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There are many resemblances between politics and management. One of them is that they both share the development of Polic

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

ies. Where should your company differ from a political institution in order to be successful?

A policy is like a map t

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

Examples of combination products may in

hat serves to guide an organization into a certain direction. A governmental policy serves in the same way to guide citiz

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

ens. The resemblance between government and management is even more striking for larger corporations with the practice of

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

corporate governance;

Corporate governance is the set of processes, customs, policies, laws and insti

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

Combination pro

utions affecting the way a corporation is directed, administered or controlled. Corporate governance also includes the re

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

lationships among the many players involved (the stakeholders) and the goals for which the corporation is governed. The p

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

rincipal players are the shareholders, management and the board of directors. Other stakeholders include employees, suppl

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

iers, customers, banks and other lenders, regulators, the environment and the community at large. (www.wikipedia.org)

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

This means that politics and business converge with the size of a corporation and with the increasing number

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

f stakeholders – especially the environment and the community.

...An important part of corporate governance deals wit

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

Following aspects would a

h accountability, fiduciary duty and mechanisms of auditing and control. In this sense, corporate governance players shou

dd to the challenges in developing combination products:

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

ld comply with codes to the overall good of all constituents.

And with this increase in size the "codes" (policies)

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

increase as well. Both politics and organization deal with credibility. Politicians are facing a hard time to remain cred

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

ible because of the enormous number of issues they are dealing with and which they need to respond to with a coherent lin

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

of policy. The more they deviate from this line the less credible they appear to be.

Larger organization can narrow the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ir focus which will make it easier to pursue a consistent policy. The difference between government (and governmental or

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

ganizations) and market organizations is that the former lacks a strategy.

In line with this reasoning, and observing re

.

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 politics, a company that lacks a strategy will have a hard time implementing a policy. Or put differently; make sure

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

Companies that provide selfless information through particip

that you elaborate a sound strategy if you do not want (internal) political debates leading you nowhere.

© 2006 Hans Boo

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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