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Just Other Articles - Who Drives You Up The Wall?
Is there someone where you work who absolutely, totally, and unequivocally drives you up the wall? Do you sometimes feel like climbing the wall all by yourself as the quickest way to escape? If you ar
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
e saying Yes! Yes! Yes! you have had first-hand experience with "The Frustration Factor," up close and personal.
The players of the world are alive and well and ready to drive you up the wall. Some a
The players of the world are alive and well and ready to drive you up the wall. Some 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
e aggressive, some passive; some are extroverts and others introverts. Whatever their personalities, they are mostly motivated by personal needs, status goals, and insecurities. If their private goals
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
are coincidentally compatible with your company's, so be it. If not, their selfish interests prevail.
Rich is an experienced player.
Rich's approach to driving people up the wall is B t B: By the Bo
Rich is an experienced player.
Rich's approach to driving people up the wall is B t B: By the Bo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
k. In a less linguistically correct time, we called this CYA.
His main play is to do things the same way he always does them. What has worked before is likely to work again. He knows people seldom fi
His main play is to do things the same way he always does them. What has worked before is likely to work again. He knows people seldom fi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d fault with his handling things in the usual way, whether it works or not.
Next, Rich always looks at how things can go sour and little at how they can succeed. He asks, "What are the three stronges
Next, Rich always looks at how things can go sour and little at how they can succeed. He asks, "What are the three stronges
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
reasons for not doing this?" His motto is nothing ventured, nothing lost.
Finally, any time he has to do something that has some risk, he spends most of his time figuring out what to say if it goes
Finally, any time he has to do something that has some risk, he spends most of his time figuring out what to say if it goes
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
sour. Of course, the best thing to be able to say is, "I was uneasy about this but went along reluctantly. I handled it the same way we always handle things. I did it By The Book."
Rich's play calls
Rich's play calls
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
or doing things the same way he always does them. He avoids all risk whenever possible and has an explanation for failure made up ahead of time. Sure, there is a more simple version of Rich's play. Do
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
not do anything new or innovative and try hard to keep others from making that mistake. What can you do?
Playing with B t B players like Rich is not a game for the impatient or impulsive. It helps to
Playing with B t B players like Rich is not a game for the impatient or impulsive. It helps to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
understand that these players have little faith in their abilities and less faith in their basic grasp or understanding of situations or circumstances. Since they do not believe they can trust their j
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
dgments or instincts, they do not take any chances on themselves.
Next, they do not have much ability to anticipate or predict the behavior of others. The idea is that they cannot predict if a specif
Next, they do not have much ability to anticipate or predict the behavior of others. The idea is that they cannot predict if a specif
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
c action will lead to praise or punishment. Usually, they think the likely outcome of following their judgments is punishment.
You can use disciplinary and other negative approaches to show that nega
You can use disciplinary and other negative approaches to show that nega
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
ive outcomes can come from playing B t B. But if you do, take pause. If the only response or reaction folks get from you is negative or critical, reasonable people do the reasonable thing. They put mo
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
st energy into avoiding negative reactions. Consider the possibility that the B t B player is a product of your negative behavior.
Suppose you are Rich's manager. His rigidly sticking to the way he h
Suppose you are Rich's manager. His rigidly sticking to the way he h
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 always done things is driving you up the wall. He never uses his personal judgment even when he knows that the old way will not work. You can say, "What do you think? Is there a better way to do thi
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
? He may say Yes in some situations or No in others, depending on what he thinks is safest. Whatever he says, the question is then, "Why would you go that way?" The idea is to walk this B t B player t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rough the decision making process. In most situations, you can close with, "You seem to have some ideas about this. Use your best judgment."
When the player starts taking more chances and making deci
When the player starts taking more chances and making deci
.
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
ions, it is important not to be too negative when things do not work out well. Avoid the temptation to second guess the player. Remember that avoiding negative reactions is why he is playing B t B. Yo
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
r goal is to teach and encourage in positive and supportive ways. The reward for the player has to come primarily through success and increasing judgment and initiative.
Now you know and there you go
Now you know and there you go
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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