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According to Julia O’Connor, president of Trade Show Training, inc. (TSTi) there a

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

re three universal components to any trade show, anywhere in the world – promotion

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

Examples of combination products may in

presentation and logistics. "While it seems simple", she said, "there are both

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

subtle and major differences in shows in the US and other countries."

Promotion -

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

marketing - is probably more universal, especially now with the Internet, said O’C

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

Combination pro

onnor, but presentation – the sales component – is more affected by culture and

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

usiness expectations.

"Americans are viewed as loud and aggressive. Even as we ex

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

pand globally, we understand we must be more relationship-oriented. We find it har

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

to change but we try to", O’Connor explained.

The biggest challenge – and the mo

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

st complaints she hears – are about the logistics component. It is the unions, t

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

e transportation and shipping problems, the set-up and tear-down. Many countries a

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

Following aspects would a

nd shows use a turnkey operation. In the States, there are different unions to per

dd to the challenges in developing combination products:

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

orm services before, during and after a show.

"It becomes confusing to individual

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

s and expensive for companies that do not understand the process in the US," O’C

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

nnor said.

Those companies planning to exhibit in the US, or those who currently

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

exhibit, often do not know where to turn for assistance. Specialized seminars, run

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

Professional from academic institutions, pharmaceutical industries, health care indust

as Camp Sho-M-Sel-M, provide the information.

Trade shows are complicated events

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

– short term with lots of details. The process is complicated by language, culture

.

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

and old habits. The more a foreign firm knows about US trade shows, the more suc

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

Companies that provide selfless information through particip

cessful they will be.

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

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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