Biopharma Production & Development Week 2015
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Transcript of Biopharma Production & Development Week 2015
19 — 22 May 2015Grand Hyatt Shanghai, China
IBCLIFE SCIENCES
4th ANNUAL 5th ANNUAL 6th ANNUAL
Produced by:
www.biopharmaproduction.com
STILL the Leading Series in China withQuality Content & a Strong Following of Top
Pharma & Biotech Stakeholders!
Yariv HefezVice President BusinessDevelopment, PortfolioManagement, Strategy andPartnering, Biosimilars Unit,Merck, Switzerland
Richard O’KeeffeExecutive Director,International Quality – Japan-Asia-Pacific (JAPAC) RegionalQuality Head,Amgen, Singapore
Shou-Bai ChaoSenior Vice President, BioVentures, Global Operations,AstraZeneca, China
Lin HongAssociate Director,Regulatory Affairs, Asia PacificRussia CIS (APAC),Abbott, USA
Dr Ira Allen JacobsOncology Portfolio GlobalMedical Lead-Biosimilars,Pfizer, USA
Dr. Martina A. SerschGlobal Clinical Lead, OncologyGlobal Development, APACBiotherapeutics Lead,Genentech, Inc. /
F. Hoffmann-La Roche Ltd.
Abdullah BaajCEO,Boston Oncology, USA
Lars DreesmannExecutive Director UpstreamManufacturing & TechTransfer H84 & PT&PE H84,Boehringer Ingelheim
Pharma, Germany
David ShenVice President,NGM Biopharmaceuticals,USA
Raj MehtaPresident – Biotech,Cadila Pharaceuticals Ltd,India
Scott LiuPresident & CEO,Henlius Biopharmaceuticals,USA
Li ShiCEO,Shanghai Zerun
Biotechnology, China
Pengfei ZhouCEO,Wuhan YZY Biopharma
Co Ltd, China
Our Distinguished Speaker Line Up
What’s Newfor 2015
C-Level Panel: Cutting EdgeInsights on China’s GrowingBiotech Market
China FDA Special Address
80+ Key Expert Speakers fromAsia’s leading Pharma & Biotech
1 Joint Exhibition & NetworkingArea
4 Days of Expert KnowledgeSharing
Revamped Program with NewSpecial Focused Tracks &Sessions
EXCLUSIVESITE TOUR!Boehringer Ingelheim’sNew BiopharmaceuticalsFacility-Shanghai China
Peng WangPresident of R&D,Yabao Pharmaceutical
Group, China
LifeSciences
08:00 Registration Opens & Morning Coffee
08:50 Welcome Address from IBC AsiaIce Breaker: Exchange Business Cards & Get to Know IndustryPeers
09:00 Chairperson’s Opening RemarksAbdullah Baaj, CEO, Boston Oncology, USA
09:10 Keynote Panel: Global Biopharma Outlook: Opportunities &Challenges 2015 & Beyond
Moderator:Yariv Hefez, Vice President Business Development, PortfolioManagement, Strategy and Partnering, Biosimilars Unit, Merck,SwitzerlandPanelists:Abdullah Baaj, CEO, Boston Oncology, USARacho Jordanov, President & CEO, JHL Biotech, TaiwanRichard O’Keeffe, Executive Director, International Quality – Japan-Asia-Pacific (JAPAC) Regional Quality Head, Amgen, Singapore
Choose Your Own Sessions from 3 Different Tracks
4th ANNUAL5th ANNUAL
6th ANNUAL
11:30 Chairperson’s Opening RemarksPengfei Zhou, CEO, Wuhan YZY BiopharmaCo Ltd, China
Chairperson’s Opening RemarksLin Hong, Associate Director, Regulatory Affairs,Asia Pacific Russia CIS (APAC), Abbott, USA
Chairperson’s Opening RemarksDr Ira Allen Jacobs, Oncology Portfolio GlobalMedical Lead-Biosimilars, Pfizer, USA
11:40Efficient Screening Strategies to SelectClones & Reduce TimelinesChaomei He, Principal Scientist, MomentaPharmaceuticals, USA
Advances in Clone Screening &Selection
Flexible Facilities & NewBiomanufacturing Technologies
Biosimilars Market Landscape
Fast-Tracking an Efficient Upstream ProcessTransfer & Scale up of BiopharmaceuticalProcessesLars Dreesmann, Executive Director UpstreamManufacturing & Tech Transfer H84 & PT&PE H84,Boehringer Ingelheim Pharma, Germany
Biosimilars on the Horizon: Opportunities
and Challenges
Dr Ira Allen Jacobs, Oncology Portfolio GlobalMedical Lead-Biosimilars, Pfizer, USA
Analytical Strategies for IncreasedQuality in Bioproduction
12:10 High-Throughput (HTP) Analytical Platformsto Assess Product Quality Attributes inCell LinesSenior Representative, Lonza
Hybrid MAb Facilities: Combining Single UseTechnology & Stainless Steel for China MAbFacilitiesNiels Guldager, Senior Technology Partner, NNEPharmaplan, Denmark
Finding Symbiotic Partnerships to Accelerate
Biosimilars Market Launches
Huiguo (Forrest) Hu, General Manager ofInternational Business, Shanghai CP Guojian
Pharmaceutical Co., Ltd, China
12:50
Networking Lunch & VIP Tables
VIP Table 1: Robin Tan, Head of Analytical Technologies, Shanghai CP Guojian Pharmaceutical, ChinaVIP Table 2: Shou-Bai Chao, Senior Vice President, Bio Ventures, Global Operations, AstraZeneca, ChinaVIP Table 3: Michelle Yu Xia, Chairman, President & CEO, Akeso Biopharma, ChinaVIP Table 4: Paul Thomas, Business Unit Head – Biosimilars, Biocon, IndiaVIP Table 5: Dr Jiang WeiDong, Chief Science Officer and Vice President, Henlius Biopharmaceuticals, USAVIP Table 6: Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd, ChinaVIP Table 7: Peng Wang, President of R&D, Yabao Pharmaceutical Group, ChinaVIP Table 8: Zou Ping, Vice Director, Shanghai CPGJ Pharma, ChinaVIP Table 9: John Xu, CSO, Shanghai Benemae Pharma & VP, Shanghai Mabicine, China
Exchange business cards and havean informal chat with key experts
during the networking lunch!
Roundtable Discussions
Each leader will facilitate the discussion for 45 minutes. Leaders will then share key takeaways on the stage for 5 minutes each.Choose your table now! Email [email protected]
2:30
Roundtable 4: GMP Regulation
Lin Hong, Associate Director, Regulatory Affairs,Asia Pacific Russia CIS (APAC), Abbott, USA
Roundtable 5: Quality by Design
Kevin Zen, Senior Manager, BiologicsDevelopment, Allergan, USA
Roundtable 6: R&D Investment &DevelopmentFei Jiang, Director, Business Development,3SBio, China
09:45 CEO Panel: Cutting Edge Insights into China’s Growing BiotechMarket
Moderator:Shou-Bai Chao, Senior Vice President, Bio Ventures, Global Operations,AstraZeneca, ChinaPanelists:Joe Zhou, CEO, Walvax Group, ChinaLi Shi, CEO, Shanghai Zerun Biotechnology, ChinaMichelle Yu Xia, Chairman, President & CEO, Akeso Biopharma, ChinaScott Liu, President & CEO, Henlius Biopharmaceuticals, USA
10:20 Government Address: China’s Evolving Biopharma Policies &RegulationsSenior Representative, China Food and Drug Administration (CFDA),China
10.45 Morning Networking & Refreshment Break
Roundtable 7: Emerging Investment Trendsin Biosimilars and Portfolio ManagementJames Huang, Managing Partner, KPCB, China
Roundtable 8: Bringing Biosimilars to theMarketDr Villoo Patell, Founder, Chairperson and CEO,Avesthagen, India
Roundtable 9: Regulatory Pathway in ChinaShaoyu Chen, Partner; Managing Director, ChinaFood and Drug Practice, Covington & BurlingLLP, China
Roundtable 1: Novel Cell Line Developmentand Bioprocess Approaches for IncreasedSpeed, Titer and Product QualityCheng Zhang, CSO, Gmax Biopharm, China
Roundtable 2: Strategies on Raw Materialand Supplier Management for Efficient, Cost-effective Biopharmaceutical ProductionChiali Liu, Manager, Microbial and Cell CultureDevelopment, GSK, USA
Roundtable 3: Applying Essential QbDconcepts in Cell Culture and BioprocessDeveopment for BiopharmaceuticalsHung Fai Poon, Director, Cell Culture, Hisun
3:30
CONFERENCE DAY ONE 20 MAY 2015 WEDNESDAY
4:00 Integrating Multi-Omics Analysis & in silicoModelling of CHO cells for Enhancing CellCulture Performance and Product QualityDong-Yup Lee, Assistant Professor, Departmentof Chemical and Biomolecular Engineering, NUS
Commercialization & Scale - UpStrategies
Case Study: Manufacturing Complex
Biosimilars
Hui Hu, Vice Director, CPGJ Research Institute,Shanghai CP Guojian Pharmaceutical, China
Update on Biosimilars Regulations &Guidelines
Case Study: Developing Biosimilars underCFDA GuidelineWen Yong, Vice Director, Drug Research Institutes,Biopharmaceutical Institute, JiangsuAoSaiKang Pharmaceutical Co Ltd, China
Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
Afternoon Networking & Refreshment Break
Biopharma Visionary Keynote Sessions
Novel ‘Omics Approaches forEnhanced Quality’
4:40
Cell Culture Media forOptimized Growth
Individual Optimization of Chemically
Defined Media
Chuan He, Process Development, Senior Scientist,Beijing Mabworks Biotech, China
Panel Discussion: Overcoming Challenges ofScale-Up: Moving Strains from Bench toLarge-Scale Fermentation & Product Recovery
Panelists:Lei Sun, Vice President, Technology andManufacture, AutekBio, ChinaWeidong Jiang, Chief Scientific Officer and SeniorVice President, Shanghai Henlius Biotech, ChinaHung Fai Poon, R&D Director, Cell Culture, HisunPharmaceutical, China
Regulatory Challenges and Development in
the US and Europe
Andrea Laslop, Head of Scientific Office, AustrianAgency for Food and Health Safety, AustrianMember, European Medicines Agency
5:15
Case Study: Key Criteria in Developing and
Gaining Approval in Biosimilars
Dr Shin Jae Chang, Vice President, Celltrion,Korea
High Throughput & High ResolutionGlycosylation Analysis ThroughoutBioprocess Development for ImprovedQualityDr Zhang Peiqing, Research Scientist,Bioprocessing Technology Institute, A*StarSingapore
5:50 Chairperson’s Summary
Networking Cocktail
VIP 1: Eric Morfin, Senior Director, Project Management and Operational Excellence, Allergan Biologics, USAVIP 2: Lin Hong, Associate Director, Regulatory Affairs, Asia Pacific Russia CIS (APAC), Abbott, USAVIP 3: Michael Grogan, Head of International Logistics & Distribution, Technical Operations, Shire Pharmaceuticals, IrelandVIP 4: Dr Vivek Mittal, Head – Legal, Lupin, IndiaVIP 5: David Shen, Vice President, NGM Biopharmaceuticals, USAVIP 6: Raj Mehta, President – Biotech, Cadila Pharaceuticals Ltd, IndiaVIP 7: Scott Liu, CEO, Henlius Pharmaceuticals, USAVIP 8: Feng Tian, Head and Director, Ambrx China
VIP 9: Wen-Chen Suen, Chief Scientific Officer, Biologics Division, HEC Pharm, China
6:00
Exchange business cards and havean informal chat with key expertsduring the networking cocktail!
7:00 End of Conference Day One
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6th ANNUAL
9:00
9:10
Novel Cell line Development Platforms& Expression Systems
9:50
Chairperson’s Opening RemarksHung Fai Poon, Director, Cell Culture, HisunPharmaceuticals, China
Chairperson’s Opening RemarksLin Hong, Associate Director, Regulatory Affairs,Asia-Pacific, Russia CIS (APAC), Abbott, USA
Chairperson’s Opening RemarksRaj Kannan, Vice President, Commercial Head,Biosimilars, Merck, Switzerland
Analyzing Cell Line Development Platforms& Amgen Case Study of Novel ExpressionSystemsDayou Liu, Senior Scientist, Amgen, USA
Global Biotech Advances
Case Study: Supply Security & Quality in 21stCentury BiotechRichard O’Keeffe, Executive Director, InternationalQuality – Japan-Asia-Pacific (JAPAC) RegionalQuality Head, Amgen, Singapore
Latest Biosimilars Technology& Best Practice Tech Transfer
Case Study: Tips for Successful Tech Transfers
Dr Joe Xin Hua, Zhou, Chief Executive Officer,Walvax Group, China
Panel Discussion: Getting the most out ofStable versus Transient Expression Systems
Panelists:Xiang Yang Zhu, CEO, Huaota Biopharm, ChinaDayou Liu, Senior Scientist, Amgen, USACheng Zhang, CSO, Gmax Biopharm, China
Disposable & Stainless Steel Hybrid Technique
Used for the Implementation of a New Process
Johannes Salzbrunn, Head of GMP Downstream/ Fill & Finish, Boehringer Ingelheim Shanghai
Pharmaceuticals, China
SMART Technologies – More than Evolution
for Biosimilars
Dr Barbara Paldus, CEO, Finesse Solutions,
Inc., USA
Morning Networking & Refreshment Break10:30
CONFERENCE DAY ONE 20 MAY 2015 WEDNESDAY
CONFERENCE DAY TWO 21 MAY 2015 THURSDAY
TRACK A: FACILITIES TRACK B: PRODUCTION
New Projects Process & Quality
11:00
Using Targeted Genome
Engineering to Advance CHO Cell
Technology
Dr Jamie Freeman, BioproductionProduct Manager, Horizon
Discovery, U.K
Case Study: Defining SpecificCritical Quality Attributes inDifferent R&D ProcessesCuihua (Chloe) Liu, Executive VicePresident, Quality & RegulatoryAffair, Alphamab, China
Case Study: New Antibody
Facility in China
Jason Li, Senior Director,Downstream Processing,Genor Biopharma, China
Redefining Consistency and
Reducing Risk with Cell Culture
Media and Supplementation
Senior Executive, BD Advanced
Bioprocessing
Choose Your Own Sessions from 4 Different Tracks4th ANNUAL 5th ANNUAL
6th ANNUAL5th ANNUAL
Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
Examining Design Principles when
Transforming to Flexible Biomanfacturing
Facilities
Strategies for Optimising Glycoslation
11:40
Overcoming the ‘Position Effect’– Targeting Integration intoChromosomal Hotspots forRapid Cell Line DevelopmentYuan Sheng Yang, Senior StaffResearch Scientist, BioprocessingTechnology Institute, Singapore
Case Study: Building an
Antibody Manufacturing Facility:
Path of a Start-Up Company
Cheng Zhang, Chief ScientificTechnology Officer, Gmax
BioPharm, China
Case Study: Insect Cell-Baculovirus System forInnovative Vaccine ProductionJohn Zeng, Executive VicePresident, Product Developmentand Clinical Manufacturing,Shanghai Zerun Biotech,China
Productive DevelopmentPartnerships (PDP) &
Biosimilar Investments
PDP and the BiosimilarOpportunity in LATAMYariv Hefez, Vice President BusinessDevelopment, PortfolioManagement, Strategy andPartnering, Merck, Switzerland
12:20
Efficient Bioprocess Design& Scaling Up Strategies
Bioprocess Design Strategies toIncrease Quality and EfficiencyZhiwei Pan, Senior Director, CellCulture Process Development,Livzon mAbpharm, China
Case Study: Manufacturing &Applications of Oligonucleotidesfor Research, Diagnostics &Therapeutics in ChinaDmitry Samarsky, ExecutiveVice President, Technology &Business Development, RiboBio,China
Case Study: Production, QualityControl & Clinical ApprovalProcess of TK006, A DenosumabBiosimilarYan Shan Huang, Senior VicePresident, Antibody Pharmaceutics,Jiangsu T-mab Biopharma, China
Identifying the Best Investment
Model and Valuating Biosimilar
Opportunities
Dr Patrik Frei, CEO, Venture
Valuation VV Asia, Singapore
1:00
Networking Luncheon & VIP TablesVIP Table 1: Masih Sabet, Associate Director Quality Assurance, APAC Technology Operation, UCB, ChinaVIP Table 2: Cuihua (Chloe) Liu, Executive Vice President, Quality & Regulatory Affairs, Alphamab, ChinaVIP Table 3: Zhonghui Lian, Deputy Chief Engineer, Technical Service Department, Beijing Yizhuang Biomedical Park, ChinaVIP Table 4: Ko Chung Lin, Chief Executive Officer, PharmaEssentia Corporation, TaiwanVIP Table 5: Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, SwitzerlandVIP Table 6: Dr. Martina A. Sersch, Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead,
Genentech, Inc. / F. Hoffmann-La Roche Ltd.VIP Table 7: Pengfei Zhou, CEO, Wuhan YZY Biopharma Co Ltd, ChinaVIP Table 8: Andy Tsun, Senior Manager & Group Head, Novel Drug and Cell Line Development, Innovent Biologics, ChinaVIP Table 9: Xiang Yang Zhu, CEO, Huaota Biopharm, China
Bring your questionsand visit the
guests during thenetworking lunch!
2:00Biomanufacturing Project
Design & PlanningEfficient Cell Culture Process
Development & Case Study of
Single-use Bioreactors
Hao Chen, Principal Scientist,Merck, USA
Best Practices for ExecutingSeismically Safe Medical NewFacilitiesEric Morfin, Senior Director, ProjectManagement and OperationalExcellence, Allergan Biologics, USA
Successfully Applying Quality
by Design (QbD) Concepts to
Develop a Robust Protein
Therapeutic Formulation
Kevin Zen, Senior Manager,Biologics Development,Allergan, USA
Market Access andCommercialization
Case Study: DevelopingBiosimilars/Biobetters inEmerging and RegulatedMarketsKo Chung Lin, Chief ExecutiveOfficer, PharmaEssentiaCorporation, Taiwan
2:40
BiomanufacturingFinance & Investment
Technology Transfer &cGMP
Developing a Strategy for
Successful Scale Up
Chiali Liu, Manager,Microbial and Cell CultureDevelopment, GSK, USA
Case Study: Financing &Investing in BiomanufacturingFacilities in ChinaPeter Fuhrman, Chairman & CEO,China First Capital, China
Case Study: Efficient TechnologyTransfer in Asia WhilstComplying with cGMPXiaoyong (Sam) Wu, OSD TechnicalLead, AstraZeneca, China
Developing Commercial
Strategies to Optimize Market
Uptake
Raj Kannan, Vice President,Commercial Head, Biosimilars,Merck, Switzerland
3:20 Afternoon Networking & Refreshment Break
3:50
Biomanufacturing SupplyChain Efficiencies
Panel Discussion: Insights intoNext-Generation Bioprocessing
Moderator:Prof Rolf G Werner, IndustrialBiotechnology Department,University of Tubingen, GermanyPanelists:Chiali Liu, Manager, Microbial andCell Culture Development, GSK, USAHao Chen, Principal Scientist,Merck, USAZhiwei Pan, Senior Director, CellCulture Process Development,Livzon mAbpharm, China
Commercial Viability of
Antibody Drug Investment
& Development
Case Study: Distributing
Biologics in Multiple Growing
Markets Efficiently
Michael Grogan, Head ofInternational Logistics & Distribution,Technical Operations, Shire
Pharmaceuticals, Ireland
Panel Discussion: Risks andOpportunities in Biosimilars/Biobetters and Key Enablers forAdvancementModerator:Salman Bokhari, ManagingDirector, Sidrapex, SingaporePanelists:Atul Deshpande, AssociateDirector, Unit Strategy Office, AsiaPacific Therapeutic Strategy Unit,Sanofi, ChinaPaul Thomas, Business Unit Head –Biosimilars, Biocon, IndiaKo Chung Lin, Chief ExecutiveOfficer, PharmaEssentiaCorporation, TaiwanTadashi Matsumoto, President/Chief Executive Officer, Reqmed CoLtd, Japan
Green & Energy EfficientBiomanufacturing Facilities
4:30
Case Study: Going Green in
Biomanufacturing
Case Study: Cold Chain
Management from
Manufacturing to Distribution of
Biologics
Masih Sabet, Associate DirectorQuality Assurance, APAC TechnologyOperation, UCB, China
Biosimilars Clinical TrialsDevelopment: KeyConsiderations in Planning andExecutionDr Arun Maseeh, Vice President,Medical Affairs, CadilaPharmaceuticals, India
ClinicalDevelopment
5:105:15
Chairperson’s Summary & End of Conference
End of the BDP Week Conferences 2015
CONFERENCE DAY TWO 21 MAY 2015 THURSDAY
TRACK A: FACILITIES TRACK B: PRODUCTION
4th ANNUAL 5th ANNUAL6th ANNUAL
5th ANNUAL
Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
Analytical Strategies for Defining
CQA in QbD Bioprocess
Development
Next GenerationBioprocessing Trends
Session 3: Complexity of MonoclonalAntibodies and Clinical Challenges forEstablishing BiosimilarityDr. Martina A. Sersch, Global Clinical Lead,Oncology Global Development, APACBiotherapeutics Lead, Genentech, Inc. / F.Hoffmann-La Roche Ltd.
Session 4: Proven Scalability of a PredefinedProcess in Bringing Biosimilar mAbs toMarketDavid Shen, Vice President, NGMBiopharmaceuticals, USA
Best Practices in Process Technology Transfer
and cGMP Manufacturing
Hao Chen, Principal Scientist, Merck, USA
Exclusive Site Tour to Boehringer Ingelheim’sNew Biopharmaceuticals Facility in Shanghai,China
PRE-CONFERENCE WORKSHOPS 19 MAY 2015 TUESDAY
POST-CONFERENCE WORKSHOPS 22 MAY 2015 FRIDAY
9.30
am –
12.
30pm
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Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
Workshop A Workshop A Special Focus Day A
Monoclonal Antibodies (Mabs)
Session 1: Trends, Challenges and Strategiesfor Biosimilar Therapeutic AntibodyDevelopmentDr Sunit Maity, AVP – Product Development,Theramyt Novobiologics Private Limited,IndiaSession 2: Next Generation of MabsJinming Gu, Senior Scientist, AbbVieBioresearch Center, USA
Achieving Operational Excellence in
Bioprocessing: Design of Experiments (DoE)
applications for Cell Culture
Hung Fai Poon, R&D Director, Cell Culture
Hisun Pharma (Hangzhou), China
Boehringer Ingelheim Biopharmaceuticals
Move to China - Operational Excellence and
Experience in 30 years Commercial
Manufacturing
Dr. Jian Huang, Director, Business Development& Key Account Management, Boehringer
Ingelheim Biopharmaceuticals, China
12.30pm – 1.30pm Networking Lunch
1.30
pm –
5.0
0pm
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Special Focus Day C Workshop B Workshop B
Special Focus Day (Continued)
9.30
am –
12.
30pm
Chairperson’s Opening RemarksWeidong Jian, CSO & VP, HenliusBiopharmaceuticals, USA
Strategies for Novel Antibodies andBiosimilars DevelopmentPei Ye, Vice President, Beijing MabworksBiotech, China
Novel Methods in Antibody Discovery andCharacterizationWeidong Jian, CSO & VP, HenliusBiopharmaceuticals, USA
Strategies in Cell line engineering ofBi Specific AntibodiesPengfei Zhou, CEO, Wuhan YZY BiopharmaCo Ltd, China
Boosting Productivity and Efficiency ofBiotherapeuticsProf Rolf G Werner, Industrial BiotechnologyDepartment, University of Tubingen, Germany
Crafting Successful Market Access
Strategies for Biosimilars in Emerging
Markets
Salman Bokhari, Managing Director,Sidrapex, Singapore
Best Corrective & Preventive Action (CAPA) &
Root Cause Analysis Practices for
Biomanufacturing Excellence
Eric Morfin, Senior Director, Project Managementand Operational Excellence, Allergan Biologics,USA
12.30pm – 1.30pm Networking Lunch
Gaining Approval for Biosimilars in the US
and Europe
Dr. Onesmo Mpanju, Principal Consultant,Independent Biopharmacuetical ProductDevelopment Consultant, Former Review
Scientist of FDA
Alan Liss, Consultant to Pharmaceutical Industry,Former Review Scientist of FDA, USA
Novel Strategies in Monoclonal AntibodiesTargeting GPCRsCheng Zhang CSO, Gmax Biopharm, China
Strategies in Fc Effector Function Analysisin AntibodiesJingyi Xiang,Head of Bioanalytics, EurekaPharma, USA
Engineering of Antibody Drug Conjugates(ADCs) technologies
Chairman Closing Remarks and End ofPost-Conference Special Focus Day
Best Corrective & Preventive Action (CAPA) &
Root Cause Analysis Practices for
Biomanufacturing Excellence (Continued)
Eric Morfin, Senior Director, Project Managementand Operational Excellence, Allergan Biologics,USA
1.30
pm –
5.0
0pm
Add Value to Your Learning withInteractive Workshops, Focus Days &
a Site Tour to Choose From!
Site TourWorkshop B
Special Focus Day C (Continued) Workshop B (Continued) Workshop C
19 — 22 May 2015Grand Hyatt Shanghai, China
IBCLIFE SCIENCES
4th ANNUAL 5th ANNUAL 6th ANNUAL
IBC’s Biopharma Development & Production
Week is the leading industry platform forpharma, biotech, CMOs, CROs, researchinstitutes, investors and industry stakeholdersto meet, network and discuss current industrytrends, establish business partnerships and beupdated on investment opportunities in Chinaand surrounding Asia.
GEOGRAPHY■ China 50%
■ Rest of North Asia 15%
■ Southeast Asia & India 10%
■ Europe 10%
■ US 10%
■ Rest of the World 5%
Who Shoud AttendChairman/ChiefExecutive OfficerChief OperationsOfficerChief Scientific OfficerChief TechnologyOfficerChief Marketing OfficerSenior Vice PresidentVice PresidentBiologicsVice PresidentBiosimilarsVice President of R&D
Vice President ofManufacturingVice President ofFacilitiesHead of Cell LineDevelopmentPrincipal ScientistHead ProcessDevelopmentGeneral ManagerDirectorBusiness DevelopmentSales & MarketingManager
INDUSTRY■ Pharmaceuticals/Biotech
50%
■ CMOs 15%
■ CROs 15%
■ Technology & SolutionProviders 10%
■ Finance/Law 10%
AbundantNetworking Opportunities& Interactive Formats
80+ Top Level SpeakersNew Pre & Post Workshops5+ Interactive Panel DiscussionsHot Topic Round Table DiscussionsMeet the Experts Via Specially Hosted VIP Lunch TablesSpeed Networking Sessions to Get to Know Your PeersConference Networking Cocktail
3 Co-located events under one roof• 4th Annual Cell Line Development &
Engineering• 5th Annual Biomanufacturing• 6th Annual Biosimilars AsiaRevamped program including special focusedtracks on:• Biomanufacturing Facilities• Biomanufacturing Production• Monoclonal Antibodies• Cutting Edge Trends in Antibody DevelopmentSpecial Site Tour & Workshop to Boehringer Ingelheim’s new biopharmafacilityEstablish Business Partnerships with local Chinese drug developers andcontract manufacturersLearn technical & practical know how from experiences on the ground in Asia-PacificShowcase your cutting edge solutions in front of key China/Asian Biopharmadecision makersSpeed Networking to get to know your industry peers
Top Reasons Why YouShould Participate:
3SBio • Abbott • AbbVie Bioresearch Center • Agilent Technologies • Akeso Biopharma • Allergan • Allergan Biologics • Alphamab • Ambrx China • Amgen • Anitia OíConnor Consulting• Astrazeneca • Autekbio • Avesthagen • BD Advance Bioprocessing • Beijing Mabworks Biotech Co Ltd • Beijing Yizhuang Biomedical Park • Biocon • Bioprocessing Technology Institute• Boehringer Ingelheim Biopharmaceuticals • Boehringer Ingelheim Pharma • Boehringer Ingelheim Shanghai Pharmaceuticals • Boston Oncology • Cadila Pharmaceuticals • Celltrion• China First Capital • Covington & Burling LLP • CPC • CPGJ Pharma • Eureka Therapeutics, Inc. • European Medicines Agency • FDA • FEF • Finesse Solutions, Inc • Genentech, Inc. / F.Hoffmann-La Roche Ltd. • Genscript • Genor Biopharma • Gmax Biopharm • GSK • Hanwha Chemical • Henlius Biopharmaceuticals • Hisun Pharma (Hangzhou) Co Ltd • Hisun Pharmaceutical• Horizon Discovery • Huaota Biopharm • Innovent Biologics, Inc. • JHL Biotech • Jiangsu AoSaiKang Pharmaceutical Co Ltd • Jiangsu T-mab Biopharma • JS Biosciences • JX Nippon Oil& Energy • KPCB • Livzon mAbpharm • Lonza • Lupin Limited • MedImmune • Merck • Momenta Pharmaceuticals • NGM Biopharmaceuticals • NNE Pharmaplan • NUS • Pfizer • PharmaEssentiaCorporation • Reqmed Co Ltd • RiboBio • Shanghai Benemae pharma • Shanghai CP Guojian Pharmaceutical • Shanghai Henlius Biotech • Shanghai Zerun Biotechnology • Shen ZhenDongYangGuang Industry Co, HEC R&D Centre • Shire Pharmaceuticals • Sidrapex • Solentim • Theramyt Novobiologics Private Limited • UCB • University of Tubingen, Germany • VentureValuation VV Asia • Walvax Group • Wuhan YZY Biopharma Co Ltd • Yabao Pharmaceutical Group • Yong Loo Lin School of Medicine, NUS
The Following Companies Have Already Confirmed their Attendance!
Here’s What Past Attendees Have to Say!“Valuable, world-class and professionally-organized, this conference wasamong the very best I’ve ever attended.”Peter Fuhrman, Chairman & Chief Executive Officer, China First Capital
“It is a great opportunity to learn biomanufacturing in China.”Kang Li, Head of Biologics, Beigene
“Very insightful conference with a broad range of issues discussed andexcellent speakers.”Ramesh Rajentheran, Managing Director, Head – AsianHealthcare, Investment Banking, Barclays
Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
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19-22 May 2015GRAND HYATT SHANGHAI
CHINA
International Marketing Partner:
Media Partners:
Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
SPONSORSHIP & EXHIBITION
GOLD SPONSOR BRONZE SPONSORS
ASSOCIATE SPONSORS SESSION SPOTLIGHT SPONSORS
EXHIBITORS
Associations:
Why You Should SponsorPosition your brand as the market leader in the biopharma industryStand out amidst competitionShowcase your latest technologies and solutionsGenerate new business contactsStrengthen existing relationships and partnerships in the industry
For more information about how you can leverage on ourevents to optimize your marketing budget and reach yourtarget audience, please contact: Ms. Yvonne Leong atTel: +65 6508 2489 Email: [email protected]
20 - 21 May 2015 • Tick the Main Conference of Interest❑ 4th Cell Line Development & Engineering❑ 6th Biosimilars Asia❑ 5th Annual Biomanufacturing
19 & 22 May • Tick the Workshop(s) You Would Like to Attend19 May • Pre-Conference 0.5 Day Workshops❑ 9.00am - 12.30pm • Best Practices in Process Technology Transfer & cGMP❑ 1.30pm - 5.00pm • Achieving Operational Excellence in Bioprocessing
19-May • Pre-Conference 1 Day Workshop❑ 9.00am - 4.00pm • Monoclonal Antibodies❑ 9.00am - 4.00pm • Boehringer Ingelheim Move to China (Incl. Site Tour)
22 May • Post-Conference 0.5 Day Workshops❑ 9.00am - 12.30pm • Market Access Strategies for Biosimilars in Emerging Markets❑ 1.30pm - 5.00pm • Gaining Approvals for Biosimilars in the US & Europe
22-May • Post-Conference 1 Day Workshops❑ 9.00am - 4.00pm • Cutting Edge Trends in Antibody Development❑ 9.00am - 4.00pm • Best CAPA & Root Cause Analysis Practices for Biomanufacturing
If undelivered, please return to:
111 Somerset Road,TripleOne Somerset #10-06, Singapore 238164Tel: +65 6508 2400 Fax: +65 6508 2408
BIOPHARMA DEVELOPMENT & PRODUCTION
Fax+65 6508 2407
Scan the QR Code with yoursmartphone and register today
Customer Service Hotline+65 6508 2401
MAIL the attached registrationform with your cheque toIBC Asia (S) Pte Ltdc/o Informa Regional BusinessServices111 Somerset Road,TripleOne Somerset #10-06,Singapore 238164
Webwww.biopharmaproduction.com
HOTEL INFORMATION
DATA PROTECTION
PAYMENT TERMS
CANCELLATIONS / SUBSTITUTION
IMPORTANT NOTE
REG
NO. 2
0010
8203
N
Payment must be received 10 business days prior to the event.To take advantage of discounts with an expiry date, registrationand payment must be received by the cut-off date.• Payment by bankers draft or cheque in S$ or US$ should be
made in favour of “IBC Asia (S) Pte Ltd” and mailed to:IBC Asia (S) Pte Ltdc/o Informa Regional Business Services111 Somerset Road, TripleOne Somerset #10-06Singapore 238164Attn: The Accounts Receivable Team
• Payment by bank transfer in S$ or US$ made payable to:IBC Asia (S) Pte LtdA/C No.:147-059513-001 (S$)A/C No.:260-457866-178 (US$)The Hongkong and Shanghai Banking Corporation Limited21 Collyer Quay, HSBC BuildingSingapore 049320Bank Swift Code: HSBCSGSGBank Code: 7232
• Payment by Credit Card (AMEX, VISA or MasterCard).The best way to pay by credit card is through our secureportal built into the website. To pay by phone please indicatethe contact name and details below and our CustomerServices Team will call within 24 hours to take payment.Please do not send credit card information by email.
The personal information entered during your registration/order,or provided by you, will be held on a database and may beshared with companies in the Informa Group in the UK andinternationally. Occasionally, your details may be obtained fromor shared with external companies who wish to communicatewith you offers related to your business activities. If you do notwish your details to be used for this purpose, please contactour Database Department at Email: [email protected],Tel: +65 6508 2400 or Fax: +65 6508 2408.
Should you be unable to attend, a substitute delegate iswelcome at no extra charge. Cancellations must be received inwriting at least 10 business days before the start of the event,to receive a refund less 10% processing fee per registration.The company regrets that no refund will be made available forcancellation notifications received less than 10 business daysbefore the event.
Please quote the name of the delegate, event title and invoicenumber on the advice when remitting payment. Bank chargesare to be deducted from participating organisations own accounts.Please fax your payment details (copy of remittance advice,cheque or draft to +65 6508 2407).Attendance will only be permitted upon receipt of full payment.Participants wishing to register at the door are responsible toensure all details are as published. IBC assumes no furtherliability or obligation, beyond the refund of the paid registrationfee, in the event of postponement or cancellation by IBC.
6 EASY WAYS TO REGISTER
RESERVE YOUR PLACE TODAY!■ Yes! I/We will attend the Biopharma Development & Production
19 – 22 May 2015, Grand Hyatt Shanghai, China■ I would like to purchase the conference presentations at SGD1000 + GST (SGD1070) per log in.
CREDIT CARD PAYMENTSThe best way to pay by credit card is through our secure on-line registration process, simply log on to the website atwww.biopharmaproduction.com and click “Register On-line”. If you would prefer to pay over the phone please complete the contactname and details and our Customer Services Team will call within 24 hours to take payment. As we treat your credit card informationin the strictest confidence, please do not send payment details by email.
Credit card contact: Department:
Direct phone number: Email:
P46271
■ I enclose my bankers draft / cheque payable to IBC Asia (S) Pte Ltd■ I am paying by bank transfer (copy attached)■ Payment by Credit Card. (AMEX, VISA or MasterCard accepted)
PAYMENT METHOD(Please tick)
• Multiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisation registering for the same event, at the same time.Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR special rate OR group rate.
• All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.• Registration fees are subject to the prevailing government tax.
Early Bird RateRegister & pay on orbefore 13 Mar 2014
Special RateRegister & pay on orbefore 10 Apr 2015
Group Rate(3 or more delegates)
Normal RateRegister & pay after
10 Apr 2015
❑ 2 Day Conference only
FEE PER DELEGATE
❑ 4 Day Package USD 2,795 USD 2,995 USD 3,195 USD 2,595❑ 3.5 Day Package❑ 3 Day Package❑ 2.5 Day Package
USD 2,595 USD 2,795 USD 2,995 USD 2,395USD 2,395 USD 2,595 USD 2,795 USD 2,195USD 2,095 USD 2,295 USD 2,495 USD 1,895USD 1,795 USD 1,995 USD 2,195 USD 1,595
CNY 7,500 CNY 8,500 CNY 9,000 CNY 7,000CNY 7,000 CNY 8,000 CNY 8,500 CNY 6,500CNY 6,500 CNY 7,500 CNY 8,000 CNY 6,000CNY 6,000 CNY 7,000 CNY 7,500 CNY 5,500CNY 5,500 CNY 6,500 CNY 7,000 CNY 5,000
Grand Hyatt Shanghai, ChinaJin Mao Tower, 88 Century BoulevardPudong, Shanghai 200121Tel: +86 21 5049 1234 | Fax: +86 21 5049 8381Contact Person: Judy XuEmail: [email protected]
Domestic China Companies (Global Headquaters Located within Mainland China)
International Companies (Global Headquaters Located Outside of Mainland China)
Register 3 Delegates andThe 4th Attends For Free!
Customer Service Hotline +65 6508 2401 [email protected] www.biopharmaproduction.com
❑ 2 Day Conference only
❑ 4 Day Package
❑ 3.5 Day Package❑ 3 Day Package❑ 2.5 Day Package
4th ANNUAL 5th ANNUAL 6th ANNUAL