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Useful Advices - Business Chemistry
Have you ever been to a networking meeting and felt totally out of place an 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 awkward? Or have you ever been part of a conversation when someone enters ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in it and the whole group falls apart? Sometimes this happens to us all. It on lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. y means that the atmosphere or chemistry of the group does not match our ou here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe look. Good chemistry in a room has energy, people talk and smile. There see d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro s to be a good feeling when you arrive. But what happens when there is not 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 chemistry and you walk into the room and everything is dead? There will alw 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 ys be someone who tries to liven up the crowd but usually fails. If you loo nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically around, you may be able to pin-point the problem. Do you remember the per 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 onality test we did? If you quickly analyze the mix of personalities in the ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi room, you may find there are too many Lions or Beavers to get the excitemen ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a t going. See if you can engage them in a conversation about a serious subje dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod t rather than trying to get the crowd to be livelier. If that fails, it is cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ime to go home and try again another time. When chemistry is lacking, you tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ften have to dig very deep to gather the strength to start a conversation. 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 ven at that, you need to like the place you are in. By trying to change you ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust r own attitude, you may change the mood others seem to be in. Another tact y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products c for the lack of chemistry is to find someone else in your organization to . 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 make the connection. If you have learned about personality types, then you elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip hould be able to match this potential client with the appropriate colleague 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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