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Main Subject - Leadership v Management
Change is one of the only certainties in life – it is constant. How we adapt to change will be one of the most determining factor in evaluating our successes or our failures. • where we end up. • who we end up with. • and what we’ve got. Change is never more appar 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 ent than in our personal development - physical - physiological - mental. • we are one time a son, to become a man, a father and on to grandfather as we proceed from infancy through to adult and old age • we are born frail and weak – gaining in strength only to r ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in turn to frailty and weakness again. • from knowing nothing to - knowing everything and on to - knowing a little bit well. Or for the true seeker – to realize that in the end ‘we know nothing’. In the business world there is also a hierarchical process of change as lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. videnced by those who become truly successful. It is this writer’s observation that those who rise to spectacular heights in their business endeavours move through a state of management into one of leadership. • from managing things to leading people. In the process here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe of making this exciting change it is necessary to move through 3 various states of dependency. 1. True dependency – as in an infants dependency on the mother. 2. Independence – like the state called ‘adolescence’ 3. Interdependence – a state of mutual support in a d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro l aspects of endeavour – playing our part well in the operation of the whole. • It is in the state of interdependence that the qualities necessary for true leadership emerge. Management is the process of assuring that the program and objectives of the organization ar 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 implemented. Leadership on the other hand, has to do with being a visionary and engaging others in the dream – exciting people and motivating them to perform to the best of their abilities. • People are tired of being Managed Richard Kerr states this in a most sim 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 le and humorous manner when he says: - “People don’t want to be managed - They want to be led. - Whoever heard of a world manager? - World leader, yes. - Education leader, yes. Political leader - Religious leader - Scout leader - Community leader - Labour leader - nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically Business leader – Yes! - They lead. - They don’t manage. - The carrot always wins over the stick. Ask your horse. You can lead a horse to water, but you can’t manage him to drink. If you want to manage somebody, manage yourself. Do that well and you’ll be ready t 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 stop managing and start leading”. John C. Maxwell, in his book ‘Develop the Leader Within You’ says that he remembers the words from the president of Hyatt Hotels: - “If there is anything that I have learned in my 27 years in the service industry, it is this – 99% o ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi all employees want to do a good job. How they perform is simply a reflection of the one for whom they work.’ • Leadership is a condition that can be acquired through applying principles. • Leadership in business is developed not discovered. Granted, some people ar ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a e born with leadership qualities but most leaders develop their skills through: - mentoring - training and - developing, dare I say it, self discipline. • Leadership is a state of personal awareness first and foremost. If we are serious about success in an ever-ex dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod anding global business market we must first develop an attitude of personal integrity. The business person that spends time honing their personal integrity will not only be successful in business but will find themself in a position of high regard and will be sought a cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ter by others for counsel on many topics. Outside-In v Inside-Out As we in Australia shift our focus away from the traditional markets in Europe and North America and begin to communicate more with our Asian counterparts, especially the Republic of China, we are face tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen with a dilemma. The methods of doing business in regards to the peripherals - Products - Marketing - Service are the same everywhere - but the manner in which we approach business – the manner in which we communicate with our counterparts in the Asian market – we 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 l, now that’s a different kettle of fish. We are faced with an oriental mind-set that has been shaped by a philosophy that is thousands of years old – a product of logic and manner that at times seems to be unfathomable to the western mind. To come to grips and under ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust stand this difference in philosophy will require a shift in thinking – one that moves away from management toward the highly pro-active state of leadership. I heard it many years ago and the words resound as strong to-day as then – You can tell a lot about a person by y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products the books they read and the people that they associate with. In other words, it’s time to go back to school and study – to learn how to become a person that commands respect and consequently, takes on the mantle of leadership. A leader is best When people barely . 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 know that he exists, Not so good when people obey and acclaim him, Worst when they despise him. ‘Fail to honour people, They fail to honour you;’ But of a good leader, who talks little, When his work is done, his aim fulfilled, They w elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ll all say, ‘We did this ourselves.’ All the best in reaching your individual potential and if ‘leadership’ is your goal – don’t forget to look behind occasionally to see who is following. Copyright, 2006, Double K Pty Ltd Thank you kevin@thehealtheducator.co 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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