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E-Folder - Being an Entrepreneurial - Creating Milestones
Today, there are people out there that all they want is to work a typical 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 day of 9am-5pm. All these people really want is the job security. People ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in feel comfortable not having to think and worry where their next paycheck lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. is going to come from. These people probably don’t take many risks in the here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe r lives. However, for those who aspire to become an entrepreneurial he/sh d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro will be willing to take risks at all costs. Starting a business can bec 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 ome very stressful. You have to worry about legal issues, business plans, 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 marketing, and advertising. All these take a toll on a person. You have t nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically be constantly motivated, and passionate about your business. You have to 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 give it all you got and to move forward. Lets be realistic here. There a ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi e going to be up’s and down’s when ever your starting your own business. ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a Being an entrepreneurial myself, I learned to “create milestones.” So, w dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod hat do I mean by creating milestones? Good questions! Creating milestones cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin is like creating goals for yourself. These can be short-term goals, or lo tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen g-term goals. These milestones could be as minute as “obtaining an LLC,” 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 or “opening a business account” to “having your product in retail stores ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ll over the United States.” By creating milestones, you really are consta y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products tly motivating yourself and others. The bottom line is, that whatever you . 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 are doing, always try to create milestones. Everyone has the opportunit elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip to succeed at anything. "If there is a will, than there has to be a way. 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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