Main Subject - Business

In any organisation, progress is frequently impaired by the time taken up to resolve problems that

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

occur again and again - usually with people's performance (or not!). At a macro level, there could

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

Examples of combination products may in

just seem to be 'lots of problems', which is a symptom in itself. On a micro level, managers are

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

often frustrated by the amount of time they spend fire-fighting, whilst the more creative work of

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

planning, developing people, marketing and more are left way behind.

There just isn't ti

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

Combination pro

me.

Build onto that the lack of fairness, that having to regularly resolve problems pos

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

ed by just a few demanding people in the team, can leave many others, including the manager himself

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

very de-motivated. Then your best people start to leave...

People issues can easily be r

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

esolved, with focus and tenacity. A recent client of mine found, when asked, 'Which 20 issues in y

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

our business, take up most of your time?', that 6 of the 20 were just one person. This is hugely d

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

emanding, both mentally as well as emotionally. And no wonder he was under pressure and feeling

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

Following aspects would a

stressed. Actually, on calculation, just over 15% of his work time was being spent with shoring up

dd to the challenges in developing combination products:

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

the performance of just one person.

So asking yourself:-

'What wastes my time?'

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

r>...can be a very revealing exercise - if you are prepared to dig deep and be very honest, or work

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

with a coach. Then, focusing on the action that must be taken, or you will personally suffer more

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

and longer yourself, sharply brings the challenge into perspective. Tackling the issue in a prog

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

Professional from academic institutions, pharmaceutical industries, health care indust

ressive and controlled way, but with a relatively short time-frame, will free up your time for the

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

real work to be done. And that will be much more satisfying - and a lot less stressful.

And 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

there will be the reward of utilising the freed up time towards really accelerating your businesses

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

Companies that provide selfless information through particip

' performance.

Have fun with this - is is most illuminating, once you get real with yourself..

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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