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“Leadership is Sacrifice. It is Self-Denial. It is in fearlessness. I

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

t is in humility and it is in the perfectly disciplined will. This is al

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

Examples of combination products may in

o the distinction between great and little men.” -Vince Lombardi

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

>

Read this famous quote by Vince Lombardi once more only this time

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

start by using sales leadership as the first words. I am not certain any

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

Combination pro

one can improve on his statement. What you can improve is your ability t

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

inspire those around you. Do you...

LOOK FOR SOLUTIONS, NOT SOMEONE TO

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

BLAME ?
Your salespeople look to you for leadership and answers. A

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

e you prepared?

RADIATE CONFIDENCE IN YOUR ABILITY TO GET THE J

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

OB DONE ?
People do not follow leaders that lack conviction.

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

ARE YOU SPECIFIC ABOUT WHAT YOU EXPECT ?
Do all of your people kn

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

Following aspects would a

ow what you want them to do and when?

TRUST YOUR PEOPLE ?

dd to the challenges in developing combination products:

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

our confidence in their performance will boost their results.

S

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

UPERVISE AND INSPIRE THOSE AROUND YOU ?
Do you motivate or are you

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

stumbling block?

FOLLOW-UP ON ASSIGNMENTS ?
Give credence

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

to what you want done. Inspect what you expect.

HOLD EVERYONE

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

Professional from academic institutions, pharmaceutical industries, health care indust

CCOUNTABLE ?
Including yourself? Do you have a written set of stand

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

ards?

Become a great leader by taking time to develop skills th

.

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

t are shared by all great leaders. You are not in your position to demon

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

Companies that provide selfless information through particip

strate how great YOU are, you are there to see how great THEY can become

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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