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If you're into mechanics and cars, then perhaps this scenario appeals to you. Just picture this: as you stand at your station, you are patient despite the excitement that abounds. Screaming fans,

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

loud engines, and brightly colored cars surround you. This is where you work. As your car pulls into the pit, you work like a maniac to make sure your driver can get back out on that track. You

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

Examples of combination products may in

ay not change tires or gas up the car, but you ensure the proper working of the vehicle so that your team can win! After all, you are one of the best NASCAR mechanics.

Steer Your Way to a Me

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

chanic Career
NASCAR mechanics have a variety of tasks in which they may specialize, including tires, brakes, and welding. And it's best to attend mechanic schools to learn these skills.

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

Just ask Lee Bob Cunningham. During the week he works as a mechanic on the Aaron's Toyota Camry (#99) in the Busch Series, fielded by Michael Waltrip Racing, and at races, Cunningham shifts gears

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

Combination pro

, changing rear tires in the pit. But Cunningham didn't just walk off the street and into a job at NASCAR after he realized he wanted to work with cars. His decision, prompted him to decide on on

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

of the mechanic schools, the NASCAR Technical Institute (Mooresville, NC), to provide him with training that would get him the job he desired.

"I've been a big NASCAR fan for as long as I can r

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

emember," says Cunningham. When he heard that there was a school where he could learn to do what NASCAR mechanics do, Cunningham looked into it immediately. He needed to gas up his mechanic caree

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

in order to go far. After spending about a year and a half at the school, Cunningham was ready to look for work with teams seeking NASCAR mechanics. He had had training in many different concent

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

rations, as each class lasts for three weeks. He learned basic automotive skills, along with fabricating, welding, and set-up. He then attended a training school that taught him to do a pit stop

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

orrectly.

Crossing the Finish Line
After attending one of the country's mechanic schools, Cunningham began putting his resume out to everyone he could. "I tried out with a lot of tea

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

Following aspects would a

s," he says. "You start to know a lot of people that way." This kind of networking is extremely vital in securing a job as one of the NASCAR mechanics. In October 2005, Cunningham received an off

dd to the challenges in developing combination products:

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

er for a job as the eighth employee at Michael Waltrip Racing. "I wanted to learn just coming out of school," he says. "It was a start-up and a small shop so I got to know people quickly and they

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

got to know me. It was a good learning experience for me."

Cunningham says that the most challenging part is the competition both on and off the racetrack. "The pit crew is pretty challenging be

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

cause you are competing against some of the Cup guys and people who have been at it for 15 years," he says. But with a certificate and training at an accredited institution, you're sure to get gr

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

at experience and train to become one of the great NASCAR mechanics.

Competition is also fierce among peers. "The probability of getting in [as one of the NASCAR mechanics] right away is pretty

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

Professional from academic institutions, pharmaceutical industries, health care indust

slim," he says. "The teams usually call the school for the top five people and there were roughly 1,600 kids in my program." But one shouldn't allow that to get in the way of a dream. Cunningham

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

idn't. His advice to overcome this obstacle? "Never give up," he says. He knows how hard it is to start out and not know anyone. However, "if you keep going back to the same places and ask for th

.

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

e same people, they get to know you." By making yourself a known presence you're sure to get somewhere, he says.

The job, though, does have some perks as Cunningham says. "I like to travel and h

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

Companies that provide selfless information through particip

re I get out and see the country," he says. And he gets to do something he likes best: work on cars. Not to mention that during any given race, "there are 150,000 fans dying to do what I'm doing.

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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