Main Subject - Business

Talk to anybody who has worked as a member of a team. You will get to listen few st

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

atements such as-

1. No body will allow you to work in the team.
2. One perso

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

Examples of combination products may in

wants to take credit for the whole work.
3. I would have completed the job on

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

my own faster than the team.
4 Why do not they tell you and discuss with you a

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

out the members of the team beforehand?
5. I will never again work in a team.

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

Combination pro

And many other such statements will be heard. Why?

Can we escape from teamwork? T

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

at looks difficult because no body specializes in all the disciplines. If you have

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

to develop a product, you must have a team of designers, production men and marketi

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

g staff along with the finance person. That brings us to the matter of co-ordinatio

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

. The leader of the team is supposed to co-ordinate the work done by others. So the

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

responsibility of failure if any must first lie with the team leader.

What should

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

Following aspects would a

team leader do? The team leader should first draw the goals, time parameters and w

dd to the challenges in developing combination products:

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

rk that needs to done to achieve the targets. Ideally The leader should then disc

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

ss these with all the members and get their suggestions and approval. What if frict

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

ion develops at this stage itself? The team leader has to improve the process by di

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

cussing the pros and cons very thoroughly and make everyone feel as if it was their

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

Professional from academic institutions, pharmaceutical industries, health care indust

decision.

The leader must have few qualities for better co ordination of the team.

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

Give respect to all the members. Give all the members a patient hearing. Listen to

.

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

heir problems and address them as soon as possible. Anticipate friction and arrange

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

Companies that provide selfless information through particip

to avoid that happening. If this is done, the team will give co-coordinated results

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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Main Subject - Team Work- How To Co-ordinate?

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