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Are you ready to take over a leadership role in your organization ? You probably feel comfortable with your industry, managing staff, technology, and poli

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

tical culture at this point. But, have you developed and fined tuned the leadership qualities that make top leaders successful ? Your first step toward su

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

Examples of combination products may in

cess is assessing your leadership capabilities. Let's see how you score on this 25 question assessment.

The following survey can be used to assess your c

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

rrent leadership capabilities, assessing others in your organization, or as a guideline for hiring C-level executives.

For each question, answer "Yes" if

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

this leadership quality is consistently met. Answer "No" if this leadership quality is sometimes or rarely met.

After answering all the questions, let's

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

Combination pro

ee how you score.

1. Inspires and motivates people around them to perform above and beyond expectations ?

2. Acts like an owner of the company no matter

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

what position they currently hold ?

3. Has a vision for the future and communicates that vision to everyone they encounter ?

4. Recognizes the importanc

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

of long term personal, team, and company goals ?

5. Committed to succeed in all activities taken to meet goals. Never gives up ?

6. Constantly searchin

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

for new knowledge and new ideas that will improve personal and company performance ?

7. Willing to learn better methods to make sure employees expand th

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

ir knowledge base ?

8. Encourages interactive communication throughout the organization ?

9. Receptive to both positive and negative feedback ?

10. Lis

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

ens to employees, peers, and customers with an open mind ?

11. Maintains a high level of trust with employees. Does not closely monitor proven employees

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

Following aspects would a

?

12. Embraces diversity and is highly receptive to ideas and people who are different ?

13. Action oriented self starter who takes calculated risks ?

dd to the challenges in developing combination products:

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

4. Thinks fast on their feet to come up with solutions to critical situations ?

15. Helps employees develop the habits they need to be more successful ?

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

16. Empowers employees to make decisions ?

17. Observes employee performance and provides constructive feedback ?

18. Stimulates and relishes change ?

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

9. Adapts quickly to change. Does not fear change but sees it as an opportunity ?

20. Realizes the importance of a positive frame of mind and attitude. R

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

mains positive in all situations ?

21. Apologizes and admits mistakes ?

22. Documents and refers to personal, team, and company values on a daily basis

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

Professional from academic institutions, pharmaceutical industries, health care indust

23. Personal, team and company values are regarded as guiding principles for all decisions ?

24. Values are documented and referred to on a daily basis

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

?

25. Basis employee performance on measurable data and uses these measurements as a training tool ?

How did you score ?

For each "Yes" answer you get

.

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

point. For each "No" answer you get 0 points.

21 - 25 points = Top notch leader in your field

16 - 20 points = Great potential to be a successful leade

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

Companies that provide selfless information through particip

with additional experience and mentoring

0 - 15 points = Additional leadership training and experience should be a priority

Copyright 2006 Dennis Somme

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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