聚焦药物相互作用研究研讨会

DDI in Drug Development Seminar

【HiRO+北京友谊医院研究型病房】联合主办 

   2022.01.17

背景介绍

BACKGROUND

临床上，多种药物联合应用于疾病治疗现象极为常见，然而， 合并用药可能会导致药物-药物相互作用（Drug-drug interaction, DDI）的发生, 进而导致疗效降低或丧失，引起不良反应, 从而改变治疗结果, 这是药物治疗常见的问题之一，也是新药开发成功的关键因素。2021年1月26日，国家药监局药审中心正式发布《药物相互作用研究技术指导原则（试行）》的通告, 进一步鼓励和引导申请人高效规范地开展药物相互作用研究工作。

因此, 2022年1月17日, HiRO携手北京友谊医院研究型病房举办DDI研讨会联合探讨DDI研究在新药研发中的应用，以及监管机构针对DDI研究策略的法规要求以及实施案例分享。

In clinical practice, patients often use multiple drugs at the same time, and these drugs may produce drug-drug interactions (DDI), which may cause adverse events or lead to reduced efficacy, thereby changing the outcome of treatment, which is one of the common problems in drug therapy and a key factor for the drug development.On January 26th, 2021, the Center for Drug Evaluation, National Medical Products Administration officially issued the "Technical Guidelines of Drug Interaction Studies (Draft)", which further encourages and guides applicants to carry out drug interaction studies in an efficient and standardized manner.

Therefore, on January 17th, 2022, HiRO and the research ward of Beijing Friendship Hospital will hold a seminar to discuss the application of DDI studies in drug development, the requirements of DDI studies by regulatory agencies such and practical experience.

研讨会议程表

AGENDA

主讲专家介绍

SPEAKER INTRODUCTION

【吕文旭 博士】

Wenxu Lyu,PhD 

HiRO 法规事务及策略规划首席顾问，为新药研发项目提供临床前及早期临床开发技术支持，专家意见以及申报策略和报告撰写，涉及小分子药物，抗体，ADC，疫苗，细胞治疗及罕见病等产品

Principal Consultant, Regulatory Affairs and Strategy. As Subject Matter Expert for non-clinical/CMC/clinical pharmacology and responsible for the consultation / strategy for the product development and IND enabling related tasks as well as relevant documents authoring. Involved small molecules, antibodies, vaccine, cell & gene therapeutic, rare disease and others

• 毕业于中国科学院上海药物所，超过20年生物医药领域工作经验，包括8年三甲医院临床药学工作以及国际知名CRO13年新药研发注册申报经验
• Ph.D. in Pharmacology/Pharmacokinetics, SIMM, Chinese Academic Science. More than 20 years experience in biomedicine, including 8 years of clinical pharmacy in hospital and 13 years of new drug R&D in CRO 
• 完成30多项IND和NDA 的差距分析以及成药性评估以及10多个产品的中美申报资料撰写， 包括药学，药理毒理及研究者手册
• Gap analysis and project evaluation for IND & NDA,30+; US & China IND documents writing (CMC/PD/PK/TOX/IB)10+
• 完成新药药代动力学筛选项目100多项（ADMET/DMPK)及IND申报项目超过20个，均成功取得临床批件
• Screening ADMET/DMPK 100+ and IND enabling DMPK/ADME package, achieved CTA 20+
• 完成10多项新药临床前开发(药理毒理，临床药理）且IND申报成功进入临床
• IND enabling pre-clinical package, achieved CTA 10+

【李江硕 博士】

Jiangshuo Li, PhD

首都医科大学附属北京友谊医院研究型病房研究药师

Research pharmacist in the Beijing Friendship Hospital Research Ward Affiliated to Capital Medical University

• 毕业于中国医学科学院药物研究所
• Graduated from the Institute of Materia Medica, Peking Union Medical College
• 主要负责药物临床试验中药品及样品的管理
• Mainly responsible for the management of drugs and samples in clinical trials
• 从事基于LC-MS技术的代谢组学分析方法开发和体内药物分析等工作
• Engaged in the development of LC-MS/MS based quantitative analysis method for small molecule drugs and endogenous metabolites
• 参与建立并完善实验室质量控制体系
• Participated in the establishment and improvement of the laboratory quality control system

上海贺维斯特医药科技有限公司Harvest Integrated Research Organization(HiRO)，是一家立足中国、面向全球的创新临床研究机构（CRO），总部设于上海。拥有全球化的运营和整合能力，公司致力于为全球客户提供全方位的解决方案和服务。HiRO努力致力于成为一家市场领先的一体化全球临床研究机构，并与生物技术公司和制药公司携手合作，将实验室的新产品推向市场，为全球患者提供更具效益的解决方案。

HiRO于2021年收购PharmaSols公司,充分利用新西兰与澳大利亚更多的患者资源,专业医疗知识和卓越的营运服务,提供给客户更专业的服务。

HiRO is a China-based globally oriented innovative clinical research organization (CRO) with its headquarters in Shanghai, China. With global operations and integration capabilities, the company is dedicated to providing its clients with a full range of solutions and services. HiRO strives to become a market-leading, integrated global clinical research organization that works hand-in-hand with biotech companies and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.

HiRO acquire PharmaSols in 2021, making full use of more patient resources, professional medical knowledge and excellent operational services in New Zealand and Australia to provide more professional services to customers.

北京友谊医院研究型病房为北京市首批研究型病房示范建设单位。病区面积2000㎡，专用病床74张，共用病床46张，条件平台面积1650㎡，同时配备有标准的药物浓度检测实验室、同位素病房和心脏毒性评价病房。病房采用“共享综合”模式，提供机构立项-材料递交-协议签署的一站式服务和伦理审批/协议审查前置服务；规范研究用表格，统一合同模板；采用2E技术和临床试验决策支持系统为代表的信息化技术和临床专业+研究型病房规范的优效合作模式，缩短项目实施周期，打造高质量、高效率的临床研究平台。

The Beijing Friendship Hospital Research Ward is one of the first demonstration units of research ward in Beijing. The ward covers an area of 2000 m², with 74 special beds and 46 shared beds. The condition platform covers an area of 1650 m² and it is equipped with drug concentration quantitative analysis  laboratory, isotope  tracer ward and cardiotoxicity evaluation ward. The research ward adopts  the "sharing and integration" mode to provide one-stop service of institution project initiation, material submission and agreement signing and ethical approval/agreement review; standardize the forms for clinical trials and unify the contract template; the information technology represented by 2E technology, clinical trial decision support system and the standardized excellent and effective cooperation mode of clinical specialty + research ward are adopted to shorten the project implementation period and create a high-quality and efficient clinical research platform.