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We are all leaders; in our families, churches, temples, lodges, clubs, businesses and fraternal organizations.

Have you ever heard of a Cult Manager? Yet where have we ever seen more loyalty, commitment and blind obedience? No such thing as a Religious Manager. There’s a huge difference betw

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

een management and leadership. “Semantics”, you say. When I went to Hotel School I was taught how to be a Hotel Manager. I found that I had to become a Leader in order to gain the loyalty and commitment of my staff.

When I first arrived to work as a manager in a hotel in Rhodesia, now Zimbab

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

Examples of combination products may in

we, the staff did the usual hotel staff things to test me. The cashier would mix up the cash register, and see if I could sort out the problem. The night chefs would stay home, and see if I could handle the kitchen at night and prepare the breakfast. I had to prove myself.

How does a manager

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

cope with that, as opposed to a leader? I was called in to a meeting of my management peers and they told me to fire a certain Functions Manager. He was a rebel and no good, they said. Lazy. Obstinate. Get rid of him! His name was Oral, I’ll never forget. I watched him at work. His staff 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

waiters would set up the conferences and do all the work perfectly while he sat outside, smoking. I called Oral into my office and fired him. Then I said, “Oral, I’ve done what everyone here wanted me to do. I fired you. Now, I’m rehiring you on my terms. Here are my terms: You can sit outsid

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

Combination pro

e and smoke all day. You never have to enter the hotel. As long as the job gets done to my satisfaction, I’m happy. If not, we will talk. How’s that?” Oral beamed. He thanked me profusely. He was happy. He did a great job. I was happy. And one day he saved me from being badly beaten up. Or

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

al, you see, was a natural leader. He understood leadership. Suffice is to say that after a while I had a loyal following instead of an obedient staff.

A leader understands that she is leading personalities with value systems, goals, fears, hopes and dreams. She knows that she can get peopl

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

e to work 24/7/365 when she pushes the right buttons. I once worked for a hotel owner for nine months with one day off in all that time. He was a true leader. Arthur Honey. He was Roger Bannister’s second when Roger Bannister broke the 3 minute mile. He could inspire, motivate and encourage p

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

eople. He never ran, raised his voice or panicked.

When I was 17 I was drafted into the army. I saw what leadership was and I saw what psychopaths did. The psychopathic, racist South African army officers got people to do things by force. They achieved very little. The true leaders in the ar

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

my got a lot more done, without fear, manipulation or force. They got soldiers volunteering for things. When your people are motivated and have a vision and a goal, they will achieve their goals and your goals together. Without pay, if necessary. Financial rewards and incentives are not the m

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

st powerful there are.

Here are some questions we should be asking the people we intend to lead:

1. What is your greatest fear and your greatest dream? Why is that your fear? Why is that your dream?

2. If you had a million dollars and lots of time and energy, what would you be doing right

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

Following aspects would a

now?

3. What feelings do you want to experience, and what feelings do you want to avoid in your life?

4. What’s the best book/movie you ever read/saw?

5. What are you most proud of about yourself? What is you greatest skill? What do you do best?

6. What are you weakest at?

7. If you coul

dd to the challenges in developing combination products:

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

d have any job, what would it be, and why?

8. What is your greatest worry?

9. How do you feel about…?

10. What would you change about this business/organization?

Ask open ended questions; draw them out. “Tell me more? What do you mean by that, exactly? Why do you say that? And? Yes?”

The

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

true leader knows that she has to know a lot about the people she wants to lead. She has to empathize and care. Show them how to measure their progress. She has to be sure that she treats them fairly and that there is a consistency about the way she leads. Regularity, honesty and consistency

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

is important. And there must be clear guidelines, consequences and reasons for what happens. Everyone must understand why they are to do what they do, what the outcome is supposed to be, the consequences for failing to do the right thing and the BIG PICTURE. The vision, the overall strategy,

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

should be understood by everyone concerned.

Most of all, each team member should know that, by reaching the company or organization’s goals, they will reach their personal goals as well. They should have a vested interest in the success of the venture. This is vitally important.

Mortimer A

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

Professional from academic institutions, pharmaceutical industries, health care indust

dler was quoted in Time Magazine in 1974 as saying, “In Aristotelian terms, the good leader must have ethos, pathos and logos. The ethos is his moral character, the source of his ability to persuade. The pathos is his ability to touch feelings, to move people emotionally. The logos is his abi

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

lity to give reasons for an action, to move people intellectually.”

I hired my last secretary in a restaurant. She and her husband asked me for a Job Description. This was my answer: “Francesca, this is your job description. Whatever it takes, 24/7, total commitment and loyalty and total hon

.

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

esty. Whatever it takes. I will be as committed to you, as you are to me. Take it or leave it. What salary do you want?” She wanted $2,000 per month. I knew that she would settle for $1,800. So I offered her $2,500. I got a fantastic secretary and a very supportive husband. She left when I em

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

Companies that provide selfless information through particip

igrated.

Very few managers know how to lead. It’s never too late to change. Leaders are firm, flexible, value-driven and honest. They have Magnificent Obsessions, driving goals and clear action plans. Their followers feel loved, secure, cared for and lucky. Together, we can do amazing things

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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Robert Allen teaches you seven essential money skills in his best selling audio program Multiple Streams of Income. Each skill sets the foundation for the next. Follow these seven money skills and you'll be on your way to financial wealth.

Not all management training programs and management training courses offer coaching techniques for manager in their courses. First of all, why do managers need to learn coaching techniques? After all managers are given management training, do they also have to be given training to be a life coach? To understand this, we have to know what a coach does. Traditionally coaching was something that was done to train sportspersons.

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