Main Subject - Business

It’s not an easy job, managing a room with potentially hundreds of people in it. How do you help them to

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

be productive?

One of the best ways is by managing the mood of the place.

Here are five pointers that

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

Examples of combination products may in

I’ve developed over the years:

(1) Identify your center’s “opinion leaders.” These are usually folks

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

in the rank and file who have no formal power, but lots of the informal kind. Perhaps nothing you can se

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

makes them leaders, and you might never consider them for management, but a simple fact remains. They h

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

Combination pro

ave followers—that’s what makes them leaders.

When you have group meetings and you mention a change in

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

procedure, observe who receives the glances from his or her peers. If they’re looking to see how Jim is

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

esponding to you, he might be one of the top dogs.

Keep a close eye on these folks, and make sure they’

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

re on the same page with you. Do this by informing them about upcoming changes, first. Ask for their sup

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

port, but don’t ever reveal that you have pegged them as being informal leaders.

(2) Patrol your center

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

on a regular basis. Wear a smile. Say “nice to see you,” and ask how people how they are doing. It’s lik

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

Following aspects would a

e being a politician who is working a crowd. It’s part of your job, and your obvious conviviality keeps

dd to the challenges in developing combination products:

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

the tone light and positive.

(3) Give the group daily goals for hitting sales targets or handling large

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

call volumes. Announce how they’re doing at crucial times. “Hey, it’s two o’clock and we’re on target;

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

eep it up!”

(4) Recognize individuals in a big enough voice for them and at least a dozen others around

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

them to hear. “Mary got another sale. Great job, Mary! Keep it up!” She’ll appreciate the praise, even

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

Professional from academic institutions, pharmaceutical industries, health care indust

if she tries to show modesty, and others will feel the heat turned up a notch or two beneath them.

(5)

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

emove sourpusses from the room, quietly, and quickly. Have a brief pep talk with them. Make sure they’re

.

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

energized before mainstreaming them again.

You may not see it in your position description, but if you

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

Companies that provide selfless information through particip

manage a call center, it’s your duty to keep it positive. Try these five things, and tell me how you do

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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