Summary - Relationships

Watch a cloud in the sky. It seems stationary. Slowly it moves and after so

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

metime, without our realizing, that cloud is gone. Sometimes love disappear

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

Examples of combination products may in

from a relationship like that cloud.

When the relationship begins, everyt

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

ing looks ok. The communication is great. Not only verbal but also non-verb

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

al communication between the partners is excellent. Slowly the rot sets in

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

Combination pro

nd there come a time when they stop communicating except when needed. The c

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

mmunication becomes need based. Earlier it was love based. What is the diff

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

erence between need based and love based communication?

Relationship and c

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

mmunication - In love based communication the partners talk to each other a

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

out everything on the earth. They speak about their love; their needs, thei

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

dreams, their aspirations and everything else that makes them feel connect

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

Following aspects would a

ed. In need based communication, the partners’ talk to each other minimally

dd to the challenges in developing combination products:

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

What is required to keep the partnership together is the communication lim

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

t and nothing beyond that. It may revolve around bill payments, and other s

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

uch talks. But this kind of communication gives no joy. It is the communica

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

ion of dead relationship.

Reviving communication in relationship - To revi

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

Professional from academic institutions, pharmaceutical industries, health care indust

e the communication the obvious answer is to talk again. Go back to earlier

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

days and recollect what all you were talking. Begin talking like that agai

.

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 the gap between the partners has widened, this kind of communication b

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

Companies that provide selfless information through particip

comes difficult in the beginning, but slowly it will break all the barriers

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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Summary - Relationships - When Love Is Lost

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