FDA局长:FDA是科学和科学家们的伟大殿堂
首页 > 资讯 > FDA局长:FDA是科学和科学家们的伟大殿堂 出自识林
FDA局长:FDA是科学和科学家们的伟大殿堂
笔记 2016-07-01 【编者按】有人说FDA才是药业科技创新的主要推手。从局长文章字里行间中对科学和科学家们的尊重上看,这个推手大概非FDA莫属了。 (译自FDA Voice “FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science” 2016年6月23日,作者:Robert Califf,医师,FDA局长。) 作为FDA局长,我为FDA使用最好的科学支持我们保护和促进美国公众健康的使命的非凡承诺感到自豪。这一点在今天尤为重要,因为科学技术迅猛发展正在帮助扩展我们对人类生物学和潜在疾病机制的理解并识别食品污染物的分子谱。 这些突破为我们研发新的治疗方法和药品,以及用满足全球化挑战的稳健体系保护食品供应,提供了前所未有的机遇。 此外,通过我与FDA超过1万名科学家中的一些人的对话,已经使来自将前沿科学应用于我们所面临的挑战的另一获益变得日益明朗。这就是在FDA最先进的实验室从事能使所有美国人的生活变得真正不同的一线问题的工作,而获得的深刻的个人和职业满意度。正如一位FDA科学家评论表示,“在FDA,你的工作真正是在前沿技术、患者关怀、棘手的科学问题和监管科学的交叉口。” 成为充满活力的科学协作环境的一部分 无论你是生物学家、化学家、流行病学家、药剂师、统计员、兽医、护士、医生或工程师,无论你是刚毕业的大学生还是经验丰富的科学家,FDA提供了一个无与伦比的机会,成为充满活力、协作文化的监管科学的一部分。 FDA科学家鸟瞰制药和食品行业,并制定指导这些行业的深入熟悉和理解的监管结构。如一名年轻的FDA科学家最近表示,“我们在这里看到不同产品的巨大广度,这有助于我们快速学习,使我们的工作有趣而富有挑战。”另一名新近经过培训的FDA科学家表示,“我们有机会在学科内和跨学科与训练有素的同事工作,以构建和保持我们的科学培训前沿。” 虽然FDA科学家的工作有助于推进科学理解,但远不止这些。因为我们的工作直接关系到监管决策。对数百万美国公众起着强大而立竿见影的影响。如另一位FDA科学家所解释的那样,“我们能够看到这些基础科学和临床进展如何应用于产生药品和医疗器械,以及如何改变人们的生活。” FDA提供了大量的奖学金、实习、研究生和教师计划,通过这些计划新晋科学家可以加入FDA并继续运用和发挥他们的技能。许多人作为全职科学家留在FDA。一位前FDA研究员表示,他们感谢FDA给年轻的优秀科学家的空间并尊重他们的发声。 解决最具挑战的科学问题 所以,虽然我可能经常吹嘘FDA开展严谨科研的责任和能力以及对美国公众的重要性,但我尽可能像谈论我们的科学一样多的谈论我们的科学家。我希望当其他年轻的有才华的科学家在权衡来自多方面科学队伍的证词后,能够鼓励他们加入FDA。 无论是出于科学家们的个人利益还是国家利益,我希望看到更多专业人士利用FDA提供的机遇就我们这个时代一些最具革命性的科学问题开展合作。我们需要最好的科学头脑来解决食品安全、医疗产品研发的挑战,评估新兴技术如何影响FDA监管的产品,从而我们的审评人员可以就产品的风险获益做出基于科学的决策。 这就是为什么在过去数年间我们已经成功地引进数千名合格的新员工,并努力填补到关键岗位。这也是为什么我们将继续寻求更多灵活性聘用等方式,使我们能够与私营部门这些职位的工资相比更具竞争力。 在FDA的职业发展机会是巨大的,我期待着欢迎下一代各种各样的科学家帮助我们实现使命。不仅对科学有益,对于FDA保护和促进公众健康也是必要的;对那些优秀科学家和他们的事业来说,这是独一无二的机遇。 编译:识林-椒 FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science Robert CaliffAs FDA Commissioner, I’m proud of our agency’s extraordinary commitment to using the best available science to support our mission to protect and promote the health of the American public. This is especially critical today, as rapid scientific and technological advances are helping to expand our understanding of human biology and underlying disease mechanisms and to identify the molecular profile of a food contaminant. These breakthroughs offer unprecedented opportunities for us to develop new treatments and cures and to protect our food supply with a robust system that meets the challenges of globalization. But there’s another benefit that derives from our application of cutting-edge science to the challenges we face, which has become increasingly evident to me through my conversations with some of FDA’s more than 10,000 scientists. And that’s the deep personal and professional satisfaction gained from working in FDA’s state-of-the-art laboratories on front-line issues that make a real difference in the lives of all Americans. As one FDA scientist commented, “At FDA, your work is really at the crossroads of cutting-edge technology, patient care, tough scientific questions, and regulatory science.” Being Part of a Vibrant Collaborative Scientific Environment Whether you’re a biologist, chemist, epidemiologist, pharmacist, statistician, veterinarian, nurse, physician, or an engineer and whether you’re a recent graduate or a seasoned scientist, FDA offers an unmatched opportunity to be a part of a vibrant, collaborative culture of regulatory science. FDA scientists gain a bird’s eye view of the pharmaceutical and food industries, and develop a thorough familiarity and understanding of the regulatory structure that guides these industries. As one young FDA scientist recently commented, “We see a tremendous breadth of different products here, which helps us learn quickly and makes our jobs interesting and challenging.” Another newly trained FDA scientist shared, “We have the chance to work with highly trained colleagues, within and across disciplines, to build and keep our scientific training cutting-edge.” While the work of FDA scientists helps to advance scientific understanding, it goes much further than that. That’s because our work is directly tied to regulatory decisions. As such it has a powerful and immediate effect on the health of millions of Americans. As another FDA scientist explained, “We get to see how these basic science and clinical advances get applied to producing medical treatments and devices and how these can make differences in people’s lives.” FDA offers a number of fellowship, internship, graduate, and faculty programs through which newly-minted scientists can join FDA and continue to apply and develop their skills. Many of these individuals remain on as full-time FDA scientists. One former FDA Fellow said they appreciate how “FDA makes room for and respects voices of young, qualified scientists.” Tackling the Most Challenging Scientific Issues So, although I may frequently boast about FDA’s responsibility and ability to do rigorous scientific research and its importance for the American public, I’m speaking as much about our scientists as our science. And I hope that when other young talented scientists consider these testimonies from our multifaceted scientific workforce they will be encouraged to join us. I want to see more professionals take advantage of the opportunities FDA offers to collaborate on some of the most transformative scientific issues of our times – both for their benefit and for the nation’s. We need the best scientific minds to tackle the challenges of food safety, medical product development, and to evaluate how emerging technologies are affecting FDA-regulated products so that our reviewers can make science-based decisions about a product’s benefits and risks. That’s why we’ve successfully added thousands of qualified new employees over the last several years and worked hard to fill mission-critical positions. It’s also why we continue to seek more hiring flexibilities and other ways that enable us to be more competitive with private-sector salaries for these positions. The career opportunities at FDA are enormous, and I look forward to welcoming the next generation of scientists of every stripe to help us fulfill our mission. It’s not only good for science and essential to FDA’s ability to protect and promote public health; it’s a unique opportunity for these talented scientists and their careers. FDA Scientists Discuss Their Cutting-Edge Research in FDA Grand Rounds Webcasts Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration |