Advice Pool - Reference and Education

Tony Holmes, a recent high school graduate and aspiring chef, realized his passion for the creation and preparation of food almost by accident, through an elective culinary class he chose to take his junior year. "I wasn't necessarily interested in [the culinary arts] at first

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

-- I just took the class for fun," says Tony. But through his classroom experience, he discovered his passion for cooking. "You get to interact with so many different people, and be creative with food," he says. "That's what I love about it."

After realizing his true love for

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

Examples of combination products may in

ll things culinary, Tony enrolled in the After School Matters program, a non-profit organization dedicated to supplying Chicago teens with unique after school opportunities, which in his case meant a culinary apprentice program. Through After School Matters, Tony has gotten p

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

enty of hands-on experience preparing and serving meals to others. "It's like school and work combined -- you get to learn while getting real world experience," he says. Each week, the students have a different theme, and all the meals they serve follow that theme. Next week, f

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

r instance, it's going to be all Irish cuisine for the folks who sample the students' dishes.

Preparing such a wide variety of foods has inspired Tony to learn everything he can about all aspects of the culinary industry. "Most people end up going into either baking and pastry

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

Combination pro

or savory," says Tony. "But I want to try to do both." For those who aren't familiar with cooking degrees lingo, "savory" refers to the study of entrees, while baking and pastry is more bread and dessert-oriented. And to become an expert in both areas takes an especiall

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

devoted and highly motivated student.

OK, so I love cooking -- now what?
For aspiring chefs, the typical length of time needed to earn their cooking degrees is between two and four years. "Two years focused on cooking, and two years learning about the business," s

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

ys Tony, who plans on completing his bachelor's degree in Chicago after earning his associate's degree at the Culinary Institute of America (CIA, Hyde Park, NY). During his senior year of high school, Tony was accepted into CIA, but faced the threat of not being able to attend

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

ue to financial difficulties. However, as his high school graduation was approaching, Tony placed first in a culinary competition sponsored by the Careers to Culinary Arts Program (CCAP). The prize? A full scholarship to CIA, where he plans on starting in January 2007.

"It pre

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

tty much humbled me because there are people out there who weren't able to be in the competition who are probably better than me," he says, regarding his first place finish. "Sometimes I still can't believe I'm going [to CIA] -- my parents didn't really want me to go out of sta

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

e -- but I'm just ready. I'm not scared at all." Many students pursue cooking degrees at CIA, but for Tony, this is a dream come true. "I just want to learn everything -- whatever they throw at me, I want to learn it."

A taste of "real world" cooking...
The CCAP co

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

Following aspects would a

petition wasn't Tony's first culinary victory. In the summer of 2005, he won another scholarship to study for one week at the Le Cordon Bleu London Culinary Institute, one of the most prestigious global culinary institutions. Aside from loving his experience so much that he wis

dd to the challenges in developing combination products:

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

es he could go back and "do it all over again," it also helped land him a job at Avec, a well-known Chicago restaurant.

"It's one of the best restaurants in Chicago, and I do a lot of prep work," he says. Prep work, in the world of cooking degrees, means getting things ready f

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

or the chefs working the "line" in the kitchen. That means doing things like making sure the right ingredients and garnishes, like parsley, are ready, and making dough or taking care of any basic food preparation the cooks may need. "They're unique and different with their food

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

and I do a lot of watching and learning about how to make different dishes," Tony says of his observations at Avec.

Beyond the classroom...
As far as his future goals, Tony hopes to open his own place, design his own menu, and serve his customers some of the best

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

ood out there. "I eventually do want to own my own restaurant," Tony says. "The dream situation would be to start working at a restaurant, and then have the owner approach me about becoming a partner." Although he's mainly got cooking degrees on his mind right now, Tony has put

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

Professional from academic institutions, pharmaceutical industries, health care indust

some thought into what sort of restaurant he'd like to run. "Most likely, it's going to be like a fine dining restaurant -- not extremely fancy, but still nice," he says. He also plans on combining American cuisine with Italian and French foods to create interesting and appeali

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

ng taste combinations for his customers.

His advice to other aspiring chefs? "You have to be passionate about it, and you have to love to cook for other people," he says. "The stuff you see on The Food Network makes it look easy, but it's a lot of hard work." Even with all the

.

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

perks, such as meeting new people and getting to do what you love, Tony insists that without passion, you won't make it very far. "There is a downside," he says. "The long hours -- sometimes you're out 'til one or two in the morning, and it can be very tiring and draining."

So

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

Companies that provide selfless information through particip

if you love to sleep more than you love to cook, then working towards cooking degrees may not be for you. But if the opposite is true, and you're ready to work hard and do what it takes to earn a living doing what you love, then find out more about earning cooking degrees today

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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All in all, I'm pretty happy with how 2005 turned out. My business is taking off. I've built a solid foundation to support even more growth (which I forecast for 2006) and I've even managed to take some time off.

Working today is much different than 50 years ago. What was once unheard of is now commonplace among today's office workers. Unfortunately, being safe on the job has also changed, but not for the better.

In the best of all worlds, however, some thought should have gone into promotion even before you create your business website. The first three items below should be given heavy consideration before even beginning.

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