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Main Subject - Manage Your Business from the Rockies, not the Prairies
The day job as a manager is all about managing your people to deliver, to meet the needs of your customers or clients and generating success after success! Right? And
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
you have consequences if that doesn't happen.
Worst case scenario is that you lose your job or your business, because your people haven't delivered. So the temptation
Worst case scenario is that you lose your job or your business, because your people haven't delivered. So the temptation
; 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
is understandable. Get in there, dirty your hands and work your socks off making it happen.
Admirable, fulfilling even!
But how much energy have you got? How
Admirable, fulfilling even!
But how much energy have you got? How
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hard do your really want to work. Indeed, how long can you take the pace of keeping everyone else afloat. Before you fall apart, or it kills you?
Or, despite all your
Or, despite all your
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
years of strife and giving your heart and soul for your business, you lose it, or your job, or both.
It doesn't seem fair does it?
But there is another way -
But there is another way -
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
and it's easy.
Use your people better
Space ships sent off into the far universe, use the gravitational pull of planets to accelerate them on
Space ships sent off into the far universe, use the gravitational pull of planets to accelerate them on
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
wards, just like gravity pulls us to earth. It's free energy!
The limited fuel that the rockets have, is used to ever-so-gently fine tune direction, so that as they a
The limited fuel that the rockets have, is used to ever-so-gently fine tune direction, so that as they a
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
proach the planet pulling them in, they alter their course to miss the planet and, with renewed energy, they carry on their mission. Clever stuff eh?
That'
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s what you can do
If you play a bigger game than spending your whole life doing the job that others can and should be doing, in the false belief t
If you play a bigger game than spending your whole life doing the job that others can and should be doing, in the false belief t
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
at you are 'helping out', then you aren't going to cut it. In fact, like I once realised, moving from one sized store to a bigger one - you cannot do it all - it's tim
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e to manage the business through the people - it's just too big for me now.
And that was a big and painful realisation for me
But I got it!
But I got it!
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
It came to me one Easter, when I was running a big store and I was filling up the Easter eggs. It was fun! But I wasn't doing what I was paid for - managing and even l
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
ading a great bunch of people, all of whom could do this better than me. It was time to do my job. The time had come to leverage their potential and crea
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
te value using my unique skills and talents.
As it happened, my office was on the fourth floor (because it had a view!) and the business traded on the lowest t
As it happened, my office was on the fourth floor (because it had a view!) and the business traded on the lowest 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 floors. And this became my metaphor for managing from high up. The Rockies, not the Prairies.
Even though I spent a lot of my time on the Prairies, I was, in my min
Even though I spent a lot of my time on the Prairies, I was, in my min
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
d, way up high. I was managing the people from above. I was managing the great people I had.
I was able to step back from working 'in the business' to 'on the
I was able to step back from working 'in the business' to 'on the
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
usiness', as Michael Gerber would say. And it made a great difference to me. I realised that part of it was showing my troops that I was working just as hard as they w
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ere, and, indeed, I could do their job pretty well.
Yet, I was also resisting where the stretch was for me - letting go of other people's jobs, and doing my own.
For
Yet, I was also resisting where the stretch was for me - letting go of other people's jobs, and doing my own.
For
.
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
me, it was a shift to the next level, Sure, I did my hands on stuff from time to time. But it was at my choice and to work with them to show soldarity and focus when t
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
he chips were down. But it was after the management stuff was done.
It was my way of bringing the Rockies down to the Prairies, yet enjoying the fruits of both
It was my way of bringing the Rockies down to the Prairies, yet enjoying the fruits of both
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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