Advice You - Business

Whether you're negotiating a peace settlement in a war-torn country or a peace settlement in an argument-ravaged relationship,

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

strong preparation is the key to success.

The following three steps will help you establish the three keys to your preparati

; 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 - why you are involved in the negotiation, how you intend to conduct the negotiation, and what are the specific outcomes yo

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

are hoping to agree upon.

1. Purpose

Knowing why you are engaged in a negotiation may seem obvious in some situations (to b

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

uy a lamp, to stop a fight, etc.), but more complex negotiations generally have more complex purposes.

Ask yourself:

-Why am

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

Combination pro

I negotiating?

-What are the potential benefits?

-What do I ultimately hope to achieve?

2. Result/Relationship Balance

A "

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

transaction" is high result/low relationship - we get what we want, and the other person is incidental to the exchange. Buying

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

a used car is generally a "transaction".

"Relationship-builders" are meetings, calls, and exchanges of value where developin

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

the relationship between the two parties is far more important than the actual tangible "result" outcome. Early meetings in a

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

ny project are usually "relationship-builders" - what gets done is far less important than connections being made.

A true "De

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

l" is where there is a high emphasis on both getting what you want and enhancing your relationship for the future - this "win/

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

Following aspects would a

win" thinking takes more time and effort, but is essential in any sort of long-term agreement. Successful political (and marit

dd to the challenges in developing combination products:

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

al!) negotiations are always predicated on achieving this balance.

Give yourself the following test:

If you had 20 points to

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

distribute between creating the Result you want and enhancing the Relationship, how would you do it?

Example (Result/Relation

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

ship):

15/5 - Transaction

5/15 - Relationship builder

10/10 - Deal

3. Outcomes and Options

When it comes to negotiation,

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

aving a clear outcome, goal, or target in mind has been shown to be one of the primary determinants in how things come out.

A

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

Professional from academic institutions, pharmaceutical industries, health care indust

sk yourself the following questions:

-What specifically do I want?

-What specifically do I think they want?

-What are some

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

plausible options that will get us both what we want?

Bonus Tip: If you're using this to prepare for an important negotiatio

.

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

, take some extra time to answer the questions AS IF you were the other person in the negotiation. You will be pleasantly surp

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

Companies that provide selfless information through particip

rised at the insights you gain from this process.

Have fun, learn heaps, and the next time you negotiate, do it like a P.R.O.

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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