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Main Subject - Disciplined Leadership
You want to manage a disciplined team, focused on achieving results, beating the competition and demonstrating continuous improvement. You want to generate enthusiasm while making measured progress toward common goals. You want the entire team to succeed, to work together and be the bes
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
t that they can be. You may be wondering how to begin.
It starts with you.
Define the Goals
Define your personal measurable objectives. Your goals must be tangible, measurable and substantive. It is not enough to define a goal as completing a task. You need to define a target
It starts with you.
Define the Goals
Define your personal measurable objectives. Your goals must be tangible, measurable and substantive. It is not enough to define a goal as completing a task. You need to define a target
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ate and a method of measuring the completion.
For example, a poor goal would be a personal challenge to lose weight. However, a good goal would be to define the amount of weight to lose and a reasonable target date to achieve the desired weight.
The same concept may apply for personal
For example, a poor goal would be a personal challenge to lose weight. However, a good goal would be to define the amount of weight to lose and a reasonable target date to achieve the desired weight.
The same concept may apply for personal
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
business goals. You may have financial targets like a budget. You may have a schedule to complete a project, research or analysis. You may need to achieve a specific quota or ranking. Whether your goals relate to your work or your personal life, you need to define them.
Write down you
Write down you
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
goals and place the list somewhere that you will see it every day.
Develop a Strategy
Your strategy consists of specific steps and milestones. The milestones are periodic measurements to determine that you are on the path to achieve your goal.
For example, if your goal is to
Develop a Strategy
Your strategy consists of specific steps and milestones. The milestones are periodic measurements to determine that you are on the path to achieve your goal.
For example, if your goal is to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
achieve a revenue quota, map out specific opportunities that may contribute to the attainment of that goal and then make a plan for each one. If the goal is to complete a project, define the steps necessary to complete the project with associated measurements and milestones.
Check in o
Check in o
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
your strategy and compare your progress at predefined intervals. Allow some flexibility in between those scheduled intervals, but challenge yourself to remain on schedule as each milestone date arrives.
List the Benefits
Identify the benefits of achieving your goals.
For exam
List the Benefits
Identify the benefits of achieving your goals.
For exam
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
ple, if the personal goal is to lose weight, the benefits may include a new wardrobe, more energy or even better health benefits. If your goal is to achieve a desired budget, identify the residual positive impact.
The benefits of achieving your goal should not by limited to attaining t
The benefits of achieving your goal should not by limited to attaining t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e goal alone. On the contrary, there are typically many benefits realized during the course of completing each step of your strategy. The benefits may include physical, financial, psychological or many other types of motivational rewards.
Organize
Organize your plan, your mater
Organize
Organize your plan, your mater
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
ials, your thoughts and your environment. This not only applies to the items that contribute to achieving your goals, but it also applies to the numerous items that may distract you from your goals.
For example, clear the clutter from your desk and clear the distractions from your sigh
For example, clear the clutter from your desk and clear the distractions from your sigh
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. If there are documents that have been sitting for several weeks or months, chances are that the documents are not high enough priority to get done, but not low enough priority that you can stop thinking about them. Create a place to store the low priority items until you are ready to
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
esolve them. In the meantime, remove the low priority distractions so you can focus on the high priority goals.
Exercise Daily Discipline
Challenge yourself to exercise daily discipline. You have purpose. The goals that you have defined are important. The way to achieve your go
Exercise Daily Discipline
Challenge yourself to exercise daily discipline. You have purpose. The goals that you have defined are important. The way to achieve your go
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
als is by structured and consistent effort and attention to detail.
Challenge your excuses. You may not feel interested in doing the necessary task or strategic objective that it takes every single day. When this happens, reflect on your passion for your established goal and do what it
Challenge your excuses. You may not feel interested in doing the necessary task or strategic objective that it takes every single day. When this happens, reflect on your passion for your established goal and do what it
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
takes to keep the momentum.
Focus on Results
Keep your focus on the final goal as you work through your strategy and maintain your daily diligence. As you head toward your goal, it should be like a beacon or lighthouse that leads your effort. Align your activity with the desire
Focus on Results
Keep your focus on the final goal as you work through your strategy and maintain your daily diligence. As you head toward your goal, it should be like a beacon or lighthouse that leads your effort. Align your activity with the desire
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d ultimate results.
As you attain each milestone in your strategy, focus on the outcome and benefits of your progress. When you have achieved your goal, focus your reflection on the results of your accomplishments.
Reward Yourself
Enjoy some small rewards for accomplishing str
As you attain each milestone in your strategy, focus on the outcome and benefits of your progress. When you have achieved your goal, focus your reflection on the results of your accomplishments.
Reward Yourself
Enjoy some small rewards for accomplishing str
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
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
tegic tasks in accordance with your milestones. If you miss your measurement or milestone, withhold your reward in anticipation of the next milestone or attainment of your goal.
When you do achieve your goal, keep your promise to yourself and savor the reward. Give yourself a small gif
When you do achieve your goal, keep your promise to yourself and savor the reward. Give yourself a small gif
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
t of recognition that you can keep as a constant reminder of your accomplishment. Sometimes you will need this as motivation when you define your next personal goals, or as inspiration to maintain daily diligence.
Lead by Example
Practice this discipline in your own activities.
Lead by Example
Practice this discipline in your own activities.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
As you develop a structure and routine for attaining personal goals with daily diligence, you will be able to share these benefits with your team. You will be able to teach and encourage them to achieve results as you have done. You will be able to help them align personal strategies wi
.
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
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
th focused goals. Eventually you will be able to share the mutual rewards of achieving personal and professional goals.
______________________________________________________
Words of Wisdom
"The first and best victory is to conquer self." - Plato
"Self-respect is the fruit of disc
______________________________________________________
Words of Wisdom
"The first and best victory is to conquer self." - Plato
"Self-respect is the fruit of disc
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
pline; the sense of dignity grows with the ability to say no to oneself."
- Rabbi Abraham Heschel
"The man who goes alone can start today; but he who travels with another must wait till that other is ready." - Henry David Thoreau
_____________________________________________________
"The man who goes alone can start today; but he who travels with another must wait till that other is ready." - Henry David Thoreau
_____________________________________________________
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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