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Mentoring

Becoming a confidant—leading through the use of past examples and experience. Mentoring is providing guidance, support and training to expedite the development of someone that has the potential to become an effective leader. Mentoring helps define ones purpose, values, skills and unique talents.

Succession isn’t limited to the President of the organization. In a privately held business, succession can be extremely important at a number of critical positions within the compa

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

ny. These positions may include VP of Operations, VP of Sales, Logistics and even front line Sales Management. Success of your company is directly dependent on the people you surround yourself with. To leverage your success and maintain competitive advantage, succession must become part of your strategic initiatives.

Classroom training is also not the only answer to improving the effectiveness of leaders and potential leaders in your company. In fact, it may have the smallest impact 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

n their progress. Actual experiences and learning from those experiences is a key part of the development process. Mentoring is essential to this experienced based learning. Good judgment is based on experience and experience is based on bad judgment. (Steve Kaufman, CEO Arrow Electronics) The key is learning from our bad judgment. This is a much more effective process if there is a mentor involved that can help you through the experience based learning process.

There aren’t many suc

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

essful people in life that haven’t had the help of someone along the way. That help may have appeared in the form of a role model, the support of a particular group, a personal friend and confidant or a hands on mentor. Mentoring involves commitment and a long-term relationship that an experienced leader makes to support the professional development of a prot?g?. It can be a formal or an informal process. Since this process is so valuable, many companies are looking for ways to create

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

formal mentoring programs. It is really all about leadership development.

Mentoring can take the form of challenging assignments that create unique opportunities to gain experience in specific leadership areas. Another tool that is becoming more popular in the formal mentoring programs is the 360-feedback review. This is a performance evaluation of the mentored individual by his peers, his manger and his subordinates. This however, should not be an isolated feedback process. Improvem

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

Combination pro

nt planning and evaluation validation must be a part of this process. The mentor and the individual’s supervisor, if they are different individuals, must actively support this process. Incomplete information and lack of follow-up and support can destroy the benefits of this process. Timing is also very critical to this process and it should always carry a positive reinforcement message to the person being mentored. Balance

Balance is important in life. The mentor must keep in mind t

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

hat people cannot “Live to Work” they must “Work to Live”. This is about keeping family life and personal values in perspective. A healthy lifestyle is important to success. This in itself will not only help minimize stress but will allow the employee to deal with stress as it occurs. We live with stress every day. The deadlines, the crisis after crisis and facing unexpected problems and events create stress in our lives. Stress does serve a purpose. It helps us become more effective.

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

It provides the “Thrill of Victory” when we succeed at something. But uncontrolled stress and too much stress can be damaging not only to our business success but also to our health in general. We often run our bodies at maximum speed constantly and expect success. Excessive, uncontrolled stress kills. If you are constantly running at full speed, you may not even recognize tell tale signs that lead to failure. It is a primary responsibility of the mentor to not allow this type of stre

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

s level to occur. Uncontrolled Stress produces many warning signs including:

1. Impatience

2. A deep sense of being tired

3. Abusive and dogmatic behavior

4. Irrational expectations

5. Difficulty in concentrating

6. Depression

7. Pessimism

8. Withdrawal from the limelight

9. Feeling tired and worn out

When you reach the twilight of your life you want to be able to say;

“I not only stopped to smell the roses, I tore off the petals and threw them into the wind!”

Why become a

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

Mentor?

Mentoring is a form of learning that goes back to ancient times when an experienced and successful teacher would take on a specific pupil to teach him everything he knew to duplicate his success. Remember the movie “The Karate Kid”? This methodology was the most effective form of creating succession. It was the original form of succession planning. By mentoring the experienced teacher could shortcut mistakes, wrong turns and other costly set backs that others make without the

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

rivilege of having a mentor? Mentoring is an honorable, old way of learning that had been forgotten but is now being rediscovered as an extremely valuable leadership development tool.

Some people say success has a lot to do with luck. The harder you work the luckier you get. Mentoring can help find the virtues, the attitude and the values necessary for success. Virtues and values are very definable. They can be defined as:

• Integrity

• Honesty

• Respect

• Compassion

• Character

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

Following aspects would a

However attitude is a state of mind. Something that changes based on circumstance and the environment. Attitude is extremely important when mentoring your potential successor. Success is very dependent on an attitude that embraces the following:

• Impatience

• Abstract unconventional thinking

• Insightfulness

• Happiness

• Calculated risk taking

• Hunger for achievement

• Decisiveness

• Self awareness

Impatience in a privately held business can be a virtue. Don’t be so patien

dd to the challenges in developing combination products:

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

t and tolerant about everything that you lose your passion and miss opportunity because you don’t see it flying by. Life is too short to drink cheap wine. Don’t allow others to dictate your schedule or control your life. It’s your life and life is short. Success comes to those who proactively go out and make things happen. They don’t sit around waiting for something to happen.

Abstract Unconventional thinking creates vision. Be a little crazy. Go against conventional wisdom when you

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

eel it in your gut. Remember, many geniuses were once considered crazy. Don’t always go along with the majority. Challenge the status quo.

Insightfulness means demonstrating passion for your ideas. Excitement breeds excitement. Success breeds success. Believe in yourself. Believe in your ideas and don’t be afraid to express that confidence but express it without demonstrating cockiness or arrogance.

Happiness is absolutely an essential ingredient to becoming successful. You must have

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

fun and be happy doing the work you do. If you do not enjoy what you are doing, you will not do it well. Money is not, I repeat, money is not the barometer of success. It’s just a way of keeping score. Unless you are happy with your work, your life and you have created a balance, money doesn’t mean anything. Learn how to laugh. Laugh at the challenges life often puts in front of you.

Calculated risk means not being afraid to stretch, to reach for something extra, to take a chance on

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

omething. Calculated risk is thought out. It is not whimsical or foolish. The odds are in your favor. The greatest risk in life is not taking any risk. Mediocrity can not become a standard in your life. Success takes guts. That means you have fortitude and a lot of character. Tell yourself, when the day comes that you retire, you will not look back on your life with regrets.

Hunger for achievement means you will not give up. You have drive. You want to succeed so badly that you think

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

Professional from academic institutions, pharmaceutical industries, health care indust

about it all the time. Being hungry means you are focused on what it is going to take for you to succeed. You have a passion, a desire and a willingness to learn.

Decisiveness is the ability to make a decision and stick to it. Execution and implementation are two important keys to success. If you have a mentor, utilize the knowledge you are gaining from the relationship. Be original in utilizing the experience and knowledge you are gaining.

Self-awareness is the ability to understand

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

you. Know your strengths but more importantly know your weaknesses. Capitalize on your strengths and work on your weaknesses. Don’t ignore them. But be happy with who you are. You wouldn’t have or be a mentor if you didn’t have the potential to become or create success.

Becoming a Mentor

Most often you will find your successor at your place of employment. Picking the right person to mentor is important. First of all, they must have gained the respect of others in your organization.

.

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

They must be recognized for their potential in the organization and demonstrate the kind of Lead leadership that excites people that will make them want to follow their lead. Accept no substitute, no stand in. However, most importantly, the candidate you select must be willing and able to take on the responsibility of learning from you. This is not something either of you should take likely. A mentor is not just someone you can go to for advice.

A real mentor is interested in the succ

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

Companies that provide selfless information through particip

essor, their life, their progress and their success. They take a proactive role in their development and their leadership effectiveness. Make your time and your successor’s time as productive as possible. Create an action plan with your successor that defines the activities in great detail. Details that you need to complete to create the success that you and your successor have defined. Specific goals and objectives with a definitive timeline are key components to the mentoring process

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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Struggling to think of things to talk about in a job interview? All interviewers would appreciate an example of how you overcame an obstacle in your life. It shows your determination, problem solving ability and what you value in your life. Anything that helps an interviewer get to know you as a person and what you would be like to work with will help them better determine if you're a fit for the job.

Some of today's flourishing companies started in garages, bedrooms or living rooms. If you think that your small home-based business will stay that way, draw inspiration from some of these entrepreneurs and start thinking big!

As a solo-entrepreneur I stand by the quote, “how you spend your energy is how you measure your success.” However, this was true even when I worked as a high-school teacher. No matter our profession, if we’re wasting energy, we’re limiting our productivity and potential.

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