Cases - Business

With the opening of a new venture and numerous reporters arriving in an hour, it felt like one of those "chickens with heads off" days. We were clos

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

e, but not ready. So like locusts to a wheat field, a swarm of people were devouring the last minute details. Then, it rained. With rain, came worms

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

Examples of combination products may in

, hundreds washing onto the entrance sidewalk. When I returned to the area, I found a manager, several department supervisors and a director outside

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

with brooms, sweeping up worms. No one asked them to sweep worms. But, with guests arriving shortly and no one else available, they found brooms an

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

d started sweeping.

They didn't get hung up over titles or roles. Instead, they did what needed to be done at the time. Their actions were what I c

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

Combination pro

ll, ego-detached. Being ego-detached frees you to do what needs to be done because it's not about you; it's about something bigger than you. It's an

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

attitude of contribution. How can I best serve today? How can I help? What can I contribute? Being ego-detached is taking the you (your ego) out of

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 picture. It's looking at the best result, not necessarily the result that's best for you.

But here's the twist. Being ego detached is not bein

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

g ego-less. I heard Donald Trump talking about egos with Larry King on CNN recently. He commented that all the successful people he knew had big ego

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

s, defining ego as confidence or self-esteem. Certainly believing in yourself and having high self-esteem are qualities to help grow personal succes

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

. I'm not suggesting you shed either. Quite the opposite. You need plenty of confidence and self-esteem in order to be ego-detached.

I learned that

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

Following aspects would a

lesson as a senior manager involved in a start-up company. One afternoon, the president saw me stapling information sheets in a conference room. Af

dd to the challenges in developing combination products:

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

ter saying good-bye to his guest he came back and asked, "Nan, what are you doing?" After explaining why meeting a FedEx pickup was critical to an i

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

mportant corporate initiative and the number of people working to meet it, he offered to help. People who are ego-detached recognize that the best u

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

se of their time and talent can vary in the moment.

I used to marvel at colleagues of mine, other Vice Presidents, who delayed getting something to

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

their boss because their executive assistant was gone for the day and it needed copying. I'm not talking about the stuff that can and should wait. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

t's those late night meetings when the boss says he'd like to review something that night and he needs a copy. Ego-detached people go to the copier,

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

copy it and walk the copy back to their boss, regardless of title. It's how best they can serve at the moment.

If you want to be winning at workin

.

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

g, don't let your ego dictate your actions, let the situation. Don't be afraid to sweep up worms from time to time. And don't be afraid to serve. As

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

Companies that provide selfless information through particip

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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I just received another one in my inbox today. The link in the email when clicked takes you to a site with a picture of some guy standing in front of a nice house with a great car and you hear this audio of him saying how much money you will make with his program and why this works and the others don't.

Open your mind to see uncertainty as a state of possibility. Limitless possibilities. So often we view uncertainty with dread and anticipation of something negative happening to us. Imagine seeing the potential of limitless possibilities that might result in wonderful things happening. In other words, expect the best instead of expect the worst.

How to know if you are becoming a slave of your work? How to find out if work is taking more attention than needed? How to know that your life is suffering because of excessive work and thoughts of work? For any work slave his/her enjoyment is in work.

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