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E-Folder - Who's Got Your Back? Joint Ventures
Entrepreneurs understand how important it is to surround oneself with strong, dependable, loyal and able people. It’s been said that, in the he 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 at of battle, the soldiers who stand by you are not the college kids and the pretty boys, but rather the ex cons, thugs, drifters and pimps. Wh ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in en the bullets are flying, somehow a PhD or MBA doesn’t make much of a difference. If you were about to trek across the ice to the North Pole, lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. whom would you choose to be on your team? Whom would you trust with your life? Would you choose someone from Greenpeace or someone from the Ma here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe rines? A “peacekeeper” or a warrior? I want the toughest character can find on my side, not some politically correct wimp who’s scared of hurti d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro g a tree or upsetting an owl’s nest. I want people who are serious about success, hungry, fearless, determined and very, very disciplined. How 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 about you? The team you build will mirror, or at least strongly aspire to, your level of integrity, motivation, professionalism and drive. You 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 r “Inner Circle” should be very carefully selected, vetted and constantly trained and tested. And when you see cracks in their veneer, you shou nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ld remove them from your orbit – fast. Sincerity, grit and focus should be a requirement, not an optional extra. Your team members will either 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 carry you or drop you. They will either be the wind beneath your wings or the quicksand under your feet. And it all depends on your leadership ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi bility. Have you ever heard of a “Cult Manager”? Probably not – it’s Cult Leader. And the best people will follow the best leaders. So, instea ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a d of bewailing your fate and complaining about the losers in your team, go to the bathroom and take a good, hard look in the mirror. You are a dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod magnet. You either attract Eagles or ducks. If you behave like a loser, that’s exactly what you’ll attract. If you accept mediocrity and compro cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin mise, that’s the team you’ll soon be scraping off your shoe. But if you set a high standard and strive for a magnificent vision, you’ll find st tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen rong people joining you, and the sky’s the limit. Together, we can do amazing things. Sales Tip Just as a leader must carefully choose his te 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 m, so must a salesperson carefully select his clients. Surround yourself with excellent people at all times. Don’t suffer fools lightly. Good p ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust eople will lead you to more good people. Invest in your clients and the ROI is great. Management Tip A few good salespeople with serious comm y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products itment and very specific goals is far better than a big bunch of wanna be’s and has-beens. Spend your time carefully. Invest in good stock. If . 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 you’re a lifelong learner, so will your team be. Set the pace, set the standard, set the example. Be selective and demand excellence. “Leaders elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip hip can be thought of as a capacity to define oneself to others in a way that clarifies and expands a vision of the future.” ~ Edwin H. Friedma 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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