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The sparkle of Clearbrook, a nonprofit human service agency whose mission is to “create opportunities for children and adults with disabilities,” is not immediately apparent in looking at the exterior of the 52-year-old organization’s headquarters. The retail s

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

pace in Arlington Heights, IL, that houses Clearbrook’s administrative offices and two business tenants that rent a portion of the space from the agency was formerly a grocery store before Clearbrook took it over in 2001.

In fact, stepping inside reveals a wor

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

place that has clearly not been visited by Martha, or The Donald. Not that Clearbrook’s interior is substandard – its high ceilings, white walls and heavily trafficked blue carpeting are classic service industry. But Clearbrook’s sparkle doesn’t lie there, eith

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

er. It starts to become apparent as you step toward a wall that’s dotted with President Carl La Mell and his VPs’ offices – a wall that showcases large, full-color photos of the agency’s 22 group homes and other care and program sites in elegant black frames. T

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

at is where the magic happens, as anyone who crosses your path in these administrative offices will tell you.

As La Mell leads you into his office (he is known by both staff and visitors for his open door policy and approachability), he is proud of the fact th

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

at the number of group homes has grown by more than a dozen since he came to Clearbrook in 1996. He’s also proud that he’s guided the agency to triple its revenues during his tenure – with inconsistent aid from the state government, even though he spends much t

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

me meeting with legislators in Springfield. However, La Mell is perhaps most proud of the commitment and development of his 650 employees.

La Mell calls into his office Hollis Gorrie, the director of the agency’s LIFE (Living and Learning in Family Environment

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

s) program, which provides services to families who choose to keep their child or adult family member with developmental disabilities in the family home rather than seek placement elsewhere. La Mell handpicked Gorrie to head the then-financially stagnant progra

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

a few years ago after he observed her leadership skills up close at a Christmas tree fundraiser. Although his vice presidents had concerns that La Mell might be “rushing her development,” he decided to promote her from her role at the time, helping Clearbrook’

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s clients find jobs in their communities.

Gorrie has exceeded expectations first as coordinator of the LIFE Program and within the last year as its director. “What was a small program with 35 to 40 clients is now the organization’s fastest-growing program, whi

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

h currently serves 225 families in eight counties and generates $3 million in revenue,” La Mell says. That kind of performance is even more amazing given that Gorrie has only been with Clearbrook for six years (four of them associated with the LIFE Program), an

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

d that she found time, with La Mell’s blessing, to earn a master’s degree in psychology.

Gorrie’s personal and professional development would not have been possible if Clearbrook didn’t endorse flexible scheduling. The leadership’s position on the practice has

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

particularly benefited the agency’s case managers, who are out of the office a good portion of the time meeting directly with client families and their developmentally disabled constituents to ensure they’re satisfied. “The flexibility we have is so nice,” says

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Penny Lush, a program manager who has been with Clearbrook for 25 years. “If something comes up in our personal life and we can’t get to the office, or if we’re too sick to come in, we can hook up to the network from our home computer and still get things done

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

”

Along with flexibility comes a willingness on the leadership’s part to be transparent with employees, with everything from the financials to assessing roles and goals. In fact, La Mell takes a two-prong approach to strategic planning: He follows the traditio

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

nal route of scheduling priorities for the coming year at a senior staff retreat, and he also takes front-line staff out for dinner and talks with them honestly and frankly about priorities and ideas that can trickle up to agency initiatives.

The overwhelming

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ense of appreciation that comes from Clearbrook’s front-line staff on being so involved and having the potential to make a difference in the organization and in this field (the direct service area of the health care industry is traditionally plagued by high tur

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

nover) is one of the reasons Winning Workplaces named La Mell a Best Boss in 2006. “Our mission is huge,” says VP of Information Technology Don Frick, “but more than anything, the camaraderie we have allows us to provide great service to people with disabilitie

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

.”

Among the many awards and photos that you’ll find in La Mell’s office – testaments from families and communities of the good work Clearbrook is doing for a demographic that rises and falls from the public sector’s radar screen – prominent is this slogan pri

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

nted out and taped to the chief executive’s inbox: “Businesses remain vibrant by meeting changing needs.” It is clear that La Mell’s people remain just as vibrant and committed to the organization’s mission because it has shown it can change to meet their needs

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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