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ORGANIZED BY
www.chinatrialsevent.com
L LY Y CC H
H EEE E
G GR R O UU P P
CLINICAL DEVELOPMENT LEADERS’ SUMMIT
November 4-6, 2014 - Beijing
2014 Theme:
Navigating the current challenges to harness China’s unique
position to bring innovative new medicines to patients globally
DAY 1: TUESDAY, NOVEMBER 4
Day 1 of CHINATRIALS features “Enhanced Discussions” that will allow us to cover topics that benefit from extended time and discussion.
12:30 pm – 1:00 pm
Enhanced Discussions & Early Conference Registration
1:00 pm – 3:10 pm
Enhanced Discussions Group I (Choose One)
Discussion #1
Medical Devices & Diagnostics (MD&D):
Clinical & Regulatory Developments
Discussion Chair:
Joalin Lim
Head of Operations of Medical Devices & Diagnostics, AP
NOVELLA CLINICAL
Medical Devices vs. Drug Clinical Trials – Are
There Any Differences?
Joalin Lim
Head of Operations of Medical Devices & Diagnostics, AP
NOVELLA CLINICAL
Effective Site Selection for MD&D Trials in Asia
Discussion #2
Innovation of OTC Products in China
•
Global and China OTC Innovation
•
Re-evaluation of OTC Drugs
•
Introduction of the Latest China Medical Device
Regulations
•
Market Access Policies for OTC Products
Discussion Chair:
Qing Li
Senior Director, OTC Medical Affairs and Medical Education
XIAN-JANSSEN PHARMACEUTICAL
Speakers:
Amit Shanker
Chief Medical Officer
BOSTON SCIENTIFIC
Criteria When Choosing the Best CRO For
Supporting MD&D Clinical Trials in China/Asia
Helen Niu
Senior Director, Head China Global Development
ALLERGAN
Lijun Zhang
General Manager
HARBIN PHARMACEUTICAL GROUP
Jia Liu
Engineer and Associate Professor
Decision of Pharmaceutical Monitoring and Evaluation
CHINA FOOD DRUG ADMINISTRATION (CFDA)
Industry Trends & Innovations in Vascluar Therapies
Jing Nie
Associate Director of Regulatory Affairs
JOHNSON & JOHNSON MEDICAL
Mike Van Zandt
President
ARC INSTITUTION
Joanna Lv
Director, Government Affairs and Communications
JOHNSON & JOHNSON PHARMACEUTICALS
MADELEINE ROOM, 7TH FLOOR
7TH FLOOR FOYER
CONCORDE ROOM, 7TH FLOOR
Discussion #3
Early Clinical Development in China:
Challenges and Solutions
Discussion Chair:
Frank Fan
Senior Medical Director
QUINTILES
Speakers:
Jack Peng
Scientific Advisor, Asia Pacific R&D
SANOFI
Yan Wu
Head of Clinical Operations and Drug Safety
HUTCHISON MEDIPHARMA
Jason Yang
Senior Vice President, Head of Clinical Development
BEIGENE
Zhong Yao
Director of Drug Regulatory Affairs
QUINTILES
CHAMPS-ELYSEES ROOM, 7TH FLOOR
DAY 1: TUESDAY, NOVEMBER 4
3:10 pm – 3:20 pm
Short Coffee & Tea Break
3:20 pm – 6:00 pm
Enhanced Discussions Group II (Choose One)
Discussion #4
Discussion #5
Discussion #6
Medical Devices & Diagnostics (MD&D):
Clinical & Regulatory Developments
Designing Clinical Trials To Meet Both Eastern &
Western Requirements
Integrated Patient Enrollment and CRC
Service: What’s New
CFDA Update: Clinical Requirements on MD&D
Clinical Trials
This session provides a comprehensive overview of the considerations of clinical trial study design to meet FDA, EMA,
and China CFDA requirements. Strategies for meeting these
expectations in the context of differences in patient populations, medical practice, safety monitoring considerations, final
label requirements, and regulatory requirements, logistics, and
technological capacity will be discussed. This session will also
briefly cover how to compile submission documents successfully to achieve final regulatory approval in China with the focus
on scientific merit.
•
New ways for enhancing enrollment and CRC
service
Davey Han
Head of Regulatory Affairs
BRANDWOOD BIOMEDICAL
CFDA Update: Recent Changes and How It Affects
the Sponsor
7TH FLOOR FOYER
Shi Pan
Vice President of Regulatory & Clinical Affairs
B BRAUN MEDICAL
ASEAN Harmonization Task Force & Asia
Regulation in MD&D
Arthur Brandwood
Chief Executive Officer
BRANDWOOD BIOMEDICAL
Panel Discussion: Practical Strategies For Proper
Regulatory Planning & Effective Management of
Medical Device Trials in China & Asia
Moderator:
Joalin Lim
Head of Operations of Medical Devices & Diagnostics, AP
NOVELLA CLINICAL
Discussion Chair:
Michael Song
Medical Director, Clinical Development, Immunology
JANSSEN
Speakers:
Steven Bramer
President, Chief Scientific and Research Officer
FIRST-STOP CBPD
Paul Dai
Senior Director, Regional Head of ICRO, AMAC/Greater China
BEIJING NOVARTIS PHARMA
Jerry Liu
Senior Medical Development Director
IPSEN
*ALL SESSION SPEAKERS ON PANEL
MADELEINE ROOM, 7TH FLOOR
6:00 pm
End of Day 1
CONCORDE ROOM, 7TH FLOOR
•
Can we implement some best practices from Japan and US?
•
Panel Discussion: Insights from industry experts and investigators
Discussion Chair:
Kevin Lin
Chief Executive Officer
JSURE HEALTH
Speaker:
Kiyoshi Aoyagi
Director
CROEE JAPAN
Hiroyuki Kakigi
Director
CROEE JAPAN
Lucy Xu
Director
JSURE HEALTH
Cory Williams
Head, Clinical Trial Management
PFIZER CHINA
CHAMPS-ELYSEES ROOM, 7TH FLOOR
DAY 2: WEDNESDAY, NOVEMBER 5
7:30 am – 8:30 am
Main Registration
8:30 am – 8:35 am
Chairperson’s Opening Remarks
FOYER GRAND BALLROOM 1, 7TH FLOOR
Simon Li
Vice President, Global Clinical Development & Regulatory Affairs
LUYE PHARMA
8:35 am – 9:10 am
GRAND BALLROOM 2 + 3, 7TH FLOOR
Current & Future Outlook of the Development Industry in China
David Martin
Managing Director
MONITOR DELOITTE
9:10 am – 10:25 am
Debate: How Does Global Headquarters View China R&D in 2014?
Moderator:
Frank Jiang
Vice President, Head of Asia Pacific Hub
SANOFI
Debaters:
Simon HedgecockZhengqing Li
Head of Project and Portfolio Management
Global Vice President, Head of MSD China R&D
NOVARTIS CHINAMSD CHINA
Tetsuomi Takano Wanmei Wang
Senior Director, Head of Asian Development Strategy Senior Director, Clinical & Product Development, Emerging Markets
ASTELLAS PHARMAFERRING PHARMACEUTICALS
Cory Williams
Head, Clinical Trial Management
PFIZER CHINA
DAY 2: WEDNESDAY, NOVEMBER 5
10:25 am – 11:00 am
11:00 am – 11:30 am
Networking Break & Exhibits
GRAND BALLROOM 1, 7TH FLOOR
TV-Style 3-Expert Interview
Clinical Research In China- Has It Become Too Difficult For Global Companies?
Host:
James Garner
Head, Unit Development Office, AP R&D
SANOFI
Speakers:
Ning XuSimon Li
Executive Vice President, Clinical & Regulatory Vice President, Global Clinical Development & Regulatory Affairs
ZAI LABORATORYLUYE PHARMA
Josh Goldsmith
Vice President, Global Sales & Marketing
LABCORP CLINICAL TRIALS
GRAND BALLROOM 2 + 3, 7TH FLOOR
11:30 am – 12:10 pm
Clinical Research in China- Clinical Research Experiences From Local Companies
•
How to run clinical research in China to speed up product registration in China for a NCE
•
How to meet the requirement of an international licensor on clinical research output in China
•
Experiences when running global trials by Chinese firm
Moderator:
Dan Zhang
Chief Executive Officer
FOUNTAIN MEDICAL DEVELOPMENT
Speakers:
Genhui Chen Joan Shen
Vice President of R&D Chief Medical Officer/Vice President
CELESTIAL PHARMACEUTICALS HENGRUI PHARMACEUTICALS
DAY 2: WEDNESDAY, NOVEMBER 5
Li TangYinxiang Wang
ChairmanChief Executive Officer & Chief Scientific Officer
BIOSTAR PHARMACEUTICAL
BETTA PHARMACEUTICALS
12:10 pm – 12:35 pm
Patient Litigation: An Interview With A Lawyer Experienced In Handling Patient & Hospital Litigation Cases
12:35 pm – 1:35 pm
Networking Lunch
Interviewer: Guest Expert:
Yingsheng LiuPhoebe Yan
Senior Site ManagerAssociate
BRISTOL-MYERS SQUIBBHOGAN LOVELLS
VIC RESTAURANT, 6TH FLOOR
Afternoon Chairperson: Nadina Jose
Managing Director
ANIDAN GROUP
ENHANCING COLLABORATION WITH INVESTIGATORS AND SITES
1:35 pm – 2:10 pm
An Interview With Top Principal Investigators: How Do We Improve Collaboration Between Hospitals and
Pharmaceutical Companies?
Interviewers: Sally Sha Jack Peng
Senior Business Development Director
Scientific Advisor, Asia Pacific R&D
TIGERMEDSANOFI
Principal Investigators:
Yimin Mao Yuankai Shi
Professor of GastroenterologyVice President
RENJI HOSPITAL CANCER HOSPITAL OF CHINESE ACADEMY OF MEDICAL SCIENCES
GRAND BALLROOM 2 + 3, 7TH FLOOR
DAY 2: WEDNESDAY, NOVEMBER 5
2:10 pm – 3:05 pm
Town Hall: Interactions With Investigators and Sites
3:05 pm – 3:35 pm
Networking Break & Exhibits
Moderators:
Amy JiangNadina Jose
Assoc. Director, Quality Ops, China R&D Managing Director
SANOFIANIDAN GROUP
Speakers:
Yimin Mao Yuankai Shi
Professor of GastroenterologyVice President
RENJI HOSPITAL CANCER HOSPITAL OF CHINESE ACADEMY OF MEDICAL SCIENCES Sally Sha Emily Tan
Senior Business Development Director
Vice President, Clinical Operations- Asia Pacific
TIGERMED INVENTIV HEALTH
GRAND BALLROOM 1, 7TH FLOOR
ASIAN REGIONAL DEVELOPMENT STRATEGIES
3:35 pm – 4:00 pm
New R&D Promotion Policy and Successful Examples of Accelerated Approval For Innovative Drugs in Japan
•
SAKIGAKE Designation System which promotes R&D in Japan aiming at early launch of innovative drugs
•Successful examples of accelerated Japanese NDA approval for first/best-in-class innovative drugs
•The Chinese pharmaceutical industry should be encouraged and attracted by the recent big changes in Japan
Tetsuomi Takano
Senior Director, Head of Asian Development Strategy
ASTELLAS PHARMA
GRAND BALLROOM 2 + 3, 7TH FLOOR
DAY 2: WEDNESDAY, NOVEMBER 5
4:00 pm – 5:45 pm
Asian Regional Development Updates and Challenges
Asia has gone through role changes since participating global drug development in the past 20 years starting from
providing trial patients to supporting and leading every function of a clinical trial which gives Asian region an growing opportunity from supporting role to leading role. While the Asia market is emerging, this region is moving forward
to be ready to“export” knowledge and innovation to the rest of world. It has been a long process in which we have
overcome one peak after other one and leant many lessons to get where we are today. What is the best role for us to
be? What is the highest value that we can contribute? How we should defining our goals and destinations to be
realistic? What does it take to reach them?
Moderators & Discussion Leaders:
Claire TanLi Ding
Asia Pacific Regional Director, Global Biostatistics
Director, China Trial Operations Group Leader, AP Coordinator
PAREXELSANOFI
Speakers:
Xun ChenAlbert Liou
Assoc. Vice President, Clinical Sciences & Operations Vice Chairman of the Board, Asia Pacific
SANOFIPAREXEL
Yaozhou ShiYunlong Tseng
General ManagerVice President, Research Development
QUEST DIAGNOSTICS CHINATAIWAN LIPOSOME COMPANY (TLC)
5:45 pm – 5:50 pm
Day 2 Closing Remarks
Nadina Jose
Managing Director
ANIDAN GROUP
5:50 pm – 6:45 pm
Networking Cocktail Reception
Network with your colleagues over some drinks and light finger food! If you’re not staying at the hotel and commuting back home, join the reception and let the traffic in Beijing pass you by!
DAY 3: THURSDAY, NOVEMBER 6
8:00 am – 8:05 am
Chairperson’s Opening Remarks Jingsong Wang
Head of China R&D
SANOFI
GRAND BALLROOM 2 + 3, 7TH FLOOR
REGULATORY DEVELOPMENTS IN CHINA
8:05 am –8:50 am
Regulatory Town Hall
•
•
The impact of recent regulatory changes
MRCTs: Has the CFDA changed its view on them?
Moderator:
Dan Zhang
Chief Executive Officer
FOUNTAIN MEDICAL DEVELOPMENT
Speaker:
Weiping LiJianwei Xuan
Senior Director, Regulatory Affairs
Advisory Professor, School of Public Health / Research Fellow
XIAN-JANSSEN PHARMACEUTICAL
FUDAN UNIVERSITY
THE RESEARCH CENTER OF NATIONAL DRUG & POLICY FORUM
8:50 am – 9:30 am
Navigating the Global Market: Challenge and Opportunities for China Innovative Drug Developers
Profound shifts in the global economy and healthcare are driving transformation in the biopharmaceutical industry, with global companies looking to China to fuel growth while local China companies look to expand regionally and globally. China companies are challenged by complexity of variable regulatory environment and dynamic value system composed
by payer, provider and patient. That requires Chinese companies to have a holistic view from Clinical Development to
Commercialization and build a strategy to improve the probability of success from drug registration, market access in
highly competitive global market. Chinese companies need to collaborate, leveraging expertise and infrastructure through partnerships, to achieve greater success than by going it alone. This session will look at mega-trends in
DAY 3: THURSDAY, NOVEMBER 6
emerging biopharmaceutical companies, focus on collaboration strategies for local and global growth and commercial success, with emphasis on how these trends are playing out in China.
Moderator:
Rick Sax
Senior Vice President and Global Head, Clinical Design & Reporting Services
QUINTILES
Speakers:
Meiyu GengLei Jiang
Deputy Head
Chief Executive Officer
SHANGHAI INSTITUTE OF MATERIA MEDICA
HAIHE PHARMACEUTICALS
9:30 am – 10:50 am
What’s The Best Model For Implementing Site Management Organization in China?
With the increasing demand of the clinical trials science and efficiency, SMO (Site Management Organization) is playing a more and more important role in the deployment and management of clinical trials. Different from the CRO, who represents the organizer’s benefits, the SMO, as a managing organization of clinical trials organizations, represents the benefits of
clinical units. As we all know, the executive termination of clinical trials is the hospital, where limited management structure and human resources shortage are realistic issues. The execution of clinical trials in hospitals is still to be improved.
Therefore the SMO was born and is gaining remarkable development these years.
Moderator:
Xiaoxiang Chen
Medical Vice President
BOEHRINGER-INGELHEIM CHINA
Speakers:
Cai CaoShuting Li
Former Director for GCP Center, CFDA
Vice President Director GCP Center
CANCER HOSPITAL OF CHINESE ACADEMY OF MEDICAL SCIENCES
Fiona ZhaoPengcheng Ha
Director GCP Center President
SINO SMO CCBR
DAY 3: THURSDAY, NOVEMBER 6
10:50 am – 11:15 am
Networking Break & Exhibits
GRAND BALLROOM 1, 7TH FLOOR
Afternoon Chairperson: Sean Zhao
Head of US Patient Safety Surveillance
ASTRAZENECA
SAFETY IN CLINICAL TRIALS IN CHINA
11:15 am – 12:00 pm
Risk Based Safety Management in Clinical Trials
Risk based safety management (RBSM) in clinical trials is widely credited for protecting human subjects during a clinical trial and ensuring integrity of study. Although the process of RBSM various significantly among pharmaceutical companies, the common elements include (1) commit to protect human subjects and integrity of safety information in the clinical trials – the organisational culture ensures that all the members of the organization give priority to patient safety; (2) understand hazards and evaluate risk – the foundation of a risk-based approach; (3) manage risk – the ongoing execution of RBSM; and (4) evaluation of effectiveness of RBSM system - learn from experience via metrics, incidents, audits and management reviews, provide direct feedback on the workings of the system, and improve it.
This session will discuss the best practice of RBSM in clinical trials and share experiences fro various types of pharmaceutical companies.
Moderators:
Ming JiSean Zhao
Senior Medical Director, Medical Safety Evaluation Head of US Patient Safety Surveillance
ABBVIEASTRAZENECA
Speaker:
Bo Zheng
Head of Data Management
GLAXOSMITHKLINE CHINA
GRAND BALLROOM 2 + 3, 7TH FLOOR
DAY 3: THURSDAY, NOVEMBER 6
12:00 pm – 1:00 pm
Safety Issues in Clinical Trials
•
The best way to prepare for a FDA inspection and the steps to be followed after the inspection
•
Cardiac safety assessments required by regulators for all new drugs including, but not limited to, QT data
•
Importance of blinded Data Management Committees (DMC) for safety monitoring and modifications of ongoing studies
Moderator:
Simon Li
Vice President, Global Clinical Development & Regulatory Affairs
LUYE PHARMA
Speakers:
Stephen GilbrideRobert Kleiman
President
Vice President, Global Cardiology/Chief Medical Officer
SG RESEARCH INTERNATIONALERT
Luana Koplowitz
Chief Medical & Scientific Officer
DUCK FLATS PHARMA
1:00 pm – 2:00 pm
Networking Lunch
2:00 pm – 4:00 pm
Experience Sharing in Post-Marketing Study of Drugs in China
products, have already launched in market. In order to ensure the safety of patients, these approved drugs in the market should actively carry out post-marketing studies. The current situation is that there are no particular laws or rules in post-marketing studies developed yet in China. So most of the current post-marketing studies in China are using the studies abroad as reference. However, China is different from western countries so how can post-marketing studies be best adapted for the China market? This session highlights experts from the supervision department, pharmaceutical companies, researchers and CROs, to share their
experiences and solutions for post-marketing studies in China.
VIC RESTAURANT, 6TH FLOOR
China has entered the phase of new drug development, where many innovative drugs, both small molecule and large molecule
Moderator:
Susan Song
General Manager
PROSWELL
GRAND BALLROOM 2 + 3, 7TH FLOOR
DAY 3: THURSDAY, NOVEMBER 6
Speakers:
Jinbo YangJun Zhu
Deputy DirectorVice President
CHINA FOOD DRUG ADMINISTRATION
PEKING UNIVERSITY ONCOLOGY HOSPITAL
Yongzhe Piao
PD Medical DIrector/Global Science Lead
ROCHE
4:00 pm CHINATRIALS 7 Concludes...See You Next Year!