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In honor of the anniversary of John Lennon’s death, I have chosen this topic. Imagine you were going on a very long, perilous and important trip. If you survive the trip, you will be r

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

ewarded with great wealth, leaning and satisfaction, but, more importantly, huge personal growth. The journey is through a treacherous and threatening environment, much of it uncharted

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

Examples of combination products may in

and unknown. And you have no idea how long the journey will take, or how you will reach the destination. In fact, imagine if you didn’t even have enough resources at the start to comp

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

ete the journey – you just have enough to get started. You will have to create new resources along the way.

Now imagine you were given the opportunity to select a group of friends and

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

fellow travelers to accompany you on this magnificent mission. You will have to trust your success and even survival to these people. You will endure difficult and dangerous challenge

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

Combination pro

and threats. There will be the temptation of greed, fear and unexpected obstacles and rewards. What kind of people would you choose? What characteristics would you look for? How would

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

you test them? After all, your very life and indeed your future fortunes would be in their hands!

Imagine you have to make a list of the qualities you will look for in this team. Now

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

make the list. Name twenty qualities you would not compromise on. What would they be? Courage, consistency, reliability, integrity? Honesty, confidence, steadfastness, dependability, f

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

idelity, loyalty, constancy? What else? How about boldness and valor? Would you really be interested in their resumes, university degrees and past experience, or would character be mor

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

important? Now here is a shocking suggestion: how many people do you now know and do business with that would fit that profile?

Business is very much like the journey I have just des

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

cribed. Those whom we choose to travel that journey with, the team we select, the joint venture partners we pick, can and do make a massive difference. We need to be very vigilant and

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

Following aspects would a

selective. Look out for red flags. Watch your associates very closely and carefully put your team together. Whenever you see a wolf among the sheep, cut bait fast. Don’t discuss it or

dd to the challenges in developing combination products:

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

ationalize it. Don’t justify or excuse it. See it for what it is and remove it.

The most valuable asset to any business is our associates and the people we work with. When you find go

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

od people, stick with them. Support them, encourage them, reward them and honor them. They’re hard to find. Business is an exciting journey and it’s wonderful to be able to travel that

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

journey. The rewards are magnificent. “You may say I’m a dreamer, but I’m not the only one. I hope someday you’ll join us…”

Motivational Quote

"You make your own dream. That's the Be

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

atles' story, isn't it? That's Yoko's story. That's what I'm saying now. Produce your own dream. If you want to save Peru, go save Peru. It's quite possible to do anything, but not to

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

Professional from academic institutions, pharmaceutical industries, health care indust

ut it on the leaders and the parking meters. Don't expect Jimmy Carter or Ronald Reagan or John Lennon or Yoko Ono or Bob Dylan or Jesus Christ to come and do it for you. You have to d

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

o it yourself. That's what the great masters and mistresses have been saying ever since time began. They can point the way, leave signposts and little instructions in various books tha

.

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

are now called holy and worshiped for the cover of the book and not for what it says, but the instructions are all there for all to see, have always been and always will be. There's n

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

Companies that provide selfless information through particip

othing new under the sun. All the roads lead to Rome. And people cannot provide it for you. I can't wake you up. "You can wake you up. I can't cure you. You can cure you." - John Lenno

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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Successful problem-solving means you must do what you promise and don’t promise what you can’t deliver. It seems obvious, but many people don’t manage to do this. This tip will help you avoid the problem.

Most of us remember the commercial that said, “I told two friends, and they told two friends, and so on, and so on, and…”, well you get the picture. This commercial, which represented Breck Hair Sham...

Running your own business, especially alone, you're bound to get stuck and feel like you've reached a plateau or worse still, you feel as if you just can't gain forward-moving motion. The danger is not in getting stuck, but in prolonged inactivity - inertia. This phenomenon is frequently observed in entrepreneurs starting a new business.

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