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Digg It - Experience Isn't Necessarily What It's Cracked Up to Be!
Isn’t it always interesting to hear somebody say “yeah, we tried that, didn’t work…”
When it was tried; what were the conditions surr
When it was tried; what were the conditions surr
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
ounding the business? How was it implemented? How were staff trained? Most questions are never answered with any clarity and real unde
; 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
rstanding. No real analysis of the changes failure or success was ever done. Meaning that an opportunity to learn was lost.
We all le
We all le
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
arn by our experiences, from walking to riding bicycles, trial and error and a few bruises and scrapes. We take actions and observe th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
results. What would we think if we made a decision and never saw the consequence of it? This could be the case if the results are far
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
out into the future or in a distant part of a larger system.
Kinda like sending an e-mail or fax and never really knowing if it got
Kinda like sending an e-mail or fax and never really knowing if it got
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
to the intended recipient! Yeah, that does happen. Fire and forget!
This in a larger extent is the problem facing businesses and orga
This in a larger extent is the problem facing businesses and orga
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
izations. We learn best from experience but often we don’t directly experience the consequences of our most important decisions.
Prom
Prom
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
oting staff, introducing new computer systems and hardware, new facilities, etc are typical of decisions that don’t leave much chance
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
for trial and error learning.
Cycles may be longer than job tenure and we all have short memories. We have seen examples of this in s
Cycles may be longer than job tenure and we all have short memories. We have seen examples of this in s
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
udent enrolment at colleges when there is a surplus of a typical field, say lawyers. Enrollment drops and students switch to other fie
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
lds. As the cycle runs its course another shortage develops. It’s much like the “buy high, sell low” philosophy so students should loo
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
k at entering a field when few are entering it to be at the gate when the next shortage is evident. Seems obvious now that I mentioned
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
it doesn’t it?
What tends to happen is that businesses form functional silos to allow managers to get a handle on their decisions an
What tends to happen is that businesses form functional silos to allow managers to get a handle on their decisions an
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
their impact. These silos often end up leading to fiefdoms which stop the free flow of information across the silos. Then process man
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
agement is introduced to allow information to travel across silos, such as ‘order to cash.’ This has not proved to really break the si
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
los but does open information flow. Still leaving room for improvement in understanding decisions and their actions.
So the question
So the question
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s; Are we really learning form our experiences? Very large organizations have developed complex management cockpits and dashboards to
.
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
try and learn from their decisions. So unless you’re working for one of the large companies with budgets nearing the GDP of a small na
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
tion, the results of your decisions may not be what you think they are.
Your ‘experience’ may be leading you and your business astray
Your ‘experience’ may be leading you and your business astray
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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