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If only two persons attend a mediation and they are both have authority to settle, then only three negotiations take place. They are between (1) person 1 and person 2, (2) person 1 and mediator, (3) person 2 and mediator. The dynamics of this are easy to manage.

More commonly

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

, at least four persons attend, namely two parties and two attorneys, in which case ten dynamic interactions may take place, as follows: (1) party 1 and party 2, (2) party 1 and lawyer 1, (3) party 1 and mediator, (4) party 1 and lawyer 2, (5) party 2 and lawyer 2, (6) party 2

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

Examples of combination products may in

and mediator, (7) party 2 and lawyer 1, (8) lawyer 1 and mediator, (9) lawyer 2 and mediator, (10) lawyer 1 and lawyer 2.

It is easy to draw a cat’s cradle to demonstrate the complex dynamics that exist in the above simple mediation, with only two parties each represented by

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

an attorney.

If this was a dinner party with five friends, the conversation would be a free for all with everyone having a wonderful time. But a mediator cannot afford to have a free for all in a mediation session. A mediation is a negotiation, and every negotiation is (howe

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

ver politely or amicably conducted) an adversarial process. It is war waged with kisses. Further, most mediations take place within a larger context of adversarial relationships, or adversarial process such as potential or pending litigation.

If there are multiple participant

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

Combination pro

s, i.e. more than two parties and two attorneys in a mediation, the cat’s cradle becomes exponentially more complex, in fact, exceedingly complex. Such negotiations can easily get out of hand. It becomes all the more important for the mediator to set herself or himself as the

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

focal point of all communications, and to control cross-table communications quite carefully, with as much finesse as possible.

No one attends a mediation without an agenda. Every person’s agenda is different.

The mediator must control the flow of communication, or the negot

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

iation will founder. That is why he was hired. With whatever subtlety or bluntness this is accomplished, it is essential. The mediator must be willing to shut off a destructive communication. He/she must also be willing to draw necessary communication out of participants who a

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

re keeping silent, even if this requires a private session.

The easiest way to control the dynamics of the situation, without attempting to stifle them, is to have the participants communicate with each other through the mediator. The slight deflection that this requires has

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

an ameliorating effect on the language and the attitude of the speaker. As this is exactly what happens in court, attorneys are used to it.

There are only two kinds of communication in mediation. The first is any communication that keeps the negotiation moving towards clarity

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

and settlement. The second is any communication that tends to torpedo, stifle or impede clarity and settlement. When “bad” communications occur, as they always do, the mediator must repair the damage and move on.

There are only two venues for a communication. The first is in

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

Following aspects would a

joint session. The second is in private session.

Joint sessions are for participants to communicate positively such facts, attitudes, interpretations, arguments, and offers as will tend to move the parties closer to the goal of settlement.

Individual sessions have two purpo

dd to the challenges in developing combination products:

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

ses. The first is to permit participants to “vent.” Venting means to express negative thoughts and emotions about the other side. The setting in which such venting takes place must be controlled by the mediator in such a way as to advance, not impede, the purpose of settlement

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

, and this means in private session. The purpose of venting is to get it said and done with. Some people take longer to vent than others. Some people never stop venting on their own volition, in which instance the mediator must make a calculated judgment when to call a halt to

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

it. The second purpose of private session is to discuss what the participants will say in joint session, or what they want the mediator to convey to the other side.

Sometimes a participant wants to express his or her thoughts, emotions, feelings or attitudes directly to the

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

other side. This is the side of mediation that is closest to therapy. The only reason to permit this is if it will advance the settlement process. How this is done is very important. There is a world of difference between on the one hand, explaining how one feels, and on the o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ther hand, engaging in an ad hominem attack on another participant. This can be quite subtle. However much a person is coached, sometimes they just cannot resist turning an account of how they feel into a personal attack. There is a simple rule concerning ad hominem attacks: d

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

on’t do it, because it never helps.

These issues do not always arise. Often, the volume and extent of these potentially explosive interactions is reduced or minimized by the parties themselves or their lawyers. Some lawyers prefer keep their clients out of the negotiations, k

.

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

eeping them on hand to ratify settlement proposals. Some parties do not want to take an active part in the proceeding, feeling that is what they retained an attorney to do for them. Also, attorneys often do not want their clients interacting directly with the other side’s atto

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

Companies that provide selfless information through particip

rney. Some clients become terribly frustrated with the other side’s attorney, seeing him or her as the supreme obstacle – sometimes such a client takes the opportunity to call the other side’s attorney a liar; the mediator should put an immediate stop to such “fighting words.”

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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