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Main Subject - Walk with the Wise
Absolutely the best business/life decision I've made in the past few years was to start ha 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 nging out with people who are smarter than me. It's like Proverbs 13:20, “Whoever walks ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ith the wise becomes wise, but the companion of fools will suffer harm.” If you want to make lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. a name for yourself, you must make friends, hang out with and learn from other people who hav here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe e already made a name for themselves. Here is the process I’ve been following for years: d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro STEP ONE: Initial Contact Call or email someone you’d like to glean valuable advice 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 from. Introduce yourself. If you have a mutual friend or contact, say that immediately. Ex 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 plain to the person that you’re “young” (in age, job, career, etc.) and would greatly appreci nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically te the opportunity to pick their brain. Suggest a breakfast or lunch meeting. STEP TWO: 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 nitial Meeting Look sharp, arrive early and be prepared. Bring something to take no ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi es with and any relevant items you’d like to share with your wise friend. Have a list of que ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a stions prepared. Shut up and listen. Take notes furiously. And when the check comes, insis dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod on paying. STEP THREE: Thank You The minute you get back to your office, write cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin thank you note either via email or handwritten. (Handwritten is better.) Promise to keep y tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen our wise friend updated on your progress. STEP FOUR: Progress Report On a freque 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 t, yet not too annoying basis, call/email the person with an update on your progress. Be sur ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust to tell he or she which pieces of their advice you actually used. If by using that advice y y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ou’ve won an award, made a sale or received any kind of visual representation of success, sen . 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 them a copy. LET ME ASK YA THIS... Do you walk with the wise? LET ME SUGGES elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip THIS... Contact five new wise people in the next month. Let me know what you learn 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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