Main Subject - Business

The other day I watched a very compelling movie produced and directed by Clint Eastwood called "Flags of Our Fathers." I

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

t was the story of the WWII battle of Iwo Jima and the resulting media coverage in the US promoting the famous picture th

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

Examples of combination products may in

at resulted from that event. The message that came from that movie was interesting and one that we as business leaders s

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

hould understand if we want to be successful.

The message was that image is more important than reality. According to t

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

he movie, the infamous picture of the six Marines raising the flag atop the pinnacle of Iwo Jima was not taken when the

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

Combination pro

flag was first raised, but in fact, at a later time after the battle, during a relatively calm moment. Although not stag

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

ed, the raising of this flag did not occur during the heat of battle, as implied, and the men who raised it were not the

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

ame ones that planted the flag initially.

Our leaders at the time were quite aware that this photograph, and the men por

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

trayed, was not as it seemed, but they seized the opportunity to create a gripping image of our brave soldiers at a time

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

when this country needed hope and the support of those at home. It worked.

As a business, it is vital that you maintain

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

an image that reflects exactly what it is you want the public to see. If you own a restaurant, you don't want patrons t

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

Following aspects would a

o walk in and see dirty tables, floors, or counters, the negative image will stay with them and your business will suffer

dd to the challenges in developing combination products:

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

. If you own an auto repair shop, you want your employees driving clean undamaged vehicles. If you own a florist, you w

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

ant all of your flowers to be fresh and attractive. If you are a doctor or a lawyer, you want your clients to see you as

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

being successful by creating images of professionalism in your office or waiting area.

Be very careful when making decis

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

ions about your image. What people see is what you will become. It only takes one moment for your prospects to decide i

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

Professional from academic institutions, pharmaceutical industries, health care indust

f you are credible or not. The image they see will determine your success or failure.

Hanging in my office, is a pictur

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

e of Pete Rose, the baseball player and manager, sliding into home plate in the style that made him famous, headfirst. H

.

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

e was once quoted as saying." ...And there is one more important reason that I slide headfirst. It gets my picture in the

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

Companies that provide selfless information through particip

newspaper." Be careful with your image, it is more important than reality, because it defines reality.

To Your Success

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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Trade magazines and newspapers offer one of the easiest ways for any business of any size to take advantage of free advertising or publicity. This method takes little time, not much effort and costs nothing. In some cases, you can even get paid.

The effectiveness of a true leader is not measured in terms of the leadership he or she exercises. It is measured in the leadership evoked. It is not measured in terms of power over his subordinates but in terms of the power he releases in his subordinates. Leadership is not measured in terms of goals and objectives but it is measured in terms of the accomplishment of others as a result of that leadership. Leadership is not measured in the decisions made, the costs cut, the plans made. It is measured in terms of the growth in confidence, sense of responsibility and acceptance of accountability of the employees that are a result of that leadership.

There’s one simple secret to productive meetings: set an agenda and stick to it. The agenda drives the content and outcomes of the meeting and, where appropriate, should reflect the needs of all attendees so everyone has a buy-in and an interest in the outcomes.

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