Main Subject - Business

We use the word team as if it is a one size fits all descriptor for a group of people who just happen to work together. I suppose it is a somewhat stimulating

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

or even motivating title, but with true teams the focus of accomplishment becomes one of successful task achievement while balancing its people and processes, b

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

Examples of combination products may in

ut make no mistake it has mutual accountability to the successfulness of the task.

High performance is a discipline. A collective discipline that is the sum o

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

its parts. Interdependently there are individual roles and functions, but collectively a product is born. Let’s define a team shall we? Now, depending on wh

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

at book we read last there will be varying definitions of a team, but they all have the same components.

A team is a group of people (more than one) with diver

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

Combination pro

se talents whose members struggle for shared ambitions (a common goal) with measurable performance and joint accountability.

• Diverse Talents

Albert Einstein

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

hit the nail on the head. You see for every action there is an equal and opposite reaction. In a team that means for everything we are good at, we are really

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

not good at something else. It’s relative. Teams and high performance are indivisible. Perhaps that is what Jim Collins meant by “who first, then what”.

•

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

Shared Ambitions

Team member contributions are made it is with a sense of purpose. These diverse talents are tied to performance and performance is tied 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

e goal. It is through the inspiration of a shared vision that team members become aligned to this common goal.

• Measurable Performance

Converting directive

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

s into specific measurable performance plans will jump-start the team to its sense of purpose.

Some groups develop performance development plans that include n

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

Following aspects would a

ebulous actions items. If teams do not address, not just what, but how, who and when, then its easy to go back to business as usual and have goals fade into t

dd to the challenges in developing combination products:

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

e sunset.

• Joint accountability

There is no “Us and them” only we. Commitment is the cornerstone to both individual and team accountable. Joint accountab

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

ility means when there is success I need to look around me at all the people that made it happen and when there are setbacks and failures I need to look at myse

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

lf equally.

Work Groups

• Leader

• Broad sense of purpose-organizational mission

• Individual accountability

• Individual products

• Measurable by impact

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

• Bobble head meetings

• Delegation

• Inattention to results

• Dependent Teams

• Leadership

• Detailed team purpose

• Joint accountability

• Product is a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ccumulative-the sum of its parts

• Measurable by assessing the accumulative product

• Open conflict and problem solving

• Joint ownership

• Commitment to re

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

sults

• Interdependent

A Rose by any other name…but does it smell as sweet? We can use the word team as loosely as we want to describe clusters of people, bu

.

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

they are not the same thing. Being called a team does not guarantee teamwork.

A group’s performance is based on individual achievement. A team’s performance

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

Companies that provide selfless information through particip

is based on individual achievement and cooperative achievement. So, at the end of the day we can call them the same, but the fragrance is definitely different

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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