Advice You - Business

MEETING DISRUPTERS: If two participants are carrying on a personal discussion that interferes with a meeting, direct a clear

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

and simple question to one of them. In order to avoid embarrassing them, address them by name before asking the question. An

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

Examples of combination products may in

lternative is to restate a previously expressed suggestion and then ask them for an opinion.

HECKLERS: A participant with a

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

egative viewpoint can continually undermine the flow of a meeting with snide comments or emotional tirades. Don’t argue or ch

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

stise this person. Focusing attention on emotional barriers, such as a heckler, deflects responsibility away from participant

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

Combination pro

and the issue at hand. If you lose your cool, the heckler wins. Beat a heckler at his/her own game by asking the person what

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

they would do. Ask the same questions of other participants by asking the same question. Raise questions that bring in the ot

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

er sides of the issue or put responsibility on the individual by taking a positive approach to redefining the problem. If the

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

heckler continues to be disruptive, chances are the group will take care of it, since the heckler is now heckling them.

ENEM

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

ES: If you know two participants with conflicting viewpoints are going to attend your meeting, reduce the conflict with caref

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

lly planned seating arrangements. Discourage “dividing up sides", which occurs when participants with opposing views line up

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

Following aspects would a

n opposite sides of the table. Break up opposing groups since any united front will promote rigidity and entrenchment in prec

dd to the challenges in developing combination products:

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

nceived ideas. When people are separated physically, they naturally tend to think separately and less dogmatically. When two

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

ndividuals are continually at odds, a different approach may work: seat them side by side. Their physical proximity often les

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

ens volume, intensity and verbal attacks are less likely.

SORE LOSERS: Voting is the quickest, most clear-cut method of maki

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

g group decision. However, it may also be the least effective. Taking a vote may force participants to make a choice before t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ey are prepared which divides the group into “winning” and “losing” camps. Those who lose may feel that their position did no

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

get a fair hearing which results in their lack of motivation to help implement the winners decision. A more productive way t

.

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

reach a decision is through consensus. The matter should be discussed until all of the participants are ready to accept the

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

Companies that provide selfless information through particip

olution. Although everyone may not feel like a winner, they all can have greater satisfaction by contributing to the solution

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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