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Digg It - Meaning and Marketing - The Eye of the Storm
It's 1954. Yes, Mrs. Patricia Smith has been a good teacher today. She has remained on task and kept her Third Grade Pupils in line. But she doesn't have to work too hard at it. She weighs 200 Lbs and if she ever grabs you and shakes you, and you can see the buttons on her blouse coming at you at almost the speed of light, so much so that you end up hypnotized and your brain feels like a pea soup - this is something you're not going to forget any time soon. It can happen. Believe me. It can happen. So 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 you had better behave. So the pulpils sit real quietly, very quietly at their desks, and look at the clock 3 feet up the wall above the black board behind Mrs. Smith's large self. Sometimes, Mrs. Smith, grows tired, sits in a chair in front of the class, spreads her legs just a bit so that you can see her thighs and a thin sheet of white to hide her crotch. The pupils sort of smile at each other as they lay their heads in their arms and peer away. To amuse herself and the class, Mrs. Smith talks a ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in bout her son George and what a good boy he is. He's her only son, her only beloved son, and they know it...have heard it time after time after time. And this kid can do no wrong. AND THEY BELIEVE IT! About half-way through the school year, Mrs. Smith brings her 3 year old Son to class to spend the day, and that's an experience none of them will ever forget. He's hyperactive and makes a wreck of the whole day for everybody. And Mrs. Smith never punishes him even one time. How does he get away with that? T lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. EY WANT TO KNOW BUT ARE AFRAID TO ASK. The pupils, however, don't lack for amusement on the day when George is present. He's an Amusement Park Incarnate. But this is now on a different day. It's now the future, after George, and... It's 10:00am and recess is only 30 minutes away. Mrs. Smith gets up from her chair, picks up a piece of chalk, and begins the most seminal lesson in all human history. She has already taught the class about conjugating verbs and now she is going to teach them how to conjug here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ate the verb "To Be". And she writes on the blackboard as follows: Singular Plural 1st. Person I AM We are 2nd. Person You are You are 3rd. Person He/She/It IS They are Mrs. Smith doesn't know it, but she has just placed the name of the Creator of the Universe on the black board and the Creator is very pleased because He/She/It likes to be seen, especially by children. The Name is - I AM. However, Mrs. d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro mith is squeezing the chalk a bit too tightly because she has just had a thought about George and the Lord of the Universe is feeling the pain. I AM has never felt so much pain since the "Big Bang". Let's just say that IT IS - right now - is having a case of upset stomach. (This is only a metaphor, of course, but it is as good as any. When it comes to I AM, be careful. Just use metaphors) Mrs. Smith feels the chalk getting hot in her hand. She looks at the chalk and is mesmerized. She trembles becau 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 se IT now has a light pink glow to it. Suddenly, like in the movie Star Wars, an image of a person appears on her left and another image of another person to her right. The person on her left is Greek. She's sure of it because she has a replica of an ancient Greek Vase on her mantle at home with a picture similar to his on it. Because George is only 3 years old and can't reach it yet, the Vase is still in one piece. Mrs. Smith takes comfort in that remembrance even in the present moment with this "st 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 anger" standing to her left. Her focus is amazing. To her right, again, out of nowhere, has appeared an image of a 19th Century Scientist with a head full of graying unrulely hair. She recognizes him too from his picture in a recent issue of Life Magazine. Also, she has read about him in science books since her own 5th grade. (Mrs. Smith likes to read and she likes to read, of course, to you know who...) She looks at them both, turning her head one way, then the other way. Then she looks again a nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically t the chalk in her hand, which has now dissolved. It is now a thin film of white spreading up her hand and arm beneath her blouse and shows no sign of stopping. If this keeps happening, she is going to look like Casper the Ghost and she knows it. The pupils meanwhile see nothing, hear nothing, but do catch a wind as at an Exit at the ground floor of a Skyscraper and an odd smell. Still, they are watching the clock very, very carefully, as they always do. The Scientist on Mrs. Smith's right whisper 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 into her ear - "Hurry, you must run and save the children." The Greek on her left says nothing, but has a look of profound sadness on his face because he would wish to take her place. But it is too late for that and he is feeling very unlucky. But he is there to grant her moral and spiritual support and to be a witness to this great event. It's suppose to be a privilege, but... "Why could He not have been 'Chosin'?" (One of my Links) Meanwhile, I AM, back at HIS?HER?ITS? Castle, is doing some quick ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi math. With not even a moment for thought, Mrs. Smith bolts from the Classroom. The children are in shock because their teacher has just disappeared. Vanished! Also, the Door to the Classroom has vanished! Did I AM borrow the door? They are now feeling a slight tingling in their ears, but nothing more, and there is very little dust. Where is Mrs. Smith now? Mrs. Smith is free of the building and is flying faster than Superwoman. In two seconds she is over Pilot knob. Another five seconds, she ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a is over West Virginia; another five, she is over Canada and gaining speed. Moments laters, she is 1,000 miles high over the North Pole and heading into outer space in an almost perfect straight line. But she just keeps on moving. She doesn't know why. She only knows that she MUST. It's almost as if she has the energy of George inside of her to drive her forward like a supercharged engine. It's an interesting feeling! Now what she doesn't know won't hurt her. She's fast approaching the Speed of Li dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ht, 186,000 miles per second. She now has shattered the Speed Limit of the Universe and there are no Star Wars Cops to catch her or pull her over. But she keeps on running and running and running. Her body is now the size of a Proton, but with the same Mass plus the Door - 239 lbs. She feels nothing, sees nothing. She just knows that SHE IS and that's all that matters. Now she knows, without knowing it, what Plato wanted. Time and Space have been left behind and she is now approaching an Unknown quant cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ity - the Speed of Light squared. She is now located somewhere beyond the farthest galaxy 20 billion light years from earth and she is fast approaching the edge of the Universe. Of course, as in any good movie, or in our Imaginations, she penetrates the hymen of the Universe One Hundred Trillion of a Trillionth of a Second before she reaches that magical threshold of speed. You know enough math to figure it out - her body mass plus the door, 239 lbs, times the speed of light squared. It's not much tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen or I AM to work with, but it's just enough. Thank you, Mrs. Smith. Thank you! Suddenly, there is a Terrible Singularity. There are no laws or rules or theories of any kind, nor is there language. The temperature is so hot, it's cold, but if you want to know - its around 6 trillion trillion degrees Fahrenheit. A brand new universe has just been born beyond the boundary of our own and it is growing temporarily, until the temperature cools down, at a speed much faster than the speed of light in any direc 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 tion it wants to. As this new expanding Universe cools down, 'ittle, bitty particles much smaller than atoms will form, and these will somehow find each other and get together and make hay, and you know the rest of the story.... don't you? No you don't. Neither do I. You see, the Imagination is Infinite. I AM smiles at the Greek Man and at the Scientist and says, "You've done a good deed today and I sure do appreciate it." And I AM is feeling much better already. However, a second thought com ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust s to MIND. I AM looks around Himself/Herself/Itself and wonders, "Where's George?" Then, just as suddenly, I AM disppears,as if HE IS is running for His/Her/Its own life. The Clock in the Classroom now stands at 10:30am. and the children have gleefully gone outside to the play while the Principal goes in search of Mrs. Smith and the school custodian. End of Story, except that.... "Whoa!" to all you Marketers! Before you go out to the Play Ground of Life to do your business, I want to make sure you h y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ave learned this lesson well: HE IS. Therefore, YOU ARE. HE IS is in you; YOU ARE are in I AM. What are you going to do with I AM? More importantly, what is I AM going to do with you? How much POWER do you have? (You will need some scales to find out exactly if you are caught up purely in the physical world) What are you going to do with it? I have just walked out my back door. It's @ 7:00am. A fall Spider has woven its web. Trapped inside the web is a lightning bug. The Spider devours . 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 the glowing bug. I have never seen this before. It is a Sign and a Wonder. TEST: How much power does the Spider now have and what is She going to do with it? (Answer to be provided in Meaning and Marketing: The WILL) Resources: Other Articles in this series Under the title of Meaning and Marketing: The Hurricane, The WILL, the Links, the Trigger Plato's "Apologia" Five Dialogues Plato, G. M. Grube, Grube G. M. A. (Translator) The Bible, Exodus, Chapter 3:14 The Bible, Gospel Of John, Ch elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip apter 8:58 The Bible, Gospel of Mark, Chapter 10:15 (That's A.M. EST) E = mc?: A Biography of the World's Most Famous Equation David Bodanis Einstein in Love: A Scientific Romance Dennis Overbye Dear Professor Einstein: Albert Einstein's Letters to and from Children Alice Calaprice (Editor), Foreword by Evelyn Einstein Chosin: Heroic Ordeal of the Korean War Eric M. Hammel THE TRIGGER: http://home.hawaii.rr.com/chosin/Main.html 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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