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Digg It - Leadership and the Harry Potter Syndrome
When looking at filling first/middle level leadership positions, the vast majority of organizations commendably prefer to promote from within. Unfo 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 rtunately, with few exceptions, the vast majority of organizations suffer from the Harry Potter Syndrome of leadership development. The day of pro ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in motion Congratulations, the position is filled. It may be a big announcement or a simple handshake in your new superior’s office. But at some poin lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. t, you get wacked over the head with a something like Harry Potter’s magic wand and poof, YOU ARE NOW A MANAGER. You will start the following Monda here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe y and thanks to the abracadabra of the magic wand, you will now BE A MANAGER. But nobody knows the batteries died a long time ago Oops, but that d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ame magic wand that was suppose to instantaneously give you all the skills you need to be an effective manager has dead batteries in it. It actuall 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 y hasn’t worked for a long time, if at all. So there you are, Monday morning, in your new office, phone is ringing, people are screaming and your n 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 ew boss is telling you that you need to get to your first of umpteen meetings for the day and you didn’t become magically transformed into superman nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ager. Ahem. How embarrassing. So you quietly take a sheet of paper, title it to-do list, and make your first entry…one case of Pepto-Bismol, priori 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 ty urgent. Welcome to your first day in your new position. So how does a manager become a manager? There are two methods that have been used thro ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi gh the ages. The first is imitation. You had a boss that you liked, and so you now attempt to do it the way she did. This may or may not work with ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a who you are and that leads us to the second method. If you are a sincere, reflective new manager, that second method is trial and error, where you dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod try something out, make mistakes and learn from them. If you are not, or like most people, just don’t have the time to be able to observe and refl cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ect on your managerial actions, the second method is called trial and error and error and error and so on. The consequences for the organization st tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen arts out as a ripple, and like an approaching hurricane with the ripples turning into waves and wind building to a furious onslaught until the dama 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 e done increases to such a degree it becomes difficult to repair. To improve the results at the end, you have to start at the beginning Each orga ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust nization that wishes to promote and create a leader, needs to fully support and develop that leader, so that they can become the productive manager y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products you need them to be. Provide a systemic developmental process which acknowledges that a truly effective manager produces increased value, producti . 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 on and results at every level of contact, as well as reduce those Pepto-Bismol costs. The investment in developing a manager to be a positive asset elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip for the organization provides one of the strongest ROI’s for any business. And don’t forget to take that magic wand and put it away. Far, far away 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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