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Advice You - Joint Venture Success Depends on Analysis
We need to know what's going on in our businesses if we intend to follow Michael Gerber's famous advi 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 ce and "work ON our businesses, instead of IN our businesses". The biggest enemy of objective analysi ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in is EGO. We want to be right, we don't want to admit to our fears, mistakes and failures, and we want lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. to look good. Gary Player said, "Sales is Ego; Profit is Reality." He's right. Successful entrepreneu here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe s forget about popularity, being politically correct or their own egos. They are self confident and s d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro rong and they measure the bottom line. Successful Joint Venture Brokers are objective, proactive and 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 ast moving. Joint Ventures are the most effective business tool available. They allow us to build ma 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 sive profits, overnight, with no money or risk and very little time, by leveraging existing resources nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically After 18 years of Joint Venture experience, I have come up with a few questions we should ask oursel 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 es and standards by which we should measure whether or not to accept or institute or continue with a ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi oint Venture. 1. Is this the best use of my time and resources, or do I have a better alternative? ( ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a If another alternative is better, cut bait.) 2. Am I spending my own time, money and resources, or a dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod I using other peoples' time, money and resources? (We should use other peoples' resources. 3. Am I cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin cting as a salesperson / hired gun? (If so, walk away immediately.) 4. Is this deal as good as I tho tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ght it would be? Is the other party doing what he or she said they would? Am I still comfortable with 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 this, or should I drop it? 5. Is this win/win and does every party benefit, or is someone being take ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust advantage of? 6. Are my partners ethical, honest and professional? 7. How can I add a back end, fu y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ther leverage this situation, increase profits and/or distribution, or sell the deal? 8. Where can I . 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 learn more about Joint Ventures? 9. How can I meet better JV partners and find better deals? (My Net elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ORK determines my NetWORTH). 10. Are my resources being optimized? Do I have underutilized resources 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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