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Subjects - Accountable or Responsible - That is the Question
When I moved from a business where I was the responsible one, to where I was the accountab
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
le one.
And it was a shock, I can tell you.
I got myself offered a great promotion, as a
And it was a shock, I can tell you.
I got myself offered a great promotion, as a
; 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
result of some big-time management shuffling at the top and a restructure. It was a big b
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
usiness and a very big change in culture for me.
Think country bumpkin to big city. It wa
Think country bumpkin to big city. It wa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
like 'Mr Smith Goes to Washington' - and more.
After six months I was exhausted and craw
After six months I was exhausted and craw
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
led back to my boss to admit defeat. I wanted out and back to where I was comfortable.
He
He
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
was having none of that and, (very nicely and very firmly), pushed me back into the fryin
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
g pan - it was that hot!
Then, one day, a realisation struck me.
I was managing things,
Then, one day, a realisation struck me.
I was managing things,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ot people.
In fact, I was the doer of much of the stuff in the business and not managing
In fact, I was the doer of much of the stuff in the business and not managing
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
my people to do the stuff they were eminently qualified to do.
Immediately, I spent time
Immediately, I spent time
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
developing the capabilities of my people, investing time in them rather than doing all the
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
jobs myself.
And things started to turn around.
This brings me to the difference betwee
And things started to turn around.
This brings me to the difference betwee
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
'accountable' and 'responsible'.
Whilst I had the energy and capacity in a much smaller
Whilst I had the energy and capacity in a much smaller
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
business, I could keep each plate spinning myself. I was responsible for all of it and the
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
often much of the 'doing' too. I worked hard and could cope with it.
When the business b
When the business b
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
ecame much bigger, I found out that I couldn't do it all any more.
Whilst I was accountab
Whilst I was accountab
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 for the performance of my business, it became time to give away responsibility to others
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, with support.
Firmly and fairly, I gave away the 'doing' and let them get on with it. I
Firmly and fairly, I gave away the 'doing' and let them get on with it. I
.
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
told them the 'what' and let them have the 'how', within a few rules we agreed.
It was s
It was s
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
ure a tough learning for me and, well, if I could, you can too.
A corner was truly turned
A corner was truly turned
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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