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Advice You - The Chicken or the Egg?
Even before I checked my calendar on Monday morning, I knew the appointment would be there. Pa
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
ssed over for promotion again, Ralph wanted specifics on why I hadn't chosen him for the position. This was not a new conversation. I thought of Ralph as my chicken and
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
egg dilemma. Ralph was the chicken. He believed he would make a great Team Leader, and when I promoted him, he would step up and show me how well he could lead. My posit
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ion was that of egg. Prove to me you have leadership skills by demonstrating leadership in the job you have now, and I'll consider giving you the next position.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
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d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
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Here's the question: is it better to do the work, knowing you will ultimately b
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
e rewarded for having done it, or should you wait until the reward is there before you do the work? Like the proverbial question of which came first, the chicken or 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
egg, people differ widely on the answer and run their careers accordingly.
New">
Here's the way I see it - one has more to lose by taking the position of
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
the chicken and waiting for someone else to anoint them, than by being the egg and anointing oneself. If I had waited to be a leader until someone offered me a leadersh
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ip position, I might still be wishing and hoping for someone to notice me. When I wanted to be a manager, I did the work of a manager by taking on more and more responsi
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
bilities. And, I got promoted. When I wanted to be a director, I did the work of a director, without questioning compensation or title. After proving myself, I got the j
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
b, the title and the compensation. Same with being a vice-president. Doing the job first, gave me the job.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
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It's the same now that I'm out of the c
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
orporate arena. Take my dream of being a writer. Changing careers after twenty-something years in management, I could have waited to write a column until I secured a wri
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
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
ting contract for one. But, why would someone pay me to write without reading my words and knowing I can. Chicken and egg again.
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
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What works for me
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
has been consistent. When I do the work first, the rewards follow. I think of it like exercising. Doing it gives me better results than thinking about it. No one likes t
.
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
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
o be called a chicken, so ... be the egg.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
soPlainText style="MARGIN: 0in 0in 0pt">(c) 2004 Nan S. Russell. All rights reserved.
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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