462

$15,715,818

$10,388,459

Expense reimbursements OTM Current FY (External)

931,933

1,266,112

1,336,650

937,625

1,401,739

Expense reimbursements OTM Prior FY (External)

(29,806)

58,078

282,586

361,554

219,655

6,273,345

6,352,784

7,920,699

17,014,998

12,009,853

Legal

1,933,556

2,063,735

2,206,994

2,271,787

2,113,917

Other

216

250

520

758

331

1,933,772

2,063,984

2,207,513

2,272,545

2,114,248

Subtotal Income Expenses

Subtotal Expenses Distributions Distribution to inventors

2,373,722

2,361,526

2,630,409

7,177,024

4,658,904

Distribution to schools (Lic. Income)

2,162,209

2,043,152

2,527,568

6,787,846

4,172,039

Distribution to third parties

Subtotal Distributions Contribution to OTM operations

196,738

158,682

299,638

759,070

664,687

4,732,670 ($393,097)

4,563,360 ($274,560)

5,457,615 $255,571

14,723,940 $18,513

9,495,631 $399,974

Table 10 Technology Transfer Activity â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Industry-Sponsored Research Agreements by School Industry sponsored research plays a key role in the technology transfer process. OTM negotiates, executes, and manages all industry sponsored research agreements (SRAs) where the sponsor is a for-profit entity and the research does not involve human subjects (i.e., not federally funded or a clinical trial). In FY11, the University entered into 51 industry sponsored research agreements. FY11

FY10

FY09

FY08

FY07

Arts & Sciences

Engineering

Medicine Social Work Total

Table 11 Industry-Sponsored Research Agreements by School â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Department/School Arts & Sciences Biology Chemistry Earth & Planetary Sciences Physics Psychology Arts & Sciences Total Engineering & Applied Science Biomedical Engineering Computer Science & Engineering Electrical & Systems Engineering Energy, Environmental & Chemical Engineering Mechanical, Aerospace & Structural Engineering Engineering & Applied Science Total Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Developmental Biology Genetics Internal Medicine Molecular Microbiology Neurology Neurological Surgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Physical Therapy Psychiatry Radiation Oncology Radiology Siteman Cancer Center Surgery Medicine Total Total Industry-Sponsored Research Agreements

FY11

FY10

FY09

FY08

FY07

2 2 0 0 0 4

0 0 0 0 0 0

0 2 0 1 0 3

2 3 0 0 0 5

1 1 1 2 0 5

3 2 0 0 1 6

2 0 1 5 2 10

0 0 1 10 4 15

0 2 1 1 0 4

0 4 0 1 4 0 8 0 5 0 0 0 0 0 5 4 0 1 0 5 0 5 42 51

0 0 0 0 0 1 14 1 5 1 0 0 1 0 1 4 0 0 1 2 0 4 35 41

0 2 0 0 0 3 12 0 2 2 0 0 0 0 3 4 0 0 0 7 0 5 40 53

0 2 0 0 0 2 14 1 6 0 0 0 4 3 1 2 0 1 1 8 0 7 52 72

0 2 0 0 4 1 6 1 3 0 0 0 2 2 7 6 0 2 2 9 0 4 51 60

Table 12 Industry-Sponsored Research Agreements by Department â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Other Agreements by Department OTM also handles other agreements in its promotion of technology transfer including confidential disclosure agreements (CDAs), inter-institutional agreements (IIAs), and service agreements. CDAs allow for the University faculty to exchange confidential information with outside third parties under obligations to protect and preserve the confidentiality of the information. Generally CDAs are entered into for the purpose of exploring a potential research collaboration or license agreement. In FY11, OTM negotiated and executed a total of 161 CDAs. The University will enter into an IIA when an invention has been created by employees of the University and employees of another institution. Each institution becomes a co-owner of the invention and the IIA determines which institution will take the lead in patenting and licensing activities. In FY11 the University entered into 3 IIAs. Service agreements were re-instated within WU in FY11 after an initial pilot program in FY10. Procedures on the use and processes for Service Agreements were further defined and a standard agreement template was finalized. In FY11, OTM executed 25 service agreements.

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property

Confidentiality Department

Inter-institutional

Service

FY11 FY10 FY09 FY08 FY07 FY11 FY10 FY09 FY08 FY07 FY11 <F11

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

0 3

1 0

3 0

2 1

5 4

0 0

1 0

0 0

0 1

1 0

0 0

1 0

0 0

Engineering & Applied Science Biomedical Engineering

Computer Science & Engineering

Electrical & Systems Engineering

Energy, Environmental & Chemical Engineering

Mechanical, Aerospace & Structural Engineering

0 8 2 0 7 4 22 2 28 11 0 1 0 1 7 1 1 2 12 7 1 8

0 8 0 0 2 1 16 1 10 7 0 3 0 0 2 1 0 0 9 7 0 11

0 5 0 2 7 2 23 0 2 1 0 2 0 2 9 1 2 0 1 9 0 5

0 7 1 3 7 2 21 0 5 3 0 0 0 1 3 1 1 3 1 7 0 5

4 4 2 3 2 3 26 0 13 1 0 3 3 2 4 2 0 2 1 6 0 0

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

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

0 0 0 1 0 0 0 1 0 0 0 0 0 2 0 0 0 0 0 1 0 1

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

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

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

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Medicine Total 125

Engineering & Applied Science Total Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Developmental Biology Genetics Internal Medicine Molecular Microbiology Neurology Neurological Surgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Physical Therapy Psychiatry Radiation Oncology Radiology Siteman Cancer Center Surgery Social Work Social Work Total Total

161

109

Table 13 Other Agreements by Department â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Material Transfer Agreements by Department OTM handles the execution of material transfer agreements (MTAs), required by the University when transferring proprietary materials in and out of WU for research use. Incoming MTAs are no-fee agreements used when the material is received from another non-profit institution or from a commercial third party for the research at WU. Outgoing MTAs are used to distribute WU materials (patented and unpatented) without charge to other non-profit institutions or forprofit companies for their own internal research activities. FY10 FY09 FY08 FY07 FY11 Academic Industry Academic Industry Academic Industry Academic Industry Academic Industry

Department Arts & Sciences Biology Chemistry Earth & Planetary Sciences Mathematics Physics Psyc Arts & Sciences Total Engineering & Applied Science Biomedical Engineering Computer Science & Engineering Electrical & Systems Engineering Energy, Environmental & Chemical Engineering Mechanical, Aerospace & Structural Engineering Engineering & Applied Science Total Medicine Anatomy & Neurobiology Anesthesiology Biochemistry & Molecular Biophysics Cell Biology & Physiology Developmental Biology Genet Internal Medicine Molecular Microbiology Neurology Neurological Surgery Obstetrics & Gynecology Ophthalmology & Visual Sciences Orthopedic Surgery Otolaryngology Pathology & Immunology Pediatrics Physical Therapy Psyc Radiation Oncology Radiology Siteman Cancer Center Surgery Medicine Total Social Work Social Work Total Total

10 0 0 0 0 0 10

1 0 0 0 0 0 1

15 0 0 0 0 0 15

1 0 0 0 0 0 1

31 0 0 1 0 0 32

0 1 0 0 1 0 2

27 1 0 0 0 0 28

2 1 0 0 0 0 3

47 2 0 0 0 0 49

0 0 0 0 0 0 0

0 2 0 1 0 3

0 0 0 0 0 0

4 0 0 0 0 4

3 0 0 0 0 3

3 1 0 0 0 4

0 0 0 0 0 0

1 0 0 0 0 1

0 0 0 0 0 0

2 0 0 0 0 2

0 0 0 0 0 0

16 12 8 20 37 16 192 43 56 1 6 19 4 5 145 22 1 3 5 47 1 27 686 1 1 700

1 4 2 0 5 3 32 4 5 0 0 5 1 0 15 4 0 1 3 3 0 6 94 0 0 95

19 11 6 25 48 17 207 42 47 1 5 15 3 0 129 25 0 3 5 56 0 35 699 0 0 718

1 3 0 1 4 1 23 0 10 0 1 0 0 0 1 2 0 2 1 1 0 6 57 0 0 61

13 10 10 25 88 8 225 41 34 1 3 26 5 2 181 34 0 2 2 47 0 24 781 0 0 817

2 2 1 3 4 0 25 2 2 0 0 2 0 0 6 3 0 2 1 3 0 2 60 0 0 62

10 15 11 34 79 8 164 52 28 2 3 14 6 6 110 35 0 4 8 31 0 25 645 0 0 674

1 2 0 0 6 1 23 1 6 0 0 0 0 0 2 0 0 1 0 3 0 2 48 0 0 51

25 11 4 25 107 9 165 45 34 2 3 25 3 8 123 41 0 6 7 33 0 22 698 0 0 749

0 0 0 3 0 0 16 5 8 0 0 3 3 0 2 4 0 1 1 4 0 5 55 0 0 55

Table 14 Material Transfer Agreements by Department â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Technology Management & Intellectual Property Social and Financial Impact OTM extends the Universityâ&#x20AC;&#x2122;s research via its involvement with the Biogenerator, local incubators, the Regional Chamber and Growth Association, the Danforth Plant Sciences Center Alliance, the Missouri Venture Forum, the Midwest Research Universities Network, and many other organizations. Together they develop channels for making WU technologies widely available and simultaneously build the economy. In FY11, WU technology was licensed to two start-up companies.

Start-up Companies Formed Invention Disclosures US/PCT Patents Filed License Agreements Industry Sponsored Research

FY11

FY10

FY09

FY08

FY07

2 136 83 48 51

2 104 76 41 41

2 125 106 44 53

4 98 94 42 72

5 101 75 45 60

Table 15 Summary of Economic Impact â&#x20AC;&#x201C; FY11 through FY07

OVCR Annual Report Fiscal Year 2011 Clinical Trials â&#x20AC;&#x201C; Industry Sponsored Clinical Trials â&#x20AC;&#x201C; Industry Sponsored This section of the Annual Report is provided by the Center for Clinical Studies. For questions regarding information within this section, please contact Yi Zhang, Director, at yzhang25@wustl.edu.

OVCR Annual Report Fiscal Year 2011 Clinical Trials – Industry Sponsored

Clinical Trials – Industry Sponsored Executive Summary The industry-funded clinical studies described in this report are performed by numerous faculty throughout the School of Medicine. There are also a number of centers dedicated to supporting clinical studies across the School of Medicine; some of these centers are highlighted below. Center for Clinical Studies The mission of the Center for Clinical Studies (CCS) is to facilitate clinical research of the highest quality – supporting the effective evaluation of pharmaceuticals, medical devices, and treatment outcomes – by providing the Washington University research community with administrative and clinical research services that move trials efficiently from initial proposal through study close-out. We assist with clinical research studies supported by federal and foundation grants and industry contracts, including strong support for investigator-initiated studies. Our services include study placement, IRB and other regulatory support and guidance, comprehensive budget development and contract negotiation, recruitment support services (including a centralized research participant database), expert study coordination, dedicated research space and quality improvement initiatives. CCS services facilitate regulatory compliance and operational best practices to optimally support the clinical research endeavor. Center for Applied Research Sciences The Center for Applied Research Sciences (CARS), established in September 2007 as a core within the WU Institute of Clinical & Translational Sciences, represents three units (the Clinical Trials Unit, the Clinical Research Unit and the Pediatric Clinical Research Unit) at the School of Medicine which support and conduct clinical studies. The establishment of CARS improves access to specialized clinical research units that contain state-of-the-art resources and where studies can be performed safely, ethically and efficiently across a spectrum of study populations, research designs and physical sites. The Clinical Trials Unit (CTU) is located on the 11th floor of the Center for Advanced Medicine. The unit is an outpatient research unit that offers dedicated research space, equipment, and nursing support for a wide range of clinical studies, particularly multi-center clinical trials. The CTU generally supports studies that require less sophisticated or intensive measurements and procedures than those conducted in the Clinical Research Unit. The Clinical Research Unit (CRU) is located on the 4th and 5th floors of Barnard Hospital. The CRU operates as an in-patient and out-patient clinical research unit for studies that require more “intense” nursing services than the studies performed in the Clinical Trials Unit or that require an inpatient stay. In addition, this unit provides specialized nutritional and lifestyle intervention research services, coordinating with the principal investigator to facilitate a comprehensive experience for their research subjects. Bionutritional or lifestyle intervention research services may be obtained separately or as part of the visits.

OVCR Annual Report Fiscal Year 2011 Clinical Trials â&#x20AC;&#x201C; Industry Sponsored The Pediatric Clinical Research Unit (PCRU) provides space, nursing and bionutritional support for clinical research projects conducted with children at Washington University. The unit is on the 11th floor of St. Louis Childrenâ&#x20AC;&#x2122;s Hospital and has exam and interview room space, a procedure area and a phlebotomy and sample processing area. Siteman Cancer Center The Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis is an international leader in cancer treatment, research, prevention, education and community outreach. It is the only cancer center in Missouri and within a 240-mile radius of St. Louis to hold the prestigious Comprehensive Cancer Center designation from the National Cancer Institute. The Siteman Cancer Center offers many different types of clinical trials. At any given time, Siteman has more than 250 clinical studies, including many collaborative efforts with other leading cancer centers throughout the country. 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. Recruitment Enhancement Core (REC) In order to improve patient accrual in clinical studies, the Regulatory Support Center (RSC) within the Institute of Clinical & Translational Sciences supports a program called Recruitment Enhancement Core (REC). The goal of the REC is to assist investigators in recruiting potential participants while ensuring compliance with all relevant regulations, including informed consent, confidentiality, privacy of health information, and the recruitment of women and underrepresented minorities. The REC provides investigators with pre-qualified, pre-screened and potential research participants. The service increases public awareness and knowledge concerning medical research needs and opportunities, and the increasing need for minority participation. This education of the community is done in a variety of ways, including radio and print advertising as well as targeted health fair promotion. This paradigm shift has been achieved by utilizing a pre-existing WU medical center resource called Volunteer for Health (VFH). The Washington University VFH recruitment program was established in September 1998 and has assisted investigators in recruitment of study participants since that time. This program includes a database, called the Research Participant Registry, with profiles of potential subjects in a variety of therapeutic areas, as well as assistance with on-campus and/or media advertising. Currently, the database contains more than 15,000 interested, consented volunteers and the REC is dedicated to developing and implementing strategic, recruitment plans that impact recruitment, university wide.

OVCR Annual Report Fiscal Year 2011 Clinical Trials – Industry Sponsored AIDS Clinical Trials Unit (ACTU) 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 1987, the Washington University ACTU has been a highly productive participant in the AIDS Clinical Trials Group funded by the National Institute of Allergy and Infectious Diseases. It conducts NIH, CDC and industry sponsored and Washington University investigator initiated clinical research trials of potential treatments for HIV and its co-infections and complications. Well established and active in the community, the ACTU provides access to research trials, community outreach and education, continuing education, and consultation for health care professionals. Currently, clinical trials at the ACTU are studying the aging and metabolic effects of long term HIV infection, treatments that may stop HIV’s destruction of the immune system; treatments that might help reduce HIV associated inflammatory, metabolic and neurological complications. Since 1988, more than 6000 individuals have participated in studies offered at our site. Oriented Research Unit (Pediatrics) The Patient Oriented Research Unit (PORU) has dedicated space on the 10th floor of the Northwest Tower 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 – FY09-FY11 The number of Industry Sponsored Clinical Trials performed at Washington University has remained stable over the last three fiscal years while the revenue received from the trials has seen a slight decrease. Over the three year period, the number of clinical trials performed at the institution has decreased from 1,348 trials in fiscal year 2009 to 1,341 trials in fiscal year 2011 (-1%). During that same time, the cash receipts from those trials have decreased by 2% from $27.3 million in 2009 to $26.7 million in 2011. For a break-down of clinical trials by department of the School of Medicine please refer to Table 1. Of the total trials performed at the School of Medicine in 2011, 711 out of 1,341 or 53% were performed in the Department of Internal Medicine. In dollar terms, this represents 50% of the total clinical trial dollars for fiscal year 2011. For a break-down of clinical trials by Division of the School of Medicine’s Department of Internal Medicine, please refer to Table 2. Also, during the period fiscal years 2009 to 2011 the number of new industry-funded, clinical research-related agreements and amendments has increased by 15%, while the number of new industry-funded Clinical Trial Agreements has decreased by 9% as is shown in Table 3.

OVCR Annual Report Fiscal Year 2011 Center for Clinical Studies

FY 2011 Department Internal Medicine Neurology Surgery Pediatrics Radiology Obstetrics & Gynecology Pathology & Immunology Orthopedic Surgery Psychiatry Siteman Cancer Center Ophthalmology & Visual Sciences Emergency Medicine Radiation Oncology Neurological Surgery Otolaryngology Anesthesiology Developmental Biology Physical Therapy Occupational Therapy Biochemistry & Molecular Biophysics Molecular Microbiology Health Behavior Research Health Administration Biostatistics Molecular Biology & Pharmacology Div of Comparative Medicine Total

Number 711 151 130 99 58 32 28 24 22 20 16 13 10 8 7 5 2 1 1 1 1 1 0 0 0 0 1,341

Dollars $13,454,716 2,020,335 2,278,585 1,426,494 756,670 1,530,071 182,676 690,760 1,767,354 647,230 518,272 458,401 683,023 111,495 55,108 62,955 35,241 $26,679,386

FY 2010 Number 794 144 117 93 63 29 33 19 22 17 15 14 12 6 9 3 1 1 2 2 1 0 2 1 0 0 1,400

Dollars $14,942,065 1,917,933 1,673,053 1,329,103 1,364,864 713,199 763,462 426,628 1,598,850 562,889 294,342 257,622 747,059 60,574 7,570 39,680 1,500 14,684 16,316 $26,731,393

FY 2009 Number 724 124 136 86 62 28 44 24 28 13 13 17 7 16 10 7 3 0 2 2 1 0 0 1 0 0 1,348

Dollars

% Inc / (Dec) FY 09 - FY 11 Number

Dollars

$13,420,533 1,989,327 1,749,474 1,031,996 2,182,770 479,948 1,158,274 1,116,948 2,066,684 503,802 382,366 162,430 847,618 60,110 53,158 33,148 28,500 10,000 -

-2% 22% -4% 15% -6% 14% -36% 0% -21% 54% 23% -24% 43% -50% -30% -29% -33% 100% -50% -50% 0% 100% 0% -100% 0% 0%

0% 2% 30% 38% -65% 219% -84% -38% -14% 28% 36% 182% -19% 85% 4% 90% -100% 100% -100% 0% 0% 0% 0% 0% 0% 0%

$27,277,086

-1%

-2%

Table 1 Industry Sponsored Clinical Trials - School of Medicine â&#x20AC;&#x201C; FY09-FY11

OVCR Annual Report Fiscal Year 2011 Center for Clinical Studies

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

FY 2011 Number Dollars 212 $4,597,255 97 828,534 72 2,513,903 72 1,462,834 44 622,977 43 649,017 31 324,792 26 722,612 21 548,392 20 329,703 20 220,280 16 79,347 11 151,991 10 105,154 5 96,374 4 143,374 3 54,202 3 3,976 1 711

$13,454,717

FY 2010 Number Dollars 218 $4,884,925 93 1,013,017 62 2,488,557 65 1,103,919 99 983,757 49 1,286,933 31 300,439 22 894,117 20 362,933 18 415,671 37 423,992 24 116,519 13 197,425 13 166,036 4 17,445 3 64,985 8 112,907 14 108,487 1 794

$14,942,065

FY 2009 Number Dollars 198 $3,543,442 87 1,089,613 42 2,272,333 64 1,292,873 89 712,489 41 924,649 24 675,271 23 1,182,340 22 219,175 18 208,003 27 242,110 18 302,855 20 228,409 14 160,885 5 48,264 6 65,265 11 74,162 14 178,395 1 724

$13,420,533

% Inc / (Dec) FY 09 - FY 11 Number Dollars 7% 30% 11% -24% 71% 11% 13% 13% -51% -13% 5% -30% 29% -52% 13% -39% -5% 150% 11% 59% -26% -9% -11% -74% -45% -33% -29% -35% 0% 100% -33% 120% -73% -27% -79% -98% 0% 0% -2%

Table 2 Industry Sponsored Clinical Trials by Division â&#x20AC;&#x201C; Department of Internal Medicine â&#x20AC;&#x201C; FY09-FY11

OVCR Annual Report Fiscal Year 2011 Center for Clinical Studies

Fiscal Year FY11

FY10

% Change FY09-FY11

FY09

Clinical Studies

261

247

288

-9%

Confidentiality Agreements

221

185

144

53%

Amendments (all types)

311

257

254

22%

11%

833

766

722

15%

Other TOTAL

Table 3 New Contracts Completed FY09 through FY11

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense

Sponsored Project Expense This section of the Annual Report is provided by Sponsored Projects Accounting. For questions regarding information within this section, please contact Joe Gindhart, Director, at jgindhart@wustl.edu.

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense Sponsored Project Expense Executive Summary This section presents an overview of expenditure activity for sponsored research projects at Washington University during the fiscal year of 2011 (FY11). The expense dollars reported are for all transactions that occur on or between July 1, 2010 and June 30, 2011. 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. Expenses associated with projects supported by sales and service agreements and clinical trials are excluded from this report. Expenditure Activity The University’s total research expenditures for FY11 amounted to $628 million, a 4% increase over FY10. The University expended $61.6 million dollars under grants funded via the American Recovery and Reinvestment Act of 2009 (ARRA). The Total ARRA expenditures increased 38%, or approximately $17 million from the prior year. The University also saw a modest increase in funding from private granting agencies. The NIH continues to provide the single largest funding stream, thus the costs for those projects represented 75% of total expenditures during the fiscal year. In addition to the NIH, the University also saw a modest increase in expenses from projects funded by private sources. The University continues to maintain a strong position in sponsored research during FY11. 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)

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense



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 nonprofit entities such as; the James S. McDonnell Foundation, Robert Wood Johnson Foundation and the Juvenile Diabetes Foundation. Voluntary Health - Sponsored agreements from non-profit health/disease specific agencies such as; American Heart Association, American Cancer Society and the National Multiple Sclerosis Society. Other – Sponsored agreements and subagreements (excluding federal pass-thru funding) from other non-profit agencies such as: Schriners Hospital for Children, Howard Hughes Medical Institute and the St. Louis Zoo.

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense 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 George Warren Brown School of Social Work Other

Sam Fox School of Design and Visual Arts 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. 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 77

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense and Human Services). The F&A costs are posted to the general ledger monthly, based upon the project’s direct or modified direct (excludes capital equipment, subcontract expenses > $25,000, patient care costs, tuition, and off-campus rent) costs and the applicable F&A rate. Cost Sharing

Defined as costs incurred under a specific cost objective which are not supported by the sponsoring agency. Cost sharing can be described as the dollar amount the University provides to support a sponsored project. The University will commit resources to support a project under the following conditions: 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 12 for a summary of the University’s cost sharing contributions. Facilities and Administrative (F&A) Rates

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

53%

Federal on-campus research rate for projects awarded during the period 7/1/02 – 6/30/06. Applied to modified total direct costs.

•

52%

Federal on-campus research rate for projects awarded during the period 7/1/07 – 6/30/11. Applied to modified total direct costs.

•

26%

Federal off-campus research rate.

•

25.8%

Federal on-campus research rate for genome sequencing center projects awarded during the period 7/1/06 – 6/30/11. Applied to modified total direct costs.

•

Federal rate for research training and fellowship projects.

•

Other

Includes various rates from federal, private and other government sponsors. 78

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense

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 the Office of Sponsored Research Services (OSRS), 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 on the SPA website, see http://www.spa.wustl.edu/.

OVCR Annual Report Fiscal Year 2011 Sponsored Project Expense

FY11

FY10

Direct Costs

% Total Direct

F&A Costs

% Total F&A

Total

% Total

Direct Costs

% Total Direct

F&A Costs

% Total F&A

Total

% Total

$395,068

83%

$139,986

92%

$535,054

85%

$391,549

86%

$134,686

94%

$526,235

87%

Private Sources

79,778

17%

11,982

91,760

15%

67,048

15%

8,972

76,020

13%

Other Government

1,207

186

1,393

1,630

190

1,820

$476,053

100%

$152,154

100%

$628,207

100%

$460,227

100%

$143,848

100%

$604,075

100%