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Advice You - Working With Passion
Last week I attended the annual conference of the North American Simulation and Gaming Association. I have served on the NASAGA Board for the past six years. During that time I have served as the Cha
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
ir twice and our company also has pro¬duced the annual conference.
Never have I learned as much about myself at one of these conferences as I did last week. One of the things that became so clear to
Never have I learned as much about myself at one of these conferences as I did last week. One of the things that became so clear to
; 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
me last week—by the people, surroundings, and events of the conference—was the power of passion at work.
I observed the passion with which many of the presenters and session leaders worked. It show
I observed the passion with which many of the presenters and session leaders worked. It show
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ed in their faces and work and, maybe more importantly, in the results they achieved in helping others learn more about their area of expertise. I observed the passion of the collective community of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
participants to seemingly never tire through a long conference program each day—with smiles and new friends and new ideas for their work.
The conference was held near one of my clients, so I spent p
The conference was held near one of my clients, so I spent p
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
art of one day working with the client team. I arrived on the client site ready to work, but dressed differently than usual. I was wearing a tie—a sight increasingly out-of-place in this strictly bus
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
iness casual organization. They asked why I was “over-dressed.”
The comments about my wardrobe led to a brief conversation as I was leaving. I shared a bit about the conference with two of my client
The comments about my wardrobe led to a brief conversation as I was leaving. I shared a bit about the conference with two of my client
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
s. They could see the excitement in my voice and body language—it was clear to them that I was enjoying this confer¬ence a great deal. As I walked out the door, one of them said, “Kevin, you are havi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ng too much fun.”
I paused just outside the door then turned around and said. “That is the way work is supposed to be. When you love the work you do, it is fun.”
My comment made an impact, b
I paused just outside the door then turned around and said. “That is the way work is supposed to be. When you love the work you do, it is fun.”
My comment made an impact, b
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
ut I didn’t think too much more about it. The following day at the conference banquet, I was given a surprise honor for my service to the organization, and I told this quick story as I said thank you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. What I didn’t do was finish the story for those at the banquet that night. Maybe they got it; maybe they didn’t. Maybe I didn’t even get it at the time.
The rest of the story is that having fun in
The rest of the story is that having fun in
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
your work comes from passion. When you find that passion, you are duty bound to share it. My work for NASAGA never took all of my time, and there were certainly weeks when I never did more than 30 m
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
inutes of work for the organization. But what drew me to be involved was a passion for my work that is represented well in this organization and at its conferences.
Having been drawn in, by all acco
Having been drawn in, by all acco
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
unts, I did a good job of helping the organization move forward. (At least many people said lots of nice things to me during the conference.) When people did say nice things or thank me, I typically
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
responded with “Thanks, but I was just doing my job.”
Just doing your job is one thing. Just doing a job you are passionate about is quite another, and that is what I learned, or re-learned or becam
Just doing your job is one thing. Just doing a job you are passionate about is quite another, and that is what I learned, or re-learned or becam
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
e clearer about, last week. When you find work that you are passionate about, miracles can occur.
I am now working on how I can live more closely in align¬ment with those things I am most passionate
I am now working on how I can live more closely in align¬ment with those things I am most passionate
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
about. Last week gave me ample proof of the power, energy and results that can be created by that alignment.
So where are you? What is your passion? Are you finding ways to express it and share it
So where are you? What is your passion? Are you finding ways to express it and share it
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
with others? If not, why not?
When was the last time you felt true joy and passion in your work? If you can’t answer that question quickly, I urge you to think about how you can find that experience
When was the last time you felt true joy and passion in your work? If you can’t answer that question quickly, I urge you to think about how you can find that experience
.
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
again (or for the first time).
Answering those questions may not be an urgent matter, but they are the most important questions you could pose to yourself today. Don’t delay – ask yourself these q
Answering those questions may not be an urgent matter, but they are the most important questions you could pose to yourself today. Don’t delay – ask yourself these q
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
uestions sooner than later. Take the actions that your answers suggest.
Find ways to express your life passions in your life and in your work. You will benefit, and so will those around you.
Find ways to express your life passions in your life and in your work. You will benefit, and so will those around you.
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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