Advice Pool - Business

Yesterday I had the distinct fun and exciting privilege of having a prescription filled. If you have not had this

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

experience I highly recommend it, as it is right up there with watching paint dry and grass grow.

While I was w

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

Examples of combination products may in

aiting I had a chance to observe this particular pharmacy's “Rock of Gibraltar, White Knight, Unsung Hero” in act

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.

Nearly every business has one of these individuals in their organization. This person is usually where the

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

action is hottest. Whenever there is a fire, they show up with the fire extinguisher, a quick fix and a word of e

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

Combination pro

ncouragement. They then move on to the next one and then the next one. Seamless and quick, never stopping, their

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

whole day is one of accomplishment and satisfaction.

This particular individual never stopped the entire time I

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

was waiting. Between answering the phone, talking with customers who were waiting and moving the line, this “prod

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

uction specialist” was every bit professional and friendly even though he never stopped for one second.

If you h

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

ave an opportunity to grow one of these individuals, I highly recommend it. You can spot this person early in the

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

r career by watching for a few clues that this could be your “production specialist.”

1. They do a little bi

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

Following aspects would a

t more than asked. They take a little bit more pride in what they do.

2. They volunteer.

3. They stay l

dd to the challenges in developing combination products:

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

ate and arrive early.

4. They don’t complain.

5. They ask for additional duties.

These are a few signa

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

ls that this person may be the next Division Manager, Vice President, CEO and Owner. They get it. They understand

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

that every day is a chance to be a little more, do a little more, become a little more. When they show up, it’s

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

all in. And these people make the Vice President, CEO and Owner look good.

If you can grow them in your organiz

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation, that’s even better. By spotting personnel that take a little pride in what they do and gradually building

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

them through goal setting and cheerleading, you can have an entire organization of “Rocks, Knights and Heroes.”

.

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

It finally came time for me to leave with my prescription, and as I walked out I glanced back at the Unsung Hero.

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

Companies that provide selfless information through particip

He had barely paused for breath and was already moving on to the next customer. Smoothly, seamlessly, tirelessly

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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