Biopharma Production & Development Week 2015

8
19 — 22 May 2015 Grand Hyatt Shanghai, China IBC LIFE SCIENCES 4th ANNUAL 5th ANNUAL 6th ANNUAL Produced by: www.biopharmaproduction.com STILL the Leading Series in China with Quality Content & a Strong Following of Top Pharma & Biotech Stakeholders! Yariv Hefez Vice President Business Development, Portfolio Management, Strategy and Partnering, Biosimilars Unit, Merck, Switzerland Richard O’Keeffe Executive Director, International Quality – Japan- Asia-Pacific (JAPAC) Regional Quality Head, Amgen, Singapore Shou-Bai Chao Senior Vice President, Bio Ventures, Global Operations, AstraZeneca, China Lin Hong Associate Director, Regulatory Affairs, Asia Pacific Russia CIS (APAC), Abbott, USA Dr Ira Allen Jacobs Oncology Portfolio Global Medical Lead-Biosimilars, Pfizer , USA Dr. Martina A. Sersch Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead, Genentech, Inc. / F. Hoffmann-La Roche Ltd. Abdullah Baaj CEO, Boston Oncology, USA Lars Dreesmann Executive Director Upstream Manufacturing & Tech Transfer H84 & PT&PE H84, Boehringer Ingelheim Pharma, Germany David Shen Vice President, NGM Biopharmaceuticals, USA Raj Mehta President – Biotech, Cadila Pharaceuticals Ltd, India Scott Liu President & CEO, Henlius Biopharmaceuticals, USA Li Shi CEO, Shanghai Zerun Biotechnology, China Pengfei Zhou CEO, Wuhan YZY Biopharma Co Ltd, China Our Distinguished Speaker Line Up Whats New for 2015 C-Level Panel: Cutting Edge Insights on China’s Growing Biotech Market China FDA Special Address 80+ Key Expert Speakers from Asia’s leading Pharma & Biotech 1 Joint Exhibition & Networking Area 4 Days of Expert Knowledge Sharing Revamped Program with New Special Focused Tracks & Sessions EXCLUSIVE SITE TOUR! Boehringer Ingelheims New Biopharmaceuticals Facility-Shanghai China Peng Wang President of R&D, Yabao Pharmaceutical Group, China Life Sciences

Transcript of Biopharma Production & Development Week 2015

Page 1: 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

Page 2: Biopharma Production & Development Week 2015

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’

Page 3: Biopharma Production & Development Week 2015

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

4th ANNUAL5th ANNUAL

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

Page 4: Biopharma Production & Development Week 2015

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

Page 5: Biopharma Production & Development Week 2015

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

4th ANNUAL5th ANNUAL

6th ANNUAL

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

4th ANNUAL5th ANNUAL

6th ANNUAL

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

Page 6: Biopharma Production & Development Week 2015

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

Page 7: Biopharma Production & Development Week 2015

ExhibitorFloor Plan 2015Grand Hyatt Shanghai

1.5m

1.5m

1.5m

1.5m

1.5m

19 1817 16 15 14 13 12

23 24 25

27 28 2926

20

21

1 2

3 4 5 6

11

10

9

8

7

6.30m6.57m

Booked

Booked

Booked Booked

Reserved Reserved

Entrance

En

tra

nce

22

Booked Booked Booked

Booked Booked

Booked Reserved Booked

Booked Booked

Booked Booked

Booked

Booked

4th ANNUAL 5th ANNUAL 6th ANNUAL

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]

Page 8: Biopharma Production & Development Week 2015

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

[email protected]

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