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Digg It - The Art of Leadership: Part One
How do we begin to understand the art of leadership and its indisputable importance in today’s 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 orld? Research, theory, and general musings on the topic can be found in abundance. In fact, i ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in f you were to do an online search of “leadership,” you’d find literally millions of entries. We lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. tried this recently and unearthed 173,000,000 on Google alone. We read, hear, and talk about l here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe eadership all the time. We read about the executives at the helm of corporate giants, like GE, d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro and high profile non-profit organizations, such as the American Red Cross. We engage in heated 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 debate about the leaders of our nation, the U.N., the local school board, and our houses of wors 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 hip. The context varies but the importance of strong leadership does not. At its essence, lead nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ership is about inspiring others to follow. (As the proverb goes, “If you think you are leading 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 but no one is following, you are simply taking a walk.”) Some postulate that leadership is fun ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi damentally about influence. Others assert that it’s about creating positive change, refusing to ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a be content with the status quo. Still others focus on the leader’s role in developing and comm dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod unicating a powerful vision… and instilling in others the collective passion to see that vision cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin fulfilled. It’s all true. A great leader knows how to inspire and motivate those around her. tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen She knows how to get the most out of her followers. She skillfully focuses her constituents on 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 the fulfillment of the organization’s goals. An exemplary leader earns the dedication and loyal ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ty of his people. He fosters commitment and trust. His followers would, literally or figurativ y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ely, follow him straight into battle. Perhaps it’s time to ask yourself: Whom would you willing . 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 ly follow into battle? What do they do to inspire this level of trust and dedication? How can elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip you learn from them to further develop your own skills and become a truly great leader of people 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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