EXECUTIVE SUMMARY

Introduction: Continued growth in research at UNTHSC, coupled with the increasing oversight responsibilities associated with this growth, led to reorganization of the Research Office in FY 03-04. In June of 2004, Glenn H. Dillon, Ph.D. joined the Research Office as the Acting Associate Vice President for Research and Biotechnology Administration. Dr. Dillon has assumed responsibility for oversight of the Office of Grants and Contracts Management, Technology Development and Commercialization, Laboratory Animal Medicine, and the Institutional Review Board. Robert W. Gracy, Ph.D., assumed the title of Associate Vice President for Research Alliance Development. In this position, Dr. Gracy will focus his efforts on continuing to develop research alliances, collaborations and partnerships with external partners. As such, this annual report on the activities of the Office of Research and Biotechnology Administration (ORBA) is submitted jointly by Drs. Gracy and Dillon. Additionally, Dr. Gracy has provided a report for the Research Alliance Development (RAD) office (full report in appendix). The reports are provided in this single document because of the close working relationship of the two offices.

A. Research Growth: Progress continues to be made toward achieving the goal of recognition as a premier research institution. The trend of enhanced research funding continued in FY 03-04; funding increased approximately 29% to an all-time high of over $21 million. Of some concern is the fact that research proposal submissions was down this year from the previous year. However, the institution is positioned to garner some special initiative funds in 04-05, and expects a number of large projects to be funded. Thus, even in the face of a reduction in submissions, strong growth in research for 04-05 is still projected. Other research performance indicators such as the generation and development of intellectual property (e.g. disclosures, patents, licenses, royalty, equity, spin-offs, etc) continue to increase.

Problems of insufficient research space will continue for at least the next few years. Both the 3 rd and 5 th floors of the new Center for Biohealth (CBH) were opened in August, providing nearly 30,000 new square feet of research space and offices. The 5 th floor is now fully occupied by funded researchers working primarily in the Aging and Alzheimer's disease, and the School of Public Health is occupying or has assigned many of the 3 rd floor laboratories. The federal construction grant proposal, originally submitted in December 03, is to be resubmitted in December 04. Our expectation is this proposal will receive a fundable score. If this proposal is funded, it will provide funds to complete the 4 th and 6 th floors of CBH. If this proposal is not funded, other funds must be identified to allow completion of CBH and continued research growth.

UNTHSC continues to make strides in attempts to expand opportunities in the areas of Biotechnology and commercialization of technologies. The hiring of Robert McClain, Ph.D., as Director of Technology Development and Commercialization, and the institution's commitment to provide funds for these endeavors will permit growth in this area. The Governor's Council on Biotechnology submitted a "Road Map", which is being implemented through the Governor's Office and The Texas Healthcare and Bioscience Institute (THBI), and the Metroplex is taking steps to bring this potential to the North Texas region. This has already brought new partners to the institution, and along with the Biotech Center , raised the profile of UNTHSC as a "Center" for the development of this new economy. The long-term effects of this on the image of the institution cannot be overstated. Much effort in the coming years will focus on achieving these potentials.

B. Strengths and Weaknesses: Each month and each quarter the Office of Research and Biotechnology (ORB) issues a report, which summarizes the research performance indicators of each of the units in the institution. At the end of the year this annual report evaluates and summarizes the strengths and weaknesses of the institution with respect to research. That is the subject of what follows in this document.

The leading sources of research support at UNTHSC continues to be federal programs (85%), most of which are from the NIH (59%). Industry support remains good and is, at least in part, attributed to the institutional decision to establish a division of technology transfer (to be renamed as Technology Development and Commercialization). State support of research has fallen from a high of nearly $2 million in FY01-02 to only $450,000 this year. While unfortunate, it does allow the institution to continue to boast (in the annual research expenditures report from the Texas Higher Education Coordinating Board) of its high Federal/State ratio of research support.

The graduate school continues to provide the foundation for most of the research. Funding to the Graduate School of Biomedical Science (GSBS) was over $15 million, roughly a 35% increase from 02-03. The GSBS share of total research support grew this past year from 65 % of total funding in 02-03 to 70% in 03-04. On a per FTE basis, research support in the GSBS is highly ranked nationally. In comparing research dollars per FTE to the 126 allopathic medical schools, funding of the GSBS Basic Science Depts (excluding pathology) ranks 12 th nationally (data obtained from AAMC website), at $370,000/FTE. The Pharmacology and Neuroscience experienced exceptional growth this year, as funding increased 70% to nearly $ 6.8 million, and an average of $590,000/FTE. This likely puts this department in the top 5 nationally on a funding per faculty basis. The Department of Molecular Biology and Immunology experienced strong growth this year, as funding increased by more than 50%.

TCOM research funding was essentially unchanged for 03-04. The Osteopathic Research Center (ORC) showed impressive gains to total funding of 1.8M (from $294,000). However, other divisions were flat or showed some decrease in funding. The department of Internal Medicine (now along with the ORC) continues to be the primary source of funding in TCOM.

The School of Public Health (SPH) showed strong overall growth in research funding this year, from 1.1M to 1.8M. This growth was primarily due to a $850,000 grant from the Robert Wood Johnson Foundation. While SPH continues be a relatively small overall percentage of total research funding (8.6%), this percentage is increased from 02-03 (6%).

Collaborative research has become the focus of major health care and medical research. UNTHSC's researchers are becoming increasingly involved in research collaborations with other institutions and within our own institution. In the past year, substantial progress has been made in some selected areas (e.g. the Aging and Alzheimer's; Osteopathic Research Center ). Joint programs are developing with other local academic institutions (e.g. Bioengineering at UTA and the Entrepreneurial Center at TCU). International collaborations are also in place (e.g. the Royal Golden Jubilee Program with Thailand ).

Weakness still exists in the research infrastructure. Funds are still being sought to complete the Center for BioHealth, and it is hoped the construction grant will be successful when next submitted. This will permit the finishing of two floors.

The lack of major funds for replacement and repair of major scientific equipment is becoming critical. If this is not addressed, the institution simply cannot expect continued strong rates of growth in research over the coming years. Left unsolved this can lead to crippling consequences. While collaborative research shows positive growth, more efforts must be made to encourage this type of research. Unfortunately, within the past year the status of the UNTHSC multidisciplinary Research Institutes has seemingly declined and their future is unclear unless attention and support can be directed toward them.

C. Projections: One correlate of research funding is grant proposal submissions. Submissions for 03-04 were down somewhat from 02-03, but still exceeded $100M. Almost three fourths of the proposals were submitted to the NIH (88% to federal agencies). The Graduate School accounted for 85% of all research fund requests, comparable to its percentage in 02-03. TCOM submissions amounted to $11.5 million, up considerably from the previous year. Proposals submitted by SPH ($2.8 million) were at there lowest level since 99-00. This is definitely of concern. The SPH is slated to bring on a number of new faculty. It is expected these new faculty will bring research grants with them, and/or be very active with regard to new submissions. If this does not occur, it will be difficult for SPH to continue to increase its contribution to overall research funding.

A second major correlate of the ability to grow research efforts is obviously availability of funds. At the federal level (which accounts for the overwhelming majority of our submissions), the research community is likely in for leaner years. We have been fortunate to have seen a doubling of the NIH budget over the past several years. This increase in the NIH budget brought the percentage of NIH submissions funded to its highest level in many years. The NIH budget is projected to be relatively flat this year, and we are already seeing a significant decrease in the percentage of proposals that receive fundable scores. This disconcerting trend is likely to continue for the next several years. This makes it even more critical for UNTHSC to invest in equipment and other core facilities so that our outstanding scientist have the best possible chance to succeed in acquiring research funding.

A strategy that has proven to be successful for UNTHSC, and is consistent with the goals of NIH, is collaborative research initiatives such as program project grants (PPG) and center grants. UNTHSC currently has one PPG, another has been approved for funding, and at least two more are in preparation for submission in late 04-05. UNTHSC should be proactive in supporting these and other large-scale collaborative funding efforts.

The development of intellectual property at UNTHSC continues to grow. This area was non-existent five years ago, and only minimal resources have been dedicated to this office. However, the performance indicators (e.g. disclosures, patent applications, patents awarded, licenses, and spin-offs per research dollar of the institution) place it among the highest in the country. The recent evaluations of technology transfer activities of this office have been very positive and have resulted in an ongoing effort to upgrade this program through the recruitment of a full time director and staff, and to allocate additional resources for Intellectual Property development. The direct linkage to the Fort Worth Technology Incubator ( TechFort Worth) and its co-location in the CBH with the Office of Technology Development and Commercialization are indicative of positive growth potential in this area of research .

The Office of Research and Biotechnology Administration : As the institution matures toward becoming a premier research institute, its research infrastructure must also mature. Reorganization of the Office of Research and Biotechnology Administration into its existing structure is consistent with this maturation. The ORBA mission and strategic plan are evaluated annually and at least one division is subjected to external review. The goals and objectives of the subdivisions of ORBA (Office of Grants and Contracts Management; Office of Technology Development and Commercialization; Office of Lab Animal Medicine; Institutional Review Board), and the success in achieving these goals, is presented below. In general, the divisions of ORBA have been successful in achieving their stated goals, and the office is well-positioned for continued success, providing critical resources are available. As federal agencies move toward implementing the Responsible Conduct of Research (RCR) mandate, the ORBA has taken several proactive steps. ORBA has developed and presented a training module ( Research Compliance 101 ) to each of the three schools. In the fall of 2003, an external evaluation of its human subjects research programs was conducted by the governing federal agency (the OHRP). This is in anticipation of planning for an accreditation for the IRB. The Department of Laboratory Animal Medicine continues to be the premier "gold standard " for such activities and a "clearing house" for the dissemination of resources relating to the use of laboratory animals in research. In this area of research compliance, review by the USDA resulted in an exemplary score and not a single area of non-compliance.

Thus, by a variety of external measures the ORB continues to mature, grow and assist in the development of research at UNTHSC. However, additional improvement can be made with additional resources. Some improvements are being achieved (e.g., hiring of Dr. McClain and an institutional commitment to support IP and technology development), whereas upgrades in services and opportunities in other areas will require more resources. In particular, as research funding increases, there will be a need for additional staff to handle these accounts. Such resources should come largely from F&A funds, which are explicitly for this purpose. The continued growth of research at UNTHSC will depend on administrative decisions to provide support for these activities.

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