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Digg It - Olympic Size Disappointment - Are any of us Really Surprised?
In a nation full of superstars one has to wonder why we fail so often as a team. The Olympic Team did not fail because of the number of gold medals won or lost. The Olympic Team faile 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 d because they were anything but a team. The amazing athletes that represented the United States in the Olympic Games should be both honored and respected. These same Olympians, howev ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in er, should remind us about how we succeed or fail as a team. The greatest images of any team, whether it be an Olympic Team or any sports team is not them holding a medal, a trophy or lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. some other symbol of their accomplishment. The greatest images are the camaraderie, the banning together, the images that exemplify and glorify what it means to be a team. In a nation here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe full of some of the most talented men and women in every field it is somewhat disconcerting that we do not accomplish more in our individual professions. With so much talent the possi d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro bilities for success are nearly boundless. Perhaps it is the talent itself that is our biggest obstacle as so many people try to be everything rather than something. Rather than being 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 a cog in a highly successful wheel, they try to be the wheel. Even in a profession as seemingly simple as website designing and marketing, we see this same flaw time and time again. 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 Rather than building a team of talented people, each a superstar in his or her own area of expertise, every superstar tries to do it all and in the end accomplishes nothing. Team build nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ing is probably the most important need in any and every business, yet team building is one of the most overlooked, underfunded, undervalued resources. The most successful companies un 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 derstand the importance of team building. A successful team starts with assembling the most talented staff and then working with that staff to foster a team atmosphere and a team menta ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi lity where the entire team shares in success and works together to overcome disappointment. The natural competitiveness in all of us often leads us to ignore the team and concentrate o ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a n the individual. The measure of success becomes the success of the individual rather than the success of the team. Think about how much a team can accomplish when the natural competi dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod tiveness in all of us leads us to not compete with our colleagues and team mates, but compete with other teams, obstacles or tasks. When we watch a group of small children playing toge cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ther or working together on a project like building a snowman or a clubhouse we can learn a lot from them. When they are working together towards a common goal with no thoughts of "I" tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen but just of working together as a team, it is amazing what this group can accomplish. Unfortunately, if you take that same group of children and assemble them 20 years later as adults, 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 that same team would likely be unable to agree on how to make a snowball rather than a snowman. When we learn as a culture to value teamwork and the success of a team there is no tell ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ing what our teams in the business world, medical world and sports world will accomplish. When we value team building above star building we may start to truly see the amazing things w y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products e can accomplish. The Olympic Team did not fail us, we failed the Olympic Team just as we fail team after team by not valuing team accomplishments as highly as we value individual acco . 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 mplishments. In a Nation of the most talented men and women in every field of business, sport and entertainment it is only a matter of time before this talent bans together and forms t elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip eams that will go down in history for accomplishing more than any individual can ever hope to accomplish and then as a nation we will finally understand the importance of team building. 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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