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Let's talk a little about leadership. I have built a team of 88 people in 30 days. How is this possib

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

le? I know it's my good looks or my irresistible charm or maybe the offer I presented to everyone tha

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

Examples of combination products may in

signed up. It's none of these things and yet it's all of these things. You have heard me say that

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

leadership is actions that personify the person. I cannot teach you leadership. I can only demonstrat

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

the commitment and fortitude to my goals that will allow you to see how I am achieving success. If

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

Combination pro

you follow the actions you will have the success also. That is right the actions.

So how did 88 peo

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

le come to cross paths and see there is great opportunity in my team? First factor is the product and

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

the website. First is the line of products, great products that fill a niche. Second is the dedicati

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

n of the leadership of the company to do what they say and deliver on time. Third is the opportunit

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

y for everyone to take this in directions that only 88 very intelligent minds can take these products

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

Here are the leadership actions that I and many others on my team have taken:

Set your goals high

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

Following aspects would a

and never waiver. Persistence is the key to anything. I once read an article from Michael Jordan that

dd to the challenges in developing combination products:

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

said in order for him to become World Champion and MVP he had to participate in thousands and thous

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

ands of losses. He personally missed tens of thousands of shots and he missed three hundred shots tha

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

would have saved the game. But today we see him as the most successful B-Ball player ever.

Set a ti

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

me of day to work your business. I personally dedicate 1 hour to my business everyday. It may come in

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

Professional from academic institutions, pharmaceutical industries, health care indust

pieces, but a minimum of one hour everyday will be spent doing business related tasks.

Next, generat

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

e some clear and concise advertising material to run your business. Look in the newspaper and internet.

.

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

Copy successful ads and their verbiage.

Finally I try to have as much fun as possible. Passion for a

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

Companies that provide selfless information through particip

nything brings joy, joy brings satisfaction and a feeling of well being, that is how it becomes fun

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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