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Social Space - Vision, Goals, Action, Which Piece Are You Missing?
There are several things you need to have at your disposal if you are going to be successful at anything. I'm going to talk about three of them here. One of these three i 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 s so much more important than the others that if you don't have it the others don't really even matter. So I'm going to keep that one for the end. First I want to talk ab ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in out VISION. VISION is the first thing you need to have to be successful. It is comprised of the realization of where you are now and more impor lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. tantly the "vision" of where you want to be in the future. It's the big picture, the ultimate destination. It's where you want to be when all is said and done. A here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe n integral part of your vision as stated earlier is realizing the situation or place you find yourself in now. Your present situation is going to be one of the d d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro termining factors in how you develop what I'll be discussing next. Here's the reason your present situation is so important. You will never be able to get where you want 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 to go if you don't know where you are starting from. Your present skills, mindset, financial situation, and any of the other current factors effecting your life all play 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 a major factor in the direction you take to get to your final destination. The fulfillment of your vision. That brings me to the second thing you need to succee nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically d... the thing that takes you from where you are now to where you want to be. GOALS. Goals are the steps you take, the milestones you reach, all 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 the stopping points along the way on your trip to your final destination. Goals are the way you measure your progress on your journey towards your vision. One o ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi my favorite descriptions of goals that I've heard is by Bob Proctor. Bob is an internationally acclaimed speaker and he describes goals this way. At least my version of ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a what he says. Say you were on your way from San Diego CA to Orlando FLA. Your vision is to get to Orlando, but first you plan a little stop in Las Vegas (GOAL 1) dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod , then Kansas City (GOAL 2), etc. etc. etc... until your vision is fulfilled and you reach Orlando. So goals need to be definite and have measu cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin rable results that lead you on your way. Don't forget to celebrate reaching your goals along the way. That's where the fun is. The third and most important thin tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen g you need though is ACTION. You must take action. That being said there really isn't a whole lot to say about taking action. It is sel 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 -explanatory. It's the thing everybody that wants to improve themselves or their situation must do. At the same time it's also the very thing that the majority of people ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust never do. I firmly believe that if you have a vision of where you want your life to go and you establish the goals necessary to get there. If you take < y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products em>action you can't help but succeed. This is not the time to discuss all the reasons why people don't take any action to accomplish their goals. 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 his is the time and the place for me to say to you JUST DO IT! Do the things you need to do to accomplish your goals. Start today. You will begi elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip n to see progress and you will get where you want to be. A vision without goals is useless and a vision without action is just a dream 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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