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Cases - Uncertainty - The Doorway To Possibilities
“The only thing that makes life possible is permanent, intolerable uncertainty; not knowing what comes next.” – Ursula K. LeGuin
“
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
Uncertainty and mystery are energies of life. Don't let them scare you unduly, for they keep boredom at bay and spark creativity.”-
; 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
R.I. Fitzhenry
About 8 years ago my life underwent a major transition both personally and professionally. Everything in my life
About 8 years ago my life underwent a major transition both personally and professionally. Everything in my life
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
seemed to be in flux. I felt at a crossroads filled with excitement and huge fear. Where was I going? What might happen next? A
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t times, I felt overwhelmed with so many questions and so much uncertainty.
One day, while at a low point, I flipped on the TV and
One day, while at a low point, I flipped on the TV and
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
caught one of the Public Broadcasting Station fundraising drives. Deepak Chopra was the featured presenter. He was introducing hi
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
s view about uncertainty. To illustrate his point, he recalled a story that involved his son during the Christmas holidays. When
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
asked what he wished for in the New Year, his son replied, “I wish for another year of uncertainty.” I felt my stomach churn when
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
I heard that! Deepak Chopra continued to speak. The essence of his message was this:
Open your mind to see uncertainty as a stat
Open your mind to see uncertainty as a stat
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
e of possibility. Limitless possibilities. So often we view uncertainty with dread and anticipation of something negative happenin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
to us. Imagine seeing the potential of limitless possibilities that might result in wonderful things happening. In other words,
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
expect the best instead of expect the worst. What if you held the thought, “I wonder what new (and exciting) experiences might be
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
coming my way?” and pondered upon the possibilities instead of fearing the unknown. What if you approached life as learning experi
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
ences rather than problems or obstacles to overcome?
If everything always stayed the same, day in and day out, what would your lif
If everything always stayed the same, day in and day out, what would your lif
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 be like personally and professionally?
Would you be growing as a person?
Imagine stepping into new experiences with an explorer
Would you be growing as a person?
Imagine stepping into new experiences with an explorer
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
’s sense of adventure and curiosity! When you open your mind and your heart to possibilities, amazing things can happen!
Your cal
Your cal
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
to action:
1. Adopt a new attitude about uncertainty. Create opportunities to approach uncertainty with an open mind and heart.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Be the explorer every day! Unleash your adventurous nature!
2. Watch what happens when you are open to possibilities. You migh
2. Watch what happens when you are open to possibilities. You migh
.
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
t find people and opportunities coming to you that you might have missed when you approached uncertainty as a negative.
3. Notice
3. Notice
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
your reaction to this exercise. Learn more about yourself. Tip: Journaling is a great tool to capture your thoughts and feelings
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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