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Service Company Roadshow|Official Interpretation on the Progress of ICH E17 in China, and Discussion on How to Improve China’s BioMed Innovative R&D
News & Events 2019.10.28 1565

For the soaring cost of drug R&D worldwide, it has become a trend to conduct R&D collaboratively. After China joined ICH, the Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) are playing an increasingly important role in drug R&D. On September 22, 2019, the Service Company Roadshow on the fourth China BioMed Innovation and Investment Conference (2019 CBIIC) was successfully hosted along the Jinji Lake, Suzhou. Chaired by Dr. Tan Lingshi, Chairman of 1st Innovation R&D Services Specialty Committee of PhIRDA, Chairman and CEO of dMed Biopharmaceutical Company, the Service Company Roadshow Session showed over 10 distinctive innovative R&D institutions via delivering expert keynote speeches and roadshows, including Center for Drug Safety Evaluation and Research of SIMM, CSA, dMED Biopharmaceutical, Fountain Medical Development, Raybow Pharmaceutical, Shanghai LIDE Biotech, Proswell Medical, and so on. 

Moderator: Dr. Tan Lingshi

 I. Experts’ interpretation on the progress in implementation of ICH E17 in China

Keynote Speech Speaker:Deputy Director Xie Songmei

Under the special invitation by 2019 CBIIC, Ms. Xie Songmei, Deputy Director of Office of Clinical Evaluation II, Center for Drug Evaluation, NMPA, made a keynote speech on ‘ICH E17 Multi-regional Clinical Trial Guide: The Progress of Implementation in China and Case Sharing’. The speech detailed requirements of ICH E17 guideline from the perspective of drug regulatory reform recently and procedure optimization for clinical trials approval, also illustrated the key elements for conducting global Multi-Regional Clinical Trials (MRCT), including MRCT protocol design and technical reserves, adjustment for clinical drug R&D strategies in different regions, and consideration for Chinese patients. By analyzing cases of success and failure that made application and was conditionally-approved in China based on MRCT data, Ms. Xie thoroughly analyzed CDE’s requirements for MRCT evaluation. To encourage innovation companies to conduct MRCT synchronously for new drugs in early stage in China for complete and comparable clinical data, so as to make a faster approval in China. The keynote speech by Ms. Liu attached great importance in the communication among CDE, R&D institutions and the enterprises, and offered explicit interpretation on pharmaceutical innovation policies and technical requirements for pharmaceutical clinical practice for clinical R&D and investment institutions.

II. An open and synergistic platform for patients’ easier access to high-quality drug

Dr. Guo Tong, President of Gem Flower Pharma, gave an inspiring keynote speech on ‘An Open Synergistic Platform to Make the Trail’. Dr. Guo had served as Vice President of BD of QuintilesIMS and has dedicated in drug development in leading international pharmaceutical companies over 20 years. Dr. Guo analyzed global trend of clinical trials, the core advantages of Gem Flower Pharma, and noted that they planned to build a patient-centered and integrated clinical research platform.

Keynote Speech Speaker: President Guo Tong

 III. Introduction to innovative drug R&D service providers: over 10 roadshow companies on preclinical service, clinical CRO, CMO/CDMO and comprehensive services, and providing comprehensive, professional and international-level services.

Preclinical CRO:

Center for Drug, Safety Evaluation and Research, Shanghai Institute of Materia, Medica, Chinese Academy of Sciences - IND Enabling Non-clinical Assessment Platform for New Drug

The Center for Drug Safety is one of the main institutions developing the GLP platform, which is a key special project of the Ministry of Science and Technology for new drug innovation during the ‘Eleventh Five-Year Plan Period’. The institution provides services including early stage and rapid toxicity screening of lead compounds, preclinical safety evaluation services, utilizing new models of molecular biology to carry out the study on the toxicity mechanism of drugs.

LIDE Biotech - New Drug R&D and Personalized Oncology with Functional Diagnose

LIDE Biotech is a medical service company focusing on ‘functional diagnosis’ for tumor precisely. LIDE's core product ‘OncoVee MiniPDX’, is a 7 days in vivo drug efficacy test, suitable to test target drug, chemo and drug affect TME-anti-VEGF etc.

Clinical CRO:

dMED Biopharmaceutical - Setting up a Strong Early Development and Clinical Pharmacology Team to Complete Pharma Value Chain in China

As a global full-service clinical CRO, dMED Biopharmaceutical is committed to delivering high quality regulatory, early development including translational science, clinical pharmacology, and pharmacometrics, clinical sciences and operations, biometrics and pharmacovigilance services at global standard from both China and US.

Fountain Medical Development - Building up a Clinical Drug Development Platform of the ICH Standards

Fountain is a global Contract Research Organization (CRO) that is able to provide clinical development services of the ICH standards with more than 1,700 employees around the world, engaged in delivery of services including Regulatory Affairs, Medical Affairs, Clinical Operations, Data Management, Biostatistics, Pharmacovigilance and third party audits and other one-stop Clinical Research to pharmaceuticals and medical device companies in United States, Europe, Japan, South Korea, India, and other countries.

Proswell Medical Company - Quality by Design (Clinical QbD) - Strengthening the Control of Early Clinical Trials

Proswell is committed to developing healthcare industry, establishing an international brand of local CRO, and providing a series of high-quality services for drug R&D and evaluation. Proswell highlights the design of clinical study protocols, circumvention plan according to the characteristics of experimental drugs, high-quality research, fast work flow and efficient clinical research services.

CMO & CDMO:

WuXi Biologics -Global Premier Biologics Platforms to Enable Innovations

WuXi Biologics is the first biologics company in China approved by both the FDA and EMA for commercial manufacturing. At present, approximately 13% of all novel biologics around the globe are developed by WuXi Biologics. WuXi Biologics has successfully launched three proprietary technology platforms around the globe, which can enable up to 60 IND applications and 3 BLA per year for their partner’s drug programs.

CMAB BioPharma - Strategies for Manufacturing Outsourcing and R&D of Biologic Drugs in China

CMAB Biopharma is a full-service contract development and manufacturing organization (CDMO) in China, dedicated to providing one-stop service from DNA sequencing to commercialize manufacturing services for biologic products. CMAB has established a manufacturing procedure that follows global GMP standards, including China National Medical Products Administration (NMPA), US Food & Drug Administration (FDA), European Medicines Agency (EMA), WHO, and PIC/S and ICH standards.

Raffles PharmaTech - Key Technologies for API Development and Industrialization of Small Molecular New Drugs

Raffles PharmaTech is a company focusing on the pre-clinical process development of small molecule API and its intermediates, customized synthesis and commercial production, striving to build itself as a standardized, efficient, high-quality and cost-effective CRO/CDMO company and first choice for domestic and foreign pharmaceutical enterprises.

Comprehensive Services:

CompMEDx (Suzhou) - Bringing Innovative Solutions to Precision Medicine: from Biomarkers to CDx

MEDx (Suzhou) Translational Medicine is an innovative company that provides unique and integrated solutions for precision medicine. MEDx offers one-stop services of biomarker discovery, diagnostic assay development, new drug clinical trial molecular tests and screening, along with the CDx development and commercialization for clients such as innovative pharmaceutical companies and clinical research organizations. 

Jiuzhou Pharmaceutical - Raybow CDMO Accelerates the R&D of New Drugs for Its Partners

Raybow Pharmaceutical (The CDMO Division of Jiuzhou pharma) is wholly-owned subsidiaries of Zhejiang Jiuzhou Pharmaceutical Co., Ltd., commits itself to global partners for the supply of ‘One-Stop Service’, covering from new drug preclinical research, API R&D and across clinical and all phase, to commercial production.

The First Row:
Mr. Li Ming, Operational Director of Center for Drug Safety Evaluation and Research, SIMM, CSA
Mr. Shi Jun, Senior Vice President of dMED
Ms. Zhang Dan, Executive Chairman of Fountain
The Second Row:
Mr.Gu Jijie, CSO & executive vice President of WuXi Biologics
Mr.Yang Debao, Director BD of Raybow Pharmaceutical
Ms.Wen Danyi, President & CEO of Shanghai LIDE Biotech
Mr.Li Yin, CBO of Proswell
The Third Row:
Mr.Nick Zhang, Chairman & CEO of MEDx
Mr.Wang Yongzhong, CEO & CMAB
Mr.Ye Weiping, General Manager of Guangdong Raffles PharmaTech


Service Company Roadshow