Subjects - Business

The internal advisor can be a specialist of any field in (the) organization. The acc

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

ountant is one of the most common examples we all know. The accountant prepares the f

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

Examples of combination products may in

inancial figures and is more than anyone else up to day with the roundabouts of the o

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

rganization.

Other (internal) advisors you often find are:

Internal communi

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

cation advisor

External communication advisor (PR)

Internal contr

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

Combination pro

HRM

ICT

Security and Risk

Tax and legal

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

Marketing or Sales

…

If you look at it, the advisory rol

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

e could pop up in any area of specialism. And this quite normal because for each of t

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

he above mentioned areas your organization would want to know things like; “what is 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

he competition doing in this area, what are market trends we need to track,” etc… Th

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

en it is possible to concentrate such a role to a single function (FTE). This -– inte

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

Following aspects would a

rnal advisor -– will then prepare for initiatives that could be commented on and amen

dd to the challenges in developing combination products:

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

ded by the group.

It is also possible to leave this role out of the official organiz

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

ation, which means that it will have to be done implicitly. The advantage is that eve

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

rybody can bring in an opinion and that the commitment to discuss certain topics (com

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

petition, market trends, etc) increases. The disadvantage is that your organization w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill probably not learn enough. Each new issue will be handled as unique and may requi

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

re a lot of effort to communicate and to resolve.

The additional value of the intern

.

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

al advisor is not only that he will select those issues that will affect the team, bu

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

Companies that provide selfless information through particip

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 - The Additional Task of an Internal Advisor

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