Advice You - Business

Barely 21, a kid really, I had just placed a foolishly large Blackjack bet at a Lake Tahoe casino. The lonel

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

y column of chips in front of me represented my net worth. This was going to be my last hand, one way or ano

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

Examples of combination products may in

her.

The dealer fanned the cards around the table. Oh, no, he drew an ace as his up card! I felt flush in

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

he face, embarrassed I had stuck it out at that table for so many losing hands in a row.

Expecting the worst

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

I looked at my cards. I held two Jacks, which in most circumstances would at least give me a draw, if not a

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

Combination pro

outright win. He peered at his down card.

“Insurance?” he asked, gazing at each player in turn. I was at

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

rd base, the last seat, so it took a while to reach me. I had been taught insurance is a sucker’s bet. You a

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

te up more cash on a bad hand not worth protecting and the dealer still beats you, with or without hitting 21

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

But this time, instead of reflexively declining the “coverage” and the additional premium I would have had

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

o pay for it, I looked at him and starkly asked: “What do you suggest?”

After a two second pause that seeme

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

to spread a sound deadening vapor throughout the casino, permitting only he and I to hear each other, he sai

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

Following aspects would a

d, “Take it!”

Would he lie to me? Was he actually admitting he held a ten beneath that ace, that he was on t

dd to the challenges in developing combination products:

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

e verge of busting me out if I didn’t accept the offer?

I bought the insurance. He had Blackjack. I recovere

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

my bet. And, tossing him a serious tip, I graciously left the table. This wasn’t a gaming episode, though

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

by all outward appearances it seemed to be. It was a negotiation, demonstrating that the most important thin

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

your counterpart has isn’t power or money or more options than you have.

He has INFORMATION that is critica

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

Professional from academic institutions, pharmaceutical industries, health care indust

to your success. If you can get him to disclose it, you’ll come up a winner.

Sometimes, it’s just a matter

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

f asking, though that’s the last thing we do. We disable ourselves by thinking “He’d never tell me that!" o

.

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’s against his interest to make such a disclosure!” You’d be surprised, as I was when that dealer helped

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

Companies that provide selfless information through particip

me out. Remember, the only sure way to take the gamble out of negotiating is to get the information you need

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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Advice You - How to Take The Gamble Out of Negotiation

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