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Digg It - Project Management: How to Eat an Elephant
1. Size up the entire job. Make sure you have a good grasp of the scope of the total project. Just how big and c
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
omplex is that job? Walk around it. Take a look from many different perspectives. Make sure you have a clear idea of the whole before
; 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
attacking the parts.
2. Sift through the mess. Sort out and throw away everything that isn’t elephant. There wi
2. Sift through the mess. Sort out and throw away everything that isn’t elephant. There wi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ll be plenty of elephant parts for you to digest – don’t take on any more than is absolutely necessary.
3. Imagine eating
3. Imagine eating
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
he last bite. Before you begin, visualize yourself eating that very last bite of elephant. Keep that image in your mind as you
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
get started, and stay focused on getting the job done, no matter what.
4. Design a strategy. How long a time do
4. Design a strategy. How long a time do
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
you have to complete this project? What are the steps you need to take? What’s the best order to eat all the parts? My computer – guru
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
nephew coined a term to describe breaking down huge data files into workable bunches – chunkify. An excellent
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
description – chunkify that elephant!
5. Gather the tools you will need. Make sure you have all the necessary eq
5. Gather the tools you will need. Make sure you have all the necessary eq
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
ipment before you start. What do you need to get the job done? Chainsaws? Meat cleavers? Sharp knife and fork? Tums for your tummy?
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
6. Get some help. Don’t try to do it all yourself – you need a team. Make the job look attractive, whatever it 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
akes – mustard, pickle relish, barbecue sauce – and you’ll have people clamoring for a chance to help you. Hey, that technique worked fo
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
Tom Sawyer, didn’t it?
7. Decide what to eat first. Decide which is the worst part (use your imagination here!)
7. Decide what to eat first. Decide which is the worst part (use your imagination here!)
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
and plan to eat that worst part first. Once that’s out of the way, the rest of that elephant may be quite tasty – or at least it will s
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
em so by comparison.
8. Take a bite. Whatever it takes, you must begin. Then take another bite. Then another.
8. Take a bite. Whatever it takes, you must begin. Then take another bite. Then another.
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
Set a pace for yourself, keep going, and don’t allow yourself to quit for any reason. How long does it take to eat an elephant? As the
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
old story goes – a bite at a time and a couple of years, and you’ll be done.
9. Clean up your plate. You can do
9. Clean up your plate. You can do
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t. How much of that elephant is left? The excuse that you are “90 percent done” means that you’re trying to hide the other 10 percent o
.
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
f that elephant somewhere. Finish the job.
10. Celebrate your success! Congratulations! You finished the task – al
10. Celebrate your success! Congratulations! You finished the task – al
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
of it. That elephant is now history, and your project is complete. High fives all around for a job well done. Now, what’s for dessert
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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