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UNIVERSITY OF CALIFORNIA ACADEMIC SENATE • IRVINE DIVISION
October 6, 2008
F. ALLAN HUBBELL, SENIOR ASSOCIATE DEAN
SCHOOL OF MEDICINE
GEORGE CHANDY, PROFESSOR
DEPARTMENT OF PHYSIOLOGY & BIOPHYSICS
Re: Proposal to Establish a M.S. in Biomedical and Translational Science
At the October 2, 2008 meeting of the Graduate Council (GC), members reviewed the Proposal for a M.S.
in Biomedical and Translational Science. However, before offering a formal recommendation, GC urges
review of the proposal by the School of Medicine’s Executive Committee. Please forward the SOM
Executive Committee’s response once received.
Although GC will provide more comprehensive comments following receipt of the Executive
Committee’s response, members would like to express their concern regarding the inconsistency between
the stated objective and the actual focus of the degree. In particular, GC is concerned with the balance
between clinical medicine and the basic sciences. All of the letters of support are from clinical medicine
and it is unclear to the Council whether students would have received adequate training in the basic
sciences before enrolling in this program.
If you have any questions or concerns, please do not hesitate to contact me.
On behalf of the Graduate Council,
Glen Mimura, Chair
C: Frances Leslie, Acting Dean, Graduate Division
Carol Sokolov, Assistant Dean, Graduate Division
Leslie O’Neal, University Editor
Jill Kato, GC Analyst, Academic Senate
Proposal for a Program of Graduate Studies
for the Master of Science in Biomedical and
Translational Science
Submitted by the School of Medicine
Contact Persons:
Alan L. Goldin, MD. PhD
Sherrie H. Kaplan, PhD, MPH
George Chandy, MD, PhD
F. Allan Hubbell, MD, MSPH
October 2, 2009
Table of Contents
I. Section 1. Introduction___________________________________________________ 4 -17
1.1. Aims and objective_______________________________________________ 6 - 7
1.2. Historical development of the field___________________________________ 7 -10
1.3. Timetable for program development__________________________________ 10
1.4. Relationship of the program to existing programs on campus
and to the campus academic plan____________________________________ 10-11
1.5. Interrelationship of program with programs at other
UC institutions___________________________________________________ 11
1.6. Department administering the program________________________________ 11-15
1.7. Plan for evaluation of the program____________________________________15-17
II. Section 2. Program 17-26
2.1. Admissions 17-18
2.2. Foreign language 18
2.3. Program of study 18-20
2.3a. Specific fields of emphasis 18-19
2.3b. Plan: Master I 19
2.3c. Unit requirements 19-22
2.3d. Required and recommended courses 22-23
2.3e. Licensing, certification requirements 23
2.4. Field examinations 24
2.5. Qualifying examinations 24
2.6. Thesis and/or dissertation 24
2.7. Final examination 25
2.8. Explanation of special requirements 25
2.9. Relationship of master’s and doctor’s programs 25
2.10 Special preparation for careers in teaching 25
2.11 Sample program 25
2.12 Normative time from matriculation to degree 26
III. Section 3. Projected Need____________________________________ 26-31
3.1. Student demand 26-27
3.2. Opportunities for placement of graduates 27-28
3.3. Importance to the discipline 29
3.4. Ways in which the program will meet societal needs 29-30
3.5. Relationship of the program to interests of faculty 30
3.6. Program differentiation 30-31
IV. Section 4. Faculty 31-47
V. Section 5. Courses 47-67
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VI. Section 6. Resource requirements 67
6.1. FTE faculty 67
6.2. Library acquisition 67
6.3. Computing costs 67
6.4. Equipment 67
6.5. Space and other capital facilities 67
6.6. Other operating costs 67
VII. Section 7. Graduate Student Support 68-69
VIII. Section 8. Changes in Senate Regulations _____________________________________69
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Proposal for a Program of Graduate Studies for the Master of
Science in Biomedical and Translational Science
Section 1. Introduction
This is a proposal submitted by the School of Medicine at the University of California,
Irvine to create a new Master of Science (MS) program in Biomedical and Translational
Science (BATS) targeting qualified physicians, and medical students who have
completed the first three years of medical school, who are interested in the conduct,
interpretation and implementation of clinical research that translates biomedical
discoveries into clinical practice, improves the delivery of high quality care and informs
healthcare policy.
The impetus for creation of the proposed program derives from two sources: the
recognition that there is an accelerating gap between the rapid expansion of biomedical
discoveries and the implementation of those discoveries into clinical practice; and the
acute shortage and inadequate training of the physician-investigator workforce. In his
vision to stimulate the application of ‘bench’ research to the ‘bedside’ care of patients,
Dr. Elias Zerhouni in the National Institutes of Health’s (NIH) ‘Roadmap’ called for the
transformation of biomedical training and mentoring to promote synergism between
physician-investigators and those trained in basic science and other non-clinical
disciplines (see EA Zerhouni, New Eng J Med 2005; 353: 1621-1623). Dr. Francis
Collins, the current director of the NIH, has underscored the importance of translational
research, along with the development of comparative-effectiveness research, by placing
them among his top priorities for the NIH research agenda (see E Dolgin, NatureNews
2009; 460:939).
The accelerated movement toward the practice of evidence-based medicine, and the
increasing interest in and funding for comparative effectiveness research support the need
for this program at this time. These two initiatives complete the cycle from ‘bedside’
care of patients to the building of bodies of evidence that can be used to identify effective
medical care practices, and to establish guidelines that define effective, high quality
patient care.
Why initiate the MS-BATS program at UC Irvine now? There are three reasons. First,
unlike many other medical schools in California and nationally, UC Irvine currently lacks
a graduate program for training physician investigators in clinical research. While there
are many excellent graduate programs, none prepare physicians to work at the border
between the clinical and basic sciences. Trainees in clinical residency and fellowship
programs must now attend Masters or certificate programs at sister UC schools, including
UCLA, UCSD or Long Beach State University to receive this training. Estimates based
on in-depth interviews with Chairs of Clinical Departments and the Senior Associate
Dean of Medical Education at UC Irvine School of Medicine indicate that we now lose
between 30 to 40 clinical residents, fellows, junior faculty and medical students to these
external programs each year.
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Second, there is a deepening shortage of clinical investigators that is national in scope.
Fewer than 2% of active physicians pursue careers in research. With the continued
emphasis on interdisciplinary translational and comparative effectiveness research at the
NIH, the limited availability of a cadre of effectively trained physician investigators will
further handicap the expansion of translational science. New medical schools programs
such as that of the Cleveland Clinic Lerner College of Medicine, training physician
investigators in innovative approaches to the integration of basic science, research and
clinical medicine, are successfully attracting exceptionally qualified students from
nationally prestigious universities. We believe that the addition of the proposed MS-
BATS program would enhance UC Irvine School of Medicine’s ability to attract such
academically oriented trainees, particularly if offered in conjunction with clinical
residency and fellowship programs.
Third, the arrival of a number of key faculty at the UC Irvine School of Medicine within
the past six years represents a critical mass sufficient to teach the curriculum that has now
been developed for the proposed program. This new curriculum, previously prepared for
a Master of Science in Clinical Research in the Department of Community and
Environmental Medicine, will serve to provide the core coursework, and the coursework
for one of the three foci (evidence-based medicine/clinical research) of the proposed
program.
For these reasons, we now propose to offer a Master of Science in Biomedical and
Translational Science (MS-BATS) at the UC Irvine School of Medicine. It will have the
following unique features:
(1) Inclusivity. The proposed program will be open to qualified students from many
backgrounds, including physicians at varied levels of clinical training and
experience interested in clinical research training (including post-MD residents,
fellows, junior faculty in clinical departments, in the School of Medicine, or
physicians practicing in the community); PRIME-LC medical students who have
completed the first three years of medical school to fulfill their Masters
requirement; non PRIME-LC medical students after they complete the first three
years of medical school, and graduate students.
(2) Flexibility. The MS-BATS program is designed to offer comprehensive didactic
training in the fundamental skills required for conducting high-quality biomedical
and translational investigation with flexible 1 or 2-year tracks in either Plan-I
(thesis or research paper plus coursework option) or Plan-II (coursework only
with final examination) options. The rigorous 16-unit core curriculum includes
courses covering research approaches in molecular medicine, design and analysis
of clinical trials, clinical epidemiology, medical statistics, and ethics in clinical
research. In addition, a multidisciplinary series of elective courses and colloquia
will be offered in one of three initial foci: molecular medicine, evidence-based
medicine/clinical research, and population health sciences. Thesis or research
projects will be conducted under the direct supervision and mentorship of a
School of Medicine faculty member, identified by an interdisciplinary Mentorship
Committee.
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(3) Interdisciplinary Mentoring Program. The interdisciplinary Mentorship
Committee will be formed from instructional faculty in the MS-BATS program,
along with interested all Academic Senate faculty members in all departments of
the School of Medicine (and their joint appointees from other academic units at
UCI) to serve as faculty mentors. Working with trainees, the Mentorship
Committee will establish a three member multidisciplinary committee for each
trainee, responsible for provides guidance and advice regarding elective
coursework, research projects and the practicalities of pursuing a career at the
interfaces between basic science, clinical medicine and public policy.
(4) Cohesive Learning Environment. Because translational science is by its nature a
multi-disciplinary endeavor, to provide a cohesive learning experience, cadres of
trainees will attend a regular seminar series and colloquia in the conduct,
interpretation and implementation of translational science. The proposed MS-
BATS program, as well as this seminar series will serve as one of teaching
programs for the Institute for Clinical and Translational Science (ICTS).
In summary, the MS-BATS program is a new research training program that is designed
to prepare physicians and medical students to conduct, implement and interpret clinical
research at the intersection between basic science and clinical medicine. It will bring
basic and clinical science faculty at UC Irvine School of Medicine together to prepare
physician-investigators capable of collaborating successfully with colleagues from
diverse disciplines to address the widening gap between ‘bench’ research and ‘bedside’
application and from bedside application to improved healthcare quality and evidence-
based clinical practice. Its implementation at this point in the evolution of clinical
translational science and comparative effectiveness research locally and nationally is
extremely timely and could substantially improve the quality of the clinical research
profile at UC Irvine School of Medicine.
1.1 Aims and objectives of the program
The primary aim of the MS-BATS program is to facilitate the rapid transformation of
basic knowledge to clinical practice through training and career development of
physician-investigators who adopt a multidisciplinary team approach to research. The
syntheses of extensive discussions with directors of similar successful clinical research
training programs in the US have led to the following specific program aims and
objectives:
1) To train a cadre of multidisciplinary clinical translational scientists who can
collaborate successfully with colleagues in basic sciences and other disciplines
in the effective conduct of high quality clinical research, and applied to a broad
spectrum of clinical issues and settings;
2) To recruit and train students from varying levels of training in clinical medicine
who are interested in conducting clinical research to maximize interdisciplinary
communication and understanding sufficient to carry out high quality clinical
translational research;
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3) To provide specific training in core competencies required to conduct clinical
research including: study design reflecting the breath and complexity of clinical
translational science applications (i.e. beyond traditional clinical trials); critical
appraisal of multidisciplinary research literature; conduct and management of
clinical research; medical statistics; research ethics; training in leadership of
multidisciplinary research teams; medical statistics, data analysis, use of data
repositories, reporting and dissemination (including preparation of research
proposals);
4) To link students with mentors from more than one discipline appropriate to
students’ research interests;
5) To integrate throughout the curriculum, the study of disparities in health and
healthcare with attention to special issues reflected in the conduct of
multidisciplinary clinical translational research and clinical effectiveness
research in minority populations (e.g. non-random geographic clustering of
minorities in communities; translation and language issues; genetic differences;
cultural competence of providers);
6) To evaluate the new training program regularly through: enhanced course
evaluations; student assessments; creation of a student/alumni tracking
database; alumni exit interviews; alumni career tracking; monitoring of mentor
performance; advisory committee evaluation of the program;
7) To broaden and synthesize the array of research and quantitative methods,
grounded in the disciplines from which they derive (e.g. randomized designs
from clinical research; survey and field research from sociology; psychometrics
or measurement science from psychology; cost-effectiveness analysis from
economics), available to those conducting and interpreting clinical translational
research. Several of these features, such as the integration of disparities
research in both substantive and methodological courses, and the synthesis of
quantitative methods from diverse disciplines such as statistics, economics,
psychometrics and clinical epidemiology, and are unique and innovative to
clinical research programs in the United States; and
8) To follow trainees after completion of their degrees to evaluate: 1) their career
paths (e.g. academia, pharmaceutical, biotech or health insurance industries,
government or regulatory agencies, web-based companies, etc); and 2) to
identify potential aspects of the curriculum requiring revision or expansion to
meet the ongoing evolution of clinical translational science and comparative
effectiveness research.
1.2 Historical Development of the Field
Traditional training paradigms for biomedical professionals focus on either the bench
(PhD researchers) or the bedside (MDs) but generally fail to bridge the gap between the
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two disciplines, as recognized by the NIH roadmap
(http://nihroadmap.nih.gov/overview.asp). Nationally, the demand for investigators
trained in the translation of basic research into clinical application and clinical practice is
increasing. This demand is being driven by two parallel forces:
1) The progressive recognition that in order to ensure that discoveries at the bench
are translated into improvements in care at the bedside and in office practice, and
to develop novel approaches that truly “transform human health”, more physician-
investigators need to be trained in programs that feature multi-disciplinary
training curricula and experiences;
2) In order to address the complex and changing nature of disease, and to maximize
the effectiveness of medicines, medical technology and medical procedures, there
is a need for more physician-investigators, policy makers and medical
practitioners trained to integrate the perspectives of basic science and clinical
medicine. This demand is reflected in the National Institute of Health’s Roadmap
for Clinical Research Training and Career Development (Zerhouni, EA, New Eng
J Med 2005; 353(15): 1621-1623; Ley et al, JAMA 2005; 294:1343-1351,
Appendix A) and is underscored by the recent Institute of Medicine Report (IOM
Clinical Effectiveness Research and Innovation Collaborative: Barriers and
Opportunities to Facilitate CER Innovation Pace and Progress, 2009).
The continuing decline in the number of physician-investigators poses a serious threat to
the success of the NIH roadmap. One recent study documented that there has been no
change in the number of physician-investigators applying for first R01 grants in the forty-
year period between 1964-2004 (Dickler HB, et al., JAMA 2007; 297:2496-2501);
another documented a shortage of clinical investigators as of 2005 (Ley TJ and
Rosenberg LE, JAMA 2005; 294:1343-1351). Furthermore, physician-investigators
proposing clinical research were less successful in obtaining funding than those
proposing non-clinical research (NIH Director's Panel on Clinical Research Report
12/97). In 2001, less than 5% of clinical researchers sponsored by the NIH were younger
than 40 years of age (Hahm J, Ommaya A, Editors, Committee on Opportunities to
Address Clinical Research Workforce Diversity Needs for 2010, Committee on Women
in Science and Engineering, National Research Council, 2006).
In recognition of this problem, in 2003, the NIH funded 66 Clinical Research Curriculum
Awards (K-30) at a number of academic medical centers. Among the Universities of
California, awards were granted to UC Davis, UCLA, UCSD and UCSF schools of
medicine. At that time, UC Irvine did not have a clinical research-training program and
did not apply. There are currently 58 degree-granting clinical research-training programs
in the US, all but 2 of which offer a Master of Science in clinical research in their
Schools of Medicine. In a recent evaluation of the success of these Clinical Research
Curriculum Awards, 44% of trainees had earned Master of Science degrees, a substantial
achievement given the relatively recent implementation of this program. Of the top 25
medical schools ranked by the US News and World Report in 2008, all had strong
biomedical and translational science training programs. As a consequence of these
programs, there has been a 115% growth of PhDs in clinical departments between the
years 1981-1999, resulting greater research intensity (more faculty and funding) and
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productivity (AAMC, Analysis in Brief, July 2001; Vol 1, No.2). The goal of integrating
the basic and clinical scientists could further amplify the research productivity of
academic medical centers.
Further support for the enhancement of research in clinical translational science and
comparative effectiveness research is evidenced by the commitment of $1.1 billion for
comparative effectiveness research by the White House to be allocated as grants from the
Department of Health and Human Services, the NIH and the Agency for Healthcare
Research and Quality (http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf).
Biomedical and translational science is defined in this proposal as: (a) basic science
studies that define the biological effects of disease pathogenesis, diagnosis and
therapeutics in human; (b) experimental non-human and non-clinical studies conducted
with the intent of developing principles for the discovery of new biomarkers, new
diagnostic, new medical devices and new therapeutic strategies; (c) clinical investigations
that provide a biological foundation for the development of improved therapies, new
biomarkers, better diagnostics, novel medical devices and more efficient modes of
delivering health care; (d) definition of guidelines for the development of drugs, devices,
diagnostics and for the identification and validation of clinically relevant biomarkers; (e)
any clinical trial initiated in accordance with the above goals, and, (f) epidemiological
and outcomes research programs that would enhance medical delivery and the quality and
effectiveness of medical care. The Institute of Medicine has defined comparative
effectiveness research (CER) as “the generation and synthesis of evidence that compares
the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a
clinical condition or to improve the delivery of care” for the purpose of assisting
consumers, clinicians, purchasers and policy makers to make informed decisions that will
improve patient health and healthcare (IOM, 2009). Because the conduct of CER will
require direct comparisons of effective interventions, in real world clinical settings,
among diverse patient groups with the goal of tailoring treatment to patient needs, the
development of new approaches to training the research community in the conduct and
evaluation of such research, as proposed for the MS-BATS program, is acute.
UC Irvine has a large community of outstanding basic and clinical science researchers
already engaged in biomedical and translational scientific research. However, because of
the lack of infrastructure, much of this work takes place in isolated groups unable to take
advantage of economies of scale and synergies that result from dialogue and exchange of
ideas between basic researchers on the one hand and clinical practitioners on the other.
Furthermore, none of these training programs are directed at physicians.
UC Irvine’s experience with developing graduate degree programs that span departmental
and school boundaries is excellent. The infrastructure of this Campus has already
embraced cross-disciplinary research, with the link between basic biology and clinical
application becoming stronger and more direct than at any other time in UC Irvine’s
history. Research collaborations between faculty in the biological sciences and clinical
sciences within the School of Medicine continue to increase, and several interdisciplinary
campus-wide graduate programs have successfully recruited and trained PhD students,
including the Medical Scientist Training Program (MSTP), the Integrated Neuroscience
Program (INP), the Biomedical Informatics Training (BIT) program, the Cellular and
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Molecular Biosciences program (CMB, previously called Molecular Biology, Genetics
and Biochemistry), the Mathematical, Computational and Systems Biology (MCSB)
program, and the Medicinal Chemistry & Pharmacology (MCP) program.
The opportunity now exists to establish a very effective interdisciplinary degree program
to train physician-investigators that will augment the graduate training mission of the
campus, and serve to enhance not only the curriculum it offers medical students and
physician trainees, but also the overall research and academic missions of the campus as
well.
1.3 Timetable for Program development, including enrollment projections.
The MS-BATS program curriculum and organization is already well developed, with
diverse support throughout the School of Medicine. The program will primarily target
qualified physicians (post-MD) as well as medical students who have completed at least
the first three years of medical school. In the future, the program could also be offered to
qualified students from other disciplines wishing to undertake the MS-BATS curriculum
(e.g. nurse practitioners, RNs, PhDs who wish to re-tool, graduate students, etc.).
We anticipate a minimum of 20 trainees per year for the first two years post-inception of
the program, with the possibility of approximately 30 trainees per year, growing to about
60 trainees by year 5 of the program. MS-BATS trainees will be largely drawn from
among: (1) medical residents and fellows who are members of departments in the School
of Medicine and who, through a competitive application process, have been selected to
enroll in the program; (2) medical students enrolled at UC Irvine after completion of the
third year who seek to augment their MD degree with MS training; and (3) junior faculty
in departments within the School of Medicine. Specifically, we anticipate approximately
10 residents and 12 fellows will participate in the program, drawn from the departments
of cardiology, anesthesiology and peri-operative care, obstetrics and gynecology,
dermatology, occupational medicine, emergency medicine and neurology. As noted
above, these departments currently send approximately 30 students to sister schools in the
UC and CSU systems for training in clinical research. We also anticipate that
approximately 8 medical students from the PRIME-LC program and from clinical
departments will enroll in this program. In the future, we plan to accept PhDs, nurse
practitioners and RNs who wish to retool by undertaking the Master of Science program
in biomedical and translational science. The MS-BATS program should not impact
campus or UC total enrollment plans.
1.4 Relation of the proposed program to existing programs on campus and to the campus
academic plan.
No program currently exists at UC Irvine for MDs to pursue Master of Science training
during residency or fellowship. UC Irvine residents and fellows must therefore go outside
the University for such training. Similarly, there is no program at UC Irvine that would
allow medical students to combine medical school training with a Master of Science
degree.
The MS-BATS program has significant differences from the MSTP program. The MSTP
program is reserved for students who have not yet obtained either the MD or PhD degree,
and will simultaneously pursue both, while the MS-BATS program will be open to
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qualified physicians (post-MD residents, fellows, junior faculty or practicing in the
community) and medical students with at least three years of medical school training.
(1) The MSTP program is not an option for medical students interested in the
commitment required for a Masters degree rather than a PhD degree;
(2) Only six entering students are selected for the joint MD-PhD degree (MSTP)
program each year. We estimate that between 5-15 medical students per year may
opt to undertake a one-year MS-BATS program after completion of pre-clinical
training in the medical school). Such a joint degree would enhance their
competitiveness for residency and fellowship programs, and would also position
trainees for several new careers in the biomedical and health care industry.
The MS-BATS program would complement and extend baccalaureate degrees in Public
Health (supervised by Dr. Ogunseitan) and the baccalaureate level research program in
Clinical and Translational Science (supervised by Dr. Galassetti). The MS-BATS
program is offered through the School of Medicine and so would not impact
undergraduate programs. Because of its emphasis on clinical research training, the MS-
BATS program does not overlap in content or emphasis with the recently approved MPH
program, supervised by Dr. Ogunseitan.
1.5 Interrelationship of the program with programs at other University of California
institutions.
As noted above, currently offered programs in the UC system with K-30 funding from
the NIH include the Master of Science programs in Clinical Research at UCLA, the
Mentored Clinical Research Training Program at UC Davis, the Master of Advanced
Studies (MAS) in Clinical Research at UCSF and the Master in Clinical Science at
UCSD. The focus of these programs is clinical research training. UCSF’s Molecular
Medicine Program offers post-residency research training positions for physicians who
are committed to a career in basic biomedical research. The Clinical Research
Enhancement through Supplemental Training (CREST) program at UCSD, although
providing some research training targeting physician-investigators, does not offer a
Masters of Science degree.
The proposed MS-BATS program has the broader goal of training physician-investigators
across the biomedical and translational science spectrum, from the study of disease on the
molecular level and the conduct of clinical research in human subjects, to the synthesis of
evidence-based medicine and the development of guidelines to improve clinical practice.
The proposed program would potentially involve over 115 faculty members from the UC
Irvine School of Medicine with expertise covering the expanse of topics in biomedical
and translational science. Through the development of the MS-BATS program, UC Irvine
will address the growing clinical research training needs of the second largest populated
county in California and serve as a model for innovative training of physician-
investigators.
1.6 Department or group that will administer the program
Organization: The School of Medicine will award the Master of Science degree in
Biomedical and Translational Science. Resources to manage the MS-BATS program,
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including the addition of a Student Affairs Officer, other administrative personnel as
needed and any required space, will be provided the Dean’s Office.
Governance: The program will be governed by an Executive Committee and a Program
Director, who will be assisted by faculty committees and an administrator.
1.6.1. Executive Committee
1.6.1.1. Composition of the Executive Committee:
The Executive Committee will consist of 8 faculty members representing different
content areas of the program, one student member, and the director. Each of the
faculty members will serve for 3-year terms, and the student member will serve for a
1-year term.
Four of the faculty will represent the Office of Medical Education in the School of
Medicine, the Health Policy Research Institute (HPRI), the PRIME-LC program, and
the Institute for Clinical and Translational Science (ICTS).
One student representative will serve on the Executive Committee;
The remaining 4 faculty members of the Executive Committee will be selected be
a vote of the participating faculty. Candidates will be nominated by the faculty, with
each department or specialty being allowed to nominate one individual. A
Department Chair will not be able to serve on the Executive Committee.
The Director of the program will serve as a member of the Executive Committee.
To facilitate the initial development of the program, 6 members of the Executive
Committee for the program’s inception have been selected from a pool of faculty
members who were involved in the development of the proposal. The remaining 2
faculty members will be chosen by election, and a student member will be selected
after the program has begun. The initial Executive Committee members are as
follows:
o Interim Director: Sherrie H. Kaplan, Professor of Medicine, Assistant Vice
Chancellor, Healthcare Measurement & Evaluation
o Maura B. Hofstader, Associate Chair, Anesthesia & Perioperative Care
o Harry T. Haigler, Professor, Physiology & Biophysics, representing Medical
Education
o Charles P. Vega, Associate Clinical Professor, Family Medicine, representing
the PRIME-LC
o Oladele A. Ogunseitan, Professor, Public Health, representing the ICTS
o K. George Chandy, Professor, Physiology & Biophysics
o Bradley Monk – Associate Professor, Obstetrics/Gynecology
1.6.1.2. Duties and responsibilities of the Executive Committee include:
Solicit/review applications for faculty participation as mentors
Routinely evaluate student/mentor relationships, progress
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Act as admissions committee
Set academic standards and establish any other requirements for continued student
enrollment in the program
Oversee management of funds
Create ad hoc committees
Receive and exercise approval of committee recommendations
Oversee and organize events and program-wide activities including seminars,
symposia, colloquia, etc.
Oversee out-reach programs
1.6.1.3. Procedures of the Executive Committee
Decisions/Resolutions of the Executive Committee will be passed by simple
majority vote of the membership of the Committee, or if a vote is taken at a regular
meeting of the Executive Committee, by a simple majority of those present, provided
that a quorum consisting of at least 50% of the Body is present.
In the event that a vote leads to a tie, the program director will be empowered to
cast a tie-breaking vote. Otherwise, the program director will not participate in
Executive Committee voting.
A tentative calendar of Executive Committee meetings will be established at the
beginning of each academic year and provided to all Executive Committee members.
In other matters, the Executive Committee will be expected to adopt procedures
consistent with common parliamentary practice.
1.6.2. The Program Director
The program director will act as the Chief Executive Officer and Chief Financial Officer
for the program.
1.6.2.1. Selection of the Program Director:
The program director will be selected by a process beginning with nomination by
the Executive Committee, which is expected to consult the participating program
faculty and administration as needed. The Executive Committee may nominate any
faculty member (other than a Department Chair) who is a current participant in the
program, or who is expected to become one prior to the start of her/his term as
Director.
The nomination of the Executive Committee will then be submitted to the Dean of
the School of Medicine for confirmation.
If a faculty member who is nominated and confirmed is currently serving on the
Executive Committee, she/he will relinquish her/his position on the Executive
Committee and a replacement will be chosen by the process outlined in these bylaws
for selection of new Executive Committee members.
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Under no circumstances may someone serve as both Director of the program and
Chair of a participating Department.
The normal term of office of the Director will be 3 years. The term will be
renewable if recommended by the Executive Committee.
1.6.2.2. Duties and Responsibilities of the Program Director
Chair Executive Committee meetings.
Act as the main liaison between the program and the administration of the School
of Medicine and with the UCI administration, the academic senate, campus
committees, and outside organizations.
Coordinate any outside funding the program may obtain.
Supervise the program administrator.
Supervise the admissions process, including the making of offers of admission to
student applicants.
1.6.3. Associate Director
Prior to the start of each year, the Executive Committee will elect one of its
members to serve as Associate Director for that year.
The Associate Director will chair Executive Committee meetings in the absence
of the Director.
The Associate Director will assume responsibilities of the Director in the
Director's absence.
1.6.4. Program Administrator
A staff member will be employed as a program administrator. This individual
will carry out administrative duties associated with running the program, including
but not limited to:
Recruiting
Admissions
Budget
Faculty Membership
Correspondence
Tracking students
Generating data for reports
The program administrator will report to the Director.
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The program administrator will serve as secretary at Executive Committee
meetings.
1.6.5. Plebiscites
Although the Executive Committee and Director will be responsible for most issues of
program governance, two types of decisions will be made only through a vote by the
participating faculty:
Changes to the bylaws: Changes to the bylaws can be proposed either by the
Executive Committee or by a supporting petition signed by at least 25% of the
participating faculty. Once proposed, the Executive Committee will make the text of the
proposed changes available to all participating faculty for a period of time sufficient for
careful review. The Executive Committee will then schedule and hold a vote of the
program membership (i.e. all participating faculty). A simple majority of those faculty
who cast votes will be required to ratify the proposed changes.
Removal of officers: Either the Executive Committee, or any group of faculty
obtaining a supporting petition signed by at least 25% of the participating faculty, can
propose that an officer of the program (program Director or member of the Executive
Committee) be removed from office. Once proposed, the Executive Committee would
notify the participating faculty, and provide adequate opportunities for faculty discussion
and review. The Executive Committee would then schedule and hold a vote of the
program membership. A two-thirds majority of all participating faculty members (not
just those who voted) would be required to remove an officer from office. Once an
officer is removed, the same process that was initially used to appoint him/her will be
used to appoint a successor. If there will be a significant delay in replacing an officer,
the Executive Committee may select an interim officer from any of the participating
faculty.
1.6.6. Program Calendar
The Program will follow the calendar of the academic year. All elections, appointments,
etc. (with fixed terms) will normally take place no later than 3 months prior to the start of
the academic year.
1.7 Plan for evaluation of the program within the offering departments and campus wide.
Based on the criteria used to evaluate the NIH K-30 Clinical Research Training
Programs, amplified to reflect the interdisciplinary training goals of the proposed
program, the MS-BATS Executive Committee, in conjunction with the MS-BATS
Program Office, will:
Evaluate admission policies for minority/gender equity, inclusion of participants
with multi-disciplinary research interests;
Evaluate research-mentoring policies for effective linkage of participants with
interdisciplinary mentors;
Conduct routine MS-BATS course and instructor evaluations;
Conduct routine evaluations of mentors;
15
Develop a computerized tracking system for monitoring the careers of all
participants in the program and program graduation rates (by department, by
faculty mentor, by trainee characteristics (e.g. junior faculty, fellows, residents
and medical students);
Develop an annual self-reported survey of participants’ academic productivity
including: degrees received since participation in the program; academic rank
and time-in-rank; publications (including number and impact; position in
authorship order; inclusion of multi-disciplinary collaborators, etc); number and
type (e.g. K awards, R01s) of grants and contracts submitted; number and size of
grants awarded; presence of interdisciplinary collaborators on grants and
contracts; time to first grant funding; percent of effort dedicated to research;
percent of time mentoring of junior investigators; honors and awards; perceived
barriers to academic advancement. Also included will be a formal evaluation of
the MS-BATS training program, research mentors and interdisciplinary
colleagues;
Develop a comprehensive integrated database to evaluate MS-BATS admission
policies, participant experiences, faculty experiences, graduation rates, etc. for
the need to modify curricula, policies and faculty participation.
Moreover, at annual MS-BATS research meetings, former trainees will be asked to
provide updated, informal information on their academic progress. Those not attending
will be asked to provide this information in writing.
As part of a routine monitoring process, mentors will be evaluated according to
traditional yardsticks such as peer-reviewed publications and grant supports, as well as by
the volume and importance of their synergistic and interdisciplinary collaborations and
innovations. These data will be regularly collected and used to provide mentors with
explicit feedback.
Chairs of participating departments and the Dean of Medical Education will also be asked
to provide yearly feedback on the impact of the MS-BATS program on the training
experience for their resident or fellow or medical student or junior faculty participants.
Annual reports regarding program effectiveness, along with recommendations for
program improvement will be made based on evaluation results.
Five year review of the program by the Academic Senate and Graduate Council. Data
collected for these reviews will include:
Admissions.
Number of applicants
Number accepted
Number enrolled
Qualifications of applicants, including previous institution, degree and year, MCAT
scores and GPA.
Academic Performance.
16
Grades
Comprehensive exam results (for Plan II students)
Thesis completion
Student Outcomes.
Honors
Awards
Publications
Time to degree
Subsequent employment
Numbers opting to pursue a PhD in a related field
Section 2. Program
Trainees in the MS-BATS program will have common core courses, but will choose
electives from a broad array of courses available in the School of Medicine (details in
appendix). All MS-BATS trainees will be required to attend the Research-in-Progress
(RIP) Series, present work in progress, critique fellow trainees work, attend Grand
Rounds and departmental seminars in the School of Medicine Departments in which they
have appointments, and attend the Annual MS-BATS Research Meetings, where their
research is presented and former trainees return to discuss career development.
2.1 Admission
2.1.1. Application requirements
Medical students: Medical students wishing to enroll in the MS-BATS program must
have successfully completed their first three years of medical school, applying during the
second year of medical school. There are a number of funding organizations that provide
fellowship support for medical students to perform research for one year during medical
school. These include NIH, HHMI and AHA. The MS-BATS program will have a
competitive selection process in which the admissions committee reviews each applicant
based on grades during undergraduate training, MCAT scores, grades during the first
three years of medical school, personal statement, and three letters of recommendation,
including one from the primary faculty advisor the student has selected.
MDs in residency programs or specialty Fellowships or Junior Faculty in clinical
departments or licensed physicians in the community: MDs that fulfill any of these
criteria may apply to the MS-BATS program. These individuals would identify a mentor
within the first 6 months of training and apply to the program with the goal of carrying
out research with that mentor. They would then enter the program at the beginning of the
next year, which would provide time for the candidate to become familiar with the
research of the faculty mentor.
17
□ US Medical Graduates: Criteria for selection will include grades during medical
school, USMLE scores, residency evaluations, personal statement, three letters of
recommendation, evidence of research ability and performance during an interview with
a designated member of the Admissions committee. Research ability will be judged
based on information from letters of recommendation, previous course work, and record
of experience. Lack of research experience will not disqualify an applicant, however
strong evidence must be provided demonstrating that the candidate is capable of
undertaking rigorous training and independent study.
2.2 Foreign Language Requirement
Non-US applicants will be required to provide TOEFL score as evidence of English
language proficiency. There are no other non-English language requirements.
2.3 Program of Study
2.3a. Specific Fields of Emphasis
The MS-BATS program will initially offer three fields of emphasis: Molecular
Medicine, Evidence-Based Medicine/Clinical Research, and Population health sciences.
Trainees from various departments can add electives specific to the content focus of their
departments. It is expected that research projects will also be related to the content focus
of the trainee’s department, but will include a multi-disciplinary approach, reflected by
the mentoring committee.
Molecular Medicine will focus on the molecular mechanisms and molecular physiology
of human disease. Evidence-Based Medicine/Clinical Research will focus on the conduct
and interpretation of clinical research and the assessment and improvement of quality of
healthcare. Population health sciences will focus on the application of epidemiologic
research and research methods to clinical practice.
Eventually, the MS-BATS program will offer medical specialty and disease-focused
elective concentrations correspond to different medical specialties and sub-specialties in
the School of Medicine (see table below). We expect that residents, fellows, junior
faculty, and community-based physicians may pursue courses within their specialty. The
areas of emphasis that we anticipate will be added to the MS-BATS course electives and
areas of focus within the first two years of the program are listed in the following table.
Students may work with participating faculty in each of these areas on research projects
in the first year of the program.
Anesthesia and Pain Ophthalmology
Diabetes and Metabolic Diseases Orthopedics
Disaster Medical Science Pediatrics
Hematology/Oncology/Radiation Pulmonary Medicine
Oncology/gynecologic oncology
Immune mediated disorders Stroke and Cerebrovascular Disease
Nephrology and Hypertension Surgery
18
Neonatology Urology
Neurology Vascular Surgery
Occupational Health and Environmental
Medicine
2.3b. Plans
The MS-BATS program will begin in July of each year to coincide with the start of the
residency and fellowship programs, and the clinical rotations of medical students in their
fourth year of medical school. FTE faculty members in the School of Medicine have 11-
month appointments and currently get teaching credit for training residents and fellows
during the summer months. Therefore, SOM faculty will be available to teach the core
courses during the summer (July-September). Faculty who have agreed to participate in
the MS-BATS program are listed below and have agreed to teach in the program as
required to accommodate this year round schedule.
We anticipate that most trainees who elect the coursework and examination option (Plan
II) will require 1-year to complete the program. Those who complete coursework and
research projects (Plan I) may require 2 years or longer. The longer programs would
accommodate the requirements of residents doing internal medicine residency program (3
years) or surgical and urology residency programs (4 years).
Trainees will be able to undertake Plan I (thesis/research project option) or Plan II
(comprehensive final examination). Trainees taking Plan I complete the core program of
16 units and elective courses of 8 units, all with grades of B or above. They also prepare a
thesis or research project based on individual study under the supervision of an advisory
committee comprising a primary thesis advisor, a faculty member in the same research
area, and two faculty members from other departments with complementary research
interests. The trainee will submit a written thesis and make an oral presentation to the
advisory committee at the end of the program, and will also be expected to present the
work at the annual BATS symposium. Trainees taking Plan II complete the core program
of 16 units plus 16 units of elective courses, all with grades of B or above. These students
will be assigned an advisory committee of at least three faculty members. At the end of
the program, they would undergo a comprehensive final examination administered by the
advisory committee. Trainees doing Plan-I or Plan-II will in addition be required to
attend the MS-BATS seminar series (see below), which would fulfill 6 units of their
requirements.
2.3c. Unit requirements
Plan I: Thesis/research project option: Note the difference in total units is because the
requirement for trainees to take MS-BATS seminars each year they are in the program.
All other requirements are identical.
19
1-year track (36 2-year-track (42 3-year track (48 4-year track (54
units total) units) units) units)
Core 1st quarter 16 units 8 units 4 units 4 units
(July-September)
2nd quarter – 4th 8 units electives 4 units electives 4 units elective
quarter (2 courses) (1 course) (1 course) MS-BATS
Thesis/research Thesis/research Thesis/research seminars (6
project (6 units) project (3 units) project (2 units) units)
MS-BATS MS-BATS MS-BATS
seminars (6 seminars (6 seminars (6
units) units) units)
Thesis
dissertation
Core 5th quarter 8 units 4 units 4 units
(July-September)
6th-8th quarter 4 units elective 4 units elective Thesis/research
(1 course) (1 course) project (2 units)
Thesis/research Thesis/research MS-BATS
project (3 units) project (2 units) seminars (6
MS-BATS units)
MS-BATS
seminars (6 seminars (6
units) units)
Thesis
dissertation
Core 9th quarter 8 units 4 units
(July-September)
10th-12th quarter Thesis/research 4 units elective
project (2 units) (1 course)
MS-BATS Thesis/research
seminars (6 project (2 units)
units) MS-BATS
Thesis seminars (6
dissertation units)
Core 13th quarter 4 units
(July-September)
14th -16th quarter 4 units elective
(1 course)
20
Thesis/research
project (2 units)
MS-BATS
seminars (6
units)
Thesis
dissertation
Plan II: Coursework and comprehensive final examination option: Note the difference in
total units is because the requirement for trainees to take MS-BATS seminars each year
they are in the program. All other requirements are identical.
1-year track (38 2-year-track (44 3-year track (50 4-year track (56
units) units) units) units)_
Core 1st quarter 16 units (4 8 units (2 4 units (1 course) 4 units (1 course)
courses) courses)
2nd quarter – 4th 16 units electives 8 units electives 4 units elective 4 units electives
quarter (4 courses) (1 course) (1 course) (1 course)
MS-BATS MS-BATS MS-BATS MS-BATS
seminars (6 seminars (6 seminars (6 seminars (6
units) units) units) units)
Comprehensive
oral final
examination
Core 5th quarter 8 units 4 units 4 units
th th
6 -8 quarter 8 units elective 4 units elective 4 units electives
(1 course) (1 course) MS-BATS
MS-BATS MS-BATS seminars (6
seminars (6 seminars (6 units)
units) units)
Comprehensive
oral final
examination
Core 9th quarter 8 units 4 units
10th-12th quarter 8 units electives 4 units elective
(1 course)
MS-BATS
seminars (6 MS-BATS
units) seminars (6
21
units)
Comprehensive
oral final
examination
Core 13th quarter 4 units
14th -16th quarter 4 units elective
(1 course)
MS-BATS
seminars (6
units)
Comprehensive
oral final
examination
2.3d. Required and Recommended Courses
Core courses (16 units; case-based and seminar format): will be case-based and deal with
real life situations in biomedical and translational science. Each course will last one
quarter and will meet twice weekly. Students will be graded on participation, on
homework assignments, and on a final examination or a term paper at the end of the
course. The four core courses will include:
CS 209A Introduction to Medical Statistics (4 units) (Dr. John Billimek)
CS210A Introduction to Clinical Epidemiology (4 units) (Dr. Sheldon Greenfield)
CS 232 Design and analysis of Clinical trials (4 units) (Dr. Sherrie Kaplan)
CS-296 Ethics in Clinical Research (4 units) (Dr. Felicia Cohn)
Depending on the field of interest, students could substitute one of the following courses
for a core course.
CB-1 Foundations in Clinical Translational Science (4 units) (Dr. Oladele Ogunseitan)
TBD Research techniques and approaches in molecular medicine (4 units) (Dr. K. George
Chandy)
To accommodate the busy schedules of residents and fellows, the courses will be offered
during the summer (July to September) either in the evenings or on weekends.
Elective Courses: will combine didactic lectures with discussion of papers and cases. See
Section 5 for details, however an example the courses offered for an elective focus in
“evidenced-based medicine” would include:
CS242: Introduction to quality of care, outcomes research, provider-patient
communication
22
CS250A/B: Introduction to clinical policy, quality of care and health services research
methods
CS243: Evidence based-medicine, practice guidelines and performance assessment
CS251: Quality, efficiency and cost-effectiveness analysis
CS253: Disparities in health and healthcare
CS254: Quality and patient safety improvement: Systems, strategies and evaluation
CS252: Cross-disciplinary research methods
CS255: Healthcare policy and politics
CS299: Research project in quality of care assessment/improvement
Students undertaking the Plan I program would take any two of these courses to fulfill
their 8-unit requirement. Students doing the Plan II program would take any four of these
courses to fulfill their 16-unit requirement.
Additional BATS MS program requirements include:
Bimonthly MS-BATS seminars (required 2 units/quarter): Given the breadth of
interests within the MS-BATS program there is a danger that individual students will
become isolated within their own research area of concentration. To engender a sense of
community and encourage exchange of ideas among members of the MS-BATS program,
the RIP Seminar is required for all trainees. Two trainees each month would present their
current research or a topic of interest. Food and beverages would be provided and the
venue alternate between the main and hospital campuses. Through attendance at the RIP
seminars, trainees would be exposed to diverse research projects in the biomedical and
translational science arena. As a further effort to strengthen amongst the trainees, MS-
BATS will host monthly research presentations by UC Irvine faculty mentors affiliated
with the program.
Annual MS-BATS Program Symposium (Spring): All trainees undertaking Plan I will
be expected to present results of their research as posters. The program committee will
select five research projects for oral presentation. Prizes will be given for the top three
poster and/or oral presentations. Trainees undertaking Plan II would be required to
present a poster outlining a translational research proposal. Alumni of the program will
be encouraged to participate by presenting posters. One alumnus will make an oral
presentation describing her/his experience since completion of the MS-BATS program.
An eminent investigator in the field of Biomedical and Translational Science will be
invited to give a keynote lecture. To actively engage the community, the program
committee would invite the participation of patient advocate groups (e.g. JDRF, MS
society etc), OCTANE, science teachers in local high schools, local biopharma and
medical device companies, investment firms, entrepreneurs. Exposure to such outreach
programs would enable graduates to understand the relevance of their efforts to the
human community beyond the doctor’s office.
Participation in clinical Grand Rounds and departmental seminars can account for 1
unit/quarter or a total of 3 units.
2.3e Licensing or Certification
None required.
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2.4 Field Examination
None Required.
2.5 Qualifying examinations – written and/or oral
None
2.6 Thesis/research project
Plan I – Thesis/research project option: Each scholar undertaking the Plan I program will
select a Primary Advisor to conduct thesis/research project as they join the program. The
Mentoring Committee will work with students to add at least two members from other
disciplines to the student’s advisory committee. Medical students will select the advisor
after program acceptance, medical fellows during the first year of their clinical specialty
training programs and medical residents during the first or second years of residency
training. Junior faculty in clinical departments and licensed physicians from the
community will also have to select a primary advisor before the start date of the program.
The advisor’s role is to guide thesis/research project, help the scholar select a Master’s
Committee, provide advice on important career decisions (job searches, extramural
funding, etc) and offer assistance with navigating the complexities of a career in both
science and medicine.
Advisors for thesis/research project will be an Academic Senate faculty member in the
School of Medicine or a joint appointee from another academic unit at UC Irvine.
The student, in consultation with the primary advisor and Mentoring Committee, will
select an advisory committee of two additional Academic Senate faculty mentors, one
from the host department and one from another department to evaluate the achievement
of the requirements for graduation. The primary advisor will serve as the Chairperson of
the committee. The Chairperson will arbitrate when there is significant disagreement
among committee members or advocate for the scholar if he/she is experiencing
difficulties gaining access to other committee members or scheduling meetings of the
committee.
It is expected that trainees will meet with their committees at least six-monthly to review
progress and set future objectives.
At no less than 3 months prior to the date that trainees anticipate completing the last of
their thesis-oriented research, trainees are required to indicate that they have had at least
one meeting with all 3 members of their Master's Committee present where a final plan
and timeline were agreed upon regarding the content and completion of the all program
requirements, the thesis project in particular. The purpose of this meeting is to ensure that
the Committee is well aware of and agrees with the final plans the scholar has made to
fulfill the program's research product requirements. The objective is to avoid last minute
submissions to Committee members, which defeat the purpose of obtaining the members'
well-reasoned advice.
At all required Committee meetings (and any other meetings held with the full
committee), the scholar should take the responsibility for setting the agenda for the
meeting, including sending out the agenda and accompanying materials (e.g., drafts of
products) by e-mail at least one week prior to the meeting.
24
2.7 Final Examination
Plan I – Thesis/research project option: The submission of an accepted written
thesis/research project will fulfill this requirement.
Plan II – Coursework and comprehensive examination option: Each scholar undertaking
Plan II will select a primary advisor on acceptance into the program. The primary advisor
will be an Academic Senate faculty member in the School of Medicine or a joint
appointee and Academic Senate member from another academic unit at UC Irvine. The
scholar in consultation with the primary advisor and Mentoring Committee will select an
advisory committee of two additional Academic Senate faculty mentors, one from the
host department and one from another department, to serve as the final comprehensive
examination committee The scholar will meet with the committee once every quarter to
discuss progress. For the final comprehensive examination, the trainee will submit a 10-
page NIH-like research proposal on any topic in Biomedical and Translational Science to
the advisory committee, defend the proposal and answer any questions the committee
asks about the proposal and about topics related to the elective concentration that the
trainee completed.
2.8 Explanation of special requirements over and above Graduate Division minimum
requirements
None Required.
2.9 Relationship of Master and Doctoral programs
Students in the BATS program who wish to pursue a Ph.D. degree will be able to apply
to one of the Ph.D.-granting graduate programs at UC Irvine.
2.10 Special preparation for careers in teaching
None Required.
2.11 Sample program
One-Year Plan I Program Sample Curriculum for a student interested in Population
health sciences
Summer Fall Winter Spring
CS 209A Introduction to CS241: Advanced Epidem 202: Genetic MS-BATS seminars
Medical Statistics clinical Epidemiology (4 units) (2 units/ quarter)
epidemiology
(4 units)
(4 units)
CS-296 Ethics in Clinical MS-BATS seminars Thesis/research project
Research MS—BATS (2 units/ quarter)
seminars (2 units)
(4 units) Thesis/research project
(2 units/ quarter) Thesis dissertation
CS210A Introduction to (2 units) submitted
Clinical Epidemiology Thesis/research
project
(4 units)
(2 units)
CS 232 Design and analysis
of Clinical trials (4 units)
25
2.12 Normative time from matriculation to degree
In response to the NIH imperative to provide programmatic flexibility and efficiency to
meet the needs of those training in clinical disciplines in parallel with graduate programs,
we have tailored the proposed MS-BATS program to be either one or two years in length
(however, completion time could be extended for some clinical specialties), to cover a
broad range of disciplines, and to be flexible in the face of clinical residency/ fellowship/
medical student requirements. The normative time to complete the program will be two
years.
Section 3: Projected need
3.1 Student demand for the program
1. Currently physician-trainees in the clinical residency and fellowship programs at UC
Irvine’s School of Medicine attend Masters programs at sister UC schools to receive
training in clinical research or translational science, as no program currently exists here.
2. Medical students who are part of the PRIME-LC program are required to complete a
Masters degree in combination with their clinical training leading to a MD degree. Most
PRIME-LC medical students currently attend programs at Long Beach State or sister UC
schools to fulfill this requirement since no program currently exists at UCI.
3. Several medical students who are not part of the PRIME-LC program have taken a
year off from medical school to carry out research in the medical specialties in which
they are planning to pursue residencies. These research experiences have been especially
valuable in the very competitive residency programs such as orthopedics, urology, plastic
surgery, radiology, dermatology, ENT and ophthalmology. Currently, these students do
not obtain credit for the research experience.
4. We estimate that 10 non-PRIME LC medical students per year are interested in
obtaining a Master of Science or MPH degree. Currently, these students have to go to
other institutions.
5. Based on extensive discussions with Chairs of the clinical departments in the School
of Medicine, the Senior Associate Dean for Medical Education, the director of the
PRIME-LC program for medical students and numerous faculty members, the following
table has been compiled showing the potential trainees who will do MS-BATS. At
inception, we anticipate that approximately 10 Fellows, 12 residents, 4 PRIME-LC
medical students, 4 non-PRIME-LC medical students, and potentially 1-2 physicians in
the community will apply for the program per year for the first 2 years. Estimates by field
of interest are outlined below in a table. We expect that number to grow to 60 in the first
5 years, the additional trainees coming from internal medicine and urology residency
programs, fellows in clinical genetics, fellows in pathology and more medical students.
26
Specialty Fellows Specialty Fellows
Allergy/Immunology 2 Occupational Health 2
Cardiology 2 Specialty Residents
Dermatology 2 Anesthesia & Perioperative 4
Care
Emergency Medicine 2 Internal Medicine 3
(Disaster Medicine)
Hematology/Oncology 2 Orthopedics 1
Gynecologic Oncology 6 Surgery 2
Neonatology 2 Urology 8
Nephrology 1 Others Medical
Students
Pulmonary Medicine 3 PRIME-LC Medical students 3-4
Clinical Genetics 2 Medical students 3-4
Urology 2 Foreign medical Graduates 3-4
6. The demand for training in biomedical and translational science is an integral
component of the NIH’s Roadmap for Clinical Research Training and Career
Development and thus is a major initiative for the country’s scientific community. Many
medical schools and teaching hospitals have responded by offering biomedical or clinical
translational degree granting programs, including Baylor College of Medicine, Boston
University Medical School, Cleveland Clinic Lerner College of Medicine, Columbia
University, George Washington University, Johns Hopkins University, Mayo Clinic, UC
San Francisco, University of Cincinnati, UMass Medical School, University of Maryland,
University of Rochester School of Medicine, University of Virginia, University of
Washington, and Yale University. However, despite the existence of these programs, the
American Associate of Medical Colleges reports that 40% of open positions for assistant
professors of medicine in patient-oriented (clinical) research remained unfilled between
2002-2004 (AAMC Analysis in Brief, December 2007 Vol 7 No 5). The percent of open
positions was highest (61%) in the schools in the lowest third by research ranking. The
need for this program is therefore acute.
3.2 Opportunities for placement of graduates
The new MS-BATS program would cater to the rapidly growing market needs of the
healthcare industry.
• Academic and research institutions: Academic institutions train educators, practitioners,
managers, policy makers, and researchers to fill every aspect of the biomedical arena,
from the discovery of key laboratory based discoveries that impact medicine, to their
27
development as viable and useful applications for the prevention, diagnosis and treatment
of disease, to the implementation and assessment of these applications for the benefit of
society.
• Healthcare financing and delivery systems: Health services delivery organizations
(hospitals, health plans, and medical groups) meet the community’s preventive, acute,
and chronic health needs, including provision of care to indigent populations. Schools of
Medicine are responsible for the total health and treatment needs of their population and
also contribute to the health of the communities they serve. The training that physicians
obtain during their MS-BATS training would inform improvements in clinical practice
and in the ability to meet community needs.
Governmental health agencies: Governmental health agencies at the local, state and
national levels need physician-investigators trained in interdisciplinary and translational
clinical research to meet the imperatives of research agenda that respond to the public’s
need for service, to assess and improve clinical practice and to monitor the health and
well-being of the public. Such agencies include the National Institutes of Health, the
Food and Drug Administration, the Centers for Disease Control, etc. California’s
Integrating Medicine and Public Health Initiative is an example of the new job
opportunities for physicians trained in a blended paradigm of biomedical and
translational science.
Non-governmental health agencies and organizations: Funded through public and private
sources, physicians trained in clinical research and translational science are in increasing
demand in organizations involved in the assessment and assurance of healthcare for the
American public. Organizations in this category range from quality assessment and
improvement organizations (e.g. the National Committee on Quality Assurance, the Joint
Commission on Accreditation of Healthcare Organizations), national physician licensing
and certification organizations (such as specialty societies, the American Medical
Association, the American College of Physicians) and advocacy groups, like the March
of Dimes and the American Heart Association, to localized groups such as community
asthma prevention coalitions.
Private for-profit organizations: Innovations in the rapidly expanding for-profit
healthcare sector also need physicians trained in clinical research and translational
science. Such groups include: advocacy groups that articulate the interests of scientific
and medical organizations to Congress, biotechnology, biomedical marketing, contract
research organizations, consulting, health insurance, hospitals, information technology,
intellectual property, investment, medical devices and equipment, occupational medicine
and environmental science, pharmaceuticals, reagent development, scientific publishing,
technology transfer, web-based companies.
As part of career counseling, the program would bring to the campus individuals in the
many different fields that impact medicine and are impacted by medicine. Trainees in the
program will thereby be exposed to different career paths besides the ones we currently
train them for. In addition a course entitled “Career pathways practicum in biomedical
and translational science” will be offered as an elective course.
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3.3 Importance to the discipline
The proposed MS-BATS program grew out of a need for training at the interface between
medicine and the traditional basic sciences at UC Irvine and around the country. Rapid
progress in cellular and molecular biology offers the prospect of a diffuse impact on
clinical medicine, offering insights about the fundamental causes of many diseases. Now
new discoveries in the laboratory can benefit the diagnosis, treatment and prevention of
disease. This has been made possible by new technology that allows scientists to identify
genetic and molecular defects resulting in disease and provide significant insights into the
biological underpinnings of disease. The suboptimal pace at which discoveries are
translating into changes in clinical practice is precisely the target of the NIH Roadmap
and CER initiatives. The trainees in the MS-BATS program will be working at this
interface between science and medicine where they will thereby be able to contribute
most directly to rapid and lasting improvements in the health and healthcare of society.
The MS-BATS program will train physician-investigators to bridge the gap between
basic science and clinical practice, and the translation of clinical research into guidelines
for improving clinical practice. Such individuals are in great demand given the rapidly
changing landscape in the biomedical and health care fields.
3.4 Ways in which the program will meet the needs of society.
There is a widely perceived need for the MS-BATS program at UC Irvine to serve the
Orange County area. The 2nd largest populated county in California, Orange County is
the 5th largest county by population in the nation and ranks 8th nationally in numeric
population growth. The bulk of that growth has resulted from an influx of ethnic
minorities, particularly Vietnamese and Mexican-Americans, such that Orange County is
now a ‘minority majority’, where no single racial or ethnic group comprises more that
50% of the total population. This diversity is reflected in the UC Irvine graduate and
medical student populations. Many of these students are interested in graduate training in
biomedical and translational sciences, but must now seek programs at other universities.
We anticipate that 20-30 students per year will matriculate into the MS-BATS program in
the first few years of the program, growing to approximately 60 students/year within 5
years. UC Irvine is the only regional academic medical center in a demographically,
culturally, and socioeconomically diverse area in the center of Southern California, and is
among the best public universities in the country with thriving programs in many relevant
areas including biomedical engineering, neurobiology, social sciences, and chemistry. As
one of the campuses of the University of California, we have an unambiguous
commitment to meaningful service to our community.
MS-BATS trained physician-investigators would meet the rapidly changing needs of the
biomedical enterprise. Orange County has an unusually large number of medical and
emerging medical technology companies. This program will help make Orange County a
unique location for integrated healthcare research by offering public lectures and courses
that describe multidisciplinary approaches towards dealing with different diseases; these
talks will be geared towards professionals, scientists, entrepreneurs, patients and patient
advocates in the county. The program will also actively engage the community including
patient advocate groups (e.g. JDRF, MS society etc), OCTANE, science teachers in local
29
high schools, local biopharmaceutical and medical device companies, investment firms,
entrepreneurs.
3.5 Relationship of the program to research and/or professional interests of the faculty.
The University of California, Irvine is a two-campus institution, consisting of the Medical
Center in Orange, CA and the Main Campus in Irvine, CA. Consequently, research
interaction between the faculty of the School of Medicine in basic science departments
(on the Irvine campus) and clinical departments (on the Orange campus) has been poor.
Furthermore, several faculty in the clinical departments of the UC Irvine School of
Medicine are unable to participate in graduate education unless they are joint appointees
in basic science departments of the school.
As the elements of MS-BATS program began to grow from an idea into a program,
School of Medicine faculty were surveyed in 2008, and many meetings were held to
determine the viability and then the shape of what became the MS-BATS program. The
programmatic research interests of many of the faculty of the School of Medicine are
consistent with the training foci of the MS-BATS program. Further faculty have
expressed considerable interest and enthusiasm in participating in the inception of a
program with the potential for having such a profound and transformational impact on the
conduct of research and training of physician-investigators at UC Irvine. The opportunity
to participate at this critical developmental point in the program and to have an integral
voice in shaping the MS-BATS program was in and of itself an attraction.
By bringing together faculty in the different departments in the School of Medicine to
participate in teaching the MS-BATS program, we anticipate the emergence of new
collaborative research interactions leading to new program projects and new training
grants. It is anticipated that a closer interaction between the different disciplines within
and beyond the School of Medicine will expedite the conversion of basic science findings
to novel medical applications and improved delivery and assessment of health care to UC
Irvine and the community it serves.
3.6 Program Differentiation.
Differences in target population: There is currently no graduate degree-granting training
program at UC Irvine for post-MD physicians. The MD/PhD program (MSTP) at UC
Irvine is restricted to 6 students per year. The program is not available for qualified
physicians who are residents, fellows, junior faculty, foreign medical graduates or
physicians in the community. The MS-BATS program provides a mechanism for these
physicians to train in biomedical and translational science so as to be able to pursue
careers working at the divide between clinical and basic research. The training the
physicians receive through this program will inform their medical practice in years to
come. It is hoped that a proportion of the trainees will pursue careers in academia.
MS-BATS also provides a mechanism for medical students after completion of the third
year of medical school to train in biomedical and translational science. Differences
between the MS-BATS and MSTP programs with respect to medical student trainees are
highlighted in section 1.4.
30
Differences in curricular focus: MS-BATS will initially offer three new foci, not offered
elsewhere on the UC Irvine campus: molecular medicine; evidence-based
medicine/clinical research; and population health sciences. Several new medically
oriented disease-focused elective concentrations not available in any graduate training
program at UC Irvine will be added within the first two years of the program: Anesthesia
and Pain, Disaster Medical Science, Evidence Based Medicine, Gynecologic Oncology,
Nephrology and Hypertension, Neonatology, Ophthalmology, Orthopedics, Pediatrics,
Pulmonary medicine, Stroke and Cerebrovascular disease, Surgery and Vascular surgery.
These elective concentrations harness the expertise available in the School of Medicine in
both the basic and clinical medical sciences.
Although the oncology and radiation oncology elective concentration of MS-BATS
overlaps the cancer biology track of CMB, the focus is very different. The courses in the
MS-BATS elective concentration are focused on applied translational and clinical
research in cancer, while the courses in the CMB elective track are focused on the basic
science aspects of cancer.
Although MS-BATS and the Masters in Biomedical Engineering (BME) share
“biomedical” in their respective names, they target different trainee groups and have
different foci. The MS-BME program targets engineers while MS-BATS targets MDs
and medical students. A few of the elective concentrations in MS-BATS recommend
BME courses, and faculty members in BME with joint appointments in departments in
the School of Medicine will be encouraged to participate in MS-BATS. We therefore see
significant synergy between the two programs. There is no curricular overlap between
MS-BATS and the Mathematical, Computational and Systems Biology program.
Medical students and MDs who complete the MS-BATS elective concentration in
Population Health Sciences would be able to transition into the new PhD program in
Epidemiology. MS-BATS would serve as a feeder for the PhD Epidemiology program.
Section 4. Faculty
Any UCI faculty member in the School of Medicine, or a faculty member from another
academic unit at UCI with a joint appointment in a department in the School of Medicine,
who is a member of the academic senate, and who fulfills all other campus requirements
for serving as the primary mentor for a Masters in Science student, can participate in the
MS-BATS program. Any department in the School of Medicine can participate in the
program.
The faculty members who have agreed to and will be participating in this program
include members of both the basic science and clinical departments in the School of
Medicine, both of whom have significant training experience. The faculty members in the
basic science departments have extensive experience mentoring graduate students as part
of the three graduate programs (Cellular & Molecular Biosciences, formerly Molecular
Biology Genetics & Biochemistry, Interdepartmental Neuroscience Program, and
Pharmacology). Many of the faculty members in the clinical science departments have
also mentored graduate students through joint appointments in the basic science
31
departments. In addition, the faculty members in the clinical science departments have
extensive experience mentoring fellows and residents who pursue academic research.
Of the 27 departments in the School of Medicine, 23 have agreed to participate in the
program. Of the 292 academic senate faculty members in the School of Medicine, 123
faculty members have agreed to participate in the MS-BATS program. Faculty have been
identified to teach all core courses and courses in each of the three initial foci. They are
listed in the table below. These faculty are aware of the program’s need to make courses
available to students on evenings and weekends, and will also work with the Executive
Committee to develop online coursework.
Additional faculty members with primary or secondary appointments in the School of
Medicine will be invited to participate in the Program following confirmation by the
Executive Committee. Participating faculty are responsible for mentoring thesis research
by trainees, serving on Student thesis or advisory committees and ad hoc committees
when asked to do so by the Executive Committee. It is also expected that participating
faculty will contribute to the recruitment of trainees, the supervision of research projects
and the teaching courses in their clinical and research specialty areas. The Executive
Committee will review, on a periodic basis, the appropriateness of the participation of
faculty members in the program, and may decide to discontinue the participation of any
faculty member at the end of an academic year. It is expected that such discontinuations
will occur only rarely. In addition, all participating faculty will be asked annually to
indicate whether they wish to continue as participants in the program.
Number and Departmental Affiliation of Potential MS-BATS Faculty
Anatomy & Neurobiology 4 Orthopedics 4
Anesthesia and Perioperative care 4 Otolaryngology 2
Dermatology 5 Pathology and Laboratory Medicine 3
Emergency Medicine 3 Pediatrics 11
Epidemiology 4 Pharmacology 7
Family Medicine 1 Physical Medicine and Rehab 1
Medicine 25 Physiology and Biophysics 9
Microbiology and Molecular Genetics 10 Psychiatry 3
Neurology 9 Radiation Oncology 1
Neurosurgery 2 Surgery 6
Obstetrics and Gynecology 2 Urology 1
Ophthalmology 6
32
Faculty Agreeing to Participate in MS-BATS Research Training Program
Department Name, Degree(s) Research Area
Anatomy and Neurobiology Hans S. Keirstead, PhD derivation of high purity human
cell populations from human
embryonic stem cells, and their
application to the treatment of
spinal cord injury and spinal cord
disease. The team utilizes
research
staff, medical staff and a full time
regulatory quality assurance
department to conduct efficacy,
safety and manufacturing
strategies that are compliant with
FDA guidelines for clinical use.
Anatomy and Neurobiology Oswald Steward, PhD Nerve regeneration in the injured
spinal cord, with emphasis on the
regeneration of the pathway that
controls voluntarily movement
Anatomy and Neurobiology Ivan Soltesz, PhD Plasticity of neuronal
microcircuits after traumatic head
injury and febrile seizures studied
with electrophysiological,
imaging and computational
methods.
Anatomy and Neurobiology Fan-Gang Zeng, PhD Use systems and modeling
approach to understand how the
ear and the brain work together to
process sounds, including human
speech and music. Develop and
design innovative prosthetic
devices and training procedures
for people who have lost hearing
and balance functions.
Anesthesiology & Michael Alkire, MD Defining mechanisms of
Perioperative Care anesthetic action on memory,
consciousness and pain
33
processing using neuroimaging
technologies of positron emission
tomography (PET), functional
magnetic resonance imaging
(fMRI) and high-density
electroencephalography (EEG).
Anesthesiology & Peter Breen, MD, FRCPC Measuring Gas Kinetics and
Perioperative Care Metabolism During Non-Steady
State in Anesthesia and Critical
Care. Experiments included
bench simulations, computer
modeling, and clinical studies.
Pathophysiology and treatment of
combined carbon monoxide and
cyanide poisoning. Respiratory
mechanics.
Anesthesiology & Zeev Kain, MD, MBA Studies children’s pain and
Perioperative Care anxiety during the perioperative
period to develop interventions to
prevent emotional trauma and
poor outcomes.
Anesthesiology & Zhigand David Luo, MD, Define the molecular mechanisms
Perioperative Care PhD of chronic pain in peripheral
nerve injury, bone cancer and
spinal cord injury using gene-chip
analysis, cellular and molecular
techniques and
immunohistochemistry to develop
novel therapeutics.
Dermatology Christopher B. Zachary, Cosmetic and Laser surgery
MBBS FRCP
Dermatology Kristen M Kelly, MD Laser Surgery in dermatology
Dermatology Sergei Grando, MD, PhD Immunobullous disorders
Dermatology Jerry L. McCullough, PhD Psoriasis
Dermatology Anand Ganesan, MD, PhD Pigmentary diseases
Emergency Medicine Kristi L. Koenig, MD, Disaster Medicine, Public Health
FACEP Preparedness, Homeland
Security, Emergency
Management, Emergency
Medical Services
Emergency Medicine Carl Schultz, MD, FACEP Disaster Medicine, Terrorism
Preparedness and Response
34
Emergency Medicine Federico E. Vaca, MD, Traffic Safety, Injury
MPH Epidemiology, Injury Prevention
and Control, Public Health
Promotion and Education
Epidemiology Hoda Anton-Culver, PhD Cancer epidemiology, genetic
epidemiology, statistical genetics,
molecular genetics and medical
informatics
Epidemiology Ralph J. Delfino, MD, Environmental epidemiology; air
PhD pollution health effects; chronic
disease epidemiology; gene-
environment interactions
Epidemiology Chad Garner, PhD Statistical and Population
Genetics
Epidemiology Christine E. McLaren, Finite Mixture Distributions,
PhD Goodness-of-fit Testing,
Statistical Modeling of Biological
Processes,Iron Deficiency
Anemia, Iron Overload,
Hemochromatosis, Epidemiology
Family Medicine Laura Mosqueda, MD examining forensic markers of
abuse and how to distinguish
them from normal and common
age-related changes, the ability
for people with dementia to
reliably report abuse, and
theoretical models that explain
the phenomenon of elder
mistreatment.
Medicine (cardiology) Jagat Narula M.D., Ph.D., Imaging of apoptosis and
FACC, FAHA, FRCP identifying atherosclerotic
plaques
Medicine (cardiology) John Longhurst, MD, PhD neurophysiologic basis of
acupuncture
Medicine (General) Sherri Kaplan, MPH, PhD Evaluating quality of care for
chronic disease in both adults and
children, evaluating physician
performance, disparities in health
and healthcare, increasing patient
participation in treatment
decisions, measurement of health
35
status and quality of life,
changing physician and patient
behavior and doctor-patient
communication
Medicine (General) Sheldon Greenfield, MD Evidence-based medicine,
guideline development and
quality standard setting, outcomes
research, heterogeneity of
treatment effects, clinical
manpower, disparities in health
and healthcare and diabetes care
Medicine (General) Dana B. Mukamel, PhD Quality of care; Long-term care;
Risk-adjusted outcomes; Racial
disparities; Health economics;
Quality report cards
Medicine(nephrology) Nosratola D. Vaziri, MD, Molecular mechainisms of lipid
MACP disorders in renal disease and II-
Role of oxidative stress,
inflammation and dysregulation
of nitric oxide metabolism in the
pathogenesis of hypertension,
progression of renal disease.
Medicine(nephrology) Hamid Said, PhD molecular mechanisms of water-
soluble vitamin transport in renal
tubular and intestinal epithelial
cells.
Medicine (Pulmonary Mathew Brenner, MD Translational optical imaging for
medicine) pulmonary critical care
diagnostics.
Specific projects include: 1) high
and ultrahigh resolution
endoscopic optical
coherence tomography for
diagnosis of airway injury,
inhalation exposures, and lung
cancer, 2) diffuse optical
spectroscopy Near-infrared
diagnostic monitoring
(including hemoglobin
component monitoring for injury,
hemorrhage, or organ
perfusion in shock states, and
36
cyanide toxicity and novel
treatment approaches).
Medicine (Pulmonary Steve George MD, PhD understanding the biology and
Medicine) physiology of the human lung as
an integrated, whole organ.
Within this context, he is
pursuing two overarching areas of
research, both of which combine
cellular and whole organ studies,
and experimental as well as
theoretical techniques: 1) nitric
oxide metabolism and 2) wound
healing and tissue remodeling.
Medicine(Pulmonary Henri Colt, MD bronchoscopy, interventional
Medicine) pulmonology, lung cancer,
tracheal stenosis, mesothelioma,
computer simulation
Medicine-(Endocrinology), Ping Wang, MD basic mechanisms of hormone
actions in
cardiac muscle and is developing
new methods to diagnose and
manage diabetes and its
complications.
Medicine(Hematology- Frank. L. Meyskens, MD Chemoprevention of cancer
Oncology)
Medicine(Hematology/Oncol Michael Lilly, MD Prostate carcinogenesis, role of
ogy) Pim kinases in cancer
development and progression
clinical trials with novel kinase
inhibitors,
Medicine (Hematology / Randall Holcombe, MD Cancer Immunology, Wnt
oncology) Signaling in Cancer, Integrative
Oncology, clinical translational
science
Medicine (Hematology / Homayoon Sanati, MD Clinical trials with novel agents
oncology) for breast cancer
and gastrointestinal cancers,
outcome studies involving
geriatric cancer patients,
quality of life for older cancer
patients.
37
Medicine (Hematology / Edward L. Nelson, MD Tumor immunotherapy
oncology)
Medicine (Hematology / Sai-Hong Ignatius Ou, Nasopharyngeal Carcinoma,
oncology) M.D., Ph.D. Head and Neck Cancer, Thoracic
malignancies, Esophageal
carcinoma
Medicine (Hematology / Rita S. Mehta, M.D. Cancer Angiogenesis,
oncology) Targeted/Individualized
Therapeutic Options, Clinical
Translational Research
Medicine (Hematology / John P. Fruehauf, M.D., glutathione and redox
oncology) PhD mechanisms in drug action, the
regulation and targeting of
vascular endothelial cells, and
differential gene expression
related to drug resistance
Medicine Steve Lipkin, MD, PhD DNA mismatch repair, Molecular
(Hematology/Oncology) epidemiology of colorectal cancer
Medicine (Infectious Disease) Donald N. Forthal, MD Viral Immunology; HIV,
Antibody, Fc receptors,
Antibody-Dependent Cellular
Cytotoxicity
Medicine (Infectious Disease) Alan G. Barbour, MD vaccines, bacteria, infectious
diseases, Lyme disease,
spirochetes, ticks, emerging
diseases, vector-borne diseases,
relapsing fever, Borrelia,
antigenic variation
Medicine (Infectious Disease) Philip L. Felgner, PhD Protein microarrays, Vaccines,
Gene Therapy, Drug Delivery,
Liposomes, Biophysics
Medicine Sudhir Gupta, MD, PhD Immunology of aging, cellular
(Allergy/Immunology) immune mechanisms,
immunodeficiencies
Medicine (Occupational and Dean Baker, MD Environmental epidemiology;
Environmental Medicine) occupational epidemiology;
occupational medicine;
toxicology; children's health;
developmental toxicity; study
design; occupational stress;
asthma; pesticides; hazardous
waste; biological markers
38
Medical Education Felicia Cohn, PhD Medical Ethics
Microbiology and Molecular Rozanne M. Sandri- Regulation of viral and cellular
Genetics Goldin, PhD gene expression by a
multifunctional viral protein
during infection with Herpes
simplex virus
Microbiology and Molecular Ruslan D. Aphasizhev, Molecular biology of
Genetics PhD trypanosomes; mitochondrial
RNA editing; mechanisms of
template-independent nucleotide
recognition and transfer
Microbiology and Molecular Alan L. Goldin, MD, PhD Epilepsy and other neuronal
Genetics diseases caused by Ion Channel
defects
Microbiology and Molecular Sidney H. Golub, PhD Science policy
Genetics
Microbiology and Molecular Klemens J. Hertel, PhD Mechanisms of pre-mRNA
Genetics splicing. Regulation of pre-
mRNA splicing and human
genetic diseases, The coupling of
transcription and pre-mRNA
splicing
Microbiology and Molecular Anthony A. James, PhD Control transmission of vector-
Genetics borne diseases, specifically
malaria and dengue fever;
development of vaccines and
drug targets for human malaria
Microbiology and Molecular Bert L. Semler, PhD RNA virus gene expression;
Genetics RNA-protein and protein-protein
interactions; mechanisms of
replication of picornavirus
genomic RNAs
Microbiology and Molecular Eric J. Stanbridge, PhD Molecular genetics of human
Genetics cancer, tumor suppressor genes
Microbiology and Molecular Ming Tan, MD Gene expression, pathogenesis
Genetics and treatment of the human
pathogen, Chlamydia
Microbiology and Molecular Marian L. Waterman, PhD Regulation of gene expression by
Genetics LEF/TCF•b-catenin complexes.
The role of the Wnt signaling
pathway in breast and colon
39
cancer development.
Neurology Michael Demetriou, MD, Glycobiology and neurological
PhD disease
Neurology Elizabeth Head, PhD Alzheimers disease
Neurology Steven Schreiber, MD Neurodegenerative diseases and
p53
Neurology Steve Cramer, MD, M. Stroke, Recovery from injury to
MSc central nervous system,
Human brain mapping
Neurology Mark Fisher, MD define the mechansims
underlying the brain's capacity to
regulate blood clotting, a process
fundamental to pathogenesis of
ischemic stroke
Neurology Carl Cotman, PhD Aging and Dementia
Neurology Claudia Kawas, MD epidemiological studies of aging
and dementia; clinical trials in
Alzheimer disease (treatment and
prevention).
Neurology John Weiss, MD, PhD Neurodegenerative disorders
Neurology Daniela Bota, MD, PhD Neuro-oncology
Neurosurgery Kim Anderson, PhD Identify disparities in the basic
science and clinical spinal cord
injury research
fields, then targeting research
development in the areas of high
priority to the population living
with spinal cord injury. Clinical
research in chronic health
problems associated with spinal
cord injury, specifically
metabolic dysfunction.
Neurosurgery Devin Binder, MD, PhD role of glial cells in CNS
pathology. In
particular we are studying the role
of astrocytes and astrocyte water
channels in epilepsy, and also in
spinal cord injury. Another part
of the laboratory is
40
working on developing
innovative optical techniques for
early detection of seizures
and brain edema.
Obstetrics and Gynecology Philip J. DiSaia, MD ovarian epithelial cancer
(Gyn/Onc)
Obstetrics and Gynecology Bradley J. Monk, MD ovarian and cervical cancer,
(Gyn/Onc) etiology, clinical significance,
and prevention of pelvic
adhesions post radical pelvic
surgery; treatment of invasive
cervical cancer; biomarkers in
gynecologic cancers; human
papillomavirus; quality-of-life
(QOL) in cancer care
Ophthalmology Henry Klassen, MD, PhD isolation and characterization of
progenitor cells from the neural
retina. These cells are then
transplanted to the diseased retina
in animal models with the goal of
rescuing or replacing lost host
neurons.
Ophthalmology Don Minckler, MD pathophysiology of optic nerve
injury in glaucoma and aqueous
shunts
Ophthalmology Lbachir BenMohamed, ocular and genital herpes
PhD. infection and immunity, vaccine
development and immuno-
evasion mechanisms.
Ophthalmology James Jester, PhD ocular cell and molecular biology,
Biomechanics and tissue
engineering of the eye
Ophthalmology Donald J. Brown, PhD Understand the relationship
between optic nerve head
structure, biomechanical
properties, intraocular pressure
and glaucoma.
Ophthalmology Jeremiah Tao, MD histologic features of
mesotherapy to determine if
inflammation is a possible
41
consequence of mesotherapy,
nylon foil 'wraparound' in late
repair of orbital fractures, orbital
decompression treatment of
juvenile-onset thyroid associated
orbitopathy, and evaluation of a
Sprague Dawley rat model of
orbital compartment syndrome
Orthopedics Vince Caiozzo, PhD the mechanistic role of contractile
and regulatory proteins in muscle
mechanics; the mechanistic basis
of muscle plasticity; and the
application of the first two
pursuits to clinically relevant
pathologies.
Orthopedics Ranjan Gupta, MD nerve regeneration and Schwann
cell control of neural injury,
animal models of rotator cuff
injury
Orthopedics Thay Q. Lee, PhD biomechanics of the shoulder and
the knee; Shoulder injury and
surgical reconstruction; Rotator
cuff tear and repair
Orthopedics Joyce Keyak, PhD Patient-specific strength
assessment of the proximal
femur, osteoporosis, hip fracture,
effect of metastatic bone disease
on bone strength, brachytherapy
for treatment of bone metastases
Otolaryngology Brian J. Wong, MD thermoviscoelasticity and shape
change in cartilage tissue, wound
healing, and applications of
optical coherence tomography in
surgery, rhinoplasty, and revision
rhinoplasty, laser surgery
Otolaryngology Sharon Fujikawa, Ph.D. Cohlear implants
Pathology Daniel Mercola, MD, PhD Prostate cancer biology
Pathology Andre Ouellette, PhD Cryptdins, defensins, mucosal
biology
Pathology Fritz Lin, MD Cancer pathology
Pediatrics Moyra Smith, MD, PhD Genetics of inherited disorders
42
Pediatrics Taosheng Huang, MD, molecular basis of genetic
PhD syndromes,
Pediatrics Doug Wallace, PhD Mitochondrial genetics
Pediatrics Feizal Waffarn, MD neonatal adaptations to perinatal
stress; Exercise and post natal
growth
Pediatrics Dan Cooper, MD Pulmonary medicine and exercise
physiology
Pediatrics James Swanson, PhD Child development studies
Pediatrics Pietro Galassetti, M.D., Type 1 and type 1 diabetes
Ph.D
Pediatrics Virginia Kimonis, MD genetic causes of muscle disease;
in particular inherited muscle
disorders that occur in
combination with diseases of
bone. Families with a
combination of muscle disease,
Paget disease of bone, and
dementia (also known as
IBMPFD) have been studied in
the laboratory, and the gene for
the disorder has been localized to
chromosome 9. By identifying the
causal gene (VCP, CDC48 or
p97) for this disorder, the
researchers are now identifying
the key pathways and functions
that are disrupted by the
mutations they have found in the
affected families.
Pediatrics Michael Zaragoza, MD, genetic causes of cardiomyopathy
PhD and congenital heart disease
(CHD; mitochondrial dysfunction
as the etiology in animal models;
molecular approaches to
understand the clinical variation
in disease progression and
outcome for patients and families.
Pediatrics Kimberley Lakes, PhD early child neurodevelopment,
national children's study, and
pediatric health disparities.
Pediatric Neurology Ira Lott, MD development and aging in Down
43
syndrome
Pharmacology Frances Leslie, PhD Addiction, drugs of abuse, brain
development
Pharmacology Daniele Piomelli, PharmD, cellular pharmacology,
PhD neuropharmacology
Pharmacology Zhou, Qun-Yong, PhD prokineticins, G protein-coupled
receptor, neuropharmacology,
neuropeptides, neurogenesis,
circadian rhythm, mouse, genetics
Pharmacology Olivier Civelli, PhD Molecular neurobiology, G
protein-coupled receptors,
Neuropeptides, Orphan receptors,
Novel neurotransmitters,
Dopamine receptors, Orphanin
FQ/nociceptin, MCH, Urotensin
II, Novel transmitters
Pharmacology Sue Piper Duckles, PhD Gonadal steroids, vascular
smooth muscle, cerebral
circulation, estrogen,
endothelium, nitric oxide,
mitochondria, reactive oxygen
species, androgen, testosterone
Pharmacology Fred Ehlert, PhD muscarinic receptors, drug
receptor interactions, antagonists,
receptor subtypes, signaling
pathways
Pharmacology Paola Sassone-Corsi, PhD signal transduction, gene
expression, oncogenesis,
circadian clock
Physical Medicine and Aileen J. Anderson, PhD Role of inflammatory
Rehabilitation mechanisms in degeneration and
regeneration in the injured central
nervous system, and potential of
human neural stem cells to
ameliorate the functional deficits
associated with spinal cord
injuries
Physiology and Biophysics Kenneth M. Baldwin, PhD Cellular and molecular regulation
of striated muscle: exercise and
hormonal alterations
Physiology and Biophysics Michael D. Cahalan, PhD Ion channels, calcium signaling,
and cell interaction dynamics in
44
the immune system
Physiology and Biophysics K. George Chandy, Potassium channels; design of
MBBS, PhD channel-modifying therapeutic
agents
Physiology and Biophysics J. Jay Gargus, MD, PhD functional genomics; molecular
pathophysiology of ion pumps,
channels, and signaling
Physiology and Biophysics Harry T. Haigler, PhD Annexin calcium-binding
proteins; interaction with
phospholipid membranes
Physiology and Biophysics James E. Hall, PhD Aquaporins in the lens; amyloid
oligomers in Alzheimer's disease
Physiology and Biophysics Todd C. Holmes, PhD ion channels, cellular physiology,
neural circuits and behavior;
circadian and visual circuits
Physiology and Biophysics Janos K. Lanyi, PhD Biophysics and structure of six
transmembrane proteins including
rhodopsin and bacteriorhodopsin
Physiology and Biophysics Ian Parker, PhD Calcium signaling and 2-photon
imaging
Psychiatry Jogeshwar Mukherjee, Design, development and use of
PhD novel imaging
radiopharmaceuticals, areas of
application include receptor
occupancy by therapeutic drugs,
imaging effects of substance
abuse drugs and role of dopamine
receptors in humans.
Psychiatry Pathik Wadhwa, MBBS, Behavioral perinatology;
PhD biobehavioral processes; stress;
pregnancy; fetal development;
prematurity; fetal programming
of health and disease;
psychoneuroendocrinology;
psychoneuroimmunology
Psychiatry Joseph Wu, MD neuropsychiatry involving FDG
and receptor imaging such as
dopamine (fallypride) with
illnesses such as depression or
cocaine addiction.
Radiation Oncology Charles Limoli, PhD radiation-induced oxidative stress
45
in both normal (neural and
muscle) and cancer (glioma) stem
cells.
Surgery (aesthetic and plastic Gregory Evans, MD, peripheral nerve tissue
surgery) FACS engineering, adult stem cell
technology and flap perfusion
studies
Surgery (colorectal surgery) Michael Stamos, M.D Laprascopic surgery, colorectal
cancer
Surgery (transplant) David K. Imagawa, MD, Islet transplant
PhD
Surgery (trauma) David Hoyt, MD Trauma surgery
Surgery (vascular) Samuel E Wilson, MD Vascular surgery
Surgery (vascular) Ian Gordon, MD, PhD Vascular surgery,
immunopatthology
Urology Ralph Clayman, MD Robotic surgery, cancer therapy
Academic Senate faculty members from other schools and programs on the UC Irvine
campus with joint appointments in any department in the School of Medicine can also
serve as thesis advisors and committee members.
Membership Qualifications:
Full-time faculty member in the School of Medicine with an Academic Senate
appointment engaged broadly in any aspect of the biomedical and translational science
arena (see definition of what constitutes BATS research under section 1.2). To ensure a
consistent and high quality training experience for the student, admission to the program
will require approval by the Executive Committee and depend on ability to demonstrate
availability of appropriate resources including a record of adequate funding, suitable
space to do biomedical and/or translational research, as well as willingness to participate
in the curriculum and other program activities.
Membership Responsibilities:
Primary advisor for thesis research
□ Guide thesis research
□ Serve as Chair of thesis advisory committee
□ Select advisory committee: one faculty member from host department, and two
faculty members from other departments, preferably one from clinical and another from
basic science
□ Guide dissertation writing and publication of data in peer-reviewed journals
46
□ Evaluate written dissertation and oral presentation, or Chair the committee that
administers the comprehensive examination for Plan II.
□ Provide career guidance
Secondary advisor for thesis research
□ Meet six-monthly with trainee and primary advisor to discuss research progress
□ Evaluate written dissertation and oral presentation for Plan I, or conduct the
comprehensive examination for Plan II.
□ Provide career guidance
Other responsibilities
Attend MS-BATS seminars – RIPs and faculty seminars
Serve on MS-BATS ad hoc action committees locally
Serve of MS-BATS admissions committees
Section 5. Courses
Core courses and elective courses for one of the three initial foci of the program
(Evidence-Based Medicine/Clinical Research) were approved by Graduate Council under
the addition of an area of focus in clinical research in the Master of Science program in
the recently disestablished Department of Community and Environmental Medicine. We
have included the course outline and approval forms in Appendix A. The core
coursework encompasses the core competencies in clinical and translational research
recently drafted (July 14, 2009) by the Clinical Translational Science National Council.
To facilitate completion of coursework by busy residents, fellows and junior faculty, and
to provide maximum flexibility in degree completion, we will develop online versions of
courses where appropriate.
Core courses in the proposed MS-BATS program:
CS 209A Introduction to Medical Statistics (4 units) [formerly Tox 209A]
CS210A Introduction to Clinical Epidemiology (4 units) [formerly Tox 210]
CS 232 Design and analysis of Clinical trials (4 units) [formerly Tox 232]
CS-296 Ethics in Clinical Research (4 units) [formerly Tox 296]
The following courses can be substituted for one of the core courses depending on
student-specific research interests.
TBD Research techniques and approaches in molecular medicine (4 units)
CB-1 Foundations of Clinical Translational Science (4 units)
CS 201A Introduction to Medical statistics
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Course goals: This course along with Medical Statistics 201B, is designed to provide
sufficient understanding of the statistics commonly used in medicine to enable clinicians
and those interested in clinical research to read and interpret the medical literature
critically, to identify appropriate statistics for basic research designs used in medicine,
and to discriminate between appropriate and inappropriate statistical applications for
common research designs.
CS210A Introduction to clinical epidemiology and medical decision making
Course goals: This course will introduce the principles and practice of clinical
epidemiology, and the epidemiologic or population-based approach to health and disease.
The course will examine the role of clinical epidemiology in clinical practice and clinical
and public policy, the changing patterns of community health problems, including the
changing nature of and risk factors for infectious diseases and chronic diseases.
CS 232 Design and analysis of clinical trials
Course goals: This course will present the history, organization and planning, rationale
for, methods (design, sampling, analysis, bias and error), limits, ethics and practical
issues involved in the conduct of clinical trials. The course will draw on examples from
the clinical literature to illustrate each topic. The impact of clinical trials on the practice
of medicine, national policy and public opinion will be discussed.
CS 296 Ethics in Clinical Research
Course goals: Students will develop knowledge of major frameworks of ethics and the
basic ethical concepts operative in public health research; familiarity with School of
Medicine of the most ethical issues facing those engaged in public health research (health
promotion, disease prevention, and epidemiological and biostatistical research); the
ability to identify, articulate and analyze ethical issues arising from public health, and to
formulate critical and well-reasoned ethical arguments; competence to participate in
ethical decision making as issues arise in public health research, practice and policy. This
course will also provide students with the historical background, current regulations.
TBD Research techniques and approaches in molecular medicine (4 units)
Course goals: This course provides hands on laboratory training in critical techniques
for basic biomedical research including: Southern/ Northern/ Western blotting,
immunofluorescence/ confocal microscopy/ immunohistochemistry, PCR, mutagenesis,
DNA cloning, siRNA, anti-sense technology, TUNEL staining, apoptosis assays,
microarrays, including DNA, protein, and tissue, ELISA, radioimmunoassays, animal
models of disease, including transgenics, knockouts, drosophila, zebra fish, and rats,
using GenBank, protein and structural databases, introduction to NMR, crystallography,
mass spectrometry and its uses in medicine. Students also participate in journal article
reviews presented in a journal club format.
CB-1 Foundations of Clinical and Translational Science (X-400 series) (4 units)
Course goals: This course introduces the rationale and imperative for clinical and
translational science intended to speed-up discoveries into health care practices. The
course will compare and contrast current impediments to clinical research with the
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potential of translational science. This course will include presentations from ICTS unit
directors and guest speakers from other funded ICTS programs around the country who
will discuss gaps in the current health care system, and the emerging role of effective
translational research and training in bridging the gaps.
Additionally required:
MS-BATS seminars (required 2 units/quarter):
Research in Progress (RIP) Seminars: Starting from the second quarter of
each year (September), the RIP seminars will be held once/month. At each
session, 2 trainees in the program would present their current research or a
topic of interest. The objective of this cross-disciplinary seminar is to educate
broad-based physician scientists who can discover fundamental biological
mechanisms and, at the same time, apply these discoveries to the cure of
disease. Food and beverages would be provided and the venue alternate
between the main and hospital campuses.
Seminars by faculty: Starting from the second quarter of each year
(September), the seminars by faculty will be held once per month. The faculty
member will talk about a research study in the broad area of biomedical and
translational science. Food and beverages would be provided and the venue
alternate between the main and hospital campuses.
Annual symposium: The annual symposium at the end of each year will be
a forum for trainees to present their research work. The program committee
will select five research projects for oral presentation. Prizes will be given for
the top three poster and/or oral presentations. Alumni of the program will be
encouraged to participate by presenting posters. One alumnus will make an
oral presentation describing her/his experience since completion of the MS-
BATS program. To actively engage the community, the program committee
would invite the participation of patient advocate groups (e.g. JDRF, MS
society etc), OCTANE, science teachers in local high schools, local
biopharma and medical device companies, investment firms, entrepreneurs.
Exposure to such outreach programs would enable graduates to understand the
relevance of their efforts to the human community beyond the doctor’s office.
Clinical Grand Rounds (1 unit/quarter): Trainees are strongly encouraged
to participate in their home department’s clinical Grand Rounds and as well as
departmental seminars.
Electives for the Three Initial Foci (Plan 1: 8 units; Plan II: 16 units)
1) Molceular Medicine: Select 2 of these courses for Plan I or 4 courses for Plan II
CS242: Introduction to quality of care, outcomes research, provider-patient
communication [formerly Tox 242]
Pharm 252: Neurotransmitter and drug receptors
Pharm 210: Chemical neuroanatomy
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Pharm 252: Neurotransmitter and drug receptors
Pharm 255: Chemical transmissions
MMG 221: Immunopathic mechanisms of disease
MMG 225: Molecular mechanisms of human disease
PB 232: Physiology of ion channels
PB 271A/B: Molecular physiology and disease
Path 236B: Graduate neuropathy
2) Evidence-based Medicine: practice guidelines and quality of care concentration: Select
2 of these courses for Plan I or 4 courses for Plan II
CS242: Introduction to quality of care, outcomes research, provider-patient
communication [formerly Tox 242]
CS250A/B: Introduction to clinical policy, quality of care and health services research
methods [formerly Tox 250A/B]
CS243: Evidence-based medicine, practice guidelines and performance assessment
CS251: Quality, efficiency and cost-effectiveness analysis [formerly Tox 251]
CS253: Disparities in health and healthcare [formerly Tox 253]
CS254: Quality and patient safety improvement: Systems, strategies and evaluation
[formerly Tox 254]
CS252: Cross-disciplinary research methods
CS255: Healthcare policy and politics [formerly Tox 255]
CS299: Research project in quality of care assessment/improvement
3) Population Health Sciences focus: Select 2 of these courses for Plan I or 4 courses for
Plan II
EPIDEM 202: Genetic Epidemiology
EPIDEM 205: Environmental Epidemiology
EPIDEM 201: Cancer Epidemiology
EPIDEM 253: Introduction to Statistical Genetics
CS241: Advanced clinical epidemiology
CS244: Chronic Disease Epidemiology
Electives for future departmental/disease-specific foci:
To provide a sense of the MS-BATS eventual programmatic breadth and scope, we have
provided the following examples of potential departmental/disease-specific coursework:
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Anesthesia and Pain concentration: Select any two courses for Plan I and any two
courses for plan II.
TBD Fundamentals of Pain Management
TBD Biology of Pain
EECS X 445.26: Regulatory Requirements for Pharmaceuticals
CLRE-251/257: Epidemiology
CS252: Cross-disciplinary research methods
CS243: Comparative clinical translational science
CS209C: Advanced Medical Statistics
BME 295: Drug Delivery
TBD Technology assessment, cost effectiveness
TBD Career pathways practicum in clinical translational science
TBD Transdisciplinary Teams for Clinical and Translational Science
Clinical Translational Science Concentration: Select 2 of these courses for Plan I or 4
courses for Plan II
TBD: Methodological Approaches in Clinical and Translational Science (4 units).
TBD: Transdisciplinary Teamwork for Clinical and Translational Science (4 units).
TBD: Career Pathways Practicum in Clinical and Translational Science (8 units).
TBD: Responsible Conduct of "Translational Clinical" Research (2 units).
Diabetes and Metabolic Diseases concentration: Select 2 of these courses for Plan I or 4
courses for Plan II
PB 271A, B Molecular Physiology and Disease
Dev Bio 232 Stem Cell Biology (4 units)
Ethics of Stem Cell Research (will find the course code)
Pharm 255 Chemical Transmission (4)
STATS 201: Statistical Methods for Data Analysis
Methodological Approaches in Clinical and Translational Science (4 units).
Transdisciplinary Teamwork for Clinical and Translational Science (4units).
Responsible Conduct of "Translational Clinical" Research (2 units).
Endocrinology Grand Rounds (8 lectures per year) (1 unit)
Career Pathways Practicum in Clinical and Translational Science (8 units).
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Disaster Medicine Science concentration: Select any two courses for Plan I and take all
four courses for Plan II.
Methodological Approaches in Clinical and Translational Science (4 units)
CS241: Advanced clinical epidemiology
STATS 201: Statistical Methods for Data Analysis
CS250A/B: Introduction to clinical policy, quality of care and health services research
methods
Environmental Medicine and Occupational Health concentration: Select 2 of these
courses for Plan I or 4 courses for Plan II
EPIDEM 264/E224: Environmental Health Science I (introduction)
EPIDEM265/E225: Environmental Health Science II (Advanced)
EPIDEM270: Exposure to environmental contaminants
EPIDEM 244: Toxic Substances in the environment
E 206 Perceptions of Environmental and Health Risks
E 245 Health Impacts of Environmental Change
Gynecologic Oncology concentration: Select any two courses for Plan I and take all four
courses for Plan II.
Hematology/Oncology/Radiation Oncology/Gynecologic oncology concentration: Select
2 of these courses for Plan I or 4 courses for Plan II
Methodological Approaches in Clinical and Translational Science (4 units).
Transdisciplinary Teamwork for Clinical and Translational Science (4units).
Career Pathways Practicum in Clinical and Translational Science (8 units).
Responsible Conduct of "Translational Clinical" Research (2 units).
EPIDEM 201: Cancer Epidemiology
CS242: Introduction to quality of care, outcomes research, provider-patient
communication
CS250A/B: Introduction to clinical policy, quality of care and health services research
methods
CS209C: Advanced Medical Statistics
CS209D: Advanced Medical Statistics
STATS 201: Statistical Methods for Data Analysis
BIO SCI X450: Fundamentals of Clinical Trials
BME X403: Human Subjects Safety in Clinical Trials
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MED X413.4: Applications of Good Clinical Practices
EECS X 445.26: Regulatory Requirements for Pharmaceuticals
MED X413.42: Implementation of Statistics in Clinical Trials
MB217A/B: Cancer Biology
TBD Translational neuro-oncology: from molecule to bedside
Immune-mediated disorders: Select any two courses for Plan I
MMG215: Molecular Immunology
MBB 221: Advanced Immunology
MMG221: Immunopathogenic Mechanisms of Disease
Neonatology concentration: Select any two courses for Plan I
TBD National Children’s Study (Pathik Wadhwa, James Swanson, Dean Baker)
TBD Human Development, Health and Disease (Pathik Wadhwa)
TBD Maternal-child health: preconceptional and perinatal health and disease (Pathik
Wadhwa)
Nephrology, hypertension concentration: Select 2 of these courses for Plan I or 4 courses
for Plan II
MBB 221: Advanced Immunology
MMG225: Molecular Mechanisms of Human Disease
PB 232: Physiology of Ion Channels
PB (TBD): Microarrays: DNA, protein, tissue - for medical applications
Neurology concentration: Select 2 of these courses for Plan I or 4 courses for Plan II
DC231D Molecular, Cellular, and Developmental Neurobiology (4 units)
Neuro 201: Systems Neurobiology
N&B 257 Advanced Topics in Dementia
PATH 236B: Graduate Neuropathology
MMG221:Immunopathogenic Mechanisms of Disease
MMG225: Molecular Mechanisms of Human Disease
PB 271A, B Molecular Physiology and Disease
PB 232: Physiology of Ion Channels
Pharm 252: Neurotransmitter & Drug Receptors
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N&B 208A/B: Systems Neuroscience
Pharm 210: Chemical Neuroanatomy
NB245 Neurobiology of Brain Aging
CS242: Introduction to quality of care, outcomes research, provider-patient
communication
CS252: Cross-disciplinary research methods
Transdisciplinary Teamwork for Clinical and Translational Science (4 units).
TBD Data management and data mining as applied to clinical trials, Patient Data
management and outcomes research
TBD Community based participatory research
TBD Telemedicine
205 Electronics for Biologists
TBD: Basics of PET imaging and Psychiatric illness (Joseph Wu)
NB245 Neurobiology of Brain Aging
Neuro 201: Systems Neurobiology
TBD: Advanced topics in translational research for spinal cord injury (2 units) (required
for those planning to do spinal cord injury research).
Translational neuro-oncology: from molecule to bedside
Ophthalmology concentration: Select 2 of these courses for Plan I or 4 courses for Plan
II
TBD: Methods in ocular cell and molecular biology (Don Brown and James Jester).
TBD: Pathogenesis of ocular disease: new frontiers in ocular medicine (Roger Steinert,
Don Minckler, James Jester and selected Ophthalmology faculty).
TBD: Ocular viral disease and vaccine development (Anthony Nesburn, Lbachir
BenMohamed and Steve Wechsler).
Biomechanics and tissue engineering of the eye (Tibor Juhasz, Don Brown and James
Jester).
Translational experiences in vision research (Tibor Juhasz, Ron Kurtz and James Jester).
Orthopedics concentration: select any two courses for Plan I and 4 courses for Plan II
BIO SCI X450: Fundamentals of Clinical Trials
EECS X445.2: Regulatory Requirements for Medical Devises
CS252: Cross-disciplinary research methods
CS209C: Advanced Medical Statistics
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CS209D: Advanced Medical Statistics
STATS 201: Statistical Methods for Data Analysis
BME 220 Sensory/Motor Systems
BME 221: Quantitative Physiology: Organ Transport Systems
Pediatrics: Select any two courses for Plan I
BIO SCI X450: Fundamentals of Clinical Trials
BME X403: Human Subjects Safety in Clinical Trials
CS253: Disparities in health and healthcare.
TBD: Developmental Biology of the Fetal and Neonatal Lung
TBD: Selected Major Congenital Malformations: Embryology; Pathophysiology and the
Scientific Basis for Treatment Strategies
Pulmonary medicine concentration: Select 2 of these courses for Plan I or 4 courses for
Plan II
1) BME X-403: Human subjects safety in clinical trials
2) CLRE 255: data management and informatics
3) MED X413.42: implementation of statistics in clinical trials qualitative research
methods system biology and clinical and translational science
4) Stats 201: statistical methods for data analysis (or) CS209C: advanced medical
statistics (with a choice based on prior level of training in statistics).
5) BME 295: advanced digital image processing (mandatory)
6) BME 295: spectroscopy and imaging of biological systems
7) TBT: methodological approaches in clinical and translational science
Statistics concentration: Select any two courses for Plan I
CS209C: Advanced Medical Statistics
CS209D: Advanced Medical Statistics
STATS 201: Statistical Methods for Data Analysis
E229: Introduction to Biostatistics and Epidemiology for Medical Fellows
EPIDEM 217: Advanced Epidemiological Methods
Pharm 252: Neurotransmitter and Drug Receptors
Surgery concentration: Select 2 of these courses for Plan I or 4 courses for Plan II
55
CS242: Introduction to quality of care, outcomes research, provider-patient
communication
CS253: Disparities in health and healthcare
CS254: Quality and patient safety improvement: Systems, strategies and evaluation
CS252: Cross-disciplinary research methods
CS299: Research project in quality of care assessment/improvement
Vascular surgery concentration: Select 2 of these courses for Plan I or 4 courses for Plan
II
CS 242: Introduction to quality of care, outcomes research, provider-patient
communication
CS 255 Healthcare policy and politics
CS 299 Research project in quality of care assessment/improvement
CS 243: Evidence-based medicine, practice guidelines and performance assessment
Urology concentration: select 2 of these courses for Plan I or 4 courses for Plan II
Bio Sci X450Fundamentals of Clinical Trials
Med X 413.42: implementation of statistics in clinical trials qualitative research methods
system biology and clinical and translational science
MED X413.43: Applications of Good Clinical Practices
STATS: 201: Statistical Methods for Data Analysis
EPIDEM 253: Introduction to Statistical Genetics
BME 200: Introduction to Biomedical Engineering (3).
Course Descriptions:
Courses offered through the School of Medicine
Course title: CS 241 Advanced Clinical Epidemiology and medical decision making (4
units)
Course goals: This course will explicate methods and analytic techniques for
approaching complex clinical epidemiologic problems. Special topics such as chronic
disease, genetic, reproductive, nutritional and environmental epidemiology will be
discussed. Decision analysis, using epidemiology to evaluate health services, and ethical
and professional issues in epidemiology will also be reviewed.
Course title: CS 242 Quality of care, outcomes research, provider-patient
communication (4 units)
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Course goals: This course will introduce the principles and practice of quality of care
research, outcomes research and provider-patient communication (patient satisfaction)
research. Current methods for development of quality of care measures, uses of
mortality, morbidity and functional status/health-related quality of life to assess quality of
care, assessment of performance of various levels of the healthcare system (from regions
and systems of health care delivery to individual provider performance), case-mix
adjustment, patient satisfaction measures, applications and determinants; and costs vs.
quality of care will be discussed.
Course title: CS 243 Evidence-based medicine, practice guidelines and performance
assessment (4 units)
Course goals: This course will review the definitions, emergence and evolution of
evidence-based medicine (EBM), guidelines and performance measures, their use in
national policy initiatives to assess and improve the quality of healthcare, and the
relevance of EBM for clinical translational science. This course will examine the
methods used to evaluate and synthesize clinical research for inclusion as EBM, the use
of EBM and other methods for development and use of practice guidelines, and the
methodologic, conceptual and policy issues involved in performance assessment.
Course title: CS 250A Introduction to clinical policy, quality of care and health services
research methods (4 units)
Course goals: This course will present an overview of the array of methodologic,
research design, construct and measurement approaches to clinical policy, quality of care
and health services research. It will examine the pervasive role of interdisciplinary
research within and beyond medicine, in defining conceptual, methodologic and
dissemination approaches to the problems addressed by evidence-based medicine, clinical
policy, quality of care, and health services research. This course will enable students to
read and evaluate critically the research designs, methodologic approaches and
conclusions of empirical studies in quality of care, clinical policy and health services
research.
Course title: CS 250B Introduction to clinical policy, quality of care and health services
research methods (4 units)
This course will explore methodologic issues involved in evaluating clinical policy and
quality of care in greater depth, including: the merits and drawbacks of observational
studies, non-randomized designs; the impact of data sources on results of clinical policy,
quality of care and patient safety studies; impact of accountability vs. quality
improvement on choice of quality of care measures; unit of analysis, hierarchical designs
and the locus of variation in quality of care measures; measures, methods and impact of
case-mix adjustment on comparisons of quality of care; impact of public reporting quality
of care assessment on quality improvement; impact of clinical policy changes on quality
of care.
Course title: CS 251 Quality, efficiency, and cost-effectiveness (4 units)
Course goals: This course covers the basic concepts and tools of economic analysis,
applied to health care markets. The course emphasizes the basic principles of demand for
medical care and health insurance, supply of health care including behavior of for-profit
57
and not-for-profit providers, and the interaction of supply and demand on the market. It
examines the financing of healthcare and the impact on costs and quality of care and
national initiatives designed to assess and improve efficiency of healthcare delivery.
Course title: CS 252 Cross disciplinary research methods (4 units)
Course goals: This course is designed to familiarize students with the research methods
beyond clinical trials available from other disciplines, including quasi-experimental
designs, survey research designs, structured observation, field research, simulation and
gaming, evaluation research, and document study, that can be used to address a broad
array of clinical research applications. The impact of discipline, including design
assumptions, target patient populations, target clinical audiences, and analytic techniques
associated with each method will be discussed.
Course title: CS 253 Disparities in Health and Health Care (4 units)
Course goals: The objective of this course is to familiarize students with the aspects of
culture that influence health status, the development of public health policy, and the
management and practice of healthcare. The course will explore how race and ethnicity
affect health and health care, including health care services and policies governing these
services.
Course title: CS 254 Quality and patient safety improvement (4 units)
Course goals: This course will review the history of national quality and patient safety
improvement efforts at all levels of the healthcare system, from organizational through
individual provider performance, the rise of “systems re-engineering” for improving
quality and patient safety, the characteristics of successful programs, the impact of
federal, state and local policies on quality and patient safety, and the design and
implementation issues involved in changing healthcare organization, provider and payor
behaviors to support improvements in quality and patient safety.
Course title: CS 255 Health politics and policy (4 units)
Course goals: This course offers political and analytical insights into understanding the
United States health policymaking and into developing strategies that influence health
policy outcomes. This course will meet the following objectives: to analyze the politics
of major health policy developments in the United States; to improve student skills in
developing political strategies for influencing health policy; to understand the ways
political analysis can improve health policy research and its implementation; to develop
skills in political strategy and case analysis.
Course title: Methodological Approaches in Clinical and Translational Science (X-400
series) 4 units
Course goals: This course covers methodological approaches for interdisciplinary and
collaborative research in 5 modules: a. Quantitative Methods in clinical and translational
science; b. Qualitative Methods in clinical and translational science; c. Legal and Ethical
Issues in clinical and translational science; d. Regulatory Issues in clinical and
translational science; e. Community Engagement in clinical and translational science. Dr.
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Ellen Olshansky, director of Nursing Science Program, and developer of the Qualitative
Methods module, will coordinate this course. Dr. Olshansky is a member of the ETC
Executive Committee.
Course title: Transdisciplinary Teamwork for Clinical and Translational Science (X-400
series) 4 units.
Course goal: This course uses the Problem-Based Learning (PBL) approach to introduce
students working together in teams to solve clinical translational challenges. The first
two weeks will include presentations by community partners on specific problems in
health care. The students are then assigned to interdisciplinary teams under the
supervision of a faculty mentor to develop proposals for solving the outlined challenges.
Dr. Daniel Stokols, who is currently the Principal Investigator on an NIH Roadmap
award program entitled “Social Ecology of Health Promotion and Disease Prevention,” is
the instructor of record who coordinates this course. Dr. Stokols is a member of the ETC
Executive Committee.
Course title: Career Pathways Practicum in Clinical and Translational Science (X-400
series) 8 units.
Course goal: This is an externship course in which students are paired with host research
laboratory or clinical/research agencies in the community and implement a proposal that
incorporates a CTS concept. Students will be encouraged to work in teams to implement
proposals approved after review by ICTS faculty mentors and community partners.
Students will spend 24 hours per week for 10 weeks on the project under the supervision
of CTSA mentor. Dr. Oladele Ogunseitan, the ETC Unit Director, and MPH Degree
Program Director is the instructor of record who coordinates this course.
Course title: Responsible Conduct of “Translational Clinical” Research (X-400 series)
2 units.
Course goals: This course introduces trainees to the complex issues involving scientific
integrity and satisfies the requirements for training in bioethics for students engaged with
clinical and translational science.
Course title: Advanced Topics in Translational Research for Spinal Cord Injury (2
units)
Course goals: This course is designed to further the understanding of the complexities of
translational research in SCI. Students will learn about the challenges associated with
therapeutic interventions targeted toward the acutely injured spinal cord versus the
chronically injured spinal cord; the inherent difficulty in translating findings from
animals to humans; failed clinical trials in SCI; FDA mandates related to SCI; and poorly
designed and controlled human “trials” in various countries.
Course title: CS 209C Advanced Medical Statistics (4 units)
Course goals: This course is designed to further the understanding of the statistics
commonly used in medicine to enable clinicians and those interested in clinical research
to read and interpret the medical literature critically, to identify appropriate statistics for
more advanced research designs and applications in medicine, and to discriminate
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between appropriate and inappropriate statistical applications for these more
sophisticated research designs and applications.
Course title: CS 209D Advanced Medical Statistics (4 units)
Course goals: This course is designed to address the statistical issues involved in selected
topics in clinical medicine involving more sophisticated research designs and
applications.
Course title: CS 241 Advanced clinical epidemiology and medical decision making
Course goals: This course will explicate methods and analytic techniques for
approaching complex clinical epidemiologic problems. Special topics such as chronic
disease, genetic, reproductive, nutritional and environmental epidemiology will be
discussed. Decision analysis, using epidemiology to evaluate health services, and ethical
and professional issues in epidemiology will also be reviewed.
Course title: EPIDEM264 or E224: Environmental Health Sciences I: Introduction to
Environmental Health Science (4 units).
Course goals: Convergence of agents (chemical, physical, biological, or psychosocial) in
the environment can emerge as diseases influenced by social, political, and economic
factors, allowing them to become rooted in society. How these agents from various
spheres come together and impact human health.
Course title: EPIDEM 265 or E225 Environmental Health Sciences II: Advanced
Environmental Health Science (4 units).
Course goals: Explores the complex relationships among exposure processes and adverse
health effects of environmental toxins focusing on specific chemicals, sources, transport
media, exposure pathways, and human behaviors. Techniques of environmental sampling
for exposure assessment are discussed
Course title: EPIDEM-202 Genetic Epidemiology (4 units).
Course goals: Concentrates on the role of genetic factors in the etiology of disease in
human populations with an objective of disease control and prevention, and the role of
interactions of genetic factors and environmental exposures in the occurrence of disease.
Course title: EPIDEM-201: Cancer epidemiology (4 units)
Course goals: Concentrates on understanding how epidemiology plays a role in the
search for cancer etiology, prevention, control, and treatment; gives an overview of
cancer research with an appreciation of the multidisciplinary nature of the field.
Course title: EPIDEM-229: Introduction to Biostatistics and Epidemiology for Medical
Fellows (4 units).
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Course goals: Designed to prepare medical fellows and other physicians for rotations in
research programs. Understanding of basic biostatistics and study design, and
interdependencies between the two. Application of principles in evaluation of medical
literature for guidance on patient care and public health policy.
Course title: EPIDEM-270/ E248 Human Exposure to Environmental Contaminants (4
units).
Course goals: Introduces foundations of conceptual thought that environmental
contaminants can impact health. Theory and principles of exposure assessment, the
continuum from emissions of a contaminant into the environment to evidence of health
effects in a population.
Course title: PHARM 252: Neurotransmitter and Drug Receptors (6 units)
Course goals: Lecture, three hours; seminar, three hours. Ligand gated ion channels, G
protein linked receptors, receptor tyrosine kinases, ligand regulated transcription factors,
their signaling mechanisms, trafficking and physiological responses. Analysis of receptor
properties by pharmacological methods, radioligand binding, and molecular biology.
Course title: PHARM 210 Chemical Neuroanatomy (4 units).
Course goals. Organization of the nervous system, especially with respect to chemical
identity of elements, for students of pharmacology. Major cell types, methods of study,
ultrastructure, synaptic organization of functionally defined systems, localization of
chemically defined cells and receptors, and brain development.
Course title: PHARM 255 Chemical Transmissions (4 units)
Course goals: Mechanisms underlying chemical signaling processes in the brain and
periphery. Molecular biology, signal transduction, transmitter synthesis and inactivation,
pharmacology of integrative function and behavior.
Course title: PHARM 252 Neurotransmitter and Drug Receptors (6 units).
Course goals: Ligand gated ion channels, G protein linked receptors, receptor tyrosine
kinases, ligand regulated transcription factors, their signaling mechanisms, trafficking
and physiological responses. Analysis of receptor properties by pharmacological
methods, radioligand binding, and molecular biology.
Course title: MMG 221 Immunopathic Mechanisms of Disease (4 units)
Course goals: Examination of the mechanisms underlying disease states mediated by
immune dysregulation. Topics include innate and adaptive immunity, autoimmunity,
immunodeficiency, inflammatory disorders, and certain infectious diseases. Emphasis on
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biological basis of immunopathologies taught from reports in the original scientific
literature.
Course title: MMG 225: Molecular Mechanisms of Human Disease (4 units)
Course goals: Provides an overview of the molecular mechanisms of human diseases,
including neurologic, hematologic, neoplastic, and infectious diseases. Students gain an
understanding of these mechanisms, as well as models of human diseases.
Course title: PB 232 Physiology of Ion Channels (4 units)
Course goals: Lecture, one and half hours; discussion, three hours. Discusses how ion
channels work (molecular/structural biophysics level) and what ion channels do in
diverse cell types (cell physiology level). From generating electrical signals in the
nervous system to regulating immune system function, channels are everywhere in the
body doing important work. Prerequisite: consent of instructor.
Course title: PB 271A/B Molecular Physiology and Disease (4 units)
Course goals: Introduces students to concepts of molecular physiology and
pharmacology related directly to human diseases.
Course title: PATH 236B Graduate Neuropathy (4 units)
Course goals: Students receive training in physiology, anatomy, and pathologic processes
of the central and peripheral nervous system. Experimental approaches to study such
processes are emphasized.
Course title: The National Children’s Study (TBD, 4 units) (Pathik Wadhwa)
Course goals: The National Children’s Study (NCS) is one of the largest and most
comprehensive longitudinal, prospective investigations of the role of and interplay
between a broad array of genetic and environmental processes (physical, chemical, social,
biological) during human development on child and adult health and disease risk. The
NCS is a multi-site project that will recruit a community-based sample of approximately
1 million women of child-bearing age and follow 100,000 individuals from conception,
pregnancy, birth, infancy, childhood and adolescence till 21 years age. UC Irvine is one
of 7 Vanguard centers of the NCS. This course will explore the theoretical and
methodological underpinnings of the NCS, with an emphasis on translational research
opportunities for graduate and postgraduate students.
Course title: Development, Health and Disease TBD (4 units) (Pathik Wadhwa)
Course goals: For any given individual, health, or the likelihood of disease, is a joint
function of that individual’s cumulative exposure to disease risk factors and susceptibility
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to risk exposure. Susceptibility, in turn, is a product of the individual’s make-up – the
genes inherited from parents at conception and the nature of the environment during
critical phases of early development. Thus, early development has obvious and critical
implications for health and well-being over the life-span. Recent insights and findings
now strongly support the notion that development is not merely the unfolding of a series
of pre-programmed steps, but rather a process in which multiple, recursive feedback
loops exist between genes and environment, and in which each component of the
developing organism/ person is both a cause and a product of change over time. Thus,
developing organisms play an active role in their own construction by evolving various
systems during embryonic and fetal life to acquire information about the nature of the
environment and use this information to guide structural as well as functional aspects of
development. The objective of this inter-disciplinary course is to discuss, understand and
appreciate the relevance of this approach to development and health. The role of the
early environment in shaping developmental processes during fetal and infant life will be
understood primarily in the context of human and animal models of behavioral processes
such as stress and social affiliation. The course aims to provide a balanced and
integrative perspective by introducing relevant concepts and readings from several areas,
including health and developmental psychology, developmental neuroscience, behavioral
medicine, obstetrics, neonatology, genetics and molecular biology, endocrinology,
immunology, epidemiology and public health.
Course title: Maternal-Child Health: Preconceptional and Perinatal Processes (4 units)
(Pathik Wadhwa)
Course goals: The goal of this course is to introduce the role of preconceptional and
perinatal processes in the context of maternal-child health, with a focus on premature
birth and its sequella. Premature birth is the single most important problem in maternal-
child health because it accounts for the majority of infant mortality and morbidity, its
prevalence is higher in the US than in any other developed nation (with large
scioeconomic and racial/ethnic disparities), and it’s causes are poorly understood. The
course will integrate approaches from epidemiology and public health with obstetrics,
neonatology, endocrinology, immunology and genetics to provide an inter-disciplinary
framework for clinical translational science in this area.
Course title: Basics of PET imaging and Psychiatric illness TBD (Joseph Wu; 4 units)
Course goals: 1. Learn about PET imaging; 2. Learn about SPM statistical parametric
image analysis; 3. Learn about PET findings in depression and other illnesses. I would
teach about basics of PET scanning principles, basics of statistical paramateric imaging
analysis (SPM), basics of PET findings in depression and other illnesses.
Course Title: Developmental Biology of the Fetal and Neonatal Lung: Postnatal
Adaptation and Maladaptations (TBD: 4 units) (Feizal Waffarn)
Course goals: (1) Review the stages of fetal lung development; (2) Review the
epidemiology of surfactant deficiency disorders; (3) Discuss postnatal lung adaptations
63
in the – (a) Term newborn infant, (b) Premature infant; (4) Discuss recent therapeutic
strategies used in managing maladaptive neonatal respiratory diseases; (5) Discuss the
burden and long term follow up of chronic lung disease of prematurity.
Course Title: Selected Major Congenital Malformations: Embryology; Pathophysiology
and the Scientific Basis for Treatment Strategies (TBD, 4 units) (Feizal Waffarn)
Course goals: (1) Discuss gene /environment interactions in the pathogenesis of
congenital malformations; (2) Review the embryology of neural tube development and
mal-development; (3) Review the embryology of cardiovascular development and
congenital heart disease; (4) Review the pathology of abdominal wall defects and current
theories of pathogenesis; (5) Discuss recent therapeutic strategies in managing selected
congenital malformations; (6) Discuss the disease burden and long term outcomes of
Neural tube; Congenital heart and Abdominal wall defects.
Course title: Translational neuro-oncology: from molecule to bedside (2 units) (Daniela
Bota)
Course goals: Brain tumors are the second leading cancer death in young adults, and the
5th leading causes of cancer death in the general population. Though the outcome of the
protean group of brain tumors is highly variable, the most common is disability and
death. The need to develop more effective treatments remains a paramount in order to
improve our results. The modern research in the field of neuro-oncology focuses on the
development of targeted treatments to the specific molecular mechanisms involved in
abnormal signaling and resistance to apoptosis. This course will concentrate on
describing the relevant molecular mechanisms for malignant growth in neurologic
malignancies, and on the understanding of the current state of development for targeted
molecules intended to stop the neoplastic growth. The process of drug
testing from preclinical trials to the clinical trials needed for FDA approval will be also
studied using examples derived from current neuro-oncology research."
Courses offered by other academic units at UCI
Course title: BIO SCIX450 Fundamentals of Clinical Trials (3 units)
Course goals: Clinical trials are designed to answer questions concerning the safety and
effectiveness of medical products. Get an overview of clinical trials regulated by the
FDA. Learn about the planning process underlying the Strategic Clinical Plan and
regulatory submissions to the FDA. Explore topics including protocol development and
implementation, i.e. study site selection, financial controls, timelines, and management of
the site's operations; proper informed consent; Good Clinical Practices compliance;
HIPAA; FDA regulations and guidelines; and post-market support studies.
Course title: Psychobiology 257: Advanced Topics in Dementia (4 units).
64
Course goals: Seminar, three hours. Understanding of dementia becomes increasingly
important as individuals live longer and the elderly account for a larger percentage of the
population. Topics focus on Alzheimer's disease and related disorders to examine
pathology, diagnosis, treatment, and basic research. Lectures are presented by
investigators actively engaged in dementia research.
Course title: N&B208A: Systems Neuroscience
Course goals: Study of the mammalian nervous system at the systems level. Anatomy
and physiology of sensory, motor, and integrative functions.
Course title: Dev Bio 232 Stem Cell Biology (4 units)
Course goals: The basic characteristics and development roles of embryonic, adult, and
cancer stem cells in the human body and in model systems and the use of experimental
and genetic methods to analyze and manipulate their properties.
Course title: DC231D Molecular, Cellular, and Developmental Neurobiology (4 units)
Course goals: Lecture, three hours. Molecular aspects of the structure and function of
neurons and glia including neurotransmission, synaptic modulation, and channels. Neural
development at the cellular and molecular level including neurogenesis, pattern
formation, trophic factors, axonal growth, and synaptic rearrangement.
Course title: MB&B 221 Advanced Topics in Immunology (4 units)
Course goals: Lecture, three hours. Literature-based, interactive discussions focused on
review of seminal historic and recent immunology literature. Student responsibilities
include reading, critical evaluation, and discussion of manuscripts.
Course title: BME220 Quantitative Physiology: Sensory Motor Systems (4 units)
Course goals: A quantitative and systems approach to understanding physiological
systems. Systems covered include the nervous and musculoskeletal systems.
Course title: BME 221: Quantitative Physiology: Organ Transport Systems (4 units)
Course goals: A quantitative and systems approach to understanding physiological
systems. Systems covered include the cardiopulmonary, circulatory, and renal systems.
Course title: BME X403 Human Subject Safety in Clinical Trials (1.5 units)
Course goals: The use of human subjects in clinical trials for drug and device
development requires sound ethical practices. Explore topics that include FDA
65
regulations and guidance, informed consent process, the make-up and function of
Institutional Review Boards (IRB), the IRB review process, and basic biomedical ethics.
Course topics are enhanced by case studies, small group discussions, and research
document reviews.
Course title: BME220 Quantitative Physiology: Sensory Motor Systems (4 units)
Course goals: A quantitative and systems approach to understanding physiological
systems. Systems covered include the nervous and musculoskeletal systems.
Course title: BME 221: Quantitative Physiology: Organ Transport Systems (4 units)
Course goals: A quantitative and systems approach to understanding physiological
systems. Systems covered include the cardiopulmonary, circulatory, and renal systems.
Course title: DB 232 Systems Cell and Developmental Biology (4 units)
Course goals: Introduces concepts needed to understand cell and developmental biology
at the systems level, i.e., how the parts (molecules) work together to create a complex
output. Emphasis on using mathematical/computational modeling to expand/modify
insights provided by intuition.
Course title: DEV BIO 245 Stem Cell Biology
Course goals: The basic characteristics and development roles of embryonic, adult, and
cancer stem cells in the human body and in model systems and the use of experimental
and genetic methods to analyze and manipulate their properties.
Course title: EECS X445.2 Regulatory Requirements for Medical Devices
Course goals: Increase your understanding of the essential U.S. medical device
regulations, including device classification, organizing pre-market notification 510(k),
and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of
topics that include: global vigilance requirements and labeling requirements, European
Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting
E.U. essential requirements, and developing a technical file for the E.U. Get a review of
device registrations in Canada, Australia, Japan and Latin America.
Course title: EECS X445.26 Regulatory Requirements for Pharmaceutical Products (1
unit)
Course Goals: This course presents a detailed overview of the regulatory requirements
for the development and manufacture of pharmaceutical products. Individuals involved in
manufacturing, quality control, research and development, and clinical studies will learn
the latest information. Explore topics that include the product development process
66
through commercialization; product characterization and pre-clinical evaluation;
pharmaceutical industry requirements; clinical trial requirements, good manufacturing
practices (GMPs); good laboratory practices (GLPs); FDA inspections, labeling, and
advertising of medical products; and preparing Food and Drug Administration (FDA)
submissions.
Course title: STATS 201 Statistical Methods for Data Analysis I (4 units)
Course goals: Introduction to statistical methods for analyzing data from experiments
and surveys. Methods covered include two-sample procedures, analysis of variance,
simple and multiple linear regression. May not be taken for graduate credit by Statistics
graduate students.
Section 6. Resource Requirements
The program is intended to be self-supporting after the first year. During the initial
development of the program, support for the position of Director and a senior
administrative officer is being provided through the Office of the Dean of the School of
Medicine, in addition to resources for student recruitment, seminars and symposia,
supplies and equipment, totaling approximately $53,000. There will be no computing
costs, library acquisition, space or other capital costs in the first year of the program.
Space for the program is being provided through the Dean’s Office. Program income
will be used starting in year 2 to support a part- or full-time administrator (depending on
the size and needs of the program) and for the needed subsequent program resources. We
are collaborating with the UC Irvine Extension program’s Certificate Program in Clinical
Trials, in addition to a potential Certificate in Clinical Research, to insure cooperation
between the MS-BATS program and other graduate level programs available at UC
Irvine.
YEAR 2010 2011 2012 2013 2014
FTE Faculty NONE NONE NONE NONE NONE
Kaplan, S., Director $25,000 $25,000 $25,000 $25,000 $25,000
Library acquisition NONE NONE NONE NONE NONE
Student Recruitment $14,200 $14,200 $14,200 $14,200 $14,200
Seminars & Symposia $9,000 $9,000 $9,000 $9,000 $9,000
Office Supplies $4,800 $4,800 $4,800 $4,800 $4,800
Equipment NONE NONE NONE NONE NONE
Space and other capital facilities NONE NONE NONE NONE NONE
Total $53,000 $53,000 $53,000 $53,000 $53,000
67
Section 7. Graduate student support
Fellows in clinical specialties: Fellows in many clinical programs have a research
requirement for board certification in their specialties. The MS-BATS program would
allow these trainees to fulfill these requirements by offering a rigorous curriculum that
would complement the clinical training.
□ Stipends: from the clinical program or departments in which the fellow is training.
□ Fees: Self-funded by the trainee.
Residents in clinical specialties:
□ Stipend: from the clinical program or department in which the resident is training.
□ Fees: Self-funded by the trainee
PRIME-LC medical students. Prime-LC students are required to complete a year of
research towards a Master degree. The MS-BATS program would be one of their options
to fulfill this requirement.
□ Stipend: PRIME-LC will cover the stipend.
□ Fees: self-funded by the trainee.
Other medical students. A number of current and previous medical students have
taken a year off from medical school to complete a year of research without academic
credit. The MS-BATS program would provide an option for these students to obtain a
Masters Degree for that research.
□ Stipend: There is no institutional support available for stipends, but the student and
faculty mentor will be strongly encouraged to apply for fellowship support.
□ Fees: self-funded by the trainee.
Non PRIME-LC Medical Student:
□ Stipend: None.
□ Fees: self-funded by the trainee.
Junior Faculty. Trainees pursuing this option of MS-BATS will typically have
significant clinical commitments.
□ Salary: from department that the faculty member belongs to.
□ Fees: self-funded by the trainee.
□ Stipend: None.
□ Fees: self-funded by the trainee.
68
Training grants and program projects. Between 2009 when the MS-BATS proposal
is submitted and 2010 when the first MS-BATS trainees will begin their training, the
participating faculty mentors in the program will apply for training grants and program
projects in the elective focus areas of emphasis to offset the cost of fees and stipends for
the trainees. Grants will be applied for from the NIH, the HHMI and other agencies.
Funding relationship with existing programs.
Stipends for Fellows and Residents: from clinical programs and do not overlap with
funding for any current graduate program in the School of Medicine or elsewhere on
campus.
Stipends for PRIME-LC medical students: from the PRIME-LC program and does
not overlap with funding any current graduate program in the School of Medicine.
Section 8: Changes in Senate regulations
No changes are anticipated.
69
MEMORANDUM
October 2, 2009
From: Alan L. Goldin
Sherrie H. Kaplan
To: Greg Evans, Chair, COHS Executive Committee
John Krolewski, Vice-Chair, COHS Executive Committee
Re: MS-BATS proposal
Thank you for your comments on the proposal to establish the MS-BATS program in the
School of Medicine. We have revised the proposal to address the concerns, as noted
below.
1). A letter from Dean Clayman is now included with the proposal, specifying his
commitment to the program. That letter provides specific information concerning funding
support, and a detailed budget is now included in the proposal in section 6.
2). Section 6 of the proposal now specifies that this program is intended to be self-
supporting from student fees after the first year of the program. How departments elect to
cover those fees (e.g. through training grants, departmental funds, etc.) will be at the
discretion of the individual departments.
3). The program has been designed with flexibility to accommodate the needs of
residents, fellows and junior faculty, making coursework available on evenings and
weekends. In addition, we are now developing online versions of courses to increase
flexibility, as described in the revised proposal. Dedicated time off from clinical duties to
participate in the program will be at the discretion of the individual departments.
4). All named participating faculty have already agreed to teach in the program as listed
in the proposal. Professors have been named for all core courses and for all courses in the
Evidence Based Medicine focus. Courses for Evidence Based Medicine were previously
approved by Graduate Council under the addition of an area of focus in clinical research
for the MS in Toxicology, which was under the now disestablished Department of
Community and Environmental Medicine. We have attached the course approval forms.
5). The differentiation of the proposed area of focus in Clinical Epidemiology and
Molecular Medicine lies in the clinical research emphasis of coursework under both foci.
There are no other biologically oriented MS programs with a clinical research emphasis.
The existing MPH is a professional degree program, and the proposed focus in Clinical
Epidemiology is an academic degree program with a clinical research emphasis.
6). The mentors for the proposed program will be vetted, evaluated and followed for
performance by the Executive Committee. The proposal now specifies that function of
the Executive Committee.
7). The Core Competencies in Clinical and Translational Research recently specified by
the Clinical Translational Science National Council have now been referenced in the
body of the proposal.
8). Drs. Kaplan and Goldin are working closely with Drs. Matkin and Dimas from UC
Irvine Extension to collaborate on a Certificate Program in Clinical Research. The
University Extension service strongly supports the MS-BATS proposal, and a letter of
support from Dr. Matkin indicating that fact will accompany the proposal.
9). We feel that the future emphasis of the program and coursework indicates the ultimate
direction for growth of this program and will be helpful to Graduate Council’s evaluation
of the long-term aspects. Therefore, we have left that section in the proposal.
10). We have corrected the typos that we were able to find.
We are grateful for your careful review and we hope these changes address the issues and
concerns. Please let us know if we can provide additional information.
September 22, 2009
From: John Krolewski, for the ad hoc committee on graduate studies
To: Greg Evans
Chair, COHS Academic Senate
RE: MS BATS program
The ad hoc committee on graduate studies of the COHS academic senate met and
reviewed the ‘Proposal for a program of graduate studies for the M.S. in biomedical and
translational sciences’ dated September 8, 2009.
Overall, the committee agreed that the proposal was significantly improved relative to
prior versions we have reviewed. The development of an MS program targeted to MDs
and medical students, focused on the development of clinical and translational research
training was viewed as a critical addition to the COHS graduate programs. A convincing
case is made for the need to train these individuals.
While we are generally very supportive of the content of the program, the proposal lacks
two key components that we believe are required for approval by the Graduate Council
and Council on Planning and Budget. Specifically, we are still awaiting a letter of
support from Dean Clayman. This letter should contain specific information regarding
the funding of the program. Second, the program lacks a budget. There appears to be a
need to fund parts of salaries for a Director, Associate Director and staff. Also, it
remains uncertain as to how many students are going to pay the MS fees/tuition (due to
go up quite a bit in the near future) and how many will be funded from other sources,
such as departmental funds or training grants. It would be useful if those departments
expecting to send students to the program would provide an indication of how students
will pay the fees (whether out-of-pocket or training grant or departmental sources). It is
also necessary for the letters from the Department Chairs to state whether residency
stipends will be used for the student during the training period and if not, where the
stipend will be derived from. Due to the severe time constraints on many residents (80
hour work weeks, weekend and evening call), the committee felt that it is not realistic to
expect successful completion of this program without the resident being given dedicated
time off from their clinical duties. This would need to be stated in the letters from the
clinical departments. The committee strongly favors a program where the resident has
complete or marked reduction in clinical duties for blocks of three or more months. For
track 1, a 1-year period would seem most appropriate.
There are many new courses proposed for this new degree program, which necessarily
begs the question about who can teach these courses, and who will absorb the fallout
from everyone’s already very full plate of teaching. This is a particular concern given
that the core courses are in the summer and proposed to be in the evening and
weekends. Note that residents frequently have call during evenings and weekends and
thus without dedicated time off from these duties, it is unclear whether they would be
able to attend these proposed courses.
There was strong support for the Evidence-Based Medicine/Clinical Research emphasis
in the proposed program, but some committee members were not convinced that the
public health and molecular medicine emphasis tracks were distinct from the training
provided by the existing MPH program and other biologically oriented MS programs,
respectively. A program focused on the clinical research track might stand the best
chance of being seen as a novel MS program.
Some additional concerns:
One is the lack of a ‘home’ department for the program, which would formally grant the
degree. In lieu of this kind of structure, how will the director ensure adequate numbers
of instructors and (active) mentors? There are some faculty listed in the proposal that
are unlikely to be qualified to mentor MS students. There should be some mechanism
for evaluating the suitability of prospective mentors.
Another is the integration with the ICTS. There is a strong letter of support from Dr.
Cooper, yet there is no mention of articulating this MS-BATS proposal with the future
CTSA. Dr. Cooper circulated a new “standards” document, issued by the CTSA
Consortium recently, which presents “Core Competencies in Clinical and Translational
Research.” This MS-BATS proposal should reflect this content or at least reference the
document, which will assist with the articulation of this new program with the future
CTSA at UCI.
A number of the courses are offered already through University Extension, specifically as
part of a Certificate Program in Clinical Trials offered during the last five years. These
courses include Fundamentals of Clinical Trials, Human Subject Safety in Clinical Trials,
and Application of Good Clinical Practice. Enrolling in these courses would require
payment of the fee structure for UNEX, in addition to the graduate student fees and
tuition already anticipated. This issue should be addressed as a budget issue, and there
also should be a letter of support from UNEX (either David Dimas or Dean Matlin) to
assure cooperation on this new venture.
The future emphasis tracks and course ideas can be deleted from the proposal.
There are numerous typos throughout the proposal, that would not be caught by spell
check (e.g., ‘each’ instead of ‘teach’), which should be addressed prior to final
submission. A number of listed letters are missing (e.g., Hoda Anton-Culver, Michael
Cahalan, etc.). A number of those listed as mentors are no longer at UCI. Most of the
letters were written in support of a previous iteration of the proposal.
Letters of Support
Ralph V. Clayman, Interim Dean, School of Medicine
Gary W. Matkin, Dean, Continuing Education
Albert F. Bennett, Dean, School of Biological Sciences
F. Allan Hubbell, Senior Associate Dean for Academic Affairs
Dan Cooper, Director of the Institute for Clinical and Translational Science
Charles Vega, Director of the Program in Medical Education for the Latino Community
School of Medicine Chairs (emails)
Alpesh Amin, Medicine
William Armstrong, Otolaryngology
Ralph Clayman (as Chair of Urology)
Gregory Evans, Plastic Surgery
Scott Goodwin, Radiological Sciences
Zeev Kain, Anesthesiology and Perioperative Care
Mark Langdorf, Emergency Medicine
Nilam Ramsinghani, Radiation Oncology
Steven Schreiber, Neurology
Feizal Waffam, Pediatrics
Jen Yu, Physical Medicine and Rehabilitation
Christopher Zachary, Dermatology
Hoda Anton-Culver, Epidemiology
Rozanne Sandri-Goldin, Microbiology & Molecular Genetics
Paolo Sassone-Corsi, Pharmacology
Mike Cahalan, Physiology & Biophysics
Ivan Soltez, Anatomy & Neurobiology
UNIVERSITY OF CALIFORNIA, IRVINE
BERKELEY DAVIS IRVINE LOS ANGELES MERCED RIVERSIDE SAN DIEGO SAN FRANCISCO SANTA BARBARA SANTA CRUZ
CONTINUING EDUCATION PO Box 6050
DEAN’S OFFICE Irvine, California 92616-6050
(949) 824-5525 voice
(949) 824-2742 fax
gmatkin@uci.edu
http://unex.uci.edu
October 6, 2009
Sherrie H. Kaplan, PhD, MPH
Professor of Medicine
Assistant Vice Chancellor, Healthcare
Evaluation and Measurement
UC Irvine School of Medicine
100 Theory Suite 110
Irvine, CA 92697
Dear Dr. Kaplan:
This is to express my support and the support of University Extension for the proposed Master of Science in
Biomedical and Translational Science. This proposed program will clearly meet a growing need in our region for
professionals qualified in translating the research produced by the University into practical and clinical
applications. University Extension has offered for many years programs related to this proposed degree including
Certificate Programs in Clinical Trials and in Medical Product Development. These programs have had steady
enrollments, but meet only a part of the need. The new program will provide an educational base for a higher level
of professional very much in tune with the workforce needs of our county and region.
University Extension is prepared to offer direct support of this program in the form of market research and
marketing, financial analysis and planning, and project management for appropriate parts of the program. Our
knowledge of the market of working adults will also be helpful as the program determines some of its important
details such as format and delivery method. As you know, we are currently working to create a certificate program
in advance of the degree to help assess the need for the program and to establish the market and identity for the
program.
Thank you for the opportunity to comment on this important program. I would be happy to supply further
information or respond to requests for help.
Sincerely,
Gary W. Matkin
Dean, Continuing Education
UNIVERSITY OF CALIFORNIA
BERKE LEY . DAVIS . IRVINE · LOS ANGELES · MERCED· RIVERSIDE· SAN DIEGO· SAN FRANCISCO SANTA BARBARA ·SAl'ITA CRUZ
Department of Epidemiology 224 Irvine Hall
Genetic Epidemiology Research Institute University of California Irvine
Center for Cancer Genet ics Research & Prevention Irvine, CA 92697-7550
(949) 824-740 I
Fax (949) 824-4773
hnp J/www.epi .uci.edu/
September 19, 2008
F. Allan Hubbell, M.D., M.S.P.H.
Professor of Medicine and Public Health
Senior Associate Dean for Academic Affairs
School of Medicine
Dear Sr. Associate Dean Hubbell,
I have had the opportunity to review and contribute to the proposal for a graduate program (M.S.
and Ph.D.) in Biomedical and Translational Science (BATS) and I am pleased to write in support
of this School of Medicine effort here at the University of California, Irvine (UCI). Through our
course offering EPIDEM 290, the Department of Epidemiology faculty already provides
epidemiology training to the target applicant group for this program; i.e. , Medical Fellows. As
such, we would continue to support the program in any way that we can.
Additionally, the Department of Epidemiology historically, on occasion, has admitted students
into the Ph.D. concentration in Epidemiology and currently has a student enrolled in school's
MSTP who will be enrolled in EpIdemiology graduate courses after he finishes two years of his
medical school education. Overall, we belIeve the proposed program is an important and
valuable addition to the campus and, in particular, the academic research enterprise within the
School of Medicine.
Please don't hesitate to call on me if the Department of Epidemiology can provide any additional
support for your proposal.
Sincerely,
Hoda Anton-Culver, Ph.D.
Chair, Department of Epidemiology
Director, Genetic Epidemiology Research Institute
Hubbell. Allan
From: Roz Sandri-Goldin [rmsandri@uci.edu]
Sent: Monday, October 06, 2008233 PM
To: Hubbell , Allan
Subject: Re : MS BATS
Dea r Alla n ,
I am wr it i n g to e xp re s s my suppor t and that o f the fa c u lt y o f the Microbi o l o gy &
Molec lar Gene tic s Dep rtment f or he chool o f Me d icine a s t er o f Sci ence ae g ree pro gram
S-
i n iomedic 1 and Tr an s l a t i na l Scien ces (M BAT S ), The memb er s o f my depa rLmen h a ve
S
i ndi cat e d th ei r willi ngness to s e r v e a s e tor s f o r the M s t ude n ts who wish to per f orm
rese r h i n Lheir l ab s.
Sin e r e l y ,
Roz
» »» »»» »» » » » » » »» » » » » »
Rozann e M. Sand ri- Gol d in , h , D,
Profess o r an Ch a i r
De p ar me nt o f M~c robio l o gy & Mole c ula r Ge netics School of Med i i n e Univer s i ty of
Ca lifo r n i a , I rvi n e Irvine , CA 92 69 7 - 40 2 5
Ph o n e : ( 9 49) 8 24 - 7570
Fa x : (9 49 ) 82 4 - 90 5 4
ema ' l : rm sa ndri @uc i.ed u
From: Sassone-Corsi, Paolo
Sent: Wednesday, October 22, 20083:23 PM
To: Hinojosa, Michele
Subject: BATS
RE: BATS
Dear Mike
First, let me thank you for taking the time to talk to our Faculty Meeting about the BATS programs. I have
collected the reactions of most colleagues, which are remarkably uniform. These can be summarized as follow:
1. The Faculty of the Department of Pharmacology is excited to participate in the BATS program.
2. Both the Ph-BATS and MS-BATS are great programs, overall well designed and important because of the
integration of basic and clinical sciences. It is felt, however, that integration of topics would serve to
decrease the number of concentrations (22 seems too many) and by the same token increase the
participation.
3. The Faculty is overall unwilling to increase the actual teaching load.
4. The faculty wishes to preserve the integrity of Pharmacology as a degree-granting program.
Hope this helps, and thanks again,
Best
Paolo
Paolo Sassone-Corsi
Distinguished Professor and Chair
Department of Pharmacology
2115 Gillespie Neuroscience
University of California, Irvine
Irvine, California 92697-4625
USA
Contact: Michele Hinojosa, Administrative Assistant
Tel. 1 9498242961
Email mhinojos@uci.edu
Tell 9498244540 (office)
Tell 9498248056 (lab)
Cell 1 949878 1478
FAX 1 9498242078
Email psc@uci.edu
http://isihighJ yci ted.com/
http://www. ucihs. uci.eduJpharmacol
From: Michael Cahalan [mailto:mcahalan@uci.edu]
Sent: Monday, October 06, 2008 2:36 PM
To: Hubbell, Allan
Subject: Re: MS BATS
Dear Allan,
I am writing to support the MS BATS proposal. This and the complementary PhD BATS
proposal under development are the most significant academic programmatic
developments in the school of medicine in the 30 years that I have been here. If
implemented correctly, they have the potential to transform the culture of the medical
school by promoting research collaborations between basic scientists and clinical faculty
in the School. I am a strong support of both MS- and PhD BATS and hope that Graduate
Council will approve it.
Sincerely,
Mike Cahalan
Michael D. Cahalan
Professor and Chair
Department of Physiology and Biophysics
Irvine Hall 285
UCI, Irvine CA 92697-4561
Phone: (949) 824-7776
Fax: (949) 824-3143
Lab Web: http://crt.biomol.uci.edu
Dept. Web : http:// .... wv..ucihs.uci.edu/pandb
Member: Center for Immunology
Cancer Center
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