Advice You - Business

We all know (well I hope we do) that part of being a good leader is in the art of delegation, trust, and looking after t

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

he people who look after us (good topic for another article!!!)

BUT who looks after us, how do we look

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

Examples of combination products may in

after ourselves?

How do we make our job(s) any easier?

Based on the premise that it helps to be reminde

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

d occasionally of business basics or best practices, I thought it would be worthwhile to share this snippet with

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

you...

Priority Vs Sequence

Two of the worst inventions are the brief case (Flappsie Hap

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

Combination pro

psie Bags) more about that in a few days and yellow stickies (unless you are the manufacturer of course).

OK, y

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

es I know, these little stickies are wonderful, they come in so handy. But they grow, and grow and grow

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

There you are, the night before or first thing in the morning...

you have planned your work for

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

the day

you have prioritised it and you are set

you know exactly what very important tasks you are

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

going to work on

You know what your priorities are. BUT, what about the sequence?

You see, apart

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

from those very important work related tasks, we also have the 'other stuff' - the calls to make, the photos to email t

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

Following aspects would a

o the family, other emails to send, and the rest.

"I'll do those later, when I stop for lunch", in fact, before

dd to the challenges in developing combination products:

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

I start on my priorities, I'll just jot down the other things I need to do on yellow stickies - they're great as 'remin

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

ders'."

So there you are, in front of your PC, or at your desk, surrounded by 5 yellow stickies as you start yo

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

r first priority.

You know, I know, we all know what happens next - they start to grow! They yell at us

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

'READ ME, READ ME? They go through this transition from gentle reminder to nagging monster.

Result - concentr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation down to 60% AND we still have those less important things to do AND we still have those yellow stickies!

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

OK, Andrew, cut to the chase.

Simple, make the less important things the priority and get them out of the w

.

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

ay.

Unless they are time dependent, they're done, they are out of the memory bank and our concentration is back

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

Companies that provide selfless information through particip

to normal, focused on what we wish to achieve AND there are no more yellow stickies!!!

Try it, and let me know

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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