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My friend took his son Tommy to Disney-land, hoping for a photograph with Capt

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

ain Hook. But just as it reached Tommy’s turn in line, the photo session ended

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

Examples of combination products may in

and Captain Hook stalked off making gruff noises suitable for a pirate.

Litt

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

e Tommy broke into tears.

Another Disney cast member came along to soothe the

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

boy, gave his parents vouchers for a free dinner in the park and took some ad

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

Combination pro

itional information.

When they returned to their hotel room that night, a col

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

orful card was waiting on the pillow with a picture of Peter Pan on the front.

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

Inside was a handwritten note:

Dear Tommy, Captain Hook can be quite nasty s

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

metimes. After all, he is a pirate! I hope you enjoy the rest of your stay wit

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

h all of us at Disneyland.

The card was signed ‘Peter Pan’, and is cherished

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

oday by Tommy (and his parents) more than any old photograph with that nasty C

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

Following aspects would a

aptain Hook!

Key Learning Point
----------------------------------

dd to the challenges in developing combination products:

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

----------------------------------------------
Put positive emotion and a

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

personal touch in your service recovery efforts. Customers will remember and c

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

herish you forever.

Action Steps
--------------------------------

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

-----------------------------------------------
The next time something g

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

Professional from academic institutions, pharmaceutical industries, health care indust

oes wrong for your customer, colleague, friend or family member, make a very s

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

pecial effort to set things right. Be a generous and magical Peter Pan, not 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

tingy pirate! Take the extra time to do something special, different, memorabl

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

Companies that provide selfless information through particip

e and rewarding. You, too, can be someone’s new favorite character in the park

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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Do you feel like one in a million at work – and not in a good way? When you run into your boss in the hallway, do you get the impression she isn’t sure who you are? Are the juicy projects always going to someone else? If you answered “yes” to any of these questions, you need to raise your work profile. Here are some tips to get you started...

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