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Main Subject - The Red Phone - Management Consulting in 30 Seconds or Less
Modern business faces complex problems; management often calls upon hi
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
ghly-specialized consultants to help them address these difficult prob
; 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
ems. If you're ever called to help identify these most pressing issue
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s, one of the easiest and quickest ways to start is to talk about the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Red Phone".
You know which phone I'm talking about -- it's the red ph
You know which phone I'm talking about -- it's the red ph
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
one that sits on it's own special corner of the desk. Lights flash wh
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
n it rings; when you answer it, the person on the other end isn't in a
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
good mood, he's not pleased, he thinks everything is your problem and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he wants you to fix it! (And ... he's right! It is your problem and
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
you do need to fix it!)
What I want to know is -- when this phone rin
What I want to know is -- when this phone rin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s, 1) Who is it on the other end, and 2) what are they upset about?
T
T
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
is spotlights a manager's hot spots, his points of pain. These are th
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
e frustrating tribulations that vex his day. If you can identify who'
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
on the red phone and what they're calling about, you've identified th
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
e most pressing problems a manager deals with.
Of course, there likel
Of course, there likel
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
isn't a real physical "Red Phone" -- but everyone knows what you mean
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
when you talk about it! Find out about these calls -- and you'll cut
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
through all the clutter to identify the areas you should address. Spe
.
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
nd your time and direct your efforts to solve these problems -- or eve
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
just ease them some -- and you'll have the greatest chance of success
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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