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Advice You - I Always Play by the Rules and It Stinks!
This week I coached a wonderfully lovely woman I’ll call Jill. She’s a bright woman, very compassionate and sweet. She’s at one of the corporations where I am an outside consultant/coach. This was our
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
first meeting but within seconds I could tell she had a lot on her mind.. and her plate.
She basically has to work 12 hour days 6 days a week to be able to keep up with her job. She’s highly in dema
She basically has to work 12 hour days 6 days a week to be able to keep up with her job. She’s highly in dema
; 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 and is spread a LOT too thin. She’s in management and so her opinion counts, but she often does the work of three people because she doesn’t want to appear to be a complainer, so she doesn’t say an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ything.
She’s got a few bosses over her who are very appreciative of the work she puts forth. And then there are a few who continue to heap more work on her already back breaking load.
Today in coac
She’s got a few bosses over her who are very appreciative of the work she puts forth. And then there are a few who continue to heap more work on her already back breaking load.
Today in coac
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing she told me that she envy’s others who have been able to be aggressive to lesson their work load. But she explained to me, that she was the TYPE WHO ALWAYS FOLLOWED RULES.
Ooops! Red flag for sur
Ooops! Red flag for sur
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e!!
For more information: mary@marygardner.com WEB: www.marygardner.com
• (What if it’s 5:00 in the morning and you’re sitting at a red light that isn’t changing.. do you run the red light or sit
For more information: mary@marygardner.com WEB: www.marygardner.com
• (What if it’s 5:00 in the morning and you’re sitting at a red light that isn’t changing.. do you run the red light or sit
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
and wait until it changes?
• How about, what if you are on the high way and there are no cars in sight and the speed limit says 65, do you go 75?
• Or what if there is a late fee of $25 if you writ
• How about, what if you are on the high way and there are no cars in sight and the speed limit says 65, do you go 75?
• Or what if there is a late fee of $25 if you writ
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
e a check to the county by a certain date and you back date a check to look like the mail’s fault? You do it because you are trying to be fiscally responsible…
• What if an employee has to take extra
• What if an employee has to take extra
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sick days from work because they’ve got sick children?
• What if you or your child has terrible mosquito bites and can’t stop itching and the drug store is closing. Would you ask them to stay open a
• What if you or your child has terrible mosquito bites and can’t stop itching and the drug store is closing. Would you ask them to stay open a
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
few minutes late for you? )
Come on! Everyone breaks rules every once in a while!! Rules are made to keep people monitored and in line but are broken all the time with good cause.
Anyway, she contin
Come on! Everyone breaks rules every once in a while!! Rules are made to keep people monitored and in line but are broken all the time with good cause.
Anyway, she contin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ued to share with me her frustration over no one noticing her crazy schedule and her continued quiet suffering.
So I asked her: “Jill, when did you learn this lesson that you always had to follow the
So I asked her: “Jill, when did you learn this lesson that you always had to follow the
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
rules? “ She replied that her dad was in the military and that she learned that you never talk back to superiors, and whether you have a great opinion or not, you keep it to yourself if it differs fr
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
m authority.
Hmmmm. “And Jill, how old were you when you learned this lesson from your dad?” Jill told me that she was about 3-5 years old, and grew up that way.
So I replied: “so you are living wit
Hmmmm. “And Jill, how old were you when you learned this lesson from your dad?” Jill told me that she was about 3-5 years old, and grew up that way.
So I replied: “so you are living wit
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
h the decision of a THREE year old. You made this decision at age THREE or age FIVE and you are STILL living with it!” “ Do you want to continue living as a THREE year old in business.. or do you want
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
to learn some NEW skills that are a bit more up to date?”
I could see her take a gulp at the realization that she is running around acting like a child when she is in her mid 40’s. She IMMEDIATELY s
I could see her take a gulp at the realization that she is running around acting like a child when she is in her mid 40’s. She IMMEDIATELY s
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
aid that she wanted to learn some new rules to live by.. and gain some new business tools.
As a matter of fact, I think I saw her pound her fist on the table when she said it! Now THAT Is a woman who
As a matter of fact, I think I saw her pound her fist on the table when she said it! Now THAT Is a woman who
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
is ready to claim her power!
I was thrilled. It made my day. What the heck, it made my week! I felt alive and so rewarded that I could make a positive impact in the way this woman conducts her life.
I was thrilled. It made my day. What the heck, it made my week! I felt alive and so rewarded that I could make a positive impact in the way this woman conducts her life.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
So ask yourself, what is holding YOU back? Do you keep repeating something over and over that isn’t helping you anymore or it’s actually prohibiting you from getting ahead? Have you asked yourself WH
.
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
Y?
A great exercise is to sit down with pen and paper and answer the question of why. If you have a reason that stems from childhood, whether it was your parents or what you were taught, then it’s ti
A great exercise is to sit down with pen and paper and answer the question of why. If you have a reason that stems from childhood, whether it was your parents or what you were taught, then it’s ti
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
me to get some new teachers and time to learn new skills.
It’s a great revelation when we see how we gain our limiting beliefs. But its even a better feeling to know that they’ll soon be past history
It’s a great revelation when we see how we gain our limiting beliefs. But its even a better feeling to know that they’ll soon be past history
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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