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Main Subject - Aunt Cecile's Tremendous Negotiation Tip
My Aunt Cecile, rest her soul, shared a secret with me before heading off to the happy hunting ground. “Gary, if 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 nyone asks you an embarrassing question, or simply one you don’t care to answer, just pretend that you didn’t hear ; 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. Usually, they won’t ask it twice.” Being the teenager I was, inexperienced in the ways of grown-up communicati lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ns, I thought there was something wrong with this morsel of wisdom. I had been taught it is impolite not to listen here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe to others, and it is outright rude to ignore them. So, where did her advice leave me? Wondering when I would use d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro it, for one thing. But as the years passed, I become more assertive and I encountered at least my share of unfrien 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 ly, if not altogether impertinent questions, so I put my Aunt’s prescription to the test, especially in negotiation 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 s. You can’t imagine how impressed I was the first time it actually worked. I thought I’d be hounded by the people nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically whose queries fell on deaf ears. I was wrong. Seldom did they ask the same question twice, and generally, once t 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 ey heard how brash they sounded, I suppose they thought better of repeating it. This “turning a deaf ear” to quest ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ions you don’t want to answer definitely has a place in negotiating. Just today, a realtor emailed me about sellin ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a g a property and he wanted to know two things: (1) What is the price I’ll accept; and (2) How much of a loan will I dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod carry? Both questions are disadvantageous to answer. To the first, I suggested he bring in a genuine offer and we’ cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ll see if it is appropriate. And, borrowing from Cecile, I didn’t even respond to the second. Why talk terms when tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen you haven’t even seen a decent offer based on price? If he’s savvy, he’ll repeat or rephrase his loan question, b 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 if I’m lucky, it will recede, at least for the time being. My Aunt’s ploy is easier to use in an exchange of ema ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ils or faxes than in someone’s company, but I suggest you try it in both settings. The idea that you simply MUST A y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products NSWER all questions posed is absolute nonsense in a negotiation. As any experienced public speaker or politician wi . 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 l tell you, there are such things as hostile questions that simply must be ignored, rephrased, or at least delayed. elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip So, don’t be suckered into answering them when they put you at a disadvantage or jar you out of your comfort zone 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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