the7th internationalsymposiuminquantitative …meeting.drugchina.net/the 7th international symposium...

The 7th International Symposium in QuantitativePharmacology·2019

THE THIRD ROUND NOTIFICATION OF ISQP

November 8-10, 2019

Sunshine Hotel Guangzhou

Dear Colleagues and Friends,

On behalf of the organizing committee, it is my great pleasure to announce that the 7thInternational Symposium of Quantitative Pharmacology (ISQP) will be held on Nov. 8th-10th,2019, Guangzhou, China. It is sponsored by the Quantitative Pharmacology Committee ofthe Chinese Pharmacological Society and organized by Guangdong Pharmacological Society,the Fifth Affiliated Hospital of Guangzhou Medical University, School of Pharmacology ofGuangzhou Medical University, the Sixth Affiliated Hospital of Guangzhou MedicalUniversity (Qingyuan People's Hospital).

With the successful practice of "model-based drug development (MBDD)", quantitativepharmacology has become an indispensable tool for new drug research & development. Itruns through the whole process of new drug research & development, greatly improving theefficiency and success rate. At the same time, it has also become the key technology of newdrug scientific evaluation. Since 2007, the Quantitative Pharmacology Committee of theChinese Pharmacological Society has successfully held six ISQP symposiums in Nanjing,Xiamen, Beijing and Shanghai, which have become one of the most influential quantitativepharmacology communication platforms in the world. The 7th ISQP in 2019 will invitewell-known experts from FDA of the United States, NMPA of China, the QuantitativePharmacological Societies of Japan and Korea, as well as academic institutions and majorpharmaceutical companies at home and abroad. The theory, method and practice ofquantitative pharmacology guiding new drug research & development will be discussedacademically and the experience will be exchanged.

The symposium will include conference reports and discussion, quantitativepharmacology forum of East Asia, China, Japan and South Korea, speech of young scholars,and the selection of excellent wall posters. During the symposium, a working conference ofthe Quantitative Pharmacology Committee of the Chinese Pharmacological Society will alsobe held.

Thank you in advance for your participation and support.

Organizer

Sponsor

Professional Committee of Pharmacometrics, Chinese Pharmacological Society

Co-sponsor

Guangzhou Medical University (The Fifth Affiliated Hospital, School of

Pharmacology, The Sixth Affiliated Hospital )

Chairmen

Qingshan Zheng Shanghai University of Traditional Chinese Medicine

Yi Fang People's Hospital of Peking University

Executive Chairmen

Xinke Zhou Xiyong Yu Haibo Zhou Guangzhou Medical University

Academic Committee (in alphabetical order by last name)

Shanshan Bi Pfizer

Nengneng Cheng School of Pharmacy, Fudan University

Yuancheng Chen Huashan Hospital affiliated to Fudan University

Yimin Cui The First Hospital of Peking University

Zeneng Cheng School of Pharmacy, Central South University

Yanhua Ding The First Hospital of Jilin University

Junjie Ding Novartis

Sheng Feng Roche


Tianxing Gong Northeast University

Rui Gao Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Feng Guo Sihuam Pharm

Zongyuan Hong Wannan Medical College

Jianchang HeAffiliated Hospital of Yunnan University of Traditional Chinese

Medicine

Xiaowen Hu Shanghai Tumor Hospital

Pei Hu Peking Union Medical College Hospital

Xiaohui Huang School of Pharmacy, Anhui Medical University

Qin Huang Former minister of Center for Drug Evaluation, NMPA

Shuangmin Ji Center for Drug Evaluation, NMPA

Yuhong HuangSecond Affiliated Hospital of Tianjin University of Traditional

Chinese Medicine

Jin Yuyan Roche

Zheng Jiao Chest Hospital Affiliated to Shanghai Jiaotong University

Guofei Li Shengjing Hospital Affiliated to China Medical University

Gailing Li Johnson & Johnson

Jia Li Lilly

Huafang Li Shanghai Mental Health Center

Liang Li FDA

Jianguo Li Kelun

Li Li Center for Drug Evaluation, NMPA

Lujin Li Shanghai University of Traditional Chinese Medicine

Xingang Li Beijing Friendship Hospital Affiliated to Capital Medical University

Xin Li Changsha Third Hospital

Yuhong Li Shaoxing People's Hospital

Beibei Liang General Hospital of PLA

Zhiling Li Pediatric Hospital Affiliated to Shanghai Jiaotong University

Dongyang Liu The Third Hospital of Peking University

Hongxia Liu Shanghai University of Traditional Chinese Medicine

Xiaodong Liu School of Pharmacy, China Pharmaceutical University

Wei Liu The Third Hospital of Peking University

Xiaofen Liu Huashan Hospital Affiliated to Fudan University

Xiaoxi Liu Novartis

Wei Lu School of Pharmacy, Peking University

Guangli Ma Heng Rui

Jianfeng Lu AskGene Pharma, Inc

Cheng Lyu CSPC

Jing Nie Johnson & Johnson

Peimin Ma GSK

Qi Pei Third Xiangya College of Central South University

Jianfeng Pei Peking University

Yan Ren BeiGene

Furong QiuShuguang Hospital Affiliated to Shanghai University of Traditional

Chinese Medicine

Dewei Shang Huiai Hospital, Guangzhou Medical University

Jianzhong Rui Eastern War Zone Hospital

Jianzhong Shen Tu The First Affiliated Hospital of Zhejiang University

Yucheng Sheng Sinovant Sciences

Haifeng Song Academy of Military Medical Sciences

Jun Shi dMed

He Sun Tasly

Bo Sun Shanghai Drug Review and Verification Center

Chaoyang Tong Academy of Military Sciences

Xin Tian The First Affiliated Hospital of Zhengzhou University

Hongyun Wang Peking Union Medical College Hospital

Dan Wang Pfizer

Xipei Wang Guangdong People's Hospital

Kun Wan Shanghai Qiangshi information Technology Co., Ltd.

Lijue Wang People's Hospital of Peking University

Xinting Wang Novartis

Yuzhu Wang Center for Drug Evaluation, NMPA

Yaning Wang FDA

Chunmin Wei Center for Drug Evaluation, NMPA

Kai Wu SIMR Biotechnology Co., Ltd

Minji Wei Institute of Clinical Pharmacology, Peking University

Xiaojie Wu Huashan Hospital Affiliated to Fudan University

Xiaoqiang Xiang School of Pharmacy, Fudan University

Kehua Wu School of Pharmacy, Peking University

Yuanyuan Xia Tianjin Institute of Pharmaceutical Research

Haitanf Xie Yijishan Hospital Affiliated to Wannan Medical College

Junyu Xu The First Hospital of Peking University

Hongrong Xu Zhongshan Hospital Affiliated to Fudan University

Ling Xue The First Affiliated Hospital of Suzhou University

Ling Xu Shanghai University of Traditional Chinese Medicine

Guoping Yang Third Xiangya Hospital of Central South University

Miao Yan Second Xiangya Hospital of Central South University

Jin Yang China Pharmaceutical University

Jiansong Yang Mosim

Shoujun Yuan Academy of Military Medical Sciences

Peng Yu School of Pharmacy, Central South University

Fan Zhang GSK

Chao Zhang Tongren Hospital Affiliated to Capital Medical University

Jing Zhang Huashan Hospital Affiliated to Fudan University

Liang Zhao FDA

Libo Zhao Beijing Children's Hospital

Qian Zhao Peking Union Medical College Hospital

Ping Zhao Bill & Melinda Gates foundation

Qingshan Zheng Shanghai University of Traditional Chinese Medicine

Wei Zhao School of Pharmacy, Shandong University

Guoping Zhong School of Pharmacy, Sun Yat-sen University

Xin Zheng Peking Union Medical College Hospital

Xuan Zhou GSK

Tianyan Zhou School of Pharmacy, Peking University

Xiaocong Zuo Third Xiangya Hospital of Central South University

Organizing Committee (in alphabetical order by last name)

Li Ban The Fifth Affiliated Hospital of Guangzhou Medical University

Zeneng Cheng School of Pharmacy, Central South University


Shuren Guo Luye Pharma

Jin He The Fifth Affiliated Hospital of Guangzhou Medical University

Hongliang Jiang Huazhong University of Science and Technology

Lujin Li Shanghai University of Traditional Chinese Medicine

Yongmei Li The Fifth Affiliated Hospital of Guangzhou Medical University

Gailing Li Johnson & Johnson

Xin Li School of Pharmacy, Guangzhou Medical University

Xianbo Li The Fifth Affiliated Hospital of Guangzhou Medical University

Chang Liu The Sixth Affiliated Hospital of Guangzhou Medical University

Hongxia Liu Shanghai University of Traditional Chinese Medicine

Dongyang Liu The Third Hospital of Peking University

LiZhong Liu The Sixth Affiliated Hospital of Guangzhou Medical University

Haiyan Liu The Fifth Affiliated Hospital of Guangzhou Medical University

Ouyang Dongsheng Duxact

Shuang Ren Hua Medicine

Yan Ren BeiGene

Jun Shi dMed

Qingchun Song Proswell Medical Company

Hongyun Wang Peking Union Medical College Hospital

Wei Wang Genrix Bio

Hongdong Wang ASMO

Tenghua Wang The Fifth Affiliated Hospital of Guangzhou Medical University

Li Wang The Fifth Affiliated Hospital of Guangzhou Medical University

Ning Yang The Fifth Affiliated Hospital of Guangzhou Medical University

Qiongshan Yang Guangzhou Fugao Pharmaceutical Industry

Yaoxuan Zhan The Fifth Affiliated Hospital of Guangzhou Medical University

Xiyong Yu School of Pharmacy, Guangzhou Medical University

Xinke Zhou The Fifth Affiliated Hospital of Guangzhou Medical University

Sichao Zheng The Fifth Affiliated Hospital of Guangzhou Medical University

Haibo Zhou The Fifth Affiliated Hospital of Guangzhou Medical University

MeiYin Chou Excellence Future

Symposium Theme & Areas of Concern

The theme of the symposium will be "Innovation • Application" and the areas of

concern will include:

Model-based drug development strategy: perspectives and cases

Pharmacometric consideration in cell therapy trial

Model-guided clinical trial design for innovative drugs

Clinical trial design for special population (such as children)

Mechanism-based PK/PD model: principles and cases

Physiologically based pharmacokinetics (PBPK) research and cases

Model based precision medication

Bridging study based on PK/PD model: design and cases

New techniques and methods in pharmacometrics

Adaptive design, Model-based meta-analysis cases

Pharmacometric methods in research and development of

Biopharmaceuticals

Symposium Communication Form

Plenary lecture: Famous pharmacometric experts make keynote reports

on the research progress and frontier problems of pharmacometrics

panel discussion

Posters exhibition

7th ISQP Schedule

Nov 8, 2019 Friday 7:30-17:30

Pre-conference course

Registration

Nov 9, 2019 Saturday 7:30-12:00 AM

7:30-8:30 Registration

8:30-8:50 Opening Ceremony

Chaired by Professor Yi Fang

Welcome Speech by Professor Qing-shan Zheng, Chairman, Professional

Committee of Pharmacometrics, Chinese Pharmacological Society (PCPC)

Nov 9, 2019 Saturday 8:50-13:00 AM

Plenary Meetings

Time Topics and Speakers

8:50-9:20 FDA’s Initiatives to Improve Efficiency in New Drug Development

Dr. Yaning Wang, FDA

9:20-9:50 Building, evaluation, application and value of the models in drug

development: cases and analysis

Dr. Liang Zhao, FDA

9:50-10:20 Pharmacometric review of new drug application in China: present

situation and prospect

Invited, CDE NMPA

10:20-10:30 Tea Break

10:30-11:00 Recent progress of modeling & simulation in drug clinical

development in China

Prof. Qing-shan Zheng, Shanghai University of Chinese Medicine,

China

11:00-11:30 Application of pharmacometrics in drug bridge trials in Japan

Prof. Yusuke Tanigawara, Keio University, Japan

11:30-12:00 Moving from basic towards systems PKPD models for corticosterioids

Prof. William Jusko, State University of New York at Buffalo, USA

12:00-13:00 Brown bag session

Demonstration of MaS Studio for pharmacometric work

Nov 9, 2019 Saturday 13:30-17:30 PM

APC (Asian Pharmcometrics Conference)

Welcome Speech by Chairwoman of APC 2019, Professor Pei Hu

Topic: The value of pharmacometrics and its application in Asia


13:30-15:00 Application of Pop-PK/PD in bridging study

Prof. Pei Hu

PK/PD Driven Drug Discovery – example of development of cytokines

for cancer immunotherapy

Dr. Jeff Lu，AskGene Pharma, Inc.)

Evolution of PK/PD modeling of biologics

Prof. Donald Mager , State University of New York at Buffalo, USA

Speakers from Japan

Speakers from South Korea

Speakers from other countries

Tea Break

15:30-16:30 Panel discussion: Which direction we should move forward?

16:30-17:30 Roundtable: Do we need an Asian organization of pharmacometrics?

Nov 10, 2019 Sunday 8:30-12:00 AM

Plenary Meetings


8:30-8:50 Population PK and exposure response modeling in accelerating

Alectinib Development

Dr. Yuyan Jin, Roche

8:50-9:10 Pop PK/PD modeling for evaluation of acceptance of foreign data in

China population

Dr. Gailing Li, Johnson&Johnson

9:10-9:30 Dose optimization considerations in oncology drug development

Dr. Jun Shi, dMed

9:30-9:50 Optimization of PK study of Biosimilars by modeling and simulation

Dr. Jianguo Li, Cologne

9:50-10:10 Exposure/response analysis using time-varying exposure matrics for

oncology drugs with significant dose modifications

Dr. Diane Wang, Pfizer

Tea Break

10:20-10:40 Pharmacometrics in the development of a first-in-class glucokinase

activator for type 2 diabetes

Dr. Li Chen, Hua Medicine

10:40-11:00 Pharmacodynamic Investigation of D1DR Agonists in the Treatment of

Breast Cancer Lung Metastasis and Disease

Progression/Pharmacodynamics Modeling

Prof. Tianyan Zhou, Peking University

11:00-11:20 Clinical Decision Support Tools: Pharmacokinetic/Pharmacodynamic

Mediated Dose Optimization

Prof. Jiao Zheng, Chest Hospital Affiliated to Shanghai Jiaotong

University

11:20-11:40 Applications of Modelling and Simulation in 505(b)(2) submission

Prof. Jing Yang, China Pharmaceutical University

11:40-12:00 Pediatric Clinical Trial Optimization

Prof. Wei Zhao, Shangdong University

Nov 10, 2019 Sunday 13:30-17:00 PM

Session 1: Modeling & Simulation


13:30-13:45 Durvalumab

Quantatitive clinical pharmacology in drug development of

Durvalumab - dose selection and ethnic sensitivity considerations

Dr. Kai Shen, Astrazeneca

13:45-14:00 The Application of Pharmacometrics in Accerlerating Clinical

Development for Novel Anti-diabetics and Anti-Osteoporosis Drugs

Dr. Dongyang Liu, Peking University Third Hospital

14:00-14:15 Exploration and application of mechanistic PK/PD model in clinical

evaluation of proton pump inhibitors

Dr. Hongyun Wang, Peking Union Medical College Hospital

14:15-14:30 Phase 1 Studies in Chinese Subjects: Assessing Ethnic Difference and

Beyond

Dr. Chen Bin, Bayer

14:30-14:45 Clinical trial design and data analysis of cQTC study

Dr. Ling Xu, Shanghai University of Traditional Chinese Medicine

14:45-15:00 PK/PD modeling and dose selection of a PCSK9-binding agent, and

prediction of a phase 3 study

Dr. Rong Zhou, Jinan Hetai medicine co.,Ltd

15:00-15:15 Systematic evaluation and analysis of population pharmacokinetic

model of vancomycin

Dr. Chao Zhang, Tongren Hospital Affiliated to Capital Medical

University

15:15-15:30 Tea Break

15:30-15:45 Population Pharmacokinetics of Antibiotics in Postoperative

Neurosurgical Patients

Dr. Xingang Li, Beijing Friendship Hospital

15:45-16:00 Exploration of pharmacokinetic/pharmacodynamic index best

predicting efficacy for combination of antibacterial agents

Dr. Yuancheng Chen, Huashan Hospital Affiliated to Fudan University

16:00-16:15 Quantitative Approaches in Cardio-oncology: Toward Individualized

Cancer Therapy

Dr. Hua He, China Pharmaceutical University

16:15-16:30 Model-Based Estimation of Probability of Pharmacological Success

for CNS Compounds

Dr. Xuan Zhou, GSK

16:30-16:45 Drug Drug Interaction Between Salvianolate Infection and Aspirin

Based on the Metabolic Enzyme

Dr. Rui Li, Xiyuan Hospital

16:45-17:00 Application and research strategy of PBPK in special population

Dr. Aixin Shi, Beijing Hospital

Nov 10, 2019 Sunday 13:30-17:05 PM

Session 2: Clinical Trials & Individualized medication


13:30-13:45 Challenges and opportunity of global therapeutic antibody industry:

Investment/Innovation/Differentiation

Dr. Joe Zhou, Genor Biopharm

13:45-14:00 ICH E17 and impact on China clinical development

Dr. Lei Diao, Bristol-Myers Squibb

14:00-14:15 TBD

Prof. Haifeng Song, Academy of Military Medical Sciences

14:15-14:30 Cancer Immunotherapy：The Beginning of the End of Cancer

Prof. Yu Wang, Beijing 301 Hospital

14:30-14:45 An exploratory study in personalized medicine: an clustering

methodology based on supercomputing

Prof. Guoping Yang, Third Xiangya Hospital of Central South

University

14:30-14:45 An exploratory study in personalized medicine: an clustering

methodology based on supercomputing

Prof. Guoping Yang, Third Xiangya Hospital of Central South

University

14:45-15:00 Model-based adaptive design

Prof. Haitang Xie, Yijishan Hospital Affiliated to Wannan Medical

College

15:00-15:15 Mechanism, clinical and quantitative study of pharmacokinetics

interaction of traditional Chinese medicine

Prof. Furong Qiu, Shuguang Hospital Affiliated to Shanghai University of

Traditional Chinese Medicine

15:15-15:30 Tea Break

15:30-15:45 In vivo absorption kinetics and dissolution kinetics in pharmacokinetic

studies

Prof. Zeneng Cheng , Central South University

15:45-16:00 Using PBPKPD to accelerate the application of New Type 3 drugs

Dr. Bo Liu, Lizhu

16:00-16:15 Application of physiologically based pharmacokinetic model in the

research of personalized drug therapy

Dr. Xiaoqiang Xiang, Fudan University

16:15-16:30 Population Pharmacokinetics of Vancomycin in Chinese ICU

Neonates: initial dosage recommendations

Dr. Zhiling Li, Children's Hospital of Shanghai

16:30-16:45 The rational use of psychotropic medications based on population

pharmacokinetics

Dr. Dewei Shang, Huiai Hospital, Guangzhou Medical University

16:45-16:55 Population pharmacokinetics and pharmacodynamics of cyclosporine

in the treatment of systemic lupus erythematosus

Qi Wang, People's Hospital of Peking University

16:55-17:05 Thoughts on quantitative pharmacology in cell clinical trials

Dr. Tenghua Wang, The Fifth Affiliated Hospital of Guangzhou Medical

University

The Youth Outstanding Poster Award

There will be a Excellent Poster Award in the conference this year. The age of the candidatesshall be under 45 years old (born after December 31, 1974), and the English Poster should besubmitted in PDF format to the Organizing Committee's mailbox by October15:[email protected] size of the poster is 60cm*90cm in the exhibition. The winners willbe awarded certificates and bonuses to encourage them. The poster requirements are asfollows:

Language: English. Dimensions: Width 60cm* Height 90cm (see image below) .The title、

authors’ names and workplaces should be in the top of the poster and consistent with thesubmitted abstract.

The clarity of the text size and graphics should be clear enough at a distance of 2m. Poster sample:

Note: Please indicate the words "The 7th International Symposium of QuantitativePharmacology" in submission emails.

Conference Registration Method:

Online Registration: http://meeting.drugchina.org On-site Registration: November 8, 2019, registration of the conference registration area.

Date and Place of the Meeting:

Registration Time: November 8, 2019

Meeting Time: November 9-10, 2019

Meeting Location: Soluxe Hotel Guangzhou. No.199, Huangpu Avenue, Tianhe District,

Guangzhou

Payment：

Registration FeeCommon

Representative

Student

RepresentativeRegistration includes

Domestic

¥2000 for one adult,¥200

payment discount for one

adult Early-bird

Registration before Oct

10,2019 (10th included).

¥900 for one student,

student ID is needed

while registration, no

early payment

discount .

Organizing Committee

will offer working lunch

and Information

package.

Accommodation will be

carried out under the

unified arrangement by

organizing committee,

and the cost at

audience's own

expense.

Foreign

$600 for one adult,$600

payment discount for one

adult Early-bird

Registration before Oct

10,2019 (10th included).

$300 for one student,

student ID is needed

while registration, no

early payment

discount .

Payment Method:Bank/Internet Banking TransferBank: Guangzhou Guangfa Building BranchAccount Name: Guangdong Pharmacological SocietyAccount number: 101001516010010542Notes: Please indicate "ISQP meeting fee" when transfer.

\

Conference Group Contact Information:Tel: 020-85959124; 02085959126Contact: Yongmei Li 13640691018

Haiyan Liu 13802736049Sichao Zheng 13760747504Tenghua Wang 13560396395Zhiqin Hu 18802043672

Accommodation Information

1、Soluxe Hotel Guangzhou：（No.199, Huangpu Avenue）

Room type Check-in date Check-out date Rates (singlebreakfast)

Superior Twin Room November 8 November 10 RMB630/room/nightSuperior Queen Room November 8 November 10 RMB630/room/night

Deluxe suite November 8 November 10 RMB1100/room/night

2、Hotels around Soluxe Hotel:

Hotel name address

DistancefromSoluxeHotel

Contactnumber

Room Rate

GuangzhouZhujiang NewTown Hilton

Hotel

NO.495,HuangpuAvenue

recommendation

Linhui Chen18022329943

QueenRoom

RMB638/room/night

GuangzhouvanburghHotel

NO.126,HuangpuAvenue

recommendation

Miss Cui13922474532

QueenRoom

RMB650/room/night

GuangzhouGuanshengKingstyleHotel

No. 11,zhongtianfu

road, huangpuavenue

recommendation

Miss Xu18811854076

QueenRoom

RMB420/room/night

GuangzhouYueda

Financial CityInternational

Hotel

No. 322,HuangpuAvenue

Straightline

distance800m

020-61133700020-61133977

QueenRoom

StandardRoom

GuangzhouLavande

Hotels(yuancun SubwayStation)

Dongjinggarden, no. 1,erheng road,daoyuanvillage,huangpu

district, tianhedistrict,

guangzhou

Straightline

distance450m

020-85618088

About 568yuan /room /night


Insail hotels(guangzhou

zhujiangnew town

racecourse)

141 huangpuavenue,tianhe district,guangzhou, 7minutes bybus from exitB of yuancunsubwaystation

Straightline

distance1km

(020)85558688



GuangzhouRiver Classverfurtonapartment

Linjiangshangpinapartment,683 linjiangavenue

Straightline

distance1.5km

020-29003030



Elaine savileinternational

hotelapartment

Floor 1, feilibusiness

building, 665huachengavenue,

tianhe district,guangzhou

Straightline

distance2.4km

(020)38888560



GuangzhouYueda

Financial CityInternational

Hotel

No. 322,HuangpuAvenue

Straightline

distance800m

020-61133700

；

020-61133977



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