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Advice You - The Motivating Power of Purpose
Patrick Atkins is Senior Manager for Agency Training of a major insu
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
rance company. When people asked what he did for a living, he used t
; 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
o reply, ‘I sell life insurance’.
In his second year of selling, a
In his second year of selling, a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ustomer died in an accident and he went to visit the widow. She was
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
distraught, of course, but she spoke to Patrick after the funeral.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
‘I always resented the money my husband spent on insurance,’ she sai
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
. ‘I thought it was wasted money that we could have used for somethi
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
ng else. But now your insurance payment is going to allow my childre
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n to stay in school and give us enough money to keep living in this
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
ouse. You’ve saved our family.’
Today, when people ask Patrick Atki
Today, when people ask Patrick Atki
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ns what he does for a living, he says with sincerity and pride, ‘I s
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
ave families’.
Patrick Atkins saves families for a living. What abo
Patrick Atkins saves families for a living. What abo
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
t you? What do you do that helps people enjoy, grow and live a bette
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
r life? What’s the motivating power in your purpose?
Key Learning P
Key Learning P
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
oint
Providing great service to others can be hard work. Your custo
Providing great service to others can be hard work. Your custo
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
ers may be upset, demanding, problematic - even mean. You need an up
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
lifting purpose to keep you going, bring you up when times are hard
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
and inspire you to keep on serving.
Action Steps
Clarify what you
Action Steps
Clarify what you
.
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
o and how it helps other people live a better life. Then, the next 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
ime someone asks what you do for a living, give them the real answer
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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