Advice You - Business

Whenever our firm is implementing change in an organization, we emphasize to the executive and mid

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

dle managers that truth telling and truth facing will be the hallmark of our process. If the peopl

; 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 with whom you are working can’t trust that you’ll tell the truth, you can’t get commitment, and

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

when you make commitment, you build hope…when you keep that commitment, you build trust, when you

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

have trust and commitment, you get ownership of the work performed and results!

Respect guides yo

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

Combination pro

u to tell the truth and adds momentum to do the right things well. If you can’t establish respect,

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

you can’t get trust. If no trust, no commitment. If no commitment, results are poor and time is w

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

sted.

It’s difficult for most to embrace changes in the way things need to be done. For business

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

ownership, they are naturally concerned about changes to the way the business got to where it is n

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

ow, will key personnel quit, the cost, will it really make us better? Thus, for our firm, we estab

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

lish trust as an immediate goal. We do this by delivering the results intended and by accomplishin

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

Following aspects would a

g what we were hired to do on time and within budget. To establish loyalty to both the company and

dd to the challenges in developing combination products:

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

to the process, we always seek to acknowledge the contribution of others and promote it, both in

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

front of them and in a public forum. Problems are discussed in private, yet we expect that “pride”

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

will not get in the way of a manager or executive apologizing to the targeted parties and doing th

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

e obvious “right thing” when an obvious “wrong action” has been done.

Finally, don’t blame someon

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

Professional from academic institutions, pharmaceutical industries, health care indust

e else when things go wrong. Demonstrate your own accountability to the commitments made to the co

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

mpany. “Step up”, make commitments and accomplish them, treat co-workers with respect, be complete

.

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

ly honest in communications, and you’ll not only “get what you measure”, but also, through a defin

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

Companies that provide selfless information through particip

ed process for positive change, you will create a powerful workplace, greater profits and revenues

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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