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Suggest - Power that Lies Within Accountability
First off... Allow me to breakdown the word *POWER*. Power is the ability to create explosive results that lies within people and things. Think a 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 bout the power within a stick of *dynamite*. There is also power within a vehicle – like an automobile. When you press the pedal, the power that li ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in es within the vehicle is ignited by the pedal. Similarly, the power that lies within the rocket ship is ignited by the fuel tanks inside of the roc lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ket. Now, let me share with you the power that lies within the word - *Accountability* Everybody... Who? Everybody... Once again, let me repeat here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe myself. Everybody means YOU! Everybody needs to be accountable to someone. The word accountability means the ability to be accounted for. For exam d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ple, anytime somebody goes on an airplane the flight attendant does a final seat count and states that all the passengers are accounted for. Which 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 means they are in their seats, they are strapped in, have their seatbelt on and are ready to go to their destination. Unfortunately, 97% of people 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 aren’t accountable to anyone. Being accountable to a boss is a joke. Meaning you show up at your job, you do your job, you go home, and you get pai nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically d. We are talking about an accountability partner. Someone that truly will stretch you, care about you and make you feel uncomfortable enough to gr 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 ow in order for you to fulfill and live your Why. That is the power of accountability. You have to ask yourself *3* questions... “Who am I account ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi able to?” “When am I accountable to them?” “How am I accountable to them?” All of my top elite coaching students are accountable to me. Check ou ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a t the power that lies within *Accountability*... The last thing any of my students want to do is email or call me for their accountability update a dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod nd say, “John, I have done nothing in order to fulfill and live my Why". Now, let’s parlay this into what people actually do in life that have no a cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ccountability partner. - - *Nothing* - - So here is what I want to ask you today... “Are you willing to stretch yourself?" "Are you willing to e tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ngage an accountability partner?” I highly suggest you have a coach (aka mentor). Not a life coach and not a baby coach. Not someone who will say, 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 “Great job, great job…” when you are truly doing nothing. Someone that is going to stretch you, make you uncomfortable in order to become comforta ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ble, every single day. Everyone has a real need for accountability because the power of your future lies within the word accountability. The questi y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ons you have to ask yourself are: “Who am I accountable to?” “When am I accountable to them?” “How am I accountable to them?” If you are not acc . 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 ountable, take a look at the statistics...97% of people at the age 65 are dead or dead broke. The major reason is because they are not being accoun elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip table for anything or to anyone. I believe in you and I believe you are worth a lot more than that. I believe you have the power to be accountable. 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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