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Paul Pomerantz:关于创新的探讨应该有中国的声音

Written on 2010/03/17 – 5:04 下午 by donglei

根据美国药物信息协会(DIA)的全球执行董事Paul Pomerantz的回答,我写了一篇很扯的人物对话稿。

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Q: what do you think of the first DIA China annual meeting?  How do you rate it given the 100 points scale? What’s your impression to China?

A:The first DIA China annual meeting was a total success.  100 on a scale of 100.  The meeting enjoyed support at the highest levels of the SFDA and gained worldwide recognition thought the participation of regulators internationally including those from the FDA, EMEA and PMDA.  We believe China is a significant player in size and influence in both drug development and discovery.  I have been very impressed by the enthusiasm of both government and industry leaders.  China has a clear commitment to innovation, quality and leadership in the development of pharmaceutical and related products.

Q: Could you share with us your career story? what’s your best achievements till now? Is there any experience that can be taken as a turning point for your life?

A:My professional degree is in healthcare administration.  I have worked in government, health care delivery (as a hospital administrator) and as a health care association executive.  As an association executive, I have led international organizations serving clinical laboratory, radiology, plastic surgery and now pharmaceutical and medical product executives.  There were three major professional turning points for me.  My first “turning point” came in 1990 when I first became an association leader and learned of the tremendous impact associations can have on motivating and educating professionals. The second was in 1997 when the organization I was working with (Clinical Laboratory Management Association) succeeded in advancing legislation mandating an Institute of Medicine Study on laboratory payment.  This affirmed for me the power of associations to develop public policy.  The third came in my position with the Society of Interventional Radiology, when we were approached by the FDA to coordinate a post market study with several manufacturers involving a specific device.  This milestone, which is often cited by the FDA as a model of private-public partnership, conveyed to me the power of collaboration and science.  The study, which was very successful, was overseen by a steering group consisting of radiologists, consumers, FDA, industry representatives and health service researchers.

Q:In the past years, is there anyone or anything that brings a major influence to your life?

A:I feel many have influenced me as mentors or as role models.  There have been some bosses, early in my career, who taught me the importance of vision and setting high standards, treating people well, hard work, leading teams to develop creative solutions to complex problems and execute projects, and concern for the patient and customer.

Q: Why did you join in DIA? Currently, what’s your focus and challenge in your work? What’s your expectation to yourself?

A:I was attracted by DIA’s mission,  excited by our vision, and impressed by all the DIA leaders and members I met.    The global nature of pharmaceutical (and related product) development and regulation, and the global challenge of health care costs, public health concerns (including pandemics, neglected diseases, and those of developing and developed nations) represent opportunities that can be best addressed through DIA’s neutral, multi-disciplinary stakeholder forum.  I think DIA can truly make a difference to improve health care delivery and health status world wide.

My major focus at this time is aligning the organization to function more effectively as a global organization, to upgrade our technology to support our members around the world, to build awareness of DIA by those who might not be familiar with us, and to update our offerings consistent with changes in the health system.

Q: You once said, “drug is not only making medicines”, when you were elected to be the president of DIA, could you share your points of drug development? How to meet the unmet clinical needs with patient oriented?

A:Two key points: First, our world has expanded from drugs to “life sciences” and includes a range of regulated medical products that range from drugs, to biologics and bio-similars, to diagnostics and personalized medicine.  Second, regulators in many countries, and thus companies, have expanded their focus from product approvals to post approval aspects including safety, technology assessment, and pricing. As a result, information technology, particularly electronic medical records and registries are playing an increasing role in DIA’s programs.

DIA has four key pillars: industry, regulators, academia, and to an increasing degree, patients.  These are represented in many DIA regions by patient organization representatives who participate as part of governance (helping set direction) and in programs.  At DIA, as for the industry and the regulators, the voice of the patient is becoming increasingly important.  Their key concerns include innovation to treat neglected diseases, improvements to current treatment and safety.

Q: Last year, DIA set up its office in China, what’s your strategy here in China? What’s your expectation to China market given its unique healthcare system and pharmaceutical industry?

A:DIA’s strategy in China is to support its national needs as identified by our advisory council.  Our advisory council includes those from regulatory (CCPIE/SFDA), multinational industry and contract research organizations, and the domestic pharmaceutical industry.  While we will make all our benefits including our peer reviewed journal available to our members in China, we have just signed an agreement with the CPA to develop a joint Chinese language newsletter, to explore additional joint programs, and expand awareness across both organizations.

We want to work with our volunteers and members in China to serve the nation to the greatest degree possible and to help facilitate its participation regionally and globally.

Q: With more and more MNCs set up its R&D center today in China, China begin to play a big role in new drug development globally, what do you think of this? What’s the strength and weakness of China compared with India in this area?

A:China has the talent and capacity to play a major role in drug development.  As a neutral organization, DIA is committed to support drug development wherever the need is.

Q: How do you comment yourself? what’s your principle as a teamleader?

A:My principle as a team leader is inclusion and participation.  I like to surround myself with the most talented, experienced, and dedicated people.  My job is not to have the answers, but to lead a group that, with good decision making, can come up with the best answers.

Q:Could you talk something about your dreams?what’s the present dream for you now?

A:Family is very important to me.  I spend much time with my grown children.  My son is married and has a 16 month old daughter who I love to watch grow.  I am also close to my own daughter who is a professional chef and caterer. I enjoy my work a great deal, but I would also like to mentor and teach others the skills to lead complex organizations.

“对于中国在自主创新上的承诺,以及对药品和其他相关产品在质量、同步开发上的全球性合作需求,都让我们意识到,中国制药行业步入了一个与国际高水平国家同步发展的时代。”

他的身边聚拢着一大批 “充满才情,富有经验和专注”的志愿者,他们来自全球各国,有着不同颜色的皮肤和眼睛,职位几乎毫无例外是跨国制药研发系统跨洲际的总监总裁级别。而被来自中国志愿者们亲切的称为“头儿”的Paul Pomerantz先生,头发花白,笑容可掬,一如美国药物信息协会(Drug Information Association,DIA)中国顾问委员会的成员们在记者面前留下的印象,轻松、平等、合作、专业。

作为全球最大非营利性科研型协会美国药物信息协会的全球执行董事,Paul Pomerantz负责实施协会的战略计划并指导DIA的全球运作。他拥有30年的行政管理经验,并在健康政策、医学会管理和保健管理方面拥有专长。

1964年,美国马里兰州30名来自制药界和学术界的专业人士创建了美国药物信息协会。作为一家非营利性科研型协会,DIA的目前已发展成为一家拥有来自80多个国家的23000名会员的跨学科组织。

对于国内制药行业尚显陌生的美国DIA, Pomerantz在讲述他个人经历之前,谈得更多是他对与药物研发、患者需求以及人与人之间的相互理解与和谐共处。而我们的对话也从去年DIA首次在中国举办第一届中国年会谈起。

2009年11月, DIA第一届中国年会在大雪纷飞的北京举行。首次中国年会的召开,对于创新型转型下的中国制药行业带了不同寻常的意义。2010年初春的北京,Pomerantz再次来到北京。

在与记者短短一个多小时的对话中,Paul始终面带微笑,语速适中,在谈及一些关键之处,他生怕自己的对记者遗漏了什么,忙不迭的打开自己的手提电脑,在启动待机时他向记者频频示意,“我的电脑有点慢。”

核心价值是奉献

问:您对去年在北京举办的第一届DIA中国年会的评价如何?如果要给它打一个分数,您给多少分?

Pomerantz:如果要我打分,我会对第一届DIA中国年会打满分。DIA每年都会在全球各个国家举办各种跟药物研发、药学信息等相关的会议。欧美日等发达国家已是DIA年会举办国的常客,对于北京召开的年会,可以说是适逢时机,也可以说是姗姗来迟。

那次会议的主题是以平坦世界的视角药物研发:创新、法规和全球化。我们的主旨就是想告诉大家,药物开发的世界是平的,在这个以研发为引擎的行业里,关于创新的探讨应该有中国的声音。

第一届中国年会得到了中国政府和中国食品药品监督管理局最高层的支持,包括SFDA局长、注册司司长以及新药审评注册的重量级官员都出席了这次会议,并在国际场合向全世界介绍中国药品监管注册近年来的新变化和举措。这对于日益全球化的制药业来说,中国政府发出的信息和信号十分重要。在那次会上,组织者别出心裁地邀请了美国FDA,欧洲药监局以及日本药品监管当局的高层官员,这是一场全球药品监管者互相学习和交流的很好的经历,把它放到中国围绕中国的热点话题探讨,彰显出在药品研究和开发领域上,就是我们常说的,中国扮演的角色越来越重要。

而中国药监当局和制药在那次会议上向世界展现出的热情让我印象深刻。对于中国在自主创新上的承诺,以及对药品和其他相关产品在质量、同步开发上的全球性合作需求,都让我们意识到,中国制药行业步入了一个与国际高水平国家同步发展的时代。

问:是什么促使您加入DIA?您目前工作最大的重点和挑战是什么?您对自己的期望是什么?

Pomerantz:如果你去看看我们这个行业协会的使命和远景,你会发现,DIA的核心价值是奉献。因为我们是一个由全世界志愿者组成的非营利性组织。DIA的文化让我着迷,我也被各个国家和地区不分种族和肤色的志愿者们,为他们的奉献精神所感动。

人类在医药健康领域面临的所有问题和挑战,如医药产品的发现研究和开发,各国药品注册法规间隔,医疗健康投入的挑战,以及像流行病,罕见病的公共健康关注,等等议题,都可以通过这个国际性组织举办的各种会议,教育,培训得到讨论,而且为保持中立性,DIA不接受任何政府机构和企业界的捐助和赞助。改变全球人类健康生态,是DIA矢志不渝的追求。目前我的工作重点是联合各地的机构更有效率地在一起工作,使之成为真正意义上的国际组织。

以患者为导向

问: 您上任DIA全球总裁的时候,曾说过“drug is not only making medicines”,能否诠释一下您对药物开发的理解?如何以患者为导向满足临床上未被满足的需求?

Pomerantz:随着现代科学技术的发展,药学科学已分为两个主要领域:一是以药物为导向,以研究和生产药物为目标的药学(drug oriented pharmacy),主要以化学、生物学、医学和工程技术等自然科学为基础。主要任务是研究、发明和生产为疾病预防、治疗和检查诊断所需要的安全、有效、经济的药物。二是以患者和社会为导向(patient and social-oriented pharmacy),以研究药物的适当提供和合理使用为目标的药学,它的任务是研究药物的使用,监督和组织协调药物、患者和社会之间的关系。

我想强调两个关键点:首先,今天的药品不仅仅是研究生产销售一个产品那么简单,其内涵已经扩充到整个生命科学领域,医药产品从传统的化学药品拓展到生物制剂,仿生产品,诊断试剂以及个体化治疗药物。第二,越来越多的国家在监管层面已把关注点从药品获批上市这一过程延伸至上市后再评价,包括安全风险、技术评估、价格和药物经济学等等内容,随之整个产业公司的研发策略也会作出相应的调整。

DIA多个领域的管理层都有患者代表,他们参与制订指南以及项目管理。以往工业界和政府监管是DIA的主流声音,而现在,患者的诉求显得越来越重要。他们对于治疗罕见病新药的需求越来越大,也十分关注已有治疗手段的安全性和适用性。

问:DIA在中国的发展采取什么样的战略?针对中国特有的医疗环境和制药环境,您对DIA在中国的发展有何期望?并采取哪些计划?

Pomerantz: DIA 在中国的策略是根据我们的顾问委员会确定的在中国的需求,支持对中国药品研发、监管、使用诸方面有帮助的活动,我们将和中国的有关监管部门、创新研发单位、国内企业、大学院校开展密切的交流和互利的合作。DIA的会员和志愿者也将努力促进中国相关部门和业界人士与其他国家和地区的同行交流和合作。

和家人看一场垒球赛

问:越来越多的跨国药企在中国建立研发中心,中国参与药物全球同步开发的程度越来越大,您如何看待中国的药物研发外包环境?对比印度,中国显现出何种优势?仍有哪些需要改进的地方?

Pomerantz:正如你所说,在药物开发领域,中国已经成为创新研发不可或缺的重要角色。随着药物开发全球化的趋势越来越明显,中国参与全球新药同步开发的程度越来越高,特别在研发外包市场,对比亚洲各国甚至是印度,无论在政策法规、知识产权还是整体创新氛围中,中国都显现出更多优势。

问:您如何带领您的团队发挥他们的最大作用?您秉承着什么样的工作原则?

Pomerantz: 作为一个团队的领导人,他必须具有很强的包容性,他要参与整个团队的建设和成长。必须时刻激发和激励和你共事的人在面对各种复杂多变的问题面前必须保持坚定的信念,并具有创造力的解决他们。而置身于与健康、药品相关的产业,对病人怀有一颗充满爱和怜悯之心是必须的。

平日里,我喜欢让自己包围在一种很强的合作氛围中,身边聚拢着那些充满才情,富有经验和专注的人。我最想达到的一种工作境界是,我不仅仅只是得到答案,而是让整个组织每一次都能做出正确和科学的决策,从而获得最佳的结果。

问:有没有一个人或一件事或者一本书对您一生带来重大影响?

Pomerantz:在我一生当中,我感觉影响我的人太多了,在某种程度上,他们可以说都成为了我人生的导师和榜样。在早期职业生涯中,我有一些上司教会我为自己的人生设立一个远景目标是多么重要,同时他们身体力行地告诉我,人需要时时反省自己,用高标准来要求和约束自己,平日里待人友善,工作勤奋。

问:能否谈谈您的梦想?您一生最大的梦想是什么?您目前最想做的一件事是什么?

Pomerantz:如果问我有什么梦想,就是和家人更多的在一起。我现在最想做的一件事是和家人一起去看一场垒球赛。家庭对我来说非常重要,我喜欢和家人在一起的时光,我儿子有一个16个月大的小女儿,我喜欢看着他们长大,我跟我女儿也很好,她在美国是一个有名的大厨师。

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