1. PATIENT-ORIENTED RESEARCH TRAINING
2. SIGNIFICANCE OF THE ICPTP
3. CLINICAL PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
4. SETTING

1. PATIENT-ORIENTED RESEARCH TRAINING.

Why should we mentor patient-oriented investigators?

• Because their numbers are declining at a time of unprecedented growth in funding for biomedical research and increased opportunities for high-quality patient-oriented studies that can bring to clinical medicine contemporary developments in fundamental biology. Furthermore, as the work of clinician-investigators has the potential to improve public health through the development of novel diagnostic and treatment strategies, their decline can adversely affect public health.
  
  
• Observations by leading academic physicians have been backed by new data. The Career Opportunities Subcommittee of the Science Policy Committee and the Office of Public Affairs, Federation of American Societies for Experimental Biology, reported two months ago the data collected during their investigation of career opportunities for biomedical research.
  
  
• An obvious question might be: Why do large and well-funded research universities, such as UCLA, need this new initiative for a patient-oriented training program? We believe that while several institutions, including ours, receive considerable amounts of research funding, none of our existing federal funding has been specifically designated to fund the training and mentoring of a cadre of patient-oriented investigators, who will constitute the next generation of patient-oriented investigators. This is the foundation of the UCLA ICPTP program.
  
  

2. SIGNIFICANCE OF THE ICPTP

This ICPTP will be the first of its kind in our institution. The UCLA ICPTP is particularly well positioned to become the country's leading advanced patient-oriented research training program which has a focus on minority issues, and will benefit from the following resources:

• 1. Large number of federally-funded research projects, totaling over $350 million in NIH research funding
  
  
• 2. Presence of GCRC programs at David Geffen School of Medicine at UCLA and Harbor-UCLA, Charles Drew Univ. of Medicine and Science, and Cedars-Sinai Medical Center
  
  
• 3. Large pool of highly-qualified MCPRSP potential applicants
  
  
• 4. Existence of established didactic training in patient-oriented investigation, including the UCLA Graduate Training Program in Translational Investigation and the UCLA Master's Program in Clinical Research (UCLA K30 Program)
  
  
• 5. Focus on Clinical Pharmacology and Experimental Therapeutics that benefits from the Interdepartmental Clinical Pharmacology Traning Program. That Program is supported by 8 academic departments and will serve as an organized unit to structure the training and mentoring of ICPTP candidates
  
  
• 6. Diversity of the Los Angeles community of patients
  
  
• 7. Presence of numerous multidisciplinary centers in virtually all areas of biomedical research, and in minority studies
  
  

3. CLINICAL PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS.

• There was in the last decades of the 20th century a veritable revolution in the basic biomedical sciences, and a parallel decrease in disease burden and life expectancy. Yet, there is much that still needs to be accomplished. Cardiovascular disease, cancer, diabetes, AIDS, depression, and many other illnesses represent enormous burdens to our society at every level: personal, familial, social, and economical. How can we best bring to therapeutics and to health care the enormous advances that are now taking place in fundamental science, such as the sequencing of the human genome. An ideal area for the interface of patient-oriented investigation, molecular medicine, and training is clinical pharmacology and experimental therapeutics. While basic science if of enormous value to expand the frontiers of existing knowledge, the application of that knowledge basis to the bedside is not always straightforward. There are considerable differences between human and animal models that hinder the direct translation of animal models into human therapeutics. Clinical pharmacology and experimental therapeutics are the disciplines that address the development of new and improved pharmacotherapy for human diseases.
  
  
• An important difference that emerges as one bridges basic science and patient-oriented investigation is the fact that in basic research experimental conditions can be standardized to a degree that is not possible in humans. Inter-individual variation in genetic background, unpredictable stressors, diet, compliance, drug interactions, co-morbidity, and belief systems are issues that importantly impact on clinical investigation. Clinical Pharmacology has its roots in the development of methods to measure drug effects in humans and to identify factors responsible for the often marked inter-individual variability in response to drug therapy.
  
  
• Multiple and highly complex skills are needed for the conduction of patient-oriented research that (1) is of high scientific value, (2) can successfully compete for funding, and (3) is conducted ethically and responsibly. Training with a focus on clinical pharmacology and experimental would directly address those needs and provide a focus for a broad and crossdisciplinary ICPTP program that is relevant to all areas of medicine. Moreover, UCLA has been developing an institutional infrastructure in the area of clinical pharmacology and experimental therapeutics, with a focus on special populations (children, women, and ethnic minorities), because those groups have not historically been the explicit focus of state-of-the-art medical inquiry. We are not only interested in having our research efforts be focused on those groups; we are also particularly committed to the training of members of under represented groups. For those reasons, we have utilized the resources and expertise provided by one of the nation's elite medical schools to develop a program that uses the state-of-the-art in medical science to provide training in patient-oriented investigation with a strong focus on under represented groups. The combination of such ongoing institutional efforts with the resources offered by the ICPTP award would make it possible for us to rapidly implement a program that would soon become a model for country.
  
  

4. SETTING

• UCLA is consistently ranked among the top ten research universities in the United States and it is the only institution in this prestigious group to have been established in the 20th century. UCLA's distinction is based on the impressive number of academic departments that rank in the top 10 nationwide. UCLA consists of 165 buildings on 411 acres, housing 13 colleges and schools, and serving nearly 35,000 undergraduate and graduate students. An important tradition at UCLA that is crucial to the mission of the ICPTP is the continuing dialogue between clinical and basic scientists, which is strengthened by the quality of research, commitment to training, availability of research funding, and physical resources. David Geffen School of Medicine at UCLA is nationally ranked among the top five hospitals and as the top institution in the western United States. Candidates with disabilities are encouraged to apply (see program overview).
  
  
• The David Geffen School of Medicine at UCLA is the 7th largest recipient of NIH funding. There are a total of 768 medical students enrolled for the MD degree and 1270 students who have enrolled for their PhDs in various disciplines of health sciences. UCLA has 12 MD/PhD slots each year and 74 MD/PhD students currently enrolled; this program has 34 federally funded positions. The majority of the basic sciences and clinical sciences departments, as well as the medical center, are presently housed in the same building. Six hundred students are enrolled in the School of Public Health.
  
  
• The David Geffen School of Medicine at UCLA defines the southern border of the UCLA campus, and it is therefore highly integrated in the academic life of the university. This complex of patient care, education, and research facilities has achieved international renown for its health care programs and scientific advancements. The first hospital unit of 350 beds was opened in 1955. The present 722-bed hospital was completed in 1970. Since its doors opened in 1955, the David Geffen School of Medicine at UCLA has grown into one of the largest health science centers in the nation, serving more than a quarter of a million people each year. Contained within the complex are the UCLA Schools of Dentistry, Medicine, Nursing, and Public Health, all key components of the proposed ICPTP, and a network of research institutes. Other David Geffen School of Medicine at UCLA components include the Neuropsychiatric Institute and Hospital, the Jules Stein Eye Institute, the Doris Stein Eye Research Institute, the Jerry Lewis Neuromuscular Research Center, the Marion Davies Children's Clinic, the Reed Neurological Research Center, and the Louis Factor Health Sciences Building, which houses the School of Nursing and the Jonsson Comprehensive Cancer Center. Finally, there are several county and private hospitals affiliated with the medical school which provide a rich environment for the education and training of medical students. Adjacent to the David Geffen School of Medicine at UCLA complex are the Life Sciences Building, Young Hall, the Molecular Biology Institute and the Molecular Sciences building which house the basic sciences departments of the College of Letters and Science including Biology, Chemistry and Biochemistry, Molecular Biology and Microbiology, Immunology and Molecular Genetics. ICPTP mentored scholars will utilize these faculties and facilities for their research training as well as medical school departments.
  
  
• Located two miles from our main campus, the VA Greater Los Angeles Healthcare System (VAGLAHS) operates 1056 beds with over a $390 million dollar budget. This is the largest and most complex healthcare facility in the Department of Veterans Affairs. That center will be an invaluable resource for research and training of MCPRSP scholars. The primary VAGLAHS affiliation is with the David Geffen School of Medicine at UCLA.
  
  
• Three of the most recent additions to the Medical Center are the MacDonald Medical Research Laboratories, the Gonda Neuroscience and Genetics Research Center, and the Ahmanson Imaging Center.
  
  
• In the fall of 1999, the University broke ground for a new, state of the art, replacement hospital on the Westwood Campus adjacent to its ambulatory care facilities. The 525-bed facility has been designed by the renowned architect I.M. Pei, whose innovative, humanistic design will play an integral role in the healing process. An underground tunnel will connect the new complex to the medical school and research buildings.
  
  
• There are two NIH-funded GCRC programs that are key resources to this application. This includes the GCRCs at David Geffen School of Medicine at UCLA and Harbor-MLK Hospital. The P.I. of this application is Associate Program Director of the UCLA GCRC, and two of the co-P.I.'s are Program Directors of the GCRC at David Geffen School of Medicine at UCLA (Isidro Salusky) and Drew University (Theodore Friedman).
  
  
• The David Geffen School of Medicine at UCLA GCRC: Since its inception in 1973, the UCLA General Clinical Research Center has received continuous NIH funding. UCLA investigators have used the GCRC to conduct work in the areas of (1) adult and pediatric HIV infection, (2) cancer, (3) gene therapy, (4) arteriosclerosis, (5) neurobiology including rehabilitation and brain mapping, (6) metabolic bone disease, (7) diabetes, (8) women's health, and (9) gastroenterology and clinical nutrition. In these research areas, UCLA clinical investigators have particularly excelled in translational clinical research utilizing basic laboratory research findings in designing and implementing clinical trials. One example of this translational emphasis has been the clinical application of laboratory observation of HER-2/neu gene expression in breast and ovarian cancers to develop a novel new therapy for breast cancer. This work was carried out by UCLA faculty, who made use of GCRC resources. The UCLA GCRC has now developed an Imaging Core, which will further support research in this area at UCLA. The GCRC was very favorably reviewed in December of 2000.
  
  
• Drew University GCRC: This program was founded in 1995 through a Clinical Research Center (CRC) infrastructure initiative from the National Center of Research Resources, National Institutes of Health (NCRR/NIH). The establishment of a CRC at Drew University has been critical in expanding patient care oriented research opportunities and training for faculty, fellows, housestaff, and students. In addition, there is a neonatal GCRC satellite in collaboration with Harbor-David Geffen School of Medicine at UCLA that has been in existence for over 10 years. A key strength of Drew and its CRC is access to a diverse patient population that is historically understudied and difficult to recruit. Presently, 20% of the population at Drew are below the poverty line. The ethnic distribution of the Drew population is 55% Hispanic, 35% Black, and 10% White/Asian.