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Main Subject - You Can't Have Juice With a Special Broiler Meal
Years ago, I frequented a well-known quick-service restaurant for their Special Broiler Meal, a fast-food lunch of broiled chicken sandwich and french fries.
But instead of t
But instead of t
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
aking the large cola with the package, I always asked for a small glass of orange juice instead. Predictably, the counter staff would freeze up with uncertainty and refer my r
; 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
quest to the floor manager.
One young manager was particularly memorable. ‘I’m sorry, sir,’ he told me. ‘You can’t have orange juice with the Special Broiler Meal.’
‘Sure I
One young manager was particularly memorable. ‘I’m sorry, sir,’ he told me. ‘You can’t have orange juice with the Special Broiler Meal.’
‘Sure I
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
an,’ I replied, ‘I do it all the time at the other outlets in your group. There is a 65 cent price difference and I am happy to pay it.’
‘That’s not the problem,’ he said wit
‘That’s not the problem,’ he said wit
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
h a touch of annoyance. ‘There’s no key on my computer to make the substitution, so I can’t let you do it.’
‘Hey, sometimes you have to break the rules,’ I said, reminding hi
‘Hey, sometimes you have to break the rules,’ I said, reminding hi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
of his brand’s multi-million dollar advertising campaign. ‘I’ll take the Super Broiler Meal, with orange juice, please.’
He realized I was not going to take ‘No’ for an answ
He realized I was not going to take ‘No’ for an answ
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
r and he could not go against a well-informed customer and his chain’s well-known advertising promise.
‘I’ll do it for you just this once, as an exception,’ he said.
‘Oh c’m
‘I’ll do it for you just this once, as an exception,’ he said.
‘Oh c’m
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
on, you can do it for me anytime,’ I replied.
‘No,’ he said again, looking me straight in the eye. ‘I will do it for you this once, but I won’t do it again.’
‘Wait a minute,
‘No,’ he said again, looking me straight in the eye. ‘I will do it for you this once, but I won’t do it again.’
‘Wait a minute,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
I asked gamely. ‘You are about to make me a happy customer. Do you really mean you wouldn’t make me a happy customer again?’
‘I will do it for you this once,’ he repeated fl
‘I will do it for you this once,’ he repeated fl
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
tly. When I received my meal, with orange juice, I gave the manager a genuine smile and said, ‘See you again next time.’
He replied, just below his breath but loud enough for
He replied, just below his breath but loud enough for
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
me to hear, ‘I don’t want to see you again.’
Somewhere within this company, computer programmers design point-of-purchase terminals to carefully limit the choices and options
Somewhere within this company, computer programmers design point-of-purchase terminals to carefully limit the choices and options
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
of customers around the world.
The accountants are happy. Daily sales reports are clean and accurate. But at the sales counter, face-to-face between customers and staff, bot
The accountants are happy. Daily sales reports are clean and accurate. But at the sales counter, face-to-face between customers and staff, bot
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
parties experience frustration.
The advertising slogan says, ‘Sometimes you’ve just got to break the rules.’ But the restaurant manager would not.
I wrote an article about
The advertising slogan says, ‘Sometimes you’ve just got to break the rules.’ But the restaurant manager would not.
I wrote an article about
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
his encounter in my local newspaper. The following week, a regional manager from the restaurant chain called and invited me to lunch.
The next month I returned to the same ou
The next month I returned to the same ou
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
tlet seeking a Super Broiler Meal, with orange juice. The counter staff smiled brightly and keyed in my order.
‘How did you do that?’, I asked in a state of pleased amazement
‘How did you do that?’, I asked in a state of pleased amazement
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
‘Now it’s easy,’ she replied. ‘Last week they put a new key on the computer to allow simple menu changes.’
Congratulations to this well-known restaurant chain. You are liste
Congratulations to this well-known restaurant chain. You are liste
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
ing!
Key Learning Point
--------------------------------------------------------------------------------
If you are going to bend the rules for your cu
Key Learning Point
--------------------------------------------------------------------------------
If you are going to bend the rules for your cu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
stomers, be ready to do it each and every time they ask. Then make life easier for them, and for you - change the procedure, or change the rules.
Action Steps
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Action Steps
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.
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
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Some rules are essential and must be maintained. Others should be refined or abandoned.
Some rules are essential and must be maintained. Others should be refined or abandoned.
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
Try suspending a different rule each week. Notice what new actions can be taken, new customer value created. Then keep the rules you really need and get rid of those you don't
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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