アジェンダ

1日目
 

2016年5月17日 (火)

7:00 to 8:30
朝食をとりながらの交流
John Rasko, Immediate Past Chair, Advisory Committee on Biologicals, Therapeutic Goods Administration (TGA)

08:00
メインカンファレンスの登録受付開始

08:50
IBC Asia代表による歓迎の挨拶

09:00
議長による開会の挨拶

生物医薬品業界のオピニオンリーダーによる基調セッション

09:10
基調講演:生物医薬品に関する世界各国の政策と市場のトレンド

  • Rapid growth in biopharma: challenges and opportunities
  • Emerging trends in biopharmaceutical production
  • Where is biopharmaceutical manufacturing heading?

09:40
パネルディスカッション:中国の生物医薬品市場:ビジネスチャンスと最大の課題

  • 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 from the vendors

Panelists:
Claudia Lin, Vice President of Quality and Compliance, Innovent Biologics, China
Joe Zhou, CEO, Genor Biopharma & Vice President, Walvax Group, China
Wenzhi Tian, Founder and President, ImmuneOnco Biopharma, China
Bai Xianhong, President, Biotech Pharmaceutical Co., Ltd

10:30
午前の休憩

バイオシミラー市場の現状

11.40
議長の冒頭発言

11:45
中国におけるバイオシミラーの将来像

  • 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 Hengrui Pharmaceutical Co Ltd

12:15
パネルディスカッション:バイオベターとバイオシミラーの選択

  • 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, and India

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
昼食

バイオシミラー製造分野における技術革新と進歩

14:30
技術を利用したバイオシミラーのキャラクタリゼーションの改善

  • Using analytical technology for better assay methods to permit process monitoring and product characterisation
  • Increasing improved expression systems to enable use of smaller bioreactors and lower cost facilities
  • Harnessing higher titers to reduce capacity requirements

Paul Thomas, Vice President - Biosimilars, Biocon Limited

15:00    
先進的かつ革新的な技術による生産能力のスケールアップ

  • 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 yield

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

15:30
午後の休憩

16:00
パネルディスカッション:バイオベター製品ラインの強化−長期的な利益と最終損益への影響

  • 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 return

Panelists:
Jinming Gu, Executive Director, Shanghai Hengrui Pharmaceutical Co Ltd
Michael Lee, Executive Biopharmaceutical Representative, Amgen

グループ討論

16:40

  • Moderator will kick-start session with (10mins) opening /introduction of the topic/issue discussed and raise related concerns/ challenges
  • Participants will form a discussion to identify the top 3 solutions/strategies to resolve the challenge/issue (30mins)
  • Moderator will summarise the key outcomes and strategies taking into account feasibility of the solution presented (5min each Moderator)

ラウンドテーブル 1
効果的な臨床試験のための体制整備:類似性研究に最適な手法−受け入れ可能な類似性のレベル
Moderator: Yanrong Dong, Senior Scientist, Alphamab Co Ltd

ラウンドテーブル 2
市場参入に向けた取り組みの強化:バイオシミラー市場で営利事業を行うCMOが受け入れられる可能性
Moderator: Chandru Chawla, Head of Biotech Business, Cipla

ラウンドテーブル 3
規制の影響:バイオシミラー市場に参入する際の知的財産権にまつわる問題の余波と考えられる影響の明確化

17:40
議長の総括、 1日目終了

18:00
夕食会

2日目
 

2016年5月18日 (水)

朝食をとりながらのワークショップ

7:00 to 8:30
CMOの選定と業績管理

  • A large part of biopharmaceutical companies now rely on outsourcing partners for the development and manufacture of biological drug substance and drug product for clinical studies and commercial supply.
  • The focus of this workshop will be on a key element in the development 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 the appropriate CMO, based on proven externalization guiding principles.  CMO performance management tools and metrics will also be discussed

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

08:30
朝のコーヒー

09:05
議長の冒頭発言

バイオシミラーへの投資と商業化戦略

09:10
基調講演
バイオシミラー:健康に対する考え方の世界的な流れと新興国市場に対する計画

  • 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 considerations

Dr. Raymond De Vré, Vice President Biologics, Dr. Reddy's Laboratories SA

法規制に関する問題

09:50
Myriadの遺伝子特許に関してオーストラリアの高等裁判所が下した判断が同国でのバイオベター開発を促進する可能性

  • 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 Australia

Grant Shoebridge, Principal, Shelston IP, Australia

10:30
午前の休憩

生物学的類似性と同等性/同質性についての研究

11:00
ケーススタディ:同等性/同質性に関する効果的な研究を支える基盤の構築

  • Integrating analytical structure and functional analyses at all levels of the clinical trial phase
  • Recognising the potential ramifications of immunogenicity of biosimilars to prompt bioassays

Bai Xianhong, President, Biotech Pharmaceutical Co., Ltd

11:40
パネルディスカッション:モノクローナル抗体の生物学的類似性に関する主な課題の概要

  • 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's Laboratories SA
Paul Thomas, Vice President - Biosimilars, Biocon Limited

バイオシミラーの加工とコスト効率の高い製造技術

12:20
ケーススタディ:Alphamabのバイオシミラー製造:理論と実践に基づく製造工程の最適化

  • Understanding  the molecular characteristics of biosimilars
  • Confirming the quality during the manufacturing process
  • Establishing the right and lean biosimilars manufacturing procedure

Yanrong Dong, Senior Scientist, Alphamab Co Ltd

13:00
昼食

14:30
ケーススタディ:バイオシミラー製造でのプロセス解析工学 (PAT) と医薬品のクオリティバイデザイン (QbD) の最適化

  • 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 processing

Hung Fai Poon, R&D Director, Cell Culture, Hisun Pharma (Hangzhou) Co Ltd., China

15:10  
ケーススタディ:ハイスループットスクリーニング (HTS) −早期段階のバイオシミラー/生物学的医薬品の開発

This session will discuss how to bring the product to the market before competitor where HTS plays a vital role. It involves in developing a product using QbD & PAT approach and that gives in-depth knowledge of product & process. HTS can be employed from gene cloning through upstream, downstream till formulation development.

Vivek  Halan, Senior Scientist, Zumutor Biologics Pvt Ltd, India

15:50
午後の休憩

市場参入と価格設定に関する戦略

16:20
バイオシミラーの商業化:価格設定戦略における各種の要因と課題

  • How do we ensure speed-to-market while maintaining a high quality of clinical evidence?
  • Maximising uptake of your biosimilar products to realize 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 efficacy

Jean-Christophe Pointeau , General Manager - Commercial Operations, Sanofi China

17:00
同等性/同質性を有するバイオシミラーの市場投入−価格設定と評価に関する懸案への対応

  • 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 commercilaisation strategies

Chandru Chawla, Head of Biotech Business, Cipla

17:40
議長の総括

18:00
最優秀ポスター賞と最優秀ブース賞の発表

プレカンファレンス
ワークショップ

2016年5月16日 (月) 09:00 - 16:00

A:バイオシミラー製造で得られた教訓の活用

Key Topics to be Discussed Include:

  • Biosimilars manufacturing and the challenges of implementing lean in this environment
  • Lean principles and how they are relevant to Biosimilars manufacturing
  • Engaging people in a Biosimilars manufacturing environment - particularly continuous shift
  • Steps and tools to implement lean in Biosimilars manufacturing
  • Lean case studies - World leading pharmaceutical company
  • Developing a plan for starting a lean journey in your organization

 

Workshop Leader:

Justin Tao
China Consulting Director
TXM Lean Solutions

 

 

  • 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 of Lean Basic -TPM (by Lean Enterprise China). Lean successful cases published in Lean Practices in China II and Learning to See (Chinese version 2013).
  • Justin has 12+ years Lean implementation experience, worked at Toyota, Otis, Kraft and Alstom.
  • He helped implement Lean in pharmaceutical and biochemical industries such as AstraZeneca, Merck Serono, Fresenius Kabi, Novozymes, and also other industries include Airbus, DMG, Sony, Philips, Festo, Gerflor, Saint Gobain, Kimberly-Clark, Stihl, Sandvik, Yves Rocher

ポストカンファレンス
ワークショップ

2016年5月19日 (木) 09:00 - 16:00

B:バイオプロセスに関するマスタークラス:生物製剤とバイオシミラーの開発と製造

Key Learning Outcomes:

  • Quality by Design (QbD) Approach in Biosimilar Development
  • Scale up / Scale Down of Biosimilar Program
  • Outlook on the Global Regulatory Affairs and Policies for Biosimilars
  • Optimising Production Costs of Biosimilars
  • Case studies/ Real life case examples for interactive classroom activity

 

Workshop Leader:

Dr Sumant Chaubey
COO & CTO
Bills Biotech-Biological & Biologics

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, Concord biotech, Biozeen- Bangalore Biotech Lab, MTR/KMS biopharma.He has worked on process development and production, NDA, collaborating with biopharma companies from USA and Europe for business modelling and partnership.

Dr Sumant started his career with Intas Biopharma and subsequently moved up as Molecular Biologist at the Institute of Human Genetics to becoming Senior Manager/ head of Biopharma Process Development at Biozeen. He then held the Biosimilar and Biologies Operations portfolio as Assistance General Manager at Micro Therapeutics Research. On the research frontier, he has experience as part of curriculum in various fields in biotechnology, e.g. molecular biology, proteomics, microbiology, microbial metabolism, immunology, biocontrol, bioinformatics, and biostatics etc. Dr Sumant is also a seasoned workshop trainer and speaker at conferences and seminars.

サイトツアー
 

2016年5月19日 (木) 14:00 - 18:00

C:Genor Biopharmaが新たに建設したcGMP製造施設を訪れる参加者限定の視察ツアー

Site Tour Leader:
Jing Tian, BD Manager, Genor Biopharma, China

Jing Tian is currently BD Manager of Genor, a leading domestic company with global capability in R&D and manufacturing of therapeutic mAb. Her main responsibility is management of licensing in/out, CRO&CMO, as well as government affairs. She is currently project manager for a CMO project in collaboration with an international company. Prior to joining Genor, she served in T-mab BioPharma and handled diverse responsibilities spanning across biologic IND application supporting, funds application and project management, intellectual property protection, and enterprise image promotion. She received a M.S. degree in pharmacology and a B.S. degree in engineering from China Pharmacuetical University, where she was trained in biology and bioengineering.

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

 

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