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I must confess that the idea for this blog was not mine. It was the idea of a good friend and business partner, Ian MacMillan.

Empowerment is a

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

really hot topic nowadays. It has been for a while. It's very popular for companies to be able to claim that they "empower their employees". Ever

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

Examples of combination products may in

one feels good about this. It sounds good after all, even if you're not sure what "empower" means you almost feel cool to be able to say "I'm emp

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

wered". What does it mean in the practical sense? Well, the theory is that you are given responsibility (read power). You are accountable for a s

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

ecific set of deliverables. You are in control! I can tell, you feel good already don't you(?).

So, that's the theory, now for some practice. Ma

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

Combination pro

y are cynics of empowerment, simply through common misuse of the word. Some might even say that Empowerment equals Abandonment. I don't believe t

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

is but I do believe that it happens. In fact, I know it does from personal experience. So how do you know whether you've been empowered abandoned

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

To start with you'll have a line manager who, previously, was a firm believer in delegation - this is always a good start. What has happened in

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

ecent times is that delegation has got a bad name. It suggests hierarchy. It suggests "Us & Them", the management and the workers. Keen to dispel

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

this way of working many have adopted empowerment as a direct replacement to delegation.

Empowerment is a good thing but it's not something to b

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

taken lightly. You, as the empowered, need support. You need someone to call when you want to check something. There's nothing wrong with checki

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

Following aspects would a

ng. contrary to popular belief it says nothing about your own ability to "grab the bull by the horns", rather it shows that [a] you know that you

dd to the challenges in developing combination products:

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

re not infallible and [b] you appreciate input from others. We're all different. We approach decisions in different ways and it's important to su

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

round yourself with people who do think differently as this is the only way to ensure that you broaden your experience rather than deepen it.

So

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

to draw to a close before the readers' attention deteriorates too far Empowerment is good, Abandonment is bad. Consider your own situation and w

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

ether you're comfortable in it. If you're not, you need to change it. This means one of two things. Change it within the environment that you pre

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

Professional from academic institutions, pharmaceutical industries, health care indust

ently work or change yourself out of the environment in which you presently work. Note, you are in control of both of these. If you can't effect

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

he former then it's either because you're not the right person to do it, or the organisation isn't right for the change. If the latter here then

.

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

ou need to heed the semi-hidden message here.

Sometimes, who must do what's right for the organisation rather than what you think is right, perh

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

Companies that provide selfless information through particip

ps what you know it's right. No-one can move mountains, so don't try. Focus your energies on something that is achievable, this benefits everyone

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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