Subjects - Business

All functions of business operate on a grounding of principled actions and behaviors. So it is with leadership. These principles define the paramete

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

rs for the leader's code of conduct. They become a framework through which decisions can be channeled and validated.

Eleven Principles of Leadershi

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

Examples of combination products may in

p have been coded by management practitioners over decades. These have stood the test of time, survived assorted applications, and produced results.

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

A list of the principles and their brief explanations follows.

1. Be proficient in all that you do. Followers expect leaders to be expert in the j

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

ob level assigned. You can get success for a while on your looks, wit, and charm but sooner or later you must produce consistent, real time results.

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

Combination pro

2. Live your values. Don't get caught in the say/do gap trap. If you profess a value of honesty then act honest.

3. Know your people and look out

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

for their welfare. Don't involve yourself in their personal lives. However, when an employee has a personal problem that soon overlaps into a perfo

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

mance problem and that is your problem. You have every right to require a person to seek professional help before it gets out of hand.

4. Keep peop

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

le informed. The greatest single breakdown in organizational dynamics is the lack of information flowing between and among those who need it. Everyo

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

ne on your team should know everything you know about a project.

5. Set the example. If you believe that workers should show up at work clean and g

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

roomed you set the example. Too many times we find supervisors at the start of a shift looking like the end of the shift.

6. Ensure the task is und

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

Following aspects would a

erstood, supervised, and accomplished. Ask questions when you assign work. It is the only way you will know for sure that everyone is on the same pa

dd to the challenges in developing combination products:

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

ge.

7. Train as a team. Sports teams practice together. Why shouldn't business teams do the same?

8. Make sound and timely decisions. A serious fa

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

ilure of leaders is to not decide. Foot dragging around making tough decisions is simply unacceptable.

9. Develop a sense of responsibility among s

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

bordinates. The only way people learn to be responsible is to be given the chance to be responsible. The leader then holds them responsible for bein

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

g responsible. That's not a play on words.

10. Employ your work group in accordance with its capabilities. Don't burn out your team trying to look

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

Professional from academic institutions, pharmaceutical industries, health care indust

good. Know your limits. It is okay to stretch and reach but don't exceed your grasp.

11. Seek responsibility and take responsibility for your actio

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

ns. A leader who accepts responsibility scares others. Because most managers practice the daily duck and hide routine anyone who steps up to respons

.

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

ibility will go far in the organization.

In Summary These principles have performed well for those who understand and apply the back corner

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

Companies that provide selfless information through particip

s of the definitions. Use them as a template to test your leadership practices

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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Subjects - Leadership's 11 Principles

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