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Subjects - Decisions: How Close Are You To A 100% Strike Rate?
Managers, team leaders and their staff can take as many as a hundred or more decisions in the course of a day, each day and every day. Many of these decisions are, of course, no more than automatic responses to familiar situations in
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
which they have to choose between two or three options. However, from time to time, we all have to take decisions on which the course of our future and that of others depends. Then, it is a question of making sure they are right. Here
; 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
are 6 principles to guide you in right decision-making.
1. Time Them. There are two traps which people fall into when making decisions: making them too soon and making them too late. Some people make decisions too swiftly and
1. Time Them. There are two traps which people fall into when making decisions: making them too soon and making them too late. Some people make decisions too swiftly and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
without due thought. This may be because they are uncomfortable with the tension that is created when a decision has to be made but they don't have all the information needed. Instead of living with tension, they make the decision be
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ore time. Other people delay making decisions because they fear making a mistake or fear the changes that will result. The best decisions are hot-iron decisions: those that are well-timed, which you make when the iron is hot and the t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ime is right.
2. Align Them. The more decisions you make consciously, the more you can align them with your goals and purposes. Studies show that the average person makes 612 decisions a day. Each one takes us closer or furthe
2. Align Them. The more decisions you make consciously, the more you can align them with your goals and purposes. Studies show that the average person makes 612 decisions a day. Each one takes us closer or furthe
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
r from our ultimate goals in life. In a week, that means 4,900 decisions. In a year, 254,800. Results are cumulative. Strategic thinking means looking at how your decisions today affect your tomorrows. When your decisions are in align
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
ent with what’s important to you, then life becomes meaningful, productive and delightful.
3. Balance Them.There are three balancing acts to be aware of in taking a good decision. They are:
• Care and not care. Do all you
3. Balance Them.There are three balancing acts to be aware of in taking a good decision. They are:
• Care and not care. Do all you
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
r worrying before the decision and once a decision has been taken, stop worrying.
• Think and act. Too much thinking puts off the action; too much action may be at the expense of thought. Seek the right balance.
• Look befor
• Think and act. Too much thinking puts off the action; too much action may be at the expense of thought. Seek the right balance.
• Look befor
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 you leap and leap before you look. See the possible risks of your decision but, once decided, take the plunge with courage.
4. Act When You Have To. You should only make decisions when you have to. Here are five "don'ts" to
4. Act When You Have To. You should only make decisions when you have to. Here are five "don'ts" to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
uide you.
• DON'T make a decision unless you have two or more equally valid options.
• DON'T make a decision if it's somebody else's responsibility.
• DON'T make a decision unless there is disagreement.
• DON'T mak
• DON'T make a decision unless you have two or more equally valid options.
• DON'T make a decision if it's somebody else's responsibility.
• DON'T make a decision unless there is disagreement.
• DON'T mak
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
e a decision about irrelevant matters.
• DON'T make a decision if it can't be turned into action. "If there's one thing I've learned in politics, it is: never make a decision until you have to." (Margaret Thatcher)
5. Don’t
• DON'T make a decision if it can't be turned into action. "If there's one thing I've learned in politics, it is: never make a decision until you have to." (Margaret Thatcher)
5. Don’t
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
Decide Without Acting. Eric Aronson tells this riddle: If 5 birds are sitting on a wire and one of them decides to fly away, how many are left? The answer is five. One bird’s decision to fly away does not mean it did!
Theodore Ro
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
osevelt said that the worst thing you could do when you have to make a decision is to do nothing. Even if you make a wrong decision, the very making of it and the learning from it are steps forward. As Frederick Langbridge added, “If
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
ou don’t follow through on a decision, someone else will pick it up and use it. When you make a decision, jump in with both feet, don’t just stick your toe in the water. Be daring, be fearless, and don’t be afraid that somebody is goi
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
ng to criticize you or laugh at you. If your ego is not involved, no one can hurt you.”
6. Keep Your Decision Under Review. Decisions are a mix of what we currently want (goals); what we currently know (information); what we b
6. Keep Your Decision Under Review. Decisions are a mix of what we currently want (goals); what we currently know (information); what we b
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
elieve (outcomes); and what we can do (actions). There is no guarantee that any of these will stay the same or that they will come right. No decision is perfect. This is because…
• half-way through the implementation of a decisio
• half-way through the implementation of a decisio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
we may realise we don't want to achieve the goal after all.
• after taking a decision, we may stumble across more information which, had we had it before, would have totally changed our decision.
• since outcomes depend on
• after taking a decision, we may stumble across more information which, had we had it before, would have totally changed our decision.
• since outcomes depend on
.
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
an educated guess about the future, we might guess wrong.
• a successful decision depends as much on motivation and skill in implementation as on getting it right.
Nobody who regularly makes important decisions affecting the liv
• a successful decision depends as much on motivation and skill in implementation as on getting it right.
Nobody who regularly makes important decisions affecting the liv
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
es of others will tell you hand on heart that they get it right every time. Decision-taking is more of an art than a science. But practice, and learning from our results, may at least take us closer down the road to a 100% strike rate
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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