IBCLIFE SCIENCES

Produced by: InternationalMarketing Partner:

LifeSciences

Media Partners:

www.biosimilarsasia.com

A Part of

Co-located with:

16 - 19 May 2016Grand Hyatt Shanghai, China

Application of Lean in Biosimilars Manufacturing

Bioprocess Masterclass: Biologics & BiosimilarDevelopment & Manufacturing

EXCLUSIVE SITE TOUR TO

Genor Biopharma’s NEW cGMP Production Facility

Gearing up Biosimilar Development withInnovation and Integration

KEY THEMESEstablishing R&D Capabilities in China

Biosimilars Investments, Emerging Markets& Market Access Strategies

Biobetters vs Biosimilars: Which Way to Go?

Establishing Similarity - What Level ofSimilarity is Acceptable?

Improving Characterisation of Biosimilarswith Technology

Scaling Up & Improving Biosimilar ProcessCapabilities

Special pricing forDomestic China Companies

Super Early Bird Discount ends29 January 2016UNRIVALLED SPEAKER LINEUP

INCLUDES:

Bai XianhongPresident,Biotech

Pharmaceutical Co Ltd

Michael LeeExecutiveBiopharmaceuticalRepresentative,Amgen

Dr. Raymond De VréVice President Biologics,Dr. Reddy’s

Laboratories SA

Paul ThomasVice President –Biosimilars,Biocon Limited

Jinming GuExecutive Director,Shanghai Hengrui

Pharmaceutical Co Ltd

Shou-Bai ChaoSVP of Bio Venture –Global Operations,AstraZeneca

George WangFounder and CEO,Mab-Venture Co. Ltd

Jean-ChristophePointeauGeneral Manager –Commercial Operations,Sanofi China

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PLUS >> PRE&POST Conference Workshops!

Exhibitors:

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REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomsimilarsasia.com

CONFERENCE DAY ONE17 MAY 2016 TUESDAY

Breakfast Meet & Greet

07:00 John Rasko, Immediate Past Chair, Advisoryto Committee on Biologicals, Therapeutic Goods08:30 Administration (TGA), Australia08:00 Main Conference Registration Opens & Morning Coffee

08:50 Welcome Address & Ice Breaker from IBC Asia

09:00 Chairperson’s Opening Remarks

Biopharma Visionary Keynote Sessions

09:10 Global Biopharma Policy & Market Trends• Rapid growth in biopharma: challenges and opportunities• Emerging trends in biopharmaceutical production• Where is biopharmaceutical manufacturing heading?

09:40 China’s Biopharma: Opportunities & Biggest Challenges• Funding and investment difficulties in China are apparent, what

are the reasons?• CFDA outlook

~ Review and approval speed of CFDA~ How cGMP guidelines have been implicated in real time

operation, not during audition~ What it takes to get approval in US/EU from China?

• Manufacturing sciences~ GMP compliant manufacturing facility in China~ Operation excellence and improvement~ Product quality: how quality is evaluated by manufacturers?~ Choosing the right partner – suppliers and CMO’s

• Different technologies: getting all the information required fromthe vendors

Panelists:Claudia Lin, Vice President of Quality and Compliance,Innovent Biologics, ChinaJoe Zhou, CEO, Genor Biopharma & Vice President, WalvaxGroup, ChinaWenzhi Tian, Founder and President, ImmuneOncoBiopharma, ChinaBai Xianhong, President, Biotech Pharmaceutical Co., Ltd

10:30 Morning Coffee & Networking Break

Biosimilars Market & Competitive Outlook

11:45 The Future of Biosimilars in China• Establishing R&D capabilities within China vs maximising

commercial opportunities• Building local expertise and talent pools for the future• Beefing up innovative and lean manufacturing facilities for

biosimilars• How is the interest and competitions affecting market entry?Jinming Gu, Executive Director, Shanghai HengruiPharmaceutical Co Ltd

12:15 Biobetters vs Biosimilars: Which Way to Go?• Considerations and barriers to entry: emerging competition –

therapeutic biologics, biobetters• How has the biosimilar development pipeline changed over the

last 12 months?• Key changes in pipeline dynamics from a class, molecule and

indication perspective• Current perceptions on indication extrapolation, switching,

substitution, pricing, naming and labelling• Addressing critical stakeholder concerns such as regional

biosimilars approvals and adoption in China, Japan Korea, andIndia

Panelists:Chandru Chawla, Head of Biotech Business, Cipla

Shou-Bai Chao, SVP of Bio Venture – Global Operations,AstraZeneca

Michael Lee, Executive Biopharmaceutical Representative,Amgen

George Wang, Founder and CEO, Mab-Venture Co. Ltd

13:00 Networking Lunch

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Innovation & Advances in BiosimilarProduction

14:30 Improving Characterisation of Biosimilars withTechnology• Using analytical technology for better assay methods to permit

process monitoring and product characterization• Increasing improved expression systems to enable use of smaller

bioreactors and lower cost facilities• Harnessing higher titers to reduce capacity requirementsPaul Thomas, Vice President – Biosimilars, Biocon Limited

15:00 Scaling Up Production Capabilities with Advanced &Innovative Technologies• How to take advantage of the lower cost of R&D in China?• Managing higher volumes and larger amounts clinical trial data• What is the ideal scale of manufacturing?• Why is perfusion technology coming strong again?• Minimising changeover times for greater yieldGeorge Wang, Founder and CEO, Mab-Venture Co. Ltd

15:30 Afternoon Coffee & Networking Break

16:00 Strengthening the Biobetter Production Line – Long TermBenefits & Implications to Bottom Line• Key strategies for establishing a cutting-edge, competitive

biobetter market• Which industry innovators are producing new bio-technologies,

manufacturing and engineering advances• Growing the contract manufacturing space with innovation for

optimised market returnPanelists:Jinming Gu, Executive Director, Shanghai HengruiPharmaceutical Co Ltd

Michael Lee, Executive Biopharmaceutical Representative,Amgen

Interactive Roundtable Discussions

16:40 • Moderator will kick-start session with (10 mins) opening/introduction of the topic/issue discussed and raise related concerns/challenges

• Participants will form a discussion to identify the top 3solutions/strategies to resolve the challenge/issue (15min)

• Moderator will summarise the key outcomes and strategies takinginto account feasibility of the solution presented (5 min eachModerator)

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Roundtable 1: Closing the Gap for Effective Clinical Trials:Suitable Methodologies for Similarity Studies – WhatLevel of Similarity is Acceptable?Moderator:Yanrong Dong, Senior Scientist, Alphamab Co Ltd__________________________________________________________________________

Roundtable 2: Gaining Better Market Access: IsCommercial CMO Acceptable for the Biosimilars Market?Moderator:Chandru Chawla, Head of Biotech Business, Cipla__________________________________________________________________________

Roundtable 3: Regulatory Leverage: IdentifyingRepercussions & Possible implications on IPR Issues WhenEntering Biosimilars Market

17:40 Chairperson’s Summary & End of Conference Day One

18:00 Networking Dinner

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CONFERENCE DAY TWO18 MAY 2016 WEDNESDAY

REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomsimilarsasia.com

07:00 CMO Selection & Performance Managementto • A large part of biopharmaceutical companies now

rely on outsourcing partners for the developmentand manufacture of biological drug substance and drug productfor clinical studies and commercial supply.

• The focus of this workshop will be on a key element in thedevelopment of a partnership between the Client (Contract Giver)and the CMO (Contract Acceptor) – the CMO selection process.

• The workshop will include a hypothetical interactive case study,offering the participants hands-on experience in selecting theappropriate CMO, based on proven externalization guidingprinciples. CMO performance management tools and metricswill also be discussed

Firelli Alonso, Senior Director, External Supply, BioTherapeuticsPharmaceutical Sciences, Pfizer Inc., United States

08:30 Morning Coffee

09:05 Chairman’s Opening Address

Biosimilar Investments &Commercialisation Strategies

09:10 Biosimilars: The Global Health Context & Plans forEmerging Markets• Biosimilar R&D investment plans in emerging markets• Establishing Biosimilarity: a seemingly familiar concept but relying

on novel development approaches• Considerations for clinical development• Post approval considerationsDr. Raymond De Vré, Vice President Biologics, Dr. Reddy’sLaboratories SA

Regulatory & Legal Issues

09:50 Will the Myriad High Court Gene Patent Decision Fuelthe Rise of Biobetters in Australia?• Summary of the Australian Myriad decision and new Patent

Office examination practice• Has the PBS sustainability package bolstered the biosimilar

market in Australia?• Update on the new guidelines for biosimilar evaluation in

AustraliaGrant Shoebridge, Principal, Shelston IP, Australia

10:30 Morning Coffee & Networking Break

Biosimilarity & Comparability Studies

11:00 Building the Foundation for an Effective ComparabilityStudy• Integrating analytical structure and functional analyses at all

levels of the clinical trial phase• Recognising the potential ramifications of immunogenicity of

biosimilars to prompt bioassaysBai Xianhong, President, Biotech Pharmaceutical Co., Ltd

11:40 Outlining the Key Considerations & Challenges for mAbBiosimilarity• Addressing the capacity needs for large-scale cell and perfusion

cultivation for mAb• Gaining reliable support and funding from government

authorities biopharmaceutical R&D• Ensuring novel clinical trial designs crucial in establishing

interchangeability

Panelists:Dr. Raymond De Vré, Vice President Biologics, Dr. Reddy'sLaboratories SA

Paul Thomas, Vice President – Biosimilars, Biocon Limited

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Biosimilar Processing & Cost EffectiveManufacturing

12:20 Biosimilar in Alphamab: Optimising the Manufacturing

Process Based on Theories and Practice• Understanding the molecular characteristics of biosimilars• Confirming the quality during the manufacturing process• Establishing the right and lean biosimilars manufacturing

procedureYanrong Dong, Senior Scientist, Alphamab Co Ltd

13:00 Networking Lunch

14:30 Optimising Process Analytical Technology (PAT) &

Pharmaceutical Quality by Design (QbD) in Biosimilar

Manufacturing• Designing effective and efficient manufacturing processes for

product quality and performance• Incorporating product formulation and process specifications

for product stability and comparability• Integrating risk-based regulatory approaches for real-time quality

assurance• Improving cycle times, reject product and waste with advanced

facilitation and continuous processingHung Fai Poon, R&D Director, Cell Culture, Hisun Pharma

(Hangzhou) Co Ltd., China

15:10 High Throughput Screening (HTS) – Early Stage

Biosmilar/Biopharmaceutical DevelopmentThis session will discuss how to bring the product to the marketbefore competitor where HTS plays a vital role. It involves indeveloping a product using QbD & PAT approach and that gives in-depth knowledge of product & process. HTS can be employed fromgene cloning through upstream, downstream till formulationdevelopment.Vivek Halan, Senior Scientist, Zumutor Biologics Pvt Ltd,

India

15:50 Afternoon Coffee & Networking Break

Market Access & Pricing Strategies

16:20 Commercialising Biosimilars: Factors & Consideration in

Your Pricing Strategy• How do we ensure speed-to-market while maintaining a high

quality of clinical evidence?• Maximising uptake of your biosimilar products to realise your

ROI (Return on Investment)• Understanding the potential future competition and how to

tailor pricing structure• Educating Pharmacist and medical personnel about using

biosimilars on patients and its potential implications vs efficacyJean-Christophe Pointeau , General Manager – CommercialOperations, Sanofi China

17:00 Marketing Comparable Biosimilars into the Market –

Managing Pricing & Evaluation Concerns• Why are large biotech and pharma companies investing in

biosimilars?• Leveraging on critical capabilities needed for upcoming and

future market competition in biosimilars• Driving cost effectiveness and maintaining product quality of

product lines• Employing price sensitivity analysis to structure your

commercialisation strategiesChandru Chawla, Head of Biotech Business, Cipla

17:40 Chairperson’s Summary

18:00 Presentation of Best Poster & Best Booth Award

7TH ANNUAL

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POST-CONFERENCE WORKSHOP 19 May 2016 | THURSDAY (09:00 - 16:00)

With more than 15 years industrial experience in biopharma R&D, bioanalytical,formulation, audits and regulatory fields, Dr Sumant has held various scientific,technical & managerial senior positions at Intas Biopharma, IHG, Concordbiotech, Biozeen – Bangalore Biotech Lab, MTR/KMS biopharma. He hasworked on process development and production, NDA, collaborating withbiopharma companies from USA and Europe for business modelling andpartnership.Dr Sumant started his career with Intas Biopharma and subsequently movedup as Molecular Biologist at the Institute of Human Genetics to becomingSenior Manager / head of Biopharma Process Development at Biozeen. Hethen held the Biosimilar and Biologies Operations portfolio as AssistanceGeneral Manager at Micro Therapeutics Research.On the research frontier, he has experience as part of curriculum in variousfields in biotechnology, e.g. molecular biology, proteomics, microbiology,microbial metabolism, immunology, biocontrol, bioinformatics, and biostaticsetc. Dr Sumant is also a seasoned workshop trainer and speaker at conferencesand seminars.

PRE-CONFERENCE WORKSHOP 16 May 2016 | MONDAY (09:00 - 16:00)

Application of Lean in Biosimilars ManufacturingKey Topics to be Discussed Include: About your Workshop Leader

Bioprocess Masterclass: Biologics & BiosimilarDevelopment & Manufacturing

Key Learning Outcomes:

Quality by Design (QbD) Approach in BiosimilarDevelopment

Scale up / Scale Down of Biosimilar Program

Outlook on the Global Regulatory Affairs and Policiesfor Biosimilars

Optimising Production Costs of Biosimilars

Case studies / Real life case examples for interactiveclassroom activity

About your Workshop Leader

Dr Sumant ChaubeyCOO&CTO,Bills Biotech-Biological & Biologics

REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomsimilarsasia.com

7TH ANNUAL

Justin TaoChina Consulting Director,TXM Lean Solutions

Biosimilars manufacturing and the challenges ofimplementing lean in this environment

Lean principles and how they are relevant toBiosimilars manufacturing

Engaging people in a Biosimilars manufacturingenvironment – particularly continuous shift

Steps and tools to implement lean in Biosimilarsmanufacturing

Lean case studies – World leading pharmaceuticalcompany

Developing a plan for starting a lean journey in yourorganization

EXCLUSIVE SITE TOUR TOGenor Biopharma’s NEW cGMP Production Facility

• Justin is 6 Sigma Black Belter, PMP, Master of Industrial Engineering;• A co-translator of Chinese version of the book, Machine that Changed

World, Getting the Right Things Done and Lean Solutions; an Author ofLean Basic – TPM (by Lean Enterprise China). Lean successful casespublished in Lean Practices in China II and Learning to See (Chinese version2013).

• Justin has 12+ years Lean implementation experience, worked at Toyota,Otis, Kraft and Alstom.

• He helped implement Lean in pharmaceutical and biochemical industriessuch as AstraZeneca, Merck Serono, Fresenius Kabi, Novozymes, and alsoother industries include Airbus, DMG, Sony, Philips, Festo, Gerflor, SaintGobain, Kimberly-Clark, Stihl, Sandvik, Yves Rocher.

19 May 2016 | THURSDAY (14:00 - 18:00)

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WORKSHOPS & SITE TOUR

REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomsimilarsasia.com

Meet Key Industry Expert Speakers and Discover In-DepthInsights and Key Updates

Interactive Expert Knowledge Sharing – Case Studies andFindings You Cannot Afford to Miss

Pre and Post Conference Workshops – Apply and AdaptLearnings with Industry Leaders

Combined Morning Plenary Focused Forums

Continuous and Dedicated Networking Hours – Build UsefulConnections with Speakers, Vendors and Regulators

Interactive Roundtable Discussions with Key Industry Experts

1 Master Exhibition Zone Showcasing Leading Solutions,Technology and Services

Who You Will Meet

GEOGRAPHY■ China 50%■ Rest of North Asia 15%■ Southeast Asia & India 10%■ Europe 10%■ US 10%■ Rest of the World 5%

INDUSTRY■ Pharmaceuticals/Biotech 50%

■ CMOs 15%

■ CROs 15%

■ Technology & Solution Providers 10%

■ Finance/Law 10%

TOP 3 REASONS Why You Should NOT Miss this Event

Overcome hurdles such as highdevelopment cost, unsettledlegislation and regulation andcomplex intellectual propertyterrain

Understanding the required investmentin expertise and diverse sophisticatedanalytics to meet very high standards ofcomparability, and designing a suitablemanufacturing process

Evaluating the mainconsiderations andrisks involved whenentering Biosimilarsmarket

Chairman/Chief ExecutiveOfficerChief Operations OfficerChief Scientific OfficerChief Technology OfficerChief Marketing OfficerSenior Vice PresidentVice President BiologicsVice President BiosimilarsVice President of R&D

Vice President ofManufacturingVice President of FacilitiesHead of Cell LineDevelopmentPrincipal ScientistHead Process DevelopmentGeneral ManagerDirectorBusiness DevelopmentSales & Marketing Manager

Strategic Branding Networking Functions Onsite Branding Product Showcase

Profile your organisation as anindustry leader and leverage onour integrated marketingcampaign to extend yourmarketing reach.• Platinum Sponsor• Gold Sponsor• Silver Sponsor

Engage your captive audience atan exclusive event hosted byyour organisation.• Hospitality Suite Sponsor• Press / VIP Room Sponsor• Lunch Sponsor• Breakfast Sponsor• Refreshment Breaks Sponsor• Cocktail Sponsor

Reinforce your branding andseize the opportunity to enhanceyour brand visibility at the event.• Onsite Banners and Stands• Conference Bag Sponsor• Lanyard Sponsor• Corporate Gift Sponsor• Documentation Sponsor• Cyber Café Sponsor

Showcase your products andsolutions and engage yourtargeted audience through theexhibition stands or tabledisplays

We would be glad to discuss customised options that would suit your budgets and help achieve your desired marketing objectives.For more information about how you can leverage on our events to optimize your marketing budget and reach your target audience,please contact Yvonne Leong at +65 6508 2489 or email yvonne.leong@ibcasia.com.sg

SPONSORSHIP OPPORTUNITIESDesign Your Leveraged Business Platform at BDP CHINA 2016 CONFERENCE & EXHIBITION

Why You Must Join Us

Super Early Bird Discount ends29 January 2016

REGISTER NOW and save up toUSD500 / CNY2,500!

Emailregister@ibcasia.com.sg

Fax+65 6508 2407

Customer Service Hotline+65 6508 2401

Webwww.biosimilarsasia.com

IBCLIFE SCIENCES

A Part of

16 - 19 May 2016Grand Hyatt Shanghai, China

7TH ANNUAL