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Advice Pool - Don't Be Stuck for an Answer
Like most businesspeople, I attend a number of trade shows, expos, seminars, open houses, service club and C
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
hamber of Commerce events every year. These events are an opportunity to learn, to socialize, and to meet n
; 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
ew people while balancing a plate of cheese cubes, carrot sticks, and meatballs. While I have become coordi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nated enough to shake hands without having my snacks slide off my plate, I have yet to overcome my amazement
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
of the lame introductory comments of most people I meet. Most of them sound as if they (and the services o
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r products they sell) are commodities and therefore no reason why a prospect should select one over another.
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
This is what I hear: “I’m an accountant.” “I’m a real estate agent.” “I’m a mortgage broker.” “I’m a h
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
airdresser.” “I’m a banker.” “I’m a manufacturer.” “I’m a financial planner.” “I’m a web designer.” Tho
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
se dull, generic, answers tell me what their job titles are, not what they do, not what problems they solve,
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
not why anyone should seek them out, not the differentiators that separates them from their competitors.
C
C
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
learly every person I meet is unique. Each has reasons for working at the professions they have selected.
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
They have passions, levels of expertise, specialties, and reasons for being at the event we have both attend
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
ed, but they rarely, if ever, communicate their uniqueness.
If part of the reason one attends those outside
If part of the reason one attends those outside
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
functions is to meet people who might be new prospective customers, these people should consider developing
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
a very short answer to the opening question, “what do you do for a living?” That answer should be designed
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
to immediately engage the questioner in further, deeper conversation.
Imagine this response to the questio
Imagine this response to the questio
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
n: “What do you do for a living?” “I’m a real estate agent.” “Oh.” Compare it to this: “I help people s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ell their homes for a higher sales price and in less time.” “How do you do that?”
When the “How do you do
When the “How do you do
.
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
that?” question comes out, you can elaborate on your uniqueness qualities. Next time you meet someone new,
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
don’t be stuck for an answer and mumble generically, have your “engaging” answer ready so you can elaborate.
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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