Main Subject - Business

Relations between two departments had deteriorated badly over the years.

One

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

was a state government agency, the other from the private sector. The culture

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

Examples of combination products may in

f these two ‘partners’ could not have been more different.

At a team-building

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

workshop, top managers from both sides decided to ‘bury the hatchet’.

They b

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

ught a large, new hatchet at the hardware store in town. On one side, the gove

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

Combination pro

nment agency wrote their festering complaints. On the other, the private secto

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

r group wrote their protests, moans and grumbles.

After agreeing to work more

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

positively in the future, both sides held a ceremony on the lawn. With photogr

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

aphers present, they dug a deep hole and literally ‘buried the hatchet’. This

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

ymbolic ritual sent a strong, positive signal that the past was past. Both sid

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

s took responsibility for the future.

Can you see these two teams standing ne

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

Following aspects would a

xt to a pile of fresh dirt? Can you hear their pledge to start again anew? Can

dd to the challenges in developing combination products:

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

you feel the commitment as they walked away from a ceremonial hole in the grou

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

nd?

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

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

-------------------------------
To overcome old wounds you may need to wo

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

k on a symbolic level.

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

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

Professional from academic institutions, pharmaceutical industries, health care indust

---------------------------------------------
Think about where your part

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

erships could be improved. Find a common phrase that captures the solution: `b

.

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

ury the hatchet', `patch things up', `water under the bridge'. Perform a cerem

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

Companies that provide selfless information through particip

nial rite or ritual that engages everyone in a gesture of new work and healing

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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