Overview

Industry Overview:
The bio-pharmaceutical industry in China is undergoing a very rapid growth. According to statistics, the bio- pharmaceutical industry achieved revenue growth-13.95% and profit growth-11.82% in 2014 and the market capacity will be expected to reach $100 billion in 2015. In the next 5-10 years, it will remain growing at the rate of 12%-20%, which attracts many multinational bio-pharmaceutical companies into China and creates lots of investment opportunities.

Policies:
The government is also making significant long-term investments in R&D and the field of life sciences is one of the China’s seven strategic pillars of growth. With the a series of laws, regulation and reforms coming out, such as newly revised Drug Registration Regulation (2014), recently issued the Technical Guideline for Development and Evaluation of Biosimilars (interim) (2015), the bio-pharmaceutical industry in China will be more standardized and flourishing in the future.

Challenges:
But there are still challenges for all market players. Multinational bio-pharmaceutical companies are adapting China regulation and laws, looking for local companies, scientific research institutions and other partners to accelerate new drugs development to serve Chinese patients better; for local pharma companies, they are facing inadequate investment in R&D, shortage of innovation drugs, the technologies and equipment are not as advanced as that in developed countries... Additionally, there is lack of a perfect scientific system about new drug registration, evaluation, approval, market access..., which also restricts the development of biopharmaceutical industry.

Our Goals:
Based on this, China Bio-Pharma Executives Summit 2015 will be launched by YIP Events on 19-20 Nov. in Shanghai. We are devoted to offering a communication platform for all market players, specifying related drug regulation laws and reforms, and expect it will be helpful to form a more standardized market and serve Chinese patients better. Meanwhile, we will help participants to recognize the next wave of opportunities and challenges in China, and then adapt their strategies in this transformation era to have a growing business in the future. More than 250 industry executives from government, biopharma company, biotech company, CRO/CMO, scientific research institutions and other market players will attend. During the event, pre-schedule one-to-one meeting is available.

We are looking forward to your participation!


Pre-Conference Site Tour


When: Wednesday, November 18th, 13:00 – 17:00


Address: Boehringer Ingelheim Biopharmaceuticals (China) Ltd., Zhangjiang High Tech Park, 1010 Longdong Avenue , 201203, Shanghai


Time: 13:00 pm - 17:00 pm


Agenda:

12:50 - 13:10  Arrival & Sign up
13:20 - 13:50  Opening & Presentation of Boehringer Ingelheim BioChina
14:00 - 16:30  Facility Tour-Manufacture
                       Facility Tour-Transfer Lab/ QC Lab
                       Oasis “Big Bus Tour”
                       Interaction with Boehringer Ingelheim experts
16:30 - 17:00  Wrap up & Farewell


Day One Morning
0800 Registration & Morning Coffee
0855 Chairman Opening Remark
Qiang Lü
Chief Scientific Officer and VP, Harbin Gloria Pharmaceuticals
0900

Biopharmaceutical Revolution Transforms the Industry Ecosystem
Christopher Round
President, MSD in China

0935 Specifying China's Reform of Drug Evaluation and Approval System
Qun ZHOU
Chief Engineer, Shanghai Municipal Food and Drug Administration
1010 Overview of USP Standards for Biologics
Bingbing FENG
Vice President & General Manager, U.S. Pharmacopeia–China
1040 Refreshment Break & Networking
1100 Update on European GMP Requirements
Lance Smallshaw
Executive Committee of the European Compliance Academy (ECA)
Associate Director of the CaSSS
1130

BioPharma Capabilities
Gianluca Pettiti
President, Thermo Fisher Scientific China

1200

Panel Discussion: Adapting China Regulation Environment --Challenges and
Opportunities under China FDA Reform
Moderator:
Will CHEN, Executive Director of Regulatory Affairs, WuXi AppTec
Panelists:
Kezhou ZHANG, Vice President of Clinical Development, Medical and Regulatory Affairs, Novo
Nordisk
Ning XU, Executive Vice President, Head of Clinical Development and Regulatory Affairs,
ZaiLaboratory
James GUO, VP for Strategic Planning and Drug Regulatory affairs, Shanghai Henlius Biotech

1230 Lunch & Networking (E-CAFÉ, Floor B)
Day One Afternoon
1400 Panel Discussion: Opportunities and Challenges in China and Integrating China into Global
Strategy
Moderator:
Fitz De Smet, Vice President, Marketing & Business Development, Thermo Fisher Scientific
China
Panelists:
Satoru Noguchi, Area Head of Greater China and Chairman of Takeda (China)
Chris Round, President, MSD in China
Jean-Christophe Pointeau, General Manager, Commercial Operations, Sanofi China
1450 ‘Open Innovation’ Strategy--Fostering Innovation Ecosystem through
Collaborating with External Partners to Accelerate Drug Development Process
Edward HU
Chief Financial Officer & Chief Investment Officer, WuXi AppTec.
1530 Refreshment Break & Networking
1600 How Outsourcing Can Add Value to Your Process Chain
Barbara Esch
Head of Marketing, Communication & Business Intelligence for the global Contract Manufacturing
Business (CMB) in Biopharmaceuticals
Boehringer Ingelheim Biopharmaceuticals GmbH
1640 Tackle Challenges of Characterization of Biosimilar Drugs with Cutting-edge Mass
Spectrometry
Rohan A Thakur
Senior Vice President, Bruker Daltonics
1720 Panel Discussion: Exploring R&D Innovation Potential in China
Moderator:
Jim LI, Chief Executive Officer, Sundia MediTech Company
Panelists:
Jennifer HU, Vice President, Head of Global Drug Discovery-Innovation Center China, Bayer
HealthCare,
Amber CAI, Head NIBR Shanghai Operations, Novartis Institutes for BioMedical Research
(China)
Kezhou ZHANG, Vice President of Clinical Development, Medical and Regulatory Affairs, Novo
Nordisk
1800 Closing Words
1820 Welcome Dinner (ALWAYS CANTONESE, Floor B)
Day Two Morning
0855 Chairman Opening Remarks
Mingde XIA
Senior Director, Johnson & Johnson Innovation Center
0900

Promoting China's Reform of Drug Evaluation and Approval System; Improving the Quality
and Efficiency of Drug Evaluation and Approval System
Hui ZHANG
Director of Biological Products Division--Department of Drug and Cosmetics Registration, China
Food and Drug Administration (CFDA)

0930 Development of Open–Access Integrated Technology Platforms to Expedite
Biologics Development
Weichang ZHOU
Senior Vice President, Biologics Development and Manufacturing, WuXi AppTec

1000 Panel Discussion: What Are the Core Capabilities to Develop, Manufacture and
Commercialize Biosimilars in Emerging Market?
Moderator:
Emily TAN, Vice President, Portfolio Management APAC, PAREXEL
Panelists:
Weichang ZHOU, Senior Vice President, Biologics Development and Manufacturing,
WuXi AppTec
Scott LIU, CEO, Shanghai Henlius Biotech
Ting XU, Founder and CEO, AlphaMab
Zheru ZHANG, CEO, Shanghai JMT-Bio
1030 Refreshment Break & Networking
1055 Treating Tumor with Active Cellular Immunotherapy--a SOTIO Perspective
Yong ZHANG
Chief Medical Officer, SOTIO Medical Research (Beijing) Co., Ltd
1125 Platform Technologies for Fingerprinting Biosimilars
Kenneth J. Fountain
Director, Biopharmaceutical Business Development, Waters Corporation
1155 Cell Culture Media Supplements:Effects on Performance and Protein Quality
Matthias Brand
Senior Market Development Manager, BD Biosciences –Advanced Bioprocessing, Greater
Asia

1230 Networking Lunch (E-CAFÉ, Floor B)
Day Two Afternoon
1400 Panel Discussion: Collaboration Strategies and Partnership Models in China
Moderator:
Mingde XIA, Senior Director, Johnson & Johnson Innovation Center
Panelist:
Weikang TAO, Vice President of Jiangsu Hengrui Medicine Co., Ltd., CEO of the R&D Center,
Hengrui Medicine
Joe ZHOU, CEO of Genor BioPharma Co. Ltd., VP and R/D Director of Walvax Group
Guochun LI, Head of Biologics, Harbin Gloria Pharmaceuticals
Siqi TAN, Vice president of Lab Solutions China, Thermo Fisher Scientific
1440 Boehringer Ingelheim BioChina BioLab & OASIS – BI’s Newest Members in its
Global BioManufacturing Network
Axel Schleyer
VP Business Development & Key Account Management, Regions Americas and Asia/Pacific
Biopharmaceuticals
Boehringer Ingelheim Biopharmaceuticals
1520 Clinical Development of Biologics
Emily TAN
Vice President, Portfolio Management APAC, PAREXEL
1550 Refreshment Break & Networking
1620 Panel Discussion: China Clinical Trials will Enter into a New Era
Moderator: Johnathan Lee, Head of Greater China Project Leadership, Quintiles
Panelist:
Ning XU, Executive Vice President, Head of Clinical Development and Regulatory Affairs,
ZaiLaboratory
Ye HUA, Senior Vice President, Head of Clinical Development & Regulatory Affairs, Hutchison
MediPharma
Joan Shen, VP, Development Head, China R&D and Scientific Affairs, Johnson & Johnson
1700

Panel Discussion: Data-Driven Models of R&D--How to Improve R&D Productivity through
Making Better Use of Existing Data?
Moderator: Jerry Wang, Head of Biostatistics & Statistical Programming, Merck Serono China
Panelist:
Ye HUA, Senior Vice President, Head of Clinical Development & Regulatory Affairs, Hutchison
MediPharma
Paul Whitehead, Informatics Center Head, Roche
Ouhong Wang, Head of Biostatistics and Statistical Programming, Amgen

1740

Closing Words





 

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