Main Subject - Business

In the post-Enron world of the early-21st century, integrity, and its cousin ethics, are words that get plenty of air time and even more lip-service. They’re tossed around carelessly, but the deeper, more difficult,

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

dialogue on what integrity is and why it matters is critically absent. Your own definition of integrity may involve nuances different from the CEO across town. But, ultimately, the quality of integrity is based o

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

Examples of combination products may in

strong values. It is the most-cited response to survey questions of what employees want in a boss. This top-ranking transcends generations and cultures. Universally, people want to work for someone they can trust.

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

Steelcase, the office equipment manufacturer, regularly conducts surveys of the worldwide office environment. In 1991, being honest, upright and ethical were very important to 87% of Canadians, and 72% of Japanese r

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

spondents. Jim Kouzes and Larry Posner, in Leadership is a Relationship, cite honesty as the most important supervisory trait in every study they have done since 1981. Over the years no fewer than eighty-seven perce

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

Combination pro

t of respondents listed honesty as number one.

Trustworthy

Integrity is the corollary to commander’s intent – the direction we receive from the boss. It is the trait that sends the message, “You can trust me to gu

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

de you in the right direction, and to watch out for you.” The reciprocal of trust is leadership in its most basic form. A leader says, “Here is what I want you to do, and I trust you to do it.” The follower says,

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

I will do it because I trust you to do the right thing.”

My formative leadership experiences were in the Marines. Those unfamiliar with the military will cite the captive employee aspect that mandates compliance by

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

a subordinate. And yes, unfortunately there are examples of people in leadership positions in the military--and in the civilian sector--who rely on the power of their position to get the job done. Ultimately, the as

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

igned task does get done, but usually, less effectively than in a situation in which the leader relies on positional power. The more-enlightened leader uses influence to accomplish the objective and acts with inte

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

rity. It is only the weak military leader who resorts to, “I am ordering you to do this.” Such comments are more often seen on television than in real life. The captive employee knows the rules and will comply with

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

Following aspects would a

them. He respects the position occupied by the weak leader, but not the leader.

Consistent

People with integrity deliver on the commitments they make and accept. They do this by knowing not only their own capabili

dd to the challenges in developing combination products:

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

y and workload, but also, that of their team. They don’t over-commit. They are able to say no and explain why. When they do say yes, they get the job done. If they later find that they cannot get it done, they quick

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

y get help and notify the appropriate people.

Non-negotiables

Too frequently, people look at the world in black and white. And that black and white is based on their values, skills, ability and experience. An acti

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

ity or decision being evaluated is labeled either right or wrong--depending on the perspective of the one doing the evaluating. But, the reality is that leaders need to be comfortable with a wide gray area that allo

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

s individual action and flexibility for the subordinate.

When I coach leaders, one of the first exercises I ask them to work through is their “non-negotiables” list. This gets to one of the classic leadership conv

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

Professional from academic institutions, pharmaceutical industries, health care indust

rsations: Do you want those following you to follow a specified path to achieve the desired result, or do you want the desired result?

Integrity is about tangible actions for an intangible concept and is the founda

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

ional element of leadership. People do not want to follow a leader they cannot trust. If they are forced to follow that leader, they will do the bare minimum needed to get by.

Integrity dictates the same behavior,

.

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

hether in public or in private. Consistency, delivering on commitments, and maintaining standards are all facets of integrity.

A bit of advice Marines often hear before going on liberty in port applies to integrity

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

Companies that provide selfless information through particip

and ethical decision-making: would you want your mother to know what you are doing? For you the question may be, would you want this to be on the front page of USA Today?

(c) 2006 FireStarter Speaking and Consultin

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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Main Subject - Integrity – The Foundation of Leadership

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