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Just Other Articles - You're The New Boss - What Now?
You're the boss. What do you do now?
Tim is nervous. He's about to start a new job as the boss of people he doesn't know. He's not coming as a savior. The team is performing up to standard, even though it co
Tim is nervous. He's about to start a new job as the boss of people he doesn't know. He's not coming as a savior. The team is performing up to standard, even though it co
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
uld do better.
Tim has the same question most new bosses have. What should I do?
Start by learning about your people and the situation. This team isn't in trouble. You don't have to take drastic action, so t
Tim has the same question most new bosses have. What should I do?
Start by learning about your people and the situation. This team isn't in trouble. You don't have to take drastic action, so t
; 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
ke the time to get to know them and to let them get to know you. Start by getting everyone together.
Getting to Know Me
You want to meet with the team and with every member individually. Start with the team
Getting to Know Me
You want to meet with the team and with every member individually. Start with the team
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
meeting so everyone hears the same basic information at the same time.
The people on your team want to know about you. They want to know who you are and where you came from and why you wound up as their boss.
The people on your team want to know about you. They want to know who you are and where you came from and why you wound up as their boss.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Most of all they want to know what your coming means for them.
Tell them how you got there. If you tell it as a short story (less than 5 minutes) you'll find it easier for you and comfortable for them.
Tell
Tell them how you got there. If you tell it as a short story (less than 5 minutes) you'll find it easier for you and comfortable for them.
Tell
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
them what you're going to do next. Tell them that you'll be talking to each one of them. They need to know that you'll be gathering information and impressions before you make any changes.
Let them know you
Let them know you
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
expectations.
Sharpe's Speech
Bernard Cornwell is a great historical novelist. One of his series is about Richard Sharpe who starts out as a private in the British Army and rises from the ranks, finally fig
Sharpe's Speech
Bernard Cornwell is a great historical novelist. One of his series is about Richard Sharpe who starts out as a private in the British Army and rises from the ranks, finally fig
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
hting with Wellington at Waterloo. It's a great read if you like military history and historical novels.
The novel Sharpe's Rifles is set just after Sharpe has been promoted from the ranks to Lieutenant. He'
The novel Sharpe's Rifles is set just after Sharpe has been promoted from the ranks to Lieutenant. He'
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
trying to learn what it's like to lead as an officer. He gets a lesson from a Spanish officer and nobleman, Blas Vivar.
Vivar tells Sharpe that he should tell his soldiers what he expects from them. The mes
Vivar tells Sharpe that he should tell his soldiers what he expects from them. The mes
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
sage should be short and clear. Here are Vivar's three rules
"They must not steal unless they will die for not stealing, they must look after their horses before themselves, and they must fight like heroes."
"They must not steal unless they will die for not stealing, they must look after their horses before themselves, and they must fight like heroes."
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Richard Sharpe modified Vivar's rules to suit his own situation, but he kept the number to three and he kept them simple. You need something similar to share. People want to know what's expected of them. On t
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
he first day, Tim might say something like this.
I expect you to do your work as well as you can.
I want you to help the team succeed. Right now one way to do that is to help me understand things.
I expect
I expect you to do your work as well as you can.
I want you to help the team succeed. Right now one way to do that is to help me understand things.
I expect
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
ou to help me and your team members stay out of trouble.
Once you've had your meeting and laid out expectations, it's time to meet with your people one-on-one and ask some questions.
Asking Questions One-on-O
Once you've had your meeting and laid out expectations, it's time to meet with your people one-on-one and ask some questions.
Asking Questions One-on-O
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
ne
The members of your team have been in their positions longer than you've been in your position. They know more about how things work. They're also concerned about how things will go for them in the future
The members of your team have been in their positions longer than you've been in your position. They know more about how things work. They're also concerned about how things will go for them in the future
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
Meet with each person individually so you can get their honest opinion and so you can learn about each other. Pick a time and place where you won't be interrupted.
Ask them questions that will help you under
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
stand what's important and which give each one of your people an opportunity to share what's important to them. Here are some questions to pick from.
What should I know about you? What shouldn't change and w
What should I know about you? What shouldn't change and w
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
y?
What are the three most important things we need to change and why?
What do you hope I will do?
What are you afraid I may do?
Is there anything else that I should know?
Learning About Your People
It he
Learning About Your People
It he
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lps if you have a simple, structured way to learn about your people. Usually you won't do this with direct questions, but with observation. But beware, you're probably going to need to take notes after you me
.
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 with someone or your learning will fly away on the wind.
What's their natural pace? Are they fast or slow? Do they seem more concerned with results or with relationships? What are their hobbies and intere
What's their natural pace? Are they fast or slow? Do they seem more concerned with results or with relationships? What are their hobbies and intere
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
sts?
What is their family situation?
What are their career goals?
If you make your expectations clear, take time to learn about the situation and learn about your people you'll be well on your way to success
If you make your expectations clear, take time to learn about the situation and learn about your people you'll be well on your way to success
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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