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"If you hear a voice within you saying, ''You are not a painter,'' then by all means paint… and that voice will be silenced."

Vincent Van Gogh

One o

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

f the biggest barriers to a profitable business is ourselves. Or to be more specific what is going on in our heads. This is what the Buddhists term

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

Examples of combination products may in

Monkey Mind' - the self-criticizing aspect of our mind that swings us from doubt, to worry, and back to doubt. It's what a client affectionately call

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

"that incessant voice in my head that doesn't shut up!!"

If you've ever heard yourself saying things like

* "How can you possibly think you're good

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

enough to ... (start your own business/try out for the part/increase your prices)"
* "Of course you're not making sales, (it's a quiet time of ye

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

Combination pro

ar/we're in a recession/it's raining)"
* "They're never going to want to do business with me; I'm (too dumb /too old /too young /not funny enough

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

not serious enough)"
* "If I were really meant to be doing x, I wouldn't be having so much trouble" then chances are that's your Monkey Mind cha

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

ter talking to you.

The good news is it never really goes away. How can that be good news you ask? Well, when Monkey Mind is at its strongest is

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

enerally when we are threatening to change the status quo. In her book Feel the Fear and Do It Anyway, Susan Jeffers First Truth is "The Fear will ne

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

ver go away as long as I continue to grow". Our Monkey Mind is playing on those fears to ensure things stay just the way they are thank you very much

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

So if Monkey Mind is set to hang around, how do we ensure we are moving forward regardless?

The first step is to recognise that the doubts, fears a

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

Following aspects would a

d worries are always going to be there, however we can decide how much of our energy goes into listening to it. We can choose at any moment to focus

dd to the challenges in developing combination products:

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

ur energy on achieving our goals rather than trying to analyse, suppress or argue with our self talk.

The second step is to check inwards that the go

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

als we are wanting to achieve are in line with our vision, and reflect our true self, rather than simply being driven by fear or moving away from fear

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

This takes some real reflection, and can be quite confronting. Having someone to support you through this process will be invaluable.

The third st

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

p is to take action. Susan Jeffers Second Truth is "The only way to get rid of the fear of doing something is to go out and do it." In fact even the

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

Professional from academic institutions, pharmaceutical industries, health care indust

step of changing your physical state can lessen the fear and allow you to move forward. A simple example of this is the fear we have in making partic

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

ular phone calls - it may be for debt collection, or to ask for new business. In these situations, the act of standing up to make the phone calls can

.

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

make you feel more powerful, thereby lessening your fear, and you actually come across as more assertive when you do make the call.

Monkey Mind is

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

Companies that provide selfless information through particip

ere to stay, and is not something that you can turn around over night, but just be thankful if you can hear it, it means you are ready to forge ahead!

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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