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Recently, I was privileged to be in Mobile, Alabama at the Senior Bowl, where all the great college football players who are graduatin

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

g seniors come together for their last big game.

I was asked to come down to conduct leadership training to 900 NFL coaches and scout

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

Examples of combination products may in

s. The NFL coaches were there, as they always are, looking at the guys who were finishing college to find out who had the potential to

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

be pro football players.

While I was there speaking to the coaches, Dom Capers came up to me. For those of you who don't know, Dom c

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

oaches the new Houston franchise, and was the coach of the Carolina Panthers for several years. He said, "John, let's do lunch, I want

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

Combination pro

to talk to you about leadership."

He had an agenda — he wanted to ask me some questions on leadership; but I also had an agenda — I

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

wanted to ask him what it was like to start an expansion team. As the head coach of the expansion Carolina Panthers, he had been so su

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

ccessful that when Houston started their franchise, they said, "We want Dom Capers here."

I sat down with him and said, "Okay, talk t

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

o me about Carolina, first of all." I'll never forget. He said, "John, there were some amazing lessons I learned. The good news is, we

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

immediately started winning, but the bad news is, we couldn't sustain that winning."

I knew that he was getting ready to tell me som

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

thing that was pure gold, and I looked at Dom and said, "Okay, talk to me about this. Why could you not sustain the winning?" He looke

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

Following aspects would a

d at me and said, "John, we took shortcuts. I went after players who could give me instant success." I think that Carolina went 9 and

dd to the challenges in developing combination products:

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

7 the first year — they had a winning record. He said, "I went after players who could help me win today, but I didn't develop and I d

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

idn't build the team for the long haul."

"In fact," he said, "I had NFL coaches come to me and say, 'Dom, don't do that. You're winni

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

ng too fast. You're going to spoil the people in Carolina; they're going to think that this is easier than it really is.'" Then he sai

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

d, "Here's the blueprint for an expansion team to become a champion: don't go for the quick fix. Build slowly and solidly.

"In the ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

pansion draft, there are so many good players and so many veteran players. If I were to pick the best players off of these other teams

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

, I believe I could have a winning record my first year in Houston; but my goal is not to have a winning record the first year. In fac

.

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

t, we've already determined that we'll take no one over the age of thirty in the expansion draft. We're going to go after young player

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

Companies that provide selfless information through particip

s, we're going to draft well, we're going to spend our time developing our players, and we're going to build slowly for the long haul.

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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I think of the many opportunities I have to offer assistance to the companies who have not made the connection between untrained employees in the area of proper telephone etiquette and reduced profits. Every connection an employee has with a customer, patient, client (or potential one) is vital to the profits of any company. I therefore offer to you, Telephone Etiquette for Businesses.

Perhaps it is crossed your mind that you could start your own oil company. I had considered this scenario recently for a fictional work.

In this article you will explore different precautions you must take for the safety of your business from fraudulent individuals and customers with whom you do transactions through credit cards. This article will definitely add valuable knowledge to ensure risk free and secure financial transactions for your business.

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