catalyst

How a life-changing idea becomes a life-saving reality

A MEDICAL MYSTERY ABROAD

Philanthropy Sparks Innovation | fall 2012

InventionWheels of

GIVE A GIFT, GET INCOME FOR LIFE

visit clevelandclinic.org/giving to learn more

TK

A Life of GivingMort and Iris November wrote the book on philanthropy; The Fine Art of Schnorring: The A to Z’s of Fund Raising

and Philanthropy is meant to inspire others. (“Schnorring” is Yiddish for “begging.”)

Mr. November’s own inspiration is his daughter, Debra Ann November, who passed away in 1977. The

couple’s gifts to Cleveland Clinic have benefited countless children by establishing The Debra Ann November

Wing for youngsters with autism, as well as The Debra Ann November Pediatric Airway and Pulmonary

Mechanics Lab for those who have breathing and pulmonary issues. Most recently, they established the Mort

and Iris November Distinguished Chair in Innovative Breast Cancer Research. Vincent Tuohy, PhD, Department

of Immunology, is the first chair holder.

Each was widowed before being introduced by a friend and rabbi. They married in 1982. On their path

together, Mr. November says happily, “We have made thousands of friends.”

InG r at itude

Catalyst | fall 2012

contents

Medicine Chest2 Healthy choices can

reverse disease

2 New test detects a rare form of cancer

3 Can bariatric surgery stamp out diabetes?

3 8,000 sleep studies — and counting

3 My Story: A medical mystery abroad

Philanthropy at Work4 Medical Mutual supports

community values

5 Profile: Lung transplant survivor Michael Roth and family

6 Schooling a new generation of doctors

6 A gift honors a father

Pyramid: Gift Planning 7 Profile: Crile Award

winner Joan Repp

8 Easy ways to give — and get — lifetime income

10 Allied Partners in Philanthropy

10 Meet your Gift Planning team

WHEELS OF INVENTION11 Cover Story: Focused. Competitive. Entrepreneurial. These are just a few of the qualities that drive Cleveland Clinic’s innovators to solve some of the most challenging medical problems.

Game Changer16 Groundbreaking

research may offer a solution for type 1 diabetes.

Cover: Photo by Michael Northrup

New test helps catch rare form of the disease

EPITHELIOID HEMANGIOENDOTHELIOMA (EHE) isn’t a household name, and not just because it’s a tongue twister. Few people encounter this very rare type of vascular cancer. Still, hundreds of U.S. adolescents and young adults are diagnosed with EHE each year.

Fortunately, EHE patients have a champion in Brian Rubin, MD, PhD, of Cleveland Clinic’s Pathology & Laboratory Medicine Institute and Lerner Research Institute. Dr. Rubin recently led an international research team that discovered an altered gene specific to EHE.

The team then developed a test that makes EHE easier to detect. “Before, people would look under the microscope, look at the form and structure of the tumor, and say, ‘OK, those cells look like the EHE pattern,’” Dr. Rubin says. “But that kind of diagnosis is subjective and really depends a lot on expertise.

“Now you don’t need to be an expert. All you need to do is say, ‘This might be EHE,’ and then test for that specific genetic alteration.”

The next step is to understand exactly how the alteration occurs and target specific drugs to inhibit it.

“We’ve already got the project under way, and we fully expect to cure this disease,” says Dr. Rubin, whose earlier research led to FDA-approved treatments for two other rare cancers. Interestingly, one of the genes involved also has been found in breast, lung and thyroid cancers. Dr. Rubin says that a therapy targeting this gene could lead to new treatments for those cancers, as well. — Laura Putre

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The Lifestyle 180 program yields disease-reversing results

AROUND THREE-QUARTERS of healthcare spending in the United States goes toward treating chronic diseases, according to the Centers for Disease Control and Prevention. That statistic is shocking, but it also can easily be reduced.

“So many of these chronic diseases — obesity, high blood pressure, high cholesterol, diabetes — are caused by lifestyle factors such as abuse of tobacco and alcohol, poor diet, lack of physical activity and very poor stress management,” says Mladen Golubic, MD, PhD, Medical Director of Cleveland Clinic’s Center for Lifestyle Medicine. “We can prevent these conditions by addressing their root causes.”

Research published in Nutrition & Metabolism, November 2011, puts hard numbers behind this approach. Dr. Golubic and colleagues measured outcomes among 429 participants in Cleveland Clinic’s Lifestyle 180 program after six months of hard work.

During Lifestyle 180, people with chronic diseases receive an intensive nutrition education, including courses in grocery shopping, reading food labels and cooking healthy meals. They also focus on physical activity, stress-management techniques and behavior modification to explore why most exercise and diet plans fail in the first place.

The numbers are encouraging. At the six-month mark, overall weight was down 6.8 percent, and waist circumference dropped by 6.1 percent. Metabolic syndrome — a major risk factor for heart disease and diabetes — decreased by 17 percent among participants. Biomarkers such as cholesterol and blood sugar dropped significantly.

Dr. Golubic was most impressed by numbers related to medication, though. People were able to stop taking 151 medications altogether, decrease their dosage of 89 medications, and avoid 24 new medications by getting their blood tests back within a normal range.

— Chris Blose

A CHAMPION AGAINST CANCER

HEALTHY CHOICES

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• D I A G N O S T I C S

• W E L L N E S S

Learn more at my.clevelandclinic.org/wellness/reclaim_your_health.aspx.

On left: Chris Stein/Getty Images; on right: Eleazar Lázaro Guerra/Getty Images, collage by Glenn Pierce

3catalyst | fall 2012

MEDICAL MYSTERY ABROAD

• M Y S T O RY

A DREAM VACATION in Jamaica in February turned nightmarish for Boston residents Sylvia and Mitchell Haber and their family when Sylvia fell seriously ill within a few days of arrival on the island.

The couple at first suspected mild food poisoning but became increasingly alarmed as Sylvia’s health rapidly deteriorated. A succession of medical treatments proved unsuccessful. Within a week, doctors in Jamaica said she was so gravely ill that they could not help her. Fearing that he would lose his wife, Mitchell, an executive with a large Web-hosting company, contacted his employer for help.

After determining the best hospital to provide the acute care needed, Mitchell’s employer arranged for Sylvia’s airlift to Cleveland Clinic Florida in Weston on Feb. 29, seven days after their trip began. She arrived in septic shock with multiple organ failure, her chances of survival slim.

Twice during her first few days at Cleveland Clinic, Sylvia went into cardiac arrest, and then she developed profuse bleeding in her lungs. Attending ICU physician and pulmonologist Gustavo Ferrer, MD, knew that her situation was dire. He requested Mitchell’s permission to try an experimental approach: injecting a coagulant called factor VII into her lungs. The treatment was not yet approved for this purpose by the FDA.

Ten minutes after the medication was administered, Mitchell heard a cheer from the room. “Dr. Ferrer came back smiling and saying, ‘We stopped it. She’s stabilized,’ ” he recalls. “From that point on, every single day, there was improvement. Her recovery accelerated faster than they anticipated. A week later, she was eating, sitting up and talking. The doctors were stunned that she recuperated as quickly as she did. They were calling her the miracle patient.”

Medical tests showed that she had a severe reaction to medication she received in Jamaica. The original cause of her illness remains unknown.

Today, Sylvia is recovering at home and taking care of her children. In gratitude, she started a personal fundraising page to support Dr. Ferrer’s work (ccf.convio.net/goto/haberfund).

“Had it not been for the incredible team of doctors and ICU nurses at Cleveland Clinic Florida, I would not have survived,” Sylvia says. “I feel great, happy and amazed.” — Elaine DeRosa Lea

STAMPEDE study shows astounding results

BARIATRIC SURGERY is generally reserved for morbidly obese patients with type 2 diabetes who don’t respond well to other treatments. But new research shows the surgery could help many more diabetics live longer, healthier lives.

Philip Schauer, MD, Director of Cleveland Clinic’s Bariatric and Metabolic Institute, and Steven Nissen, MD, Chairman of the Department of Cardiovascular Medicine and Lewis and Patricia Dickey Chair in Cardiovascular Research, led the study, called STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently). The results, published in March in the New England Journal of Medicine, were widely covered in the national news media.

For a year, researchers tracked the progress of 150 diabetic patients between 25 and 100 pounds overweight. Compared with those who received other therapies, bariatric surgery patients were three to four times more likely to experience complete remission of their diabetes. Forty-three percent of them showed complete remission, compared with only 12 percent of patients who did not have surgery. Similarly, 37 percent of patients who had sleeve gastrectomy, another type of surgery, showed complete remission.

In addition, “almost all of the patients who had bariatric surgery no longer needed to take daily insulin injections,” says Dr. Nissen, who calls the results “an out-of-the-park home run.” — Laura Putre

• R E S E A R C H

ROLL BACK DIABETES

8,000+The number of sleep studies performed by Cleveland Clinic’s experts each year. Sleep studies help determine whether a serious medical condition, such as sleep apnea, is responsible for poor sleep quality.

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Mitchell and Sylvia Haber with their son, Matthew, and daughter, Alli

On left: Chung Lee; on right: photo courtesy of the Haber family

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When it comes to supporting the Cleveland community, “We say ‘yes’ more often than ‘no,’ ” says Jared Chaney, Executive Vice President of Medical Mutual of Ohio.

Over the years, Medical Mutual, the oldest and largest health insurance company based in Ohio, has made significant contributions to programs and projects at Cleveland Clinic.

This year, the company has contributed to Cleveland Clinic healthcare education summits on the patient experience and personalized healthcare and, as it does every year, supported the HeartThrob Ball fundraiser for Cleveland Clinic Children’s Hospital and The Scott Hamilton CARES Initiative fundraiser for the Taussig Cancer Institute. It also has made major gifts to the Sydell and Arnold Miller Family Heart & Vascular Institute and the Glickman Urological & Kidney Institute.

“Personalized healthcare and focusing on the patient experience make sense,” Mr. Chaney says. “When the payer, provider and patient all have something at stake, then each will be rewarded through savings based on better outcomes.”

In addition, Mr. Chaney, who is Chief Marketing and Communications Officer at Medical Mutual, contributes his personal time as a volunteer on the Children’s Hospital HeartThrob Ball committee.

“What Cleveland Clinic does

COMMUNITY VALUES

is extremely important to the community, the state and the world,” Mr. Chaney says. “We appreciate its role in medicine and the community, and we hold similar values.” — Elaine DeRosa Lea

“ When the payer, provider and patient all have something at stake, then each will be rewarded through savings based on better outcomes.”— Jared Chaney

Medical Mutual of Ohio Executive Vice President Jared Chaney, left, and CEO Rick Chiricosta

Don Gerda/Cleveland Clinic

5catalyst | fall 2012

In 2008, Michael Roth of Bloomfield Hills, Mich., and his wife, Janie, learned that he had an incurable, terminal lung disease called idiopathic pulmonary fibrosis (IPF).

“It is all so surreal,” Mr. Roth says. “You resign yourself to it, but you don’t want to believe it.”

When they learned at a local hospital that the only way to extend his life was a lung transplant, the couple asked that he be placed on the waiting list. “The hospital turned me down because of age — even though they said my overall health was excellent. Quite the irony,” says Mr. Roth, who was over the hospital’s age cutoff of 65.

Finally, through recommendations of doctors and friends, they came to Cleveland Clinic, which has one of the largest lung transplant programs in the country and where Mr. Roth was given the chance he was hoping for. On Dec. 19, 2010, he had a transplant.

“Cleveland Clinic really embraced us,” Mrs. Roth says. “They didn’t treat my husband like a case but a person who needed a future.”

Grateful for the care he received, the Roths made a philanthropic gift supporting a gathering for lung transplant survivors and the lung transplant team. Marie Budev, DO, MPH, Director of Cleveland Clinic’s lung transplant program, helped organize the event. The two-day “Celebration of Life” at the InterContinental Hotel on Cleveland Clinic’s main campus in September drew more than 420 people.

“I recognize how very lucky I am every day that I have life,” Mr. Roth says. “After my transplant, my wife and I asked how we could give back and also help our fellow transplant patients. This event is our start.” — Elaine DeRosa Lea

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CELEBRATING LIFE AFTER TRANSPLANT “ Cleveland Clinic really embraced us.

They didn’t treat my husband like a case but a person who needed a future.”— Janie Roth

Michael and Janie Roth, center, with children Julee, left, and Jared, right. Not pictured is son Jaimey.

Tackling Tough Transplants

Since 1990, Cleveland Clinic surgeons have performed a total of 1,155 lung transplants. Out of that total, 520 were single transplants and 635 involved both lungs.

Ken Baehr/Cleveland Clinic

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A SCHOOL FOR A NEW GENERATION OF DOCTORS

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Honoring a Father

To address a shortage of primary care doctors in Ohio, a new partnership is creating an osteopathic medical school at South Pointe Hospital, a Cleveland Clinic hospital in Warrensville Heights, Ohio. The Brentwood Foundation, a nonprofit for advancing osteopathic medicine, has made a $5 million gift to South Pointe Hospital to support this effort.

“We seek opportunities to carry out our mission of promoting good care by preventing illness and championing wellness and medical education,” says Roger F. Classen, DO, Brentwood Foundation President. His father was the founder of Brentwood Hospital, an osteopathic hospital that was a precursor to South Pointe Hospital. He also was a strong supporter of Ohio University (OU) in Athens, Ohio.

The creation of this medical school is the result of a partnership between Cleveland Clinic and OU. The agreement builds on their 35-year relationship training physicians. OU students go to South Pointe Hospital for their third- and fourth-year clinical rotations.

The new school is needed to increase the number of family medicine, pediatric and internal medicine physicians in Northeast Ohio, especially those who will practice in underserved urban and rural areas. The first class of 32 students is scheduled to start in July 2015.

The Brentwood Foundation has a history of supporting osteopathic medicine at Cleveland Clinic. In 2008, it committed $5.5 million to establish both the Theodore F. Classen, DO, Chair in Osteopathic Research and Education and education programs at South Pointe Hospital and Cleveland Clinic. Leonard Calabrese, DO, of the Rheumatologic and Immunologic Disease Department, is the chair holder.

“Our commitment is to education at South Pointe Hospital, and over the years, we have been very involved with the medical school,” Dr. Classen says. “Now, we have the opportunity to do even more, and we are very excited. This was my dad’s dream, and he would be so happy with this big, exciting new adventure and to see how great this new partnership will be.” — Elaine DeRosa Lea

Cleveland Clinic patient Paul Meyer “walked a long and unusual road,” says his daughter, Amy Hoopis.

He passed away from renal cell carcinoma in 2011. But it’s his life that Mrs. Hoopis and her mother, Jane, celebrate with a personal fundraising page supporting Cleveland Clinic research into the disease that Mr. Meyer battled for 14 years.

“I don’t think anyone expected it to go the way it did, for him to keep relapsing and coming back,” Mrs. Hoopis says. “Cleveland Clinic was our only hope. It always had an answer. He survived because of the right doctors, his personality and personal strength.”

When she was 16, her father’s health declined. He began setting goals.

“He wanted to go to my high school graduation,” she says. “When I graduated, his next goal was my wedding. He danced with me at my wedding, and then he wanted to build a beach house so he could play on the beach with his grandchildren. He got to do all of that! He got to meet his grandchildren when the odds were seriously against him.”

Mrs. Hoopis and her mother established their personal fundraising page to help friends and family honor Mr. Meyer. More than $2,600 has been raised so far.

“As the anniversary of his death comes up, this page will be a comfort for us,” she says. — Elaine DeRosa Lea

To learn more about Mr. Meyer, go to: ccf.convio.net/goto/paulmeyer.

To create your own Cleveland Clinic Personal Fundraising page, visit giving.ccf.org/personalfundraising or call 216.448.0667.

From left: Roger Classen, DO, Brentwood Foundation; Jack Brose, DO, Ohio University Heritage College of Osteopathic Medicine; and David Bronson, MD, Cleveland Clinic

Paul Meyer with daughter Amy Hoopis

Upper left: Don Gerda/Cleveland Clinic; lower right: Photo courtesy of Amy Hoopis

7catalyst | fall 2012

PYRAMIDIdeas on fInancIal, estate and gIft plannIng for frIends of cleveland clInIc

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Willie McAllister/Cleveland Clinic

Inside This Section

GIVE NOW, GET INCOME FOR LIFE CHARITABLE GIFT ANNUITIES This powerful type of gift can support Cleveland Clinic’s mission while providing you and/or your loved ones lifetime income. A gift annuity provides flexible options and can be funded with a number of different assets.

J oan Repp of Maumee, Ohio, received the 2012 George W. Crile Sr. Award on June 19 at the annual Partners in Philanthropy celebration.

Established by the Pyramid Legacy Society, the award honors recipients for long-standing service, extraordinary commitment and outstanding contributions of time, talent and resources to Cleveland Clinic.

On first learning that she would receive the award, “I felt delight, amazement, gratitude, satisfaction and humility,” she says, “but the true gift is in the giving.”

Mrs. Repp’s gifts to heart research were made in honor of her husband, Victor, who passed away in 2006. A professor of manufacturing technology at Bowling Green State University for 30 years, Dr. Repp was a skilled craftsman who built furniture and constructed one of his family’s homes. He and his

The Gift in the Giving

Joan Repp, 2012 George W. Crile Sr. Award Recipient wife also built a legacy of giving to others.

“My husband always believed in philanthropic giving,” Mrs. Repp says. “When we started out, we were two teachers who didn’t have much but our youth, our physical capital and each other — that was enough to last us 56 years together.” As their income and family grew and their interests broadened, so did their giving, through “frugal living and good financial advice,” she says.

Dr. Repp was a Cleveland Clinic patient for 35 years, from when he had a heart attack at the age of 46 until he passed away at the age of 81.

“It seemed as though every time Victor developed a new problem, Cleveland Clinic had a new answer, each more sophisticated than the last,” Mrs. Repp says. “Cleveland Clinic enabled us to maintain a high quality of life, travel to 38 countries and attend the marriages of our oldest grandchildren.” — Elaine DeRosa Lea

Joan Repp, left, and daughter, Anna Williamson

8 catalyst | fall 2012

T I M I N G I S E V E R Y T H I N G

Immediate Charitable Gift AnnuityIn exchange for your gift, Cleveland Clinic

guarantees annual payments to you and/or a loved

one for life, with the income to begin immediately.

The income stream calculation for all gift

annuities is determined by the date of the gift and

the age(s) of the beneficiary(ies).

Deferred Charitable Gift AnnuityA deferred charitable gift annuity (DCGA) works

just like an immediate charitable gift annuity,

with one difference: Payments begin at a set

time in the future, at least one year from the date

of the gift. The advantage of waiting is that the

longer the payments are deferred, the larger the

payout rate and annual payment amount. The

immediate benefit is a larger charitable income

tax deduction.

Flexible Deferred Charitable Gift AnnuityA flexible deferred charitable gift annuity

(FDCGA) is similar to a DCGA, with an added

benefit. With a DCGA, you decide at the time of

the gift when you would like payments to begin.

But an FDCGA lets you choose from a range of

dates when you wish the payments to begin,

as long as you wait at least one year. Again, the

longer you wait to begin payments, the larger the

annual payment.

Each of these charitable gift annuity variations

also offers additional advantages. For instance,

the examples assume that you are the beneficiary,

but a family member or other loved one may be

added or substituted. Charitable gift annuities

can be established with as little as $5,000.

Given the simplicity and many benefits, we

hope you become a partner in Cleveland Clinic’s

future by establishing a gift annuity, perhaps one

every year to increase the payment amount and

benefits, providing lifetime financial security for

you and a loved one.

Now more than ever, establishing a charitable

gift annuity with a financially healthy institution

such as Cleveland Clinic is an opportunity that

should not be overlooked. With so many options,

the charitable gift annuity is versatile enough

to meet both your financial goals and your

philanthropic objectives.

The Choice Is Right Make a charitable gift now and receive guaranteed income for life. The humble charitable gift annuity is one of the simplest, yet most versatile, gift

planning methods. It is powerful enough to support the mission of Cleveland Clinic,

while providing lifetime income for you or a loved one.

Please contact

Gift Planning

to establish a

charitable gift annuity.

You may call

216.444.1245 or

800.223.2273,

ext. 41245,

or send an email to

giftplanning@ccf.org.

A CHARITABLE GIFT ANNUITY

9catalyst | fall 2012

A S S E T S U S E F U L F O R E S TA B L I S H I N G A C H A R I TA B L E G I F T A N N U I T YEnjoy additional benefits by funding a charitable

gift annuity with assets other than cash:

Appreciated Securities• Avoidpayingaportionofthecapitalgainstax

• Anytaxablegainisspreadoutoveryour

expected lifetime

• Aportionofyourincomeistax-free

Life Insurance• Removelifeinsurancefromyourestateand

avoid estate and income taxes

• Aportionofyourincomeistax-free

Commercial Annuities• Avoidpayingaportionofthecapitalgainstax

on commercial annuities that have accrued

considerable gain (which are taxed as ordinary

income)

• Additionaltaxablegainisspreadoutoveryour

expected lifetime

• Aportionofyourincomeistax-free

Qualified Retirement PlansA charitable income tax deduction may offset the

tax you pay upon withdrawal

Real EstateRelieves you of the burden of maintaining and

selling the property

(Note: Real estate is vulnerable to market

fluctuation. Therefore, a gift of real estate is

subject to approval by Cleveland Clinic’s Real

Estate Acceptance Committee.)

If you own one of these assets and would like

to discover how you can turn it into a charitable

gift for Cleveland Clinic and income for life

for you or a loved one, please visit our website at

clevelandclinic.org/giving or send an email to

giftplanning @ccf.org or call 216.444.1245.

Example:John Smith contibutes

$25,000 to Cleveland Clinic

to establish a gift annuity. He

is 70 years old, so his annuity

payment rate is 5.1% He will

receive an annual income of

$1,275 ($25,000 x 5.1%) for

his lifetime.

His gift also produces

a charitable income tax

deduction of $8,673. In his

28% tax bracket, he may save

$2,428 on taxes this year.

The anticipated benefit to

Cleveland Clinic is $30,776,

which means that his initial

gift of $25,000 has more

than doubled by producing

a larger gift to Cleveland

Clinic, and returning lifetime

income to Mr. Smith along

with an immediate charitable

deduction.

$25,000Charitable Gift Annuity

John Smith5.1% Payout for Life

LifetimeBenefits toJohn Smith$22,828

Benefits toCleveland Clinic

$30,776

Total ProjectedBenefits $53,604

Tax Savings $2,428(charitable deduction of

$8,673 x 28% tax bracket)

Remainder will help build Cleveland Clinic’s future

Expected Lifetime Payments $20,400 (projected lifetime of 16 years

X annual payments of $1,275 each year)

1 0 catalyst | fall 2012

PYRAMID

You can plan for

your future while

supporting Cleveland

Clinic through a

charitable gift.

If you would like to

learn about additional

charitable opportunities

that might be a good fit

for you, we invite you

to request our Ways to Give brochure.

If you wish to discuss, in confidence, a plan that

best suits your family and charitable goals, please

call Cleveland Clinic’s gift planning professionals at

216.444.1245.

You also may send an email request to

giftplanning@ccf.org, or visit us online at

clevelandclinic.org/giving. We look forward to

assisting you.

CLEVELAND CLINIC IS GRATEFUL

FOR ALL GIFTS.

We would be glad to work with you and your advisers to arrange a gift plan that best suits your objectives. To discuss your charitable goals in confidence with one of our gift planning professionals, please call 216.444.1245 or 800.223.2273, ext. 41245, and ask for Gift Planning, or send an email to giftplanning@ccf.org.

top row: amanda steyer, esq.; JennIfer Kealy, esq.; nelson J. WIttenmyer Jr., esq., InstItute vIce chaIrman; anne corrette

bottom row: lIsa tersIgnI; nancy mccann; KatherIne collIn, esq.

Meet Our Team

Ways to Give2 0 1 2 P A R T N E R S

Barbara Bellin Janovitz, Esq., Reminger Co., LPA

Karen L. Greco, Esq., Kohrman Jackson & Krantz, PLL

Joseph W. Kampman, Esq., Ziegler Metzger LLP

Ellen K. Meehan, Esq., Squire Sanders LLP

William M. Mills, Esq., Singerman, Mills, Desberg & Kauntz Co., LPA

Lu Anne Morrison, MAI Wealth Advisors, LLC

Jodi Nead, JPMorgan Chase

Ryan C. Olds, Cedar Brook Financial Partners

Jon J. Pinney, Esq., Kohrman Jackson & Krantz, PLL

Laurie G. Steiner, Esq., Budish, Solomon, Steiner & Peck, Ltd.

Missia H. Vaselaney, Esq., Taft Stettinius & Hollister, LLP

William Weston, JPMorgan Chase

The Gift Planning team is part of Cleveland Clinic’s Philanthropy Institute.

Allied Partners in

Philanthropy (APP) is

a society established

by Cleveland Clinic to

thank and recognize

allied professionals

(attorneys, accountants,

bankers, brokers,

financial planners,

etc.) who have helped

facilitate a charitable

gift to Cleveland Clinic.

If you have assisted your

client(s) with a gift to

Cleveland Clinic, please

contact Nancy McCann

at 216.445.8980

or send an email to

giftplanning@ccf.org.

ALLIED PARTNERS IN PHILANTHROPY

Photo courtesy of Cleveland Clinic

How does one of the world’s foremost heart disease researchers find himself deep in the bowels of the — bowels?

Stanley Hazen, MD, PhD, is not a digestive researcher, so he was as surprised as anyone when his research led him into the digestive system. Nonetheless, Dr. Hazen has made headlines for research that links the bacteria in a person’s gut to heart disease risk.

First published in April 2011 in the journal Nature, Dr. Hazen’s research has shown that the way our bodies break down a common nutrient found in animal products may have a potent effect on whether we develop heart disease, and it varies from person to person. The discovery could lead to everything from a new, powerful diagnostic tool — currently in the works with partner company LipoScience — to changes in our diet, new probiotics or nutritional supplements, not to mention a continuing robust research program.

WHEELS

By Chris Blose

Focused. Competitive. Entrepreneurial. These qualities drive Cleveland Clinic’s innovators to solve some of the most challenging medical problems.

F INVENTION

1 1catalyst | fall 2012Photo by Michael Northrup

1 2 catalyst | fall 2012

The initial discovery was unexpected, but Dr. Hazen and his team were prepared to act on the results in any case.

“I say to people in the lab that you have to be scientifically fearless,” says Dr. Hazen, who holds the Leonard Krieger Chair in Preventive Cardiology. “What that means is, if the results of an experiment say that you need to go in X direction, and you have no expertise in X direction, you try to become the world’s leading expert in X direction. You start doing experiments on X.”

Dr. Hazen has a history of doing exactly that. A physician who specializes in preventive cardiology, with a PhD in biophysical chemistry and molecular biology, he has hired geneticists, animal studies specialists and other experts when his own studies suggested

that’s what his lab needed. He also was the scientific founder of Cleveland HeartLab, launched by Cleveland Clinic Innovations to commercialize Dr. Hazen’s research.

In a way, Dr. Hazen, his lab and his colleagues are the prototype of innovation at Cleveland Clinic: cross-disciplinary. Driven by creativity and curiosity. Entrepreneurial and unafraid to pursue commercialization. Focused on the greatest needs in healthcare.

Perhaps most important, they follow where the science leads them.

HEART HEALTH AND HUMAN NEEDSTo Dr. Hazen, innovation starts with human needs. And when it comes to human needs, a healthy heart is one of the biggest.

Heart disease remains the United States’ No. 1 killer, claiming roughly 600,000 lives per year, according to the Centers for Disease Control and Prevention. On top of that, each year, nearly 800,000 Americans have their first heart attack.

Dr. Hazen’s research is rooted in clinical studies with heart patients. He and his team first collected blood samples from 10,000 people, then followed them for three years to determine who went on to have a heart attack or stroke or died. They then compared those who did have a cardiac event with a gender- and age-matched control group.

They started by casting a wide molecular net, scouring the blood for common traits leading to disease.

“In each person’s plasma, we measured many, many

“ I say to people in the lab that

you have to be scientifically

fearless. What that means

is, if the results of an experiment say

that you need to go in X direction,

and you have no expertise in X

direction, you try to become the

world’s leading expert in X

direction.” — Stanley Hazen, MD, PhD

different things, not knowing what they were,” Dr. Hazen says. “We had this unbiased view of every single compound we could see by mass spectrometry and asked, from a statistical standpoint, is there something in the plasma that seems to associate with a risk of having a cardiac event?”

Of the 20 or so compounds that fit the description, several existed only in the presence of bacteria. So, Dr. Hazen started wondering, where do we have a lot of bacteria in our bodies? The answer: the gut.

The team narrowed its focus to the way our bodies process, or metabolize, the common lipid found in the walls of animal cells, lecithin, which, along with cholesterol, is a major component of egg yolk. This led them to the products of that metabolic process:

››

J. Kyle Keener

1 3catalyst | fall 2012

choline, trimethylamine N-oxide (TMAO) and betaine. Follow-up studies have further linked these compounds to heart disease in animal models, and Dr. Hazen is now pursuing further human clinical trials — on top of LipoScience’s test for TMAO.

To Dr. Hazen, the heart-gut discovery connects several dots. Because each person’s gut flora is different, this research could help explain why one person can have a poor diet but still not be at risk for heart disease, while someone else really does need to watch cholesterol and animal fat intake more carefully.

Call it creative problem-solving. It started with a simple blood test, but the results of that blood test have branched off in several unexpected directions.

Being open to such surprises is a key attribute of innovators and inventors, says Joseph Hahn, MD, Chief of Staff. In his 36 years at Cleveland Clinic, he has seen that attitude pay off time and again.

“We really stress that we want to find creative people who will help solve problems that patients have,” Dr. Hahn says of the way Cleveland Clinic attracts its best and brightest. “It’s everything from diagnostic testing to devices to drugs to procedures.”

BRIDGING THE GAPBack in 2000, while also serving as Chairman of the Division of Surgery, Dr. Hahn was the founding Chairman of Cleveland Clinic Innovations, the entrepreneurial arm of the institution designed to find commercial partners and establish spin-off companies based on breakthroughs such as Dr. Hazen’s.

“ We really stress

that we want to find

creative people who will help solve problems that patients have.

It’s everything from

diagnostic testing, to

devices, to drugs, to

procedures.”

— Joseph Hahn, MD

Dr. Hahn would have liked for Innovations to be in place 20 years sooner. Early in his career, he and a colleague developed an electrode that could be implanted in the brain to treat and monitor neurological conditions. At the time, the Food and Drug Administration (FDA) would not let them sell the electrodes, but they could use them in patients. So they worked with Cleveland Clinic’s Biomedical Engineering (BME) department to make the electrodes. Dr. Hahn traveled the country demonstrating how they worked to other doctors.

“Some guy who saw our show on how to do them went and patented it,” Dr. Hahn says, with equal parts humor and regret.

It’s fitting, then, that Dr. Hahn was there for the beginning of Innovations, an enterprise that helps creative problem-solvers commercialize their ideas. Patients also benefit from research that otherwise may have been nothing more than a journal article.

Part of the goal is to bridge the gap between the two very different worlds of academia and industry, says Geoffrey Vince, PhD. Dr. Hahn helped recruit Dr. Vince back to Cleveland Clinic — he had started here as a postdoctoral fellow — after the latter’s successful stint in industry. Also an inventor, Dr. Vince served for five years as vice president, Clinical Affairs and Advanced R&D, for Volcano Corp., a company that commercialized his own highly advanced intravascular ultrasound technique.

“The most difficult thing I think for inventors today is what is called the ‘valley of

death,’” Dr. Vince says. “This is where the National Institutes of Health funds the research — the ‘R’ in R&D. What they don’t fund is the ‘D,’ the development, which is, ‘Now we have something that works for patients.’”

Unfortunately, industry heads and venture capitalists are not all that interested in funding development until research is proved to work in human trials, which happens fairly late in the process. Getting innovations from one side of the valley to the other is part of what both Innovations and BME do. They also market and package complex ideas so they are easily understood on both sides of a deal.

“Not everyone who is a venture capitalist has a PhD in electrical engineering or molecular biology,” Dr. Vince says, “and on the flip side, PhDs do not speak the language of venture capital.”

In addition, Dr. Hahn notes, many researchers feel uncomfortable working with industry. But done properly, with the right policies in place, an academic-industry relationship can result in products that change patient care.

“We’ve created an atmosphere where it’s not bad to work with industry,” Dr. Hahn says. “We’ve put

››

Photo courtesy of Cleveland Clinic

1 4 catalyst | fall 2012

BEYOND MEDICINEAsk Chris Coburn, Executive Director of Innovations at Cleveland Clinic, about the most promising products coming out of his office, and he’s just as likely to mention healthcare information technology (HIT) as medical treatment.

“In the current age of healthcare, innovation is not restricted to the laboratory or the operating room,” Mr. Coburn says. In fact, the fastest-growing portion of Innovations’ portfolio is HIT, which in 2012 makes up about 20 percent of Cleveland Clinic inventions. That number should grow as the national healthcare landscape continues to evolve.

For example, employees from medical operations and finance have licensed an electronic tool designed to improve data mining and analysis to help doctors make smarter

decisions. The resulting spin-off company, Explorys,

now has its technology in around 80 hospitals, where it serves more than 13 million patients.

“We’re talking about all of Cleveland Clinic’s 43,000 employees being potential innovators,” Mr. Coburn says.

things into place, checks and balances, such as our conflict-of-interest committee, but we welcome industry to come here and work.”

LAB TO MARKETBy the numbers, Cleveland Clinic’s welcoming atmosphere is paying off. Innovations started in 2000 with three employees and has been led by Executive

“ Part of the goal is to bridge the gap between the two very different worlds

of academia and industry.” — Geoffrey Vince, PhD

››

corporate venturing, in the mix with heavy hitters such as Novartis, Johnson & Johnson and Eli Lilly.

Mr. Coburn attributes these successes in part to recognition that Cleveland Clinic exists for patient care, research and education. Innovations can support and enhance all three.

“It’s important to equip the organization itself in a way that these objectives can be pursued,” Mr. Coburn says. “It requires an approach that builds new competencies into the organization, whether it’s growing the level of commercially relevant research or helping investigators think

Director Chris Coburn since its establishment. Now chaired by renowned hand surgeon Thomas Graham, MD, Cleveland Clinic’s Chief Innovation Officer and holder of the Justice Family Chair in Medical Innovation, Innovations has a staff of about 65 employees.

A handful of invention disclosures a year quickly turned into 100, then 200

and now nearly 300. Since it began, Innovations has overseen 600 product licenses and 53 spin-off companies that have raised nearly $700 million in equity financing. In August, Innovations earned its largest-ever single investment of $30 million for the spinoff Cleveland Heart Inc. to develop a new, improved artificial heart. That follows on the heels of Boston Scientific’s $78 million acquisition of Cleveland Clinic spinoff Intelect and its leading-edge deep-brain stimulation guidance software initially developed in BME. Innovations has reached No. 4 in the world for healthcare

Lower left: Yu Kwan Lee/Cleveland Clinic; upper right: Tom Merce/Cleveland Clinic

Geoffrey Vince, PhD, leads a tour of the Lerner Research Institute.

1 5catalyst | fall 2012

into new studies on everything from the effect of portion size — eating too much, too fast seems to increase the formation of TMAO — to how probiotics, functional foods and possibly supplements

about how to see their work in a commercial way.”

Among those competencies, Innovations educates researchers and doctors about the commercialization process, then partners with them to get the technology to patients. Expert staff members help to clear big hurdles such as FDA approval for new products. Innovations establishes companies, recruits management, secures initial financing and executes licenses. Recently, Innovations established a national Innovation Alliance, managing commercialization for other hospital systems through on-site Cleveland Clinic employees.

For Dr. Hazen’s gut flora research, Innovations identified a number of potential commercial partners and then developed the relationship with the commercial partner that licensed the technology. Licensee LipoScience has a simple blood-based diagnostic testing platform based on nuclear magnetic resonance (NMR) imaging — a platform that works effectively for finding and quantifying TMAO, the compound Dr. Hazen has linked to heart disease risk.

No specific timeline has been announced, but Dr. Hazen hopes that a TMAO diagnostic test will be ready to introduce for clinical use in the next year. Whether it proves more powerful and more accurate than current measures, such as cholesterol testing, remains to be seen, but at the least, it can complement them. Dr. Hazen also thinks his work will help individualize nutrition recommendations for patients. In addition, he and his team have followed the diverging paths of his research

THE FRUITS OF LAB LABORSWhen researchers or clinicians at Cleveland Clinic have ideas for a product or prototype, they often turn to the Department of Biomedical Engineering (BME), led by Geoffrey Vince, PhD. Dr. Vince’s team has a way of turning ideas into inventions.

Of the 53 patents awarded to Cleveland Clinic in 2011, more than a quarter came out of BME, Dr. Vince says. And of the 32 licensed technologies, six came from BME. Here, Dr. Vince shares the “eclectic eight” inventions he thinks are poised to reshape patient care:

A BETTER ARTIFICIAL HEART. Based on the work of Leonard Golding, MD, and mechanical engineer Dave Horvath, this new take on the artificial heart has a single moving component, which makes it less likely to need repair or replacement than traditional devices. It has been commercialized through Cleveland Heart.

CANCER DETECTION TOOLS. Ninety percent of cancer deaths are caused by metastasis, or the spread of tumor cells. Aaron Fleischman, PhD, and Maciej Zborowski, PhD, are working on a diagnostic test to better detect tumor cells circulating in the bloodstream. The initial version was licensed to an Indiana startup.

TINY TREATMENT FOR CANCER. Vinod Labhasetwar, PhD, leads a team using nanoparticles to better deliver cancer drugs. The goal is to target therapy to diseased cells while leaving healthy tissue alone.

THE BIONIC KNEE. The style of prosthetics used by most above-the-knee amputees was first developed in 1954. William A. Smith, DEng, PE, has developed a new version that is a massive upgrade that helps people walk with more efficiency and less pain, encouraging a higher quality of life through a more active lifestyle.

A BOOST FOR THE HEART. William A. Smith, DEng, PE, is working on an improved ventricular assist device to give the heart a boost in blood flow. The device, ranging from .17 of an inch to .55 of an inch, can help patients who are waiting for a heart transplant or recovering from surgery. It is the basis of spinoff Perfusion Solutions.

AID FOR ARTHRITIS. More than 70 million people worldwide deal with the pain of arthritis. Anthony Calabro, PhD, is studying a unique protein modification linked to the joint damage caused by the disease. In the future, doctors may be able to “cleanse” the joint of this modification and prevent such damage. Calabro’s foundational hydrogel technology has been licensed to Lifecore Biomedical.

SCAFFOLDS FOR SOFT TISSUE REPAIR. Kathleen Derwin, PhD, is working on adaptable materials that can be used to repair soft tissue damage in areas like the rotator cuff and the abdominal wall. (Read more on the inside back cover of this issue of Catalyst.)

A CURE FOR INCONTINENCE. Upwards of 50 percent of women have some form of incontinence by age 50. Margot Damaser, PhD, and her team are looking at the role of child-birth in this process, as well as novel treatments such as growth factors and stem cell therapy.

can alter TMAO levels and the disease process.

All the while, he remains open to new partners and products with the potential to take his work further than he could on his own — and with

the overall goal of improving patient care.

“All the science in the world will only get you so far,” Dr. Hazen says. “You have to have someone who can execute on it.” n

1 6 catalyst | fall 2012

game changerll

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WE KNOW THAT RISK factors for type 2 diabetes include genetic predisposition and being overweight and inactive. But 6 percent of Americans with diabetes have type 1, which hits hard and out of the blue as an immune disease. Once known as juvenile diabetes, type 1 is commonly diagnosed in babies and young children whose bodies do not produce adequate amounts of insulin, a pancreatic hormone that regulates blood sugar.

Since 1923, the only means of survival for people with type 1 diabetes has been daily insulin injections. Although medical science found a way to provide patients with insulin-producing islet cells — the types of cells normally found in a healthy pancreas — their immune response kills these cells, and the body cannot regenerate them.

How do we get around this response? One way is to surgically transplant mature islets from a donor pancreas. While transplant patients have remained insulin-free for as long as 10 years, as with other kinds of transplants, there’s a lifelong need for immune-suppressant drugs. Also, the demand for this treatment is high, and the donor supply is low. Patients also must live close to transplant facilities, and there are few. For instance, there are none in Ohio; the closest is in Pittsburgh.

I’m excited to report, however, that there’s new hope for helping

A SOLUTION FOR TYPE 1 DIABETES?

provide oxygen to or properly shield the insulin-producing cells. With the technology we’re exploring, a patient would need to connect only once a day to a laptop-sized computer unit that controls oxygen distribution to the device. Studies show that cells can live inside this device for at least six months, and we’re testing survival beyond that time frame.

With further philanthropic support, we could expedite this groundbreaking research, leading to phase 1 safety trials in humans within the next three years. Because of such support, millions of people in the very near future may be able to say that they used to have diabetes but now enjoy healthy, normal lives.

Dr. Jensen is in the Department of Stem Cell Biology, Cleveland Clinic Lerner Research Institute, and holds the Eddie J. Brandon Endowed Chair in Diabetes Research.

The world is facing a diabetes epidemic — 300 million people now live with the disease, with 26.2 million of them in the United States alone. Of these, 6 percent have type 1 diabetes.

By Jan Jensen, PhD

people with type 1 diabetes live normal lives, free of insulin injections and the chance of complications, including blindness and heart and kidney disease. At Cleveland Clinic, we’re collaborating with an outside company to develop a protective device the size of a small jar lid that contains insulin- producing islet cells. The device would be implanted under the skin during an outpatient procedure.

Our goal is to provide a cure for type 1 diabetes.

With this device, patients would no longer need insulin because the implanted cells would replace their pancreatic beta cells and keep blood sugar at normal levels. Also, because this procedure wouldn’t involve transplantation, patients would not need immune-suppressant drugs.

Although other such devices have been tried, they were ineffective because they could not

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With this device, patients would no longer need insulin because the implanted cells would replace their pancreatic beta cells and keep blood sugar at normal levels.

Illustration by Glenn Pierce

I nnovat ion

Rotator cuff tears and abdominal hernias have two things in common: They are both caused by soft tissue

injuries, and they both occur frequently. Surgeons perform nearly 250,000 rotator cuff repairs and 350,000

hernia repairs each year in the United States, with hernia repairs alone costing $3.2 billion.

New ways to repair soft tissue would promote healing and save money — even a 1 percent reduction in

hernia repairs would save $32 million a year.

Kathleen Derwin, PhD, Associate Staff at the Department of Biomedical Engineering at Cleveland Clinic’s

Lerner Research Institute, and her team are developing new biologically based materials for augmenting soft

tissue repairs. Results are encouraging for rotator cuff repair, which with philanthropic support could soon

advance to human trials.

“In the future, these materials will be adapted to help regenerate soft tissue in extremity, skin, fascia and

genitourinary injuries,” Dr. Derwin says.

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catalystVolume 10 | Issue 3 Fall 2012

Kathryn DeLong, Director, Development Communications

Elaine DeRosa Lea, Communications Manager

Chris Blose, Managing Editor

Brandon Wamsat, Project Manager

Glenn Pierce, Art Director

Caroline E. Couig, Photo Editor

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Editorial, Design and Project Management

Bernadette Peoples, Environmental Services at Solon Family Health Center, with Isaac, a shepherd-beagle mix in the Volunteer Services Department’s Canine Caregiver program

FPOFPO

Photo Neil Lantzy/Cleveland Clinic.