Advice You - Business

Singapore is a small country, always looking for new ways to expand, grow and su

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

cceed. That requires a constant stream of creative policies and innovative, fres

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

Examples of combination products may in

ideas.

A high-powered panel of financial industry players was convened to help

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

open up the financial sector. Their mission was to propose new ways of stimulat

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

ng investment and development in the banking, securities, insurance and fund man

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

Combination pro

agement industries.

The charter to this group was especially open-minded and de

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

anding. At a press conference introducing the panel members, one leading governm

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

ent official said:

‘If we implement all the recommendations your panel comes up

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

with, then you have not succeeded. You must go further, giving us ideas and sugg

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

estions beyond what we are ready to implement at this time.’

What a powerful wa

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

to ask for – and demand – ‘over the horizon’ thinking.

Key Learning Poin

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

Following aspects would a

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dd to the challenges in developing combination products:

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

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To keep your culture vibrant and evolving, you must consider ideas

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

hat are well beyond what makes sense right now. You must look ahead today, look

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

beyond tomorrow and look `over the horizon' for the future.

Action Steps

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

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

Professional from academic institutions, pharmaceutical industries, health care indust

-----
The next time you seek a truly fresh perspective, challenge your team

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

to create proposals beyond what makes sense today. If they offer only practical

.

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

suggestions you can implement right away, they've failed. If they force you to a

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

Companies that provide selfless information through particip

higher plane to see what might be in the future, they - and you - have succeeded

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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Advice You - If We Implement Them All, You Have Not Succeeded

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