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A child who bites tests the most patient parent's strategies to the limit - and almost all toddlers try out biting behaviors at sometime

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

in their development. For several reasons, this is not OK! 1) You cannot allow your kid to create a habit of biting - or any other viol

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

Examples of combination products may in

nt behavior. 2) You don't want your kid to discover biting as an effective attention-getting behavior. And 3) you don't want to create a

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

parent/child pattern of act, react, react, and react.

My two-year-old nephew surprised me with test bite one day. I was start

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

ed of course. Confidently and with clear-headed resolve, I lowered him quickly to the floor. I told him I was not going to allow him to

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

Combination pro

hurt me. And, I turned on my heels and backed away. Abruptly and firmly (but not with anger), I withdrew a few paces and watched his rea

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

tion.

He was shocked! I'm not sure what he expected - but my calm withdrawal seemed to surprise him. And, he clearly didn't like it. He

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

quickly sought me out and engaged me to re-connect. I was sure I had handled the situation with wisdom - he wasn't going to bite me aga

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

n! Or so I thought.

I dismissed the incident. He didn't try another test bite and I thought we had easily sailed through this common to

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

ddler stage - no harm, no foul. And, then a few days later, we made a quick stop at the supermarket on the way home from the park. As I

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

arried him through the aisles, he tried to pull away from my arms apparently hoping I'd put him down. In my hurry to get home, I told hi

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

Following aspects would a

that our trip was a fast in-and-out. To my complete surprise, he leaned close and bit my neck....wow! Out of the blue! No warning!

My

dd to the challenges in developing combination products:

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

first reaction was to put him down quickly and withdraw a little. So I did. When his feet hit the floor, off he went to the cookie shelv

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

s. How clever! Sometimes biting behavior is about retaliation or power. But usually it is about getting a reaction out of us.

Emotional

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

withdrawal is far more likely to discourage a child from biting than creating a lot of emotional whoop-la about it. Without an entertai

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

ing reaction the kid gets no pay-off. However, my brilliant nephew anticipated MY response to his biting and he used it masterfully to g

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

Professional from academic institutions, pharmaceutical industries, health care indust

et to the cookies.

Epilogue: My nephew never bit me again. He was a smart kid and he knew me well enough to know that I'd never give hi

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

a big show. And he knew me well enough to know that I'd always withdraw (which he didn't want me to do). However, he also was clever en

.

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

ough to use his "misbehavior" to get what he wanted.

This example is demonstrates the brilliance of our kids. They are excellent opport

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

Companies that provide selfless information through particip

nists. They do what works for them. It's our job to know them, their needs and their motives well enough to stay two-steps ahead of them

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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Examples, ideas and tips on hhe key factor of business success: branding: how to differentiate your business and promote just that--with this unique method. Includes tips from business, community, political, sports and education leaders on business ethics and branding in an entirely new way.

There are major differences between how you sell in a Regular Sales Call versus at a Trade Show. In other words, just because you can sell well, doesn’t mean you can sell well in the trade show environment.

Have ever watched the TV show Star Trek and heard of the Romulan disruptor stun weapon? Have you ever thought about what it disrupts? Does it disrupt all the molecules in the person on the receiving end of the ray gun? What about a real stun gun? What does a real stun gun disrupt?

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