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Just Other Articles - If I Knew Being Brave Was So Scary I Never Would Have Tried It
I’m feeling really scared right now, not because I’m in a scary situation, but because I was brave and it was scary.
In reality it was a little incident that brought me to this scary place; I h
In reality it was a little incident that brought me to this scary place; I h
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
ad to assert my rights in a business dispute and request that someone else fulfill their obligations. Sounds reasonable enough. Even sounds like a daily occurrence for some business people. 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
Examples of combination products may in
mm…then why is it that facing a reasonable, somewhat daily occurrence makes me so very scared? I’m guessing that it has nothing to do with this specific incident, and everything to do with my a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ygdala. Yes, I said amygdala, not armadillo!! However, if I had an armadillo it would scare me too!
The amygdala is the part of our brain that holds emotional memories; those two words emotio
The amygdala is the part of our brain that holds emotional memories; those two words emotio
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 memories are the key. Whenever we are faced with a stressful event or crisis, which awakens our emotional memories, our amygdala “hijacks” our working memory. We then experience the classic
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
“fight or flight” reaction, with a flood of adrenalin and cortisol. When cortisol levels are high, we make more mistakes, are more distracted, and can’t remember as well; even if we are only tr
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
ing to recall something we just read. In other words, when we are hijacked by our amygdala we all become very, very scared.
The trick to dealing with hijacks in the work place is to become mo
The trick to dealing with hijacks in the work place is to become mo
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
e self-aware and make different choices. First recognize what you are feeling, second realize which one of your emotional memories caused the hijack and finally choose to respond in a new way.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Of course all of this requires being brave, but you can’t be brave until you have first been scared. Think of it this way, being scared is the first step in being brave.
In my case, my amygda
In my case, my amygda
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
a hijacked my emotions (meaning simply that I was really, really scared without a really, really good reason) when I had to assert my rights and request someone fulfill their obligation. Althou
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h this might cause some of us to be intimidated there is a smaller select group of us that would feel more scared than intimidated. I was not so much scared of requesting someone do their job,
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
s I was scared that they would think I had no right to tell them what to do, even though they were working for me. My rights seem to always be trumped by someone else’s right to act however the
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
want, even if they are treating me unfairly. When my rights are involved – I recognize that the first thing I feel is “scared”; a classic hijack!
Second, I had to realize the root cause of th
Second, I had to realize the root cause of th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
t feeling. Trust me on this one, once you know your root cause it is easier to see that all the emotion you are pouring into a hijacked situation is really coming from another place, a place in
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
your emotional memory. This is a little like once you have been traumatized by a rabid, foaming at the mouth dog, in the future, the mere sight of any dog can cause you to run for the hills. A
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
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
classic “fight or flight” amygdala hijack moment!
Finally, we can all choose to respond to hijack attempts in a new way. Just because you have tried to be brave in the past and ended up over-t
Finally, we can all choose to respond to hijack attempts in a new way. Just because you have tried to be brave in the past and ended up over-t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e-top scared in the process doesn’t mean that is how you will always react. Once you have recognized you are in the midst of a hijack moment, and realized the root cause, then remind yourself t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
at because you are now more self-aware, you have the power to choose a new, healthier response. Oh yeah, you will still be scared the first few times you try this, but each time you should be j
.
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
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
st a little less scared and a little more brave.
There you have it; why being brave is so scary. In reflection, if I had known becoming brave would have required so much of being scared first,
There you have it; why being brave is so scary. In reflection, if I had known becoming brave would have required so much of being scared first,
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
I would have done it anyway. I prefer to be more self-aware by recognizing my feelings, realizing why I feel them, and responding to them in a healthier manner. Well, at least most of the time
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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