Main Subject - Business

Skilled negotiators know that they must lead their opponents toward their goals in order to achie

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

ve a viable result. They bring passion to the negotiation to establish their conviction and commi

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

Examples of combination products may in

tment to the outcome. Many corporate negotiators lack the passion of personal investment and tend

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

to seek quick resolution rather than excellence when negotiating for their companies. Unfortunate

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

ly many developers are handling their own accounts and their passion permeates the discussions. M

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

Combination pro

ny retail bankruptcies are the result of bad real estate decisions. That is not surprising when o

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

ne considers the differing interests of those making the deals. The company representatives are w

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

orking for salaries and bonuses. Their opponents are often working to protect their personal asse

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

s and build personal wealth.

Whenever you agree to take on the leadership of a negotiation do so

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

only if:

- You believe in the cause.

- You can make a personal commitment to winning.

- You h

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

ve the time, energy and interest to fully pursue a victory.

It is not fair to those you represen

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

Following aspects would a

t to offer less. Doing so places them in jeopardy from the start.

If you are not able to do this

dd to the challenges in developing combination products:

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

, you can offer to consult and provide support and guidance to those leading the endeavor. This i

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

often effective as it allows the other person to have the passion and vigor to lead while you pr

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

ovide the expertise. Knowing your limitations is essential. Don't take on assignments that you ar

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

ill-prepared to handle properly.

Passion and conviction are compelling arguments. The non-verba

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

Professional from academic institutions, pharmaceutical industries, health care indust

l signals emanating from a person of conviction are clear:

- A firm handshake.

- Looking the ot

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

her person unwaveringly in the eyes.

- Standing straight and facing the room squarely.

- Moving

.

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

through the room with dispatch.

- Asking for coffee or water before being asked.

These are sign

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

Companies that provide selfless information through particip

s of one in control, one expecting results, and one ready to start. They are the mark of a leader

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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