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What values and principles drive your business? More importantly, does the leader of your business consistently demonstrate these values?

This month, I will address an important l

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

eadership characteristic that is all too often overlooked in our society today – integrity. Although many leaders use this term to characterize themselves, I find very few that ar

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

Examples of combination products may in

able to even tell me what it means to have integrity.

It’s not necessarily their fault, the definition found in the dictionary “the quality or condition of being whole or undivid

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

ed” isn’t exactly crystal clear.

So what does this word – integrity – really mean?

Let’s start by looking at the definition offered by best-selling Christian author V. Gilbert Be

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

rs: “A person of integrity is one who has established a system of values against which all of life is judged.”

In other words, a person with integrity has carefully determined exa

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

Combination pro

ctly what principles and values are most important to them and decided that these will guide all of their actions. In addition, the most important characteristic of a person with

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

ntegrity is that they live by these principles regardless of the situation or circumstance.

That’s what makes it so tough to have integrity. You can’t have “service to others” as

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

one of your core values and then choose to only spend time with people that improve your situation (help you make more money, gain more influence, etc…). If your principles and v

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

lues truly guide your actions, you will seek out those in need and help them regardless of the return to you personally or professionally.

Unfortunately, some business leaders don

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

’t understand the importance of integrity. They will argue that it is their job to get results, regardless of the principles and values that influence their decisions. These are

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

he same presidents and CEO’s who advocate misleading their customers and suppliers as long as it drives more profit to the bottom line.

What they don’t realize is that although th

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

Following aspects would a

ey might succeed in improving profit in the short term, they are significantly damaging their long term ability to develop a successful and loyal team of employees.

Why? I believe

dd to the challenges in developing combination products:

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

that the answer is trust.

Employees will not give their best efforts and truly follow a leader unless they trust him/her. The words of Dwight Eisenhower reinforce this concept: “

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

In order to be a leader a man must have followers. And to have followers, a man must have their confidence. Hence the supreme quality of a leader is unquestionable integrity. If

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

man’s associates find him guilty of being a phony, if they find that he lacks forthright integrity, he will fail. His teachings and actions must square with each other.”

If we c

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

an agree that integrity is a critical component to becoming an effective leader, how do you become a person that practices the “quality or condition of being whole”? I would recom

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

Professional from academic institutions, pharmaceutical industries, health care indust

end three basic steps as a guideline:

Decide what principles/values are most important to you and write them down somewhere that you will refer to frequently (weekly at a minimum)

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

. Note: If this is your first time contemplating your core principles don’t get frustrated if you draft many versions. This is a challenging process and one of the reasons so few

.

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

people take the time to do it.

Share your principles/values with your closest friends and associates. You will need the help of others to hold you accountable to these concepts.

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

Companies that provide selfless information through particip

Practice these principles/values in everything that you do. Not just at work and during management meetings. These core concepts should guide every single decision that you make

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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Are you bored to distraction with your current career? One tip that may help you decide on a new direction for yourself is simply to walk around your home. Play detective and discover yourself.

This document outlines our thinking about what a good performance appraisal and performance management process should be.

Will the continuous advances in technology replace the profession of selling in the foreseeable future?? I am not a fortune teller or a mystic, but I do believe that we will see dramatic changes in the roles salespeople play in their organizations and the economy in general. During the next several years and stretching into the next few decades there will be dramatic and all encompassing change in every industry, field and profession. No one will go untouched by the swath that will cut across every age group and discipline.

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