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What is the aspect of the role where CIOs can make the biggest impact? What c

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

an we do to make that impact? In Change Management, you have to identify a com

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

Examples of combination products may in

elling need to change. Do you have an organization that will support you? Do

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

you have the skills? Do you have the relationships? What's your mission?

The

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

door between the Chief Information Officer CIO and CFO offices is opening wide

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

Combination pro

r, and the executives are building a path to regular interaction that allows t

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

e Information Technology IT function to excel in meeting the business' needs,

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

not simply to comply with regulatory mandates or budgetary strictures.

The

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

ost time-absorbing activity is ensuring that Information Tecnology IT systems

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

are efficient across an organisation, through careful delegation, "You won't

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

get into the chief executive's office if his PC is down!"

Companies are incre

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

Following aspects would a

singly handing CIOs the role of change agent. They're getting that responsib

dd to the challenges in developing combination products:

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

ility because of their unique position at the nexus of multiple trends. And co

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

puting resources are pooled and tailored for simpler management and better uti

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

lisation.

Finance and Information Technology IT can lead the way in setting s

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

andards and developing platforms to support collaboration inside the company a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd in the extended enterprise - for instance, customers, distribution channels

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

and suppliers.

Publishing Guidelines: You may publish my article in your new

.

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

sletter, on your website or in your print publication provided you include the

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

Companies that provide selfless information through particip

resource box at the end. Notification would be appreciated but is not required

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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