Advice Pool - Relationships

“Let it go, Indianna.” It was a simple statement from a scene near the end of the movie, “Indianna Jones and the Last Crusade:. The hero, Indianna Jone

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

s, was in pursuit of the Holy Grail in order to save his father’s life. In the end, he had to choose to let the Grail go, even though it was close at h

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

Examples of combination products may in

and.

Hearing the statement in the movie, “Let it go, Indianna”, had an immensely profound effect upon me, personally. It was like this huge bullhorn s

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

creeching in my brain, “Listen to what he’s saying! Let it go!” I had some issues in my life at the time that I was grasping onto desperately. But I

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

really needed to let them go.

Life has those kinds of issues. Some of them are very close and deeply personal. Some things may be causing pain, right

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

Combination pro

now, even as you read this. Other things will hurt tremendously if you let them go. But you know you must still let them go. There comes a time in 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

ur lives when there are certain things or issues we have been dealing with that just need to be let go. We know they need to be let go. But sometimes,

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

even the act of change can be a deterrent to our personal progress. We are afraid of change and what may happen to us as a result of the change.

Ther

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

e are so many things and issues we deal with on a daily basis. Here are a few that often require a change of letting go:

(1) Relationships. When our

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

relationships reach a point that they hurt us or prevent us from progressing to our full potential, we need to consider letting them go.

(2) Death of a

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

friend or loved one. Death is a change that is thrust upon us, usually without warning. This can be highly devastating to our soul if we can not find

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

Following aspects would a

a way to deal with our loss and let them go. We will always feel of their absence, because we loved them so much. But our lives must learn to go on.

dd to the challenges in developing combination products:

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

(3) The shoulda, coulda, woulda of life. This is probably the most common, the most frequent situations that we need to learn to let go of. Here are

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

a few:

a. Parenting Skills. Children are not born with an accompanying shrink-wrapped manual of instructions. It is probably because every child is d

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

ifferent. It is simply a process of trial and error. Lots of trials. Lots of errors. After having had six children of our own, and in spite of our t

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

rials and my errors, I’m glad we had them. I’d still like to kick their rear ends from time to time, but they’re all good kids. I can honestly say tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t hardly a day goes by when I don’t wonder if I should have or have not done such-and-such differently. That’s my need to let go.

b. Grudges. Highly

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

destructive and painful to all involved. Let them be and let them go!

c. Personal Failures. No one is perfect. We all make mistakes from time to tim

.

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. Some of those mistakes are real doosies, too! But we only truly fail when we cease to strive to be better. We only lose when we quit. Accept your

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

Companies that provide selfless information through particip

mistakes and learning opportunities and pick yourself up and move on.

Never give up.

Never quit.

But let the bad from the past go.

Just let it go..

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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Who among us hasn’t fallen into the trap of believing that in order to be worth our salt as managers, we must be omniscient, omnipresent, and omnipotent? In Truman-esque fashion we declare that the buck stops with us, and confuse taking responsibility for getting results with being responsible for controlling everything that happens with a project, department, or business unit. Managers who take responsibility for results are performing a leadership function that involves setting a vision, establishing goals, devising a strategy, and managing resources. Instead of focusing on how each task is done, the process is evaluated. Instead of reviewing everyone’s work, work habits are assessedto make sure that people have the skills and resources they need for high performance.

Would I continue to patronize an airline that is consistently fifteen minutes late, but which treats me like a prince? Or, would I defect, giving my loyalty to a no-frills, cattle-call carrier that ignores me but gets me to where I need to go on time?

As interest rates have risen in the last six weeks from record lows, homeowners are once again face with finding viable options to reduce the amount of interest paid on their home loans. The rush to...

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Advice Pool - Let It Go

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