methodology fall 2013

16
METHODOLOGY The Research and Education Newsletter of Houston Methodist V-Chip” or volumetric bar-chart chip, will be used to detect biomarkers for hepatocellular carcinoma, the most common cause of liver cancer. The device only requires a drop of blood from a finger prick. >> CONT. PAGE THREE FALL 2013 Scientists from the Houston Methodist Research Institute will receive a total of $4.2 million from the National Institutes of Health to develop a small, low-cost device for rapid point-of-care blood tests. Two grants will fund applications for the technology in drug testing and liver cancer risk assessment. Versatile chip tests for liver cancer and drugs by David Bricker & Rebecca Hall, Ph.D. The V-chip applications are based on technology previously developed by Houston Methodist nanomedicine faculty member Lidong Qin, Ph.D. His “V-Chip,” or volumetric bar-chart chip, can detect biomarkers in a single drop of blood. The V-Chip is composed of two thin, 3” x 2” slides of glass. In between the slides are separate wells for three things: hydrogen peroxide, as many as 50 different antibodies, and a dye. After adding the patient’s sample of blood, serum, or urine, a shift in the glass plates initiates the test by bringing the wells into contact and mixing the four ingredients. As the molecules mix, an enzymatic reaction creates oxygen gas that pushes the dye up columns on the slide. How far the dye travels is roughly proportional to the amount of biomarker present in the patient sample- in this case, drugs or liver cancer risk biomarkers. The end result is a visual bar chart that Qin says is accurate and easy to read.

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Page 1: Methodology Fall 2013

METHODOLOGYThe Research and Education Newsletter of Houston Methodist

V-Chip” or volumetric bar-chart chip, will be used to detect biomarkers for hepatocellular carcinoma, the most common cause of liver cancer. The device only requires a drop of blood from a finger prick.

>> CONT. PAGE THREE

FALL 2013

Scientists from the Houston Methodist Research Institute will receive a total of $4.2 million from the National Institutes of Health to develop a small, low-cost device for rapid point-of-care blood tests. Two grants will fund applications for the technology in drug testing and liver cancer risk assessment.

Versatile chip tests for liver cancer and drugs

by David Bricker & Rebecca Hall, Ph.D.

The V-chip applications are based on

technology previously developed by

Houston Methodist nanomedicine faculty

member Lidong Qin, Ph.D. His “V-Chip,”

or volumetric bar-chart chip, can detect

biomarkers in a single drop of blood.

The V-Chip is composed of two thin, 3” x 2”

slides of glass. In between the slides are

separate wells for three things: hydrogen

peroxide, as many as 50 different antibodies,

and a dye. After adding the patient’s sample

of blood, serum, or urine, a shift in the glass

plates initiates the test by bringing the wells

into contact and mixing the four ingredients.

As the molecules mix, an enzymatic reaction

creates oxygen gas that pushes the dye up

columns on the slide. How far the dye travels

is roughly proportional to the amount of

biomarker present in the patient sample- in

this case, drugs or liver cancer risk biomarkers.

The end result is a visual bar chart that Qin

says is accurate and easy to read.

Page 2: Methodology Fall 2013

The five-year project has been funded by a

$1.3 million grant from the National Institute

of Neurological Disorders and Stroke to Todd

Eagar, Ph.D., an immunologist in the Department

of Pathology and Genomic Medicine at Houston

Methodist Hospital.

Eagar’s group will examine how two important

cellular systems spur the development of

multiple sclerosis (MS). Eagar will also look

The NIH-funded project will also help the

scientists determine whether Notch and

gamma secretase may be adequate drug

targets in future human clinical trials. Read more

online: HoustonMethodist.org/hmrinews

at how these two systems affect the behavior

of T and B cells, the autoimmune culprits of

brain cell degeneration in MS.

Past studies by Eagar and others suggest that

dismantling either the Notch signaling pathway

or an upstream regulatory protein complex

called gamma secretase, decreases the severity

of MS symptoms.

Immune cell silence may alleviate multiple sclerosis

Contents

Featured News

Versatile chip tests for liver cancer and drugs ................. 1

Immune cell silence may alleviate multiple sclerosis .......... 2

Balloon pumps placed in a new way through the arm ............ 3

Ashton & Wray publish comparative effectiveness policy treatise........ 4

Autism four times likelier when mother’s thyroid is weakened ...... 5

Pelvic cancer trial at two Houston Methodist hospitals ....... 6

Imaging Research Highlights ................................ 4

Inside the Institute .............. 8

Education News ...................12

Awards & Accolades .........14

New Funding Awards & Applications .....................15

New Employees ...................15

New Visitors ..........................15

Editor-in-Chief Rebecca Hall, Ph.D.

Design & Art Direction Doris Huang

Content Coordinator Michelle Shemon

Contributing Writers Carol Ashton, M.D. David Bricker Rebecca Hall, Ph.D. Mike Liebl, Pharm.D. Katherine Meese Gayle Smith Alyssa Sunkin Nelda Wray, M.D.

METHODOLOGYThe Research and Education Newsletter of Houston Methodist

Todd Eagar, Ph.D.

We think gamma secretase is important for T and B cells to talk to each other,” Eagar said. “This project will look at how the interactions between T and B cells promote inflammation. We are very interested in how we can use drugs like gamma secretase inhibitors to suppress the immune system during phases of inflammation.

by David Bricker

Phot

o: B

illy

Stew

art

Read more online: HoustonMethodist.org/hmrinews

Houston Methodist Research InstituteOffice of External RelationsIAMNEWS-001 | 10.2013 | 150

Page 3: Methodology Fall 2013

V-Chip

MD Anderson Department of Epidemiology

Chair Xifeng Wu is the co-principal investigator

with Qin for the $2.1 million NCI-funded project

that uses the V-Chip to detect risk biomarkers

for hepatocellular carcinoma (HCC), the most

common cause of liver cancer. Biomarkers

include antigens of hepatitis viruses B and C,

aflatoxin (a fungal toxin that at high doses is

associated with cancer risk), and metabolic

indicators of alcohol consumption, obesity,

diabetes, and iron overdose.

“Most of the burden of HCC is borne by people

who have low income, with the highest incidence

rates reported in regions of the world where

infection with hepatitis B virus is endemic,”

Qin said. “Developing an accurate and low-cost

technology that assesses the risk of cancer

could make a big difference to people who

ordinarily can’t afford expensive tests.”

Qin and Houston Methodist co-investigator

Ping Wang received another $2.1 million in July

from the National Institute on Drug Abuse to

develop the V-Chip for use in drug testing.

“The proposed test will provide clinicians

with a fast and reliable method to test for

the presence and quantity of drugs in patient

blood,” said Dr. Wang. “This is especially

useful in emergency room settings, where

every minute counts.”

Read more online:

HoustonMethodist.org/hmrinews

>> CONT. FROM PAGE ONE

3

Balloon pumps placed in a new way through the arm

A change in how a life-saving balloon pump is placed inside the aorta could help some heart failure patients survive long enough to get a heart transplant and improve outcomes, said a team of doctors from Houston Methodist DeBakey Heart & Vascular Center in an upcoming issue of the Journal of the American College of Cardiology: Heart Failure.

Balloon pumps improve blood flow and are usually used temporarily with patients who

are receiving treatment for advanced heart failure--they keep patients alive while they

wait for a new heart. Traditionally, the pumps are inserted into the aorta through the

femoral artery near the leg.

“There are problems with that approach,” said Jerry Estep, M.D., the Heart Failure paper’s

lead author. “Because of where the incision is, there is going to be a risk of infection,

especially for those waiting for a heart because it can be a prolonged ordeal. We think

this may be a problem because literature suggests heart failure patients who become

immobile can become debilitated easily. Their physical ability is extremely important

going into a big surgery like heart transplant.”

Instead, the team of cardiologists and cardiovascular surgeons looked at whether

inserting the intra-aorta balloon pump (IABP) through a small incision in the arm’s left

axillary-subclavian artery worked better. Estep and his colleagues reported that this

minimally invasive approach was successful in all 50 patients. For the 42 patients who

ultimately received new hearts, the doctors saw a decrease in pulmonary hypertension

and improvements in kidney and liver function while waiting for a heart. The 90-day

post-transplant survival rate was 90 percent, and the five month-survival rate was

better than for patients who receive an IABP via other means.

Complications to the insertion of the IABP through the arm were reduced. Compared

to a leg insertion, which resulted in about 30 percent post-operative infections, arm

insertion resulted in zero infections.

Also contributing to the heart failure paper were Andrea M. Cordero-Reyes, M.D., Arvind

Bhimaraj, M.D., Barry Trachtenberg, M.D., Nashwa Khalil, Matthias Loebe, M.D., Ph.D.,

Brian Bruckner, M.D., Carlos M. Orrego, Jean Bismuth M.D., Neal S. Kleiman, M.D., and

Guillermo Torre-Amione, M.D., Ph.D.

Read more online: HoustonMethodist.org/hmrinews

by David Bricker

Page 4: Methodology Fall 2013

4

Center for Outcomes Research co-directors

Carol M. Ashton, M.D. and Nelda P. Wray, M.D.,

released their new book, “Comparative

Effectiveness Research: Evidence, Medicine,

and Policy,” July 2013 with Oxford University

Press. The writing of the book was funded

by the 2008 Robert Wood Johnson Foundation

Investigator Award in Health Policy Research

to Ashton and Wray, for innovations in the

field of health policy.

The book is the first comprehensive analysis

of comparative effectiveness research

policy to be published in the era of the

Patient-Centered Outcomes Research

Institute (PCORI). The 2010 Affordable Care Act created PCORI, a new research

institute mandated to conduct and support comparative effectiveness research—

to understand best practices in medical care.

The authors tell the story of the odyssey of comparative effectiveness research

legislation, how proposals were made and molded, and the people and organizations

who influenced the process. A case study in health policy-making, it is based on

the interviews of over 100 policy-makers and thought leaders conducted by Ashton

and Wray as the legislative process leading to the PCORI unfolded between 2008

and 2010.

The federal government projects that, by 2018, over $700 million per year will be

deposited into the Institute’s trust fund and available to support PCORI’s mission.

Ashton and Wray point out that understanding the context of how evidence is

generated, used, and perceived by the various stakeholders in the medical care

system is necessary for predicting the extent to which PCORI will actually improve

patients’ outcomes and control health care costs.

The book presents a comprehensive and insightful treatment of the role evidence

plays—or does not play—in U.S. health care. The wide-ranging implications of

federal investments in comparative effectiveness research will be an integral

part of the future of today’s thinkers, researchers, health professionals, and

students of health and public policy.

ISBN-10: 019996856X | ISBN-13: 978-0199968565

Ashton & Wray publish comparative effectiveness policy treatiseby Carol Ashton, M.D. & Nelda Wray, M.D.INSTITUTE

QUICK FACTS

Million in Research Expenditirues Worldwide

1400 Credentialed Researchers

Members Worldwide

Trainees

Million in Total Funding

540120

37840

500270

Thousand Sq Ft Research Space

Clinical Protocols

Page 5: Methodology Fall 2013

5

Pregnant women who don’t make nearly enough thyroid hormone are about 4 times likelier to produce autistic children than healthy women, report scientists from Houston Methodist and Erasmus Medical Centre in an upcoming Annals of Neurology .

The association emerged from a study of more than 4,000 Dutch mothers and their children,

and it supports a growing view that autism spectrum disorders can be caused by a lack of maternal

thyroid hormone, which past studies have shown is crucial to the migration of fetal brain cells

during embryo development.

“It is increasingly apparent to us that autism is caused by environmental factors in most cases,

not by genetics,” said lead author Gustavo Román, M.D., a neurologist and neuroepidemiologist

with the Houston Methodist Nantz National Alzheimer Center. “That gives me hope that prevention

is possible.”

The most common cause of thyroid hormone deficiency is a lack of dietary iodine – common

throughout the world, including developed countries. The World Health Organization estimates

nearly 1 in 3 people are affected globally. A 2005 CDC-University of Kansas study estimated

that in the U.S., where iodine deficiency had been practically eradicated thanks to iodized salt,

1 in 7 Americans is believed deficient.

Autism four times likelier when mother’s thyroid is weakenedby David Bricker

The present work was based on the Generation

R Study, conducted by Erasmus Medical Centre

(Rotterdam, Netherlands) doctors and social

scientists, in which thousands of pregnant women

were voluntarily enrolled between 2002 and 2006.

Blood was withdrawn from the mothers at

or around 13 weeks into their pregnancies to

measure levels of thyroid hormone T4 and two

proteins that could indicate the cause of thyroid

deficiency. Six years later, mothers were asked

to describe the behavioral and emotional

characteristics of their children using a

standardized psychology checklist.

Researchers identified 80 “probable autistic

children” from a population of 4,039 -- a number

consistent with the Dutch rate of autism spectrum

disorders. 159 mothers were identified as being

severely T4 deficient (defined as having 5 percent

or less of normal T4, but producing a normal

amount of thyroid stimulating hormone),

and 136 were identified as mildly T4 deficient.

The researchers found a weak association

between mild T4 deficiency and the likelihood

of producing an autistic child, but a strong

association between severe T4 deficiency

and autism (3.89 more likely, as compared

to mothers with normal thyroid hormone).

A lack of dietary iodine interferes with

normal thyroid function, leading to pregnancy

complications, as well as deafness and

developmental delay in the baby and loss

of control of fat and sugar metabolism and

heat generation in the mother.

It is well established that expecting mothers’

poor thyroid function (whether caused by poor

diet, disease, or genetics) can lead to serious

problems with fetal brain development, but

only in the last 10 years or so has hypothyroidism

been implicated as a possible cause of autism

spectrum disorders.

Previous work by Román and others has shown

that a deficiency of T4 during a crucial period

of embryonic development causes mild to

severe brain development errors, such as the

lackluster migration of specialized brain cells

from the cortex to the outer areas of the

cerebrum -- a characteristic of autistic brains.

In a 2007 review Román published in the

Journal of the Neurological Sciences, he

presented a wide swath of evidence that the

near-epidemic rise in autism diagnoses – which

Román says cannot be accounted for by height-

ened awareness alone -- could be at least partly

the result of an iodine-starved diet and/or

exposure to toxins that interfere with normal

thyroid function.

Read more online: HoustonMethodist.org/

hmrinews

Page 6: Methodology Fall 2013

6

A trip to a Houston Methodist emergency room for a swollen leg uncovered a major surprise for Pauline Stevens - a 25- centimeter pelvic tumor about the size of a soccer ball .

Pelvic cancer trial at two Houston Methodist hospitals

The mass was determined to be cancerous,

and it had spread from Stevens’ uterus to

her ovaries. Following surgery to remove

the tumor, Stevens, 75, volunteered for a

endometrial cancer study offered at two

Houston Methodist locations: the Texas

Medical Center and Sugar Land hospitals.

Aparna Kamat, M.D., director of gynecologic

oncology at Houston Methodist Hospital,

is principle investigator of this randomized

phase III trial that compares two treatment

regimens in patients with advanced stage

endometrial cancer. The study is funded by

the NCI and sponsored by the Gynecologic

Oncology Group. It compares two treatment

regimens in patients with advanced stage

endometrial cancer: standard chemotherapy

(carboplatin and paclitaxel), with or without

cycles of cisplatin chemotherapy plus

radiation therapy.

“We use a combination of chemotherapy drugs

because each works in different ways to stop

the growth of tumor cells, either by killing the

cells or by preventing them from dividing.

This study will help us determine if radiation

therapy offers more benefit for these patients

in addition to chemotherapy,” says Kamat.

Stevens is part of the investigational arm of the

study. She had her radiation therapy treatment

at Houston Methodist Hospital in the Texas

Medical Center, and her chemotherapy treatments

are under way at Houston Methodist Sugar Land

Hospital. After chemotherapy ends in October,

Kamat will follow Stevens’ progress for at least

another five years.

Although the exact cause of endometrial cancer

is unknown, increased levels of estrogen appear

to play a role, and obesity is the single highest

risk factor. Most women with endometrial

cancer whose cancer has spread outside the

uterus generally receive chemotherapy alone

or in combination with radiation. Currently,

clinicians and researchers are trying to determine

the most effective treatment plan for these

patients, both in terms of outcomes as well as

the side effects associated with therapy.

Read more online: HoustonMethodist.org/

hmrinews

Endometrial cancer starts in the inner lining of the uterus and is the most common gynecologic malignancy in the United States. Approximately 42,000 new cases are diagnosed every year.

by Gale Smith

Page 7: Methodology Fall 2013

IMA

GIN

G R

ESEAR

CH H

IGH

LIGH

TSImaging Research Highlights

7

Christof Karmonik, Ph.D., Bob Grossman, M.D., and Amit Verma, M.D. are

developing a new imaging technique for patients with epilepsy in the MRI core.

Epilepsy causes spikes in brain activity that can be seen with EEG- even when

patients are on medication. The researchers are using EEG combined with

fMRI to visualize the networks of the brain that support the generation of the

spike discharges. This may be of great use in patients that have otherwise

normal MRI scans and also to define the functional areas and networks that

cause the patients to have seizures.

Paola Decuzzi, Ph.D. is engineering

discoidal polymeric nanoconstructs (DPNs)

that can be visualized by MRI and PET as

they move through the body to target a

disease site (like a tumor, arthritic knee,

atherosclerotic plaque, damaged heart

tissue or blood vessel), and deliver a

therapeutic payload.

• Fully separated preclinical and clinical research areas

• Waiting and recovery areas for clinical research subjects

• Preparation room with easy access to the vivarium for preclinical experiments

• MRI in immediate proximity to the PET/SPECT imaging core thereby enabling

high-throughput multi-modality imaging studies

Support is available for experimental design, image acquisition, and image analysis.

Visit HoustonMethodist.org/mri-core or contact Jessica Hwang

([email protected], 713-441-7979) for more information.

Gerard E. Francisco, M.D. of UT Health is

leading a collaboration with Houston

Methodist, Rice, and University of Houston

on two studies in the MRI core. The first

maps brain activity of stroke patients who

are undergoing brain-machine interface

controlled robotic-assisted training of arm

and hand movements. The second follows

brain activity in spinal cord injury patients

who are training their arm and hand motor

function with a robotic device to see how

the brain changes as they learn to control

the devices. The goal is to use these patterns

as maps to help guide patients that have

lost motor control of hands/wrists

to recover control during rehab.

The Magnetic Resonance Imaging core of the Houston Methodist Research Institute houses a state-of-the-art 70 cm wide-bore 3.0 Tesla whole-body human magnetic resonance imaging scanner dedicated to research studies. Features of the facility include:

Combining fMRI and EEG for Epilepsy

Imaging maps brain response to robotic hands

Watch drug delivery in real time

By Christof Karmonik, Ph.D. & Rebecca Hall, Ph.D.

MRI CORE Phot

o: C

hris

tof K

arm

onik

Page 8: Methodology Fall 2013

Inside the Institute

8

MORTI Clinical Trials Management System goes liveThe go-live date for the updated Clinical Trials

Management System is Oct 25. Register

for training through myLearning or contact

[email protected]

for more information.

New American Veterinary Medical Association guidelines The NIH Office of Laboratory Animal

Welfare has issued new AVMA Guidelines.

The Vertebrate Animal Section (VAS) of

grants and contracts must be consistent with

the 2013 Guidelines. Refer to NOT-OD-13-098,

grants.nih.gov, for more information.

Give your ideas a voice at Houston MethodistThe Faculty Research Council would like

to hear your ideas on how to improve

administrative operations at the Research

Institute and the Education Institute. Contact

them by email at tmhrifacultyresearchcouncil@

houstonmethodist.org.

The Houston Methodist Research Institute has a new name and logo. The Houston Methodist Leading Medicine will replace the former Institute logo to reflect our support of research throughout the system. Employees can download new logos and templates from the brand website as they become

available: marketing.methodisthealth.com/brand/

Our legal name remains The Methodist Hospital Research Institute, with a DBA Houston

Methodist Research Institute. For guidance, please contact Rebecca Hall

([email protected]).

Research Institute continues NIH Competitiveness Initiative Did your NIH grant application score

within the 15th percentile, but not get

funded? Resources are available to

increase the competitiveness of your

resubmission, including pilot funding,

bridge funding, grant writing assistance,

and facilitation of collaborations.

For more information, contact

Homer Quintana (hquintana@houston

methodist.org, 713-441-7250).

Information for the NIH extramural grantee community during the lapse of federal government fundingThe NIH has issued guidance on proposal

submissions and other activities during

the lapse in government funding. Please be

advised that the NIH continues to accept

proposals, which will be processed when the

NIH reopens and proposal submission dates

will be revised. The Research Institute will

fully support proposal submissions during

the funding lapse. For more information,

please refer to the NOT-OD-12-126 or

contact Gary Lingle in the Office of Grants

& Contracts.

Research Institute gets new name and logo

Mathew Ware and Biana Godin, Ph.D. won 2013 BioArt Award from the Federation of American Societies for Experimental Biology.

Page 9: Methodology Fall 2013

INSID

E THE IN

STITUTE

9

US Congress tours of the Research Institute

Harvard Business Review health care innovation forum launched

Institute for Academic Medicine strategic planning continuesThe academic strategic planning integration

committee, chaired by Dr. Antonio Gotto,

approved the plan on Aug 26. Budgetary

planning is in progress. For more information,

contact Ed Jones (eajones@houston

methodist.org).

The Houston Methodist Research Institute was honored by visits from U.S. Representative John Culberson, and staff from the offices of U.S. Senator John Cornyn, U.S. Representative Al Green, and U.S. Representative Pete Olsen this August.

The visits centered on the need for funding the preclinical/early phase clinical studies

that bridge the gap to commercialization of research innovations so they can reach the

market and impact clinical care. Tours included site visits to MITIE and research labs,

with demonstrations of research advances in Houston Methodist core technologies.

Honored guests included Sarah Whiting, legislative director for Rep. Pete Olson;

Gregg Orton, legislative director for Rep. Al Green; Catherine Knowles, legislative director,

and Brittany Seabury, deputy director Rep. John Culberson; and Laura Holland, health

legislative assistant and Jay Guerrero, deputy director for Sen. John Cornyn.

Harvard Business Review and the New

England Journal of Medicine have launched

an eight-week online forum for health

care leaders seeking to increase value by

improving patient outcomes and reducing

costs. Find more online: hbr.org

From left to right: Mauro Ferrari, Ph.D., Barbara L. Bass, M.D., FACS, Rep. John Culberson,

Shanda H. Blackmon, M.D., MPH, FACS, Brian J. Dunkin, M.D., FACS and Puja G. Khaitan, M.D.

Page 10: Methodology Fall 2013

Inside the Institute

10

Upcoming EvEnts

UPCom

INg

EVENts

october 28 Computational Modeling of Atherosclerosis in the

Coronary and Carotid Arteries Nenad Filipovic october 30 Research Institute Employee Town Hall Research Institute Employee Diversity Fair

A Portrait of Nanomedicine and it’s Ethical Implications Mauro Ferrari, Ph.D. november 4 Image Based Response to Treatment in Oncology Dimitris Visvikis, FIPEM november 9-13 Society of Neuroscience Annual Meeting november 19 Leadership Conversations Series Mauro Ferrari, Ph.D november 25 Computational Modeling, Essential to Innovation in Surgery William W. Lytton, M.D., Ph.D. December 9 Pumps & Pipes 7 December 11-12 Leading Clinical Research: Quality processes at

Houston Methodist Research Institute December 17 Leadership Conversations Series A.Osama Gaber, M.D., F.A.C.S. Feb. 17-21, 2014 Cardiac MRI Workshop march 6-8, 2014 Total Endovascular Series: Lower Extremity II and Limb Salvage march 13-15, 2014 Re-Evolution Summit V: MICS Hands-On Summit march 22, 2014 Cancer Biomarkers Conference April 11-13, 2014 Southwest Valve Summit II- On the River

Page 11: Methodology Fall 2013

INSID

E THE IN

STITUTE

11

Housed within the vivarium, cGLP facilities perform risk/safety assessments in pre-

clinical models under FDA guidelines to ensure the quality and reliability of research

data. Adherence to cGLP standards is required for safety studies, at the final stage

of preclinical development, in order to move into clinical studies. The Comparative

Medicine core provides the physical space and guidance needed for cGLP studies at

Houston Methodist. For more information, contact Dr. Melanie Ihrig (mihrig@houston

methodist.org).

Houston Methodist manufactures products and complex biologics in two on-site

cGMP facilities. The 4000 sq ft cGMP Laboratory on the 12th floor of the Research

Institute building is designed to produce clinical grade pharmaceuticals, nanoparticles,

vaccines and other biologics for preclinical and clinical studies. In addition, clinical

grade products from the cyclotron and radiopharmaceutical cGMP lab on the bottom

floor are used for imaging in Houston Methodist Hospital and in the research Imaging

Suite. The location immediately next to the Imaging Suite allows researchers to

perform studies with short-lived radio-isotopes that cannot be done elsewhere in the

Texas Medical Center. For more information on the 12th floor cGMP facility, contact

Daniel Fraga ([email protected]). For more information on the cyclotron

and radiopharmaceutical lab, contact Max Yu ([email protected]).

The AOCT provides Clinical Trial Management System study set up including calendar,

budget and milestones for all clinical trials at Houston Methodist at no charge. In com-

bination with the Cockrell Center for Advanced Therapeutics, it also offers additional

fee-for-service resources and administrative support for clinical trials operations. Involve

the AOCT early to develop your clinical study budget so that you can design the most cost

effective study. The following services are currently available:

For more information, contact [email protected] or Julie Sicam.

F D A C U R R E N T G O O D L A B O R A T O R y P R A C T I C E F A C I L I T I E S

F D A C U R R E N T G O O D M A N U F A C T U R I N G P R A C T I C E F A C I L I T I E S

T H E A C A D E M I C O F F I C E O F C L I N I C A L T R I A L S & T H E C O C K R E L L C E N T E R F O R A D V A N C E D T H E R A P E U T I C S

Bridging the Valley of Death: Preclinical & Early Phase Clinical Trials by Rebecca Hall, Ph.D.

‘Translational research’ was coined twenty

years ago by the National Cancer Institute to

describe research innovations transitioning

to clinically useful products—research

oriented to making tangible differences in

the lives of patients. While many institutions

realigned their missions to include transla-

tional research, in so far as it can be thought

of as ‘applied research’, actually reducing

translation to practice by efficiently moving

innovations into the clinical realm is a

challenge taken on by few.

Translational research requires specialized

clinical, manufacturing, and regulatory

expertise. It also requires significant

financial resources, and a mechanism for a

hand-off to industry partners. Without these

resources to bridge innovations to Phase II

and III clinical trials, innovations will fail to

reach the market and impact patient care,

regardless of their potential to advance

the practice of medicine.

Houston Methodist understands the

challenges and has invested in building the

Research Institute to address this ‘valley

of death’ in the translational research

cycle. As industry has become increasingly

conservative with investment in early stage

translational research, we also believe that

nonprofit institutions with humanitarian

public health missions need to help

shepherd innovations through this critical

stage in medical product development.

Several critical areas of infrastructure at

the Research Institute are available for

research at the preclinical/Phase I-II stage:

• Protocol Development

• Budget and contract set-up

• Research nursing/coordinators

• Study design and statistical analysis

• Project/site management

• Data management (CRF Development)

• Regulatory support (IND/IDE)

• Nurse & MD workspace

• Inpatient beds

• Procedure & private infusion rooms

• Sample Processing Laboratory

Page 12: Methodology Fall 2013

Education News

12

Dr. Andrew Avarbock, a dermatologist at Weill

Cornell Medical College, was a resident when

he first witnessed the devastation that severe

cutaneous drug eruptions can cause – and he

never forgot it. One of his patients sprouted an

acute skin rash after taking a medication — a

reaction that doctors can do little to treat and is

often fatal.

Stymied by few ineffectual tools in the doctor’s

treatment chest, he wanted to understand the

underlying causes of the reaction and develop

better treatments. There was only one problem:

in the hustle and bustle of residency, he had

never learned how to conduct clinical research.

for Academic Medicine, chairman of the

Department of Urology at Houston Methodist

Hospital, and professor of urology at Weill

Cornell.

“If you don’t know anything about statistics

and how to power a study you might end up

with worthless data, or maybe you should

be doing a registration trial and not a clinical

trial,” said Dr. Boone. “The training allows

you to pose your clinical question and answer

that question with planning and foresight.”

Now Dr. Avarbock is getting his chance.

Houston Methodist and Weill Cornell Medical

College have joined forces to offer an

accelerated clinical research training

program to junior faculty who are interested

in conducting clinical trials. Avarbock is one

of five from Weill Cornell faculty and three

from Houston Methodist–Drs. Jorge Darcourt,

Eric Bernicker, Huie Lin that have joined the

program.

The one-year program is the collaborative

brain child of Dr. John Leonard, associate

dean of clinical research for Weill Cornell,

and Dr. Tim Boone, co-director of the Institute

The program began July 17 with a four-day

workshop at the Cornell Club in New York City.

The workshop featured didactic coursework,

small-group sessions, and invited speakers.

It also provided faculty with an introduction

or refresher to the foundations of clinical

research, including research design and

methodologies, data management and analysis,

and the regulatory process. Over the next year,

each of the faculty will develop and conduct

a clinical research trial, receiving mentorship

and guidance from more experienced clinical

researchers at Weill Cornell and Houston

Methodist.

Weill Cornell and Houston Methodist launch new collaborative clinical research training program

2

The Mentored Clinical Research Training Program is an exciting venture for Weill Cornell and Houston Methodist that builds upon our thriving partnership to provide critical insight and growth for our faculty,” said Dr. Stewart, vice dean at Weill Cornell. “It will not only enhance the bridge we built nearly 10 years ago between the North and South, but also advance treatments and therapies we can offer our patients.

” HoUstoN mEtHoDIst ACADEmy UPDAtE

by Alyssa Sunkin, Weill Cornell Medical College

From top left to right: Drs. Timothy Boone (HM), Jorge Darcourt (HM), Gloria Chiang (WCMC), Andrew Avarbock (WCMC), Jonathan Zippin (WCMC) and John Leonard (WCMC). From bottom left to right: Drs. Chun Lin (HM), Eric Bernicker (HM), Carl Crawford (WCMC), and Halina White WCMC).

Page 13: Methodology Fall 2013

EDU

CATIO

N N

EWS

133

Houston Methodist Global Health

Care Services and the Methodist

Center for Professional Excellence

in Nursing graduated their first

cohort of nursing leadership trainees

from Saudi Arabia in August. With

executive mentorship, trainees

received leadership and professional

development training, and developed

strategies to improve patient care

in their home country. For more

information, contact Katherine Meese

([email protected]).

Houston Methodist trains Saudi Arabian nurses

Houston Methodist trainees can now learn laboratory fundamentals and techniques with the

online educational video collection from JOVE SE. Employees can access JOVE via the library

resources on MyHR web (sslvpn.tmhs.org).

The fifth annual national CV Fellows Bootcamp provided hands-on training in and discussion of the

latest advances and techniques in cardiovascular medicine. The event was organized by the Houston

Methodist DeBakey Heart & Vascular Center, DICET, and MITIE, and sponsored by 13 industry partners.

Nearly 90 academic sessions covered topics including traumatic aortic injury, cardiac pacemakers,

implantable cardioverter-defibrillators, nuclear cardiac imaging, and current trends in managing venous

thoracic outlet syndrome. Find more information online: HoustonMethodist.org/CVFellowsBootcamp

JOVE Science Education

Cardiovascular bootcamp trains 150 fellows

Annual Biomedical Engineering Society Conference

The Academy exhibited at the BMES conference in Seattle, Washington, Sept. 25-28. More than 3,250 attendees had the opportunity to browse open postdoctoral positions and learn about the translational research education programs available at Houston Methodist.

Housotn Methodist/UH Graduate Fellowship

The University of Houston Cullen College of Engineering and the Houston Methodist research Institute have created a joint fellowship opportunity for Ph.D. students who wish to pursue a degree in engineering and translational biomedical research. For more information, contact Amy Wright ([email protected])

Postdoktoberfest

Houston Methodist postdoc trainees joined their TMC colleagues from the National Postdoc Association for a networking event on Oct. 3 at the TMC Commons. NPA membership is free through the Houston Methodist Academy. Join online: HoustonMethodist.com/Academy

HoUstoN mEtHoDIst ACADEmy UPDAtEFall Diversity Fair

The Academy will host the next Diversity Fair on the second floor, outside the Research Institute auditorium, Oct 30, 3-4 pm. The theme will be Thanksgiving and fall traditions in America.

by Katherine Meese

by Amy Wright

by David Bricker

International nurse leadership trainees Ahmed Al-Khaibary, BSN, RN; Aliyah Ali Al-Qarni, BSN, RN, andSultan Saleh JemahAlkhaibari, BSN, RN: pictured with Houston Methodist senior vice president and chief nurse executive Ann Scanlon McGinity, Ph.D., RN, FAAN.

Page 14: Methodology Fall 2013

14

Awards & Accolades AWAR

Ds &

ACCoLADEs

Congratulations to mary schwartz, m.D., for receiving the Excellence in Education award from the American Society of Cytopathology.

Congratulations to philip cagle, m.D., for receiving the Pathologist of the Year and Distinguished Patient Care awards from the College of American Pathologists.

Congratulations to David Haviland, ph.D., C.Cy., for passing the International Cytometry Certification Examination with the International Society for Advancement of Cytometry. (isac-net.org).

Congratulations to Katherine perez, pharm.D. for receiving the American Society of Health-System Pharmacists (ASHP) Foundation’s Literature Award for Innovation in Pharmacy Practice.

Congratulations to mathew Ware and Biana godin, ph.D. for their 2013 BioArt Award from the Federation of American Societies for Experimental Biology.

Congratulations to Rita serda, ph.D., James gu, ismail meraz, ph.D. and victor segura ibarra of the Scanning Electron Microscopy Core and the Department of Nanomedicine for being selected as finalists in the SEM contest judged by FEI and National Geographic.

Congratulations to Hung-Jen Wu, ph.D., postdoctoral fellow in the Department of Nanomedicine, for his appointment to a tenure track assistant professor position in the Chemical Engineering department at Texas A&M University.

Congratulations to muralidhar L. Hegde, ph.D. for receiving the Environmental Mutagenesis and Genomics Society Emerging Scientist Travel Award.

The Research Institute sponsors several award opportunities for faculty and staff. For more information, contact Mariana Pope, [email protected], in the Office of Governance & Faculty Affairs.

The Research institute president’s Awards for transformational Excellence for publications in high impact journals and peer- reviewed grant awards.

The virginia and Ernest cockrell, Jr. scholars Award for innovative translational and clinical research projects.

The career cornerstone Award for Research Institutes members receiving their first NIH grant as a primary or co-primary investigator.

Page 15: Methodology Fall 2013

15

New Funding Awards & Applications

New Employees

New Visitors

Department of Cardiovascular Sciences: $3,500,000, Miguel Valderrábano, RO1, 5 yrs, National Heart, Lung & Blood Institute

$2,500,000, John Cooke, UO1, 3 yrs, National Heart, Lung, & Blood Institute

$800,000, John Cooke, RO1, 2 yrs, National Eye Institute

$344,000, Stephen Little, 3 yrs, National Science Foundation

$300,000, Nazish Sayed, 4 yrs, American Heart Association

$300,000, Jack Wong, 4 yrs, American Heart Association

Applications: John Cooke (10), Andrea Cordero, Mark Davies, Jerry Estep (2), Yohannes Ghebremariam (3), Homam Ibrahim , Saverio La Francesca , Stephen Little , Jack Wong (2), Nazish Sayed, Dipan Shah

Department of Nanomedicine

$2,100,000, Lidong Qin & Ping Wang, RO1, 3 yrs, National Institute on Drug Abuse

Department of Cardiovascular SciencesKankana Bardhan, Postdoctoral FellowIsabel Bernges, Graduate Research FellowLance Blau, Postdoctoral Fellow 1, Cardiovascular SurgeryJinyu Chen, Sr. Research AssistantNga Diep, Senior Research AssisantKim Donlon , Clinical Research Nurse, CardiologyAnne Fombu, Clinical Research Nurse, MDHVCGianfranco Matrone, Postdoctoral FellowPhuong Nguyen, Clinical Research Nurse, MDHVCCathryn Stegmoyer, Clinical Research Nurse, MDHVCRoman Sukhovershin, Postdoctoral FellowXiaoyu Tian, Postdoctoral Fellow 2Nicholas Craig von Sternberg, Graduate Research Fellow, CardiologyDongxin Zhao, Postdoctoral Fellow 1

Department of NanomedicineXin Han, Graduate Research FellowJoon Hee Jang, Postdoctoral FellowMyeong Chan Jo, Postdoctoral FellowVaidotas Kiseliovas, Graduate Research FellowYing Li, Postdoctoral FellowChang Liu, Postdoctoral FellowYu Mi, Postdoctoral FellowAsad Moten, Undergraduate Research FellowSuhong Wu , Graduate Research FellowXiaoyan Wu, Postdoctoral Associate

Department of Systems Medicine & BioengineeringJared Gilliam, Postdoctoral Fellow 3

Department of Translational ImagingYinhan Zhang, Research Associate IAndrea Zuniga, Administrator

Cancer ResearchPavana Dixit, Research Associate I, Rad OncMurali Hegde, Scientist, Rad OncSankar Mitra, Scientist, Rad OncShilditya Sengupte, Research Scientist, Rad OncSandra Soliz, Special Projects Coordinator

$2,100,000 , Lidong Qin, RO1, 4 yrs, National Cancer Institute

$400,000, Ennio Tasciotti, R21, 2 yrs, National Cancer Institute

Applications: Rita Serda, Haifa Shen (2), Alessandro Grattoni, Guoting Qin, Jason Sakamoto, Yujun Song, Yong Yang

Department of Systems Medicine & BioengineeringApplications: Stephen Wong (2)

Department of Translational ImagingApplications: Zheng Li (2)

Cancer Research $75,000, Kapil Bhalla, 1 yr, National Cancer Institute

Applications: Barbara Bass, Kapil Bhalla (3), Jenny Chang (4), Yi Liu, Brian Miles, Alvaro Munoz, Sankar Mitra (3)

Inflammation & EpigeneticsApplications: Qi Cao, Wei Zhao

Diabetes &Metabolic Disease Applications: Tuo Deng (2), Anisha Gupte, Dale Hamilton, Willa Hsueh, Ke Ma

Clinical Trials SupportDevon Miller, Project Coordinator, AOCTEileen Dickman, Director, Clinical Research and Business Development, CCAT

Communications & External RelationsDoris Huang, Sr. Creative Services Specialist

Comparative MedicineChristopher Smith, Animal Care Technician II

Diabetes & Metabolic DiseaseVasumathi Theegala, Sr. Research Assistant

Governance & Faculty AffairsNelcy Ramirez, Project Specialist

Inflammation & EpigeneticsXiang Chen, Postdoctoral FellowXikun Zhou, Postdoctoral Fellow 1

MRI CoreJeff Anderson, Research Associate I

Research ProtectionsCatherine Simmons, Quality Assurance Analyst

Research TechnologyTamara Coleman, Business Systems Analyst IIAlbert Prado, BI Specialist III

NeurosciencesJonathan Wiese, Clinical Research Nurse, Neurology

Tissue Engineering & Regenerative MedicineSebastian Powell, Research Assistant I

Transplant ImmunologyWenhao Chen, ScientistAini Xie, Postdoctoral Fellow 1

Infectious Disease $1,400,000, Todd Eagar, 5 yrs, National Institute of Neurological Disorders & Stroke

$400,000, Muthiah Kumaraswami, 2 yrs, National Institutes of Allergy & Infectious Disease

Applications: Carly Filgueira (2), Edward Graviss (3), Adriana Rosato

Neurosciences

Applications: Stanley Appel, Muralidhar Hegde, Kenneth Podell

Transplant Immunology

$300,000, Xian Li, R56, 1 yr, National Institutes of Allergy & Infectious Disease

Applications: Wenhao Chen (2), Xian Li, Omaima Sabek (2)

Department of Cardiovascular SciencesSergio Ibarra, Visiting Postdoctoral Fellow, CardiologyNilay Patel, Visiting High School Student, Cardiovascular SurgerySu Yeon Choi, Visiting Scientist, MDHVCMaris Zamovskis, Visiting Graduate Research Fellow

Department of Systems Medicine & Bioengineering Liyuan Zhu, Visiting Graduate Research Fellow

Department of Translational ImagingSara Esposito, Visiting Graduate Research FellowCarmen Iodice, Visiting Graduate Research FellowNasim Taheri, Visiting Graduate Research Fellow

Cancer ResearchArijit Dutta, Visiting Graduate Research Fellow, Rad OncKaterina Kaczmarski, Visiting Undergraduate Research FellowMonika Vishnoi, Visiting Postdoctoral Fellow, Surgery

MITIEJiaxing Qi, Visiting Graduate Research FellowMahbubur Rahman, Visiting Graduate Research FellowRemi Salmon, Visiting Graduate Research FellowNanomedicineStefania Acciardo, Visiting Undergraduate Research FellowMarta Anna Balliano, Visiting Graduate Research FellowClaudia Corbo, Visiting Postdoctoral FellowMarco Farina, Visiting Graduate Research FellowAmanda Miller, Visiting Undergraduate Research FellowRoberto Palomba, Visiting Postdoctoral FellowQian Wei, Visiting Postdoctoral Fellow

NeurosciencesSimon Fisher Baum, Visiting Scientist, NeurologyAndrew Ferguson, Visiting Undergraduate Research Fellow, UrologyAndrew Cris Hamilton, Visiting Scientist, NeurologyVictor Lizarraga, Visiting Graduate Research Fellow, UrologyFangmei Lu, Visiting High School Student, NeurologyRandi Martin, Visiting Scientist, NeurologyTatiana Schnur, Visiting Scientist, Neurology

Outcomes & QualityDoris Jackson, Visiting Postdoctoral Fellow, Human Resources

Transplant ImmunologyYi Ting Serena Shen, Visiting Graduate Research Fellow, Medicine

Page 16: Methodology Fall 2013

Houston Methodist Research Institute

6670 Bertner Ave. | Houston | TX 77030

Houstonmethodist.org