Main Subject - Business

Success is what you want for you and your business, isn't it? Although success means different things to different people, there are some ingredients that are necessary

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

to have in the mix. One of the most important ingredients is being effective as a businessperson. So, whether your business is small or large, new or growing, you nee

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

Examples of combination products may in

d to be effective.

Being effective is doing the ‘right’ things well. Now, it’s simple to say that you’re choosing to be more effective, but following this through with

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

actually being effective isn’t always easy. It’s a journey and there will be roadblocks along the way. First you’ll need to identify these obstacles and beware, because

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

they’re not always obvious and not always easy to identify. After all, your ego will be kicking and screaming to keep you where you are. Your ego doesn’t want you to ch

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

Combination pro

ange and will do everything it can to stop you and this is often done in very subtle ways.

Being more effective will require you to be more self-aware and to observe wha

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

t’s going on. This isn’t an opportunity to give yourself a hard time or to keep asking why. That gets you nowhere. It’s an opportunity to observe with detachment, noti

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

ce things and then choose different actions.

So, what do you notice that blocks you from being effective? One possible obstacle is what a friend and I have nicknamed th

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

‘Dog With a Bone Syndrome’. You know how when a dog starts gnawing on a bone he doesn’t want to let go at all. Well, as people, we can be similar when we’re faced eith

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

er with a problem or we’re doing something that clearly isn’t working. We keep on trying to do something about it, change it or resolve it, but it doesn’t seem to matter

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

what we do, nothing changes and progress certainly isn’t being made. In trying to do something about it our ‘mind chatter’ kicks in and adds to it with ‘Just try one mo

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

Following aspects would a

re thing,’ ‘Perhaps you just need more information’ or ‘I’m sure the solution will come soon’. These are all ways in which your ego tries to keep you stuck where you are

dd to the challenges in developing combination products:

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

and not change.

All the time your ego is keeping you here, you’re not moving towards being more effective. When you keep ‘trying’ you’re like the dog hanging on to the

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

bone for dear life. This stifles your creativity and your own ability to come up with answers and solutions. You’re attached to this too tightly and need to let it go.

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

Your ego will fight to stop you from letting go. It can be interesting to observe this fight within yourself. You need to shift from your ego and conscious mind, to yo

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

ur body and sense of being. To shift here, you need to be totally present and to let all thoughts go. When you’re finally able to let it go, it will come back when the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ime is right and solutions will appear. I find this particularly if I let something go prior to sleeping. The answers or ideas are often there clearly for me when I awa

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

ke.

I invite you to be more effective and take a few minutes to answer these questions for yourself. What you need to let go of so that you can be more effective? Wha

.

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 is currently going on for you that’s making you struggle or try too hard? If you let this go, what different actions do you need to take?

Increase your self-awareness

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

Companies that provide selfless information through particip

so that you notice and observe the obstacles, and then choose different actions. Your level of effectiveness will increase and affect the level of your business success

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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Stop wasting time looking for papers lost on your desk, running down to the office supply store for last minute printer ribbons, or working 24-7. Use these 10 tips to get more organized, streamline your repetitive activities and plan ahead to prevent office crises and uproar.

There are two prevalent approaches to the development of Datawarehouse Architectures: A. Data Warehouse (DWH) bus architecture (introduced by Ralph Kimball) B. Corporate Information Factory – CIF (introduced by Bill Inmon) In this article we analyse and compare these two approaches.

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