Advice You - Business

Recently, I had one of those "aha moments" while in the bathroom – I might have been brushing my teeth. I'm told that we are more creative around water – and I certainly find my bathroom a great creative lab for me! Anyway – the thought I had was, "Fear fogs the brain."

Now that may not be a profou

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

nd thought– but it was to me – and I've been seeing how this situation operates more and more as time unfolds. The less fearful we are, the more present we can be with our lives, our work, and our relationships.

Let me give you an example. I have a new client who resides and works on the east coast

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

Examples of combination products may in

. He's bright, accomplished and terribly unhappy with his present job situation. From the outside looking in, you might say he has it all – a good job, a great wife and family – yet he feels unsettled.

Truth be told, he feels like he's living a lie. And authenticity is one of his highest values!

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

He feels constricted and in fear – he has a family to support – he's sole provider at this time – and he's followed his father's prescription – get a good, solid, respectable job. He's done that. He's fearful about changing – and he's miserable inside because the real essence of him is not being exp

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

ressed in his work.

He's had trouble getting clear about what he really wants because he is so immersed in the fear of his situation. He fears in particular that there's no way out of this dilemma. He's not alone. Haven't we all felt stuck and mired in the fear of such a situation at some time in

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

Combination pro

our lives? We can't think straight because our monkey mind has us by the throat – that's the part of our thinking that grips us when we are about to make changes in our lives. Monkey mind loves to keep us in the status quo. It's deadening, yet predictable.

Someone recently told me about a bumper s

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

ticker that's a response to such a monkey mind perspective: "Don't believe everything you think!"

So how does anyone – including my client – gain clarity in the midst of such challenging life decisions – when gripped by fear – when brains are fogged?

Well let's start with what doesn't seem to work.

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

It's so tempting to go to others and complain about our present circumstances. We find others to bond with and play the "ain't it awful game." When we do this, we don't feel alone – there's a temporary relief in getting some of the fears off of our chests – but in the long run, there's no clarity

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

in this. It's just part of the same old game.

It often doesn't work to tell close family members such as spouses, parents (if you're an adult child), siblings, extended family members – they may start colluding with your fears. It's not that they are bad people, but they want to keep you safe. The

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

y may tell you to quit whining – after all, you should be lucky you have a job! That snaps you back to the status quo with a dose of guilt on top of your fear. Again, no maliciousness here, just status quo. And perhaps this outward expression is familiar because it's what your monkey mind has told

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

ou already. However, Helen Keller got it right when she said:

"Security is mostly a superstition. It does not exist in nature, nor do the children of men as a whole experience it. Avoiding danger is no safer in the long run than outright exposure. Life is either a daring adventure or nothing."

S

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

Following aspects would a

o if these avenues don't bring you to clarity, what does?

Well, have you noticed that you get clearer after you've taken a long walk or exercised? Danced? Done yoga? There's something about this mind – body connection. The endorphins start getting produced and the fear we once had seems to vanish.

dd to the challenges in developing combination products:

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

Lately I've found that I actually have to stop my treadmill during the midst of my workout because I've had a clear thought that I have to write down so that I don't forget it.

Others get clearer when they write or journal – they see their own thoughts spill out on the page – and they get a sense o

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

f what they are thinking. Writing also can be a great way to dump a lot of emotion out on paper – no one else has to be there – just you and your pen and paper or fingers running over the computer keyboard. People who have artistic skills gain the same effect through drawing or doodling.

Still othe

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

r people get clear when talking with other people – articulating what's going on. Such people need to be unconditional, not clouding the issue with their own opinions or advice – allowing the person trying to get clear to tell the truth, be seen and accepted. The Quakers actually have a practice for

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

this – it's called a discernment committee – when someone wants to get clear, a group of congregants gather around and allow the person to speak his mind while the others just listen. Parker Palmer explores this process in his small but profound book, Let Your Life Speak: Listening for the Voice of

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

Professional from academic institutions, pharmaceutical industries, health care indust

Vocation. This is also, by the way, the place in which a professional coach can come in – someone well trained in the skills of listening and articulating.

Some people find fear drops away from them after they've witnessed others experiencing life threatening illnesses or even come through such an

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

illness themselves. Such incidents may wake them up to the realization that they have nothing to lose. The fears they were experiencing were minor compared to the threat of death or near death. This experience has put everything in a different perspective.

Getting away from it all – on retreat or

.

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

vacation can also create enough space between you and your circumstances to free you up and get clear.

So here are some questions for you to chew on as you explore this notion of clarity no matter whatever method you choose:

• What do you need to clarify most in your life?
• How does fear cloud

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

Companies that provide selfless information through particip

your present and your future?
• What would be your preferred method of gaining clarity?
• What's your next step in getting clear?

My challenge to you is to put some time and energy into clearing the foggy areas in your work and life. Get on with your life and live it as clearly as you can

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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