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How do you build a team that is already present? The least you want is that the members understand each ot

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

her. That is an essential first step in team building.

This can be done by an external assessment. Compan

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

Examples of combination products may in

ies are not equipped to do this by themselves, nor should they focus on these kind of activities, which oc

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

cur sporadically. And there is another benefit by using a third party.

But first search for a simple onli

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

ne organizational assessment. In such an assessment you will have your team respond to a series of "diffic

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

Combination pro

lt" questions about their organization (either focussing on the current situation or a new one). Take for

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

example, this question and think how you might respond:

There is a new solution available on the market.

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

Your organization is already involved in a project with a fixed deadline. However, the new solution will g

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

ive you a lot of extra features and will bring more innovation. What is your response?

"We cont

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

inue with the project as is and park the new development for later concern" (A).

"We start a new

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

investigation, it could be the opportunity we are waiting for" (B).

Different team members w

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

Following aspects would a

ill respond differently to such a question. Reckon what will be the outcome if you have fourthy of them.

dd to the challenges in developing combination products:

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

Normally the result of such assessment will be measured in various dimensions.

Than you should present th

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

e results to the individual members. And additionally you could set up a workshop to discuss the outcome o

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

f the group. Not to learn the individual answers (that will reduce the incentive to participate), but focu

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

ing on where the team is aligned and on what issues the team in out of balance.

The discussion in such a

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

Professional from academic institutions, pharmaceutical industries, health care indust

workshop will serve as a teambuilding event. You could do this with or without a predefined benchmark. A b

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

enchmark will help if there is a strategy set, otherwise you can leave this open if you want input for new

.

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

possible directions.

Internet is a powerful means of providing such alignment tools. And they are there

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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