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A vision statement should communicate two things. One is open for the

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

public, the other should only be shared within the organization.

To

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

Examples of combination products may in

start with the latter, a vision should elaborate on the uncertainty o

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

f the future. Because even though it is uncertain, you should do some

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

hing with it. You might find scenarios that would sound plausible and

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

Combination pro

than focus on one of them to be the statement of conviction. We all

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

ave an opinion about the future. To know it, just talk or write about

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

it, and you will find out what you come up with. This is however not

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

something you want to share with clients.

When you think about the r

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

ole, place or position of your company in this future you have just p

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

ctured, you enter the area of the second aspect of the vision. Brains

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

Following aspects would a

orming about this one, would require that the first step is set; you

dd to the challenges in developing combination products:

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

need a vision about the (not to near) future.

A vision may change ov

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

r time and needs continuous adjustments as new ideas come by or when

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

new truths become clear. The future is made today and each day may br

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

ng a surprise, although (real) changes do not come that often.

Discu

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

Professional from academic institutions, pharmaceutical industries, health care indust

ssions about the role of your company in the future are the driving f

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

rce for any strategy. In this strategy you will outline and communica

.

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

te how you will get there. A strategy without a vision is a battle (s

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

Companies that provide selfless information through particip

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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