Advice You - Business

Have you ever had one of those “ah-ha” moments when you quickly gained a greater awareness than you ever had before? I must say, that as bad as I felt in this place, prison wa

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

s an intense learning lab. I didn’t know that going in, but in retrospect I am glad I took notes, because the lessons and opportunities for growth were coming at me quickly.

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

Examples of combination products may in

How easy it would have been to miss those lessons.

Often folks grow weary when they hear people talk of learning through adversity. All too often we prefer life to be a smoot

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

ride with few bumps in the road. Fortunately, I’ve experienced both and while there is joy in a calm pleasant ride, more times than not my greatest learning has been during 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

urbulent times. The next section that follows is an excerpt from my Memoirs from Prison. In each of these one can capture a learning pearl – something that can be applied in

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

Combination pro

veryday life, if only we let it.

October 5, 1995.

Buck, my roommate, and I talked for a long while last night. He is a spiritual person, doing his time, the best he can. He

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

has five children in been in federal penitentiary in Atlanta, Georgia. I'm surprised, but I like this guy, he seems to shoot straight.

Last night, Buck asked me a question.

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

I don't recall today what it was, but I remember his response. He looked to me with a puzzled look, and said, “word?" I didn't understand, and repeated his statement with, “

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

ord?" He said, “Yeah -- word?” I must admit I didn't have a clue what he meant. Then he looked at me and said, “You just don't understand a brother do you?" And with that

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

he walked out of the room.

I just stood there. I had no clue what just happened. Three days in prison, and we just hit a communications stumbling block. Moments later, Buck

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

returned to the room and said,” I'll make you an offer. I'll teach you how to communicate in the hood, if you'll teach me how to talk, so I can get a job when I get out of her

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

Following aspects would a

e.” “Deal?”

At that moment, I began to understand the term -- success -- in a whole new light. I had always defined success in terms of one's possessions. But in here, we h

dd to the challenges in developing combination products:

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

ave no possessions. Success can be defined as being safe while in prison and getting out of prison safely. Buck recognized that I am a fish out of water. This is not my envi

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

onment. But he is willing to help me achieve success here, if I could help him achieve success outside of prison. What an amazing opportunity that is placed before me.

Now,

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

it’s over ten years later and that lesson still rings clear. Success in one’s life is not really measured by the “trappings” of success. Sure a big house, nice watch, expensi

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 car, fine jewelry all are indications of abundance of resources – money. But none of them truly define success. I was, by all accounts, successful – at least that’s what ev

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

Professional from academic institutions, pharmaceutical industries, health care indust

eryone thought. Yet, by making unethical choices I gained a clear understanding of true success in one of the most unexpected places – prison.

Thankfully – Success – is a jou

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

rney and at times, even when we don’t like it, we’re given the opportunity to find success in small ways and odd places. This gift that was given has opened many doors for me

.

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

to share with others. For information on how that can benefit you or your organization or to receive my Choices ezine contact elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

com">www.chuckgallagher.com or e-mail me at chuck@chuckgallagher.com. And remember you can live success – the choice is yours

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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