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Advice Pool - Unveiling the Value of Your Expertise
All of us have knowledge, expertise, and experience that others can benefit from. This is one of the reasons we play some of the roles in life that we play: leader, trainer, teacher, coach, mentor, an
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
d more. We all can contribute to other’s success with our expertise. Unfortunately, some things keep us from doing this as successfully as we could.
This article will outline several of the things tha
This article will outline several of the things tha
; 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
t get in our way and suggest ways to improve our ability to succeed in having our expertise used successfully by others.
Ignorance
Here is a fundamental truth - most of us don’t recognize how m
Ignorance
Here is a fundamental truth - most of us don’t recognize how m
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
uch we know. When we’ve done something for a long time, or read about an idea in 21 places, we assume everyone knows that information. This just isn’t true! Our familiarity and deep understanding gets
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n our way, because we assume others know what we believe to be obvious.
The first key to getting your expertise used is to proclaim it to yourself. Recognize that what you know is significant and valu
The first key to getting your expertise used is to proclaim it to yourself. Recognize that what you know is significant and valu
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
able. Without this recognition you won’t know what to share if asked.
Attitude
Before you go too far down this “Man, I’m smart” mental path though, recognize that arrogance is the next stumbli
Attitude
Before you go too far down this “Man, I’m smart” mental path though, recognize that arrogance is the next stumbli
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
ng block. Certainly, we need to recognize our expertise. Of course we need to value what we know.
But none of this makes us better than the other person. My advice? Lose any budding arrogance.
When
But none of this makes us better than the other person. My advice? Lose any budding arrogance.
When
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
we are arrogant about what we know, our advice is more about an opportunity to show what we know, than it is about genuinely helping others. When we are confident we can focus on the other person’s nee
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s. Be confident in what you know and always be willing to learn more.
Focus on being generous but helpful in your knowledge sharing. By remaining confident in your knowledge and keeping your focus on
Focus on being generous but helpful in your knowledge sharing. By remaining confident in your knowledge and keeping your focus on
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
the other person’s needs, you will have your attitude in the right place.
Memory
Often the challenge we have in sharing our knowledge and expertise is that we don’t really remember what it is
Memory
Often the challenge we have in sharing our knowledge and expertise is that we don’t really remember what it is
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
like to be a beginner in this area. Even once we recognize the value of what we know, we take shortcuts in explaining it to someone else.
How?
By using jargon or skipping what seem to be obvious step
How?
By using jargon or skipping what seem to be obvious step
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.
In order for us to successfully transfer our knowledge, or teach someone what we know, we must break the steps down. We must share each piece of information one step at a time.
We have learned thi
In order for us to successfully transfer our knowledge, or teach someone what we know, we must break the steps down. We must share each piece of information one step at a time.
We have learned thi
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
information and so can others. But we must teach them from their perspective, not ours – remembering what it felt like to be a beginner.
Connect the Dots
My daughter loves to color and has ma
Connect the Dots
My daughter loves to color and has ma
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
ny coloring and activity books. One of the activities found in many of these books is something I used to call a “Dot to dot.” In a dot to dot puzzle, you draw straight lines from point 1 to point 2 t
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
o point 3, etc.
By looking at the page before you start to connect the dots, you can’t really tell what is going to be drawn. You may have some clues based on how many other lines and related pictures
By looking at the page before you start to connect the dots, you can’t really tell what is going to be drawn. You may have some clues based on how many other lines and related pictures
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
exist on the page, but until you complete the puzzle, you don’t really know what you have.
Our expertise is like that. We are asked to share what we know with others for their benefit. What our job
Our expertise is like that. We are asked to share what we know with others for their benefit. What our job
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
eally is is to set a context and provide a bigger picture for them. Telling them the steps or the procedure or the technical components of something isn’t enough. They need to know the situation the e
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nvironment, the surroundings. They need to understand the relative priority and importance of the various things you are teaching them.
As the “expert” you help them complete their own mental puzzle b
As the “expert” you help them complete their own mental puzzle b
.
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
y guiding them in connecting their own dots.
Making these connections is how we will be most successful in having our expertise valued and used by others. And you can only connect these dots when you
Making these connections is how we will be most successful in having our expertise valued and used by others. And you can only connect these dots when you
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
have the other three barriers reduced or eliminated for yourself.
Your success will expand as you expand the success and capabilities of others and the lessons of this article can help make that happen
Your success will expand as you expand the success and capabilities of others and the lessons of this article can help make that happen
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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