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E-Folder - Strategic Planning - Who Is Missing from Your C Level Executive Team
Strategic planning is truly about executing a continuous process improvement plan. Ideally, specific strategies (thoughts 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 ) and tactics (actions) usually created within the C-Level Executive Team cascade down throughout the organization touchi ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ng each and every department and employee. Within most executive business management teams, there are the following indi lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. viduals (in smaller companies these roles maybe combined):
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe Financial Officer
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro Technology Officer
These C Level Executives are responsible for managing the strategic plan and answerable ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc to the Board of Directors, the shareholders and their employees. What is consistently missing from the C-Level Executive 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 team is the CPO or the Chief People Officer. Robert H. Waterman wrote that "Organizations exist for only one purpose: nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically to help people reach ends together that they couldn't achieve individually." Since organization are comprised of pe 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 ople and people are needed to execute the strategic plan, does it not make sense to have a Chief People Officer? The exc ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi usion of the Chief People Officer from the C-Level business management team and overall operations truly reinforces that ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a the things within the business are more important than the people. During the last 20 years as technology exploded in th dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod e business world, companies were quick to identify a CIO (Chief Information Officer) and a CTO (Chief Technology Officer) cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin . Now in the 21st Century almost every company has someone in these roles. Yet, people, the mainstay of any organizatio tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen n, are still not given the same recognition as bits of information or pieces of hardware. Is it a wonder that the execut 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 on of the strategic plan still foils many organizations? Human capital is a far greater asset than information and hardw ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust are. Without people, the need for all the currently identified C-Level executives would not exist. For it is the people y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products who market, sell, make and deliver the products and services. If you are a CEO, maybe now is the time to reconstruct yo . 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 ur C-Level Executive team to reserve a place at your management table for your Chief People Officer (CPO). Who knows, yo elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip 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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