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I took a trip last fall to explore western North Dakota with my best friend. We were a couple of Thelma and Louise adve

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

nturers who set out on the drive across the state to go back in time to visit Medora, the former home of Roughrider and

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

Examples of combination products may in

president Theodore Roosevelt and current home of the Theodore Roosevelt National Park.

Here's your North Dakota histo

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

y lesson: Medora was founded in April of 1883 by a 24-year old French nobleman, the Marquis De Mores, who named the tow

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

n after his wife Medora, daughter of a wealthy New York City banker. With financial backing from his father-in-law, he

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

Combination pro

ounded the town of Medora east of the river, building a meat packing plant, a brick plant, a hotel, stores, and a large

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

home (Chateau de Mores) overlooking his new town.

It was a fun trip, and, although I've lived in North Dakota all my

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

ife, I've only been to Medora maybe twice that I can remember. It's easy to forget about the beauty and diversity we ha

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

ve right in our own backyard.

Since eastern North Dakota, where I live, is relatively flat (OK, REALLY flat), I don't

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

ave much experience driving my five-speed CRV in hilly terrain. While driving through Theodore Roosevelt National Park

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

and observing bison up close and personal, I found myself cruising along in fifth gear, only to find myself struggling

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

Following aspects would a

to make it up the hills of the park. The harder I tried to get up the hills in fifth, the more my little car complained

dd to the challenges in developing combination products:

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

and strained. I forgot that the only way to climb the hills effectively is to shift down to fourth and even third gear

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

to pick up speed and traction.

What a great metaphor for our lives. Only when we take time to shift into a lower gear

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

an we get the traction we need to make it up the hills. It took a trip out west to remind me yet again to slow down and

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

enjoy the view - both the new view in unfamiliar territory - but also the view I look at every day when I cruise throu

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

Professional from academic institutions, pharmaceutical industries, health care indust

h my life in fifth gear. Now each time I shift down - including last weekend when I found myself in standstill traffic

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

during rush hour trying to get out of Minneapolis - I think about the hills of western North Dakota, and the message I

.

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

ot from the hills and the bison. Before my shift (pun intended), that traffic might have really gotten me upset. It's t

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

Companies that provide selfless information through particip

aken just that subtle shift to get a whole new perspective.

Shift into third and notice what you don't notice in fifth

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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