There’s No Other Hospital Like It

U. S. Department of Health and Human Services • National Institutes of Health

PROFILE 2009

N I H C L I N I C A L C E N T E R 

DIRECTOR’S ANNUAL REPORT 
D • Annua l report 2009

Message from the Director 1

Recent Clinical Center Achievements 3

Advancing Clinical Research 4

Patient Activity and Support 18

Organizational Improvement/Teamwork 26

Training the Next Generation 31

Noteworthy 40

Organization and Governance 46

contents

PROFILE 2009
expanding opportunities

In 2009, the NIH Clinical Center will face numerous challenges and opportunities. 

A new Presidential administration will mean new priorities for our country, and the 

Clinical Center must be prepared to respond quickly and thoughtfully. Another major 

challenge will be to address continuing resource constraints. Several years of essentially 

flat budgets have strained our ability to achieve an optimal level of clinical research 

support activity

A thorough review of the Clinical Center is planned for 2009. It will be conducted by 

a new group mandated by Congress, the Scientific Management Review Board. This 

review will be part of the Board’s overall examination of NIH. The goal is to provide 

recommendations for enhancing the agency’s mission. Aligned with this review will be 

our continuing careful assessment of the needs of our institute colleagues so that the 

most appropriate, highest quality clinical research and patient care resources are 

in place. 

The Clinical Center will continue to define and play key roles in clinical research 

worldwide in 2009. Numerous collaborations are opening doors to remarkable new 

opportunities. Through partnerships with the Clinical and Translational Science 

Awards network and other external groups, we are able to offer clinical research 

training resources, informatics tools, and a unique research environment to support 

new areas of research. We will be working with the Uniformed Services University 

of the Health Sciences and the Department of Defense to find new ways to diagnose 

and treat traumatic brain injury and post-traumatic stress in both military and civilian 

populations. More than a thousand potential patients have sought to participate in the 

NIH’s new Undiagnosed Diseases Program, a collaboration with the National Human 

Genome Research Institute and the NIH Office of Rare Diseases. The program, 

which is expected to continue to grow, is a tangible reminder that our hospital truly 

is a “house of hope.” 

The Clinical Center team—which includes patients, our partners in discovery—

enables medical discovery and advancement every day. Our hospital’s successes are 

possible because of their combined dedication and commitment to excellence.

John I. Gallin, MD

Director, NIH Clinical Center

M ESS A G E FR O M T H E d i r ecto r

Annua l report 2009 • 1
As America’s research hospital, we will lead the global effort in training today’s 

investigators and discovering tomorrow’s cures.

To provide a versatile clinical research environment enabling the NIH mission 

to improve human health by:

• Investigating the pathogenesis and natural history of disease

• Developing state-of-the-art diagnostic, preventive, and 

therapeutic interventions

• Training the next generation of clinical researchers

• Ensuring that clinical research is safe, efficient, and ethical.

O u r vision

O u r m ission

There’s No Other Hospital Like It
Annua l report 2009 • 3

R e c ent Clini c a l Center A c hie v e m ent s

in 2008 w e :

Established new partnerships and expanded existing ones. For example, 

• Through collaborations with the Clinical and Translational Science Awards network, the 

Clinical Center will serve as a hub for clinical research training, provide leadership in 

defining the role of clinical research nursing, and develop and share informatics tools that 

support clinical research. 

• Under a new $70 million initiative with Uniformed Services University of the Health 

Sciences and the Department of Defense, the Clinical Center will play a key role in clinical 

research studies on traumatic brain injury and post-traumatic stress disorder, investigations 

that will involve both members of the military and civilians. 

Offered renewed hope to patients seeking answers through the Undiagnosed Diseases 

Program.

Provided new opportunities for training in clinical research worldwide. A modified version of 

the Clinical Center’s course “Introduction to the Principles and Practice of Clinical Research” was 

offered in Beijing, the first time an adaptation has been presented live outside NIH. 

Advanced the Data Transformation Initiative, a project that enables the Clinical Center to 

define and share operational data in ways that can be benchmarked with other hospitals. The 

initiative is the first step in moving the organization’s management data from an activity-based 

costing model to a hospital industry standard. 

Continued to enhance and broaden informatics resources to support clinical research 

and patient care, including CRIS, the Clinical Research Information System; BTRIS, the Biomedical 

Translational Research Information System; and ProtoType, an automated protocol writing tool.

Continued to meet the challenge of tight resources by asking staff to do more with less and 

carry out the Clinical Center mission while containing costs.

Sought opportunities to be eco-friendly, which in the Nutrition Department has led to 

changes that are environmentally friendly and help keep costs down.

Improved communications with referring physicians in response to a survey of more than 

3,000 physicians nationally. 

Expanded volunteerism by creating a patient ambassador program, which provides special support 

to patients while helping to reduce costs.
4 • Annua l report 2009

Advancing Clinical Research

protocols by research type

(onsite intramural protocols, fiscal year 2008)

Clinical studies are medical research studies (or protocols) 

in which human volunteers participate. Clinical trials

are studies developing or investigating new treatments 

and medications for diseases and conditions. Natural 

history studies investigate normal human biology and 

the development of a particular disease. Screening studies 

determine if individuals may be suitable candidates for 

inclusion in a particular study. Training studies provide 

an opportunity for staff physicians and other health-care 

professionals to follow particular types of patients.

Clinical trials phases 

Phase 0: An initial first-in-human study (20-30 

participants) under an exploratory IND 

(investigational new drug) for early 

identification of biologic and molecular 

markers in new clinical agents. There is very 

little agent exposure with no therapeutic or 

diagnostic intent.

Phase I: Researchers test a new drug or treatment 

for the first time in a small group of people 

(20–80) to evaluate its safety, determine a safe 

dosage range, and identify side effects.

Phase II: The study drug or treatment is given to a 

larger group of people (100–300) to see if it is 

effective and to further evaluate its safety.

Phase III: The study drug or treatment is given to 

large groups of people (3,000 or more) to 

confirm its effectiveness, monitor side effects, 

compare it with commonly used treatments, 

and collect information that will ensure 

safe usage.

Phase IV: These studies are done after the drug 

or treatment has been marketed. Researchers 

continue to collect information about the 

effect of the drug or treatment in various 

populations and to determine any side effects 

from long-term use.

Total active protocols: 1,449

Clinical trials: 632 (44%)

Training: 28 (2%)

Sample data analysis: 59 (4%)

Screening: 72 (5%) 

Natural history 

(disease pathogenesis): 646 (45%)

(12 protocols are pharmaco-dynamics/kinetics studies.)

Breakdown of clinical trials

Total clinical trials: 632

Phase 0: 9 (1%) 

Phase I: 209 (33%) 

Phase I-2: 30 (5%) 

Phase 2: 332 (53%)

Phase 3: 35 (5%)

Phase 4 17 (3%)
Annua l report 2009 • 5

Dr. David Bluemke (left), 

director of Radiology 

and Imaging Sciences 

at the Clinical Center, 

and Dr. Andrew Arai 

(right), senior investigator with the National 

Heart, Lung, and Blood 

Institute, demonstrate 

the new CT scanner 

with Gregory Henderson, CT scan technician. 

The machine came 

to the CC through an 

NHLBI-CC partnership.

Stronger, faster, better—the new breed of 

computed tomography (CT) scanner captures 

the image of an entire organ in only one 

rotation. In a partnership with NHLBI, 

Radiology and Imaging Sciences at the Clinical 

Center installed one such machine in August. 

“We plan to expand this type of collaboration 

with institutes to broaden the imaging capability 

and expertise offered at the Clinical Center,” said 

Dr. John I. Gallin, CC director. 

The newest CT scanner captures images 

in milliseconds, reducing patients’ radiation 

exposure and diagnosis time. “Instead of standard 

X-ray films of the abdomen or chest in a 

fraction of a second, we now can get a full 3-D 

CT scan that contains much more information 

for the patients and their physicians in 0.2 

seconds,” said Dr. David Bluemke, director 

of Radiology and Imaging Sciences. Older 

technology pieces together multiple scans to 

give doctors and researchers a three-dimensional 

image.

This new technology delivers remarkably 

detailed pictures of the inside of the body. 

To capture the entire heart cycle, older scanners 

used helical, or spiral, methods, which required 

a large amount of overlap in rotations resulting 

in high radiation exposure, according to Dr. 

Andrew Arai, an NHLBI senior investigator. 

“By getting the whole heart in a single rotation, 

radiation exposure to the patient decreases 

significantly,” he said.

The new CT scanner also lends itself to 

new applications such as perfusion imaging. 

The injection of X-ray contrast material that 

circulates in the bloodstream can show if the 

heart muscle is receiving adequate blood supply 

under stress or rest conditions. The first studies 

using the new machine will focus on lowradiation dose cardiac exams, with later NHLBI 

trials using the scanner to study coronary artery 

disease and myocardial perfusion.

The quick and comprehensive output of the 

scan will reduce the need for multiple tests and 

invasive procedures, which cuts diagnosis time 

from hours or days to minutes.“I have great 

confidence that in the future all CT scanning 

will be done this way,” said Bluemke.

CC PARTNERS WITH NHLBI ON A POWERFUL NEW CT SCANNER
6 • Annua l report 2009

Accurate patient information collected efficiently is the goal of any 

point-of-care testing program. The 

Clinical Center took a giant step 

forward to broader adoption of 

such a program in 2008 when the 

Department of Clinical Research 

Informatics worked with the 

Department of Anesthesiology and 

Surgical Services and the Department of Laboratory Medicine to 

deploy a Central Data Station, a 

machine to upload point-of-care 

testing results into the Clinical 

Research Information System and 

Laboratory Information System. 

Anesthesiology and surgical services staff use a 

handheld device at the patient’s bedside to measure blood gases, electrolytes, and glucose levels. 

This and other point-of-care testing instruments 

calculate results on the spot. There is no need to 

send a patient’s samples back to a lab. “Within 

two minutes you have your results, as opposed to 

waiting perhaps 15-20 minutes for the main lab 

results,” said Marti Shepherd, nurse anesthetist 

and point-of-care testing coordinator for the 

department.

Results are fed directly into the Central Data 

Station. Eliminating manual entries means fewer 

opportunities for transcription errors or misplaced 

paper forms. The immediacy of the dock and load 

system frees nurses for more patient care. With 

phase one now complete, the Department of 

Clinical Research Informatics plans to implement 

other point-of-care testing projects for nursing and 

other patient care services. 

POINT-OF-CARE TESTING BRINGS FAST RESULTS

Nurses Marti Shepherd 

and Betty Patterson 

from the Department of 

Anesthesiology and Surgical 

Services demonstrate the 

use of the bedside point-ofcare testing device.

Dr. Jim Cimino shows 

Vien Vanderhoof of NICHD 

how to access and navigate 

BTRIS, the Biomedical 

Translational Research 

Information System.

Cimino Shares BTRIS Vision At CC Forum

“The problem we’re trying to solve is access to research data,” Dr. Jim Cimino said 

during a 2008 introduction of the Biomedical Translational Research Information 

System (BTRIS). “BTRIS is intended to provide researchers with easy access to 

clinical data derived from multiple sources, including the clinical information systems 

at the Clinical Center, for their on-going trials,” said Cimino, chief of the Laboratory 

for Informatics Development and BTRIS project director. He notes that the system 

also allows investigators to search across data sets to answer new questions and shape 

fresh ideas for future studies. Principal investigators volunteered data from 29 protocols involving 8,000 patients to test the new system.

In a demo of BTRIS at a town hall meeting in September, Cimino walked attendees 

through the steps to reach lab results, medicine dosage, and other information of interest to researchers. Without the newly developed technology, one had to download 

each patient’s data from the Clinical Research Information System. “To do this manually would take you quite a bit of time,” Cimino said.

NIHers had the opportunity to work in a BTRIS demonstration environment 

through during the fall. “In that time, the BTRIS team received many positive 

reviews and recommendations that will feed into the development of BTRIS 1.0, 

due out in July 2009,” said Cimino. 
Annua l report 2009 • 7

A new resource aimed at increasing community 

involvement and clinical research education in the 

region was introduced in 2008. It’s a mobile clinic, 

an extension of NIAID’s Vaccine Research Center’s vaccine clinic at the Clinical Center. 

According to Dr. Barney Graham, NIAID senior 

investigator and chief of the clinical trials core and 

the viral pathogenesis laboratory, the clinic team 

will use the mobile unit to raise awareness about 

HIV vaccines, enhance the capacity for enrolling 

healthy adults into outpatient studies, and make 

participation in clinical trials more convenient. 

“These volunteers are typically employed, busy 

people, and we hope the mobile clinic will make 

enrollment in trials more convenient and at the 

same time extend the visibility of NIH and the 

Clinical Center,” he said. 

VRC staff plan to take the clinic anywhere they 

are currently involved in HIV/AIDS and other infectious disease outreach, including neighborhoods 

in Baltimore, Frederick, and the District. They 

will continue to work with HIV/AIDS organizations, city health departments, churches, college 

campuses, and outreach event organizers, but in an 

expanded capacity. 

In his welcoming remarks, CC Director Dr. John 

I. Gallin noted the recent attention to mobile 

health facilities in providing care to rural and underserved areas within the US and abroad. 

“This is an exciting experiment in how to reach 

out to new volunteers. We hope it will bring more 

participation to all clinical research activities, as 

well as attention to NIH, NIAID, and the Clinical 

Center,” Gallin said. 

In his remarks, Dr. H. Clifford Lane, deputy 

director for clinical research and special projects at 

NIAID, outlined the history of the VRC, which 

opened in 2000 to spearhead vaccine research 

from basic to applied science. The VRC has developed and implemented 20 protocols, of which 10 

are complete, he said. The VRC’s work has included not only HIV/AIDS, but also established and 

emerging viral infections such as Ebola, Marburg, 

H5 influenza, West Nile, severe acute respiratory 

syndrome (SARS), and smallpox. 

“The VRC is a genuine national asset that contributes to the health of the nation and the world,” 

Lane said. “It’s wonderful to see this new outreach 

to the DC-area, which is one of the places in the 

US that is hardest hit by HIV. There’s such a great 

need for prevention, and this mobile clinic will 

reach out to the community outside the NIH gate 

to bring in new volunteers.” 

All smiles in front of a mobile 

clinic from NIAID’s Vaccine 

Research Center (VRC) and 

the Clinical Center, VRC

Clinical Trials Core Chief Dr. 

Barney Graham (second 

from left) and Deputy Chief 

Dr. Julie Martin (far left) join 

VRC nurses and administrators during the clinic’s launch 

on June 6. 

CC, NIAID Vaccine Research Center launch mobile

clinic to take research, education messages to the streets
8 • Annua l report 2009

Nutrition Research Day 2008 drew participants 

from across the country in a week-long CC-NCI 

nutrition and cancer prevention research practicum. Representing all levels of training, from 

undergraduate to PhD, attendees learned about the 

role of clinical research dietitians at the CC and 

a sampling of nutrition-related protocols. Nutrition as a field is also increasingly involved in the 

cutting-edge territory of biomedical informatics, 

which Dr. James Cimino, chief of the Laboratory 

for Informatics Development, defined in his 

presentation as the art and science of organizing knowledge of human health and disease and 

making it useful for problem solving. Madeline 

Michael, chief of clinical nutrition services in the 

Nutrition Department, described the 

CC’s experience transforming practice from paper 

to electronic health records and designing nutrition documentation for research. Dr. Amy Subar, 

a nutritionist with NCI, shared how her team 

developed an automated, self-administered 24-

hour dietary recall system. By answering a series 

of questions about what they ate, patients created 

a food list of what they consumed the day before 

that—with further probing about food preparation, additions, and portion size—leading to the 

assignment of a standard USDA food code that is 

used to calculate a total nutrient and food group 

intake for the reporting day. 

Vaccine Evaluation 

Clinic 

The Clinical Center provided 

clinical research support in 

developing NIAID’s new Vaccine Evaluation Clinic on 5NE-S. 

Ribbon cutting was held Dec. 1, 

2008, World AIDS Day. The patient-care unit includes state-ofthe-science infrastructure for the 

safe conduct of clinical research 

protocols involving new vaccines 

and vaccine technologies that 

require high-level containment. 

Clinic staff will include (from left) 

Olga Vasilenko, clinical data 

manager, nurse Kathryn Zephir, 

Dr. Nilu Desai, and Sara Hubka, 

nurse practitioner. 

Merel Kozlosky, director of 

the NIH dietetic internship 

and supervisory metabolic 

dietitian, welcomed attendees to the 2008 Nutrition 

Research Day March 18. 

NUTRITION RESEARCH DAY SHARES NEW TERRITORY

EXPLORED BY CLINICAL RESEARCH DIETITIANS

 
Annua l report 2009 • 9

Clinical research nursing (CRN) is nursing practice with a specialty focus on clinical research and 

the care of clinical research participants. It includes 

care provided to research participants in addition 

to activities that support protocol implementation, 

data collection, and human subject protection. 

Despite nursing involvement in clinical research 

for decades, the CRN practice domain is not 

well defined or documented. Expansion of the 

national and international clinical research 

enterprise requires investigators, health policy 

makers, regulators and clinical research sponsors to 

understand the important role that clinical research 

nurses play in assuring patient safety, integrity of 

protocol data, and ongoing informed consent, all 

within the context of effective and appropriate 

clinical care. Nursing at the Clinical Center has 

undertaken a multi-year project to describe and 

define the CRN domain of practice and lead the 

way in establishing CRN as a recognized specialty 

practice area.

In 2008, the first set of validation activities was 

conducted. These activities focused on a role 

analysis of the practice demonstrated by the more 

than 900 clinical research nurses at the Clinical 

Center. A critical review and synthesis of themes 

from available literature and practice documents 

was conducted. Structured interviews were 

conducted with CC nurse managers and clinical 

staff representing inpatient units, outpatient clinics and day hospitals, along with research nurses 

from five institutes and centers within the NIH 

intramural program. All were asked to define both 

the formal position roles and the informal roles 

and activities for nurses in their respective areas. 

Interview data analysis revealed two separate role 

clusters within the CRN domain of practice—the 

Clinical Research Nurse and the Research Nurse 

Coordinator. Five proposed dimensions (distinctive 

categories of activities) emerged: clinical practice, 

study management, human subjects protection, 

contributing to the science, and care coordination and continuity. Clinical Research Nurses had 

most activities clustered within the dimensions of 

clinical practice and care coordination. Research 

Nurse Coordinator role descriptors included the 

dimensions of study management, human subject 

protection, and care coordination. 

The validation process continued with a review 

of the literature, research-management degree and 

certificate-granting programs, certification tests 

from research organizations, and NIH clinical 

research nurse position descriptions. The goal was 

to identify and code specific activities within the 

two CRN roles. 

The final step of the validation process is currently 

under way to achieve consensus on the activities 

and dimensions within the CRN Domain of 

Practice. A survey was developed and has been 

distributed to an expert panel of nurses who 

actively provide or supervise clinical research care 

and Clinical and Translational Science Awards, 

General Clinical Research Centers (GCRC), and 

NIH. Future projects will include role profile 

studies to compare clinical research nursing roles 

in different practice settings.

Indian Health Service

Nursing and Patient Care Services and the Indian Health Service (IHS) have collaborated with the National 

Alaska Native American Indian Nurses Association (NANAINA) since 2006 to begin training staff at IHS clinical 

facilities to conduct research and evidence-based practice projects. In May 2008, a workshop was held for 

IHS nurses throughout a five-state area at the Northern Navajo Medical Center in Shiprock, New Mexico. 

A research development meeting in Bethesda followed in July. These workshops resulted in evidence-based 

project development including 2008 NANAINA Summit podium and poster presentations by IHS nurses 

from New Mexico, North Dakota, and Oklahoma. An additional $40,000 grant by the National Center of 

Minority Health and Health Disparities was awarded to further support interagency collaboration with the 

Indian Health Service. 

A specialty: clinical research nursing
10 • Annua l report 2009

2008 Bench-to-Bedside Awards

The NIH Clinical Center created the Bench-to-Bedside awards program in 1999 to speed translation of 

promising laboratory discoveries into new medical treatments by encouraging collaborations among basic 

scientists and clinical investigators. Since 2006, the program has been open to research teams made up 

of intramural and extramural partners. Awardees for 2008 are listed below.

g ene ra l c a t Eg o r y

NCI

NIAID

Ludwig Institute for Cancer Research

Weill Medical College, Cornell

NINR

University of Maryland

Targeting cancer-testis gene expression 

for lung cancer therapy

Molecular mechanisms of glial cell modulation 

of chemotherapy-induced painful peripheral 

neuropathy

D. Schrump, MD, NCI; V. Lobanenkov, 

PhD, NIAID; L. Old, MD, Ludwig Institute 

for Cancer Research; and N. Altorki, MD, 

Weill Med College, Cornell

X. Wang, MD, PhD, NINR; S. Dorsey, 

RN, PhD, and C. Renn, RN, PhD, 

U of MD

teams projects principal investigators

a i d s c a t Eg o r y

NCI

University of California, San Diego

NICHD

Case Western Reserve

NIAID

NHLBI, Children’s National 

Medical Center

NCI

New strategies to decrease and 

eradicate HIV-1 reservoirs

HIV-1 suppression by Acyclovir in patients 

coinfected with human herpes viruses from basic 

mechanism to clinical application

Non-invasive cardiac 3T MRI for evaluation of 

premature coronary artery disease and myocardial dysfunction in adolescents and young adults 

with HIV acquired in infancy and childhood

F. Maldarelli, MD, PhD, NCI; 

E. Reid, MD, UCSD

L. Margolis, PhD, NICHD; 

M. Lederman, MD, Case Western

C. Hadigan, MD, MPH, NIAID; A. Gharib, 

MD, NHLBI; R. Cross, MD, MS and

S. Clauss, MD, CNMC

teams projects principal investigators

a i d s / m ino r ity h e a l t h c a t Eg o r y

NIAID 

Johns Hopkins University

Uganda (Makere Medical School, 

Mulago Hospital)

NCI

FDA

University of Washington

Hepatitis B and HIV co-infection in Uganda

Development and evaluation of a nanoparticlebased HIV-1 p24 antigen assay for monitoring 

therapy in resource limited settings

T. Quinn, MD; S. Reynolds, MD, NIAID, 

Uganda; and L. Stabinski, MD, MPH, 

NIAID; C. Thio, MD and G. Kirk, MD, 

MPH, PhD, JHU

F. Maldarelli, MD, PhD, NCI; I. Hewlett, 

PhD, FDA; L. Frenkel, MD, U of WA

teams projects principal investigators
Annua l report 2009 • 1 1

m i n o r i t y h e a l t h & h e a l t h d i s par i t i e s c a t Eg o r y 

NIDDK

University of Michigan

Toward molecular-marker based management of 

diabetic nephropathy in Pima Indians

R. Nelson, MD, PhD, NIDDK; 

M. Kretzler, MD, U MI

teams projects principal investigators

rar e d ise a ses c a t Eg o r y

NHGRI 

University of South Carolina

University of Texas-MD Anderson

NHLBI

NIH Clinical Center

NIH Clinical Center 

NHLBI

INOVA Fairfax Hospital

NHLBI

Harvard

Temple University

NIH Clinical Center

NHLBI

Imperial College, London

NIAID

NCI

Predicting the response to treatment using 

gene mutation profiling in metastatic melanoma 

patients

Graft-Versus-Host Disease: novel cellular therapy 

using selective thawing of umbilical cord blood 

to obtain an aliquot for ex-vivo natural killer cell 

expansion and infusion following allogeneic hematopoietic stem cell transplantation

Evaluation of the platelet transcriptome expression profile in pulmonary arterial hypertension

Characterization of Jak/Stat activation in patients 

with monosomy 7 and the development of targeted therapy for patients using a Jak2 inhibitor

Development of immunotherapeutic strategies to 

overcome tolerance in leukemia

Recombinant human IL-& (CYT107) as immunomodulatory therapy for idiopathic CD4 lymphopenia: a phase I/IIA open-label pilot study

Y. Samuels, PhD, NHGRI; P. Buckhaults, 

PhD, U of SC; P. Hwu, MD, U of TX-MD 

Anderson

R. Childs, MD, NHLBI; S. Vasu, MD, CC

R.F. Machado, MD, NHLBI; 

N. Raghavachari, PhD, CC; 

S. Nathan, MD, INOVA

E. Sloand, MD and N. Young, MD, 

NHLBI; J. Groopman, MD, Harvard

A. J. Barrett, MD, NHLBI; K. Rezvani, 

MD, PhD, Imperial College School of Med

J. Brenchley, PhD and I. Sereti, MD, 

MHS, NIAID

teams projects principal investigators

 wo m en’s h e a l t h c a t Eg o r y

NHLBI

NCI 

NICHD

NIDDK

Sackler School of Med, Tel Aviv, Israel

Immunogenicity of quadrivalent human papilloma virus vaccine (HPV Types 6, 11, 16, 18) in 

recipients of reduced intensity hematologic stem 

cell transplantation (HSCT)

Histaminergic pathways and energy intake in 

obese women

A. Chenoy, MD, NHLBI; P. Stratton, MD, 

NICHD; L. Pinto, MD and L. Wood, 

MD, NCI

J. Yanovski, MD, PhD, L. Yanoff, MD, 

and C. Cropp, PharmD, NICHD

teams projects principal investigators
12 • Annua l report 2009

Bench-to-Bedside Awards program

More than 400 investigators have collaborated in 135 projects since the NIH Clinical Center’s Bench-toBedside awards program was begun in 1999. Funding has totaled about $24 million. Here is a look at 

some of the research advances this program has generated. 

B2B spotlight | Novel cancer vaccine

Bench-to-Bedside awards in 2003 and 2005 have 

led to the introduction of a new cancer vaccine 

developed from the blood cells of healthy donors. 

Acute lymphoblastic leukemia (ALL) is the most 

common childhood cancer. Statistics show that for 

20 percent of pediatric patients with ALL, and half 

of the adults who are diagnosed with the disease, 

the final result will be death.

One way doctors have treated ALL is to perform an allogenic stem cell transplant (SCT). In a 

best case scenario, SCT results in what’s called a 

“graft-versus-leukemia (GVL)” effect, whereby the 

immune system from the donor cells wipes out 

residual cancer, and becomes part of the cure. But 

this effect is not as strong in ALL as it has been 

shown to be in other cancers of the blood.

Dr. Alan Wayne is the clinical director and head 

of the hematologic diseases section at the NCI’s 

Pediatric Oncology Branch and Center for Cancer 

Research. He is also the principal investigator for 

a clinical trial designed to develop a new vaccine 

strategy to enhance the GVL effect after SCT for 

the treatment of ALL and other blood cancers.

In this Phase 1/2 pilot trial, the goal is to develop 

a novel cancer vaccine that will treat children and 

adults with blood cancers that have either recurred 

or persisted despite a previous SCT. This is one of 

the first attempts in human subjects to use cells 

taken from healthy stem cell transplant donors to 

develop cancer vaccines. Previously, a patient’s own 

blood, bone marrow, or tissue was used in vaccine 

development.

A typical method of treating patients with relapsing leukemia following a SCT is to infuse lymphocytes from a healthy donor into the patient. 

In some types of leukemia, this procedure leads 

to an 80 percent cure rate. Not so in ALL where 

the cure rate is less than 10 percent. One reason 

for this, researchers speculate, is that the ALL cells 

aren’t as “visible” to the lymphocytes.

To make these cells more easily seen, researchers 

have created a vaccine from specialized cells called 

dendritic cells, which present proteins to the 

lymphocytes and direct their attack. These dendritic cells are cultured and matured in vitro by 

the Clinical Center’s Department of Transfusion 

Medicine Cell Processing Section.

Patients in this trial receive two small vaccine 

injections from the cultured donor cells every 

other week. Then, once each month, they receive 

standard donor lymphocyte infusions. This happens over a three-month period with outpatient 

visits to the Clinical Center’s Day Hospital. The 

first patient received the investigational vaccine last 

spring. Wayne, and his colleagues hope to test the 

vaccine in 12 individuals before moving on to the 

next phase of the study.

“We are excited about all of this expertise and 

multiple technological advances converging on 

a clinical need: better therapies for individuals 

whose cancer relapses after a stem cell transplant,” 

Wayne said.

The current trial is designed to test the safety and 

effectiveness of the vaccine. However, Wayne said 

he could see a day when the vaccine could be 

given as a way to prevent cancer relapse as part of 

the initial transplant procedure.

“It’s always a race between the disease and the 

treatment,” Wayne said. “The less disease patients 

have at the start of the race, the better off they are.” 

In front are NCI’s Dr. Alan 

Wayne and Dr. Crystal 

Mackall. In back (from left) 

are Dr. Elaine Jaffe, NCI; 

Dr. Terry Fry, NCI; 

Dr. Rodger Kurlander, CC; 

Dr. David Stroncek, CC; Kelly 

Richards, NCI; Hua Zhang, 

NCI; Dr. Mary Alice StetlerStevenson, NCI; 

Dr. Ronald Gress, NCI; 

and Dr. Mark Raffeld, NCI.
Annua l report 2009 • 1 3

B2B spotlight | intractable pain

Messengers with good news to deliver can count 

on a warm reception. Bearing bad news? Your 

watchword should be the cliché, “Don’t kill the 

messenger.” 

But what if killing the messengers—in this case, 

pain-responsive neurons in the sensory ganglia—

can be proven as a practical way to manage 

intractable pain? 

That’s the central question in research being done 

by Dr. Michael Iadarola, chief of the Neurobiology and Pain Therapeutic Section at the National 

Institute of Dental and Craniofacial Research, 

and Dr. Andrew Mannes in the NIH Clinical 

Center’s Department of Anesthesia and Surgical 

Services. 

Iadarola’s team is about to launch a Phase I clinical 

trial of a new pain-relieving drug called resiniferatoxin (RTX). He called the drug a single-shot 

dose of analgesic that lasts forever. “We call it a 

‘fire and forget’ missile,” he said. The target neurons in the sensory ganglia connect the body to 

the spinal cord, and interrupting this one specific 

class of pain sensing neurons will eliminate the 

connection and eliminate some, but not all, types 

of pain. 

This research was funded, in part, by a B2B award 

Iadarola received from the NIH Clinical Center 

in 2001, and the clinical trial is the culmination 

of a long journey both for the drug and the doctor. The experimental drug comes from Morocco 

where it is isolated from latex of the plant Euphorbia resinifera. The latex from this cactus-like plant 

has been used for topical pain relief, as well as for 

other medicinal uses, for thousands of years.

RTX has a molecular structure similar to capsaicin, the active ingredient in hot peppers. Like 

capsaicin, RTX binds to the same pain receptor 

in a neuron, but 500 to 1,000 times more tightly. 

Capsaicin causes an ion channel called TRPV1 

in the sensory neuron to open briefly allowing a 

small amount of calcium and sodium ions to flow 

into the cell. That generates the burning sensation 

one associates with eating a hot pepper. RTX, 

however, holds the channel open for a much 

longer period, flooding the cell with enough 

calcium to kill it. Within an hour, most neurons 

with a TRPV1 channel are compromised or dead. 

They do not grow back. 

Not all neurons have TRPV1 channels, and RTX 

doesn’t affect the ones that don’t. These TRPV1-

positive neurons are contained in the dorsal root 

ganglion. Their nerve endings are in the skin 

where they respond to sensations of moderate 

heat and in the internal organs where they seem 

to be the main messengers of pain from cancer 

and inflammation.

Iadarola credited the B2B award for getting the 

ball rolling in the translational direction of this 

research. “First off, it got us started thinking 

about, and actually doing something about, taking 

laboratory findings and bringing them into clinical 

practice,” he said. “Not that we didn’t want to do 

this, but we had a basic science laboratory and we 

had no mechanism to take findings from live-cell 

imaging with a microscope and translating that 

into a clinical protocol. Getting the B2B award is 

what got us started on what has been a long road.”

The B2B award funded some of the early research that extended the lives of family pets at the 

University of Pennsylvania Medical School. These 

dogs suffered from painful conditions that made 

them candidates for euthanasia. “These animals 

were enrolled into the protocol, they were treated 

From left are Brian Bates, 

NIDCR; Dr. Andrew Mannes, 

CC; Dr. Michael Iadarola, 

NIDCR; Dr. Kendall Mitchell, 

NIDCR; Ruth Yaskovich, 

NIDCR; and Jason Keller, 

NIDCR.
14 • Annua l report 2009

with RTX and it was like magic,” Iadarola said. 

“They went home pretty much pain free, and the 

pain control lasted the duration of their lives. One 

treatment led to almost complete pain control. 

Most of the dogs came off their concurrent 

medications, like NSAIDS or opiates.”

Iadarola said the efficacy of the drug’s effect on 

the dogs and lack of side effects were very strong 

incentives to move into the next phase of the 

clinical journey: testing RTX on humans suffering from intractable pain. This transition occurred 

with the help of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse of 

NIDA who were experts in the development of 

treatments for addictive drugs. First, the research 

team needed a clinical grade drug. “That was a 

very long adventure,” Iadarola explained. But after 

a few false starts, Iadarola said they have enough of 

the experimental medication to use in studies for 

several years. He said having the B2B funds was 

very helpful in this step as well. 

Iadarola noted that his team is just about to kick 

off the clinical trial with their first patient. 

Dr. Mannes, a long-term collaborator and anesthesiologist, is the person who will inject the RTX. 

They hope to enroll as many as 24 into the study. 

Injection of the RTX into the cerebral spinal fluid 

space around the spinal cord is tricky business because the patient is placed under general anesthesia 

for 60 to 90 minutes while the drug does its work, 

killing off the pain neurons in the spinal cord. If 

the treatment is successful, the patient should no 

longer have to rely on high doses of morphine or 

other opioids to control pain. 

“We hope this is the beginning of a much bigger 

program for pain control,” Iadarola said. “This is 

a very versatile agent and approach. We can use 

this not only in people with end stage cancer, but 

hopefully in a lot of other specific pain conditions 

if we can demonstrate both safety and efficacy. 

Safety is one of the key components here, and 

we’re very cognizant of that.”

B2B spotlight | smith-magenis syndrome 

Smith-Magenis Syndrome (SMS). It’s not a household-name disease. In fact, many times it’s 

mistaken for something else entirely, like Down 

Syndrome. Other times, it’s missed completely.

Thanks to the B2B awards program, a team of 

dedicated researchers is working to not only 

increase awareness of the syndrome, but to find 

new and better ways to treat it.

Leading the team is Dr. Ann C. M. Smith. She’s 

the “Smith” in Smith-Magenis Syndrome. Working at Children’s Hospital in Denver as a genetic 

counselor in 1981, she saw her first two patients 

within six months of each other. Both infants had 

failure to thrive; defects of the heart and palate; 

developmental delay; a typical facial appearance; 

short stature with small hands and feet; low muscle 

tone; and motor delays, among other signs. They 

were identified to have a small missing piece from 

the short arm of chromosome 17, called “deletion 

17p11.2”. She described and presented these cases 

at a 1982 meeting of the American Society of 

Human Genetics and began collaborating with Dr. 

Ellen Magenis, a cytogeneticist at Oregon Health 

& Sciences University (who gave the condition 

the second half of its moniker). They published a 

paper together in 1986 identifying the first nine 

individuals with deletion 17p11.2, expanding the 

now-trademark characteristics to include middle 

ear problems, hoarse voice, ocular abnormalities, 

sleep disturbances, and neurobehavioral features, 

such as hyperactivity and autistic-like repetitive 

behaviors. 

Smith is now a senior genetic counselor on contract with NHGRI, having recently retired from 

the medical faculty at Georgetown University 

Medical School. The research team she leads has 

received two B2B awards, the first in 1999.

“That award went, in part, to establish the multidisciplinary research team at NIH, which allowed 

us to focus on research efforts to understand the 

clinical and molecular manifestations of SMS,” she 

said. It resulted in a natural history protocol and 

Front row (from left) are 

Hanna Hildenbrand, CC

Rehabilitation Medicine; 

Ann Smith, NHGRI; and 

CAPT Michaele Smith, CC

Rehabilitation Medicine. 

In back are Rebecca Morse, 

NHGRI; Dr. Maryland Pao, 

NIMH; Beth Solomon, CC

Rehabilitation Medicine; 

Dr. Wallace Duncan, NIMH; 

and Dr. Marjan Huizing, 

NHGRI.
Annua l report 2009 • 1 5

allowed her to convene a SMS research roundtable 

with the parent’s support group PRISMS to bring 

together experts and researchers in the field. The 

natural history protocol, Smith said, yielded several 

publications and the description of new findings, including the validation of early expressive 

speech delays caused by underlying physiological 

issues related to low muscle tone, decreased tongue 

strength and movement, laryngeal and palatal 

abnormalities, poor suck reflex, and difficulties 

transitioning to solid foods. This initial B2B award 

also funded a pediatric nasal endoscope used to 

visualize the palate and vocal cord function.

The sleep disturbance that occurs in the syndrome 

is chronic and seen across all ages. “A lot of parents 

thought their children were sleeping very well as 

infants,” Smith said. “We’ve identified the sleeping 

disturbance as young as nine months of age. They 

were so quiet, they weren’t alerting their parents. 

They weren’t crying.” 

The initial protocol also showed that many of the 

kids with SMS have short stature. “We’re collecting 

growth data to generate specific growth curves,” 

Smith explained. Other findings of the initial 

natural history protocol showed that SMS patients 

tend toward obesity during adolescence and have 

lowered immunoglobulins, and hypercholesterolemia (elevated total cholesterol, triglycerides, 

and/or LDL cholesterol).

“One of genes in this region (of the chromosome 

deletion) is involved in cholesterol management. 

A second gene is involved in IgA deficiency. So it’s 

interesting because these children only have one 

copy of these genes,” Smith explained.

The natural history protocol also defined an earlier 

onset of sensory neural hearing loss, which can 

occur shortly after age 10, and increased frequency 

of hyperacusis, which is a condition described as 

an over-sensitivity to certain frequency ranges of 

sound. 

The research team got a second B2B award in 

2004, which Smith said was being used to assemble 

an approach to what she called “the novel inverted melatonin circadian rhythm” found in SMS 

patients. Where most of us produce the sleep hormone melatonin at night, people with SMS produce it during the day. Where light suppresses the 

formation of the hormone in most folks, it doesn’t 

in SMS patients. People with SMS experience 

chronic sleep disturbances with frequent nighttime 

and early morning awakenings compounded by 

daytime sleepiness. 

Smith said the second B2B award was used to fund 

a new Phase I treatment trial. It paid for several 

medical devices, such as digital thermometers, and 

Actiwatches—which are wristwatch-like accelerometers used to measure an SMS patient’s activityrest cycle in the home setting and give the researchers 

a good idea of the patient’s sleep pattern. Actigraphy is less invasive than standard EEG sleep 

studies (the gold standard) and provides a continuous estimate of sleep based on wrist motion for a 

prolonged period. The objective information about 

the dynamics of home sleep in the context of behavioral and developmental changes was critical to 

the design of the phase 1 sleep treatment trial that 

began in 2008 at NIH. 

The second B2B award also funded the purchase 

of bright light boxes and creation of a melatonin 

tablet used for the treatment study. “Melatonin 

isn’t regulated by the FDA. You can buy it at health 

food stores,” Smith said. “But for NIH, we wanted 

a purer form of melatonin with a time delayed 

release. So the Clinical Center’s Pharmacy Department developed a coated tablet.”

Patients with SMS began enrolling in the protocol 

in April 2008, along with healthy adults who 

tested the safety, and efficacy of the melatonin 

tablet. 

The official statistics on SMS suggest that one out 

of every 25,000 children is born with SMS. Smith 

thinks that number is too low—more like one out 

of every 15,000. She said that with improved molecular genetic techniques for examining chromosomes when health-care providers see a child with 

speech and motor developmental delays, they may 

be able to diagnose more children who might have 

gone unrecognized. Smith said many SMS patients 

are not identified until school age when the sleep, 

and behavioral issues are readily apparent. The oldest was identified at age 65.

Smith looks at herself as something of a “team 

captain.” “I’ve got some stellar researchers who, 

before they met this syndrome, didn’t know a thing 

about it,” she said. “Now, probably, they have more 

experience than anyone else in the world with the 

syndrome, having seen more individuals.”

She is excited by the prospect of new discovery in 

the Phase I trial, funded by the latest B2B award. 

“I think this population can actually offer us a 

better understanding of something that is so 

unusual—this inverted circadian rhythm of melatonin,” she said. “That biologic conundrum to me 

is the piece that, if we can understand it, will open 

a new understanding of this syndrome.” 

“We’ve identified the 

sleeping disturbance 

as young as nine 

months of age. They 

were so quiet, they 

weren’t alerting their 

parents. They weren’t 

crying.”

—Dr. Ann C.M. Smith
16 • Annua l report 2009

Protocol tests 

type 2 diabetes 

medication to 

treat severe asthma

Two Japanese patients with 

type 2 diabetes and asthma 

sparked the idea. They started 

taking pioglitazone hydrochloride (HCI), a medication 

used to treat type 2 diabetes, 

and noticed that their asthma 

also improved.

Coincidence? There is no published data in humans on the topic, so it’s impossible to know until 

research can move beyond anecdotal evidence. 

Dr. Stewart Levine, principal investigator with 

NHLBI’s Pulmonary and Vascular Critical Care 

Medicine Branch, launched one of the first randomized, placebo controlled, double-blind pilot 

clinical trials in patients with allergic asthma to 

find out whether pioglitazone HCI (Actos) is 

effective for treating patients with asthma who 

do not respond to standard therapy.

Pioglitazone belongs to a class of medications 

called thiazolidinediones, which have been shown 

to have anti inflammatory effects. These medications have been used to improve asthma in preclinical studies, so there is compelling evidence 

that this approach might be useful for asthmatic 

patients.

According to Levine, 22 million people in the 

US have asthma, and approximately 10 percent 

of those patients have severe cases. The mild to 

moderate treatments don’t work for them, so 

Levine’s goal is to find new treatments for people 

with moderate to severe asthma. Often already using inhalers, these patients’ next options would be 

oral corticosteroids or injectable anti-IgE therapy. 

Levine hopes that about 50 asthma patients between 18 and 75 years of age who have had asthma 

for at least one year and whose symptoms are not 

well controlled with current treatments will choose 

to enroll in his study.

The study has three phases. First, candidates are 

screened with blood and urine tests, breathing 

tests, an allergy skin test, chest X-ray, electrocardiogram, and echocardiogram. Participants are given 

a device to measure and record lung function and 

asthma symptoms at home for four weeks before 

starting the study medication. Lung function is also 

measured at clinic visits before and after inhaling a 

bronchodilator medicine and participants are admitted to the hospital for fiberoptic bronchoscopy 

and lavage—a test to examine the lung’s airways.

In phase two, participants are randomly selected to 

receive either pioglitazone or placebo, a look-alike 

pill with no active ingredient, once a day for 10 

weeks. They return to the clinic after two weeks to 

repeat the tests done in the first phase and to monitor any reactions to the study drug or placebo. If 

there are no problems, the amount of medication 

is increased and they return for follow-up evaluations every two weeks for eight weeks. Pulmonary 

function tests and bronchoscopy and lavage are 

repeated after 10 weeks on medication.

In the last phase, patients return for follow up one 

month after stopping the medication or placebo 

to monitor their asthma. Because pioglitazone is 

an already FDA-approved medication commonly 

prescribed for type 2 diabetes, about seven million 

people have already taken it. According to Levine, 

the main side effects are weight gain, edema, and 

anemia. Long-term use of this class of medication 

has been associated with worsening heart failure in 

diabetic patients who use insulin, as well as bone 

fractures, so patients will be monitored with bone 

density assessments.

If the results from Levine’s pilot study look promising, he hopes to open it up in a few years to 

patients with severe asthma at multiple locations. 

According to Levine, there is an important unmet 

need for the development of new treatment options 

for patients with severe asthma. “If pioglitazone or 

other medications could be shown to be effective 

for the treatment of severe asthma, this would represent a wonderful new option for these patients.”

NHLBI’s Dr. Stewart Levine, 

technician Clara Jolly, and 

patient and fellow Jonathan 

Lam demonstrate the pulmonary function tests that trial 

participants will receive to 

monitor the progress of their 

asthma. 

RESEARCH | S POTLI G H T S
Annua l report 2009 • 1 7

Promising pilot study by CC researchers 

treats deep vein thrombosis 

Clinical Center researchers have developed and 

published a novel treatment for blood clots in the 

legs that appears to be safe and effective, according 

to their pilot study. 

Deep vein thrombosis (DVT) is a common but 

serious health problem that happens when a 

blood clot, or thrombus, forms in the deep veins, 

particularly in the lower leg or thigh. Complications occur when the clot breaks off and travels 

to the lungs, resulting in pulmonary embolism, a 

potentially fatal condition. Lack of movement is a 

risk factor for DVT, which is why long-distance 

airline passengers and patients who recently had 

surgery or were hospitalized often hear about the 

condition. 

Most patients with DVT are treated with medications to thin the blood and compression stockings. However, studies have shown that one-third 

of these patients will suffer from post-thrombotic 

syndrome, characterized by pain, swelling, or 

changes in skin color. Another third are likely to 

have another clot or pulmonary embolism within 

five years of their initial DVT. 

Clot-dissolving therapies could potentially protect 

against these occurrences, but can pose a bleeding 

risk. Therefore, lead author Dr. Richard Chang, 

chief of the interventional radiology section in 

Radiology and Imaging Sciences, sought to 

develop a safe, effective, and affordable clotdissolving treatment regimen for DVT. 

For the pilot study, the researchers injected or 

“laced” the clots of 20 acute DVT patients with 

alteplase, a clot dissolving agent. Alteplase binds to 

the clot, so the procedure does not require continuous infusion of the drug, as do other clotdissolving therapies. With this treatment, after 

lacing one vein segment with alteplase, the interventional radiologist can immediately direct 

catheters to treat other vein segments to ensure 

that the entire clot has been adequately treated. 

The patients also received blood thinners. 

The new treatment restored 

blood flow 

throughout the 

deep venous 

system in 16 

(80 percent) of 

the 20 patients 

during therapy 

with complete 

resolution of 

symptoms in 

18 patients (90 

percent) after 

six months of 

treatment with 

blood thinners. 

Alteplase left the 

patients’ circulatory system within two hours of 

treatment, reducing the risk of subsequent bleeding. “This treatment regimen is able to clear blood 

clots rapidly and safely, restoring blood flow in the 

veins of the lower leg, and the results are durable,” 

said Chang. 

There were no cases of clinically important 

pulmonary embolism or serious bleeding during 

the treatment, and no cases of post-thrombotic 

syndrome or recurrent clotting during the more 

than three years that the researchers followed the 

patients. “With this therapy, pain and swelling 

resolve rapidly, and, in most cases, the patient is able 

to resume all normal activity within a week,” said 

the study’s co-author, Dr. McDonald Horne from 

the hematology section of Department of 

Laboratory Medicine. 

The CC researchers’ paper, “Deep Vein Thrombosis 

of the Lower Extremity: Direct Intraclot Injection 

of Alteplase Once Daily with Systemic Anticoagulation—Results of a Pilot Study,” appeared in 

the February 2008 issue of Radiology, a monthly 

scientific journal devoted to clinical 

radiology and allied sciences. The authors caution 

that larger clinical trials are required to further support the efficacy of the treatment.

Researchers who collaborated on the project stand in 

front of scans showing (from 

left) a pilot study participant’s 

veins before and after the 

alteplase treatment. (Back 

row, from left): Drs. McDonald Horne, Richard Cannon, 

Richard Chang, and Anthony 

Kam. (Front row, from left): 

Drs. Clara Chen, and Edie 

Mao. Not pictured: Thomas 

Shawker. Cannon is NHLBI

clinical director.
18 • Annua l report 2009

HOME STATES OF ALL ACTIVE CLINICAL CENTER PATIENTS

workforce distribution fy 2008 budget by major category

351.9 million

0-99

100-499

500-1,999

2,000-9,999

10,000 +

Patients come to NIH from 

every corner of America 

seeking answers to their 

scientific and medical questions. 

Finding these answers through 

leading-edge clinical research 

is the sole mission of the 

NIH Clinical Center, guiding 

all of its activity. 

VT 115

NH 163

MA 987

RI 96

CT 570

NJ 1699

DE 360

DC 6128

MD 26,984

Nursing & patient care/support 

services 41% 

Administrative & operations 17%

Clinical departments & 

imaging sciences 

departments 42% 

Salaries and benefits 53%

NIH assessments 7%

Drugs 10% 

Contracts (labor) 9%

Contracts (non-labor) 9%

Equipment 4%

Supplies 6%

All other 2%

The Clinical Center has a staff of 

approximately 2,000.

WA

584

OR

337

CA

2307

ID

148

MT

108

WY

49

NV

152 UT

418

CO

491

AZ

468

NM

208

ND

53

SD

52

NE

168

KS

293

OK

285

TX

1560

MN

504

IA

262

MO

542

AR

173

LA

441

WI

620

IL

1015

IN

653

OH

1309

MI

1146

TN

601

MS

215

AL

343

GA

1095

NC

1335

SC

619

FL

2413

VA

11,902

PA

3171

NY

2840

MA

185

WV

KY 742

440 

AK

72

HI

79

Patient Activity and Support
Annua l report 2009 • 1 9

6,096

5,825

6,105

9,263

9,435

9,460

51,575

51,189

51,311

8.3

8.6

8.5

95.151

90.889

90,254

1,165

1,239

1,329

1,357

1,372

1,390

1,449

237

251

241

180

205

166

155

437

450

474

487

505

484

478

06

07

08

Admissions

06

07

08

New patients

06

07

08

Inpatient days

06

07

08

Average length 

of stay (days)

06

07

08

Outpatient

visits

7.9% decrease

4.4% decrease

4.8% increase

4.6% decrease

1.9% increase

0.3% increase

10.6% decrease

0.7% decrease

0.2% increase

4.9% decrease

3.7% increase

1.5% decrease

9.4% decrease

4.5% decrease

0.7% decrease

02

03

04

05

06

07

08

Active

Protocols

02

03

04

05

06

07

08

New

Protocols

02

03

04

05

06

07

08

Principal

Investigators

PA TIENT AC T I V I T Y

on s ite C LIN CA L AC T I V I T Y FOR 2002–2008
20 • Annua l report 2009

In May 2008, NIH introduced a new clinical research program that will aim to provide answers to 

patients with mysterious conditions that have long 

eluded diagnosis. Called the Undiagnosed Diseases 

Program, the trans-NIH initiative will focus on 

the most puzzling medical cases referred to the 

Clinical Center by physicians across the nation. 

“A small number of patients suffer from symptoms 

that do not correspond to known conditions, 

making their care and treatment extraordinarily 

difficult. However, the history of biomedical 

research has taught us that careful study of baffling 

cases can provide new insights into the mechanisms of disease—both rare and common,” said 

former NIH Director Dr. Elias A. Zerhouni, who 

made a point during his six-year tenure at NIH 

of encouraging trans-NIH initiatives. “The goal 

of NIH’s Undiagnosed Diseases Program is twopronged: to improve disease management for individual patients and to advance medical knowledge 

in general.”

The new program was the culmination of efforts 

by Dr. William A. Gahl, NHGRI clinical director; 

Dr. John I. Gallin, director of the NIH Clinical 

Center; and Dr. Stephen Groft, director of the 

NIH Office of Rare Diseases. “The NIH Clinical 

Center, the nation’s clinical research hospital, 

provides an extraordinary environment for excellence in both patient care and collaborative clinical 

investigation,” said Gallin. “This new program 

will capitalize on a rich set of skills already at 

the Clinical Center to help patients with unusual 

medical conditions. These patients often partner 

with us in clinical research to identify new diseases 

or new treatment.”

To evaluate each patient enrolled in the new 

program, NIH will enlist the expertise of more 

than 25 of its senior attending physicians, whose 

specialties include endocrinology, immunology, 

oncology, dermatology, dentistry, cardiology, and 

genetics. Gahl, who is an expert on rare genetic 

diseases, directs the new program. 

“We have developed a stringent referral process 

to ensure this program deals with those cases that 

have truly confounded medical experts,” Gahl said. 

“We will be very selective when it comes to 

patient eligibility. Our focus is strictly on conditions that have not been diagnosed.” 

An undiagnosed disease is what brought Amanda 

Young and her family to the Clinical Center in 

1990. Years of intensive testing led to a diagnosis of 

an IRAK-4 deficiency. An extremely rare genetic 

mutation affects her body’s ability to create a 

protein needed to fight bacteria, leaving her vulnerable to life-threatening infections. The oldest 

of only about 20 patients known to have the deficiency, Mandy seems to have put the worst behind 

her. Entering a career in motivational speaking, 

Mandy is positive about her future. She looks 

forward to visiting her Clinical Center “family,” 

including Gallin—her doctor—and she’s ecstatic 

that the Undiagnosed Diseases Program will be in 

place to help others like her. 

“This new program will be more than a place for 

families to come for help,” Mandy said. “It will be 

their place to come for hope.”

To be considered for the program, a patient must 

be referred by a physician and provide all medical records and diagnostic test results requested by 

NIH. Patients, as many as 100 a year, who meet 

the program’s criteria will then be asked to undergo additional evaluation during a visit to 

the Clinical Center that may take up to a week. 

Dr. William Gahl (from 

left), clinical director of the 

National Human Genome 

Research Institute; Dr. John I. 

Gallin, director of the Clinical 

Center; Amanda Young, a 

special representative from 

the patient community; and 

Dr. Stephen Groft, director of 

the Office of Rare Diseases, 

at the launch of the Undiagnosed Diseases Program. 

TRANS-NIH UNDIAGNOSED DISEASES PROGRAM 

TO HELP NAME PATIENTS’ PUZZLING CONDITIONS

 
Annua l report 2009 • 2 1

During the program’s first five months, more than 

1,200 inquires were received from potential participants and the team screened 400 charts. About 

40 cases were accepted in 2008. 

Two nurse practitioners manage logistics for the 

new program, which will use existing facilities and 

staff already at the NIH Clinical Center, NHGRI, 

and ORD. Funding for the program includes 

$280,000 per year from the ORD. 

In organizing the Undiagnosed Diseases Program, 

NIH reached out to patient advocacy groups that 

often serve as a source of information and support 

for people struggling with mysterious ailments. 

“We hope to build upon our strong working 

relationships with many patient advocacy groups. 

These organizations provide a crucial link in our 

nation’s efforts to improve human health through 

biomedical research,” said Groft.” We hope that 

this new partnership of NIH researchers, advocacy groups and patients will give hope for many 

Americans who now face troubling medical symptoms with no clear diagnosis.”

White coats are nothing new in the Clinical Center’s halls, but burgundy ones are. Proudly showing the colors are the 65 volunteers with the Patient Ambassador Program, launched Oct. 1, 2008. 

The program will help lower the cost of the messenger and escort contract by extracting duties that 

volunteers can perform. Initial savings totaled about $150,000 and more are expected. The program 

also helps strengthen community relations and foster inclusion and diversity A task force led by 

Denise Ford, CC Hospitality Services, and Courtney Duncan, CC Volunteer Services, devised a plan 

to recruit and train the team. Volunteers include staff scientists, retirees, high school students, and the 

disabled. Patient ambassadors handling patient transport in Radiology and Imaging Sciences and the 

Department of Anesthesia and Surgical Services, medical record transport, and wheelchair management. Volunteers are asked to commit a minimum of four hours of service a week for one year.

Denise Ford (at left), chief 

of hospitality services and 

patient ambassador program 

coordinator, and Courtney 

Duncan (at right), director 

of volunteer services and 

patient ambassador program 

co-coordinator, stand with 

one of the first groups of 

patient ambassadors at 

their orientation. 

Clinical Center launches patient ambassador volunteer program

"This new program 

will be more than a 

place for families to 

come for help. 

It will be their place 

to come for hope."

—-Amanda (Mandy) Young
22 • Annua l report 2009

The Department of Laboratory Medicine’s phlebotomy service’s new electronic queuing and waittime display system is helping minimize wait times for patients while preserving patient confidentiality. It’s been so effective, wait times have been cut in half.

Selecting the new system was the culmination of staff efforts to find ways to improve the patient 

experience in phlebotomy. The CC Pharmacy Department also uses an electronic queuing system.

Veronica Washington, phlebotomy supervisor, proposed the idea for an electronic system. She saw 

how long waits frustrated patients because patients had no way of tracking where they were in the 

queue for service or understanding why others who arrived later were seen first. 

Also, the team wanted to be able to immediately identify cases where phlebotomy orders were not 

yet available in CRIS (the Clinical Research Information System) so that staff could proactively 

obtain the orders—averting a common reason for patient waits. 

Under the service’s new system, staff greet arriving patients, confirm orders for blood work, and 

give each patient a numbered ticket. Patients use the ticket number, which is displayed on an electronic screen, to track their place in line. 

Ronald Stokes, who has visited the CC as a patient for 23 years, said after his first experience with 

the new system, “I didn’t think the wait time was very long in phlebotomy before, but this made 

things even faster. Veronica and her staff are wonderful. They always have a smile and take care of any 

problems that come up. They make it pleasant to come here even though you’re coming because of 

an illness.” 

The phlebotomy staff are evaluating patient feedback on the new system. The next step will be to 

add electronic kiosks, which will allow patients to enter their names and collect their tickets.

Phlebotomy supervisor 

Veronica Washington checks 

in CC patient Ronald Stokes. 

New phlebotomy system helps alleviate wait times for patients, staff
Annua l report 2009 • 2 3

Many Clinical Center patients young and old alike 

dread the needlesticks involved in starting an IV 

or other lines. Some patients consider venipuncture to be one of the most painful and frequently 

performed invasive procedures. The CC’s Vascular 

Access Device Service (VAD), a collaboration 

between the Critical Care Medicine and Nursing 

Departments, continuously evaluates new technologies that will improve venipuncture care for 

patients and recently adopted a novel technology 

to ease the placement of venous catheters. 

Debbie Gutierrez, nurse manager for the VAD 

team, said that many CC patients’ veins are difficult to find on the first try because of the types 

of rare conditions they have or the medications 

they take. 

For several years, VAD has used ultrasound imaging 

to more easily determine the difference between 

a vein, which looks like a round dark circle that 

squishes easily, from an artery, which looks like a 

pulsating circle that doesn’t change shape from 

the pressure of the ultrasound probe. Watching the 

ultrasound screen, the nurse can identify a vein, 

line up the dots on the ultrasound probe with the 

vein, and observe the needle, which shows up as 

a bright white speck, penetrating the vein. “This 

allows us to reach the vein on the first try every 

time,” Gutierrez said. 

When VAD began ultrasound placements, they 

would perform fewer than 60 per month. Now 

they are doing about 300 monthly. 

For economy and efficiency without compromising patient comfort, VAD adopted a new method 

of visualizing veins that uses a special light to 

provide a map of where the veins are located in 

the extremities. Using a combination of green 

infrared light and projection technologies, the 

viewer locates subcutaneous veins and projects 

their location onto the skin’s surface in real-time. 

This makes the process of inserting needles and 

catheters more efficient and comfortable for 

both CC patients and nurses. needle sticks.” 

Dr. Anthony Suffredini, senior investigator in 

critical care medicine, said that the VAD team is 

“doing an outstanding job and hope that by using 

these new technologies that they will make an 

excellent vascular access service even better with 

the new approaches.” 

NEW VEIN ACCESS TECHNOLOGY INCREASES PATIENT COMFORT

3 SW-N nurse Mara Vecchio 

demonstrates how the new 

vein finder illuminates patient 

veins.

Gently read magazines are in demand. Recycling 

them is helping brighten the day for Clinical 

Center patients. Magazines covering a variety 

of interests are a great resource to help patients 

pass the time while at the CC for appointments. 

It’s easy to make the drop. Red-roofed collection 

bins are located in the elevator lobbies of the P2 

and P3 parking garages and outside the patient 

library on the 7th floor of the Hatfield Building. 

Patient library and Red Cross volunteers collect 

and sort the magazines, make sure address labels 

are removed, and distribute them at least weekly 

to waiting areas in clinics, radiology, and phlebotomy.

Recycled Reads—R&R for CC patients 
24 • Annua l report 2009

Hope flows from one patient to

another in art tile project 

A treasure chest of frustration. A lone goldfish 

swimming in a bowl. The word “hope” stretched 

across a sunrise. 

These are just a few of the themes of masonite 

tiles decorated by Clinical Center patients as 

part of a project called “The Art of Healing.” 

It was conducted by the Rehabilitation Medicine Department’s Recreation Therapy Section. 

More than 100 tiles have been collected so far—

all filled with images and phrases that capture 

the personal symbols of patient experiences at 

the CC. 

Patients saw the process as a way to make a 

statement about their experience of illness, have 

their voices heard, and give a thing of beauty 

back to the CC community. 

Many tiles were made during a weekly drop-in 

clinic. Megan Robb, a board certified art therapist at the CC, and Natalie Haynes, a certified 

recreation therapist, traveled to patient units so 

that patients who must remain in bed, connected to medical devices, or in isolation had 

a chance to participate. Their works of art will 

be displayed in a flowing wall installation at 

the CC. Family members, caregivers, and staff 

helped patients create their tiles. 

 “It’s a good visual reminder for staff that receiving care here can be a simultaneously fearful 

and hopeful experience, where our patients may 

alternate between feeling powerful and vulnerable as they progress through their journey,” 

Robb said. 

Megan Robb (left), a board 

certified art therapist, and 

Natalie Haynes, certified 

recreation therapist—both 

within the Rehabilitation 

Medicine Department’s Recreation Therapy Section—

help patient Danielle Harriott 

and her mom, Cassandra 

Christopher, create tiles for 

the project that remind them 

of their home in Kingston, 

Jamaica. They painted 

the green-blue color of the 

ocean, the white sandy 

beaches, and their country’s 

flag. 

Clinical Center patient Heidi Peck, now a high 

school senior in Mountain Home, Idaho, has 

played the flute since she was in fifth grade. But 

doctors thought at one time that she might not 

play again.

Heidi has a type of kidney and liver disease that 

results in underdeveloped lungs in some patients. 

When Heidi’s mother, Debi, researched her 

daughter’s disease, she found the NIH protocol 

Heidi is currently enrolled in and contacted the 

doctors involved.

It was Heidi’s mom who thought of a concert as a 

way to thank CC staff. “She’s an inspiration to all 

of us that, no matter what’s going on, you can still 

do what you love,” said NHGRI nurse Joy Bryant.

Winner of several music performance competitions and college scholarships, Heidi is still 

deciding on a college, but plans to major in music 

performance. She is in her third year playing with 

the Treasure Valley Youth Symphony, part of the 

Boise Philharmonic. 

A musical thank you

Heidi Peck
Annua l report 2009 • 2 5

Siblings are super 

The Clinical Center Pediatric Clinic, NCI’s 

Pediatric Oncology Branch, and the Children’s 

Inn hosted a sibling day on July 15, 2008, to 

recognize and honor siblings aged 7 to15 of NIH 

pediatric patients. 

Brothers and sisters of children enrolled in NCI, 

NIAID, NICHD, NHLBI, and NIMH protocols 

participated. 

The group experienced the Department of 

Laboratory Medicine’s “Fantastic Voyage” demonstrations and a tour of the Department of Rehabilitation Medicine’s Biomechanics Laboratory. 

In therapeutic recreation activities, the kids shared 

their expertise as super siblings in the form of a 

newspaper advice column and made worry boxes 

to express what they might be experiencing as 

their patient sibling receives care.

At the end of the day, each sibling received a 

medal and a laminated certificate declaring them 

a “super sibling.” At the award ceremony, one boy 

said, “This is the best day of my entire life.” 

CC medical technologist Teresa 

Genson Bauch demonstrates 

to (from left) Lindsey Hancock, 

Shaquille Jones, Jolly Rop, and 

Emilie Hancock the importance 

of hand washing, as event organizer Dr. Lori Weiner peeks in to 

see what the kids are learning. 

The Edmond J. Safra Family Lodge 

welcomed a pair of famous visitors on 

December 13: Marvin Hamlisch, Oscar, 

Grammy, Tony, Emmy, and Pulitzer 

Prize-winning composer; and Santa. 

Since 2005, Hamlisch has performed 

at the Lodge during the holidays 

to bring cheer to the residents. 

He was joined this year by a vocalist, 

harpist, and violinist from the 

National Symphony Orchestra.

Special visitors at the Safra Family Lodge
26 • Annua l report 2009

Bad weather hits the Bethesda area. Clinical 

Center staff, patients, and family members can’t 

get to—or leave—Building 10. The roof of the 

Edmond J. Safra Family Lodge collapses and guests 

need to be moved to the Clinical Center. This was 

the scenario that CC staff members played out in 

February during an emergency drill to test the 

activation of the code yellow emergency management plan. 

The drill was also the first test of a new mass notification system that uses automated phone calls 

and emails to provide open and immediate contact 

for staff during a disaster or emergency. 

The drill is one of the ways the Clinical Center 

stays prepared to respond to emergency events 

in accordance with the Joint Commission’s six 

critical functions for emergency management: 

communications, resources and assets, safety and 

security, staff responsibilities, utility management, 

and clinical and support operations. 

Laura Lee, special assistant to the deputy director 

for clinical care, said a key objective of the drill 

that was extremely successful was practicing communication within departments through emails 

and phone trees. 

All CC departments played a critical role in testing 

their internal communication processes, assessing 

staffing needs, assessing supply levels, and food and 

shelter needs. 

David Folio, chief of the Nutrition Department at 

the Clinical Center, is among the nation’s hospital 

food service managers looking for more ecofriendly ways to carry out essential operations. 

Their goal is to help create a healthier environment in their health care communities. 

The CC Nutrition Department collaborates with 

Maryland Hospitals for a Healthy Environment 

(MD H2E), part of the University of Maryland’s 

School of Nursing. MD H2E is working with the 

national campaign for healthy food in health care 

through Health Care Without Harm, an international coalition of organizations whose mission 

is to transform the health-care sector so that it is 

ecologically sustainable without compromising 

patient safety or care. 

Folio’s approach is to question every practice 

within the department and ask if it could be better 

in terms of saving money and helping the environment. “The Nutrition Department’s budget 

remains flat, but food costs keep going up. The 

way we have been able to come in under budget 

for the past four years is to find ways to reduce 

costs. Sometimes making environmentally friendly 

changes can also save money,” he said. However, 

before adopting each proposal, Folio evaluates it to 

make sure it is a sound business decision, in addition to being green. 

The CC activated its central 

command center to coordinate hospital-wide logistics 

and communications during 

February’s disaster drill. 

Staff also manned a nursing 

command center (below) to 

coordinate patient capacity 

and available beds, distribute 

staffing assignments for the 

accessible labor pool, and 

monitor public safety. 

Organizational Improvement/Teamwork

Emergency drill provides 

a learning exercise, 

chance to practice

Nutrition Department

efforts seek ecological, 

economic savings
Annua l report 2009 • 2 7

He’s also gradually reducing the department’s carbon footprint by purchasing smaller, more energyefficient pieces of food service equipment as older 

machines need to be replaced and technology 

improves. 

Most foods on patient room service menus are 

cooked to order. The department’s new highspeed oven combines convection, microwave, and 

infrared cooking technology to prepare individual 

servings 10 times faster while using less energy 

and preserving nutrients and taste. The new oven 

is not the only eco-friendly food service equipment change. Plastic air-strip curtains hang over 

all walk-in refrigerator and freezer doors to lower 

the amount of energy used and the CC electric 

bill. Used fryer oil is collected and recycled into 

biofuel. A cardboard compactor minimizes waste 

volume. The dish room pulper reduces 10 trash 

cans of food waste into one. 

 “It takes time to research products, analyze the 

business decision, and pressure distributors to offer 

eco-friendly products. It’s a continuous process 

of learning, questioning, and considering new 

ideas—wondering all the while what’s best for the 

CC mission, our patients, and the planet,” Folio said.

Food service workers Alekos 

Polyzos (above) and Crystal 

Cavin break down breakfast 

trays for the dish room pulper. 

The team dumps food and paper 

items into the water flowing over 

the conveyor belt, which moves 

it forward, and stacks the dishes 

into a machine that washes, 

rinses, dries them. The pulper 

gurgles and thumps as it extracts 

the liquid from the items and 

chops them into tiny pieces. 

Lionel Coriolan (left) cooks a 

pizza in one minute with the 

Nutrition Department's new 

high-speed oven. 

going green...what it means

Item

New milk vendor

Room service program

Soup broth purchased as a 

base, rather than cans

Re-useable cup

Rechargeable batteries for 

staff pagers

Annual Cost Savings

$6,500

Cost-neutral. Food costs go 

down, but labor costs go up

$3,800

$15,000

$400 within three years 

after the cost of batteries 

and charger

Environmental impact

Packaged in paper, not plastic, 

containers

Reduces food waste as patients 

order only what they want

4,370 fewer cans used per year

125,000 fewer disposable cups used

144 fewer batteries used per year

Patient impact

Recombinant bovine 

growth hormone-free

Meets patient requests 

on demand

No difference for 

patients

Cup is a nicer product 

for patients

No difference for 

patients
28 • Annua l report 2009

The Housekeeping and Fabric Care Department (HFCD) received the CC’s fourth Patient 

Safety Champion Award, which is given annually 

to individuals or teams demonstrating a sustained 

commitment to a safe patient environment. 

From May to November 2007, the Clinical Center 

experienced an outbreak of Acinetobacter baumannii. 

Managing an outbreak with such an organism 

requires a coordinated team approach. In addition 

to aggressive medical and nursing care, special 

attention to the patient care environment is 

essential. In response to this challenge, the housekeeping team received additional training, applied 

innovative cleaning practices far more stringent 

than typical in a patient-care unit, and maintained 

a positive attitude. Their efforts sanitized every 

single item in affected patient rooms with one 

thorough cleaning. HFCD built quality assurance 

checks into the process before repeating cleaning 

tasks and followed up with a second quality 

assurance check. 

HFCD Chief Rob Mekelburg said the intensive 

cleaning, combined with the communication and 

education efforts from the entire patient-care team, 

were instrumental in eliminating the organism at 

the CC. “We’re proud of our housekeeping team 

and their important role in containing this organism, 

as well as their ongoing, overall contribution to 

the patient-care team,” Mekelburg said. 

When notifying HFCD of their award, Henderson thanked the team on behalf of CC patients 

for their efforts. “Acinetobacter baumannii often 

infects the sickest, weakest patients who are least 

able to fight off an infection—often those in the 

ICU. The HFCD team had to come up with ideas 

beyond conventional strategies to quickly solve this 

patient-care issue. This involved a lot of extra work 

and training,” Henderson said, noting that the 

CC has not identified a single isolate since early 

December 2007 and developed a strategy in case 

of a recurrence.

Housekeeping staff named CC patient safety 

champions

Experiences for many Clinical Center volunteers 

offer both personal and professional enrichment. 

For Dr. Cynthia Guime-Gonzalez and Vanessa 

Flores, who both began as volunteer Spanish 

language interpreters, their work here has helped 

pave paths to becoming physicians and establishing 

medical practices. 

Guime-Gonzalez began volunteering here in 1998 

during vacations to visit relatives in Bethesda. She 

earned her medical degree in Panama in 2008 and 

has returned to the U.S. for a residency. Originally from Ecuador, Flores was a summer research 

student with the NHLBI’s vascular medicine 

branch for three years and interned in the Social 

Work Department’s volunteer office in 2004. A 

medical research career has long been Flores’ goal. 

“Coming to NIH gave me that perspective and 

also raised my awareness about public health issues. 

I want to collaborate with research institutions and 

be a part of the evolution of improving medicine.” 

Flores is in the NIH Undergraduate Scholarship 

Program, which offers competitive scholarships to 

students from disadvantaged backgrounds who are 

committed to biomedical, behavioral, and social 

science health-related research careers. She will 

return to NIH to serve one year of full-time employment for each year of scholarship tuition she 

receives to attend a combined MD and master’s 

program in clinical research at the University of 

Pittsburgh’s School of Medicine.

Because the CC is a special hospital, with patients 

coming here to participate in research, the personalities of the staff are also special, according to 

Guime-Gonzalez. “They’re friendlier, not rushed, 

and they take the time to explain things. They understand that most of the information about a disease comes from the patient, so people here listen 

to what patients say and feel so they can provide 

the best treatment. I really admire the NIH staff at 

all levels. It feels like a big family here.”

CC VOLUNTEERS FIND BRIDGE TO MEDICINE

(from left, standing): Latiff 

Yacoob, Donald Bryant, 

George Kennedy, Dr. David 

Henderson, Roger Rizer, Ronald Jones, Nathan Grey, and 

Angela Michelin. (from left, 

seated): Fikirte Gebremichael, 

Belaynesh Bekele, Abeba 

Syefu, Sonia Vaquiz, and 

Teresa Guevara. HFCD team 

members not pictured: Teresa Scheler, Larry Williams, 

Maria Bommarito, Florencia 

Zaldivar, Annette Poindexter, 

Teresa Fuentes, and Selina 

Gyimah

Dr. Cynthia Guime-Gonzalez (left) 

and Vanessa Flores. 
Annua l report 2009 • 2 9

Though a testament to one’s abilities, a promotion

to supervisor role from individual performer can 

be a challenge. To support a successful transition, 

the CC Office of Organizational Development 

has implemented Supervisory Essentials, a training 

program with strategies to effectively transition.

 “In an effort to support their success and to provide a strong foundation on which to advance into 

positions of increasing responsibility, it is essential 

that we provide supervisors with the necessary 

tools to do their jobs,” said Maureen Gormley, the 

CC’s chief operating officer.

The program is designed for new and current 

CC supervisors, soon-to-be supervisors, and team 

leaders. Attendees will learn how to use influence 

and delegate, as well as how to apply motivational 

principles to assess employee needs, build upon 

strengths, and recognize and reward performance. 

The course provides basic knowledge on how to 

work effectively with human resource and administrative officer colleagues.

The CC Executive Committee has endorsed the 

supervisor training a required course beginning in 

2009. 

Out and about

Clinical Center staff led and participated in a 

variety of walks and runs in 2008. In May, it was 

the first ever Take a Hike Day (top right). About 

2,000 NIHers participated in this 3-mile noncompetitive walk and fun run. The NIH Office 

of Management—in partnership with the Office 

of Research Services, Division of Amenities and 

Transportation Services, and the NIH Clinical 

Center—coordinated the event, which was held 

in conjunction with the 2008 National President’s 

Challenge and the HealthierFeds initiative. In June, 

about 40 NIH colleagues participated as Team 

NIH at the 2008 Komen National Race for the 

Cure to fight breast cancer. Despite the heat and 

humidity, Team NIH was the first team to cross 

the finish line (bottom right).

In October, about 100 NIH staff gathered for a 

1.5 mile wellness walk to celebrate National 

Physical Therapy Month. When done on an 

employee’s lunch break, the walk plotted for 

the Physical Therapy Month event would be an 

easy way to fit in exercise, said physical therapist 

Bart Drinkard, CC Department of Rehabilitation 

Medicine.

new course in the essentials of supervising offered
30 • Annua l report 2009

Each year, the Clinical Center honors the more 

than 1,000 nurses who are committed to fulfilling the unique needs of the agency’s public health 

mission with a week-long celebration sponsored 

by Nursing and Patient Care Services. The CC 

interpretation of the American Nurses Association’s 2008 theme, “Nurses Making a Difference 

Everyday,” emphasized the broad impact that 

nurses, especially those involved in clinical research, 

have on how patients receive health-care treatment. The CC observance was May 5-9.

Dr. Patricia A. Grady, director of the National 

Institute of Nursing Research (NINR) and one 

of the speakers at the week’s opening ceremony, 

reflected on “how exciting and complicated it is 

to be a clinical research nurse at the CC—one of 

the most important places in the world because 

it’s where ideas are developed and tested, a place 

where you know you’re making a difference all 

across the country and the world.” 

 

Dr. Donna Berry, vice chair for research and the 

Myrene C. McAninch term professor in nursing at 

the University of Washington’s School of Nursing, 

opened the celebration with her keynote address, 

“Patient-Centered Technologies—Making a Difference in Patient Care.” 

According to Berry, an opportunity exists to begin 

moving patient-clinician interactions to times and 

places that are more convenient to patients. For 

example, Berry and her team developed electronic 

questionnaires that could be answered at home 

through the Web or in clinic waiting rooms with 

a laptop to shift when and where intake interviews occur. The idea, developed by nurses, offers 

a way to enhance the process of intake. During 

the week-long event, staff were able to visit the 

1SE patio for an interactive nurse education fair 

with stations highlighting topics including CRN

2010, the Public Health Service, nutrition, shared 

governance, and ideas for broadening professional 

development. 

On May 7, Dr. Margaret Bevans and Sandra 

Mitchell, both of the CC Nursing Department, 

presented CC Grand Rounds on issues related 

to hematopoietic stem cell transplants. At the 

opening ceremony, CC Director Dr. John I. Gallin 

called this lecture a “landmark” Grand Rounds 

because it marked the first time in the series that CC 

nurse scientists presented their research conducted 

at the CC. “The nurses make this place so special 

and make it work on a daily basis,” Gallin said. 

The specialty practice of CRN was the theme 

of the presentations at the closing ceremony. Dr. 

Clare Hastings, chief of Nursing and Patient Care 

Services, said that other nurses involved in clinical 

research around the country and across the world 

were waiting for someone to clearly define the 

CRN role. “The CC leads the US in developing 

the specialty practice model for CRN, so it’s appropriate for us to define CRN roles and contributions and develop and disseminate practice 

documentation, standards, and management tools,” 

she said. 

According to Hastings, the long-term outcomes 

for the CC’s CRN 2010 initiative include: 

• Defining the practice domain; 

• Establishing practice standards; 

• Determining core competencies; 

• Developing content for the certification 

process; and 

• Creating tools to assist CRNs in specialty 

practice development and documentation. 

Week celebrates science, practice of

clinical research nursing

Dr. Donna Berry, vice chair 

for research and the Myrene 

C. McAninch term professor 

in nursing at the University 

of Washington's School of 

Nursing, opened the week of 

celebration with her keynote 

address. 

3NW received the 2008 

“Best Collegial Practices” 

Patient Care Area Award. 

From left are Tanjanell Simon; 

Caroline Stewart; OP8 team 

members Amy Nelson, Liz 

Formentini, Rose McConnell, 

Jakki Plummer, Barbara Corey, 

Margie Lloyd, Jean Hammer, 

Sten Witzel, France Sundt, 

Brent Bonfiglio, and Gregg 

Roby; and Dr. Clare Hastings. 
Annua l report 2009 • 3 1

Course on clinical

research presented in China

Clinician-scientists and biostatisticians from the 

National Institutes of Health were instructors in 

a modified version of the Clinical Center’s course 

“Introduction to the Principles and Practice of 

Clinical Research” to Beijing in November 2008.

This is the first time an adaptation of the course, 

offered at the Clinical Center annually since 

1995, has been presented live outside the NIH 

in Bethesda. “More than 7,500 participants have 

enrolled in this course since its inception and it 

has been videoconferenced to 29 locations in 

the US and to seven countries,” noted Dr. John I. 

Gallin, director of the Clinical Center and course 

leader along with Dr. Frederick P. Ognibene. “We 

are honored our colleagues in China offered this 

opportunity to broaden education and training in 

the conduct of clinical and translational medical 

research.”

The course taught in China covered clinical 

research design, ethics, methodology, and data 

analysis. “Better health and health care for the 

future depend on successful and productive clinical research today,” said Gallin. “Medical research 

involving human subjects must be safe, ethical, and 

efficient. This course provides a strong foundation 

in these basics.” 

The NIH Clinical Center has been invited back to 

provide more training in China in 2009 and is exploring partnerships to take the training to Russia 

and sub-Saharan Africa. “The goal of this program 

is to help countries become self-sufficient in 

providing their own training in clinical research,” 

Gallin said. 

Live lectures included: “Clinical Research Project 

Design and Guidelines,” presented by Dr. Laura 

Lee Johnson, NIH National Center for Complementary and Alternative Medicine; “Institutional 

Review Boards and Integrity in Research,” Dr. 

Jerry A. Menikoff, director, Office for Human 

Research Protections, Office of Public Health 

and Science, Office of the Secretary, Department 

of Health and Human Services; “Clinical Case 

Studies and Meta-Analysis,” Dr. Charles Natanson, 

Critical Care Medicine Department, NIH Clinical Center; “Clinical Research Methodology,” Dr. 

Dennis O. Dixon, National Institute of Allergy and 

Infectious Diseases; and “Ethical Principles and 

Bioethical Questions,” Dr. Reidar Lie, Bioethics 

Department, NIH Clinical Center.

Rotation swap serves NIH 

trainees and FDA reviewers

Before each drug, vaccine or treatment device can 

be distributed for public use, it must be proven safe 

and effective. A new rotation lets clinical researchers, including trainees, to learn the regulatory 

process first-hand at the Food & Drug Administration (FDA). It also accommodates FDA investigators and trainees who would like to learn about 

Clinical Research at the Clinical Center.

The FDA Clinical Pharmacology Rotation, led 

by Dr. Juan Lertora, from the Office of Clinical 

Research Training and Medical Education and 

director of the Clinical Center’s Clinical Pharmacology Program, is open to all clinical research 

trainees and other interested personnel. Since the 

CC specializes in translational research, fellows 

from various programs could use the skills taught 

in this rotation, Lertora said.

Participants will learn about guidelines on therapeutic area-specific drug development and how 

to prepare an Investigational New Drug (IND) application. In the FDA Center for Drug Evaluation 

and Research (CDER), participants will review 

pre-clinical and clinical data on investigational 

drugs, take part in specialized therapeutic team 

meetings and meetings with sponsors, and contribute to an IND 30-day safety review. Trainees 

sign a confidentiality agreement because of the 

proprietary nature of the information discussed at 

the meetings they may attend.

 “Scientist exchange is a novel and critical way to 

give scientists both at NIH and FDA an opportunity to leave their routine and pursue independent, 

but related, knowledge of clinical pharmacology, 

Training the Next Generation
32 • Annua l report 2009

Alex Razzook, a project engineer in the CC Rehabilitation 

Medicine Department’s Physical Disabilities Branch, gives 

the CTSA scholars an overview of the clinical movement 

analysis lab. It’s a unique 

resource using cutting-edge 

imaging technology to map 

human muscle movement 

while patients walk or run 

so that therapists can help 

patients learn how to move 

better. It also gives researchers investigating stroke, Parkinson’s disease, and brittle 

bone disease insights into 

how their patients move. 

drug development and clinical medicine,” said Dr. 

Lawrence Lesko, director of FDA CDER’s Office 

of Clinical Pharmacology and Biopharmaceutics. 

Lertora described the program to the Clinical 

Fellows Committee in July. “This type of rotation 

in a high-powered governmental agency that has 

a primary role in drug development, evaluation, 

and approval is exactly the kind of experience that 

sets an NIH clinical fellowship apart from all other 

programs in the country,” said Dr. Brian Porter, the 

committee’s co-chair. “I am unaware of any other 

training program that could offer such a flexible, 

unfettered learning experience with a major federal agency partner, such as this.” 

CTSA scholars visit

The Clinical Center is anxious to embrace new 

Clinical and Translational Science Award (CTSA) 

partnerships. That's the message 18 CTSA scholars 

and program administrators heard from Dr. John I. 

Gallin, CC director, during a spring 2008 visit. 

They represented Emory University, Johns 

Hopkins University, the Mayo Clinic College of 

Medicine, Rockefeller University, University of 

Pittsburgh, and Washington University, six of the 

38 academic health centers in 24 states that are 

part of a national consortium aimed at transforming how clinical and translational research is 

conducted at academic health centers across the 

country. 

In 2012, when the program is fully implemented, 

approximately 60 CTSAs will be connected with 

an annual budget of $500 million. 

Gallin told the visitors that new CC-CTSA 

partnerships would complement research that is 

done intramurally and extramurally. “Our hope is 

that partnerships among intramural and extramural 

investigators will enrich both investigators’ 

research programs,” he said. 

A major opportunity for collaborations is through 

the Bench-to-Bedside program created by the 

Clinical Center in 1999 to speed translation of 

promising laboratory discoveries into new medical 

treatments by encouraging collaborations among 

basic scientists and clinical investigators. The program has been open to research teams made up of 

intramural and extramural partners since 2006.

Informatics tools developed at the Clinical Center 

also offer specialized resources in support of clinical 

research. One is ProtoType, a Web-based clinical 

protocol writing tool that provides investigators 

with a standard protocol structure, online help, and 

templates of suggested language. Investigators use 

it to put ideas for new protocols into the proper 

format to satisfy regulations and facilitate review. 

Gallin also shared with the group the vision for 

BTRIS—the Biomedical Translational Research 

Information System now in development. Investigators can use to help identify promising new 
Annua l report 2009 • 3 3

avenues for research and foster data-sharing across 

NIH institutes and with extramural collaborators. 

“We’re building this data repository so that it will 

be compatible with the CTSA sites’ repositories. 

We envision that one day we will have a national 

clinical research data repository,” Gallin said “The 

opportunity to tour the CC first hand and meet 

outstanding leaders in the research community 

provided considerable excitement for each of the 

clinical research scholars. They identified important new resources at the NIH for support of their 

respective innovative multidisciplinary clinical 

research programs,” said Joan M. Lakoski, associate 

vice chancellor for academic career development 

at University of Pittsburgh Health Sciences and 

CTSA program committee chair.

Program aims to prepare

next wave of imaging 

scientists

A new competitive research-training program aims 

to recruit radiologists and nuclear medicine physicians to the NIH to participate in translational 

research. A partnership between the National Institute of Biomedical Imaging and Bioengineering 

(NIBIB) and Radiology and Imaging Sciences at 

the Clinical Center, the Imaging Sciences Training Program (ISTP) will prepare participants to 

move forward in their careers through exposure to 

hypothesis-driven research. 

“The goal is to train them with necessary skills 

and techniques to carry out hypothesis-driven 

research, to present findings at scientific meetings, 

write an IRB-approved protocol, and compete for 

grants,” said Dr. Joseph Frank, director of the ISTP. 

He cited computer-assisted diagnosis, radiofrequency ablation of tumors, cellular imaging, and 

DNA repair as potential areas for interest for ISTP

applicants. Fellows could be placed in Radiology 

and Imaging Sciences or with other investigators, 

depending on availability. 

All enrolled in the ISTP will receive didactic training in biostatistics, grant writing courses, and instruction on writing a scientific paper are also part 

of the training, a one-to-two-year fellowship. The 

ISTP will accept recent medical-school graduates 

as well as those who have completed their residency or fellowship for the program’s six slots. 

“With Dr. Frank’s leadership and in partnership 

with NIBIB, the ISTP will become the premier 

program nationally to provide translational research 

training for the clinician scientist involved in advanced imaging programs,” said Dr. David Bluemke, director of the CC’s Radiology and Imaging 

Sciences.

Dr. Richard Childs 

named 2008 Distinguished 

Clinical Teacher

Dr. Richard Childs, senior clinical investigator in 

NHLBI’s Hematology Branch and a commander 

in the US Public Health Service, received the 2008 

Distinguished Clinical Teacher’s Award. The recipient is a mentor, chosen by NIH clinical fellows, 

who guides professional growth by helping trainees 

identify and develop skills and talents, set and 

achieve goals, anticipate roadblocks, and overcome 

obstacles.

Chairperson of this year’s selection committee of 

fellows, Dr. Jennifer Heimall from NIAID, presented Childs with the award, given annually since 

1985. Heimall read from her peers’ comments 

regarding their chosen mentor: 

• “He is absolutely the best teacher I have ever 

had the pleasure of working with.”

• “Under his tutelage, I have been motivated 

to strive for and achieve exceptionally high 

standards in both patient care and research. 

He is an excellent role model.”

 “I am thrilled and absolutely honored to win 

this award,” Childs said. “It is humbling to be 

nominated by members of the fellows committee, 

particularly when one considers there are so many 

outstanding physicians dedicated to teaching some 

of the brightest and most creative research-oriented 

fellows in training.” As recipient of the award, 

Childs will deliver the annual John Laws Decker 

Memorial Lecture June 10, 2009. 

Dr. Jennifer Heimall, chairperson of this year’s fellows 

committee, presented the 2008 

Distinguished Clinical Teacher’s 

Award to Dr. Richard Childs. 
34 • Annua l report 2009

“See one, do one, teach one.” A motto within 

medicine expressing the obligation to teach those 

a step behind, it’s the goal of the Clinical Research 

Training Program (CRTP) that places researchminded medical and dental students in mentored 

clinical or translational research projects in a field 

matching their personal interests and goals.

Eight years ago Dr. Michael Dimyan, now a 

neuro-rehabilitation fellow with the human cortical physiology section in the NINDS, participated 

in CRTP. He returned to NIH in 2006 and from 

2007-2008 mentored CRTP fellow Erick Tarula, 

who is currently a fourth-year medical student 

from Charles Drew University of Medicine and 

Science. 

“For medical students training at other hospitals, 

there is usually little exposure to fellows, who 

primarily teach senior residents,” noted Dimyan. 

“This program is different. Medical students work 

with fellows at a time when fellows really begin 

to define themselves career-wise. Observing the 

fellows—who themselves are learning new techniques, navigating unwritten rules, and 

demonstrating that instead of an instruction booklet there are multiple paths to reach your goals—

helps medical students clarify their understanding 

of themselves, what they want, and how they want 

to get it.”

Dimyan credits his return to NIH to the positive 

experience he had as a medical student in the 

CRTP. He describes the year as extremely inspiring and influential. So much so that after leaving 

NIH, he kept in touch with both mentors 

Dr. Mark Hallett, chief of the NINDS human 

motor control section, and Dr. Takashi Hanakawa, 

currently a professor of cortical function disorders 

at the National Center of Neurology and Psychiatry 

in Tokyo. Dimyan’s project during his 2000-2001 

CRTP academic year focused on imaging brain 

activity during motor planning, imagery, and 

movement.

Also influential was Hallett’s ability to bridge the 

gap between being a scientist and a clinician. 

“He is a rare person in still being an outstanding 

clinician and an amazing scientist as well. There are 

Dr. Michael Dimyan (left), a 

neuro-rehabilitation fellow 

with NINDS’ Human Cortical 

Physiology Section of the 

Medical Neurology Branch 

and CRTP participant Erick 

Tarula, currently a fourth-year 

medical student. 

Role reversal for NINDS

fellow, CRTP alum
Annua l report 2009 • 3 5

Office of Clinical Research

Training and Medical

Education

The Clinical Center programs to train the next 

generation of clinical researchers continue to 

expand. Established in 2003, the Office of Clinical 

Research Training and Medical Education offers 

three courses (Introduction to the Principles and 

Practice of Clinical Research, Principles of Clinical 

Pharmacology, and the required Clinical Research 

Training for principal investigators) and manages 

the NIH-Duke program in clinical research leading to a Master of Health Sciences in Clinical 

Research degree, Clinical Center Grand Rounds, 

the NIH Clinical Research Training Program 

(CRTP) for medical and dental students, the 16 

approved Accreditation Council for Graduate 

Medical Education (ACGME) residencies and 

fellowships at the NIH, the Annual Clinical 

Fellows’ Orientation and other educational and 

training programs. More than 30,000 students 

worldwide have participated in the full range 

of CC clinical research educational programs; 

including its web-based training.

In 2008/2009, there are 952 enrollees (547 from 

21 remote sites) in the Introduction to the Principles 

and Practice of Clinical Research course and 

537 enrollees (200 from 13 remote sites) for the 

Principles of Clinical Pharmacology course.

very few people who can do both,” he said. 

“Observing subtle aspects of behavior and 

movement, which are the products of the nervous system, is what makes a great neurological diagnostician. Then as a clinical researcher, 

the challenge is to use those observations to 

address what might be a subtle, yet scientifically 

critical question,” Dimyan said. CRTP demonstrated a way for Dimyan to mix the clinical 

and scientific aspects of neuroscience, which 

helped shape him and his career.

Tarula also benefited from the program’s 

emphasis on mentoring around both clinical 

research skills and professional development. 

Dimyan and Tarula worked together in Dr. 

Leonardo Cohen’s laboratory studying brain 

functioning through electromagnetic stimulation. Tarula’s CRTP project focused on the 

cerebellum’s role in motor learning using 

transcranial magnetic stimulation.

 “Michael really took me under his wing, 

showed me the ropes, and helped me develop 

my own project. He has helped mature both 

my clinical and scientific skills, things I need to 

become a successful clinician-scientist,” Tarula 

said.

Tarula is already continuing the medical community’s tradition of mentoring. He worked 

with students at his former high school and 

spoke at the 2008 National Network of Latin 

American Medical Students conference, encouraging others to go into clinical research.

 

As a mentor, Dimyan encouraged Tarula to be 

confident in the work that he has put into his 

CRTP project and to project that confidence 

to his interactions with medical colleagues and 

patients. “Your patients depend on you to be 

confident, especially in neurology where you 

see a lot of bad disease that robs memories, personality, and a lot of what makes you human.” 
36 • Annua l report 2009

Mention of a changing political landscape drew 

cheers from the 321 medical and dental students 

representing 78 schools gathered at NIH for the 

Sixth Annual Clinical Investigator Student Trainees 

(CIST) Forum in November. 

Dr. Michael M. Gottesman, NIH deputy director for intramural research, acknowledged the 

enormity of the upcoming transition—a new 

US president, HHS secretary, and NIH director. 

“Despite all of the changes, NIH and the federal 

government are very strongly dedicated to the 

idea of training research scientists who can really 

pick up on the thread of improving public health 

in this country,” Gottesman said in welcoming the 

attendees.

Dr. John I. Gallin, Clinical Center director, echoed 

the sentiment. “To see all the young people in the 

room representing the future of research science, 

I feel very excited and hopeful of change.”

The students, who represent the next generation 

of clinician-scientists, met November 6 and 7 for 

lectures and panels comprised of leading researchers speaking on recent changes in medical research 

methods and technologies as well as the range of 

career options for clinical researchers, a tour of the 

Clinical Center’s newest labs and patient care and 

research units, and networking opportunities with 

peers and potential mentors. 

Student participants included Howard Hughes 

Medical Institute (HHMI)-NIH research scholars 

and HHMI medical fellows; Doris Duke Charitable Foundation clinical research fellows; students 

sponsored by National Center for Research 

Resources/Clinical and Translational Science 

Awards (NCRR/CTSA) programs; NIH Clinical 

Research Training Program fellows; Sarnoff 

Cardiovascular Research Foundation fellows; 

Applied Epidemiology Fellowship participants at 

the Centers for Disease Control and Prevention; 

Fogarty International Clinical Research Scholars; 

Students attending the annual 

Clinical Investigator Student 

Trainees Forum were able to 

tap into advice from successful clinician-scientists during 

networking sessions, with 

the students branching out to 

networking lunches grouped 

by research interests. The 

session on pulmonary critical 

care attracted 30 students. 

Sixth annual CIST Forum engages 

and inspires students
Annua l report 2009 • 3 7

and the NIH MD/PhD Partnership Training 

Program fellows.

A highlight was a presentation illustrating the 

importance of mentoring in students' training in 

clinical research, “Mentoring Teams in Clinical 

Research: Project in Tugela Ferry, South Africa, 

on Multi-Drug Resistance in Tuberculosis.” Dr. 

Gerald H. Friedland, professor of medicine, epidemiology, and public health at Yale University 

School of Medicine, is the study’s lead investigator. 

Joining him on the panel were four of his protégées 

at various stages in their training. 

“The work done by members of the Friedland 

team is an excellent example of how senior clinicians nurture and enrich their students’ educational 

experiences,” noted Dr. Frederick P. Ognibene, 

director of the Office of Clinical Research Training 

and Medical Education at the Clinical Center. 

A series of lectures entitled “Translation from the 

Bench to the Bedside: Innovations in Imaging Sciences,” was moderated by Gallin and a panel about 

“The Importance of Mentoring in the Development of Careers in Clinical and Translational 

Research,” was led by Ognibene. 

Speakers for the imaging lectures were Dr. N. Reed 

Dunnick, Fred Jenner Hodges Professor and chair, 

Department of Radiology, University of Michigan, 

“Better Living Through Imaging;” Dr. Ronald 

M. Summers, chief of the Clinical Image Processing Service, CC Radiology and Imaging Sciences, 

“Virtual Bronchoscopy and Virtual Colonoscopy;” 

and Dr. David A. Bluemke, director, CC Radiology 

and Imaging Sciences, “Insights Using MRI and 

CT in Evaluating Cardiovascular Disease.”

Participating in the panel discussion on mentoring 

were Dr. Peggy C. Nopoulos, professor of psychiatry, pediatrics, and neuroscience and director of the 

Iowa Doris Duke Clinical Research Fellowship 

Program and of the Psychiatric Iowa Neuroimaging Consortium University of Iowa Carver College 

of Medicine; Dr. Lars F. Berglund, professor of 

medicine, associate dean of clinical and translational 

research, and program director, Clinical and 

Translational Science Center, University of California Davis School of Medicine; and Dr. Timothy 

G. Buchman, Edison Professor of Surgery, professor of anesthesiology and of medicine, Washington 

University School of Medicine. In the presentation, 

Buchman noted, “There are only two things you 

own: your integrity and your passion. Guard them 

and grow them.”

Attendees were able to tap into advice from 

successful clinician-scientists during networking sessions, with the students branching out to 

networking lunches grouped by research interests. 

The session on pulmonary critical care attracted 30 

students. “You really need to pick something you 

love—that will make you happy,” urged Dr. Stewart 

Levine, chief of NHLBI’s Asthma and Lung Inflammation Section and acting chief, Pulmonary and 

Vascular Medicine Branch. 

The forum included tours of the Clinical Center. 

“I don’t think many of us had seen such a large 

hospital devoted to clinical research,” said Parham 

Khalili, a NCRR/CTSA-sponsored student at 

the University of Chicago Pritzker School of 

Medicine. Emily Williams, a HHMI fellow at the 

University of Pennsylvania School of Medicine, 

noted peer connections as her biggest takeaway 

from the meeting. “It’s so intriguing to hear about 

their research and what the different medical 

schools are like,” she said.

 

“You really need to 

pick something to 

love–that will make 

you happy.”

—Dr. Stewart Levine
38 • Annua l report 2009

Palav Babaria (left) and 

Michelle Scott tell of their 

time spent addressing 

multi-drug resistant tuberculosis in South Africa. 

For a student engrossed in research, the lab can 

begin to feel like a home away from home. For 

Doris Duke Charitable Foundation Clinical 

Research Fellows Michelle Scott and Palav 

Babaria, stationed in South Africa in 2007 and 

2008, it was more than a feeling. 

The two spent the year in Tugela Ferry in the 

province of KwaZulu-Natal working on two 

studies aimed at fighting the drug-resistant tuberculosis (TB) epidemic in the area. The leading 

infectious disease cause of death in the world, TB 

accounts for 30-40 percent of the annual morbidity in HIV patients. 

The students and their mentors—Dr. Neel R. 

Gandhi and Dr. Gerald H. Friedland—presented a 

panel discussion describing their experiences during the CIST forum. Gandhi is assistant professor 

in the Departments of Medicine and Epidemiology & Population Health at Albert Einstein College 

of Medicine. Friedland is professor of medicine, 

epidemiology, and public health at Yale University 

School of Medicine. 

While drug-sensitive TB is very responsive to 

treatment, South Africans and their neighbors 

suffer from stronger strains of the disease. Multidrug-resistant TB (MDR TB) is not cured by two 

of the most popular TB drugs, isoniazid and rifampicin. The second-line drugs used on MDR TB 

are less effective and exponentially more expensive, 

require longer therapy, and create risk for more 

adverse reactions, Gandhi said. Extensively drug 

resistant TB (XDR TB) sufferers have limited options, as isoniazid, rifampicin, and the second-line 

drugs do not treat the disease.

Fellows Scott, attending Harvard Medical School, 

and Babaria, attending Yale School of Medicine, 

worked to characterize and bring treatment to 

patients in KwaZulu-Natal, home to a large HIVinfected population. The MODS (microscopic-observation drug-susceptibility) study implemented 

a recent faster, cheaper way first developed in Peru 

to diagnose and characterize TB. Previously tested 

only in low-HIV prevalent settings, MODS was 

tested in South Africa for its sensitivity and specificity on dual HIV-TB patients.

The other study, the Community-Based MDR

TB Study, tested the effectiveness of bringing 

care to into patients’ homes. Tugela Ferry, an area 

roughly the size of Manhattan, had one hospital 

and one tar road. “We believe that an alternative 

treatment—one that would bring the treatment to 

the patients instead of the patient to the treatment—would work,” Gandhi said. A nurse visited 

the home on weekdays to administer a treatment 

vaccine, supplemented by monthly visits to a clinic 

to repeat sputum and drug-susceptibility tests.

More than the physical and technical obstacles 

of administering medical care in a developing 

country, the mental and social challenges wore on 

the fellows. “I don’t think there was a single day 

in Tugela Ferry that I didn’t see someone die,” 

Babaria said. While tragic, such casualties steeled 

her commitment even more to the research she 

and her team worked on. Babaria noted that it 

helped to e-mail her mentor or voice her concerns during their weekly scheduled phone calls. 

“That was really great to have someone invested 

in the research, but invested in us as people, too,” 

said Scott.

Fellows recount African research

experiences at CIST Forum
Annua l report 2009 • 3 9

 “Mentoring is the soul of our profession,” said 

Friedland. “The traditions and the skills and the 

culture of what we do are passed down.” He 

emphasized the responsibility of mentorship: 

“A mentor must convey the excitement.”

Another hurdle Scott and Babaria faced was the 

skepticism of the locals they were there to serve. 

The South Africans were wary of them as foreigners, wondering what they wanted from them, they 

said. In time, though, the research team earned the 

trust of the people they wanted to care for. Before 

their fellowship ended, Scott and Babaria became 

mentors of a sort to the caregivers in Tugela Ferry. 

“We didn’t want things to fall apart when we left,” 

Scott said.

Far from falling apart, the work the fellows began 

is thriving. “I can proudly tell you that both 

projects are enrolling patients and we are seeing 

promising results,” Gandhi told the CIST Forum 

crowd.

Babaria has returned to KwaZulu-Natal since her 

fellowship ended and is impressed with the growth 

in the project and technology. Scott plans to carve 

out some time soon to return also. 

2008 CIST keynoter

Delivering the 2008 CIST keynote address was Dr. 

Ralph Snyderman, chancellor emeritus of Duke 

University and James B. Duke Professor of Medicine at the Duke University School of Medicine. 

He spoke on the historical impact of science on 

medical research and the transition seen today 

toward personalized medicine. “When you’re in 

the forest, it’s hard to look at it from the outside in, 

but I hope you see how dynamic your profession 

is and how it is teetering on a really big change. 

You can be a part of that.” he said. 

Snyderman named the tools trainees should employ to succeed: persistence, curiosity, passion, and 

creativity. He warned the students, though, not to 

give too much weight to predetermined milestones such as grants or awards. “What it’s really all 

about is the value of your self-worth,” Snyderman 

said. “The real thing is having that insatiable curiosity of yours satisfied by your own mind.” 

Grand Rounds in JAMA

NIH investigators presenting at NIH Clinical Center Grand Rounds have been invited to 

submit manuscripts based on their presentations to the Journal of the American Medical 

Association (JAMA). The manuscripts are featured as “Grand Rounds at the National Institutes 

of Health—Clinicians Corner.” Rounds presentations have for the past two years focused on 

clinically relevant topics from a bench-to-bedside perspective, said coordinator Dr. Frederick 

P. Ognibene, who directs the Office of Clinical Research Training and Medical Education. 

In 2008, manuscripts accepted included: “Evolution of Novel Small-Molecule Therapeutics 

Targeting Sickle Cell Vasculopathy” and “Pulmonary Hypertension: An Increasingly 

Recognized Complication of Hereditary Hemolytic Anemias and HIV Infection.” 

Others are currently being considered.
40 • Annua l report 2009

Chief operating officer earns 

presidential rank award

For her exceptional service to 

the American people, Maureen 

Gormley, the Clinical Center’s 

chief operating officer (COO), 

has been awarded a Presidential 

Rank of Meritorious Executive. The annual award is presented to members of the Senior Executive Service 

(SES) for sustained accomplishments. Nominated 

by their agency heads, reviewed by citizen panels, 

and designated by the president, candidates are 

evaluated on results-oriented leadership; balance 

of the needs and perspectives of clients, stakeholders, and employees; and relentless commitment to 

public service.

“This award is a singular honor for Maureen and 

the Clinical Center,” said Dr. John I. Gallin, CC director. “It honors her commitment to our mission 

and her sincere dedication to her work.” Gormley 

has served as the CC’s COO since 1999, joining 

NIH in 1987 as an administrative fellow in the CC 

Office of the Director. Between those posts she was 

special assistant to the CC director and chief of Administrative Management and Planning. Gormley 

earned a bachelor of science in nursing from the 

Boston College School of Nursing and a master 

of public health degree from the Yale University 

School of Medicine. Gormley serves as executive 

secretary to the NIH Advisory Board for Clinical 

Research and led the activation effort for the 234-

bed Mark O. Hatfield Clinical Research Center. 

Clinical Center greets 

new director of radiology

Dr. David Bluemke has been 

named the Clinical Center’s 

director of Radiology and 

Imaging Sciences. He also 

has been awarded tenured 

scientist status at NIH. 

In announcing the appointment, Dr. John I. Gallin, 

CC director, said, “Dr. Bluemke’s breadth of experience and expertise will be an extraordinary asset 

to NIH’s imaging sciences programs.”

Bluemke, who holds joint appointments at NHLBI 

and NIDDK, had been clinical director of the 

MRI division at Johns Hopkins and professor of 

radiology and medicine at the Johns Hopkins 

University School of Medicine.

Bluemke, an American Heart Association fellow, 

conducts research on cardiovascular disease and its 

complications and seeks to better understand how 

subclinical disease can be detected with newly 

developed imaging technologies, described, and 

tracked over time.

His group at Johns Hopkins was the first to 

describe the use of myocardial delayed enhancement in arrhythmogenic right ventricular dysplasia 

(ARVD). He is the world-recognized imaging 

expert in this extraordinarily difficult-to-diagnose 

condition and was the principal investigator of the 

MRI reading center for the US ARVD multicenter trial. His group was also one of the first to 

demonstrate a method for multi-station MR angiography for peripheral vascular disease and to use 

MRI for direct intravascular, ultra-high resolution 

evaluation of atherosclerotic plaque in humans. His 

expertise in imaging also includes oncologic disease 

and the evaluation of cancer with MRI.

He was a lead author on four multicenter clinical 

trials evaluating the use of novel contrast for MRI 

for oncologic applications, the largest multi-study 

of MRI in the evaluation of breast cancer, and a 

multi-center trial in cardiovascular disease. He is 

currently studying cardiovascular disease with MRI 

Noteworthy
Annua l report 2009 • 4 1

in the Epidemiology of Diabetes Interventions and 

Complications trial involving more than 1,000 type 

1 diabetic patients and the Multi-Ethnic Study of 

Atherosclerosis study of 6,800 individuals.

To date, Dr. Bluemke has authored more than 260 

peer-reviewed publications and 27 book chapters 

and monographs. He sits on the editorial boards of 

several journals: Radiology, the Journal of Computed 

Axial Tomography, Journal of Magnetic Resonance Imaging, Applied Radiology, and the International Journal of 

Cardiovascular Imaging.

He is a member of the board of trustees for the Internal Society of Magnetic Resonance in Medicine 

(ISMRM), board member of the North American 

Society of Cardiovascular Imaging, current chair 

of the American College of Radiology (ACR) 

Cardiac Accreditation Committee, past program 

chair of the ISMRM Cardiac MR Study Group, 

and has been appointed to the AHA Council on 

Radiology and Intervention, the ACR Committee on Standards for Body MRI, and for Standards 

and Accreditation for Body and Neuroradiology 

Magnetic Resonance.

His most recent awards include an outstanding 

teacher award from ISMRM in cardiovascular 

imaging, the Journal of the American College of 

Cardiology elite reviewer award, two Executive 

Council awards and a silver medal from the American Roentgen Ray Society, and Cum Laude and 

contrast agent awards from the Society of Computed 

Body Tomography and Magnetic Resonance. 

In 2007 he was named among the top 10 radiologists by Medical Imaging and among America’s 

Best Doctors by Castle Connolly Medical Ltd.

He earned his medical degree at the University 

of Chicago’s Pritzker School of Medicine as part 

of the medical-scientist training program and his 

PhD from the University of Chicago’s Department of Biophysics and Theoretical Biology, where 

he studied the evaluation of three-dimensional 

macromolecules using advanced computer modeling techniques. He holds an undergraduate degree 

in chemical engineering from the University of 

Wisconsin-Madison and a master’s in business 

from Johns Hopkins University. He was a fellow in 

cross-sectional imaging in diagnostic radiology at 

Johns Hopkins School of Medicine and completed 

residency training at the Johns Hopkins Hospital.

New CFO joins CC director’s staff

Maria Joyce is the Clinical Center’s new 

Chief Financial Officer (CFO). 

Joyce is a CPA in the state of Maryland and holds 

a master’s in business administration from Johns 

Hopkins University and an undergraduate degree 

from Shepherd University. Before coming to the 

CC, she was the director of the Division of Financial Operations at the Program Support Center 

within the Office of the HHS Secretary, where she 

was responsible for accounting operations, financial 

reporting, financial systems, debt management, and 

travel management. She also served as the director 

of NIH’s Office of Business Systems and Finance in 

the Office of Research Services (ORS), where she 

was the CFO and CIO for ORS and the Office of 

Research Facilities. 

Her federal government tenure also includes time 

at the Federal Deposit Insurance Corporation, 

where she worked in accounting policy, internal 

auditing, and enterprise financial systems development. She spent 10 years in the private sector, at 

MCI and Marriott’s corporate headquarters, 

performing accounting, finance, and project 

management functions. 

Since 2003 Joyce has been a member of the NIH 

Federal Credit Union’s Board of Directors, where 

she is also the treasurer. She is also a member of 

the credit union’s assets and liabilities management 

committee and the information technology 

committee. 

Her awards include a 2004 NIH award for design 

and implementation of a best practices approach 

for lease planning and analysis, a 2003 GSA 

achievement award for real property innovation 

and honorable mention for best innovative practice, 

a 2003 NIH award for outstanding financial leadership responding to security needs, and a 2003 

NIH award for organizational “delayering.” 
42 • Annua l report 2009

DeChristoforo named pharmacy chief

Robert DeChristoforo has been named chief of the CC Pharmacy 

Department. A Pharmacy Department employee for 28 years—14 of those 

as chief of the clinical pharmacy section and two periods as acting department chief—DeChristoforo helped his teams provide “unparalleled clinical 

and developmental pharmaceutical support to investigators and patients 

alike,” said Dr. John I. Gallin, CC director.

DeChristoforo received a Bachelor of Pharmacy degree from the Massachusetts College of Pharmacy and a Master of Science in Pharmacology 

from Northeastern University in Boston. He completed an American 

Society of Health-System Pharmacists-accredited hospital pharmacy 

residency at the US Public Health Service Hospital in San Francisco.

He is a Fellow of the American Society of Health-System Pharmacists and throughout his career has been an active contributor at the local and national levels to ASHP activities. He is a two-time recipient of the CC Director’s Award, and also received a 

partnering award from the National Institute for Occupational Safety and Health for his work with the National Occupational 

Research Agenda.

CC employees honored with NIH Director’s Awards

Four Clinical Center employees received 2008 NIH 

Director’s Awards. 

Clockwise from top left: Michael Alexander, hospitality

services coordinator, accepts his award for creating

a welcoming environment from NIH director 

Dr. Elias Zerhouni (right); Dr. Bradford Wood and 

Dr. Elizabeth Jones, Radiology and Imaging Sciences, 

received awards for leading the CC imaging program

during a time of change and transition; and Joseph 

Hendery, chief of credentialing services, was honored 

for providing high quality credentialing and privileging 

support.
Annua l report 2009 • 4 3

 Retired CC nurse reaches a 

Valentine’s Day milestone

Last Februrary, Rosa Lee Powell (with flowers) 

became the first African-American woman to 

make 100 whole blood donations to the NIH 

blood bank at the Clinical Center. Department 

of Transfusion Medicine staff helping mark the 

occasion are (from left) Margaret Dodson, donor 

resources specialist; Dr. Susan Leitman, director of 

blood services; and Jackie Brown, donor resources 

specialist. A mental health nurse at NIH for more 

than 15 years, Powell began donating blood when 

she heard that the blood bank particularly needed 

donations from individuals with her blood type. 

She then learned that as an African American, her 

blood donations could benefit Clinical Center 

patients with sickle cell disease. 

According to Leitman, the best transfusion match 

for an African-American patient with sickle cell 

disease usually comes from an African-American 

donor. Sometimes sickle cell patients are unable 

to proceed with life-saving marrow transplants 

because of an insufficient supply of blood from 

African-American donors. One in six African 

Americans may be a match for a specific patient. 

“Sickle cell patients are often young and need the 

blood. It extends their life,” Powell said.

Transfusion Medicine laboratory 

dedicated to Charley Carter

The Clinical Center’s Department of Transfusion 

Medicine (DTM) dedicated the Charles S. Carter 

Cellular Therapy Laboratory within their Cell 

Processing Section in June 2008. 

Carter, who died in 2006, co-founded the cell 

processing laboratory and worked as a biologist, technologist, and supervisor in DTM for 24 

years. The words engraved on his plaque describe 

Carter as “a wizard in the laboratory with an uncanny ability to grow cells in culture and a special 

affinity for medical instrumentation. His career 

was marked by energetic, innovative practical 

thinking,” as well as devotion to CC patients. 

 “A lab is more than just the walls, benches, and 

equipment within it. A lab is also the people who 

work there and their spirit,” said Klein. “Even 

those working in this lab today who never knew 

Charley are imbued with his spirit of creativity.” 

In a 2006 tribute to Carter published in Cytotherapy,

former DTM section head Dr. Elizabeth Read, 

who worked with Carter to develop methods 

for radiolabeling cells for in vivo cell trafficking 

studies, described how his career “was inextricably linked with the development of modern 

cellular engineering.” His career at NIH started as 

a summer volunteer in what is now the National 

Institute of Dental and Craniofacial Research. 

He was hired as a technician in Dr. Joost Oppenheim’s lab, where he spent three years learning basic research. “The experience nurtured his passion 

for immunology and cell biology, and gave him a 

mature understanding of scientific investigation 

that imbued his future work,” Read noted. DTM 

hired him as a lab technician in 1982. According 

to Read, Carter was “recognized early on as one 

of the most skilled and innovative developmental 

technologists in our field” and would develop new 

procedures rather than rely on those previously 

used by a colleague. 

Carter had a special genius for devising novel 

methods for preparing cellular therapies for 

Several members of the 

Carter family attended the 

dedication, including Carter’s 

widow Laura, a medical 

technologist in FDA’s 

Laboratory of Cellular 

Hematology, and his 

daughter Kate. With them 

is Department of Transfusion 

Medicine Chief Dr. Harvey 

Klein. 
44 • Annua l report 2009

clinical trials. He was a key figure in a small team 

of scientists who prepared the first gene-corrected 

cells to treat a child with severe combined immunodeficiency syndrome. Media coverage of 

the event included a November 1991 U.S. News 

and World Report cover of him standing in the lab 

pipetting cells. 

His work was critical to the progress of numerous 

other intramural cell therapy programs, such as 

gene marking and gene therapy trials with investigators from several ICs. That same decade, Carter 

worked with NCI and NHLBI to develop new 

procedures for depletion of T cells from allogeneic 

bone marrow and peripheral blood stem cells to 

prevent graft versus host disease. 

Other NIH cell therapy programs, many of which 

are still ongoing, that Carter’s work benefited 

include dendritic cell tumor vaccines for cancer 

immunotherapy, iron labeling of cells for diagnostic imaging, and culture-expansion of natural killer 

cells. Current CPS Chief Dr. David Stroncek said 

that he and his staff hope to “keep up Charley’s 

good work as we move forward in the laboratory.” 

In his lifetime, Carter authored or co-authored 

more than 75 publications on investigative methods for cell collection, ex vivo processing and 

preservation, and characterization and testing 

of cell therapy products. He received both the 

Clinical Center Director’s Award and the NIH 

Director’s Award. 

Carter’s mentoring and training of a generation of 

scientists from around the world in good laboratory practice as applied to research biologics inspired 

an award of its own. DTM medical technologist 

Jean Gildner presented the first CPS Technologist of the Year award to Peter Chen. Dedicated to 

Carter’s memory, the awardee is selected by their 

peers for their qualities in leadership, mentorship, and “Charley-ship”—which they defined as 

the willingness to smile, get to know others, and 

remember even in the worst moments the importance of the work at hand. According to Gildner, it 

was in Carter’s capacity as a supervisor that he influenced his colleagues the most. Klein also shared 

emails and phone calls he’d received to mark the 

occasion from Carter’s former colleagues, fellows, 

and friends around the globe—one coming from 

as far away as Norway. 

In the words of Jo Lynn Procter, supervisor of 

operations for the section, it was “a special day to 

be with those who knew, worked with, and loved 

Charley.” Well-wishers stretched down the long 

hallway and around the corners near the laboratory, which was built in an area that used to be part 

of the roof of the old building before the need for 

such a lab existed at NIH.

NIH recognizes Lasker recipients

Members of the NIH intramural research community who have received a prestigious Albert Lasker 

Medical Research Award are recognized in a new 

exhibit on the first floor of the Clinical Center. 

It’s in the hallway east of the clinic elevators. Since 

1945, Lasker awards have recognized the contributions of scientists, physicians, and public servants 

who have made major advances in the understanding, diagnosis, treatment, cure, and prevention of human disease. Seventy-five Lasker Award 

recipients have gone on to win a Nobel Prize. 

The Lasker awards are administered by the Albert 

and Mary Lasker Foundation. Mary Woodard 

Lasker (1901–1994) was a champion of medical 

research. She and her husband, pioneer advertising 

executive Albert Davis Lasker (1880–1952), established a legacy of philanthropy and public support 

of important causes. Mrs. Lasker, recognized for 

her singular contribution to the growth of the 

National Institutes of Health, once said: “If you 

think research is expensive, try disease!” 
Annua l report 2009 • 4 5

Staffers complete integrative 

medicine fellowship

Two Clinical Center employees completed the 

prestigious two-year Bravewell Associate Fellowship Program in Integrative Medicine in 2008

They were Dr. Gwenyth Wallen, chief of the 

research and practice development service, 

Nursing and Patient Care Services, and Dr. Jay 

Shah, senior staff physiatrist, Rehabilitation 

Medicine Department.

The comprehensive program, offered through the 

University of Arizona Medical School’s Program 

in Integrative Medicine, includes 1,000 hours of 

instruction in biologically based therapies (phytochemicals, supplements, and botanicals), mindbody therapies (breath-work, progressive muscle 

relaxation, and meditation), manual medicine 

(massage therapy, osteopathy), and spirituality and 

energy medicine (qigong, reiki), among others. 

Various whole system therapies are also presented, 

including homeopathy, traditional Chinese medicine, and Ayurvedic medicine. Fellows complete 

three residential weeks in Tucson. Curriculum 

presented via the Internet—videos, e-mails, and 

online discussions—allowed fellows to participate 

from across the nation. 

In addition to these studies, the Bravewell Collaborative also provided Shah and Wallen with the 

opportunity to complete clinical rotations at one 

of the eight leading clinical centers comprising 

the Bravewell Clinical Network.

The Bravewell Collaborative is a community of 

philanthropists dedicated to advancing integrative 

medicine through the funding of research initiatives and collaboration with like-minded physicians and organizations. It emphasizes healing that 

focuses on the entire person—body, spirit, mind, 

and community.

Wallen is the first clinical nurse scientist fellow 

to complete the program. She currently studies 

the health behaviors of Hispanics and AfricanAmericans with rheumatic diseases, including 

their use of complementary and alternative 

treatments. She is also conducting a randomized, 

controlled clinical trial exploring the use of hypnosis as a pain and symptom management strategy 

for the treatment of sickle-cell disease patients.

In her clinical rotation at The Penny George Institute for Health and Healing at Abbott Northwestern Hospital, Minneapolis, Wallen attended 

inpatient rounds and shared her current and future 

research plans with the interdisciplinary integrative health team. Feedback she received included 

the suggestion for a renewed focus on the relationship between an individual’s susceptibility to 

hypnosis and biomarkers such as nitric oxide and 

Vitamin D levels. 

“The fellowship has been great for me both 

personally and professionally because it honed my 

knowledge and skills in integrative medicine, but, 

also, I’ve been able to share my research and just 

the idea of doing this kind of research,” Wallen said.

Shah echoed the sentiment, noting that complementary and alternative approaches too often 

rely on anecdotal evidence. “This is an excellent 

program because it emphasizes the importance of 

scientific evidence-based integrative approaches 

wherever possible,” said Shah. He also enjoyed the 

opportunity to present his research and to encourage research among his peers.

The Bravewell Fellowship, together with his clinical rotation at the University of California, San 

Francisco’s Osher Center for Integrative Medicine, 

reaffirmed for Shah the importance of integrating 

the bio-psycho-social aspects of health care with 

modern science to provide optimal patient care. 

Shah and his colleagues are studying the biochemical milieu of myofascial trigger points—discreet, 

palpable, hyperirritable nodules in taut bands of 

skeletal muscle. He commonly treats myofascial 

pain with “dry needling,”a form of mechanical myofascial release with the goals of reducing 

abnormal muscle contractures, relieving pain, and 

restoring range of motion and function. Although 

he uses acupuncture needles, Shah emphasizes that 

dry needling is quite different from traditional 

acupuncture—a practice from ancient China 

based on the flow of energy through acupuncture 

meridians. He teaches dry needling and other 

treatment techniques through Harvard Medical 

School’s “Structural Acupuncture for Physicians” 

course. 
46 • Annua l report 2009

CHAIR: Edward J. Benz, MD 

President and Chief Executive Officer 

Dana Farber Cancer Institute

VICE-CHAIR: Ronald G. Evens, MD 

Senior Executive Officer 

BJC HealthCare

Duane F. Alexander, MD 

Director

National Institute of Child Health and Human

Development

Barbara M. Alving, MD 

Director

National Center for Research Resources

Elizabeth B. Concordia, BA, MAS

Executive Vice President

University of Pittsburgh Medical Center 

President

Hospital and Community Services Division 

Robert M. Dickler 

Independent Consultant

Maria C. Freire, PhD 

President, The Lasker Foundation

Donald Ganem, MD 

Investigator

Howard Hughes Medical Institute

Professor of Microbiology and Medicine

University of California San Francisco

Thomas R. Insel, MD 

Director

National Institute of Mental Health

Daniel L. Kastner, MD, PhD 

Clinical Director

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases

 

Michael J. Klag, MD, MPH 

Dean

Johns Hopkins Bloomberg 

School of Public Health

Crystal Mackall, MD 

Chief, Pediatric Oncology 

Branch 

Head, Immunology Section

National Cancer Institute

Peter Markell 

Vice President of Finance

Partners HealthCare System, Inc.

Henry F. McFarland, MD 

Chief

Neuroimmunology Branch

National Institute of Neurological 

Disorders and Stroke

Olufunmilayo (Funmi) Olopade, MD 

Walter L. Palmer Distinguished Service 

Professor of Medicine and Human Genetics 

Director

Center for Clinical Cancer Genetics

University of Chicago

Monica Skarulis, MD 

Chief

Clinical Endocrine Section

National Institute of Diabetes and 

Digestive and Kidney Diseases

Neal S. Young, M.D

Chief

Clinical Hematology Branch

National Heart, Lung, and Blood Institute

Ex Officio Members

John I. Gallin, MD

Director

Clinical Center

National Institutes of Health

H. Clifford Lane, MD

Chair

Medical Executive Committee 

Clinical Director

National Institute of Allergy and 

Infectious Diseases

Michael M. Gottesman, MD

Deputy Director for Intramural Research

National Institutes of Health

 

Executive Secretary

Maureen E. Gormley, RN, MPH

Chief Operating Officer

Clinical Center

National Institutes of Health

Senior Staff Support

Richard G. Wyatt, MD

Executive Director

Office of Intramural Research

National Institutes of Health

ADVISORY BOARD FOR CLINICAL RESEARCH 

NATIONAL INSTITUTES OF HEALTH (2008–2009) 

Governance

The NIH Advisory Board 

for Clinical Research oversees the Clinical Center’s 

resources, planning, and 

operations. The Board also 

advises on NIH’s overall intramural program, including 

priority setting, the integration and implementation 

of research programs of the 

individual institutes and 

centers, and overall strategic 

planning for the intramural 

program. 

Comprised of NIH clinical 

and scientific leaders and 

outside experts in management of health care and 

clinical research, the 

Board advises the NIH deputy director for intramural 

research and the Clinical 

Center director and reports 

to the NIH director.

Organization and Governance
Annua l report 2009 • 4 7

Medical Executive Committee members (2009)

NIH Clinical Center

The Medical Executive Committee is made up of clinical directors of the NIH intramural clinical research programs 

and other senior medical and administrative staff.

H. Clifford Lane, MD 

(Chair) National Institute of Allergy and 

Infectious Diseases

William A. Gahl, MD, PhD 

(Vice Chair)

National Human Genome Research Institute

James E. Balow, MD 

National Institute of Diabetes and Digestive and 

Kidney Diseases 

Richard O. Cannon, III, MD

National Heart, Lung, and Blood Institute

Carlo Contoreggi, MD

National Institute on Drug Abuse 

Raymond A. Dionne, DDS, PhD 

National Institute of Nursing Research 

Demetrio Domingo, DDS, MS

National Institute of Dental and 

Craniofacial Research

William B. Ershler, MD

National Institute on Aging

Frederick L. Ferris, III, MD 

National Eye Institute 

Mary Kay Floeter, MD

National Institute of Neurological 

Disorders and Stroke

Clare E. Hastings, PhD, RN, FAAN

NIH Clinical Center 

Markus Heilig, MD, PhD

National Institute on Alcohol Abuse 

and Alcoholism 

Lee Helman, MD

National Cancer Institute

David K. Henderson, MD 

NIH Clinical Center 

Stephen G. Kaler, MD, MPH

National Institute of Child Health and Human 

Development

Daniel L. Kastner, MD, PhD

National Institute of Arthritis and Musculoskeletal 

and Skin Diseases 

Henry Masur, MD 

NIH Clinical Center 

Deborah P. Merke, MD, MS

NIH Clinical Center

Robert Nussenblatt, MD 

National Center for Complementary 

and Alternative Medicine 

Maryland Pao, MD 

National Institute of Mental Health

Brian Porter, MD, PhD, MPH

National Institute of Allergy and 

Infectious Diseases

Steven A. Rosenberg, MD 

National Cancer Institute 

Carter Van Waes, MD, PhD 

National Institute on Deafness and 

Other Communication Disorders 

Darryl C. Zeldin, MD 

National Institute of Environmental 

Health Sciences

Ex Officio Members

John I. Gallin, MD 

NIH Clinical Center 

Patricia A. Kvochak, JD

Deputy NIH Legal Advisor

Richard G. Wyatt, MD

Office of Intramural Research, NIH 

Laura M. Lee, RN

NIH Clinical Center
48 • Annua l report 2009

Deputy Director for 

Clinical Care

David K. Henderson, 

MD

 Department of 

 Anesthesia and 

 Surgical Services

 Zena Quezado, MD

 Department of 

 Laboratory Medicine

 Thomas A. Fleisher, MD

 Critical Care Medicine 

 Department

 Henry Masur, MD

 Pharmacy 

 Department

 Robert DeChristoforo, 

 MS

 Rehabilitation 

 Medicine 

 Department

 Leighton Chan, MD

 MPH

 Department of

 Transfusion 

 Medicine 

 Harvey Klein, MD

 Positron Emission 

 Tomography 

 Department

 Peter Herscovitch, 

 MD 

 Medical Record 

 Department

 Patricia Coffey, RHIA

 Office of

 Credentials

 Servicies 

 Joseph Hendery, 

 RHIA

Pain and Palliative 

Care Service

Ann Berger, MSN, MD

Internal Medicine 

Consult Service

Fred Gill, MD

Pediatric Consult 

Service

 Deborah Merke, MD

 Veterinary Care 

Program

Lisa Portnoy, VMD

Director

John I. Galin, MD

Chief Operating Officer

Maureen E. Gormley, MPH, RN

Assistant Director for Ethics and 

Technology Development

Lisa Marunycz, RN, MBA

Diversity Management and Minority Outreach

Walter Jones, MS

Chief Operating 

Officer

Maureen E. Gormley, 

MPH, RN

 Deputy for 

 Administration/

 Office of 

 Administrative 

 Management

 Lynda Ray

Deputy for 

 Operations and 

Workforce 

 Management

Hillary J. Fitilis 

 Nutrition 

 Department

 David Folio, MS, RD

 Edmond J. Safra 

 Family Lodge

 Lawrence Eldridge, 

 MSHA

 Office of 

 Organizational 

Development

Deborah Gardner, 

 PhD, RN

 Office of Purchasing 

and Contracts

 Sydney Jones

 Housekeeping and 

 Fabric Care 

 Department

 Robert Mekelburg, 

 MBA

 Materials 

 Management 

 Department

 Francis LaBosco, 

 MS, PD

 Social Work 

Department

 Adrienne Farrar, DSW

 Spiritual Ministry 

Department

John M. Pollack, MDiv, 

BCC

 Office of 

 Communications, 

 Patient Recruitment 

& Public Liaison

 Sara Byars

 Office of Facility 

 Management

James Wilson

Chief Nursing Officer

Clare Hastings, 

PhD, RN, FAAN

 Deputy Chief

 Ambulatory Care 

 Services

 Karen Kaczorowski, 

 MHSA, RN

 Deputy Chief 

 Inpatient Services

 Tannia Cartledge, 

 MS, RN 

 Chief, Research 

 & Practice 

 Development 

 Service

 Gwenyth Wallen, 

 PhD, RN

Chief Financial 

Officer

Maria Joyce, MBA

 Office of Financial 

 Resource 

 Management

 Daniel P. Rinehuls 

 Office of 

 Management

 Analysis & Reporting

 Melissa B. Moore, 

 MSW, MBA

 Office of Protocol 

 Services

 Kim Jarema, RHIA

Bioethics Department

Ezekiel Emanuel, 

MD, PhD

 

Chief Information 

Officer

Jon W. McKeeby, 

DSc

 Department of 

 Clinical Research 

 Informatics

 Jon W. McKeeby, 

 DSc

Radiology 

and Imaging 

Sciences

David A. Bluemke, 

MD, PhD, MsB

Office of Clinical Research Training 

and Medical Education

Frederick P. Ognibene, MD

Hospital 

 Epidemiology Services

David K. Henderson, MD

Clinical Epidemiology &

Biostatistics Service

Robert Wesley, PhD

Laboratory

for Informatics

Development

James J. Cimino 
National Cancer Institute (NCI)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute 

(NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism 

(NIAAA)

National Institute of Allergy and Infectious Diseases 

(NIAID)

National Institute of Arthritis and Musculoskeletal and 

Skin Diseases (NIAMS)

National Institute of Biomedical Imaging 

and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development (NICHD)

National Institute on Deafness and Other 

Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial 

 Research (NIDCR)

National Institute of Diabetes and Digestive and 

Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences 

(NIEHS)

National Institute of General Medical Sciences 

(NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and 

Stroke (NINDS)

National Institute of Nursing Research (NINR) 

National Library of Medicine (NLM)

Center for Information Technology (CIT)

Center for Scientific Review (CSR)

John E. Fogarty International Center (FIC)

National Center for Complementary and 

Alternative Medicine (NCCAM)

National Center for Minority Health and 

Health Disparities (NCMHD)

National Center for Research Resources (NCRR)

NIH Clinical Center (CC)

NATIONAL INSTITUTES OF HEALTH 
DEPARTMENT OF HEALTH 

AND HUMAN SERVICES

National Institutes of Health

NIH Clinical Center

clinicalcenter.nih.gov

NIH Publication Number 09-7382

January 2009