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Advice You - The Power of Questions
I began as the founder and CEO of EMJ, a computer distributing company that grew from zero to
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
over $350,000,000 in sales. I sold EMJ to SYNNEX, and became the CEO of SYNNEX Canada, a co
; 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
pany that does over $1 billion in sales. One thing I have learned through these years of exp
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
rience is the power of questions.
One of my passions is the study and practice of time manag
One of my passions is the study and practice of time manag
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ment.
After 25 years of running EMJ, I had developed systems and methodologies to deal with
After 25 years of running EMJ, I had developed systems and methodologies to deal with
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y time and my schedule. When I started working at SYNNEX, those systems that had served me w
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
ll for so many years, no longer worked. All of a sudden I had too many emails; I had too man
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
meetings; I had too many people asking for a piece of my time. I wasn’t being efficient and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
needed a change.
The question that I asked myself was “How can I change my systems to allow
The question that I asked myself was “How can I change my systems to allow
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
me to handle the increased volume?”
For a company to continue to thrive, we need to ask ours
For a company to continue to thrive, we need to ask ours
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
lves these “how” questions and never accept the status quo. We need to look at every process
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
to figure out if there is a better way of doing it. There is tremendous power in the questio
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
s that we ask.
I find too often, people ask the “why” or worse yet, the “why not” question.
I find too often, people ask the “why” or worse yet, the “why not” question.
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
Either way they get an answer. Why they cannot lose weight, why they cannot get ahead etc.
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
Substitute “how” and the answers become powerful.
If I were to ask the question, “How can we
If I were to ask the question, “How can we
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
ship 5 percent more?”, usually the answer is that we keep doing the job the same way that we
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
ave always been doing it except we need to work a bit harder. If we ask big questions like, “
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ow can we sell 50 percent more?”, our mind automatically figures that we need to do something
.
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
differently than what we have been doing and come up with more creative solutions.
The power
The power
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
ul questions to ask are “How” and make the “How” big enough that there has to be a big change
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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