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Your Space - March Madness - Are You in the Game?
While sitting at home eagerly watching March Madness, I was looking at my brackets attempting to pick the next national championship team and I felt compelled to write this letter to you. Let me say upfront that I am an avid sports fan and can’t imagine what life would be without sports. However, I know not everyone has the same appreciation and this letter, though about basketball, is really about being our own champions of choice. Yep, it is about you and me. Here is my question, “Are you in the game or are you sitting in the nose 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 bleed section of the stands as a passive observer watching your life go by?” Hmmm, really consider this. Are you playing your “A” game or are you settling for a D-? Well the truth is, I asked myself this question and I must be honest. I am not totally in the game like I know I can be. I have really been on the sidelines… kind of warming the bench and cheering for my teammates, coaches, referees, waterboys/watergirls, mascots, and anyone else who walks by. Now, I absolutely must commend myself because I have moved from the top of ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in he arena down out of my nose bleed seats to the bench. I am progressing and getting closer. (Yes, I do totally believe in celebrating every step! Whooohooo!) My friends, I know that I can still play a much, much better game that will be even more rewarding and fulfilling. How about you? As I look at the college players playing their hearts out on national TV, I realize that although the CBS TV contract is worth billions, the players are not legally allowed to “profit in the form of money” from the sport. Yet, they are giving thei lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. all for a dream, a vision, an opportunity, a chance to play! What about you? Are you giving your all even though you aren’t being adequately compensated for your dream, your vision, your chance? I see several themes that are emerging as 64 teams strive to make it to the Final Four. Leadership principles I noticed are: • The best players are in the game as much as possible. They don’t want to warm the bench or watch the game from the stands. They want to be in the game. • The great players shoot when they have the ball here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe If they have the ball and can make the shot…they don’t hesitate to shoot it. • When you look at the best players, you can see the confidence on their faces and in their body movements. This confidence helps the ball to go into the hoop when they shoot. • The great players realize that you have to be on the court to play. They are willing to get out there, get dirty, and sweat for the whole game (both halves at about 20 minutes each). • The best players shoot often and recover quickly when they miss shots. • The b d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro st players want to win. They aren’t just playing because they have nothing better to do. They want to win! • The best shooters aren’t just shooting aimlessly. They are sizing up the best shots and passing when they feel that someone else on the team has a better chance of making the shot. • They listen to the coach and recognize that he/she is a partner in their success. • Each player has a role on the team. They delegate roles and decide what it will take to win the game before they start. • The teams play un 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 il the last second. They will foul, shoot, and do whatever it takes in an effort to win. They will not give up until the time runs out on the clock. • While the game is going on, they fully engage themselves in playing the game. They don’t have one foot on the bench and the other foot on the court. They have both feet on the court and they run back and forth – excluding time outs and half time – for the full 40 minutes on a court that is 94 feet by 50 feet. • To withstand the physical challenges of the game, the best playe 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 s have a workout plan that keeps them in shape mentally and physically. • When they don’t win the game they are not happy. They take the loss personally and immediately shift their focus to the next time. You might be asking how this applies to you and I, and I am glad you asked that question. It is time for us to ask ourselves if we are playing the game as if we are looking to win the Final Four, or if we are just playing the game of life recklessly to get by. With the things that you want most in your life, can you honestly nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ay that you are fully on the court and in the game? Are you taking the shots when you have the opportunity, or are you waiting until you get closer to the basket? Are you hoping that you will have a better shot? The truth is, no shot is guaranteed to go in. We have a much better chance of making the shots we actually take. If we don’t shoot, we can’t make it. I always use my life as a testimony because I really want to be vulnerable so that you and I can both make the shot. As I looked over theses questions, I realized that it is 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 time for me to take more shots. I created the following quiz to gauge your readiness to reach the Final Four in your life. Are you experiencing a personal March Madness? Decide what the ball or game is a metaphor for in your life before you take the quiz (e.g., your career, your relationship, a new relationship, entrepreneurialism, your weight, or whatever it is you need to SLAM DUNK). Rate each item using a scale of one to ten with one being the lowest score and ten being the highest. Rate from 1 to 10 March Madness Quiz (1 being ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi least and 10 being highest) I am in the game as much as possible. (Examples: If you are in sales, you are knocking on every door you see. If you want to be in a relationship, you are putting yourself in the places where this will be most successful.) I am looking for opportunities (new ideas, new clients, new relationships, etc.) whenever possible. I exude confidence in my face and in my other nonverbal behavior. I am getting out there, getting dirty, and sweating to reach my goal. I am shooting the ball often and recovering quic ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a kly when things don’t go my way. I am totally focused on being successful at _________ (fill in the blank) I have a clear plan of attack and execute. I often delegate to others. I have a success coach or accountability partner who helps me focus. I know my roles and responsibilities. I am totally engaged with __________ for a specific amount of time daily. I have both feet in the game and believe that my success is possible. I physically exercise. I exercise my mind through reading/ listening that empowers me. I exercise my s dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ul. I view obstacles as opportunities and I quickly develop a new plan when my old plan is not working. 130- 160 Congrats! You are in the game! You are making some really difficult shots. You continue shooting and passing as needed. You know that you are true contender for the championship. You are a real champion of choice. You make the choices that others only dream about. It isn’t easy and congrats on doing it. You get the chances to sweet taste of success! High five! 81-129: You are on the court. You get to play, but you cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin aren’t a starter, yet. Brainstorm ways you can become the starter. Imagine what it would be like if you consistently played in the game. How would your life be different? What are you going to do about it? Below 80 – You are not on the court. Get in the game! You are guaranteed to miss the shots you don’t try. It’s time for a full court press. • Decide what you want and go after it. • Create a Plan • Follow through • Become a life- long learner. Read/listen to success strategies that will help you reach your tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen oal. • Create a support system and eliminate toxic people from your life! 130- 160 Congrats! You are in the game! You are making some really difficult shots. You continue shooting and passing as needed. You know that you are true contender for the championship. You are a real champion of choice. You make the choices that others only dream about. It isn’t easy and congrats on doing it. You get the chances to sweet taste of success! High five! 81-129: You are on the court. You get to play, but you aren’t a starter, yet. B 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 ainstorm ways you can become the starter. Imagine what it would be like if you consistently played in the game. How would your life be different? What are you going to do about it? Below 80 – You are not on the court. Get in the game! You are guaranteed to miss the shots you don’t try. It’s time for a full court press. • Decide what you want and go after it. • Create a Plan • Follow through • Become a life- long learner. Read/listen to success strategies that will help you reach your goal. • Create a supp ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust rt system and eliminate toxic people from your life! 130- 160 Congrats! You are in the game! You are making some really difficult shots. You continue shooting and passing as needed. You know that you are true contender for the championship. You are a real champion of choice. You make the choices that others only dream about. It isn’t easy and congrats on doing it. You get the chances to sweet taste of success! High five! 81-129: You are on the court. You get to play, but you aren’t a starter, yet. Brainstorm ways you can bec y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products me the starter. Imagine what it would be like if you consistently played in the game. How would your life be different? What are you going to do about it? Below 80 – You are not on the court. Get in the game! You are guaranteed to miss the shots you don’t try. It’s time for a full court press. • Decide what you want and go after it. • Create a Plan • Follow through • Become a life- long learner. Read/listen to success strategies that will help you reach your goal. • Create a support system and eliminate t . 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 xic people from your life! 130- 160 Congrats! You are in the game! You are making some really difficult shots. You continue shooting and passing as needed. You know that you are true contender for the championship. You are a real champion of choice. You make the choices that others only dream about. It isn’t easy and congrats on doing it. You get the chances to sweet taste of success! High five! 81-129: You are on the court. You get to play, but you aren’t a starter, yet. Brainstorm ways you can become the starter. Imagine w elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip at it would be like if you consistently played in the game. How would your life be different? What are you going to do about it? Below 80 – You are not on the court. Get in the game! You are guaranteed to miss the shots you don’t try. It’s time for a full court press. • Decide what you want and go after it. • Create a Plan • Follow through • Become a life- long learner. Read/listen to success strategies that will help you reach your goal. • Create a support system and eliminate toxic people from your life 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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