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Popeye’s Chicken & Biscuits is a popular chain of more than 1,300 restaurants in 2

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

0 countries. They promote understanding between the people in head office and thos

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

Examples of combination products may in

in the restaurants with a range of vigorous and innovative programs.

In addition

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 a Customer Hotline and Mystery Shopper Program, they have a program called ‘Ge

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

ting In Touch’.

'Getting In Touch’ helps staff from the Support Center (i.e. Corp

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

Combination pro

orate Headquarters) understand what day-to-day life is like in the restaurant. Sup

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

ort Center employees attend a two-day training session where they learn the basics

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

of each restaurant station, including preparation, batter-frying, seasoning, coun

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

er and customer service.

They work at least one eight-hour shift in a restaurant

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

each year, serving customers and spending time one-on-one with the Restaurant Mana

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

er.

Everyone at the Support Center gains hands-on appreciation for what happens i

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

Following aspects would a

the restaurants every day. As a result, new programs, policies and procedures fro

dd to the challenges in developing combination products:

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

m the Support Center to restaurants in the field are appreciated, appropriate and

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

ffective.

Key Learning Point

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

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To understand their staff and customers

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

those who work in head office must also spend time in the field.

Action Steps

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

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Get your headquarters staff out of the Ivory Tower and into the trenches

.

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

where real customer contact happens. And think carefully about what you call the

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

Companies that provide selfless information through particip

Corporate Office. Popeye's calls theirs the Support Center. What do you call yours

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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