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This is another way I might describe our LIVING THE FULFILLED LIFE PROGRAMS. One of the ways we create a sens

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

e of community is with the Goose Story that follows that I believe I first heard when I was involved with Lan

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

Examples of combination products may in

mark Education. It's a powerful metaphor of what's possible when we join together in the spirit of commUNITY

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

:

THE GOOSE STORY

Next fall, when you see Geese heading South for the Winter . . . flying along in V format

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

on . . . you might consider what science has discovered as to why they fly that way:

As each bird flaps its

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

Combination pro

wings, it creates an uplift for the bird immediately following.

By flying in V formation the whole flock add

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

at least 71% greater flying range than if each bird flew on its own.

PEOPLE WHO SHARE A COMMON DIRECTION AN

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

D SENSE OF COMMUNITY CAN GET WHERE THEY ARE GOING MORE QUICKLY AND EASILY BECAUSE THEY ARE TRAVELING ON THE T

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

RUST OF ONE ANOTHER.

When a goose falls out of formation, it suddenly feels the drag and resistance of tryin

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

g to go it alone. . . and quickly gets back into formation to take advantage of the lifting power of the bird

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

in front.

IF WE HAVE AS MUCH SENSE AS A GOOSE, WE WILL STAY IN FORMATION WITH THOSE WHO ARE HEADED THE SAME

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

Following aspects would a

WAY WE ARE.

When the Head Goose gets tired, it rotates back in the wing and another goose flies point.

IT I

dd to the challenges in developing combination products:

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

SENSIBLE TO TAKE TURNS DOING DEMANDING JOBS WITH PEOPLE OR WITH GEESE FLYING SOUTH.

Geese honk from behind

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

to encourage those up front to keep up their speed.

WHAT DO WE SAY WHEN WE HONK FROM BEHIND?

Finally . . .

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

nd this is important. . . when a goose gets sick, or is wounded by gunshots, and falls out of formation, two

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

other geese fall out with that goose and follow it down to lend help and protection. They stay with the fall

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

Professional from academic institutions, pharmaceutical industries, health care indust

n goose until it is able to fly, or until it dies; only then do they launch out on their own, or with another

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

formation to catch up with their group.

IF WE HAVE THE SENSE OF A GOOSE, WE WILL STAND BY EACH OTHER LIKE T

.

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

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

Companies that provide selfless information through particip

This article can be reprinted freely online, as long as the entire article and this resource box are included

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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