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What's happening with the CTSA?

Dr. David Guzick, M.D., Ph.D.

March 20 , 2007

The NIH Clinical and Translational Science Award (CTSA) was truly affirming for the many faculty members who were committed to the idea and who worked tirelessly on the application. Several months have now passed, however, and things may have seemed to quiet down on the CTSA. I know what you're thinking: "$40 million is a lot of money. Where is it all going? And how does it help me?"

This newsletter is the first update on the CTSA. There will be other periodic updates as news unfolds on different parts of the grant.

Let's start with some vocabulary. The CTSA is the award to the School of Medicine and Dentistry from NIH, which funds 11 key pieces of research infrastructure (summarized below) in support of clinical and translational science. The CTSI is the Institute that subsumes the broader clinical and translational science enterprise at URMC—both the infrastructure funded by the CTSA, and the research programs that are served by this infrastructure. The overarching objective of the CTSI is to coordinate and integrate the scientific, educational, administrative and regulatory elements of clinical and translational science. Under the CTSI, we will augment the ability of our faculty to conduct multidisciplinary clinical and translational research, to stimulate and nurture new investigators to become clinical and translational scientists, to contribute nationally to new knowledge and techniques that diagnose, prevent and treat human disease, and to establish an environment that catalyzes their application to community clinical practice.

Budget Allocation

So how will the $40 million be allocated to achieve these goals over the next 5 years? Here is an approximate breakdown of the specific components ("Key Functions") of the CTSI supported by this award, along with the amounts allocated to each component and the names of the Key Function Director(s):

  1. Initiate and implement educational and training programs that promote career development in the distinct discipline of Clinical and Translational Science (T. Pearson); ($11.3M);
  2. Continue operation of the NIH-funded General Clinical Research Center (GCRC) at UR, strengthened by enabling research participants and investigators to interact more effectively, and to extend the reach of the GCRC into community-based translational research (J. Gerich); ($7.7M);
  3. Develop new cores for technologies and resources that support clinical and translational science (S. Welle); ($6.0M);
  4. Enhance biomedical informatics to facilitate data access and sharing, intra- and inter-institutionally, in a manner that safeguards data security and privacy, and ensures best practices (D. Krusch, D. Wang, H. Wu); ($2.6M);
  5. Evaluate the UR CTSI through rigorous performance criteria, for individual key functions and for the CTSI as a whole, and provide administrative oversight and grants management (A. Dozier); ($2.2M);
  6. Support the design of new clinical and translational studies by drawing on the disciplines of epidemiology, biostatistics and ethics (S. Fisher, R. Holloway, D. Oakes, A. Yakovlev); ($2.0M);
  7. Integrate regulatory resources to assure that interactions between research participants and clinical investigators occur at the highest standards of regulatory compliance and management efficiency (G. Chadwick, G. Liders); ($1.9M);
  8. Develop novel methodologies for clinical and translational research, including research design, biomedical laboratory technologies, and mathematical and statistical modeling (E. Schwarz, J. Treanor); ($1.8M);
  9. Partner with community organizations to facilitate efficient dissemination of information on the importance, safety and value of clinical and translational science, and to reduce disparities in participation in clinical and translational research (N. Bennett, K. Fiscella, P. Szilagyi); ($1.8M);
  10. Initiate innovative pilot studies that foster interdisciplinary collaboration in the application of these novel methodologies (R. Moxley, R. Rosier); ($1.8M);
  11. Develop a consortium of research partners consisting of Upstate New York institutions to foster translation of basic science discoveries and sharing of resources on a regional basis (T. Pearson); ($0.9M).

So what's been happening so far? Briefly, the administrative structure is in full swing: weekly Executive Committee meetings, monthly Administrative Committee meetings of all Key Function directors, formation of External Advisory and Industry Relation committees, etc. and NIH has already site visited us.

Below are headlined two major accomplishments so far in the area of education and training: the training grants awarded to medical and graduate students; and the career development awards to two faculty members. In the near future, there will be newsletter updates on three other initiatives: pilot study grants, funds to develop new research methods, and plans for the CTSB—our academic home for clinical and translational research.

Grants in Education, Training and Career Development

To introduce these CTSA training grants, I must provide a proper introduction to the role played by Tom Pearson. Tom wears many hats. In addition to being Chair of the Department of Community and Preventive Medicine and Senior Associate Dean for Clinical Research, he has been my Co-PI on the CTSA, the author of the Key Function on Research Education, Training and Career Development, and the principal driver of the process by which these awards were made.

As part of the CTSA, Tom set up an Education Directorate, a committee that meets to review applications for the various categories of education, training and career development awards. This drew upon experience over the past seven years with the successful Clinical Research Curriculum Award (funded by a K30 Award from NIH), which has now been folded into the CTSA. Members of this committee, who worked very diligently and thoughtfully in the course of this process, are: Nancy Chin (Director of the MPH Program), Tom Fogg (CTSA Administrator), Robert Gross (Director of the Academic Research Track Program for medical students), Robert Holloway, (Director of the K12 Program), Paul LaCelle (Senior Associate Dean for Graduate Education), Kerry O'Banion (Director of the MD-PhD Program), and Denham Ward (Associate Dean for Faculty Development), with Tom Pearson as Chair. The Directorate meets at least monthly to develop CTSA educational programs, including the launching of three new degree programs: an MS in Translational Research, an MS in Clinical Investigation (already approved by the New York State Education Commission), and a PhD in Translational Biomedical Sciences. The Directorate also reviews applications for CTSA educational funds and evaluates progress of funded trainees.

Training grants to medical students. The Academic Research Track (ART) for medical students was begun in 2002 to provide an enriched research-oriented curriculum to those students who are potentially interested in a career in academic medicine. This includes a year-out for mentored research. Under the capable leadership of Robert Gross, MD, PhD, Professor of Neurology, this program has flourished. As part of the CTSA, students can be provided with a structured research experience, a stipend, and waived tuition if they pursue an M.S. or M.P.H degree. This year, we are supporting three medical students--James Bradley, Taylor Buckley, and Shawana Swann--who are currently engaged in year-out research.

James Bradley

James Bradley is working with Ilan Goldenberg, MD, Research Associate Professor of Medicine and Arthur Moss, MD, Professor of Medicine and Director of the Heart Research Follow-Up Program on Congenital Long-QT Syndrome (LQTS). This syndrome is a genetic disorder associated with a high-risk for sudden cardiac death in a relatively young and otherwise healthy population with no structural heart disease. The International LQTS Registry was established in 1979 at URSMD with the objective of providing a better understanding and management of LQTS. James' project is designed to determine and assess the risk factors of all-cause mortality among genotyped positive LQT1, LQT2, and LQT3 subjects in comparison with genotyped negative LQTS subjects, and to stratify risk and evaluate the severity of risk in LQT1, LQT2, and LQT3 populations.

Taylor Buckley

Taylor Buckley is working in the Center for Musculoskeletal Research under Dr. Regis O'Keefe, MD, PhD, Chair of the Department of Orthopaedics and Rehabilitation Medicine. He is investigating the effect of lead on chondrogenic commitment in mesenchymal stem cells and subsequent bone formation and mineralization in vivo, using separate murine models of endochondral and intramembranous ossification. Anticipated results will provide insight into the mechanism by which lead affects skeletal development, which is clinically important in communities, such as Rochester, where there is the potential for high exposure to lead in some populations.

Shawana Swann

Shawana Swann is working with Eva Pressman, MD, Associate Professor of Ob-Gyn and Director of the Division of Maternal-Fetal Medicine. Shawana designed, implemented, and is now recruiting subjects for, a study in which 100 women will be randomized to either manual or spontaneous removal of their placenta during cesarean section. The purpose of the study is to determine if one method of placental removal is superior with respect to blood loss, post-op infection (endometritis), and operating time. Publication is expected in Summer 2007.

Next year, I am pleased to report that we will be able to support at least 7 additional medical students during their research year.

Training grants to MD-PhD students during graduate-school years: The CTSA also provides support for pre-doctoral training in translational research leading to the PhD degree. In future years, we will support both PhD, and MD-PhD students who are doing translational research. For this year, we have been able to support four MD-PhD students:

Kate Eisenberg

Kate Eisenberg is a student in the Epidemiology graduate program. She is working under Edwin van Wijngaarden, PhD, Assistant Professor of Community and Preventive Medicine. Kate's research is on the epidemiology of lead exposure in recently-arrived refugee children in the United States. She is working with state refugee health programs and local refugee healthcare providers to collect blood levels and other data from refugee children just after they arrive in the U.S. and again 3-6 months later. Her goal is to determine the risk of lead exposure after refugee resettlement and the associations between behavior, culture, world region of origin, and lead exposure.

Susan Lee

Susan Lee is a student in the Neuroscience graduate program. She is working under Dr. Loisa Bennetto, Assistant Professor of Clinical and Social Psychology. Susan's research focuses on a class of visuomotor neurons in the ventral premotor cortex (area F5) of the macaque monkey. These neurons are activated while a macaque monkey performs goal-oriented actions or observes the same action being performed by others. An analogous "mirror neuron system" (MNS) has been demonstrated in humans, and it has been proposed that deficits in the MNS may lead to cascade of impairments that are characteristic of autism spectrum disorders (e.g., deficits in imitation, theory of mind, and social communication). Susan's goals are to use fMRI and behavioral assessments of children with and without autism to better understand the role of the MNS in multimodal integration. MNS involvement will be tested in various functions, such as language and gesture comprehension, and anticipated results will have significant impact on behavioral therapy.

Kevin Makino

Kevin Makino is a student in the Health Services Research graduate program. He is working with Bruce Friedman, PhD, Professor of Community and Preventive Medicine. Kevin's research is focused on analyses of health policy alternatives targeted at reducing disparities in health and healthcare among pediatric populations in the United States.

Kofi Mensah

Kofi Mensah is a student in the Microbiology & Immunology graduate program. He is working under Eddie Schwarz, PhD, Professor of Orthopaedics in the Center for Musculoskeletal Research. Kofi's research is on identifying biomarkers for inflammatory arthritis with Edward Schwarz, PhD and Christopher Ritchlin, MD. He will use cell and tissue samples from both murine models and human patients with inflammatory arthritic conditions to make comparisons and correlations. This work stems from clinical observations about differences in the presence of joint erosions seen with inflammatory arthritis between different autoimmune diseases like SLE and RA. The biomarkers that are elucidated from this work could serve as clinical tools to monitor disease status and the efficacy of anti-arthritic therapy. They could also clarify the role of various biological pathways in the development of autoimmune arthritis, which will lead to more effective medications.

Faculty career development awards (K12): The CTSA Program also supports a K12 Program, providing 2-3 fellows or junior faculty members with 2-5 years of funding in their transition from trainee to independent translational researcher. These are the premier training awards of the CTSA, providing up to 75% salary support, tuition for coursework as needed, and some research project funds. At the end of this period of support, the CTSA Scholar should have established his/her own laboratory and be well on the way to their own research funding. These positions will be a key investment in the building of a translational research faculty at URMC.

Barbara Gracious, MD

Barbara Gracious, MD, is an Assistant Professor of Psychiatry with secondary appointments in Obstetrics and Gynecology and Pediatrics. She has been studying how systemic effects of bipolar disorder and its pharmacologic treatment affect physical health, particularly in adolescent females. Her CTSI K12 award proposes to examine the clinical significance of valproate-induced changes on bone metabolism during the period of peak bone growth, a period crucial to establishing a healthy skeletal system. Direct goals of this work will be to establish screening protocols to assist in determining the prevalence, and risk for, development of osteopenia during treatment with psychotropic medications. She is working collaboratively with Edward Puzas, PhD, Professor of Orthopedics, and Donna Giles, PhD, Professor of Psychiatry and Neurology in linking together potential hormonal and cellular mechanisms for these changes. This interest ties in with broader work she has done examining effects of flax oil on childhood bipolar illness, as well as the risk for metabolic syndrome in bipolar adolescents, that will lead to simple strategies to prevent adverse metabolic changes in this population. Dr. Gracious has received support for her research to date from the National Research Science Award T-32 program established by Dr. Eric Caine, Chair, Department of Psychiatry, the National Alliance for Research in Schizophrenia and Affective Disorders, and the Stanley Medical Research Institute.

Melanie Wellington, MD, PhD

Melanie Wellington, MD, PhD, Assistant Professor in Pediatrics and Infectious Disease, is developing a research program focused on understanding how immune defense mechanisms protect against the human fungal pathogen, Candida albicans. Healthy individuals are exposed to C. albicans but do not develop disease because their phagocytes recognize and respond to the pathogen. By studying these recognition systems, Dr. Wellington hopes to identify therapies to prevent or treat C. albicans disease in immunocompromised patients. This project has grown out of the work she did at UR as a Pediatric Infectious Disease fellow and as a graduate student with Dr. Gus Haidaris, Associate Professor of Microbiology and Immunology and Dr. Frank Gigliotti, Professor of Pediatrics and Infectious Disease. Dr. Wellington looks forward to establishing a research laboratory that will investigate this potentially life threatening disease by using basic molecular techniques, animal and in vitro models of human disease, and eventually, clinical studies.

Wendi Cross, PhD

On a final note that underscores the validity of the review process , Wendi Cross, PhD, Assistant Professor of Psychiatry, was awarded a K12 but happily will return the award because NIMH just awarded her K23. Wendi's work focuses specifically on developing and testing models and methods for training individuals charged with carrying forth a variety of evidence-based interventions into community settings. Procedures are developed specifically to allow efficacy trials to translate into effectiveness research, and effectiveness research to translate into community-based practice, where many interventions can be delivered by nonprofessionals in schools, neighborhood clinics, and other nontraditional settings. The NIMH award affirms our CTSA judgment; and we are pleased that Wendy's only request is that she continues to participate in the CTSA educational curriculum.

Meliora,

David S. Guzick, MD, PhD
Dean, School of Medicine and Dentistry