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Advice You - Business Process Management;Company Policy
I would acknowledge the author of this tale I am about to tell about company policy if only I know who wrote it. It is one of those stories that you see handed out at training courses or published on the internet without a hint
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
of who the author was.
The story begins....
"Start with a cage containing five monkeys. Inside the cage, hang a banana on a string and place a set of stairs under it.
Before long, a monkey will go to the stairs and start to
The story begins....
"Start with a cage containing five monkeys. Inside the cage, hang a banana on a string and place a set of stairs under it.
Before long, a monkey will go to the stairs and start 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
climb towards the banana.
As soon as he touches the stairs, spray all of the monkeys with cold water.
After a while, another monkey makes an attempt with the same result; all the monkeys are sprayed with cold water.
Pretty s
As soon as he touches the stairs, spray all of the monkeys with cold water.
After a while, another monkey makes an attempt with the same result; all the monkeys are sprayed with cold water.
Pretty s
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
oon, when another monkey tries to climb the stairs, the other monkeys will try to prevent it.
Now, turn off the cold water. Remove one monkey from the cage and replace it with a new one. The new monkey sees the banana and want
Now, turn off the cold water. Remove one monkey from the cage and replace it with a new one. The new monkey sees the banana and want
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
to climb the stairs.
To his surprise and horror, all of the other monkeys attack him.
After another attempt and attack, he knows that if he tries to climb the stairs, he will be assaulted.
Next, remove another of the origin
To his surprise and horror, all of the other monkeys attack him.
After another attempt and attack, he knows that if he tries to climb the stairs, he will be assaulted.
Next, remove another of the origin
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
l five monkeys and replace it with a new one. The newcomer goes to the stairs and is attacked. The previous newcomer takes part in the punishment with enthusiasm.
Again, replace a third original monkey with a new one. The new
Again, replace a third original monkey with a new one. The new
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
one makes it to the stairs and is attacked as well.
Two of the four monkeys that beat him have no idea why they were not permitted to climb the stairs, or why they are participating in the beating of the newest monkey.
After
Two of the four monkeys that beat him have no idea why they were not permitted to climb the stairs, or why they are participating in the beating of the newest monkey.
After
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
eplacing the fourth and fifth original monkeys, all the monkeys that have been sprayed with cold water have been replaced. Nevertheless, no monkey ever again approaches the stairs.
Why not?
Because as far as they know that's
Why not?
Because as far as they know that's
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the way it's always been around here.
And that's how company policy begins ..."
It is a good tale. It is funny and it brings out the point but is too ludicrous to be true in real life?
A company that I worked for in South Am
And that's how company policy begins ..."
It is a good tale. It is funny and it brings out the point but is too ludicrous to be true in real life?
A company that I worked for in South Am
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
rica operated in a business environment that included hyperinflation. Prices would rise in the local currency by more than 60% per month. Minibar prices at the hotel I often stayed at increased everyday.
The product the compan
The product the compan
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
sold was fully imported and paid for in US dollars. Customers who ordered product on credit only had to miss paying their invoice by a few days after the due date to get a hefty discount on the quoted price in money of the day
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
terms.
To stop the company from bleeding money a policy was put in place that all orders were to be vetted and payment organised before the product would be loaded and delivered. The process usually took a few hours but could
To stop the company from bleeding money a policy was put in place that all orders were to be vetted and payment organised before the product would be loaded and delivered. The process usually took a few hours but could
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
take a day or two in exceptional circumstances.
The organisations that bought products from this company were large organisations themselves. Therefore the production department that needed the product did not always know what
The organisations that bought products from this company were large organisations themselves. Therefore the production department that needed the product did not always know what
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
the accounts payable department had organised.
As you can imagine there were occasional delays in delivering the product, which the production department of the customer did not appreciate. This caused great angst on occasion
As you can imagine there were occasional delays in delivering the product, which the production department of the customer did not appreciate. This caused great angst on occasion
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
and threatened to upset long term relationships with valuable customers.
So, another policy was enacted whereby the despatch department of the supply company called their "gold" customers telling them about the progress of th
So, another policy was enacted whereby the despatch department of the supply company called their "gold" customers telling them about the progress of th
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
ir order, keeping them updated every half hour or so.
When I saw this company some six years after the policies were enacted, inflation was running at eight percent per annum and falling. Price timing was no longer an issue. H
When I saw this company some six years after the policies were enacted, inflation was running at eight percent per annum and falling. Price timing was no longer an issue. H
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
owever, there now was a department of fifty people taking care of their "gold" customers.
When I asked how many customers actually caused a problem with payment timing now inflation was under control and what impact it had on
When I asked how many customers actually caused a problem with payment timing now inflation was under control and what impact it had on
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
he business, the answer was "none and none".
"So why are the checks being made that delays customers orders that causes a department of fifty people to exist?" was a natural follow up question. The answer to which was, "It's c
"So why are the checks being made that delays customers orders that causes a department of fifty people to exist?" was a natural follow up question. The answer to which was, "It's c
.
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
ompany policy".
I believe that all organisations I have worked for and with have had a tranche of policies which are out of date, do not fit the environment in which the organisation now finds itself and cause significant leve
I believe that all organisations I have worked for and with have had a tranche of policies which are out of date, do not fit the environment in which the organisation now finds itself and cause significant leve
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
s of inefficiency and ineffectiveness.
The solution to this often unseen problem is to review all policies and processes which are three or more years older, for their purpose. Otherwise we all risk making monkeys of ourselves
The solution to this often unseen problem is to review all policies and processes which are three or more years older, for their purpose. Otherwise we all risk making monkeys of ourselves
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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