比毛毛更可爱的是毛毛的月月

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药品供应链管理研讨班9月苏州召开

2011/08/02 – 3:25 下午

由药物信息协会(DIA)主办的“供应链管理研讨班”将于9月21日在苏州召开。据了解,本次会议将汇聚中美政府监管机构,药典专家、中外制药企业质量专家就加强原料药和辅料用户、企业和监管部门之间的紧密合作以确保消费者的安全和利益等专题进行研讨。

“随着药品生产的日益全球化和产业链的转移,药品从原料生产到最终产品销售这一供应链近一步拉长。”据本次会议主席、美国药典委员会中华区总经理胡江滨介绍,原来由单个国家、单个供应商生产药品的模式日益被多个国家多家供应商的模式所取代,“虽然这样药品生产可以降低成本并实现利益最大化,但伴随著供应链拉长而来的风险和管理给政府和产商都带来了巨大的挑战。”

在几年前发生的肝素钠事件之后,世界各国对药品生产监督问题给予了更多关注,例如美国FDA进一步加强了对海外生产设施的监督,以及寻找更多途径提高对全球药品供应链的监管执法。FDA在《2011-2015年药品监管战略重点规划》(草案)中指出,复杂的全球供应链、国际贸易、受监管产品的国外采购和生产,以及日益增加的进口产品数量和复杂程度,迫使FDA重新建立评估手段,以确保供应链的安全性。

“美国FDA特别强调加强全球供应链的安全统一,这对于全球制药监管也有借鉴。”胡江滨说。据该规划公布的数据,2010年财政年度,共有超过2000万种进口食品、器械、药品和化妆品运抵美国入境港口,该数量为十年前进口数量的3倍,大批受监管的产品来自于全球150多个国家30万家以上的工厂。规划认为,FDA必须取得更多、更好的产品供应链相关信息,并在产品的整个寿命周期内监视这些信息,建立一个强大的全球安全联盟。为此,美国FDA及各国监管机构将供应链的管理列为面向21世纪制药界所面临的最大挑战之一。

近年来,我国食品药品监督管理部门高度重视药品生产、供应的全方面管理。药品供应链安全管理,对于产品各领域的协调程度要求极高。8月1日发布的《药品经营质量管理规范》征求意见稿,将药品经营质量管理的内涵延伸至整个药品流通供应环节,包括药品购进、销售、储存、运输、服务等,旨在通过在药品流通过程中采取适当及有效的质量控制措施,以保障药品质量安全。“国内企业必须意识到外部世界对供应链安全的重视,以及技术检测手段的更新换代。为应对这一挑战,需要新的策略。对于供应链安全这个话题在国内制药界将是一次全新的探讨。”胡江滨认为。

此次为期两天的研讨班旨在提供一次全方位的,深入互动的研究和探讨。中外制药企业将就供应链管理的合规性要求;采购、发放、供应商质量控制及供应链流程中遇到的问题,供应链环节中不同角色的作用与责任以及如何建立有效供应链流程的优势与劣势进行探讨。

两个媒体人的战略联盟

2011/06/28 – 4:21 下午

PharmAsia News的DJ“两个人的记者战略联盟”在微博上宣告成立。

http://q.weibo.com/906049

能干些啥呢?

这个联盟就是一中一英的记者,可以邀请同样采访人写同样的文章,不过语言不同,发表媒体不同,影响群体不同,这是两个人的战略联盟建立的目的。

群简介:一个用英语写稿,一个用中文写作。他的朋友是她的,她的资源是他的。中外医药研发创新有一说一。

读书笔记

2011/04/22 – 4:28 下午

不具有专业背景的我,这些日子断断续续很艰难地读完了《美国药品监管法规核心理念概述——药品注册批准前检查》的前三章,居然觉得有点意思。

以下是在阅读第一章用铅笔划下的语句,有些是为防止瞌睡划下的,有一些是精神振奋时划下的,有些词汇从未接触,有些如此熟悉。

1.在审批过程中增加了一个新的步骤——达标审查。

2.Compliance 在国外制药行业常指符合法规要求,反义词为违规。“达标”的提法在1998年前首先出现于我国GMP检察的官方文件中。

3.当产品研发结束时,研发历史报告、通用技术文件(CTD)/NDA以及从产品研发转为生产的技术转移文件。

4.确保临床试验、生物利用度研究以及安全性研究所用物质的生产工艺与注册申报工艺之间存在相关性。

5.目标是促进减少FDA所要求的药品注册批准前监查的数据,以使FDA能将资源更有效地应用于批准后监查或cGMP检查。

6.如果企业能够证明对生产工艺有透彻的理解,那么FDA将给予他们灵活性。这个协议将为新药申请的化学、生产和控制(CMC)部分指定一个管理办法,意在为注册申报的灵活性提供一个框架。

7.。。。。哪些内容是信息性的(即阐述产品和工艺的研发历史),哪些是注册申请中将来应遵守的承诺。

8.。。。促进ICH Q8药品研发和ICH Q9质量风险管理的有效实施。

9.在批准后做各种变更时,此系统(process analytical technology,PAT)也为监管/注册审评提供了灵活性。

10.在通用技术文件药品研发章节中,有对工艺深入了解的论证。

11.通过对产品与工艺知识的阐述,证明质量已经建立在系统之中,从而给FDA以某种信心

12.在Janet Woodcock博士撰写的FDA白皮书中,她认为目前药品的研发过程已无法跟上基础科学创新的步伐。。。研发人员仍用20世纪的研发手段来评估21世纪的发明。

13.一同寻找和解决。。。这项工作包括两方面:一是识别出最重要的工艺方面的问题,并且排列出优先次序;二是鉴别出能够获得最大重大改进的领域。。。一旦将这些领域鉴别出来,FDA将和研发单位一起,确定并解决关键的研发问题。

14.2006年初,FDA推出了一项重大举措,就是放宽了I期临床试验药品生产的cGMP要求。。。目的是在保证研发早期阶段药品的安全性和有效性的同时,简化并促进药品研发过程。

15.企业原先每年为符合联邦法规CFR 210和211而收集产生的数据需848625个工时,法规变更后,将会缩减至50000个工时。

16.这些要求对于I期临床的早期研究来说实在是太繁重了,以至很多顶级的医药研究机构无法在他们的实验室中进行这些发明性研究。

17.“企业、社会和FDA的共同目标是使药品生产部门达到一个最高效、最灵活、最富有弹性的理想状态,从而在没有大量法规监管的条件下也能可靠地生产出高质量的药品。”

18.质量源于设计的目标是确保企业对于他们的药品生产工艺有更深刻的以知识为基础的理解。(理解一词画圈)

19.要求企业在产品研发阶段根据所掌握的知识,形成对关键工艺、产品属性、设计控制、检测方法的科学见解。(科学见解一词画圈,就是FDA要求。。。具有科学见解)

20.设计空间关注的是一个生产工艺中某一个关键步骤的温度控制,而不是此温控设备的类型。

21.企业确立特定药品设计空间的能力(能力一词画圈),能证明他们对产品和工艺的知识水平。

22.质量综述并不降低药品研发所要求的研究数量,它只是减少了审评员在审核时必须研究资料信息的数量和种类。

23.质量综述将有助于快速解决潜在问题或争论的早期鉴定,以便获得第一轮的注册批准。。。质量综述将最终促进企业和监管者之间的信心和信任。

24.很多公司都处于极度紧张忙乱的状态,以临时抱佛脚的状态准备FDA的注册批准前监查。令人欣慰的是,如今那种短期的疯狂已被长期的努力准备所取代。

19位作者分别来自药厂、CRO,无一来自FDA。为什么制药工业界对FDA每一次具体细小的规则都那么当真?

组织本书翻译的郑强告诉我:

这点恐怕是美国与中国的主要差别。FDA关注的是制定和解释法规,以及对企业合规的检查和评判。批准前检查是专有名词,目的是FDA要到现场核实企业申报的工艺确实可以在满足GMP的条件下实施。这个检查的科学成分是很重的。

FDA历来承认企业比他们对工艺更了解,对工艺实施中的质量控制(GMP)更熟悉。所以,FDA检查时关注的重点是听企业讲述它的工艺实施和GMP保障是如何做的,其科学合理性如何。

我们的企业通常科研能力不够,对工艺和GMP的科学理解弱,注重点是应对GMP检查,而不是搞清工艺实施与GMP保障之间的关系。所以,国内更关注SFDA或地方药监局是怎么说,尤其是在职的人怎么说。

对于一个好的企业,抓质量是它本身的事,因为质量是竞争力和生产力,是有内在动力的。

——非常给力的解释。

我感觉FDA期望的演变过程中,处处放置弹簧,扩张法规的灵活性以及强调企业的自理能力,这是信任和信心的来源。

于我而言唯一的启发是对月月的教育,要放弹簧。

2011上海生物样本库建设研讨会7月举行

2011/03/25 – 3:43 下午

得知甘院长那儿将于今年7月份召开一个大约300余人关于生物样本库建设与管理的会议,我在这儿也帮忙宣传一下。

 

2011年上海生物样本库建设研讨会

国际标准化生物样本库的建设与管理

 

档次规格高:本次会议邀请国际和国内生物样本库建设中的顶级学者和专家分享其宝贵经验。所邀请的专家包括泛欧洲生物样本库BBMRI的负责人,UKbiobank的负责人,法国生物样本库标准的起草者,国内有中国医学科学院中华民族细胞库的建设者,泰州人群队列研究样本库的建设者,专家阵容之强大在国内该领域会议内无出其右;

 

影响面广:本次会议拟邀请参会听众200人,全部是中国各医院的主任级以上负责人员。他们是各单位生物样本库的建设规划的制定者和管理者。大会为厂家与用户交流提供了绝佳的平台;

 

专业性强:上海医药临床研究中心牵头上海生物样本库建设项目已有多年的经验,本次会议着重于讨论生物样本库的管理与质量控制,专业性强,针对性强,回答了目前国内从事生物样本库建设项目的科研人员最关心和最紧迫需要解答的问题;

 

 

  • 生物样本库的建设与管理
  • 生物样本库的质量控制
  • 生物样本库建设中的伦理问题
   演   讲   主   演   讲   嘉  
8:30-9:00
会议开始
9:00-9:10 致辞 上海市科委领导
9:10-9:30 致辞 上海医药临床研究中心 甘荣兴
议题一:生物样本库建设与管理
9:30-10:00 BBMRI样本库的建设与管理 BBMRI负责人Kurt Zatloukal
10:00-10:30 UKbiobank的建设经验 UKbiobank负责人
10:30-11:00 泰州人群队列样本库建设 复旦大学生命科学院
11:00-11:15 茶歇
11:15-11:45 中华民族永生细胞库的建设和管理 中国医学科学院
11:45-12:15 肿瘤样本库的建设 复旦大学附属肿瘤医院
12:15-13:30 赞助商(午餐赞助商)
13:30-14:00    
14:00-14:30 法国生物样本库建设 INSERM
14:30-15:00 肝癌组织样本库建设 复旦大学中山医院
15:00-15:15 茶歇
议题二:生物样本库建设中的质量控制
9:00-9:30 质量管理体系的建立 法国INSERM
9:30-10:00 UKbiobank的建设经验 Paul Downey
10:00-10:30 泰州人群队列样本库建设 复旦大学生命科学院
10:30-10:45 茶歇
10:45-11:15 欧洲biobank项目中的质控 法国INSERM
11:15-11:45 biobank项目中的质控 Sophie Tuffet
11:45-12:15 生物样本质量与高通量测序 深圳华达基因副总 张勇博士
赞助商(午餐赞助商)
13:30-14:00 biobank项目中的质控 Christian Demanze
14:00-14:30 欧洲生物样本库质控 待定
14:30-15:00 中国生物样本库建设中的质控 待定
15:00-15:15 茶歇
15:15-15:45 生物样本库建设中的伦理问题 Bruno Clement
15:45-16:15 上海生物样本库建设的伦理讨论 胡庆澧教授
16:15-16:45 产品介绍 待定
16:45-17:15 产品介绍 待定
         
  • 上海医药临床研究中心
    电话:021-33676344
  • 联系人:张扬
    传真:021-33676373
    E-mail: training@scrcnet.org
    网址:www.scrcnet.org
    公司地址:上海市徐汇区田林路140号10号楼(200233)

2010批准药品注册申请1000件

2011/03/01 – 5:13 下午

既然说到药审中心,想起来年前还有一些审批数据没有放上来。这是注册司公开的数据,注册白皮书的PPT做的非常酷,用了卡其色。不过转换不过来这里。

2010年1月至2010年12月,共受理药品注册申请4734件(按受理号计),其中境内申请4135件,进口申请599件(不含再注册)。 境内申请中,新注册申请1702件,补充申请2433件,分别占41%、59%。

在1702个境内新注册申请中,中药申请105件,化药申请1528件,生物制品申请69件。中药申请中,新药(含创新药)72件、占中药申报量的69%;改剂型21件、占中药申报量的20%;仿制12件、占中药申报量的11%;化药申请中,新药(含创新药)596件、占化药申报量的39%;改剂型110件、占化药申报量的7%;仿制822件、占化药申报量的54%。

审评时限方面, 中药除注射剂外,已实现了在时限内审评;化药超时品种305个,占20.3%,超时中位时间13天;生物制品超时品种25个,占25%,超时中位时间35天。

截至2010年12月31日,我们共批准药品注册申请1000件。其中批准境内药品注册申请886件,批准进口114件。在886件药品注册申请中,新药有124件,占14%;改剂型111件,占13%;仿制药651件,占73%。 

 

药审中心机构改革

2011/03/01 – 4:58 下午

提议DJ采访药审中心机构改革的话题进展缓慢。

这事来的很早了,早到两个月前注册年会完毕的第二天,CDE的网站就挂出来了。悄无声息,既没新闻发布会,也没有国内媒体报道。

关于药审中心,我读了罗氏的吕玉真2万6千多字的博士毕业论文——《从工业界的视角展望在我国建立药品审评和审批质量管理规范的必要性和内涵》,指导老师是李自力。郑强对此文的评价是,“不是每一个北大国际药物工程管理硕士项目的学生都能写出这样的文章”。

彻底犯懒

2011/02/21 – 4:48 下午

我说我最近心悸,苏岭说我是彻底犯懒。原来犯懒也会让人生病。

在20多位顾问成员的努力下,DIA第三届中国年会雏形已现。

我似乎感受到一项宏大工程的细节之美。

 

 

 

 

The 3rd DIA China Annual Meeting

药物信息协会(DIA)第三届中国年会

Quality & Standards—— Elevating China Pharmaceutical Development

质量与规范——中国制药业的升级路径

Pre-conference Workshops: May 15, 2011

会前研习班:2011年5月15日

Conference & Exhibition: May 16-18, 2011

大会及展览:2010年5月16-18日

Crowne Plaza Sun Palace Beijing

No.12 Qisheng Middle Street, North-East 3rd Ring Road, Yunnan Dasha ,Chaoyang District, Beijing, P.R. China

北京新云南皇冠假日酒店

北京市朝阳区东北三环七圣中街12号云南大厦

     

 

Program Co-Chairpersons联席主席 

Co-sponsored by

 1. 希望简短些并能总结前两次会议并展望本次会议的结果

        2. 名单上人员的支撑及单位需更正,那些不积极参加的人

员建议删除。

China Center for Pharmaceutical International Exchange of the SFDA

合办单位:中国医药国际交流中心

 

China’s drug innovation and development are moving ahead rapidly. A local, as well as global, perspective will help all players involved to exchange critical information for research and strategic positioning in an increasingly complex regulatory landscape.

中国药物的创新和发展日新月异。本次大会将从地区乃至全球的视角帮助参会人员对日愈复杂的监管环境中的研究和策略定位进行探索和交流。

This third DIA China Annual Meeting will serve as an international, neutral forum for attendees to collectively discuss how China can play a leadership role in drug development. Speakers from major regulatory agencies, industry, and academia will present and lead the panels and sessions.

药物信息协会(DIA)第三届中国年会作为一个国际性的中立论坛,参会人员将对中国如何在药物发展中扮演领导角色进行探讨。来自管理机构、企业界和学术界的演讲人将出席并主持会议的讨论。

This multidisciplinary meeting will benefit all professionals from regulatory agencies and institutions, the biopharmaceutical industry, investigational sites, contract research organizations, and academia. Together we can better understand how to reach the next stage for our profession as well as deliver benefits for human health and well-being globally.

本次大会涉及众多领域及学科,将有益于来自监管机构,科研院所、生物制药、临床研究基地、合同研究机构和学术界的专业人士就提升本专业的水平,在中国乃至全球新药研发中发挥更重要的作用互相交流、切磋和探讨。

KEY SESSIONS AND TOPICS主要分会与议题

 

–          CMC/cGMP 化学、生产、质控/cGMP

–          Clinical Research, Drug Safety & Pharmacovigilance药物临床开发与安全警戒

–          Regulation, Development & Practices 药政法规及实践

–          Clinical Data Management and Statistics临床数据管理与统计

–          Medical and Scientific Affairs医学事务

–          Capability & Capacity Building, Clinical Development/Regulatory Strategy临床开发与建设

–          QA/QC in Clinical Development, Regulatory Requirements/Practices临床开发中的质量保证与质量控制

 

WHO SHOULD ATTEND 参会人员

This program will benefit individuals involved in:

本会议将有益于从事以下领域的工作人员:

–          Regulatory affairs法规监管事务

–          Clinical research临床研究

–          Drug R&D strategies药物研发战略

–          Quality assurance and quality control质量保证和质量控制

–          Drug safety and pharmacovigilance药物安全与药物警戒

–          Strategic sourcing/planning战略资源与规划

–          Bioinformatics生物信息学

–          Biostatistics生物统计学

 

Simultaneous translation will be available on May 16-18.

516-18日将提供同传服务

 

CONTACT INFORMATION

联系方式:

Conference: For general inquiries and registration, contact Mr. Fei XIE at fei.xie@diachina.org

会议咨询:一般咨询与注册,请与谢飞先生联系,Emailfei.xie@diachina.org

Exhibits: Ms. RunShan CHEN at: ting.chen@diachina.org

展览咨询:请与陈润珊女士联系,emailting.chen@diachina.org

James CAI, MD

President, Pangu Biopharma Ltd.

Vice President, Clinical Development aTyr Pharma Inc

蔡学钧, 医学博士

盘古生物制药有限公司总裁

aTyr Pharma Inc. 临床开发副总裁

 

ZHAO Yajun

Director-General, China Center for Pharmaceutical International Exchange, SFDA, China

赵亚军

中国医药国际交流中心主任

 

Program Vise Chairperson组委会副主席

John J. HU, PhD

Vice President, International General Manager, USP-China

胡江滨, 博士

美国药典委员会国际部副总裁兼中华区总经理

 

Program Committee
3rd DIA China Annual Meeting

会议组委会

Paul DAI, MD, Director, Clinical Development, Beijing Novartis Pharma Co., Ltd., China

戴欣 医学博士

北京诺华制药有限公司临床开发总监

杜文民
GUI Min

Bristol-Myers Squibb (BMS) Director of CMC AP, China CMC & Operation of the Global Regulatory Science

桂敏

百时美施贵宝全球注册科学部亚太区CMC,中国CMC和运营部的总监

GUO Xiaojun

Safety Manager-Patient Safety

AstraZeneca China

郭晓军

阿斯利康中国研发部高级经理-患者安全

Laurence HUANG

Executive Director, Regulatory Affairs AstraZeneca Pharmaceutical Co., Ltd.

黄彬

药政事务执行总监

阿斯利康制药有限公司

JIAO Qingan, MD

Director, Clinical Research Unit, R&D China, sanofi-aventis, China

焦庆安 医学博士

赛诺菲-安万特中国研发中心中国临床研究中心总监

LI Haiyan, MD

Vice Director, Peking University Clinical Research Institute; Director, Drug Clinical Trial Center, Peking University Third Hospital, China

李海燕 医学博士 教授

北京大学临床研究所副所长,北京大学第三医院药物临床试验机构主任

LI Ning, MD, PhD

Senior Group Regulatory and Medical Policy Director, Sanofi-Aventis, China

李宁 医学博士

赛诺菲-安万特中国区集团注册和医学政策高级总监

LI Shuting, MD

Cancer Institute & Hospital Chinese Academy of Medical Sciences

李树婷 医学博士

中国医学科学院肿瘤医院伦理委员会秘书

Daniel LIU, PhD

刘川

Jessica LIU, MD

Senior Director of Clinical Operations

Head of Asia-Pacific,

Global Clinical Operations,

INC Research

刘佳 医学博士

Joanne LIU, MS

Regional Director, Asia Pacific Data management Center

Global Data Management & Standards

Merck. & Co. Inc,China

刘宗范 硕士

默克全球临床数据管理中心亚太区总监

MENG Yuan

Head of Country Pharmacovigilance, Greater China Bristol-Myers Squibb Company

孟渊 百时美施贵宝公司大中华区药物警戒经理

Roger QU, PhD

Senior Director, Department of Statistics

Pfizer China R&D Center

曲鹏

辉瑞(中国)研究开发有限公司统计部总监

Frank SHEN, PhD

Head of Biometrics and Clinical Study Management, Roche Product Development Center in Asia Pacific

沈志华 博士

罗氏药品临床研发亚太中心生物统计与临床研究管理总监

Lily SUN, MD, Director of Medical,

Pfizer Pharmaceutical Ltd., China

孙丽梅 博士
辉瑞制药(中国)有限公司医学部总监

Claire TAN

谭朝瑜

童成
WANG Peng, PhD

Chief Scientific Officer,

Simcere Pharmaceutical Group, China

王鹏 博士

先声药业首席科学官

William WANG, PhD

Head of Asia Pacific Hub, Department of Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc, China

王武保 博士

默克研究所生物统计与研究决策科学部亚太区运营总监

Jenny WU

Site head and Chief Medical Officer, Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.

吴健宇

默克雪兰诺(北京)医药研发有限公司研发中心负责人、首席医学执行官

Catherine XIE

Safety Evaluation & Reporting Site Planner

Pfizer(China) Research and Development Co., Ltd

谢珺

辉瑞(中国)研究开发有限公司安全评估和报告总监

XU Ning, MD, MBA

Executive Director, Head of Clinical Development Service, Covance, China

徐宁 医学博士

科文斯公司执行总监,中国临床研究事业部负责人

Wendy YAN

Global Regulatory Strategist, Global R&D Center, Bayer Healthcare Co. Ltd.
闫小军

Rachel YANG, MD, PhD

Director, Product Strategy, Health Sciences Global Business Unit, Oracle Corporation, China

杨佩蓉 医学博士

甲骨文(中国)软件系统有限公司生命科学全球事业部产品策略总监

ZHANG Dan

Chairman & CEO, Fountain Medical Development Ltd.

张丹

方恩医药发展有限公司董事长兼首席执行官

Tony ZHANG, PhD

Managing Director, and Site Head, Eli Lily Global R&D, China

张彦涛 博士

礼来制药中国研发董事总经理

ZHEN Ling

甄岭

 

3rd DIA CHINA ANNUAL MEETING ADVISORS

第三届药物信息协会中国年会顾问委员会

Karen J. ATKIN, MD

Vice President, R& D Center, AstraZeneca China

Karen J. ATKIN 博士,阿斯利康中国药物研发部副总裁

BI Honggang,PhD

Vice President and General Manager, Covance China

毕红钢 博士

科文斯中国公司副总裁及中国区总经理

Wen CHANG, PhD

Head of Regulatory Intelligence and Advocacy, Asia Pacific Region, Global Drug Regulatory Affairs,

Beijing Novartis Pharma Ltd

张薰文 博士

诺华全球药事法规亚太地区战略发展研究部主任

JIN Kewen, PhD, General Manager,

Charles River Preclinical Services, China

金克文 博士

上海查士睿华生物医药科技有限公司总经理

Frank JIANG, MD, PhD

Vice President, Global R&D and Head

Asia Pacific R&D, sanofi-aventis, China

江宁军 博士

赛诺菲-安万特全球研发副总裁 亚太区研发总裁

LI Jinju, PhD

Director of Drug Research Supervision Division, Department of Drug Registraion of SFDA, China

李金菊 博士  

国家食品药品监督管理局药品注册司药品研究监督处处长

SU Ling, PhD

Vice President, Asia Pacific Research Organization, Pfizer, China

苏岭 博士

辉瑞(原惠氏公司)亚太区临床研究组织副总裁

TAN Lingshi, PhD

General Manager,Pfizer(China)R&D Co., Ltd. China

谭凌实 博士

辉瑞(中国)研究开发有限公司总经理

YAO Chen

Vice Director, Peking University Clinical Research Institute,  Head of Department of Biostatistics 

Peking University First Hospital,China

姚晨 教授

北京大学临床研究所副所长

北京大学第一医院药学统计室主任

ZHANG Beibei

张蓓蓓

 

Sunday, May 15, 2011   Pre-conference Workshops

  1. 学习班的目的及讲者的题目需明确。
  2. 可移2个学习班至16日上午。

 

8:30 – 17:30  Workshop 研习班 1

如何遵循GCP规范准备和应对药政稽查的最佳实践

About the workshop 研习班介绍

Who should attend  参加者

 

Learning Objectives学习目标

 

Speakers: 讲师:Earl Hulihan, Kim Nitahara, Byungia Marciante (FDA) (Confirmed)

Lead: Daniel Liu

 

 

8:30 – 17:30  Workshop 2  研习班2

生化分析方法的开发和验证

 

About the Workshop 研习班介绍

Who Should Attend 参加者

Learning Objectives学习目标

Speakers 讲师:  Fa Zhang, PhD (J&J), Shaolian Zhou (Novartis), Yun He (BioDuro )

 

 

8:30 – 12:30: Workshop 3  研习班3

疫苗临床研发及法规

Lead: 刘佳、Bill Wang

 

About the Workshop 研习班介绍

 

Who Should Attend 参与者

 

Learning Objectives学习目标

 

Speakers 讲师:

 

 

13:30 – 17:30: Workshop 4   研习班4

Ethical medical writing practices – every document, every time, every country

伦理医学报告写作

 

About the Workshop 研习班介绍

 

Who Should Attend 参与者

 

Learning Objectives学习目标

 

Speakers 讲师: Karen Woolley (confirmed)

 

 

 

8:30 – 17:30: Workshop 5  研习班5

New CDISC Global Approach course

Lead: 谭朝瑜

 

About the Workshop 研习班介绍

 

Who Should Attend  参与者

 

Learning Objectives学习目标

 

Speakers 讲师:

 

Monday, May 16, 2011

 

PLENARY SESSION 全体大会

 

13:30-14.15 (45′)    年会开幕大会 (三层 云南厅)Opening Ceremony (3F YunNan Grand Ballroom A+B+C)

JANE CAI主持并介绍来宾。

会议主席(JAMES CAI,赵亚军)致辞。

James CAI, MD

President, Pangu Biopharma Ltd.

Vice President, Clinical Development aTyr Pharma Inc

蔡学钧, 博士

盘古生物制药有限公司总裁

 

ZHAO Yajun

Director-General, China Center for Pharmaceutical International Exchange, SFDA, China

赵亚军, 中国医药国际交流中心主任

 

致辞并发奖。

Richard O. Day, AM, MB, BS, MD, FRACP

President, Drug Information Association

药物信息协会候任主席

Professor of Clinical Pharmacology, St. Vincent’s Hospital, Australia

澳大利亚,圣文森(St. Vincent’s)医院,临床药理学教授

 

Paul Pomerantz

Worldwide Executive Director

Drug Information Association

药物信息协会全球执行总监

 

14:15-15:00 (45′)    特邀贵宾演讲  邵明立 先生国家食品药品监督管理局局长

                    keynote speaker: Mr. Shao Mingli Commissioner of SFDA, China                      

15:00-15:15 (15′)   茶歇 Tea Break

15:15 -15:45 (30′)   演讲一:Speech 1China Drives to “Indigenous Innovation”.   演讲人:Speaker Mr. James McGregor/ Michael Zielenziger

15:45-16:15 (30′)   演讲二:中国新版GMP 综述   演讲人:Speaker SFDA(孙咸泽)

16:15-17:30 (75′)   辩论会:迈向医药强国的中国式跨越  Opening Debate 

                   参与者:Participants 苏岭(主持)、董瑞平、李自力、李宁、张伟(SFDA)、冯毅(CDE)、施一功教授

 

18:00-19:30 (90′)    联谊招待酒会Networking Reception 特邀嘉宾演讲常昊?

 

 

Monday, May 17, 2010

 
8:30 – 10:00  SFDA Town Hall Meeting: 十一五主要成绩及十二五规划及展望

Speaker: 局办主任/副主任主持,注册司,安监司,器械司?,稽查局,评审中心

    CDE, CDR, CDC, CMD 各派人介绍十一五主要成绩和近期计划

  (需交流中心协调国合司局办)

–          临床核查的回顾总结李金菊

–          指导原则/CTD

–          政府在鼓励创新方面的举措-回顾  杨建虹、冯毅

–          信息管理、数据库等董江萍

–          国家局政策法规总体规划

–          中国在APIC中的角色  丁建华

 

 
10:30 – 12:00     PARALLEL TRACKS – SESSION 1                     平行会议第一场  

Track 1

Track 2

Track 3A

Track 3B

Track 3C

Track 4

 

药物临床开发与安全警戒                                  Clinical Research, Drug Safety & Pharmacovigilance

1.是否将质量有关内容移到QC/QA部分

 

药政法规及实践

Regulation, Development & Practices

1.  能否增加一些国外的讲者e.g. WHO西太平洋地区负责伦理的人员?

2.  白皮书解读部分能否加一位学者给予解读或评论

3.  一位学者给予解读或评论

4.  eCTD部分能否加入国外经验分享

 

数据管理与统计

Data Management and Statistics

  1. 1.    请确认演讲者
  2. 2.    在十八日下午Bill Wang可否增加一内容:Drug Development Globalization vs. Regionalization

医学事务

Medical and Scientific Affairs

 

临床开发与建设

Capability & Capacity Building, Clinical Development /Regulatory Strategy

药品标准与质量

Drug Standard and Quality

 

 

Session 0101

Session 0102

Session 0103A

Session 0103B

Session 0103C

Session 0104

 

Quality in clinical research, drug safety & pharmacovigilance

 

Chairpersons会议主持

Hannah Chen

Guo Xiaojun, 郭晓军

 

1. What are the key inspection findings?

Challenges we are facing in conduct clinical trials (20 min)

Byungja Marciante (FDA)

FDA Officer (Hannah to further confirm)

 

2.  Panel discussion

¨       Insufficient source documents – main challenge due to medical system in China?

¨       Missing data (AE and SAE)

¨       Safety information reconciliation between clinical database and safety database due to inconsistency of source document reporting

Helen Li (Pfizer)

Chen Yuling (307 Hospital)

Zhou Aiping

(CAMS, Tumor Hospital)

Wang Yuhong (Roche)

A Sr. CRA (TBD)

 

3Case study: How do we improve source documents to meet GCP requirements?   1 case oncology and 1 case non-oncology protocols and 1 case of SAE case to be distributed to audiences in advance; some of them will be invited to the panel to join the discussion

¨        Verification of subject eligibility according protocol requirements – what source document we must have

¨       Clear Definition of SAE (Death as outcome, disease progression)

¨       Clear instruction of SAE management

Above panelists + some audiences

 

 

 

 

 

Session 1

AD (Adaptive Design) 

 

Chairpersons会议主持

Roger QU(Pifzer)曲鹏

Robert LUO (Pifzer)罗震

 

Panel or Debate

 

Topics:

Part 1 –  an oncology case (or other applicable disease) . Imbed the “guidance comparison” session in this:

– Is China ready for adaptive design (e.g., DMC ready)?

– Discuss different options: fixed sample, GSD, SSR

– Why we need adaptive design  and How can the adaptive design increase quality (speed, resource, result)

– How the ICH,FDA guidance, and SFDA guidance differs (focusing on why, what, how)

Format:

  – A panel discussion for DMC in China

(The panel could consist of the speakers in the first part plus all of the lead and maybe more )

 

其他讲者:

   1 speaker from the regulatory perspective on the practice of DMC and adaptive design in its broad sense (Sue-Jane Wang)

   – 1 speaker from the perspective of DMC members (Irving K. Hwang)

   – 1 speaker from China, topic could be the current practice of DMC in China or comparison of sFDA guidance and ICH and FDA guidance (we are seeking a speaker familiar with the current practice in China, not necessarily a statistician)

 

Part 2 – 1 or 2 cases for adaptive designs

(The format of the second part could be further refined.)

Roger QU

曲鹏(Pifzer)

Robert  LUO

罗震 (Pifzer)

Chairpersons会议主持

James CAI

Zheng GU(顾峥)

Irving Wang (王敏)

Session 1:

What is MA/SA, its role & responsibility in biopharmaceutical value chains and transferring scientific data into patient centric medical practices

(Half of a day)

Topics:

• Overview of Medical & Scientific Affairs definition, position, role, responsibility, competency requirement  in professional medical information communication, patient safety, regulatory compliance and product life cycle management

Speaker:

Dr. Rick Sax, VP Global R&D of AstraZeneca (TBC)

 

Reshape your clinical development strategy in China? Join the experts to learn if China clinical development has delivered its promises, find out what are the gaps, and how to reshape your strategy in the next 3-5 years.

 

Chairpersons会议主持

Frank JIANG

Lingshi TAN

Tony ZHANG

 

Session 1:

Phase Capability, Crossing the chasm

-The data burden and regulatory hurdle for first in man trial in China are relatively high compared with other countries. Experts and industry observers will delineate root causes for this phenomenon and contemplate solutions to bridge the gap in the drug development value chain. Capabilities (readiness) will be a focus of the discussion. 

Potential speakers:

-HU Bei 胡蓓

-ZHANG Dan (Fountain Med)张丹

-GAN Rongxing (Covance)甘荣新

-Roisin Armstrong/Chew Lan Chong

 

Session 2:

Has China delivered its promises for global pivotal studies? Strategy, Gap analysis and Recommendation

Topic:

• Growing market potential and abundance in patients needing medical breakthroughs in China have driven the number of international muliticentered trials in China to triple in 2009 over 2008. Numbers aside, what has kept the country from becoming a dominant player for first in kind pivotal trails? Where are the limiting factors and how are the problems addressed?

Potential speakers:

-Rae Yuan

-Wang Min

-Karen Atkin (AstraZeneca)

 

 

Chairpersons会议主持

John HU (USP)

Min GUI

Charles TONG

 

Session 1

2010版中国药典-how to deal with different compendia

How to Strengthen the Interactions between Standard-Setting Organizations and manufacturers (如何强化标准建立机构和企业间的互动)

SFDA Perspective (new)

FDA Perspective (new)

WANG Ping or LI Huiyi

(ChP 1 speaker)

Susanne Keitel (EDQM)

John HU胡江滨(USP)

Erin Wang (Lily)

 

Panel Presentation + Case studies, Q&A

 

 

 

12:00 – 13:30 Lunch 午餐

 
13:30 – 17:30 (Break 15:00 – 15:30)    PARALLEL TRACKS – SESSION 2           13:30 – 17:30 (茶歇15:00 – 15:30)    平行会议第二场  

Track 1

Track 2

Track 3A

Track 3B

Track 3C

Track 4

 

药物临床开发与安全警戒                                  Clinical Research, Drug Safety & Pharmacovigilance

药政法规及实践

Regulation, Development & Practices

数据管理与统计

Data Management and Statistics

医学事务

Medical and Scientific Affairs

临床开发与建设

Capability & Capacity Building, Clinical Development /Regulatory Strategy

药品标准与质量

Drug Standard and Quality

 

 
Session 0201 Session 0202 Session 0203A Session 0203B Session 0203C Session 0204  
IRB/IEC practices and issues in China

Chairpersons会议主持

Paul Dai 戴欣

Mao Yimin 茅益民

 

Panel discussion- #1

What are the impacts of new issued IRB/IEC guideline?

Liu Haitao刘海涛

(Institute of Clinical Research, Beijing University)

Xiong Ningning

(Jiangsu Provincial Hospital of Traditional Chinese Medicine)

Eva Yang (Bayer)

 

Panel discussion- #2

Efficient and high quality site management

Study site management

¨       Investigator’s responsibilities

¨       Site resource management

¨       Management of clinical research center

¨       Clinical research coordinator

 

Li Haiyan (No. 3 Hospital of Beijing University)

李海燕(北医三院)

Hannah Chen (GSK)

Grace Wu (Pfizer)

 

Topic    

中国新药研发?监管的?趋势 (1.5 h)

LI Jinju, 李金菊SFDA

PFDA代表,

CAO Cai/LI Jianming

曹彩/李见明CDC

  (每位讲者25分钟,Q&A最短15分钟)

 

Topic 4  

中国新药研发指导原则体系的完善(1.5 h
 
Guidelines for New Drug research & development are one of the important tools to guide China new drug development. In the last few years, SFDA already issued more than 70? technical guidelines and more than –guidelines are requesting comments or under drafting. In this section, SFDA will provide an overview on the systemically technical guideline development planning and will illustrate, describe and discuss these new guidelines from SFDA’s point of view

 

HOU Renping

候仁萍SFDA注册司)

WEN Baoshu

温宝书 (CDE)

Industry代表

 (每位讲者25分钟,Q&A最短15分钟)

 

 

Session 2

Adopting International Standards and Improving Data Quality

 

Chairpersons会议主持

Joanne LIU (Merck)刘宗范

Daniel Liu (Medidata)刘川

Rachel Yang (Oracle)杨佩蓉

 

Panel Discussion, Q&A

 

Topics:

Regulatory Guidelines and international data standards with regards to computerized systems

• A newly published GCP guideline: computerized systems in clinical research – current data quality and data integrity concepts

• CDISC application and trends: e-Protocol frameworks and EDC scope with CDISC elements

• Foundation and strategy of e-clinical practice: computerized systems validation for the e-system’s lifecycle

刘川邀请到3-4位讲者

杨佩蓉正在联系CDISC的讲者,刘宗范正在寻找有关DM roledata quality的讲者

 

Session 2  (Panel Discussion)

 

Adopting International Standards and Improving Data Quality

 

Topics:     

Implementing data quality measures that integrate people, process and technology

• A winning strategy on data quality — putting the right pieces together (culture, infrastructure, information technology and SOPs). 

• EDC implementation in China: historical defects, current environments and challenges of data management

• Data Manager’s Role in data quality and KPI for data management process

• Improving data quality with partnerships and collaborations (Sponsor, CROs, Investigators, Clinical Data Manager, CRAs, and Biostatisticians.)

 

Joanne LIU (Merck)刘宗范

Daniel Liu (Medidata)刘川

Rachel Yang (Oracle)杨佩蓉

Session 2:

Establish practical and effective medical/scientific affairs strategy

Topics:

• Evidence based medicine in established markets and emerging markets: case study of LCM

Speaker:

Dr. Dominique Roome, VP Global Medical operations

• China experience

Speaker:

Dr. Gao Runlin, People Hospital Beijing China

• Working with Marketing and Clinicians on evidence based medical-marketing communication

• Epidemiology study and outcome study

• Post marketing study and data assembling

Speaker:

Li Huafei, Medical Liaison Manager

AstraZeneca China

• Publication and DA

• From concept, strategy, resource planning, execution and communication

Speaker:

Joyce Li, VP Medical of NovaMed Pharma

• Promotional material development and review

Speaker:

Dr. Gu Zheng, Medical Director of Sanofi-Aventis China

• Establish an a-player team

Speaker:

Dr. Jane Lin, Medical Director of Baxter China

 

Session 3:

Regulation update and trend Topics:

• SOX

• Legal and compliance perspective

• MOH Clinical path initiative

Speaker:

Katherine Wang, Sidley Austin LLP

 

Session 4:

Clinical outcome-research

Topics:

• Outcomes Research Impact in Medical Practice

Speaker:

Dr. Danyi Zhang, CMO of

Vital Strategic Research Institute (VSRI)

 

Session 5:

Operational excellence-Debate and Group discussion of specific cases

(2 hours)

Topics:

• All, facilitated by Dr. GU Zheng

(Roundtable discussion)

Session 3:

Modernize clinical development through New technology

 

Due to its highly regulated nature and long development timeline, medicines are not normally associated with the image of cutting edge technologies. Have we overlooked what technology can deliver for improving patient adherence, data integrity, quality of the studies, and overall probability of success? This panel will invites experts from several different fields and examine the possibilities of leveraging technological innovation to speed up medicine development. A must attend session. –

Potential Speakers:

-Michael AIbara, others?

 

 

Session 4:

TCM development – What we can learn from? 

– Traditional Chinese medicine (TCM) personifies personalized care, tailored therapy, systems biology, and out-come based medicine. While the complexity of multi-components and multi targets mechanism have thwarted traditional Western clinical research approach, it will be rewarding to learn with an open mind on what’s the state of art on TCM clinical development.  

Potential speakers:

-Bradley Marchant

-SFDA

-(Jockey club TCM institute, HK?)

-Selwyn Fung

 

 

Session 2:

QbD-结合案例分析以及PAT新技术介绍

 

Chairpersons会议主持

GUI Min (BMS)桂敏

Charles TONG (BMS)童成

 

Topics:

Implementation of QbD Principles in Drug Development and Real Time Release Testing (RTRT)

Drug Product Development Utilizing QbD

Speaker:

GUI Min (BMS)桂敏

 

Practical Considerations for Implementation of Real Time Release Testing (RTRT)

Speakers:

Charles TONG (BMS)童成

 

 

Session 3:

Supply Chains Management (SCM)

Chairpersons会议主持

John HU (USP)

 

Topics:

 

1. Pharmaceutical Reference Standards: Overview and Role in Global Harmonization (Dr. Matthew Borer, Eli Lily)

 

2. Vendor qualification (Dr.Joan Ruan, BMS)

 

3. Building a Quality Mindset with Your Partner to Manufacture Safe Clinical Materials(Dr. HUNG CHIH CHANG. Eli Lily)

 

 

 

 
 

 

 

Wednesday, May 18, 2010

 
8:30 – 12:00 (Break 10:00 – 10:30)    PARALLEL TRACKS – SESSION 3                 8:30 – 12:00 (茶歇 10:00 – 10:30)      平行会议第三场

 

 

Track 1

Track 2

Track 3A

Track 3B

Track 5

Track 4

 

药物临床开发与安全警戒                                  Clinical Research, Drug Safety & Pharmacovigilance

药政法规及实践

Regulation, Development & Practices

数据管理与统计

Data Management and Statistics

医学事务

Medical Research and Medical Affairs

临床开发中的质量保证与控制

QA/QC in Clinical Development, Regulatory Requirements/Practices

1.能否将QC有关内容从临床转到这部分

生物制药

Biologics

 

 

Session 0301

Session 0302

Session 0303A

Session 0303B

Session 0305

Session 0304

 
From compliance to beyond compliance – how to manage the safety data throughout product life cycle

Chairperson会议主持

Conny Mo磨晓垚

Catherine Xie 谢珺

 

Presentation

Quiz and awards + Panel discussion

 

¨   Overview  in evolving regulatory requirements from global major HAs

¨   China safety regulation and implementation challenge

¨   Safety signal detection in professional assessment of ICSR

¨   Experience sharing of Signal management and Interpretation strategies in different phases of product life cycle

 

Presenters:

  1. 1.   EMEA Officer of Drug Safety
  2. 2.   Xu Jiaqi, SFDA (Conny to confirm)
  3. 3.   Sonja Brajovic, FDA, Medical Officer (Confirmed)
  4. 4.   Craig Harford, VP, Safety Surveillance & RM (Pfizer)

 

Panelists:

Above speakers + some audiences

Topic 5  

中药研发的规范化与国际化  (1.5 h)          

CHEN Yixin/WANG Hainan

陈易新/王海南SFDA

HU Jun胡军CDE

SUN He孙鹤(天士力)

 (每位讲者25分钟,Q&A最短15分钟)

 

Topic 6

美国 aNDA 的要求与实践(2小时)
FDA
代表

恒瑞代表

海正代表
With the rapidly growing pharmaceutical market in China, more and more domestic pharmaceutical companies are seeking the opportunities to enter into global market. aNDA is  one of fast and cost-effective way to launch products into global market. In this section, US FDA will give an introduction on how to apply for aNDA in US. This section will also include the speakers from domestic companies to expose real cases and share their experiences about their aNDA application in US.

The analysis of the 2010 China Drug Registration Whitepaper (or the Annual Report)
In 2009, China SFDA issued its first drug registration whitepaper (annual report) in SFDA website and got very positive feedback from public. In this section, SFDA or sb else will present comprehensive information about drug registration status in 2010, analyze the drug development trends, and further goals etc.

   (每位讲者25分钟,Q&A最短20分钟)

 

 

 

Session 3:

Talent need in China (e.g. epidemiology, health economics, clinical sciences)

 

Chairperson会议主持

Tony ZHANG张彦涛 (Eli-lily)

 

看张彦涛的follow up,也可考虑将此session换成刘川说的内容(CDISC的内容)

 

Session 4:

How to design and implement a meaningful and interpretable post-marketing studies

Tony ZHANG张彦涛 (Eli-lily)

 

 

Session 2:

Maximize Medical and Scientific Affairs contribution to drive evidence based medical communication to clinicians and medical marketing in China and/or emerging markets

Speakers:

Topics:

• What are publication strategy and how to assemble the data

• What are China regulations regarding issues PMS, Off-label communication, sharing scientific research paper, plus the practice best

• International and Asian experience and practices of MA/SA

• Ask expert @ a case Chinese MA/SA or

• Roundtable and panel discussion, case study of

• Promotional material development and review

• What are clinical path (MOH initiative)

• SOX/global compliance vs creative Medical marketing

 

 

Chairpersons会议主持

Spring WANG

Joanne LIU

 

 

Session 1:

Focus on Quality Control in both early and late clinical Development

Speakers:

Topics:

   o What are the key QC steps to drive good quality study

    o What are the major findings of QC from agency perspectives

o Experiences sharing

QA/QC management at study site (LI Haiyan)

    o Case studies

4 presentations inc. Case studies

Interactive panel discussion

 

 

Session 4 – Biologics

 

Chairpersons会议主持

GUI Min桂敏

 

Topics:

  • ICH Q5E biological process change
  • Biotech Comparability
  • Biosimilar

 

Proposed speakers:

CHANG Weihong (SFDA)

industry speaker (桂敏邀请)

David LIN (BCG Consulting) 

Duu-Gong WU (PharmaNet Consulting)

 

Round Table

圆桌讨论

 

 

12:00 – 13:30 Lunch 午餐

 
13:30 – 17:30 (Break 15:00 – 15:30)    PARALLEL TRACKS – SESSION 4           13:30 – 17:30 (茶歇15:00 – 15:30)    平行会议第四场  
Session 0401 Session 0402 Session 0403A Session 0403B

Session 0405

Session 0404

 

    Pharmacovigilance 1

 

Clinical Data Management and Statistics 2

 

1. Experiences and lessons sharing from oncology drug development

 

Chairperson: 会议主持

George Chen, one oncologist

 

Case Study

¨   Accelerating oncology portfolio in Asia

¨   Investigator perspectives: opportunities and challenges of running oncology trials in China

 

 

TBD (George to provide the list after Chinese New Year)

 

2. Operational excellence

Chairperson: 会议主持

Jessica Liu

Cai Yan

 

¨   Operational Excellence to improve trial conduction efficiency

The fundamental elements of clinical safety operational excellence – a good safety system (including database and workflow management, etc.).

Effective liaison management of sponsor, CRO and investigator/site

 

1. Presentation

Cai Yan

 

2. Presentation

Sun Yonghui (Novo Nordisk)

 

3. Debate

Debate host: Xu Ning (Covance)

Debate team 1-leader: Jessica Liu

Debate team 2-leader: Cai Yan

Topic 7   

2010年药品注册白皮书解读 (1.5 h)

ZHANG Wei

张伟SFDA

FENG Yi

冯毅CDE

Industry代表

 (每位讲者25分钟,Q&A最短15分钟)

 

Topic 8   

新药临床研究过程中的变更管理   

(包括临床方案变更和药学毒理变更) (1.5 h)

FDA代表

PI代表

Industry代表

  (每位讲者25分钟,Q&A最短15分钟)

 

 

Two backup topics —     

Topic 9   eCTD电子申报的进展

Topic 10 • Pharmaceutical IPR and data protection in China

Session 5:

Ethnicity and Global Drug Development  Panel Session

 

Chairperson: 会议主持

William WANG (Merck)王武保

Bob Powell (Roche)

 

Other Speakers:

Bruce Binkowitz (Merck)

James Hung (FDA)

 

Session 2

Session 2:

Focus on QA in both early and late clinical development, plan is to especially focus on PK and phase I study QA/QC

Speakers:

Topics:

• Representatives from sponsor, investigator sites,  CRO and agency to share:

    o QA findings

    o Case studies

    o QA/QC in PK and phase I study

4 or 5 presentations inc. 

Case studies

Interactive panel discussion

 

 

Session 5 (with FDAAA)

U.S. FDA New CMC/GMP Guidance and Hot Topics

ICH Q3

Round Table Discussion

圆桌讨论

 

Chairperson: 会议主持

Charles TONG (BMS)童成

 

Topics (tentative):

¨   IND Guidance

   Chuck Hoiberg

¨   Impurities and Polymorph in ANDA

   Chi-wan CHEN

¨   Process Validation Guidance Mark Tucker (Genetech)

¨   PAI program.

 

 

* Chuck Hoiberg,

 Chi-wan Chen,

 Mark Tucker (Genetech)

(All proposed speakers are former managers in ONDC/ONDQA or former FDA field investigator)

 

                     

亲爱的:要展现,不要讲述——读《中国科学革命》

2010/12/31 – 5:38 下午

描述,行动,对话。

这是今年让我感动的为数不多的一篇稿件。它出自于自由撰稿人Rebeeca Kanthor的笔下。这篇2010年春节用英文撰写的稿件,被翻译成中文,用A4纸打印装订,当时躺在上海临床研究中心张炯的办公桌上。因无电子版本,要回来后我抽空就录入一些,直到今天才敲打完成。

之所以令我感动,是因为这是一篇在行走的报道。《中国科学革命》,如此宏大高远的题目,要到图书馆捧回来厚厚一堆材料么?要从百度上下载各种数据库的参考论文么?Rebeeca Kanthor用她的眼睛,用她的脚步,用她的心灵,仅仅从泰州医药城走到张江,跟各种人物对话,让他们发声,让他们展现。不需要用严谨的问题提纲,不需要咄咄逼人的揭示性观点,星巴克,子弹头,人物的表情,着装,直接的话语,巨像出一篇让你看得到和感受得到的稿件。

在列夫托尔斯泰形容其名著《战争与何平》的力量时,他说:“我不讲述、我不解释、我只是展现,让我的角色替我说话。”

优秀写作的基本原则:要展现,不要讲述。给我看你所看的一切,用文字来描述一幅画面,然后,我就可以跟随你的脚步。

令我深有感受的第二个原因,是Rebeeca从泰州到张江的路线,我在2008年也走过一遍,那是在一天之内,所到之处如此相同,CMC(泰州医药城的缩写,那是我第一次听说CMC在申报时代表质量、生产和控制)、桑地亚,张江。路上也不停的跟各种人聊天,王小川、杜莹,所听所观所感跟这位外国记者非常相似,在这篇文章里,尽管没有看到任何深沉的观点,没有对任何问题加以揭示和阐述,但隐约你可以感受到这就是中国的生物科技革命的原生态。

因为她运用了大量的实例,而一盎司的实例比得上一吨概括。里面的一些人物,如杨青,在最近已经离开辉瑞加盟阿斯利康。杨青博士从辉瑞离职,带走了与很多医生和研究人员的联系,也带走了在中国开展研究和临床试验的经验。

如果说,作者最重要的目标之一就是让读者亲眼目睹,讲述不仅使阅读枯燥,而且使读者被动地接受信息。展现则让读者自己想象,自己得出结论,经历顿悟。好记者会让被采访者的语言和动作来做这个工作。“让事情发生,而不要讲它是如何发生。”如果做到这一点,读者就能真正走进报道中去。本来横亘于事件和读者之间的记者消失了。

文章的结尾尤其耐人寻味,“中国其他的高科技园区同样能成功么?中国的生物科技能在一个层面上与美国竞争吗?仅凭我乘车回家的这段时间内是无法回答这些问题的。”

仅凭我乘车回家的这段时间内是无法回答这些问题的。我欣赏她的态度。

一些看似很大的矛盾,在写稿的过程中总希望有人来定论,作为记者,又怎么能够说得清?

祝各位新年进步。

中国科学革命

Rebeeca Kanthor

china-sci-revolution1

为了更深入了解中国东部生物科技的蓬勃发展,我到了中国最大的药品生产和出口基地——泰州。泰州是中国东部一个三类港口城市,距离上海约300公里。推土机和建筑工人正在大兴土木,而三年前,农民们还在这方圆10公顷上的土地耕种。

中国医药城(CMC)的建造始于2006年,现已完成五分之一。由于我是在春节前几天来的,这里比较安静。我们的车旁仅有一辆电单车在行使。

尽管CMC还在初级建造阶段,已有许多大楼拔地而起。中国国家食品药品监督管理局已在此设立办事处,且有200家公司迁入泰州。在今后10年间,将有1000家企业进驻。

这是一个庞大的项目,整个城市将以生物科技和医药行业为基础。一个医院、豪华别墅、公寓楼、研发中心、咖啡馆、一个四星级酒店——这些都在蓝图中。

泰州目前最大的阻碍是引进能够将这个城市转换为一个创新基地的人才。泰州距离上海很远,但政府正在解决交通问题。一条新的直达高铁贯穿首都北京和泰州,这或许部分应该感谢胡锦涛主席是泰州人。下午6点乘坐这列高铁,第二天上午7点即可达北京。另一条高铁将在两年内完成,届时将缩短到上海的时间到一个小时。

1月份时,泰州开始建造机场,预计将在18个月内完成。

我的导游指给我看CMC的缩略图,在大屏幕下应找出无数大楼的模型,看上去就像“乐高”的梦幻世界,整个城市呈现在我们面前。但这一梦想,是通过政府各界领导人的支持得以实现的。在前面几步,我们可以看到支持CMC发展的政界领导人的大幅照片陈列在门口处。我的导游提醒我说:“我今天见到江苏省的副省长路过这里。”

很快,我便和CMC的“市长”何榕交谈起来,我可以感受到这样一个梦想是经过精心策划的。“我们并不是在建造一个高科技园区,我们是在建造一个城市。这是一个完整的项目。”他说道。他从一开始便参与到了CMC的开发中。

他的语速很快,正如中国许多政府官员的说话方式,言谈中有许多药店,语气抑扬顿挫。他招待来宾的俱乐部有四个装饰华丽的私人宴会厅,分别具有中国、日本、美国和欧洲的不同风格,从而确保来宾无论从何地来,均能宾至如归。

他的步伐矫健,目的明确。午餐期间,他与外国商人谈笑时候仍电话不断,并有一名省级政府官员拜访。每一个人都希望能够与他交谈,无论是希望向他就开发CMC给出建议,或是希望能够在快速发展的园区内驻留。

他希望能够参与竞争,但不希望中国被视为一种威胁,“我们希望赶上美国,但不会压倒美国,”他说道,“我们正在学习美国的成功经验,我们得到了政府国家级的高度支持这是非常重要的。”

何荣相信CMC所尝试的是一项新的事物。“为什么各位来到这里?”他问道,“我们所做的是不一样的事情,其他人在建造的高科技园区,说的是‘我会卖给你一片地。’”但何榕的观点不同,“我必须带着科学家的梦想并让它成为现实。我们在这里是为科学家效力的。”

风景和星巴克

离开CMC,我乘车3小时到了上海。从快速发展的农村到城市,马路上的车辆列成了长长的一排。为了消磨时光,我跟同乘的旅客交谈开来。这名旅客是一位美籍华人博士兼首席执行官,他在那天下午与何榕见面。“这是我第三次去CMC了,”他说道,“我既看到了让人振奋的一面,也看到了一些潜在问题。”他担心由于泰州的地理位置很慢吸引人才长期在CMC工作,而且认为要等5年到10年以后才能看到效果。

但尽管如此,他还是因被何榕接见而激动,因为“你是在和决策者对话,且他和你的视角是一样的。”

在上海,我乘坐地铁到2号线的终点站。我要去的是张江高科技园区,这是政府相关的开发项目,园区内已满是生物科技公司。

携带笔记本电脑的乘客下了地铁后座上往返班车——一辆具有未来气息的子弹头列车。列车在园区的软件、半导体和生物科技区的站点停靠下客,总路线长度为25公里,横跨各条以科学家命名的道路,如哈雷路。跨国公司和本地大学学院之间只有咫尺之遥。

尽管园区应是一个繁忙而喧闹的地方,围绕园区的6车道马路上仅有来回的班车在行使。这是只有在上海郊区能够看到的场景,而市区的道路通常是拥挤的。我穿过感恩教堂,不远处能看到几个便利店和一个星巴克,这是我所见到的唯一不是住宅或办公区域的地方。

在张江,80%的工作人员年龄在35岁以下,而殷宏并不能算他们中的一位,但也差不多。作为张江高科技园区的副总经理,他曾经亲历园区从1996年起的成长,见证了它从主导轻型制造业到主导高科技的转变过程。

“随着中国经济的发展,人们对健康的需求变得越来越重要,” 殷宏告诉我道,“中国人希望得到与美国人相同的医疗标准。我们相信美国的先进技术和药物能够造福中国人民。”

中国快速发展的医药市场是上述行业转变的一个原因。“国人不断增长的需求是外国公司的最大商机,” 殷宏说道,“这是外国公司喜欢在中国做生意的原因。他们拥有市场和合适的人。”但他认为中国的患者都很理性,不会只关注外国的品牌。“美国公司需要在中国设立研发中心,开发适合中国人的药物。”

“张江繁荣了”,殷宏说,部分是因为它的地理位置。“上海早已成为生物科技开发的绝佳地段。管理层的人员均有国际化的背景和视角。规定和监管都是透明的,”他说道,“我们已经与跨国公司建立良好的关系,因此他们觉得在这里做生意是安全的。”

园区的环境,他夸耀道,非常适合大型公司与小型公司之间展开合作。“我们已建立了一条生态链。”创新技术在这里遍地开花,他还指出过去数年间,已有119家制药行业的总获批进入园区。

殷宏确实是一名好的推销员。他在结束他的介绍时,还告诫那些仍抱有疑惑的人说:“没有抓住此次机遇的人必将在今后输人一步。”

辉瑞

当我问殷宏我还应该和谁谈的时候,他首先想到的就是杨青(Steve Yang)。杨青是海归的代表人物——海归是对出国留学后回国工作的中国人的叫法。

作为一名年轻的大学毕业生,杨青离开中国到美国留学,并在18年后的2006年以辉瑞亚太区副总裁的身份回国。“在那时,中国的研发还处在艰难阶段,”他回忆道,“当我还在上海读大学时,张江四处是农田。中国的经济发展如此迅速真是奇迹。”

杨青说现在的经济环境使他联想到不同时期的美国。“我觉得市场充满活力,就像我在90年代看到的硅谷。那时充满机遇,企业家也受到尊重。”他回忆道。

今天,杨青在中国感受到了美国所不具有的那份激情。“在美国,氛围冷冷清清,生物科技行业的发展受到抑制,”杨青说,“在中国,有几种因素推动发展。政府为基础研究提供资金,这确实令人觉得创新标准在逐渐提高。”中国的生物科技并不像美国那样定义严格,且在中国,生物科技的界限是模糊的,它混合着新药合同研究组织(CRO)、基础研究团体和综合研究公司。

杨青说,海归是繁荣中国生物科技行业的重要因素。“这些海归具有创新理念和知识。我经常开玩笑说这里是一个迷你的新泽西州加上东海岸。你在这里会遇到许多和我一样的人,因为许多科学家——特别是资深科学家,曾在美国或学术界工作的人。在任何高科技研发中心内,你可以看到很多海归,这其实是一个非常小且联系紧密的圈子。”

杨还强调说现在仍有一些因素使得你在中国工作变得不方便。

首先,从美国进口试剂需要几周的时间。空间同样是个问题,因为张江高科技园区已经被塞得满满当当了。

“所以新公司不得不去其他地方落脚或等待空席”,杨青说。“我们实在没有地方了。”

开发医疗器械

在离开杨青的办公室后,我开始逛园区。殷宏的助理建议我找一家新设立公司的首席执行官谈谈。

TY Hu在美国的时间接近有20年,回国后,他与4名同事共同设立了一家医疗设备研发中心。

TY Hu又高又瘦,身穿卡其裤,一件长袖T恤和一件宽松的羽绒背心。他虽然靠着椅子,但谈到他的工作时,依然很兴奋和率直。在医疗设备行业,Hu认为早先进入是对公司有利的,他预测,“在5年间,市场将充满像我们一样的研发中心生产的医疗器械。”

Hu告诉我中国的潜能把他拉回国。“仅凭中国的人口,就对任何产品具有吸引力了,”他说道,“我这个行业的市场以每年30%的速度递增。这在世界其他地方是看不到的。”

 

不但如此,Hu得益于其海归身份和美国公民的身份。“我们踩在线上,”他说,“当我们需要法律保护时,我们是外国人。当我们需要政府拨款时,我们是中国人。”

中国东部的城市都迫切希望跳上生物科技这辆大车,且不同的地区******不同的激励政策。Hu说:“如果你在苏州或无锡,他们会给你很多激励:低成本,甚至是免费的土地,让你设立公司或作为股权获得银行贷款,初始资金和授权。离上海越远,获得的鼓励政策越多。”

尽管有这些福利,没有公司能保证成功,例如,Hu说,对于小公司而言,中国的运营成本并非一直有竞争优势。由于基础供应不能到位,他不得不依赖进口,而对于加工而言,由于劳工成本低,所以看起来比较低廉。但同时技术成本区花费更多。

然而这些挑战不能阻挡Hu。“这确实是个很好的市场,晚进入市场的代价太大了。早进入市场时我们在这里的原因,而并非一贯处于成本的考虑。”他说,“我们的成功依赖于我们是否能够在当地生存下来。”

同时,当地市场缺乏医疗设备行业的人才,因此,Hu还要依赖来自美国的研究人员。

探寻新药合同研究组织

我想了解当地新药合同研究组织如何区别于一家跨国公司的研究组织,因此,我到了桑迪亚,希望和王小川进行交流。在寒冷的办公室里,王全身裹着冬衣。桑迪亚的首席执行官看上去就像你的一位友好的姑妈。

她说起她的公司时就像在说她的家人,但她还具备直截了当的商业理念。她在90年代作为联合国教科文组织的成员来到美国,之后便进入了生物科技领域。当她觉得时机成熟时,她回到了中国。“我看到环境在变化,人们的观念在改变,政府在改变,所以我相信历史性的机遇来到了,尽管我在美国有体面的工作和舒适的生活,我还是回到了祖国。”她说,“无论你的母亲如何丑陋,”她坦率地说,“你仍然爱她。所以,虽然我们很多已拿到美国身份,我们仍然与祖国有着这层联系。我们在这里有亲人和朋友。我们仍然挂念。”

王小川认为中国的生物科技要赶上美国仍有一段路要走。大多数本地公司不过才成立几年,缺乏药品研发经验。“药品研发,需要经验。”王强调说。

王说中国制药业需要本地创新。“你可以通过从中国的制药公司生产出来的新药数目判断,这是一个很好的预示。如果他们只是生产仿制药,那只是在复制,不是一个真正的制药行业。”虽然,中国的新药很少,王小川预见到了改变:“我听说有许多,或许是上百种新药正在研发。”

作为一家本地公司,桑迪亚曾到过张江高科技园区。“张江政府好的方面在于他们真的喜欢学习,而且他愿意帮助和支持我们。”王小川告诉我,“他们经常到我们公司问我们,‘我们能为你们做什么?我们能帮助你们?’”

但是,王不满意的是那里是郊区。“我希望那儿的文化生活水平能够改善,可以提供更多便利和更高层次的生活水准。我们除工作以外还需要有好的生活。这非常重要。”她说。

中国的生物科技发展越来越繁荣,美国人需要担心么?“我认为,美国应该为此高兴而不是担忧,”王说道,“科学是无边界的。任何国家开发出来的重要技术应造福全世界。”她说的时候像一个真正的外交家。

从水稻到罗氏

为了了解张江高科技园区内发生的变化,我采访了罗氏公司。

自1994年搬到张江高科,罗氏是第一家落户张江高科的企业。在那时,张江高科技园区还在一片水稻田里。在中国完成学业后,Andreas Tschiry回到了瑞士,但觉得生活无趣于是又回到了中国。这次是作为罗氏中国研发中心的总经理。

在张江高科技园区内工作,对于罗氏而言是一个很好的经历。Tschiry 说:“我们得到许多支持,这里对于各种问题都是坦诚公开的,这些是我在西方未曾见到的。”

Tschiry预测了许多问题,“中国将成为一个重要的创新国家。”他称,“但我看到,这种崛起引起了西方国家的恐惧。我认为我们应该专注于合作,而不是继续持有偏见的态度。” Tschiry说,他的语气带有责备。“医疗行业应该服务全人类,如果我们只是强调竞争,我们错过许多机会。”

谈到中国生物科技的将来,Tschiry保持着慢而稳的语调。“我为生物科技的发展感到兴奋。但我的是理性的兴奋,”他说,“你是这里的合作伙伴,你必须支持你的份额,并扮演好一个负责任的企业角色。在过去数年间,有得到快速发展的方面,有需要继续努力的方面。”

颇具风险的回报

在回家前,我穿过街道去拜访张江高科的一位全能明星——记黄埔医药公司总裁杜莹。当我进到杜莹的办公室时,我看到墙上摆放着有她照片的《福布斯》杂志。她站在办公桌旁,正对着手机说话,耳边挂着蓝牙。

她的话语间断但直击要点,且富有深意。2001年,她离开了辉瑞,开始在中国创立公司。回忆起张江高科技园区的转变,杜说:“那时,许多人对中国创新研究的能力表示怀疑。现在,人们相信这里是研发的地点之一。因为有有利的配套设施,你看到许多人都回国了。”她说,“风险投资业来到中国。市场本身也证明了这一点。”

作出回国的决定,对杜莹来说并不容易,“我从没有想过我会回来,我整整考虑了6个月,才决定接受这份工作。”她说,“这并不是出于好奇和冲动。我希望我能创造影响力,做一些不同的事情,所以,我成为了第一批回国的海归。”

开始时是比较困难。“我们回来时,张江这里非常偏远。”杜莹回忆道,“你觉得自己并没有很多资源。”但同时,这又带来了更多的创新空间。杜说:“你将拥有什么比你已经拥有什么更重要。那种希望,那种激励,推动着许多人。”

即便在将近10年后,她说作为一位开拓者仍需要付出很多。“直到今天,你依然是在位这个行业铺路,这将是一条无止境的道路。”

生物科技行业比起几个高科技园区所能包含的内容要大得多,杜莹认为,但在中国发芽的一些生物科技高科技园区有点被误导了。“这并不是必须的,且可能是一种浪费,”她说,“从政治角度来看,各地方政府给予支持是件好事。但底线是:你有基础设施么?你有足够可以支撑的资金么?你有吸引力吗?”她的建议是:“变的不同,不做同样的事。”

我走回到子弹头列车时,感觉到张江是一个成功的故事。但中国其他的高科技园区同样能成功么?中国的生物科技能在一个层面上与美国竞争吗?仅凭我乘车回家的这段时间内是无法回答这些问题的。

To learn more about the explosion of biotechnology in eastern China, I take a trip to China’s largest production and export base of medicines, Taizhou, a third-tier coastal city almost 300 miles from Shanghai. Just three years ago, where the bulldozers and construction workers now shift piles of dirt, farmers once tilled 10 square miles of farmland. Construction for the massive China Medical City (CMC) began in 2006, and one fifth has been completed. As I visit just before the Chinese New Year break, the place is quiet. The only vehicle on the road besides ours is a lone electric bike.

Despite CMC’s beginning stages, many buildings already have popped up. China’s State Food and Drug Administration has opened offices here, and 200 companies have moved in. In 10 years, there will be 1,000. It’s an ambitious project; an entire city based on the biotechnology and pharmaceutical industries. A hospital, luxury villas, apartment complexes, R&D, cafés, a four-star hotel—it’s all in the blueprints. Taizhou’s biggest obstacle for now is bringing in the people who will transform the city into an innovation capitol. The city is far away from Shanghai but the government is tackling its transportation problem head-on. A new direct high-speed train line runs to the capital, Beijing, perhaps thanks in part to the fact that China’s President Hu Jintao hails from Taizhou. Hop on at 6 p.m. and you arrive the next morning at 7 a.m. Another high-speed train line is in the works and will be finished in two years, shortening the commute to Shanghai to one hour. In January, ground was broken for an airport that will be finished in 18 months.

My guide points out a scale model of the CMC, and tiny buildings light up in sync to the wide-screen video blasting out facts and figures behind it. It looks like a Lego dreamland, an entire city laid out below us. But it’s a dream that’s being made possible through the support of government leaders from the national on down. That becomes apparent just a few steps away, where large photos of politicians who have supported the CMC’s development line the room’s entryway. In case I haven’t gotten the message, my guide adds for emphasis, “I saw the vice governor of Jiangsu province walking around here today.”

Soon, I’m talking to He Rong, the “mayor” of CMC, and I can see that this dream is a well thought out one. “We’re not building a high-tech park—we’re building a city. It’s a complete package,” he says. He has been involved in the development of CMC from the start.

He talks fast. In the manner of many government officials in China, bullet points pepper his speech, which rises and falls in exaggerated cadences. The clubhouse where he entertains his visitors has four ornately decorated private banquet rooms, in Chinese, Japanese, American and European style to make sure his guests feel comfortable wherever they’re from. He walks briskly, with purpose, while juggling a banquet lunch with foreign business people with numerous phone calls and a visit from provincial government officials. Everyone wants a word with him, whether to give advice on how to develop CMC or to gain a foothold in the fast-developing park.

He wants to compete but doesn’t want China to be seen as a threat. “We want to catch up to the U.S. but not overtake them,” he says. “We are studying the U.S.’s successes and we have top government support at national levels—that’s really important.”

He Rong believes the CMC is attempting something new. “Why is everyone coming here?” he asks. “We’re doing something different here. Everyone [else] is doing high-tech parks, saying, ‘I’ll sell you a piece of land.’” But He Rong takes a different approach: “I have to take the dreams of the scientists and make it reality. We’re here to be the maids for the scientists.”

Scenery And Starbucks

Leaving CMC, I embark on a three-hour car ride to Shanghai. As we alternate between zipping past farmland and the occasional city and sitting in long lines of tra c, I pass the time by chatting up my fellow passenger, a Chinese-American doctor and CEO who met with He Rong that afternoon. “ is is my third time to CMC, he says. “I see both excitement and potential trouble.” He worries that it will be di cult to attract talent to stay long term at CMC because of its remoteness, and says the results won’t be visible for  ve to ten years. But regardless, he is jazzed up from his audience with the “mayor” because “you’re talking to the decision maker, and he has the same vision [as you].”

In Shanghai, I board a subway train and ride out to the last stop on Line 2. I’m heading to Zhangjiang High-Tech Park (ZJHTP), a government-associated development  lling up fast with biotech firms.

Passengers carrying laptops jump off the subway and onto a shuttle—one with a futuristic bullet train design— that makes stops around the high-tech park’s software, semi-conductor and biotechnology neighborhoods, spanning 25 square kilometers and crossed by streets named after scientists like Halley. Multinationals and local university departments are all within a short walking distance of each other.

Despite the fact that the park is a busy and bustling place, the six-lane roads around it feel empty except for the shuttle, a sign that I’ve made it to the edges of Shanghai, a teeming metropolis whose city center is usually packed with cars. I pass the large THanksgiving Church, but beyond that, a few convenience stores and a Starbucks are all I see that isn’t housing or o ce space.

In Zhangjiang, 80 percent of the workers are under the age of 35, and while Yin Hong isn’t quite one of them, I think he could pass for one when we meet. As ZJHTP’s vice general manager, he has seen the park grow from its start in 1996 and watched it switch focus from light manufacturing to the high-tech sector.

“As China’s economy develops, people’s needs for healthcare are becoming more important,” Yin Hong tells me. “Chinese want to have the same quality of medical care as Americans. We believe that American advanced technology and medicine can beneFIt Chinese people.”

China’s fast growing medical market is one reason for the swi development of the sector here. “tHe increased demands of people in China are a big opportunity for Western companies,” Yin Hong explains. “That’s the reason why overseas companies love doing business in China. They have the market and the right people.” But he believes that Chinese patients are savvy enough to not just look to a foreign brand name. “There’s a need for R&D in China for U.S. companies, because medicines need to be made more suitable for Chinese people.”

Zhangjiang has thrived, Yin Hong says, partly due to its location. “Shanghai has already become a very good place for biotech development. Management people have an international perspective. The rules and regulations are transparent,” he says. “We have built a good relationship with multinationals, so they feel safe doing business here.”

The environment at the park, he brags, is ripe for cooperation, with larger companies working together with smaller companies. “We have formed an ecology chain.” Innovation is starting to breed here, he says, pointing out that 119 new drug patents have been approved in the past few years.

Yin Hong certainly is a good salesman. He ends his pitch with a warning for those still in doubt: “Whoever doesn’t jump on this opportunity might lose out in the future.”

Pharma From Pfizer

When I ask Yin Hong who else I should talk to, Steve Yang’s name is one of the first to pop up. He’s the quintessential sea turtle—the nickname given to Chinese who went abroad for study and are now returning in droves to capitalize on opportunities here. As a young college grad, Yang left China for the U.S., and returned 18 years later as Pfizer’s vice president, head of R&D, Asia, in 2006. “At that point, China was very di erent,” Yang recalls. “When I went to undergrad in Shanghai, [Zhangjiang] was all farmland. It’s almost a miracle to see China’s economic development progress so fast.”

Yang says the environment reminds him of a different era in the U.S. “I think the environment is vibrant. It really feels like Silicon Valley [when] I was there in the ’90s. During that time there was a lot of optimism. Entrepreneurism was respected,” he remembers.

Today, Yang feels an excitement in China that the U.S. lacks. “In the U.S. the mood is sober because the biotech industry is facing constraints,” Yang states. “In China, there are several factors driving the growth. There’s government funding for basic research. It does feel like it raises the innovation level.” Biotech in China is not as strictly defined as in the U.S., Yang adds, and in China boundaries are blurred, incorporating contract research organizations (CROs), basic research groups and integrative research firms.

The sea turtles, Yang says, are an important factor to China’s biotech boom. “There’s a very strong sense of innovation and intellectual rigor. I often joke this is a mini New Jersey plus the Eastern Seaboard. You bump into people like myself, as many scientists—especially senior ones—have worked in the U.S., or in academia. Anywhere you have critical mass of high-tech R&D you see the returnees. It’s actually a very small and tight-knit community.”

Still, Yang emphasizes that there are some stumbling blocks that make working in China inconvenient for now. For one thing, importing sample reagents from the U.S. can take a few weeks. Space also poses a problem, because ZJHTP is full. “So new companies have to go somewhere else or wait for vacancy,” Yang points out. “We’re literally running out of space.”

Developing Devices After leaving Yang’s office, I return to walking around the park. Yin Hong’s assistant suggests that I speak with the CEO of a young startup. After spending close to 20 years in the U.S., Ty Hu returned to China to found a medical device R&D center with four colleagues. Tall and lanky and dressed in khakis, a long sleeved t-shirt and a pu y down Southpole vest, he’s laid back but speaks excitedly and candidly about his work. In the medical device sector, Hu thinks being an early player will give his company an advantage. “In five years, the market will be populated with devices from centers like ours,” he predicts.

Hu tells me that China’s possibilities pulled him back. “The sheer size of the population is incredibly attractive for any product,” he remarks. “The market for my area is growing at 30 percent year over year. Nowhere in the world can you find that.”

Moreover, Hu reaps the benefits of both his returnee status and U.S. citizenship. “We step on the boundary,” as he describes it. “It’s an important advantage. When we need legal protection we’re on the foreign side. When we want state grants we’re on the Chinese side.”

Cities in eastern China have been eager to jump on the biotech bandwagon, and different areas offer various incentives. As Hu explains: “If you’re in Suzhou or Wuxi, they give you a tremendous amount of incentives: low-cost, even free land so you can build your offices or use as equity to get bank loans, start up funds, grants. The further away from Shanghai you are, the more incentives you’ll get.”

Even with all the handouts, no company is guaranteed success. For example, Hu explains that operating in China is not always cheaper for smaller companies. Basic supplies are not available, so he has to rely on imports. Manufacturing, on the other hand, is cheaper because of lower labor costs, but technology costs more. Still, the challenges aren’t stopping Hu. “It’s really the market. We can’t afford to come in late. Being here earlier is the reason we’re here, not cost,” he says. “Our success depends on whether we can survive locally.”

At the same time, the local area lacks the needed talent in medical devices. So Hu depends on researchers from the U.S.

Exploring A Cro

I wanted to get a sense of how a local CRO’s experience differs from a multinational’s, so I headed over to Sundia for a talk with Wang Xiaochuan. Bundled in a winter coat inside her chilly office, Sundia’s CEO looks like your friendly auntie, and she speaks of her company as her family, yet she also possesses a straightforward business sense. After going to the U.S. as a UNESCO fellow in the 1980s, she entered the biotech field. When she felt the time was right, she returned to China. “I see the environment is changing, people’s minds are changing, government is changing, so I believe the historical opportunity is here, even though I had a decent job and good life in the U.S.,” she explains. “It doesn’t matter how ugly your mother is,” she puts it bluntly. “You still love her. So a lot of us are American citizens but we still have this connection. We have relatives and friends here. We still care.”

Chinese biotech has a way to go before it catches up with the U.S., Wang believes. Most of the local companies are just a few years old, she notes, and lack experience doing drug discovery and development. “For drug development you need experience,” Wang asserts.

Wang says the industry needs local innovation. “You can see how many new drugs come from Chinese pharmaceutical companies. That could be a good indicator. If they’re just doing generic drugs, just copies, that’s not a real pharmaceutical industry.” Although China has not produced many new drugs so far, Wang foresees a change: “In the pipeline, I hear there are lots, maybe hundreds.”

As a local company, Sundia has had a positive experience at ZJHTP. “The good part about Zhangjiang’s government group is that they really like to learn, and they want to help and support us,” Wang tells me. “They often come to our company and ask, ‘What can we do for you guys? How can we help you?’” But Wang isn’t so happy with the cultural desert that is the suburbs. “I wish that the cultural life here could be better and provide more convenience, and a higher level lifestyle for us. We need some life in addition to work. That’s important,” she says.

 

“ Science never has boundaries. Any country which has developed great technology is a benefit to the whole global society. ”

 

Should Americans be worried about China’s biotech boom? “I think America should be excited rather than concerned,” Wang says. “Science never has boundaries. Any country which has developed great technology is a benefit to the whole global society.” Spoken like a true diplomat.

From Rice To Roche

To understand the changes that have occurred in ZJHTP, I visited Roche, the first company to move into ZJHTP in 1994, back when the park was still in the midst of rice paddies. After studying in China, Andreas Tschirky returned to Switzerland but felt so bored that he was inspired to come back to China, this time as the Roche R&D Centre China’s general manager.

Working in ZJHTP has been a good experience for Roche. As Tschirky describes it: “We had much more proactive support and openness to problems … than I have ever observed previously in the West.”

Still, Tschirky expects even more ahead. “China will become a major innovator in the future,” he claims. “What I see at the moment is a very fearful attitude in the West. I think we should focus on partnerships [rather] than maintaining this very biased attitude,” Tschirky says, with a hint of chastisement in his tone. “The healthcare industry has to serve humanity. If we just emphasize competition, we miss a lot of opportunities.”

Speaking of China’s future in biotech, Tschirky keeps a measured tone. “I’m excited about this development, but I’m excited in a realistic way,” he says. “You are a partner here. You have to pay your fair share, to play your role to be a responsible organization in China. There are things that have progressed significantly in the last few years, and there are things that we still have to work on.”

A Risky Return

Before heading home, I cross the street to meet one of ZJHTP’s all-stars, Samantha Du, Hutchison MediPharma’s CEO. When I enter Du’s office, I see her Forbes cover shot hanging on the wall. She is standing by her desk, talking on her cell phone with a headphone attachment plugged into her ear. She speaks short and to the point, but full of depth. In 2001, she le a position at Pfizer to start this company in China.

Remembering that transition, Du says, “Back then, most people were very skeptical about China’s ability to do innovative research. Now people believe this is one of the places to do R&D. Because there is the supporting infrastructure, you see people coming back.” She adds, “VCs are coming to China too. The market itself also justifies it.”

It wasn’t an easy decision for Du to come back to China. “I never thought I would come back. It took me a good six months to decide to take [the job],” she says. “There was curiosity. I wanted to make an impact, do something different. So I became one of the first group of sea turtles to show up on China’s shore.”

It was tough at the beginning. “When we came back it was very remote,” Du recollects. “You felt you didn’t have many resources.” But there’s more to innovation. As Du points out: “What you have is less important than what you think you will have. That hope, that incentive, drives a lot people.”

Even after close to a decade back in China, she says being a pioneer takes a lot of energy. “You’re still paving the road for the industry. It’s an exhausting place to be.” The industry is bigger than a few high-tech parks can handle, Du believes, but some of the biotech high-tech parks sprouting in China are a bit misguided. “It’s not necessary, it may be a waste, she says. “From the political savvy point of view it’s a good thing for every local government to support. The bottom line is: Do you have the infrastructure, do you have sustainable funding, do you have the attraction?” Her advice? “Differentiate. Don’t do the same.”

As I walk back toward the shuttle train, I believe that Zhangjiang is a success story. But will other high-tech parks succeed the same way? And will Chinese biotech ever compete at a global level with the U.S.? It will take far longer than my ride home to answer those questions.

 

“这个药靠谱”

2010/10/18 – 3:48 下午

收到冯部托人寄来的奇正消痛贴膏包裹,因为秋风起颈椎病犯了。

得知在贴某企业的某膏药,冯部说换这个试试,“这个药靠谱”。

这个药品广告卖的牛,从药审中心管协部部长口里说靠谱的药,我想同类中没别的比这更靠谱了。

像这种药通常是怎么审出来的呢?也需要做临床试验招募受试者伸脖子贴一剂么?很好奇啊。

“本品是藏族验方,国家保密方”,冯部对此不置可否。

整整6盒,够用好一阵子。据网上调查,98%的上班一族都有颈部问题。我小范围地在报社及外围调查了一圈,果不然。

 83年的小钟,当记者的时候整天说脖子疼交不出稿子。当了公务员日日炒股后症状彻底消失。

DIA的Steven,天天电话会议T出颈椎病来了,个子长到2米,脖子承受的压力恐怕只有长颈鹿知道。

上海临床研究中心的张炯,疼起来的时候吊脖子,还要朝着天空喊三次“这样活着有什么意思啊!”据说十分有助于症状缓解。

X光片中脊柱受损变形,冯部说可以到北京看看藏医,老爸的意见是少对电脑,少对稿件。

遇见一份生动的工作

2010/10/09 – 11:54 上午

这是典型的谭勇式语言,总在不断的假设构建又迅速推倒,任何华丽的词藻在他们面前都低到尘埃里去了。在他的办公室,贴着写着只言片语代表他意念的小纸片。我愿意在自己这个空间帮着宣传一次这个招聘广告:

遇见一份生动的工作

如果我们懂得,我们遇到的每个人都在挣扎。

如果我们懂得,我们遇到的每个人都有价值。

如果我们懂得,我们遇到的每个人都将幸福。

资深编辑/记者,产业研究员,市场经理。

同时欢迎新闻专业、药学专业、经济管理等相关专业应届毕业生。

《医药经理人》杂志(月刊)简介:

她一出生就风华正茂,一破土就成参天大树,但她看到的仍然是自己的卑微。

她的光芒和影响力正在影响更多的读者和同行,但她思考的却是如何突破传统行业媒体模式从而走出一条新路。

她相信梦想的力量,更清醒现实的残酷。她记录历史,更将推动历史。

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