Summary - Relationships

For a relationship to last, there are few basic requirements. The rapidity

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

with which relationships are breaking in the modern days is a matter of c

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

Examples of combination products may in

oncern and we should try to find out how to make a relationship that lasts

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

for a long time. The major factors that affect the survival of a relation

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

hip are as below -

Selection Of Partner - Sometimes, our selection of par

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

Combination pro

tner may be wrong. We may have nothing in common and our values and goals

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

may be very different. With bad selection from the beginning, no relations

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

ip can survive for long. One of the main reasons of wrong partner selectio

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

n may be hurry in selection of partner and inattention to the true nature

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

of the selected partner.

Communication - bad communication is another rea

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

on for break ups. Partners are unable to tell about true feelings to each

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

Following aspects would a

other for many reasons including fear of conflict. Sometimes, non-verbal c

dd to the challenges in developing combination products:

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

ommunication is made which fails in sending the message.

Expectations - H

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

igh expectations in a relationship is another reason. We expect that after

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

we fall in to a relationship, we will become happy, satisfied and feel goo

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

d at all the times. That does not happen. This creates frustration and lea

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

Professional from academic institutions, pharmaceutical industries, health care indust

ds to blame on the relationship.

Sustaining relationships is difficult. I

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

gives joy, but demand lot of efforts. Relationship is no solution to all

.

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

our life problems. Sometimes it creates its own problems. For a relationsh

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

Companies that provide selfless information through particip

ip that lasts, we have to take care of all the aspects of the relationship

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 - How To Make A Relationship Last

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