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Do you have a Gantt chart for each one of your projects, on your wall? (By the way, a Gantt chart is just a chart with time along the hori

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

zontal and the tasks drawn on as long thin boxes). If you don't already use them, here's why I think they are worth it:

1. Communicat

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ion: everyone can see the project, where they fit in, and why if they go late they will affect others.

2. Monitoring progress - by colo

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

uring in the Gantt chart you can make sure you're keeping up with the Today line, and you can take action as required if you're not keepin

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

g up (crashing tasks, slipping the programme, whatever). Without a coloured-in Gantt chart you can only say you're about half way through

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

and probably on schedule - not good enough! Your weekly or monthly progress meetings will probably be based around the Gantt chart (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

do have these don't you??)

3. Planning loading - by looking vertically you can see the weeks or months when everything is going to hit at

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

once, so you can slide some of the floating tasks to reduce the peaks, and even if you can't level out the peaks you can plan accordingly

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

- extra people, overtime, or taking longer over the project.

4. The big loading over-view: you can add up all your projects and make sur

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 that the department as a whole will be able to cope with the total planned workload and therefore keep it's promises. And of course if

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

it can't you can use this loading plan to either get the customers to choose which project they want first (they can't have them all) or t

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

o lobby for more resources using logic and without appearing negative or pessimistic.

5. The Gantt chart can be used to generate a predic

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ted cost curve, since it shows the amount of labour and the moments of capital expenditure during the project. then, during the project,

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

you can make sure you stick to the plan. Without a predicted cost curve you are reduced to hoping that the rate of expenditure will be ap

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

proximately linear - unlikely!

6. Interpreting cost figures: the accountants are telling you that you're underspent: but is that good? O

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

nly if you're keeping up with progress! More likely you're running late and that's why you're underspent. Maybe you're a long way behind

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

, and for the work you have done you're OVER spent? The Gantt chart is the only way you can know this.

6. Assessing whether subcontracto

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

rs know what they are doing - ask to see their Gantt chart - they do have one don't they? If not - worry! During the project have a regu

.

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

lar meeting to see how the colouring-in of progress is getting on.

7. Blowing your own trumpet - why not show your boss and your custom

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ers that you are in control, that you know what's going on with your project

So there we are: Gantt charts: go on, you know you want one

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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