Advice You - Business

Many solopreneurs work in a team environment either with their client's staff, or with subcontractors. Having spent over 20 years in a teaming environment b

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

efore becoming a solopreneur 13 years ago, I know that during the course of any highly functioning team effort, the leadership and followership roles flow 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

ck and forth between the members.

An observer of such a team would see that at any moment, the person on the team who has either information, wisdom, or cr

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

eativity to offer steps quietly forward to assume the leadership position. After she has delivered her knowledge to the group, she then steps quietly back i

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

to the role of a follower, as the next person slips into the leadership position. This ebb and flow of leadership and followership is one of the hallmarks o

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

Combination pro

a highly-functioning and productive team.

"So you did this just because all your friends did it? If all your friends laid down on the tracks in fro

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

nt of a train, I suppose you would too? Do you want to be a follower all your life?" -- Your Mother

You Mother was right. To be effective in toda

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 teams, you can't be a follower all your life. You need to step out into the glare of the lights and assume the leadership mantle, contributing your uniqu

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

specialness, knowledge, and creativity to the group. In this way, the work product of the team is strengthened.

This leadership role is not granted you by

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

title or position. Instead, you take on the role voluntarily. And your team members grant you the role because of your expertise, credibility, reputation,

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

r influence. In other words, it is a temporary role on the team that you earn over time.

To be effective in this type of leadership role, you must first se

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

Following aspects would a

ure the respect of your team members in at least one of the following three areas:

1. Knowledge. You must have respected expertise and proven judgement in

dd to the challenges in developing combination products:

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

areas relevant to the team's goals.

2. People Skills. You must care about your team members and value the team's goals.

3. Performance. You must show that

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

you are willing to take on tasks and activities that actually help the team meet their goals.

To build respect and credibility in either of these three are

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

s, you must first be a terrific follower. Not the type of follower your Mother railed against. But the type of follower who is committed to helping the team

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

reach their goals. A follower who contributes focus and influence to getting the work product delivered to the required standards of quality and timing. A

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

Professional from academic institutions, pharmaceutical industries, health care indust

ollower with a courageous conscience and controlled ego. A follower with the ability to think creatively and critically, who is self-motivated, proactive an

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

self-disciplined.

This week, monitor your role on the team's of which you are a member. Are you shifting smoothly in and out of the roles of leadership an

.

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

d follwership as appropriate to you and the team? Or are you failing to step into the leadership role when appropriate? Or failing to step back and contribu

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

Companies that provide selfless information through particip

e in the role of a follower? What could you change about how you shift between these roles to better contribute to the team?

Copyright 2004, Rose Hill, In

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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