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Digg It - Next Steps to Success
What happens when progress slows right down - and nothing happens between you and your team?
There is a stifling stench of
There is a stifling stench of
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
paralysis.
It's time to ensure you have next steps in place.
'Next Steps to Success' is a simple tactic to ensure that pro
It's time to ensure you have next steps in place.
'Next Steps to Success' is a simple tactic to ensure that pro
; 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
ress on a topic is made clearly, quickly and precisely.
Ken Blanchard has a great little (and as always, easy to read) book
Ken Blanchard has a great little (and as always, easy to read) book
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
called 'The One Minute Manager meets the Monkey'. This is all about the 'monkey'.
By ensuring that there is always a 'next
By ensuring that there is always a 'next
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tep' in any discussion, issue or problem, which is clearly defined, owned by someone and timescaled, you will be much more l
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
kely to have progression.
So what is this 'next step' and how does a monkey fit into all this?
Well, the 'next step' is so
So what is this 'next step' and how does a monkey fit into all this?
Well, the 'next step' is so
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
e actual piece of activity that someone (and it is best if it isn't you! I'll come on to that later), takes accountability f
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
or delivering, demonstrably and in a certain timescale.
If you've come across SMART objectives, it's along those lines and
If you've come across SMART objectives, it's along those lines and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ery tactical. It happens and happens fast - usually.
This 'next step' in a process, means that things keep moving and someo
This 'next step' in a process, means that things keep moving and someo
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 is signed up to the progress by doing the next link towards the final outcome. Think of it as a monkey jumping from each p
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rson's shoulder to the next. The 'doer' takes the monkey with them - and you ensure that it isn't usually you!
By keeping t
By keeping 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
is as the goal, step by relevant next step, the overall outcome is achieved.
Who is the 'doer'? Well, that depends on who i
Who is the 'doer'? Well, that depends on who i
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
best placed to do the doing! In developmental management and team cultures, as many individuals as possible get involved in
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
taking the 'next step' (carrying off the monkey!).
Whilst it is easy for a manager to take the brunt of these, it is very u
Whilst it is easy for a manager to take the brunt of these, it is very u
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
seful to help others take these 'next steps, even if they are not experts in that area of their work.
Using 'next steps' as
Using 'next steps' as
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
a developmental exercise can be very valuable for individuals who want to stretch their experience and develop their capabil
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
ties.
Without just 'dropping them in it', by providing ongoing support, whilst giving them the accountability to deliver (a
Without just 'dropping them in it', by providing ongoing support, whilst giving them the accountability to deliver (a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
strong learning in itself), a manager can evolve a highly skilled and broadly experienced team around who will enable contin
.
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
ity when times get tough.
And a succession planning process which evolves without too much effort.
Things get done, people
And a succession planning process which evolves without too much effort.
Things get done, people
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
get developed, the manager delegates effectively, making the best of his or her time.
Now how great a solution is that then
Now how great a solution is that then
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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