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My husband, oldest son, and I had the pleasure of enjoying a meal at C&C Supper Club in Fish Creek, Wisconsin during a recent trip to Door County.

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

The building houses a supper club for dining along with a bar with games and live entertainment on many weekends.

We were very hungry when we arr

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

Examples of combination products may in

ived so we went directly to the dining room to eat. We were offered a table near the large fireplace in the dining room. It was a nice cozy place

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

to sit on the cool fall evening we dined there.

The dinner entrees at the restaurant come with a choice of potato, soup or salad, and bread. In

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

ddition, the supper club has an extensive wine collection they have a suggested wine for each of the entrees they offer.

One of our diners opted f

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

Combination pro

or soup with his meal and ordered the French Onion soup. He said it was delicious and that it tasted how French onion soup should taste, with a th

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

ick hearty soup base, a piece of crusty French bread placed on top of the soup, and topped with bubbling hot cheese.

The other members of our dini

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

g party had salad instead of soup. The restaurant has 4 distinct salad choices; a house salad with your choice of 12 dressings; an iceberg wedge w

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

ith choice of dressing; beefsteak tomato slices with bleu cheese; and a spinach salad with hot bacon dressing. We had the house salad and spinach

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

salad. Both were very good and had a pretty presentation.

Two of us decided on the Alaskan King Crab Legs as our main entr?e. They were a great

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

hoice. The crab legs come pre-split so which makes it much easier to pull out the sweet crabmeat and dip it into the melted butter that was provid

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

Following aspects would a

ed. Our only complaint was that we couldn’t get all the crab legs finished before they started to get cold.

The other member of our dining party

dd to the challenges in developing combination products:

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

had the surf and turf, of which there were several options. He chose prime ribs and shrimp. Both items were cooked to perfection and tasted very

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

good. The rosemary baby red potatoes that he chose to have with his meal were also very good.

The bread that came with the meal was also very go

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

d. Our only complaint was that it was served cold. The bread would have tasted even better had it been served warm.

For dessert one of our dining

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

party had an ice cream drink, the restaurant’s purple hooter which was a combination of vanilla ice cream, raspberry liquor, and cr?me de cocoa.

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

Professional from academic institutions, pharmaceutical industries, health care indust

It was served in tall glass and was topped off with whipped cr?me and red sprinkles. The other two members of our dining party tried the raspberry

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

?clair cake for dessert. It was a rich dessert that tasted a lot like cheesecake. It had a mousse filling, raspberries, and ?clair puffs in it, a

.

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

nd was topped with pecans. It was very good.

The meal, including dessert and beverages was just under $100 for three people and we felt it was we

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

Companies that provide selfless information through particip

ll worth the money. Everything we had tasted good and was of good quality. It’s a good place to have a relaxing dinner when you’re in Door County

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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