Main Subject - Business

Having been in business for over 25 years I have seen some excellent ne

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

gotiators. The way they operate is to work with your concerns and show

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

Examples of combination products may in

they understand your position. To these operators, negotiation is both

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

skill and an art and some have developed it to such a high degree tha

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

t you could even think it is a science. We all negotiate every day in s

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

Combination pro

ome way or another so becoming more skilled is something that would ben

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

ft us as individuals, and benefit our businesses and organisations. Mos

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

tly the outcomes are not earth-shattering but when the negotiation is i

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

mportant follow this advice to reach the best outcome for all parties.

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

Whenever we want something we almost always enter a negotiation, unless

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

a straightforward purchase in a shop; but even there I know several pe

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

Following aspects would a

ople who will attempt to negotiate as a matter of principle.

The simpl

dd to the challenges in developing combination products:

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

st thing to understand therefore, is that for the negotiation to be suc

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

cessful, both parties need to be involved in the outcome, and both part

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

ies need to feel that their interests were not only protected but satis

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

ied.

Before attempting any negotiation, make sure you are up to date a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd aware of your customer/client/co-negotiator's current needs.

Be pre

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

pared to walk away without an agreement if you feel that either party's

.

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

needs are becoming overlooked.

When you next need to enter a negotiati

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

Companies that provide selfless information through particip

on, check your strategy here first. It just may make all the difference

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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