Summary - Self Improvement

"We should not only use all the brains we have, but all we can borrow." -Woodrow Wilson

Leave it to a chil

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

d to remind you of the importance of humility and the willingness to learn from everyone.

One day, my daugh

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

Examples of combination products may in

ter Alexandra was home sick from school. Since she was home, I took her with me when I went to run some err

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

ands. That morning, I was working on a piece of business marketing literature. So I took it with me to rev

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

ew at lunch and pencil in a few changes.

While we were standing in line to get our lunch, Alexandra noticed

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

Combination pro

the paper I was holding and asked to look at it. I thought, "Sure, what does it hurt to make her happy and

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

let her take a look?" I handed her the marketing piece and asked her what she thought. Honestly, I just 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

anted to satisfy her request. I did not expect to learn from her perspective.

What followed was amazing.

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

watched as my eight (almost 9) year old daughter carefully and thoughtfully reviewed what I had developed.

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

She then offered two or three very insightful and helpful comments on what she got from the brochure. To b

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

e honest, it never occurred to me to seek input on this piece from my child. I very nearly made a huge mist

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

Following aspects would a

ake.

As we grow in both knowledge and skills, it is easy to discount or ignore input from people that we pe

dd to the challenges in developing combination products:

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

ceive as less skilled or knowledgeable than we are. Whose input do we discount? Maybe it is our children,

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

our spouse, our employees, people with less formal education, and . . . the list goes on and on. Is it poss

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

ible that they see something we don't see? Despite what we think sets us apart from them, could we learn fr

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

om their perspective and experience?

Virtually every successful person I know or know of says that their wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

lingness to continue learning was critical to their success.

So for now, I encourage you to remember this s

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

imple tip... Always be open to learning.

Copyright 2005, Guy Harris

You may use this article for electroni

.

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

c distribution if you will include all contact information with live links back to the author. Notification

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

Companies that provide selfless information through particip

of use is not required, but I would appreciate it. Please contact the author prior to use in printed media

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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Summary - Always Be Open To Learning

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