Main Subject - Business

Let me tell you a secret.

Things don’t always go the way we want them to.

Let me tell you another secret.

We don’t always hear what we want to hear.

Duh.

These two statements are hardly secrets; we all know they ar

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

e true. If they aren’t secrets, then why do we act surprised when it happens? And worse, why does the surprise often turn to pouting?

Adult Pouting

Most adults don’t walk around with a pout on their face, but

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

Examples of combination products may in

that doesn’t mean they aren’t pouting. Pouting is when we are having an internal pity party because we haven’t gotten what we wanted, things haven’t gone the way we’d hoped they might, we heard something we didn’t want

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

to hear or disagree with, or we have to work on something when we would rather be doing something else.

So we pout.

Some Examples

We are called to a meeting, when we wanted to be working on the important proj

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

ct on our desk. We think things like, “I don’t need to be at this meeting. Tammy could have handled it. Why am I here? Can’t they see that my time could be better utilized elsewhere? This is ridiculous.”

Or we are

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

Combination pro

’t asked to go to the meeting and we see ourselves as really being able to contribute (or really wanting to be there because it is about an important change that we want to be in-the-know about). We think, “Why can’t I

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

be there? My experience would make a difference. Besides, this could have been my chance to shine for the new VP over in Marketing. Being there would be a much better use of my time than working on these numbers. T

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

is is ridiculous.”

Or we sit in the airport because of a delay. We sit and we sit. We miss our connection because of the delay. We miss the events we had planned for the evening. And we are still in Buffalo (or whe

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

ever). We think about what we are missing. We think about the stupid airlines or the stupid weather or the stupid travel agent that booked this itinerary.

Poor us.

In all of these cases (and a hundred others I could

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

share) we keep our thoughts inside ourselves. We are so busy with our own internal conversation about us, that we miss any chance to benefit from the situation. In order to capitalize on any experience we have to be

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

resent for it. When we are pouting, we clearly aren’t present in the situation or experience. We are too busy focusing on ourselves.

It is time to get over ourselves. Lose the pout and get yourself out(side) of your

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

Following aspects would a

elf.

We can become much better leaders and professionals we can get past our internal language and live in the present moment. The present offers us:

• Opportunities to learn

• Opportunities to teach

• Opportunitie

dd to the challenges in developing combination products:

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

s to reinforce positive behaviors in others

• Opportunities to see our world in new ways

• Opportunities to enjoy our day more fully

Staying in pouting mode closes the door to all of these opportunities because we do

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

’t see them –we are too busy thinking about ourselves.

Getting the Pout Out

To capture the opportunities in the present we have to “Get the Pout Out,” here are some ways to do that:

• Acknowledge your feeli

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

gs and move on. Give yourself permission to feel bad for yourself. You have one minute, starting now. Then let it go, get on with life and the situation you are in.

• Hear the opportunity knocking. Remind

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

yourself of the opportunities you will find in the situation, even if this isn’t where you would prefer to be. Have you ever gone somewhere you didn’t want to go and were surprised how much fun you had? That can happ

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

Professional from academic institutions, pharmaceutical industries, health care indust

n again, right now, but only if start looking for it.

• Listen more completely. One of the best ways to become more present is to listen more carefully to those around you. Pay closer attention in the meeting.

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

Listen for ideas and perspectives that interest you.

• Observe more closely. You never know what you might miss. You never know what you will learn.

As a leader you have a responsibility to be present. Peopl

.

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

e look to you for direction, ideas, and a good example. Staying present, even in tough or challenging situations is a great example to set.

More importantly though, as an individual, striving to reach your own potenti

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

Companies that provide selfless information through particip

l, moving past the pouting moments give us a chance to fully live our lives. This habit allows us to find enjoyment, growth, and better relationships in situations that might not have seemed that favorable at the start

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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