Subjects - Business

It's been a pretty good weekend around the place - not done a lot, but I have done what I've wa

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

nted to do - and that makes the difference.

I changed my role when I first left the employed w

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

Examples of combination products may in

orld. Having been a manager for over 25 years. I became a true employee with a manager b

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

reathing down my neck. It was the most difficult thing to accept. It wasn't because I co

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

uld do it better (although, then again...!), more it was that I had just no control at a

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

Combination pro

ll. And I realised that most people who have jobs are total employees and have little say in wh

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

at they do or how they do it. They are 'done to' rather than deciding for themselves and gettin

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

creative and involved.

Sadly I didn't realise this until I was a manager no longer, but what

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

I did realise and share with you now is that to be totally disempowered in your role is demoral

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

ising and depressing.

Whilst I realise that perhaps I am more creative and need space to think

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

and 'invent', which some people may not feel quite so intensely, I don't want to assume

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

Following aspects would a

that. I recognise that everyone needs a little involvement, at least, in what they do a

dd to the challenges in developing combination products:

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

nd how they do it. Empowerment/engagement whatever you want to call it - it makes

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

that difference.

If I can leave you with a thought to take back into your businesses and work

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

laces, it is this:-

"What can I do today that will empower at least one person i

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

n my team like never before - and how can I build that into our culture from now on."<

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

Professional from academic institutions, pharmaceutical industries, health care indust

/b>

A big challenge? Maybe. But what a gift you will give to your people - and ulti

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

mately yourself and your business too.

And I got loads of stuff done in the garden, tha

.

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

t I chose to do. And gardening is not normally what I do much at all! Interesting.

If y

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

Companies that provide selfless information through particip

ou want more on this - there is a page on the website that tells you more. Click the link below

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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Subjects - Empowering Others - Giving Them Some Control

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