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Digg It - Are You Good, Great Or Awesome?
Are you good, great or awesome? One of the early lessons I learned about speaking (and bus 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 iness as a whole) was from Lou Heckler. Man, talk about a great last name for a humorist, ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in uh? Anyway, here’s what Lou told me in 2003. I never forgot it: There are three kinds lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. of speakers in the world. First, there’s a GOOD speaker. After he’s done with his talk, a here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe dience members come up to him, shake his hand and say, “Good speech. Thanks a lot!” Then, d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro there’s a GREAT speaker. After he’s done with his talk, audience members come up to him, s 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 ake is hand and say, “Great speech! That story about that guy you met on the bus really hi 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 a nerve. Thanks a lot!” Then, there’s an AWESOME speaker. After he’s done with his talk nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically audience members come up to him; but instead of shaking his hand, they give him a business 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 card and say, “I want you to do that for my company.” Wow. And this isn’t just about ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi iving speeches, either. This is about value. This is about perception. FOR EXAMPLE: a pr ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a spect comes to your website. He has a look around. And then he emails you with one of the dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod following responses: 1. Dear You: I just stumbled across your site, and I’ve got to say – cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin t’s really good. Thanks a lot. Sincerely, Mike. 2. Dear You: I just stumbled across your tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen site, and I’ve got to say – it’s really great! Love those articles and video testimonials! 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 Sincerely, Mike. 3. Dear You: I just stumbled across your site, and I want to hire you. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust all me this afternoon. Sincerely, Mike. Which email would you want? THE BOTTOM LINE: thi y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products is about excelling at doing what you do … particularly in front of people who can buy fro . 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 you NOW. Good. Great. Awesome. Take your pick. LET ME ASK YA THIS.. elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip Are you good, great or awesome? LET ME SUGGEST THIS... Email me and explain why 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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