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Digg It - Business Owner's Manifesto: Must Do's
A GOOD INVESTMENT – I am the Leader of this business and am responsible to see that the business is treated and evaluated on
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 same basis as any business investment I might make, both in terms of time and money invested. I may have paid managers a
; 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
nd staff to perform some or even all of the day-to-day tasks, but ensuring an adequate return on investment (blood, sweat and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
money) is my responsibility and my responsibility alone.
ACHIEVING SECURITY/ROI – I recognize that there are two components
ACHIEVING SECURITY/ROI – I recognize that there are two components
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
of an adequate return: First, time invested must be compensated through salary, benefits and perks; AND, money invested must
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
be guaranteed a fair rate of return plus a premium for the level of risk assumed (by operating a small business – usually 3-5
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
% over prime). Adequate returns do not just happen; they are achieved through planning and action. This commitment involves
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
setting realistic, quantifiable goals; taking the steps necessary to see to it that those goals are achieved; that results a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e measured and meet expectations; that we celebrate our victories; and, that we adapt, as needed, along the way.
IT'S A BUSI
IT'S A BUSI
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
NESS – I am responsible to ensure that the business I have invested in has a real business and community purpose. This means
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
: I must be realistic about not throwing good money after bad; about separating real business activity from my own ego gratif
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
ication; and about assuring at least a baseline of security for myself and those who depend on this business by taking pruden
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
risks.
I am responsible to the people who work in my business. This involves: establishing organizational goals; providing
I am responsible to the people who work in my business. This involves: establishing organizational goals; providing
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
direction about their responsibilities in meeting these goals; setting standards of performance; and providing job performanc
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 feedback. This organized approach frees employees to perform effectively because it assures them that their positions are
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
not held capriciously at my whim and that their paychecks are not constantly in jeopardy. This approach also facilitates 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
tifying organizational successes and potential roadblocks. In a world of rapid change, just a little perceived security goes
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
a long way.
Finally, I am responsible to myself, my family and my other stakeholders to engage in an active program of succ
Finally, I am responsible to myself, my family and my other stakeholders to engage in an active program of succ
.
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
ession planning. Timely, thorough succession planning can facilitate a smooth transition when the day comes that I determine
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
that: the business is no longer viable; I have personally had enough of it; or, it has just become time for me to step aside
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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