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Questions are magic. If we as independent professionals put questions to proper use, we will not only discover our own speci

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

al career path, we will be able to get and achieve anything we want. In this article, I share some ideas about how to use the magic

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

Examples of combination products may in

of questions.

Don't ever hesitate to ASK. Recently a man who was taking one of my classes shared that he had experienced an

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

incredible hour of face-to-face interaction with Brian Tracy, the well known speaker and author. He was attending a convention wher

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

Tracy was the featured speaker. "How much did you have to pay for this?" asked another attendee. "The price of a cup of coffee," w

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

Combination pro

s the answer. My student had called Tracy ahead of time and asked if they could meet for coffee sometime during the convention. Oft

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

ntimes, all we need to do is ASK for something we want and we will be happily rewarded by receiving it. Just remember, that

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

he worst that can happen is that the answer might be, "No."

The most important questions when planning our futures are those we

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

ask ourselves. In his well-written book Career Management for the Creative Person Lee Silber talks about how, "The possi

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

ilities are limitless, which makes the concept of planning a career overwhelming." Following are a sample of the questions Silber s

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

ggests we ask ourselves:

Who is doing what I want to do and what steps did they take to get there?
W

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

Following aspects would a

om could I ask how they did it?

What obstacles might I face along the way and how will I deal with them?

dd to the challenges in developing combination products:

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

What are the decision makers along the way looking for and what do I have to do to meet those needs?

Where

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

s the action happening?
What can I do to close the gap between what I want and where I am now?

What s

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

ills do I need to acquire?
Can I make a living at this?

What steps do I need to take? In what

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

order?
What action can I take right now, today?

When asking yourself important questions, take t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e time to write down your answers. There is something powerful and lasting about putting your pen to paper. There is a feeling of p

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

rmanence and a call to action when we express ourselves in writing It is almost like making a contract with ourselves. Moreover, w

.

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

will be less likely to "go back on our word."

Just remember that asking good questions will work their magic. But, also re

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

Companies that provide selfless information through particip

ember that the excellent communicator not only asks questions, he and/or she listens to the answers from both themselves and others

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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E-Articles - Attention Independent Professionals -- Questions Are Magic

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