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Advice You - Fear of Success? Fear of Failure?
What's holding you back? One of my clients came to me saying he wanted to expand his business - something he had thought about for years. He described the changes he want 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 ed to make but he had taken limited action to make those changes happen. When he talked about what he wanted, his eyes lit up, he smiled, and there was passion and joy in ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in his voice. Years? What was stopping him? I listened as he expressed his internal conflict. He said “ My business is going well, and it’s not like I have to make changes, m lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. aybe it's not that important… on and on." Bottom line - some part of him inside continued to feel unfulfilled. On the surface, it sounded like the changes he wanted to ma here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe e were for financial gains. Talking further, he realized he was really speaking of a level of service (how he wanted to help people improve their quality of life) and pers d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro onal fulfillment (actualizing his values, purpose, and vision) that would come from aligning who he is and what he does in a BIGGER way. We discussed the things he told h 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 imself that allowed him to remain stationary. His initial objection was “If I put myself out and take some risks- what if I fail?” (What if this or that happens??? ) I rep 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 ied, “ With all the years of experience you have thinking about what you want without committing to action, you have brilliantly SUCCEEDED in FAILING! “Congratulations!!!” nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically His eyes widened, and he burst out laughing. By doing nothing, he insured his success at failing. Going forward in our coaching sessions, we focused on his attitudes abo 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 ut success/failure AND identified his values, needs, purpose, and vision. Increased self-awareness enabled him to make choices and design strategic actions to create great ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi r life satisfaction and self-fulfillment. Consider a change you have been thinking/talking about for a while without much progress. To learn more about what may be ho ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a lding you back from moving forward, ask yourself: -- What is your definition of success? What does success mean to you? Be specific. -- Identify specific successes. dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod What made them successes for you? What value did you receive from succeeding? -- What fears, concerns, or assumptions do you have associated with success? -- How would y cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin our life change if you were/felt more successful? (at whatever) -- What would you have to give up? What would you gain? -- Who would you become? (happier, self-confident tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen authentic, stronger???) In exploring your attitudes about failure, consider the following: -- What is your definition of failure? What does failure mean to you? 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 -- If you fail at something, does that define YOU as a failure? -- What specific failures have you experienced? What value have you received from failing? Be specific - ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust - What fears, concerns, or assumptions do you associate with failure? Are they true? -- Can there be success in failure? If yes, how? If no, say more. -- If you could no y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products fail, what would you be doing? Who would you be? Fear of success/failure are two sides of the same experience. By definition, success and failure is perceived from multi . 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 ple viewpoints. Both results offer opportunities for self-discovery and change. Developing the clarity to know who you are on the inside is a key ingredient to achieve ric elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip h outcomes with ease, strength, and focus! To live fully, you must fully participate – succeeding and failing for the joy of the experience. Copyright 2003, Lorraine Cohe 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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