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Business Dump - September 16 is Stepfamily Day!
In the United States, and perhaps in other countries as well, September 16
has been designated as “Stepfamily Day”. A day dedicated to the stepfam
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
ily. A day to honor all the StepHeroes out there who choose every day to be parents to ALL the children in their lives.
What will you do
What will you do
; 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 honor your family on this special day? Some communities have
picnic celebrations planned. Some blended families choose to spend the day
togeth
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
r, as a family, without any electronic devices on for the whole day.
Other stepfamilies go to a favorite place with friends and play together. And
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the vast majority let the day go by as any other day and miss the chance to
honor themselves for all the effort and hard work it takes to make
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
blended
family work. Why? Because they do not even know this day exists for them. They
are not aware of all the resources out there for them. T
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
ey believe that they
are the only ones who are experiencing what it is like to be in a blended family
and they feel all alone.
This
This
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
could be a great opportunity to reach out to other step and blended
families in your community. What would it be like to arrange a spontaneous
p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t-luck, where you invite two other families you know who are also blended, and
ask each of them to invite two blended families that they know. Hav
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
some
activities planned for the different age groups of children, and plan to meet at
a location that can accommodate you all (one of your home
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
; a nearby park or
playground; a community center; …). This doesn’t have to be fancy and you do
have to spend a ton of money. In fact, you can h
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 each family bring one of
their favorite games to play, and see what you discover – how many are the same?
How many are different? Which ones
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
have never been played? Which ones are the
ones everybody knows and has? … Spend the day connecting and being with others
who are blending too.
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
br>
Step and Blended Families that choose to make this kind of effort are always amazed at the rewards that happen unexpectedly. Oftentimes
Step and Blended Families that choose to make this kind of effort are always amazed at the rewards that happen unexpectedly. Oftentimes
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
, they enjoy the
experience so much that they decide to make it a monthly event, with a different
theme each month.
Are you finding
Are you finding
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
ourself excited and elated by this idea? Or are your first
thoughts those of resistance or dread? Notice how your mind is responding to
this ide
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
. Is it coming up with all kinds of reasons why you could not or would
not or should not do this? While all those reasons may appear to be valid,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
chances are they are not necessarily true. Our minds have a way of keeping us
from trying or doing anything that is different or out of the ordi
.
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
ary. This is
a natural, healthy defense mechanism designed to keep us safe. The problem is
that what we perceive as safe is often just what is f
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
miliar. The unfamiliar is
then deemed to be unsafe, when the reality is that it can be very safe, fun,
fulfilling, and full of new possibilities
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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