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Top Adding - How Our Business Is Like A Rose
We have all seen a rose bush. That beautiful rose, all closed up. We are waiting fo 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 r it to open up, watch it blossom and grow. When I saw one the other day, it start ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in d me thinking. That roses are like many new businesses. A new business starts out lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. s one of many, like our rose is one of many on that bush. Some roses blossom and so here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe e don’t. Some last longer than others, and some just drop off, break or die just li d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ke businesses do. The first rose is the beginning ( a chance for our business to g 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 ow). In the beginning days of our new venture everything is wonderful, fresh, we se 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 all the possibilities. However, as we move along (down the stem of our rose) we en nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ounter some thorns. The thorns are the things that can go wrong. They are the littl 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 e bumps and problems we all encounter in our business. However, we continue to move ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi down the stem and grow our business. Every business has it thorns. Moving down th ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a stem is moving forward and growing the business, letting it blossom and open, util dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod zing all the petals. Realizing that some petals are going to fall off, but the rose cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin is still there. Some people will insist in their business things are always rosy, tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen that there are no thorns. Come on, no thorns, no problems. Sorry, I can’t believe t 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 at. All of the various businesses I’ve both run and worked for had there own set of ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust problems. However, if you nurture and take the steps to take care of the rose, it y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products will blossom and renew itself on a yearly basis, just like our businesses which con . 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 inue year after year, with something new happening each year. So let today be the elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ay you allow your business to start blossoming! Copyright 2007, DeFiore Enterprise 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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