Advice You - Business

I was in the middle of a hot negotiation.

Both of us felt we were making inexorable progress toward a mu

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

tually satisfactory deal, but I caught a cold.

So, instead of communicating by phone, I decided to carry

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

Examples of combination products may in

on our “discussions” via email, admittedly a less interactive medium, but one that has definite strengths

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

.

I simply made this shift by announcing at the beginning of an email, that I’d be relying on it for 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

next few days instead of the phone.

I thought email would be serviceable because it can disguise the sta

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

Combination pro

te of your health at the moment, whether it’s a froggy throat, sniffles, or the sort of general sloth or

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

eakness that I loath to show at any time, but especially during negotiations.

But even more significant,

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

in good health or bad, email can slow the tempo, make each message more deliberate and thoughtful, and o

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

course, get things reduced to writing that might otherwise become mere ephemera, and in a legal sense, u

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

nusable or relatively worthless later on, should there be a dispute about what one party, or both promise

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

.

In this case, my counterpart expressed surprise that there wouldn’t be phone contact, but nonetheless

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

Following aspects would a

he persevered and gave me answers to most of my questions.

But he declined to comment on the most import

dd to the challenges in developing combination products:

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

nt query, one dealing with money, and this tipped me off that he was trying to nuance, to fudge, to embro

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

ider, instead of biting the bullet and committing to ante up hard dollars and cents.

On at least an unco

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

scious level, I suspected he was not “in with both feet,” that his overall commitment to a fair deal was

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

absent.

In a word, there wasn’t a deal, and there wasn’t going to be one, and a quick exchange of emails

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

Professional from academic institutions, pharmaceutical industries, health care indust

confirmed this fact.

I’m a subscriber to the notion that a bad deal is far worse than none, because a ba

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

d one, sooner or later will be undone; it must be, and that can be messy, costly, and it’s almost always

.

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

istracting.

So, when you’re negotiating, use the media that will serve your purposes, and when it is in

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

Companies that provide selfless information through particip

your interest to shift, from face to face to the phone, or from the phone to email, don’t hesitate to act

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 - Negotiation Speaker Says Sometimes It Pays To Get Off The Phone & Onto Email

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