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Digg It - Traits of a Leader: First Lead Yourself
Strong leaders understand that to successfully lead others they must first be able to successfully lead their own lives. Being the leader of your life t 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 akes the following: self-awareness, humility, maturity, self-confidence, and objectivity. It also takes the ability to receive criticism from others an ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in d accept that you may not always be right or may not always have the best answer. Most of all there must be an openness to learn and change. Here are s lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. even things you can focus on to lead yourself first: 1. Balance external forces with your own internal thoughts – Too often we allow external forces to here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ush us into things even though we may not fully agree with the direction. Your head and your heart are strong internal gages. You can listen to the wor d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ld around you and then check in with your heart. Your emotion will respond. Check in with your head. Your knowledge will answer. 2. Learn new things – 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 Knowledge is power. Take time to read, attend a seminar, or participate in a roundtable. 3. Take off the blinders – Heighten awareness around all aspe 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 cts of your life. Those areas include: family, spirituality/religion, health, recreation, environment, fitness, work/career, money, friends, and personal nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically growth. Most of us only focus on 2-3 areas at a time and lose sight of the rest. Identify what you can do to strengthen those areas that have been outs 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 ide of your blinders. 4. Create an open ear to criticism – Ask for feedback. Be willing to listen with your defenses down. In order to change we must ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi first identify what changes make sense. Outside supporters are sometimes more objective than we will be with ourselves. 5. Have a mentor – We are never ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a too old to learn from someone else. Find a person who you respect that would be willing to share of their time and wisdom. 6. Use the word “No” approp dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod iately – Somewhere along the way we get so caught up in thinking we have to do everything asked of us (particularly women) that “No” is a forgotten word. cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin I agree that there are things we must do. The concern lies with the things we take on and know that we should be saying “No” and we say “Yes” anyway. tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen 7. Treat yourself with respect – From external indicators like dressing professionally to internal ones such as eliminating negative self-talk; we can a 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 ll find ways to treat ourselves with respect. 8. Clarify your values – When asked, most of us can articulate our company’s value statement or set of cor ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust values. It’s typically more difficult to articulate our own values. Identify your core values. 9. Learn from experience – We know hindsight is 20/20, y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products but I often find people not slowing down long enough to look back. Reflection is one of the best forms of on-the-job training. When we look back and r . 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 eflect on our actions we can more objectively assess what went well and what could have been done differently. Are you already actively engaging in all elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip nine suggestions? If so, “Bravo”! If not, pick one that you want to focus on. Identify what you can do over the next month to take action in this area 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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