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FEELING JUST FINE WITH OCCUPATIONAL HEALTH NEW VALIDATION FOR HEALTH CARE’S MOST IMPORTANT BUT UNHERALDED PROCESS

PUTTING CERTAINTY IN UNCERTAINTY

© 2014 Yoh Services LLC | A Day & Zimmermann Company

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WHAT’S INSIDE 03 Putting Certainty In Uncertainty 09 Feeling Just Fine with Occupational Health

13 New Validation for Health Care’s

Most Important But Unheralded Process


PUTTING CERTAINTY IN UNCERTAINTY

As health care and life sciences face great change, one thing remains the same: Those companies that will thrive will do so because of their people and the talent they attract and retain.

Few industries have ever faced the degree of change now confronting American health care and life sciences. New technologies, the Affordable Care Act (ACA), the end of blockbuster drugs, and the rise of personalized medicine will forever change an industry that today accounts for more than onesixth of the American economy.

For some businesses, change spells trouble. But for others, great opportunities hide in the chaos. Who wins and who loses depends on the quality of people an organization can attract and the talent it can apply to solving the incredible number of challenges now upon us. The entire American health care system is being reinvented, somewhat on the fly. This new patient-focused, results-driven world has cut funding and investments and requires smart organizations Š 2014 Yoh Services LLC | A Day & Zimmermann Company

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to become more nimble and responsive.

At the same time, a mind-boggling number of medical advances places us closer to solving the riddles of human health. Genome sequencing has unraveled the mysteries of our very DNA, bringing with it treatments and protocols personalized to the individual. But proving the efficacy of sequencing-based, patientspecific processes, finding the dollars to bring them to market, and making them available on a mass scale demands high-level talent. In fact, talent is now the great differentiator—not just the quality but also the management of that talent. Here’s where the opportunities exist now and what every organization needs to know at this stage of industry change:

WHERE THE JOBS ARE For every health care niche, there will be those that surge ahead and those that fall behind. Classical clinical research is already feeling the strain. “Big pharma is getting squeezed on many fronts,” says Tammy Browning, Senior Vice President of U.S. Field Operations at Yoh. “On the one hand, the era of blockbuster drugs is coming to a close and with it the massive investment pharma makes to bring a drug to market. On the © 2014 Yoh Services LLC | A Day & Zimmermann Company


other hand, the Affordable Care Act redefines how the industry will be reimbursed, placing emphasis on results instead of procedures or prescriptions.”

Ironically, as clinical employment slackens, the need to manage the recruitment, onboarding, and training of clinical talent becomes even more critical. As drug companies are being forced to do more with less, they need to re-evaluate their hiring practices. More are turning to contingent and temporary clinicians in order to avoid long-term fixed costs or permanent workforces. “Contingent or temporary workers provide the flexibility clinical research and drug companies need to meet uncertain program demands, where development can be quickly shut off or accelerated according to demand, reimbursement, and policy decisions,” says Browning.

Now more than ever, it’s imperative that these companies work closely with staffing firms deeply embedded in clinical research and can quickly tap talent communities, building a pipeline of potential candidates ready for deployment. “It goes without saying that in times of uncertainty, the need for smarter, more effective, and less costly talent management can © 2014 Yoh Services LLC | A Day & Zimmermann Company

define the very success of new drug development, product extension, or commercialization,” says Browning. “It’s at these times when partnership becomes more critical.”

UNEXPECTED OPPORTUNITIES While clinical research tightens its belt, other areas of health care offer broader horizons. Personalized treatments promise to revolutionize human health. Someday soon, we all may have our genome sequenced, providing doctors a roadmap into a precise treatment that will only work for an individual patient. Achieving that result requires a mesh of clinical, IT, big data, and even quantum computing talent that will work as a team to treat patients’ unique cases.

“Personalized medicine will open entirely new employment markets because of the connection between technology and health care,” adds Browning. “The ability to capture, curate, and analyze huge amounts of data generated through clinical trials, medical journal publishing, and DNA sequencing will bring together clinician and technician as they sort through billions of options for the effective treatment of disease.” p. 5


Staffing firms that straddle the line between health care and technology can provide tremendous value. It’s estimated today that America will need 1.5 million data scientists and engineers—an emerging job category. To find this talent, firms will need to tap very specific talent communities populated on one side by Ph.D.-quality engineers and on the other, bachelor-degreed clinicians who can apply advanced findings to treatment.

“In itself, personalized medicine will fundamentally rework the talent equation in health care,” says Browning, “an eventuality that every health care provider and life sciences company must prepare for now.”

OCCUPATIONAL HEALTH Once the backwater of American health care, occupational health will take on new importance under the ACA and as employers are called upon to impact behaviors that reduce health costs. Already, a Philadelphia-based health care chain has announced that it will no longer hire smokers. But it isn’t heartless. The company has charged its internal occupational health professionals with developing a range of programs to affect behavior, such as smoking cessation, weight loss, fitness, and diabetes management and control. “Occupational health care will take on a new and important role, opening new jobs © 2014 Yoh Services LLC | A Day & Zimmermann Company

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and employment opportunity,” says Browning.

Some of that growth will come from insurance and claims management firms. These companies are morphing and positioning themselves as partners in the health of their clients’ employees. That can take the form of online and telephone support and consultation—one-on-one counseling to help manage chronic or lifestyle diseases, thereby reducing incidents that spike costs. “We see huge employment opportunity in this domain,” continues Browning. “Nurses, clinicians, physician assistants, and health educators are going to be asked to support an entire health care system through advice and education.” Finding these people—many of whom have not yet been minted—will require new levels of expertise and imagination, a challenge that staffing solutions firms, like Yoh, are already moving to meet by expanding their traditional footprint in health care and life sciences.

AN AGING POPULATION All this change comes at a time when baby boomers are aging and their demand for health care is increasing. That demographic fact places new considerations on both industry and employees. The RN workforce, © 2014 Yoh Services LLC | A Day & Zimmermann Company

for example, is expected to grow 19 percent from 2012 to 2022, with the need for an additional 525,000 replacement nurses, bringing the total number of open nursing positions to 1.05 million by 2022.

Finding these professionals requires fresh and innovative approaches to talent recruitment and retention. “We’re going to see health care and life sciences adopt recruitment practices now common in other areas of the economy,” says Browning. “In areas such as engineering and IT, where talent is at a premium, companies are outsourcing all or parts of their recruitment process in order to gain the efficiency and accountability that a specialized partner brings to the equation.”

The RN workforce, for example, is expected to grow 19 percent from 2012 to 2022, with the need for an additional 525,000 replacement nurses, bringing the total number of open nursing positions to 1.05 million by 2022.

While uncertainty brings with it a great deal of stress and concern, there are solutions, models of recruitment management that will be applied to the quickly changing health care environment. For those companies that embrace these new models, and work closely with their workforce management partners, there’s much to gain in calming the chaos and finding opportunities hidden within the change.

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GET WELL SOON Š 2014 Yoh Services LLC | A Day & Zimmermann Company

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FEELING JUST FINE WITH OCCUPATIONAL HEALTH

Poor employee health costs business about $1 trillion annually in absenteeism, lost productivity, and workers’ compensation. Companies are beginning to feel the squeeze, as workers’ comp and other medical costs continue to rise.

A study by the National Council on Compensation Insurance (NCCI) showed that the percentage of workers’ compensation claims complicated by a secondary illness nearly tripled from 2000 to 2009, and that such claims cost twice that of otherwise comparable claims.

In turn, companies are taking a new, hard look at hiring on-site occupational health and safety (OS&H) professionals. “It’s not just the growing cost of workers’ comp,” says Rachelle Rolshoven, Manager at Yoh Health Care. “The Affordable Care Act -- Obamacare -- is driving a greater interest in wellness, and employers are coming to understand that there may © 2014 Yoh Services LLC | A Day & Zimmermann Company

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be a distinct business benefit to having someone on site to help them manage this new territory.”

Smoking cessation, cholesterol testing, weight management programs, even blood sugar checks to screen for diabetes are all programs piquing the interest of employers. “The healthier your workforce is,” says Rolshoven, “the better, the more productive your workforce is.”

As a result, demand is growing for occupational health professionals. According to the Center for Disease Control’s (CDC) 2011 National Assessment of the Occupational Safety and Health Workforce, employers expected to hire more than 25,000 OS&H professionals between 2012 and 2017, a 52 percent surge over the 48,000 professionals already at work.

Unfortunately, the same CDC study found that in 2011 training and educational programs graduated only 2,800 new OS&H professionals at the bachelor’s degree level and higher. In the years leading up to 2017, just under 13,000 OS&H professionals will be entering the workforce, a

© 2014 Yoh Services LLC | A Day & Zimmermann Company

shortfall of 12,000 versus the anticipated demand. “Finding well-trained OS&H employees is a big challenge for many companies,” says Rolshoven. “There is a growing need in the industry, yet many of the current occupational health nurses are retiring, and younger nurses and nurse practitioners are not as well-educated about occupational health.”

Part of the problem is the lack of training opportunities. The aforementioned CDC study showed that there had been an overall decline in OS&H training program funding over the previous five years. While funding from outside sources held steady or increased, funding from within academic institutions had decreased. “A perfect example of this trend can be seen in the University of California, Irvine, which used to have an occupational health certification program for nurses,” says Rolshoven. “The program was discontinued eight years ago, and there’s been nothing established in the area since to replace it.”

Specialized staffing solutions firms like Yoh work with clients across the country to find occupational health nurses, and nurse practitioners, physician assistants, and medical assistants in occupational safety and health.

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“Because of the growing demand and dwindling supply of quality OS&H professionals, a strategic staffing partner is key for organizations that are becoming more active in this space,” explains Rolshoven. “Yoh has been focused on this particular area for more than 30 years. We are extraordinarily well networked within the occupational health field and keep our finger on the pulse of the industry, which gives us the reach we need to find the right occupational health candidates for clients.”

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PUT TO THE TEST Š 2014 Yoh Services LLC | A Day & Zimmermann Company

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NEW VALIDATION FOR HEALTH CARE’S MOST IMPORTANT BUT UNHERALDED PROCESS The recent rise of biotech promises more personalized, more precise, and more effective treatments for everything from rheumatoid arthritis to cancer. This $63 billion sector of the U.S. health care industry is one of the fastest growing segments, jumping nearly 37 percent from 2008 to 2012.

And while the space offers new hope in the field of medicine, it also presents new challenges for manufacturers. Competition among manufacturers is reaching a boiling point and the resulting race to market places a premium on effective and efficient regulatory compliance and validation.

Validation in particular is crucial to ensuring patient safety and providing an invaluable check on manufacturers’ facilities in this increasingly regulated market. Validation is the process of examining the equipment and facilities used to produce medicines and medical devices -- in short, ensuring the 1 millionth pill off the line is just as effective and safe as the first. The validation industry has changed considerably in the three decades since the Food and Drug Administration © 2014 Yoh Services LLC | A Day & Zimmermann Company

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(FDA) mandated the practice. More recently a new generation of drugs and a health care market made more competitive by the Affordable Care Act have made top validation professionals more essential than ever to protecting patients, preserving reputations, and controlling costs. Here are four reasons why:

1. Ever-more sophisticated and valuable medicines. Some biotech drugs, such as new cancer medications, are incredibly complex and expensive, especially new personalized medicines customized to specific patient needs. In this new environment, validation professionals are being called upon to deliver greater diligence and care in assuring equipment works repeatedly. “The growing specialization of medications means greater risks in validating the manufacturing process -- any errors could equal millions of dollars in unnecessary costs,” says Rick Kohlhepp, Executive Vice President and General Manager, Validation Services at Yoh. “When there’s more cost and complexity in the manufacturing, you need professionals with more nuanced understandings of efficient and effective validation approaches.”

© 2014 Yoh Services LLC | A Day & Zimmermann Company


2. Reputations can be ruined by a single dose. The greater expense and intricacy involved in validating biotech drugs raise the stakes for manufacturers, which face an increasingly restrictive regulatory environment. “Your reputation walks out the door with your validation professionals,” says Kohlhepp. “You have to make sure you’re getting the highest quality talent that understands the complexity, cost, and consequences of effective validation.” Unfortunately the best professionals are often difficult to come by. “Even when they’re available,” adds Kohlhepp, “they’re often only available for a week or a week and a half at a time.” Partnering with an experienced validation talent provider can help deliver the right professionals exactly when they’re needed.

3. A surge in high-profile mergers and acquisitions. The tight window for many validation engagements is more readily capitalized on by larger manufacturers, which employ vendor-neutral programs to augment their staff. They call upon dozens of companies to source specific expertise for a particular project. But with accelerating mergers and acquisitions © 2014 Yoh Services LLC | A Day & Zimmermann Company

among large pharma companies, few are opening new manufacturing plants that require a large-scale validation. Instead, more and more are looking for revalidation in smaller doses to ensure recently acquired, costly equipment will achieve the best patient outcomes. The revalidation process is critical to this transition phase, and one that should be handled by only the most experienced validation professionals.

4. Emerging manufacturers can’t miss a step. Emerging pharma, biotech, and medical device manufacturers must compete with the larger, established players using far fewer resources, emphasizing the need to avoid costly errors and delays in bringing new products to market. Adding to the challenge, these emerging players are more often opening new facilities and installing new equipment that requires validation, but because of their size and infancy, don’t have the capacity to do so in-house. The fate of these emerging companies is even more closely tied to effective validation because they don’t have other products to fall back on and a single error could trigger their downfall. In these instances, a team of outside validation experts can efficiently vet the equipment and processes through project-based

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validation while avoiding unnecessary spend now, and later down the road.

As medicines and medical devices grow more personalized and complex, validation professionals will grow increasingly vital to proving these treatments are produced safely and effectively for every patient. Mergers continue to drive more intense competition, in which the push to ready drugs for market mandates shorter timelines and tighter budgets. All of which underscores the importance of working with a partner that maintains a pool of top validation talent to ensure compliance, control costs, and promote more positive patient outcomes.

Š 2014 Yoh Services LLC | A Day & Zimmermann Company

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YOU NEED IT. WE HAVE IT.

Yoh is here. Yoh is there. Yoh is virtually everywhere. All in and busy going all out, doing everything it takes to take you where you want to go – forward. How? By foregoing the talent pool in favor of our own sea of talent, helping you find just the right person for the job or just the career you’ve been searching for.


Yoh magazine june14