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Main Subject - Disneyland Makes Real Magic
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
Examples of combination products may in
rise.
I was impressed by the rides, shows and dedicated staff (called ‘cast
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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