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Digg It - Back To The Future – The Love We Once Had
Why falling ‘out of love’ with your business sentences you to failure. Ms D Reamer, set up her gardening business almost three years ago. Now she sat 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 patiently in The Business GP’s waiting room. Receptionist: Ms Reamer, the Business GP will see you now. Ms R: Thank you very much. Ms R makes ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in her way down the corridor thoughts running like freight trains through her head. The echo of the knock on the door brings her back to reality. A calm lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. , collected voice beckons her in from the other side. GP: Good morning Rebecca, how are you doing today? Ms R: Doctor I am drawn towards a feeling of here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe despair. GP: Really! That is serious, could you elaborate more as to why you feel that way? Ms R: Well I will try. You see, my business is doing r d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro eally well. (Pauses) GP: That is good though so there must be more. Ms R: Yes, well, er, oh I just can't figure it out. Business is ‘booming’ but I 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 can’t seem to make it work for me. GP: Describe the symptoms for me please. Ms R: I seem to need more and more staff and make less and less money. G 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 P: Hmmmmmm I have seen this before. Ms R: You have? (The sense of relief is apparent across her face) So what is it that I am missing? The Business G nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically P wrote on a piece of paper and passed it to Ms D Reamer. Ms R: LOVE?????? GP: Well simply you have ‘fallen out of love with your business’ and need 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 to go ‘back to the future’ to see where it went wrong. Ms R: But I love my job (in a very defensive manner). GP: I have no doubt that you love your j ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi b but you have fallen out of love with it to some extent. We need to find how, what has changed? Tell me about your job when you first started. Ms R ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a : Well I would tidy up gardens and make them look presentable. GP: That involved pruning – yes? Ms R: Yes GP: How did you do that? Ms R: Well I pru dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ned a bush for example and placed the cuttings in a bin. GP: What happens now then? Ms R: Well I am so busy now that I prune and someone else will ti cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin dy up. GP: Thought so. Ms R: What? GP: Problems in business tend to be simple. I have a philosophy called ‘Renaissance Management’ which will expla tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen in in more detail. Ms R: Sounds perfect – how do I find out more? GP: I run surgeries on it but also find out about it here http://en.wikipedia.org/w 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 iki/Renaissance_Management Ms R: Fantastic so what do I need to do? GP: You need to love your business again. By employing ‘cleaners’ you have gener ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ated more work. Employ more gardeners and clean as you go. It might not sound a lot but the extra 8 feet (the distance from the top of the bin to the y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products floor and back again) makes more work for no reason. Keep it simple and love every detail don’t try and palm off the bits you don’t like. Ms R: That . 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 is fantastic. The GP writes a prescription and passes it to Ms R. Ms R: Keep it simple! Why thank you so much GP: My pleasure Rebecca call in whene elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ver you need any help Ms R leaves and The Business GP completes the file. He picks up the phone ‘Jean, I will see the ‘Renaissance Selling’ team now. 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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