Bai Lu: Ecosystems for biological high-tech innovation

      在中国的创新热潮中,生物科技领域的投资被很多投资人青睐。国家和地方政府也出台了各种政策和措施来推动生物高科技产业的发展。在近日举办的网易经济学家夏季论坛的创业分论坛上,鲁白教授介绍了中国生物高科技创新的现状,和发达国家的差别以及对未来发展的展望。在他看来,中国要想在生物医学产业有长足的进步,立足于世界发达国家,需要的不仅是技术和资本,而且要构建一个完整的生物高科技生态系统。他还建议中国设立一个类似美国国立卫生研究院的国家大实验室,可以为生物高科技产业的发展发挥重要作用。以下是鲁白的演讲全文:


      现在有相当一部分有识之士预见生物高科技可能是下一波经济的增长点之一。许多投资人也对于生物高科技表现出一股特殊的热情和兴趣。生物高科技产业的发展与其他高科技产业一样,不仅仅是靠投资和技术就能够解决的,它需要一个生态系统。我今天想借这个机会,从四个方面讲一讲生物高科技产业发展所需要的生态环境。


      中国生物高科技创新地位如何?

      根据美国等发达国家这么多年来所积累的经验、发展生物高科技产业需要一些特殊的要素。结合我们中国现在已经具备的一些情况,我想先做一个中国生物医药界现状的分析。

      首先,生物高科技需要最前沿的生物医学的研究,也就是基础研究。在最近的五年左右,中国的生命科学的研究呈现了一个非常强劲的成长,有爆发的趋势。高水平的研究经常可以在世界顶级的杂志上出现,但从总体上来讲,我们的水平还处于跟踪他国的状态,我们还是相当缺乏原创的研究。

       第二,我们所需要的是人才,特别是具有创新能力的人才团队。这里面包括了两个方面,一个是具有领导创新能力的领军人物,另外一个是需要大批具有高端科学素养的科技研究人员。通过这几年从海外引进也好,从国内一流大学的培养也好,这支队伍出现了非常快速的增长。

      第三是政府的支持,这里包括资金以及政策方面的支持。在这方面应该讲中国的政府,特别是中国的各级地方政府做得相当出色,我们在各个地方可以看见各种各样的高新区、孵化器。在政策、空间、资金,以及各种服务上,中国政府提供了相对全球也相当先进的政府引导以及支持作用。

      另外还有一个方面,我今天需要花一点时间讲的。我们也许还缺乏一个国家水平的实验室,一个能够在国家水平上支持大科学研究的生物医药机构。

       生物高科技的发展需要完整的产业链,需要有基础研究、研发、生产、服务,在这方面中国也有自己发展的特色。有两个方面特别值得提一下,一个是外包公司(Contract Research Organization, CRO),中国的外包公司可能是全世界最好的,著名的代表就是上海的药明康德。CRO行业一开始从化学药物做起,现在逐渐走向生物医药的外包,以及临床实验的外包。它们做的项目相对发达国家而言是高质量,高效率,好的服务,还低成本。这非常有中国特色,或许是降低中国生物高科技发展壁垒的一个很好的促进因素。另外,CRO行业还培养一大批训练有素的一线研发人员。第二个是跨国公司,全世界几乎所有的生物医药跨国公司都纷纷把研发部向中国转移。跨国公司的进入,当然主要是为其自身利益所驱动,但它们也间接地为国内医药界带来了一系列国际规范的研发手段、规章制度、行事方式,这对中国医药界与世界接轨是有很大帮助的。同时,跨国公司引进了一大批有经验有管理能力的领军人才,这些人中的相当一部分后来自己出来创业。这些都无疑对中国的生物高科技产生了推动作用。


      还有,科技产业的发展需要投资,我们国内投资的总体情况是比较短视,比较缺乏专业性,这方面需要在今后几年得到提高。当然,中国在最近几十年里面,对企业家、创业精神、创新特别推崇,中国的生命高科技界也不例外,表现出对创业的空前热情。

      这其中还涉及到一个特别重要的部门,就是监管部门。做生物高科技产业跟其他企业不一样,由于这方面的产品大多跟人的生命有关,所以一定要有政府的监管,就是我们所谓的中国食药监局。中国的食药监局在过去的几十年,工作相当不如发达国家,这主要表现在它的专业性和效率上。但在最近这段时间,食药监局已经有了相当大的变化,我们期待会有更多实质性的进步。


      如何构建健康的生物高科技产业生态系统

       总体来讲,人们对中国的生物高科技产业的发展是非常乐观的。刚才我讲到一个产业的发展是要有生态系统的,下面我从四个不同的方面来讲生物高科技产业所需要的生态系统。

      第一个生态系统是从基础研究到转化研究,再到应用的生态圈。基础研究,大家非常清楚,包括我本人,是做有关生命科学的基础研究,基础研究是生物高科技所依赖的基石。也许各级领导和投资人最关注的是最后一个环节,就是它的应用跟开发,其实应用和开发包括两个方面,一个方面是临床的应用,另外一个方面是产业的应用。但这些应用最初起源于基础研究,都需要有一个桥梁,把它向应用转化,这在生命医学界叫转化医学。

      下面我来讲一讲这三个部分。第一部分是基础研究,一定是高水平的基础研究才能产生高水平的生物高科技产业。什么是第一流的基础研究?我在这里简单列了一些我认为是第一流的科学研究。其中包括:
1)经典领域里的重大突破(比如:表观遗传学、蛋白泛素化);
2)可以被广泛应用的新的研究方法和技术(比如:二代自动测序技术 , 基因编辑技术);
3)显而易见的实际应用(比如:肝炎病毒受体的发现, 阿尔茨海默症致病基因的发现);
4)提出全新的概念(比如:RNA 干扰);
5)打破传统的理论体系(比如:人类诱导多能干细胞,iPS cell);
6)开创崭新的领域(比如:重组DNA, 人类基因组)。

      以上每一个重大的基础科学研究的突破,都带来了生物高科技产业的巨大变化和飞跃。

      所谓转化医学。简单地说,就是怎样从实验室的学术研究转化到治疗病人的临床应用,这里面包括很多内容,包括动物模型、早期诊断、病人的选择、生物标记物、药代动物学等等。一般的程序是在动物或者是细胞上先做实验,发现治病的可能性,然后在正常的人上做一些探索性的研究,最后转到临床上去,经过这样一个转化的过程。也有一种是反向转化,从人身上入手,通过模拟人的疾病反应来构建实验动物模型,最后设计实验来研究疾病的具体机制。

      临床研究目前在中国非常薄弱。什么是临床研究,就是某一种疾病状况,经过反复的研究,最后变成了大家公认的一种病。比如说阿尔茨海默症,是德国的一位医生经过研究以后命名的疾病。还有,某种疾病诊断的方式,疾病的治疗方式,这些都是临床研究。

      临床研究的一个典范是美国的国立卫生研究院(NIH)中的临床研究中心,它包括一个可能是全球最大的研究型医院,这个医院不治疗一般的病人,只针对参加研究的病人——他们是专门来参加临床实验的。所以这是一家专门用于转化和临床研究的医院,因为相关的工作在别的地方,比如在大学或企业都不能够做的。这是非常特别的,在我们国家没有这样的地方。
      第二个生态系统是中国的生物医药界,这里面有四个环节和其特有的现象。

      第一个环节是国内的制药和医疗器械产业,它亟待转型,它们基本上是在做仿制,这些企业遇到了越来越严峻的挑战,需要快速转型,创新因此变成非常重要的任务。

       第二个环节的外包公司,那是一个欣欣向荣的产业,我前面已经讲了,外包公司在中国乃至全世界,在促进生物高科技领域的发展方面,提供了一个非常好的研究平台,让各个行业都能够参与。

       第三个环节是跨国公司研发部进入中国,除了本身的需要之外,对中国的生物高科技产业其实是巨大的推动,主要包括三个方面,一是人才,可能大家知道在跨国公司中国研发部工作的人,平均不会超过五年就会离开,离开就会参加到国内的生物高科技产业当中去。二是跨国公司的一些做法,一些制度,很快被中国的企业学会。三是他们也带去了很多制药,或者生物医疗仪器产业的经验。在中国做研发,有各种各样的困难,跨国公司的探索积累了一定的克服这些困难的经验。

      而第四个环节是生物高科技公司。这个环节最近几年发展很快。有两个方面在刚才前面都已经提到了,一个是高科技的产业一定要有壁垒,中国的生物高科技公司对这一方面现在越来越重视。另外一个就是企业家精神,它表现为领导力和创新性。中国企业在这方面也进步很快。

      第三个生态系统是创新创业圈,也就是孵化器生态。我们从一个创业者的需求出发,知道创业者不仅仅需要资本,还需要一系列的配套服务,包括法律、财务方面的配套服务,包括生活方面的服务,孵化器起到了重要作用。更重要的是技术创新上的支持,任何一个创新者可能了解的只是某一部分非常局限的技术上的问题,我们需要有一个环境来帮他对技术上的问题查漏补缺;能够为他匹配创业导师,让有经验的人帮助他们少犯错误。最后是跟企业,跟市场对接。

      第四个生态系统就是研发、临床、监管、市场这样一个圈层。刚才我已经讲到了,研发我们需要更注重的是中国自己的原创,具有知识产权保护的原创,这是生物高科技产业的基石。第二部分是临床,在中国的临床研究相当薄弱,我们需要在制度上,在资本上,在科学技术上都加以更多的投入,更多的关注。我这里要特别讲一下的是监管,因为这是这个行业特别特殊的地方,监管包括怎么来评估一个生物高科技是不是可以运用到人身上,还有就是怎么从市场,从病人身上得到反馈,这一系列都是需要我们给政府起到反馈作用的。最后是市场,市场也是有它的特殊性,这不是一个消费者自己能够解决的。这里面有三个部分,一个是医生,一个好的医疗用品,医生愿不愿意开是很重要的;接着是病人自己愿不愿意用;然后就是谁来付,保险公司愿不愿意付,政府愿不愿意付,还是私人自己付,怎样定价,这一系列构成了生态圈。

      最后,我特别要再次强调一下,中国缺少这里缺了一个东西,在发达国家几乎都有,而在中国还没有的国家层面的大机构,那就是类似像英国的MRC,美国的NIH这样的机构。美国NIH有两个功能。一是对生物医疗方面的的基金。NIH的总预算为每年310亿美金左右,由国会批准政府拨款。这可能是目前中国国内生物医药科技投资总额的二十倍还不止。相对其他科学的领域,物理也好,化学也好,还有其他方面也好,中国的投入都不低,但是生命医学科学方面,中国的投入远远低于那些发达国家,这是一方面。NIH的预算的85-90%,是用来投给分布在全美国各个大学的科学家,以基金的形式来支持他们的研究。

      NIH的第二个功能是其院内研究。NIH内部是由26个研究所组成的所谓的国家实验室,这个国家实验室专门从事一些在大学,或者企业不能够开展的研究工作,其中就包括一些大型基础研究项目,也包括大型的平台,和大数据。

      我们国家也非常需要这样一个生物医学方面的国家实验室,可以在四个领域开展工作。第一部分的工作是多学科、大投入的协同研究,目标非常明确的大型的基础科学项目,以及在安全、项目管理、运营等方面比较复杂的大科学问题。第二部分是类似NIH的临床研究中心,里面专门从事转化和临床的研究。第三部分是国家性的科研公共平台,NIH有一部分职能就是把全世界所有跟生物医学有关的文献储备建库以供大家检索,另外还有构建药物筛选库、细胞库、动物模型库,进行科研监管、课题评估等等。第四部分是人才的培养。国家实验室可以为整个生物医药产业界提供各种各样的人才,所以人才培养也是国家实验室的重要作用之一。

      了解了生物高科技产业四个不同的生态圈,我们就知道,中国的生物高科技产业如果要发展,不仅需要简单的投资,或者是简单的技术创新,而是需要构建生态圈,我们需要多方面的配合,才能使中国的生物高科技能够达到和接近世界水平。

谢谢大家!
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5. Third Party Web sites and Links. This Web site may contain links or references to other Web sites maintained by third parties over whom 4B Technologies has no control. Such links are provided merely as a convenience. Similarly, this Web site may be accessed from third party links over whom 4B Technologies has no control. 4B Technologies makes no warranties or representations of any kind as to the accuracy, currency, or completeness of any information contained in such Web sites and shall have no liability for any damages or injuries of any kind arising from such content or information. Inclusion of any third party link does not imply an endorsement or recommendation by 4B Technologies.

6. Medical Information. This Web site may contain general information relating to various medical conditions and their treatment. Such information is provided for informational purposes only and is not meant to be a substitute for advice provided by a doctor or other qualified health care professional. Patients should not use the information contained herein for diagnosing a health or fitness problem or disease. Patients should always consult with a doctor or other health care professional for medical advice or information about diagnosis and treatment.

7. Forward Looking Statements. This Web site contains forward-looking statements about 4B Technologies' financial and operating performance, business plans and prospects, in-line products and products in development that involve substantial risks and uncertainties. Actual results could differ materially from the expectations and projections set forth in those statements. Such risks and uncertainties include but are not limited to, among other things, the uncertainties inherent in pharmaceutical research and development; decisions by regulatory authorities regarding whether and when to approve drug applications and supplemental drug applications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of 4B Technologies's products; competitive developments; the ability to successfully market both new and existing products; trends toward managed care and health care cost containment; governmental laws and regulations affecting health care, including without limitation regarding pharmaceutical product access, pricing and reimbursement; and general economic conditions, such as interest rate and foreign currency exchange rate fluctuations. 

8. Non-Confidential Information. Subject to any applicable terms and conditions set forth in our Copyright Declaration, any communication or other material that you send to us through the Internet or post on a 4B Technologies Web site by electronic mail or otherwise, such as any questions, comments, suggestions or the like, is and will be deemed to be non-confidential and 4B Technologies shall have no obligation of any kind with respect to such information. 4B Technologies shall be free to use any ideas, concepts, know-how or techniques contained in such communication for any purpose whatsoever, including but not limited to, developing, manufacturing and marketing products.

9. Trademarks. All product names, whether or not appearing in large print or with the trademark symbol, are trademarks of 4B Technologies, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. The use or misuse of these trademarks or any other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, criminal law, the law of privacy and publicity, and communications regulations and statutes. Please be advised that 4B Technologies actively and aggressively enforces its intellectual property rights to the fullest extent of the law.

10. Copyrights. The entire contents of this Website are subject to copyright protection. Please refer to our Copyright Declaration that explains the use of content on this Website. 

11. Void Where Prohibited. This Web site and its contents are intended to comply with the laws and regulations in the People's Republic of China ("China"). Although the information on this Web site is accessible to users outside of China, the information pertaining to 4B Technologies products is intended for use only by residents of China. Other countries may have laws, regulatory requirements and medical practices that differ from those in China. This site links to other sites produced by 4B Technologies various operating divisions and subsidiaries, some of which are outside of China. Those sites may have information that is appropriate only to that particular originating country. 4B Technologies reserves the right to limit provision of its products or services to any person, geographic region or jurisdiction and/or to limit the quantities or any products or services we provide. Any offer for any product or service made on this Web site is void where prohibited.

12. Governing Laws. This Terms of Use Agreement and your use of the Web site shall be governed by the laws of China. Any legal action or proceeding related to this Web site shall be submitted to Suzhou Arbitration Commission in Suzhou.

13. Miscellaneous. If any provision of this Terms of Use Agreement is held to be unlawful, void or unenforceable, then such provision shall be severable without affecting the enforceability of all remaining provisions. 4B Technologies reserves the right to alter or delete materials from this Web site at any time at its discretion.

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