Life Sciences 2014

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LIFE SCIENCES

How Roche Diagnostics is poised to alter women’s health around the globe, plus a closer look at the company’s expansive northeastside headquarters.

In partnership with

©2013 Roche Diagnostics. All rights reserved. 671-52190-0113

Because of us, Gail and Steve can still dream of parenthood.

Every day at Roche Diagnostics we work to help patients like Gail live longer, healthier lives and focus on their dreams, not their disease. That’s why we’re advancing the cause of women’s health by developing tests that help doctors decide which patients need closer monitoring.

Together, we’re making advances that make a difference, because dreams are what matter most.

Doing now what patients need next

Learn more about Gail’s story at http://becauseofus.roche.com/Gail

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Changing the Landscape in Women’s Health

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Roche’s cobas® HPV DNA test for cervical cancer screening can transform how the disease is detected and treated by physicians around the world.

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Personalized medicine, which has its roots in molecular oncology, is traditionally described as the right treatment for the right patient at the right time.

“I think that still holds true, but its role is now expanding,” says Alan Wright, M.D., MPH, chief medical officer for Roche Diagnostics, noting that personalized medicine is now venturing into the preventive-care arena.

Roche is one of the leaders in personalizing medicine. In the mid-’90s the company developed the first personalized pharmaceutical, Herceptin for breast cancer, and has continued its tradition of innovation in the realms of both pharmaceuticals and diagnostics.

“We can leverage both of our core competencies to lead the way in personalized diagnostics for personalized medicine,” says Whitney Green, senior vice president of molecular diagnostics at Roche.

Molecular diagnostics, which identify genetic characteristics based on specific mutations, play a key role in developing increasingly effective screening tests.

One of those tests changing the global landscape in women’s health is the Roche cobas® HPV DNA Test for cervical cancer screening.

“There are about 4,000 fatalities per year in the U.S. alone from cervical cancer,” Green says. “The goal of Roche is to reduce the number of women suffering from this disease by developing better diagnostics.”

Making history In the mid-1940s, Dr. George Papanicolaou introduced the Pap test to screen for cervical cancer. After its adoption in the

1960s, the incidence of cervical cancer and deaths due to the disease decreased by more than 60 percent. It’s no wonder the Pap has been the standard of care for cervical cancer screening for the past 50 years.

As the Pap test technology evolved, it became possible to pinpoint pre-cancerous cells and then diagnose three stages of cervical pre-cancer.

However, since a pathologist interprets the results, there’s the potential for human error. And the test doesn’t catch all incidents of the disease.

“The way to correct for that was to

test more often, so we would be more likely to capture those true ‘abnormals,’” says Mark Gentry, M.D., a specialist in obstetrics and gynecology with Hendricks Regional Health Medical Group.

But the introduction of HPV DNA testing signaled a new approach that’s changing the paradigm in cervical cancer screening. Instead of focusing on whether cancer is already present, Roche’s cobas HPV Test detects the presence of human papillomavirus, the virus responsible for virtually all cases of cervical cancer.

The cobas HPV DNA Test specifically November 2014 | LIFE SCIENCES 3

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47,000 women in the U.S. participated in this study, with an age representation that closely mirrored the demographics of the U.S. population.

Findings confirmed that the Pap test alone missed a significant amount of disease. One in 10 women who had a negative Pap test result but were positive for HPV 16, for example, already had cervical precancer. Another study showed that approximately one-third of women who had a normal Pap result were found to have cervical cancer precursors or cancer.

From Gentry’s perspective as an OB/ GYN, the most important finding is that patients who test negative for the Roche

With longer time between cervical cancer screening tests, patients can use their annual wellwoman exam to discuss with their doctor other important issues.

of Public Health–Bloomington. “It will transform how we reach women who are underscreened for cervical cancer.”

Compared to the Pap, the Roche cobas HPV Test is a more objective and sensitive tool that can be used to assess a woman’s risk and monitor at-risk patients closely, so that if cancer or pre-cancerous disease does develop, it can be treated early.

Putting it in perspective Initial results from the ATHENA study, a landmark three-year clinical trial that evaluated the performance of the Roche cobas HPV Test compared to the Pap test, were released in 2011. More than 4 LIFE SCIENCES | November 2014

test are twice as likely to be free from cervical cancer after three years than women who receive a negative (normal) Pap test.

The cobas HPV Test was initially approved by the U.S. Food and Drug Administration in April 2011 as a screening test for cervical cancer to be used in conjunction with a Pap test, known as co-testing.

Later that year, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated their guidelines for cervical cancer screening to indicate that Pap/HPV DNA co-testing was now preferred to Pap testing alone for women ages 30 to

65. If a Pap test result (with no HPV cotest) comes back negative, the guidelines recommend that women be re-tested every three years; if both co-testing results come back negative, the re-testing interval is five years. It’s a case of “watch and wait” with follow-up testing for women who have a normal Pap test and a positive HPV DNA test.

Shifting roles Results from the ATHENA study have some wondering if the lead role in cervical cancer screening should be given to the cobas test instead of the Pap. This April, Roche’s cobas HPV Test received an expanded approval by the FDA for primary screening of cervical cancer—the only test to receive this status since the Pap. “The FDA found that, in fact, HPV testing first is comparable, if not superior, to cytology testing first,” Wright says.

Roche is increasing awareness about the importance of HPV-based screening by working with patient-advocacy groups and other organizations that influence the development of guidelines for medical practice. Roche cleared one hurdle when the test received FDA approval. The next obstacle is gaining acceptance in physicians’ offices, but the process of incorporating new science into longstanding medical practices is traditionally a slow one.

“We’ve also invested in a dedicated professional sales team to talk to practicing OB/GYNs and educate them on cobas HPV screening and HPV 16 and 18 genotyping,” Green says.

What it means for women & healthcare providers Longer time between tests and a reluctance to give up the familiarity of the Pap will likely be the main concern for women.

“I tell my patients, we’re not taking something away,” Gentry says. “The technology has changed, and you’re actually getting a better negative predictive value for greater reassurance that you won’t have the disease.”

Since a specimen won’t need to be gathered at every annual well-woman visit, that time can now be used for women and their providers to discuss other issues.

“HPV primary testing would signifi-

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detects HPV 16, HPV 18, and 12 additional HPV genotypes that put women at a higher risk for developing cervical cancer. HPV 16 and HPV 18 are responsible for 70 percent of all cervical cancers.

“The unique aspect of the Roche test is that we have the ability with one sample and one test to differentiate among those different genotypes,” Green says.

That has huge value for physicians, researchers, and, ultimately, patients.

“Knowing if a patient has a high-risk genotype has much more meaning for me,” says Dr. Beth Meyerson, co-director of the Rural Center for AIDS/STD Prevention at Indiana University School

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cantly simplify the process,” Gentry says.

The act of gathering the specimen in a physician’s office is the same for both tests. However, the HPV DNA specimen is conducive to self-sampling via vaginal swabs, and, in the future, that could have huge implications for women worldwide.

“For me, I think of the opportunities for outreach screening in venues where you can’t do a Pap,” says Meyerson, who envisions kits being made available in public restrooms, walk-in clinics, and other venues. “You can start to see how technology can bring the system closer to women and girls who don’t have access to healthcare.”

the role of vaccines Vaccinations for HPV are recommended for girls and boys 11 or 12 years of age, but they haven’t been universally adopted.

“Testing will be necessary until every young woman and man has been vaccinated,” Meyerson says. “We have not uniformly normalized HPV vaccination as part of our preventive-care immunization regimen in the U.S. That means at least for now, we’ll always have to test.”

Another concern is how long the vaccines will last.

“How long will they provide protection for a young woman—particularly women who are vaccinated in their early teens who are most likely to be sexually active for a number of years afterward?” Gentry says. “The answer is, we don’t know yet.”

photos courtesy kirk forbes

Looking to the future “I think we’re at the beginning of the journey,” Roche’s Green says. “Personalized healthcare can be a factor for improving outcomes, reducing adverse effects, and reducing overall costs in the future.

And molecular diagnostics are going to be a critical component of that.”

Developing diagnostics that improve breast cancer treatments continues to be an emphasis for Roche. Other prominent projects include establishing tests to target treatment for lung and colon cancer, osteoporosis, and heart disease.

“Roche is a company that emphasizes innovation,” Wright says. “We’re always developing new tests in anticipation of what patients will need next.”

The Kristen Forbes EVE Foundation One family channels its grief into educating people about HPV, with the ultimate goal of eradicating cervical cancer.

In 2007 at age 22, Kristen Kristen Forbes Forbes had everything going for her. She’d just graduated from IUPUI and had landed a job in Walgreens’ management program. She was young, beautiful, and full of life.

But four weeks into her new job, she noticed swelling in her right ankle. Within three weeks, she received a diagnosis of stage III cervical cancer.

Her Pap test had been normal just 18 months earlier.

Kristen put up a fight, but succumbed to the disease 12 months later.

“At that point, every friend Brenda and I talked to knew nothing about HPV,” says Kirk Forbes, Kristen’s father. “They’d never heard of it.”

In 2010, Kirk and his wife, Brenda, created the Kristen Forbes EVE (Educate, Vaccinate, Eradicate) Foundation to teach the public about HPV, its vaccine, and the test, and to encourage women to use these life-saving tools.

“Between the Roche cobas® HPV Test and the vaccine, there’s no excuse why we can’t eradicate these HPV-caused cancers,” Forbes says.

Forbes has shared Kristen’s story on The Dr. Oz Show and regularly makes speeches at Indiana colleges. He and Brenda presented to the Women in Government Foundation, a group of female state legislators based in Washington, D.C. The EVE Foundation receives support from Merck and Glaxo SmithKline, the makers of the HPV vaccine, and Roche Diagnostics, the developer of the cobas HPV DNA Test.

Collaboration with Roche has proved mutually beneficial.

Roche provides the Forbeses with up-to-date information and education and speaking opportunities. A film of the Forbeses talking about the effects of cancer on a family helps Roche put a personal face on the disease and shows employees what their research and products really mean.

Kirk Forbes on set at “We can never say thank you The Dr. Oz Show enough to everyone at Roche for their support of our efforts,” Kirk says. “It’s been priceless.”

The Forbeses are excited that Kristen’s story, and those of four other young women, are featured in Someone You Love: The HPV Epidemic, which has appeared in several international film festivals, including the Heartland Film Festival.

“Our final goal is to raise our glasses in a toast when the CDC announces that cervical cancer and other HPV-caused cancers are eradicated,” Kirk says.

—shari held

by Shari Held November 2014 | LIFE SCIENCES 5

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Building a Promising Future

In 2012, Roche Diagnostics announced a $300 million investment in its Indianapolisbased North American headquarters.

Improvements are slated to continue for the next decade.

These changes seek to do more than create pretty new buildings and cuttingedge technology. They’ve been designed to encourage creativity and collaboration among employees. A close look at the

workplace structure in 2012 revealed that the current office space was not being fully used, and key working groups were separated by walls and distance, says Carole Puls, communications business partner for Roche Diagnostics Operations.

“We think about the way employees work and want to extend the Roche brand into how the buildings are built and what they look like,” Puls says.

Getting to Know Roche Diagnostics A brief history of the powerhouse company.

Roche Diagnostics focuses on innovative healthcare advancements, specifically relating to the area of diagnostic tests. These are intended to help medical professionals detect and determine the best course of treatment and potential cures for a number of diseases and conditions, including diabetes and cancer.

Roche Diagnostics, whose North American headquarters is located in Indianapolis, employs 4,600 workers. About two-thirds of the Indianapolis employees support sales and marketing efforts. The campus also manufactures about 1.9 billion of its ACCU-CHEK® test strips each year.

Roche Diagnostics headquarters The Roche Group has more than 80,000 employees worldwide and invests about $9 billion annually in research and development.

Roche Diagnostics’ early beginnings were quite humble. In 1964, Willard “Bill” Eason left his chemical-engineering job at the Ford Motor Company and founded a company called Bio-Dynamics Inc. in his Indianapolis garage. Eason launched the first unimeter, a device that allowed doctors to perform accurate analyses of certain lab tests right in their own offices. By the end of its first year, Bio-Dynamics had more than $150,000 in sales. B io-Dynamics moved to the basement of the Indiana University Medical Center before purchasing land that is now the site of Roche Diagnostics.

Boehringer Mannheim Corp. acquired Bio-Dynamics in 1974. The company launched Chemstrip® bG diabetes test strips, whose sales reached $1 million by 1979. Researchers also developed the ACCU-CHEK® brand, the gold standard in diabetes care.

Roche acquired Boehringer Mannheim in 1998. Roche in Indianapolis currently has five business areas: Molecular Diagnostics, Centralized Diagnostics, Point of Care, —Lori D. Roberts Tissue Diagnostics, and Diabetes Care.

6 LIFE SCIENCES | November 2014

To that end, the new Learning and Development Center is set to open in the second half of 2015. The building will train 1,500 customers annually in Roche technology. The second phase will house support staff and field representatives.

The laboratory building opened in August and brings five separate labs under one roof. It allows for greater environmental control and flexibility.

The RDC office building, slated to open in early 2016, also brings together employees. The structure will incorporate Roche’s European architectural history with efficient technology, maximum natural light, and sustainability features.

Outdoor courtyards will give employees a place to collaborate.

An employee amenities center with a cafe, a conference space, and wellness, fitness, and career centers will also open in 2016.

With alternative workspaces, Roche is moving away from “cube farms.” This workspace seeks to establish an open, collaborative work environment with specific rooms designated for small, medium, and large groups of employees.

Construction plans call for environmentally conscious materials and techniques.

Roche was just recognized again as an industry leader in sustainability on the Dow Jones Sustainability Indices, Puls says. Its commitment can be demonstrated in plans for the Learning and Development Center, which will consume 43 percent less energy per square foot than its predecessor.

“It’s really about how people work,” Puls says. “Employees typically don’t sit at their desk for eight hours a day. We want to make sure we’re providing work environments for the kind of work they want to do.”

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by Lori D. Roberts

photo courtesy roche diagnostics

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Roche Diagnostics’ North American headquarters is undergoing a multimillion-dollar transformation.

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Striving to be the Best

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Roche Diagnostics places its employees at the forefront.

photo courtesy roche diagnostics

For the past two years, Roche Diagnostics in Indianapolis has been named one of the Fortune 100 Best Companies to Work For—the only Indiana-based company to make the prestigious list. But as recently as 2010, when a new leader took over, that accolade seemed impossible.

When Jack Phillips made the move to Indianapolis to helm Roche Diagnostics, his first step wasn’t about business strategy. He quickly saw the biggest reason the company had missed its sales targets the previous two years: a poor corporate culture. It was time for some changes.

“It was pretty humbling to see that feedback, but it became our burning platform,” says Bridget Boyle, Roche vice president of human resources.

After senior leaders instituted new cultural beliefs designed to restore employee confidence, changes were apparent. By the end of 2010, the company achieved its projected business results.

In 2011, a global-engagement survey indicated that nearly 75 percent of its employees felt engaged or highly engaged in the company. Satisfied employees are better for business.

“Culture sets the tone for everything else that happens at work,” Boyle says.

“Want a great business result? Build a dynamic, diverse workplace where employees are expected to take risks and add their voices to the conversation.”

Focus on health & wellness Take a closer look at Roche’s Indianapolis campus, and you’ll see why the company is earning honors. Employees can work out at Roche’s low-cost fitness center, take advantage of walking trails, and visit the wellness center for minor illnesses and injuries. Boyle says revamped—and less expensive—food offerings in the cafeteria have led to an increase in employees

A private park on the Roche Diagnostics northeastside campus is the site of Camp Roche, a summer program for employees’ children held in partnership with the YMCA.

opting for the salad bar each day.

Investing in employees The company benchmarks its salaries against other companies in comparable industries and strives to be at or above market in its offerings, Boyle says. Employees can earn a percentage of their base salaries above and beyond their regular paychecks each year in March, depending on the company’s profit targets.

“It’s a huge signal to employees that the business they’re working in is thriving, it’s growing, and they’re getting to share in that growth,” Boyle says. “It sends a very strong message.”

Roche leaders take listening to employee feedback seriously. Every 18 months, personnel are surveyed on their work environments and job satisfaction.

Employee feedback delivers results.

When workers requested a summer

option for their kids, the company answered that wish. Begun in 2012, Roche offers a summer program for employees’ kids ages 6 through 12.

Perhaps what’s most telling is that the majority of employees who work for the company want to continue to do so.

Roche’s turnover rate typically ranges between 3.9 and 4.3 percent.

Clearly, people want to work—and remain working—at Roche. Its philosophy of investing in employees leads to better business, and better business leads to better lives for those who are diagnosed and treated with Roche products.

“We have to offer people a culture where they can grow, develop, and achieve their own definitions of success,” Boyle says. “When we do that, the business success comes naturally.”

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© 2013 Roche Diagnostics. All rights reserved. 461-52902-1113

Doing now what patients need next We believe it’s urgent to deliver medical solutions right now — even as we develop innovations for the future.

We are passionate about transforming patients’ lives.

We are courageous in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do and how we do it. We are many, working as one across functions, across companies and across the world.

We are Roche.

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From FORTUNE Magazine, February 3, 2014 © 2014 Time Inc. FORTUNE “100 Best Companies to Work For” is a registered trademark of Time Inc. and is used under license.

FORTUNE and Time Inc. are not affiliated with, and do not endorse products or services of, Roche Diagnostics.