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Negotiations are comprised of small groups of people struggling to accomplish a mission. Such groups can be viewed as teams. Teams are man

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

agement challenges. When viewed collectively, the two opposing negotiating forces actually comprise a potential team populated by competin

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

Examples of combination products may in

g forces. This discord threatens the team environment.

If you are expanding your team, you are adding the management challenge of having

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 manage the people on your team. You assume responsibility for your team's preparation, pre-engagement research and the role each co-ne

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

otiator will play. You need most importantly to establish a global goal for the team and strategy for the pending session. If you are pa

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

Combination pro

rt of a negotiating team but not the team leader, make sure you know the team's goals and objectives. If they are not clear, ask for clari

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

fication. Success is being part of a winning team; not knowing why your team failed. Worse yet is to not know why! If the other side brin

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

s in a team of negotiators, You need to take steps to engage and manage their team.

If you are facing a team of negotiators, welcome the

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

opportunity as a management challenge. Apply basic team building tactics to begin to merger the two teams:

- Welcome the other team to t

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

he negotiation.

- Observe the other team's pecking order and note who your prime opponent defers to, if anyone. This may tell you who th

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

real decision maker is.

- Don't assume the primary speaker is the actual team leader or decision maker.

- Pepper random members of th

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

Following aspects would a

e other team to uncover latent leaders or issues that need to be addressed. Interview each new member of the team as to their role, qual

dd to the challenges in developing combination products:

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

ifications and specific area of expertise.

- Establish your role as the overall discussion leader stating clearly and concisely the obje

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

ctive of the day’s discussions.

- Look for areas of disagreement or conflict between the other team members. Typically non-verbal commun

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

cations reveal such discord.

- Take time to fully debrief the other team, individually, before launching into the issues of the day.

Ne

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

gotiating is small group management challenge. Seek to engage and involve the other team as part of the collective team. This will predict

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

Professional from academic institutions, pharmaceutical industries, health care indust

ably come as a surprise to them. Confusing your opponent is often a viable negotiating tactic.

The group is dysfunctional at the start. T

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

eir are conflicting goals and objectives. You can establish an informal leadership role if you are able to establish a common goal for the

.

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

collective group. This is not as hard as it sounds. You have all invested the time and money to attend the meeting. That presumes a commo

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

Companies that provide selfless information through particip

n goal. Try to find a way to establish that goal as the primary purpose of the meeting in a fashion that addresses the needs of both sides

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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