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Margaret Hamburg博士在Biobay的演讲内容分享给大家
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Margaret Hamburg博士上周来生物纳米园和苏州晶云药物参观访问，座谈会中，Hamburg 博士开场就说她在FDA一直尝试着让FDA成为新药研发企业的“Partner”, 而不是“Watchdog”。药品监管以服务病人为宗旨，一切为了病人的“Benefit”，基于研发团队掌握的“Science”，促进新药创新而非死守陈规。她还说道，通过全球的合作，创新的步伐才能加快，只有通过充分的合作交流，才能确保人类能找到适合自己的方式，研发出优质药品。 我们有幸参与交流，现将Margaret Hamburg博士在Biobay的演讲内容分享给大家，期望给国内新药研发同仁带来更多启发，更多斗志，更多希望。就像她在演讲结束时对新药企业代表说的：“你们会问，新药研发十年后将会是什么情景？我想，真正推动未来的是科学以及更好的药品给我们带来的兴奋和机会。” As you may or may not know, I step down from being the commissioner of the US FDA a little over a month ago, after having served for 6 years. During that period, focus a great degree of attention on a couple of areas of work that are highly relevant to what you all are doing and envisioning for Biobay, I believe. One was to really advance the underlining science of product development, so that there was a more comprehensive approach from discovery through the research and development to the product, review, approval and ongoing oversight in the market place. For too long I believe that the parts of the R&D ecosystem have been what we call stockpiled without adequate integration and collaboration. And frankly we have slowed, I think, the process of translation of discovery into real world product as a result. And because of the enormous advances of science and technology today and the opportunities that they represent to really deliver new, better, safer products to patients, we all have an obligation to do a better job and to work together more effectively. One thing that I’ve already been struck by, and I’ve talked to people here this morning and listened to you around the table, is the appreciation that it’s not enough just to do interesting research and discover new good ideas but we have to from the very beginning be thinking about “Is this discovery that will really make difference for patients? How do we build in the necessary quality for a real product from the very beginning? How do we do the studies and design the research and development agenda to get us over the finish line for a product as quickly as possible?” From the FDA prospective of the United States, that has meant strengthening the science within the FDA so that we would be fully equipped to work with the research and development team, the innovator, the product developers. It’s meant that we need to have the knowledge and tools for more efficient, modern regulatory review. And it’s also meant that we need to collaborate in research to develop that new knowledge and tool to enable us to more effectively translate from the initial research and discovery opportunity into products and ensuring appropriate use in the market place, whether it’s bio-markers that are identified, characterized and validated for use in accelerated approval or for targeting therapies. Whether it‘s innovative clinical trial designs to enable critical scientific questions to be asked and answered more quickly and efficiently and to decrease the time that the clinical trials take, the cost of clinical trials and the number of patients required for clinical trials or how can we, you know, really utilize real world data, past studies, information from healthcare delivery, to ask and answer critical questions about safety, efficacy of products as well. Data mining certainly becomes increasingly important, when you think about all of the data being generated from genomic studies and other advances in science and technology as well. So really trying to improve FDA as a scientific agency and really making sure that the database, the scientific research agenda is developing the right tool for FDA to be a better partner, as a regulator to the research and development process. We also have recognized that in addition to engaging in a more open collaborative way with the scientific community within the United States. It’s essential that we engage more effectively with the scientific community internationally and with the regulatory community internationally that we see a harmonized and aligned regulatory standard to make it easier for scientists and companies that are working across countries. But also that we work across borders, across disciplines, across sectors to continue this event of what I call regulatory science so that we have knowledge and tool necessary to really have the most efficient streamlined and modern R&D process. So I have really tried during my ten year at the FDA to make the FDA less of a watch dog and more of a partner and the scientific enterprise, the product development enterprise and in the efforts to really ensure the public that we all serve that we deliver on the promise of science. So when I looked at Biobay, looked at the work that all of you are doing, looked at the other models for scientific collaboration, and the incubation of promising companies and promising products, I see that really as an important element of the future. You were saying you wonder what will come in, you know, ten years and beyond. Well, I think that, what is really driving the future is the excitement and opportunity of the science and the better products. The more they really match knowledge of the underlining mechanisms of disease and human biology, the more effectively we’re going to be able to move from good idea and new discovery into a really world product and we have to make sure we’re all working together to make that possible. And to me that’s why I want to come here, why I think it’s very exciting to hear about your work, addressing different elements of this, to hear about your backgrounds and how you reflect the new reality of the world, training, and working in different sectors, different countries, but all toward a common goal of building the knowledge and the skills and creating the scientific understandings that will make us able to do a better job for citizens and our nations. So I really appreciate being here and really excited by what I’ve learned so far; appreciate being here with my colleagues from different sectors as well. And I hope that even though I am no longer the commissioner of food and drug administration in the United States and I will still be able to have some impact on the kinds of the issues that we’re talking about this morning. Thank you. |
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