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We spent two days at Disneyland when my daughter, Brighten, was seven years o

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

ld. I found the entire park to be a well-oiled, emotionally fulfilling enterp

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

Examples of combination products may in

rise.

I was impressed by the rides, shows and dedicated staff (called ‘cast

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

members’).

Many cast members wear colorful pins commemorating Disneyland his

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

ory and lore: Bambi’s birthday, Mickey and his friends, Piglet, Pooh, Beauty

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

Combination pro

and the Beast. On arrival, Brighten was given a lanyard with four identical p

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

ins she could trade with any cast member in the park.

Each time Brighten met

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

someone with colorful pins she admired, that person knelt down to meet Brigh

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

en at eye-level. With a genuine smile, they said enthusiastically, ‘Would you

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

like to trade pins with me?’ It sounded like the most exciting moment of the

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

ir lives.

At seven years old, choosing can take time, especially with so man

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

Following aspects would a

y pins to pick from. Brighten never felt rushed to make a choice. And every t

dd to the challenges in developing combination products:

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

me a trade was made, the staff gave Brighten a big ‘Thank you!’ and a friendl

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

y smile.

I don’t remember which pins Brighten traded. But I will never forge

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

t the energy and joy Disneyland staff brought to those precious moments of hu

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

man contact.

Key Learning Point

Business is not a cold process of swapping

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

Professional from academic institutions, pharmaceutical industries, health care indust

ervices, money and goods. It’s a living, thriving appreciation of the dynamic

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

connection between us.

Action Steps

Live today with enthusiasm, energy and

.

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

joy. You are a chosen cast member in the greatest show on earth – your daily

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

Companies that provide selfless information through particip

life. (And remember, the curtain is always open.) Disneyland makes real magi

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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