Super Early Bird Discount ends UNRIVALLED SPEAKER LINEUP 29 … · 2016-01-22 · Quality by Design...
Transcript of Super Early Bird Discount ends UNRIVALLED SPEAKER LINEUP 29 … · 2016-01-22 · Quality by Design...
IBCLIFE SCIENCES
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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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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 [email protected] 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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08:30
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 [email protected] 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 [email protected] 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 [email protected]
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!
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