Main Subject - Business

Negotiation is not a process by which you try to destroy the other party. Rather, it is a process by which you reach a ce

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

rtain result. Good negotiation occurs when all parties are truthful, and they connect and interact successfully with each

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

Examples of combination products may in

other. Good negotiation cannot happen if either party is trying to boost their ego in the process. People can win while

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

elping the other person get what they want.

We were born to negotiate just as we were born to walk. You may not even rea

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

ize that you are negotiating when you talk to business associates, friends, children, and anyone in your communication rea

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

Combination pro

m. Some people think negotiation is confrontational. Good negotiation is not confrontational, and you really can negoti

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

ate “win-win” results.

Preparation is the key to being a good negotiator. If you are not prepared, you may not be able t

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

explain the results you want, you may not be able to evaluate all the issues and alternatives, and you may give up too so

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

n. There are certain essential steps that prepare you for the negotiation:

1) Set clear expectations and clear goals;

2

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

Identify any undisputed points;

3) Anticipate the counter-offers you could make or receive;

4) Know every det

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

il and every issue;

5) Anticipate what the other party wants;

6) Decide what is the highest/lowest you will give

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

Following aspects would a

or take; and

7) Be ready to explain why this the highest/lowest you will give or take

When the negotiation starts, state

dd to the challenges in developing combination products:

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

that it is your objective to reach a win-win result. Keep your goal in mind and listen carefully to what is important to

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

he other party. Take notes if necessary. Be calm, courteous, unemotional, and relaxed. Isolate the points of disagreeme

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

t and try to find solutions for each of them.

Ask “what,” “how,” and “why” questions to better understand the other perso

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

’s values and what is important to them. Continue to isolate the points of disagreement and find solutions for them. Ack

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

Professional from academic institutions, pharmaceutical industries, health care indust

nowledge the points of agreement that you have reached up to this point.

Repeat the process, moving each party closer to

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

he other until you have full agreement. If you cannot reach a result that is mutually agreeable, agree to disagree at tha

.

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

moment, give yourselves time to think about it, and schedule another meeting. It may take time and work, but you can neg

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

Companies that provide selfless information through particip

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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