Summary - Relationships

Designing your own relationship vision requires a shift in your thinking.

Most of

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

us seem to stumble into relationships and marriage, and then continue to sort of ma

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

Examples of combination products may in

e it up as we go along. It's been my clinical experience that relationships take mu

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

h more conscious planning to be successful. I guess if I was selling insurance I wo

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

ld be saying, "Most people don't plan to fail, they just fail to plan."

But what i

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

Combination pro

we were able to design our relationships in the way we would most like them to be?

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

What would that be like?

A starting point for this vision is the question: "If you

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

knew you couldn't fail, and you could create your relationship any way you would wa

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

t it to be, what would it be like?"

Step by step, create a plan

Creating y

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

ur relationship vision is really quite easy. Discuss and choose two or three areas

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

here you would like to design your relationship.

For each area you have decided to

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

Following aspects would a

work on, simply follow this four-step process:

Brainstorm: Come up with as

dd to the challenges in developing combination products:

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

many ideas as possible. No idea is too silly or impossible at this stage. This is n

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

t a time for criticism or "yes, -but ...." Use your creativity. All ideas are acce

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

table at this point.

Decide on two or three ideas that will head you in the

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

direction you want to go.

Delegate: Assign different tasks to each partner,

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

Professional from academic institutions, pharmaceutical industries, health care indust

including a date they should be done by.

Follow through - This is probably

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

the most important and yet most difficult of the three steps. It does not matter ho

.

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

good your intentions and ideas might be, you have to follow through.

This four-st

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

Companies that provide selfless information through particip

p process can help you to design consciously the kind of relationship you both want

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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