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Being

Being is about the here and now yet most of us dwell in another time and place either in the past, what we did yesterday, what happened last year, what someone said to you at a meeting last week that still upsets you or the wonderful evening you had with a partner and why can’t it al

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

ways be like that. Or we are in a time that is based on what might happen to us in the future. Millions of people spend there lives hoping that they will win the lottery and the industry knows that much of our world is based on dreams that are in the future.

A friend of mine spends hours ea

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

Examples of combination products may in

h day dreaming about what she will do with the money if she wins the lottery, she says ‘I get myself a glass of wine and sit thinking about buying a new house, a new car or going on a fabulous cruise and yet I know its all a dream it will never happen to me’ – and it never does!

If she was

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

illing to spend the same amount of time on creating her environment right now she would see things differently. This ‘future’ world thrives on our desires for something that we don’t yet have, based on something that we think we desire. The future holds a particular hook for us and this unre

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

al world remains elusive and is a major source of depression, discontent, aggression and loneliness. If everything we do is wrapped up in something which is in the future like, ‘I can’t wait for Friday to go out and enjoy myself.’ Or ‘I am really looking forward to our holiday in the summer

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

Combination pro

’ And ‘I saw a red dress and can’t stop thinking about it; I’ve got to have it’. All of these moments spent thinking and waiting for something that is not in the here and now, wastes our valuable energy when our lives could be filled with what we are doing right now, and that is focussing o

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

creating and practicing the creating game.

When the moment arises that we get any of these things the gratification is short lived as we begin to dream about the next thing that we want. Dreaming does not create anything. To experience peace and harmony and happiness we should learn to s

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

imply ‘Be’ in the now. Easy to say not easy to be! How do we do it? Being in the now does not stop us from creating holidays or planning events; it means that once the creation is formed to go on holiday or to go to the theatre and we are clear about this action, we can then remain in the m

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

ment to continue our day, without the clouds of dreaming, reminiscing and distraction that causes inner discomfort. Simply being is not an easy concept for many people and the questions people ask are often – but who should I be? I don’t know who to be. What do you mean – just be?

To just

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

‘be’ means that we have to make the moment that we are in, the best it can be. This is day to day creating. This means that we give our present moment our full attention, we stay with exactly what we are doing, moment by moment. I find it easier to help people to look at what kind of person

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

hey would like to be, even if they are not sure of what that is, they can begin to put together a blueprint of themselves as they would like to be. I believe that if we spend time looking at who we want to be – that we have a better chance to encourage that state of being.We can create ours

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

Following aspects would a

elves in any image that we chose, we simply need to focus with intent. It is true that our exterior world is a reflection of our inner world. This means that whatever is going on in your life, whatever chaos, dreams, loneliness, uncertainty that’s happening in your life is a direct mirror of

dd to the challenges in developing combination products:

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

what is going on inside you. If you are experiencing an angry relationship this means that the anger is inside you.

If your exterior world is calm, peaceful and contented so it will be inside you. If your life is boring you can be certain that this is what is going on inside yourself. ‘Bein

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

’ can be made easier if you chose and create a way to be, and this can be used as a reminder to help you to work with ‘being’

When I chose to be completely compassionate and loving without conditions it was an enormous commitment for me, yet as big as this was it gave me an internal framewo

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

rk with which to work with. I found that my daily activities whatever they may be and however they turned out could be examined from this new state of being. I asked myself, as often as I could remember in the moment ‘I am love and compassion’ I am doing this from a place of being compassion

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

te, it was never easy it still isn’t but this enabled me to shift from a different place – it didn’t always work and when I was full of resentment and anger toward some people it took enormous effort, but gradually it changed. Some changes were dramatic and some more subtle. When things didn

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

Professional from academic institutions, pharmaceutical industries, health care indust

t work out in alignment with my creation to be compassionate and loving I could at least examine this and ask myself later ‘what would love have done’ and I had a new framework for the next time.

When we make a choice about creating ourselves, it opens up a whole new real world. Through exe

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

rcise and time we can shift the dwelling on the past and dreaming about the future into which we are choosing to be today. When we are ‘being’ something higher than being caught in the past and future world – when we decide to proactively create ourselves, our concentration stays with the gr

.

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

at things that are created from this new state of being. Your life shifts and the desire to be somewhere else changes. How can it not? If you are being loving and compassionate in all that you are – why would you wish to be anywhere else but in the here and now? What could be better that tha

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

Companies that provide selfless information through particip

state and no matter what you do and where you go you can be this ‘being ‘all of the time I any circumstance.

You can learn more about creating your life from the 24 principles in my book The Creating Game at www.thecreatinggame.com

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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