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E-Folder - Change Happens - Anticipate It - Embrace It
Like everyone else, I have received countless emails with long lists extolling nostalgic virtues from
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
“the good old days.” Usually those lists remind us of youthful innocence and end with the belief th
; 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
t the world would be a better place if we could only return to that age of “pre-digital” naivety. Bu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
face it; change is going to happen no matter what. Each change modifies our personal and business l
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ves for better or worse.
My observation is that those (especially in a business environment) who res
My observation is that those (especially in a business environment) who res
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
st our constantly changing environment often suffer; those who embrace it and work to judicially affe
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
t positive change are able to bring new, better products and services to their customers, manage thei
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
businesses more efficiently, fend off competition, and lead their businesses to greater stability as
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
they move into the future.
Unless we are adept at reading tea leaves or deciphering the vision in a
Unless we are adept at reading tea leaves or deciphering the vision in a
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
rystal ball, seeing the future is best done by being aware of the key factors that affect your busine
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s and then developing plans to become proactive if or when those key factors become modified in some
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
ay. If traffic patterns are important to you then seek to be aware of planned road construction and
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
evelop “what-if” strategies well in advance of changes in traffic patterns. If changing fashion or d
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
sign is crucial then read everything you can get your hands on about how fashion or design will affec
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
your industry and consider what happened to most purveyors of millinery and buggy whips. If our agi
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
g “baby boomer” population is a demographic that you work with, learn more about the changing tastes,
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
needs, and lifestyles of this key portion of your business and plan on changing the products and serv
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ces you offer to make your business more attractive to them as they age.
The future belongs to those
The future belongs to those
.
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
who are in position to take advantage of the changes it will bring so position yourself, your busines
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
, and your staff to embrace it rather than resist it and end up with a large inventory of buggy whips
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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