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Advice You - Read and Conquer!
How often have you heard of a CEO or manager deciding some or other book is the ultimate tool in direction for his or her business? It’s been books like Tom Peters’ In Search of Excellence, we still are thanks Tom. Execution by Bossidy and Charan,
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
all those executioners sure made a difference. Good to Great by Jim Collins and organizational focused books like Patrick Lencioni’s 5 Dysfunctions of a Team seem to find a slew of managers trying to create programs around them.
Usually they have
Usually they have
; 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
o idea of the effort it takes to introduce change in an organization. Even if they do have the smallest notion their expectations are way higher than reality!
So what do you do? You’re a manager you just read the most amazing book and the examples
So what do you do? You’re a manager you just read the most amazing book and the examples
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
were just awesome. You lie back and think how amazing your organization would appear under the framework you so recently read about.
Well the easiest is obviously to give the book to everyone and tell them to get on with it. As an added bonus the
Well the easiest is obviously to give the book to everyone and tell them to get on with it. As an added bonus the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
re are no costs associated with this approach. Potential results to be reaped. Zero. Could even be negative. Your staff may think your have totally lost contact with the real world and never read another thing you pass on or even listen to your tho
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ghts again. Ever.
You could get Millie from accounting to lead everybody in reading a chapter a week over coffee? Maybe not.
Call the author. After all the only reason they wrote the book was to market their services. Now this can be interesting.
You could get Millie from accounting to lead everybody in reading a chapter a week over coffee? Maybe not.
Call the author. After all the only reason they wrote the book was to market their services. Now this can be interesting.
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
Some authors are just that. Authors, not consultants. They may have a few friends in consulting they can refer you to.
Contact a few local consultants and see if they can help. Then you discover that it’s going to cost some money to bring about ch
Contact a few local consultants and see if they can help. Then you discover that it’s going to cost some money to bring about ch
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
ange in your organization and the consultant and his band of brothers and sisters are going to be around for a very long time.
The book only had 280 pages why should I need thirty some odd consultants, pages of deliverables, daily meetings, weekly
The book only had 280 pages why should I need thirty some odd consultants, pages of deliverables, daily meetings, weekly
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
meetings, monthly meetings and even monthly meetings about the monthly meeting. The staff become fazed by all the consultants and their productivity slips. Your customers are starting to leave. The deliverables proclaim you to be outperforming the
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
enchmarks. Some thing just doesn’t feel right?
It isn’t.
There is no simple approach to implementing change in an organization but it doesn’t help that it becomes driven by outsiders. You can develop a change program from inside. Yes, you’ll prob
It isn’t.
There is no simple approach to implementing change in an organization but it doesn’t help that it becomes driven by outsiders. You can develop a change program from inside. Yes, you’ll prob
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
bly need a consultant or facilitator who has done this type of thing before.
So here’s where to start.
Have a town hall meeting – get everyone together. You may need several meetings depending on how large your organization is. Talk about the bus
So here’s where to start.
Have a town hall meeting – get everyone together. You may need several meetings depending on how large your organization is. Talk about the bus
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
iness and ask the staff for their ideas. If you want them to read the book let them know it’s the one that got you thinking! Be honest.
Have smaller meetings and gather a few more ideas for improvement. Nothing more. Post the ideas for all to read
Have smaller meetings and gather a few more ideas for improvement. Nothing more. Post the ideas for all to read
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
and comment.
Then break the business into ‘teams’ these could be along functional lines or across functional. Both can work.
Next run a focused session to build a plan for the future. It’s like a strategy session but the whole business is doing
Then break the business into ‘teams’ these could be along functional lines or across functional. Both can work.
Next run a focused session to build a plan for the future. It’s like a strategy session but the whole business is doing
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
t. Now they have all read the earlier notices and thought about the problems they also know what the general goals of the organization are as best they can. They know whats going on in your organization.
My suggestion is develop a series of questi
My suggestion is develop a series of questi
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
ons based on the previous years business:
What worked?
What didn’t?
What can we learn from that?
If we changed one thing what would it be?
What values do we strive to live by?
What functional activities are carried out by
What worked?
What didn’t?
What can we learn from that?
If we changed one thing what would it be?
What values do we strive to live by?
What functional activities are carried out by
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
his team?
Is one more important to our success than any other for next year?
Split into small activity or role groups
List typical goals for each activity – (SMART goals)
Back in one group
Select only your top ten goals, ch
Is one more important to our success than any other for next year?
Split into small activity or role groups
List typical goals for each activity – (SMART goals)
Back in one group
Select only your top ten goals, ch
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
ose a Champion for each
Develop a plan to achieve each one – manage this for the year on a weekly, and monthly basis
If you can get your business broken down into teams and working their own goals to reach organizational objectives. Some resu
Develop a plan to achieve each one – manage this for the year on a weekly, and monthly basis
If you can get your business broken down into teams and working their own goals to reach organizational objectives. Some resu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lts will surprise you how quickly they can happen! Others will take a while, like a year for the result to be recognized. You will be writing your own book.
“If you could get all the people in an organization rowing in the same direction, you coul
“If you could get all the people in an organization rowing in the same direction, you coul
.
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
dominate any industry, in any market, against any competition, at any time.”
This approach is essentially the approach Jack Welch and his MIT guys developed and called “Work-Out” It took GE to a value of over $500B. It works and it can work for y
This approach is essentially the approach Jack Welch and his MIT guys developed and called “Work-Out” It took GE to a value of over $500B. It works and it can work for y
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
u without the expense of the MIT guys!
While this can be done in house it would probably be best facilitated by a professional.
You can transform an organization but it's the realm of experienced people who implement it.
Make your next year rock
While this can be done in house it would probably be best facilitated by a professional.
You can transform an organization but it's the realm of experienced people who implement it.
Make your next year rock
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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