Advice You - Business

Clarifying and implementing corporate core values – corporate DNA – will result in a business advantage.

Two question

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

s every company should ask:

1. Why did each employee select our company and why do they stay?
2. Why did each

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

Examples of combination products may in

ustomer select us and why do they let us continue to serve them?

Those are easy to answer if your company's core valu

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

s – or corporate DNA – are clearly defined and communicated. Core values should be created to highlight or market 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

company's true personality. Core values are not words or statements made up by creative teams or marketing consultant

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

Combination pro

. Core values are the existing principles that drive behavior within the company. And they don't change over time but

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

continue on as guideposts for company growth.

For instance, many companies describe themselves using the word “qualit

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

y.” But what does quality mean? And how does an employee get or give more of it? It is not a value word that can dr

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

ve behavior. Core values must be specific about the behavior that's expected from employees.

Here is an example of c

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

re values developed by two different companies. The value statements fit each company perfectly.

COMPANY ABC:

We of

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

er diverse backgrounds of experience
We openly communicate with respect
We thrive in a quick and agile learn

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

Following aspects would a

ing environment
We are focused on strategic change by linking research to solutions
We are ambitious, proact

dd to the challenges in developing combination products:

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

ve and persevering about growth

COMPANY XYZ:

We operate through teamwork
As individuals, we are community role

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

odels
We are resourceful
We know how to translate various points of view
We offer an enjoyable experien

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

ce

Each company's core values frame the kind of individual who would best thrive at the company. Recruiting director

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

at each company should use these value statements to make sure that new hires understand AND FIT these values. These

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

Professional from academic institutions, pharmaceutical industries, health care indust

are statements that must drive behavior and can be supported or discussed during employee performance reviews.

As Jim

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

Collins says in his book Good to Great, make sure the right people are on the bus. The company value statements shou

.

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

d describe the bus and all the seats that are needed to offer a competitive business advantage.

For more information

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

Companies that provide selfless information through particip

n developing core values, click on Core Values

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 - Core Values For Business Advantage

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