Main Subject - Business

It's a great sunny day so it's time to get out and enjoy the weather. Ma

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

ny of us would like to, but we have projects due, tasks that need to be

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

Examples of combination products may in

one, people that we need to see, and money that needs to be made. What i

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

your company gave you that time off as compensation for the great effor

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

that you gave to the team to finish a project on time?

See, when it co

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

Combination pro

es to teamwork the main focus is for the team to work together. In a “Wi

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

ning” team there is an equal balance of people that have unique strength

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 and weaknesses. Take the example of the “Chicago Bulls” of the 1990s.

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

ichael Jordan was the greatest basketball player to play the game, but d

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

d they win a championship every year that Michael had played? No.

It to

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

k a (D-type) Michael Jordan to lead the team and control the outcome. It

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

Following aspects would a

took a (I-type) wild and energetic Dennis Rodman to keep the team fun an

dd to the challenges in developing combination products:

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

interesting. It took a (S-type) Scottie Pippin, Bill Cartwright, and Jo

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

n Paxson to support the team. And it took the (C-type) analytical mind o

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

f Phil Jackson (coach) to create a foundation for the players to play on

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

In the end they (Chicago Bulls) were able to capture six championships

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

Professional from academic institutions, pharmaceutical industries, health care indust

ithin eight years. What is your team made up of, ...all Jordans, ...all

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

acksons, ...all Rodmans, ...or all Pippins, Cartwrights, Paxsons?

It is

.

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

your choice who’s on your team. For this next month try finding the righ

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

Companies that provide selfless information through particip

people for the right job, and you will have a “Winning” team every time

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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The author describes a vision of leadership that you can use throughout your career. It's a vision that will also help enrich your life.

We have been talking about choosing groups to participate in that meet your needs and goals as a business professional. Once the decision is made on which groups to belong to, then a certain level of participation is required in order to achieve the individual goals set by the business professional.

What if we lived with an underlining set of principles to use our minds to see through the other person’s eyes with empathy when negotiating? What if everyone had John Nash’s “Beautiful Mind” and immediately worked toward a win/win? What if negotiations between people of different nationalities was not about winning and losing but about long-term future relationships?

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Main Subject - Working as a Winning Team

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