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Digg It - Once Upon a Time
So there you are at a social or business event. You are in line for appetizers (bet you can’t w 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 ait to get to those spicy wings) and you strike up a conversation with the person next to you 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 line. You introduce yourselves, shake hands, and quickly the question, “What do you do for a l lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ving” is asked.” It’s the moment of truth! Ordinarily one’s response is a generic, dull, unins here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe pired, noun stating, “what you are” instead of “what you do.” It is as if one were to say, “I se d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro l a commodity” or even worse, “I AM a commodity.” Once that commodity statement is finished, th 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 e response is typically a tepid “uh huh” accompanied with glazed-over eyes. That’s not the resp 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 nse you want is it? If you want to attract business, your tactic should be to engage the person nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically you are speaking with so you can impress them with the benefits of being your client. In order 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 to impress, you have to describe your product or services in terms the listener can relate to an ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi d to make them understand what makes you stand out from your competition. Imagine if a banker s ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a aid, “I help people maximize their ability to finance their business” or a florist saying, “I ma dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod e brides feel so special on their wedding day” instead of “I’m a banker, “I’m a florist.” If cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin you engage your listener the response you get is usually, “how do you do that?” It allows you t tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen talk about your creativity, your passion for being of service, your level of quality, your comm 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 itment to making a difference in your clients’ lives. It allows you to tell a story that adds t ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust e very human emotions of pain, hope, trust, fear, and appreciation as well as resolution, commit y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ment, and ultimately “happy endings.” Your listener can relate to that story, can imagine being . 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 in that situation, and will become emotionally attached to story’s people, situations, and outco elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip mes. So create a story to describe, “what you do for a living.” It was a dark and stormy night 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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