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Your Space - A Tribute to Edna
To the world you might be one person, but to one person you might be the world. – Unknown
This week I had a coaching session that caused
This week I had a coaching session that caused
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
me stop, sit back and reflect on why we're really here.
My client, M, and I have been working together with a focus on building her bus
My client, M, and I have been working together with a focus on building her bus
; 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
ness, however, for this particular session, M advised she had learned of a dear friend's death earlier that morning, and wanted to honor
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
er by reflecting on the powerful impact she made on her life.
M had married young and moved far away from her family. Still a teenager,
M had married young and moved far away from her family. Still a teenager,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
she and her husband settled in a small community in a beautiful mountain region.
Because she was so young and had little in common with
Because she was so young and had little in common 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
embers of the community, she felt as an outsider.
One day, she visited her local post office where she met the Post Mistress, Edna. Edn
One day, she visited her local post office where she met the Post Mistress, Edna. Edn
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
immediately made M feel welcome and opened her home and heart to her.
Through the many years that followed, Edna supported M through th
Through the many years that followed, Edna supported M through th
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
births of her children, the heartbreaks that life inevitably brings, the trials and tribulations of raising a family, and the joys and c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
lebrations that follow each victory.
Edna was there when M lost her parents and M was there when Edna lost her husband and several of he
Edna was there when M lost her parents and M was there when Edna lost her husband and several of he
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
children. Edna would listen and support M without judgment. She showed love and acceptance to M and everyone else she encountered.
As
As
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
M and I spoke about Edna, we reminded ourselves that in the end, it never matters how much wealth or material possessions you accumulate,
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
how successful your business is or how many notches you have under your belt.
What matters is that you made this world a better place,
What matters is that you made this world a better place,
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
ust by being a part of it.
M is a wonderful, caring and generous woman who recognizes the greatness in everyone, and extends support and
M is a wonderful, caring and generous woman who recognizes the greatness in everyone, and extends support and
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
strength to others instinctively.
I believe that M is someone else's Edna, although she may not be aware of it right now and may never k
I believe that M is someone else's Edna, although she may not be aware of it right now and may never k
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
ow who she has touched the way Edna has touched her.
If I can have an impact on someone's life the way Edna had on M's, I will have achi
If I can have an impact on someone's life the way Edna had on M's, I will have achi
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
ved my purpose.
I hope some day I too will be given wings as Edna has so I may move on to the next level of my being.
Take some time to
I hope some day I too will be given wings as Edna has so I may move on to the next level of my being.
Take some time to
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
ay to think about how you are impacting others' lives.
Do you encourage, support and accept others as they are?
What can you do today t
Do you encourage, support and accept others as they are?
What can you do today t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
make someone feel as though they are accepted and not judged?
Acknowledge the greatness in others and encourage them to be proud of who
Acknowledge the greatness in others and encourage them to be proud of who
.
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
they are. Listen to their ideas and praise them for the things they do well.
All we can do is help each other to be the best we can be.
All we can do is help each other to be the best we can be.
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
Love each other no matter what and support each other when the times get tough.
Edna has passed the torch. Hold it tight and carry on
Edna has passed the torch. Hold it tight and carry on
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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