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Your Space - Ever Lost A Job Or A Business - Welcome To The Club
I can recall over 30 years ago when I was fired from my first sales position. I had two c 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 hildren with another one on the way and not a spare dime to my name. I can remember as if ; 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 were yesterday the overwhelming sense of desperation I felt. I was letting my family d lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. wn; I was even letting myself down. I didn’t know what to do or where to turn. I only kne here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe I needed a job and I needed one NOW. Several years after that, I also lost a business. d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro he story and the gory details are too long to burden you with. Suffice it to say, I once 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 again felt this tremendous sense of despair. Everything I had worked so hard for was gone 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 in less than a week. What defines you? Your success? Your position? Your power or fame? nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically s it who you know or play golf with? It’s just a job, folks – nothing more. You got that 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 one; you can get another one. Now, I am not an advocate of jumping from one ship to the n ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi xt every six months or every time your boss or company does something you dislike. But, f ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ew people today stay at the same job or career their entire life. If you have, I salute y dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod u. If you haven’t, I would ask you what were your reasons for leaving? Jobs are about wo cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin k, not fun. We don’t tell our friends that we can’t stay out late partying because we ha tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen e to go to ‘fun’ tomorrow. We work so we can create lifestyle – so we can have fun, trav 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 l, spend, etc. If you find yourself out of work, see it as an opportunity to improve you ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust rself, your life, your lifestyle or your relationship with someone. See it as an opportun y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ty to get into another position or career that is more consistent with your goals, needs, . 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 desires or philosophy. Whining won’t help. Complaining won’t help. Blaming others won’t elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip elp. Feeling sorry for yourself won’t help. Giving up won’t help. Got it? Now go for it 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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