Main Subject - Business

The world is racing towards seamless commerce and instant communications. Fast comp

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

uters and networks provide the grease.

But people design the business processes we

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

Examples of combination products may in

use. And sometimes, someone puts sand in the grease.

A local college ordered two c

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

pies of my video-based learning programs. They had my pricelist and knew exactly wh

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

t they wanted. I was the only supplier.

But their Finance Department insisted upon

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

Combination pro

sending a ‘request for quotation’, then receiving a ‘written proposal’ so they coul

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

send a ‘purchase order’ from which I would provide an ‘approved invoice’ – all bef

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

re delivering the products! That’s a lot of paper back and forth (hardcopies requir

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

d, in duplicate) without a smidgen of added value.

One government agency ordered t

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 entire Ron Kaufman learning library. The products were delivered promptly with ou

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

usual invoice enclosed.

But the agency insisted our invoice be re-written as it w

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

Following aspects would a

s dated February 28, the same day as shipment, while the products were delivered on

dd to the challenges in developing combination products:

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

March 1.

Finance refused to accept our invoice as it was dated before delivery, ev

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

n though the invoice accompanied the products and the products were now delivered.

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

Key Learning Point
----------------------------------------------------

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

---------------------------

The need for speed in today's economy is rea

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Get rid of the sand that grinds the gears and slows everything down. Grease up!

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

br> Action Steps
-----------------------------------------------------------

.

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

--------------------

Look closely at your business processes and procedu

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

Companies that provide selfless information through particip

es. What can be streamlined? What can be reduced? What can be eliminated altogether

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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Main Subject - Who Put Sand in the Grease

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