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Advice You - The Few & the Many: Free Trade, Outsourcing, & Communication
Have you noticed that some sound ideas get bad publicity? Two I
have in mind are outsourcing and free trade.
No doubt you could name others, but looking at t
No doubt you could name others, but looking at 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
hese two
initiatives helps us understand a communication challenge for
many companies and not-for-profit organizations.
Free trade and outsourcing both pr
Free trade and outsourcing both pr
; 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
oduce a few (well, relatively
few) big losers, and many (very many) small winners.
More specifically, free trade leads to big losses for a relatively small
More specifically, free trade leads to big losses for a relatively small
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
number of companies and their employees.
Companies can go out of business or be forced to drastically
restructure; employees can lose their jobs. The adjus
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tment pains
they suffer are very real and very significant.
On the other hand, all consumers in a country that adopts free trade are winners. In other word
On the other hand, all consumers in a country that adopts free trade are winners. In other word
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s, just about everybody. The
gains for each person are small, yet, taken together those gains
far outweigh the losses suffered by the losers. And the gains
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
keep paying dividends year after year.
The story is much the same for outsourcing. A few employees take a very big hit, losing their jobs. At the same time
The story is much the same for outsourcing. A few employees take a very big hit, losing their jobs. At the same time
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
, though, a
lot of other employees get to keep their jobs because their
companies become stronger. A few suffer for the many.
Which do you hear more about
Which do you hear more about
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
? You hear far more about the losers,
of course. Why? Well, as a former news writer and announcer I can
tell you that losers holler louder and longer. They
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
actively seek
media coverage. And that's not all: stories about layoffs have an
inherent drama that stories about the preservation of jobs just
can't mat
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ch.
In addition, small-scale winners often don't know they've won, how they've won, or what they've won, so they don't march in protest or call news confer
In addition, small-scale winners often don't know they've won, how they've won, or what they've won, so they don't march in protest or call news confer
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
ences. Add to that the general
principle that good news isn't big news.
What do you do if you face a decision leading to many small winners and a few big
What do you do if you face a decision leading to many small winners and a few big
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
osers? First, hammer away at the context,
at the circumstances that drive the decision. For example, don't
announce to employees that a new piece of equipm
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
ent that does the
work of three people will make you more efficient. Rather,
explain the competitive pressures that force greater efficiency,
and the con
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
sequences of failing to meet those pressures.
Don't assume everyone shares your knowledge. Few stakeholders understand the broader picture, and even if they
Don't assume everyone shares your knowledge. Few stakeholders understand the broader picture, and even if they
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
could, the
pressure of day-to-day events may keep them focused on just one
piece of it. It's essential to start with as few assumptions as
possible.
Com
Com
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
municate frequently: in advance, during, and afterward.
Explain the problem, outline the options, list the decision
criteria, announce the solution, and re
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
port on how well the
solution has worked. Or not worked, which becomes the new
problem.
You won't convince everyone your decision is the right one, but
You won't convince everyone your decision is the right one, but
.
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
ou might convince enough people to make further progress
possible.
In summary, when a few people suffer big losses and many others make small gains, you c
In summary, when a few people suffer big losses and many others make small gains, you c
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
an expect the losers to complain very
loudly, and the winners to say little or nothing. To deal with these
situations, communicate frequently and carefully
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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