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Leadership success is dependent upon a number of factors, and those that some of the

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

nation's most outstanding leaders have identified as key to success are listed below.

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

Examples of combination products may in

We contacted some of our clients and others who have been identified as outstanding

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

by their colleagues and employees, and they identified the behaviors that, in their o

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

inion, made the difference in the level of success achieved and also set a company ap

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

Combination pro

art from its competitors.

A Act as a mentor and help staff develop their skills

B B

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

fair

C Coach

D Delegate appropriately

E Exhibit self-control

F Foster self-confi

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

dence

G Gain respect by keeping your word and honoring theirs

H Have the self-confi

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

ence to make decisions and move forward

I Involve others in decision making

J Be ju

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

st -- without that characteristic you cannot command respect

K Keep your commitments

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

L Listen carefully

M Make motivational matches

N Note achievements and praise in a

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

Following aspects would a

timely manner

O Overcome objections by pointing out benefits not negatives

P Plan a

dd to the challenges in developing combination products:

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

head and be able to work the plan

Q Quietly support and encourage

R Recognize indiv

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

duality

S See the big picture and be able to help others see it, too

T Take care to

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

be open-minded and open to new ideas

U Understand and use good communication skills

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

V Verify information before acting on or responding to it

W "Walk" as well as talk

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

Professional from academic institutions, pharmaceutical industries, health care indust

teamwork

XYZ Avoid the negative and build upon the positive

Kearney & Associates

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

P.O. Box 1090, San Leandro, CA 94577
Phone: 510 614 8682 * Fax: 510 614 8683

.

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

Email: eik1@earthlink.net * Web site: elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

eyalliance.com">www.ekearneyalliance.com

THE ABCs OF LEADERSHIP (copyright, 2002

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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