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)

8:00
メインカンファレンスの登録受付開始

8:50
IBC Asia代表による歓迎の挨拶

9:00
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

9:10
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?

9:40
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

CMOへのアウトソーシングと自社製造

11:45
CMOと自社製造:CMOへのアプローチが必要となる時期

  • How do CMOs control the operations?
  • Scheduling/ Timeline
  • Meeting client requirements
  • Cost issues: Viable option for the manufacturers?
  • Challenges in transferability of analytical and formulation processes to CMO

Senior Representative, Boehringer Ingelheim Biopharmaceuticals

単回使用機器とステンレス製機器の技術

12:15
単回使用機器を用いた継続的なバイオプロセス:顧客価値と操業開始に向けた作業

  • The value proposition of integrated systems
  • An update on the state of art and what is currently available
  • Key features of an integrated purification unit at development scale and for GMP manufacturing

Rob Noel, Business Development, Manager, Pall Life Sciences, United Kingdom

12:45
ケーススタディ:バイオテクノロジー施設設計の新たな方向性:単回使用機器とステンレス製機器を組み合わせた大規模施設に対応する技術の影響

  • Impact of hybrid technology
  • CAPEX & OPEX
  • Regulatory requirements and facility layout principles
  • Multiproduct downstream flexibility
  • Automation strategy for commercial and market supply
  • ADC facilities

Niels Guldager, Senior Technology Partner, NNE Pharmaplan, Denmark

13:15
生物製剤関連企業の幹部を交えた昼食会
VIP 1: Qing Qiao Robin Tan, Head of Analytical Science, Shanghai CP Guojian Pharmaceutical, China
VIP 2: Yanshan Huang, CEO, Zhejiang Doer Biologics, China
VIP 3: Hongtao Lu, Executive Vice President, Scientific Research, Zai Laboratory, China
VIP 4: Frederic Rohmer, General Manager, Lilly Suzhou Manufacturing, China

Exchange business cards and have an informal chat with the above guests during the networking lunch!

14:30

コールドチェーン管理

可視化の推進による製薬業界のコールドチェーンにおけるオペレーショナルエクセレンスの推進

  • What is the promise of telemetry?
  • Relevant and actionable data to secure decisions and minimize risks across the supply chain
  • Case studies: real life pilots on RAP e2 containers using Envirotainer's integrated visibility solution

Steve Winyard, Pharma Cold Chain Industry Expert, Envirotainer

15:00

バッチ製造と連続製造

パネルディスカッション:バッチ製造と連続製造:円滑に運営するための方策

  • Reducing process development time and manufacturing cost / Cost of good vs the other
  • Impact on the facility design
  • Impact on quality
  • Control strategies
  • Regulatory considerations
  • PAT
  • Cutting-edge technique and results of perfusion cell culture: regulation vs. approval of the produced medicine
    • How to report batch / validation failure, with respect to contamination?
    • Change of upstream and downstream process and its reporting and documentation
  • Risk analysis and risk mitigation
  • How to increase flexibility & facilitate the plant's growing needs of producing drugs?
  • Pros & cons of different mode of operation
    • Analysing which one is more suited for one type of product or environment or regulation
  • Other new trends of continuous manufacturing
    • Large vs. small molecule

Moderator:
Steven Lee, CEO, DRL Biologics Singapore Operations Pte Ltd, Singapore

Panelists:
Rob Noel, Business Development, Manager, Pall Life Sciences, United Kingdom
Suyamburam Sathasivam, General Manager R&D Biotechnology, Sun Pharma, India
Joe Zhou, CEO, Genor Biopharma & Vice President, Walvax Group, China
Kim Wong, Director, Facilities & cGMP Support, BioProcess Research & Development, Sanofi Pasteur Ltd, Canada
Hang Zhou, Director of Biologics, Wuxi AppTec Biopharmaceuticals, China

15:40
午後の休憩

16:10
グループ討論

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

ラウンドテーブル 1
ステンレス製機器と単回使用機器
Moderator:
Fei Jiang, Director, Business Development, 3SBio Inc, China

ラウンドテーブル 2
バイオマニュファクチャリングと品質管理におけるオペレーショナルエクセレンス
Moderator:
Bill Huang, Lean Practitioner

ラウンドテーブル 3
技術移転を成功裏に進めるための方策
Moderator:
Kim Wong, Director, Facilities & cGMP Support, BioProcess Research & Development, Sanofi Pasteur Ltd, Canada

17:10
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

9:00
議長の冒頭発言

バイオマニュファクチャリングの品質と効率

9:10
製造工程の効率的な運営と品質に関する規制の遵守

Senior Representative, Boehringer Ingelheim Biopharmaceuticals

9:50
ウィルス減少/除去技術とウィルス排除技術

  • Viral filtration and validation of the product with respect to viral freedom
  • Viral safety for culture media
  • Virus reduction technology, and its regulation

10:30
午前の休憩

 

分科会A:施設

分科会B:製造

11:30

議長の冒頭発言

議長の冒頭発言

11:40

施設についての計画立案:費用と投資

臨床試験実施申請資料 (IND) の提出

ケーススタディ:新たなバイオマニュファクチャリング施設の計画立案時の費用構造

  • New facility cost comparison between US and China
  • Options to reduce new facility cost
  • Cost estimation model for new facility
  • Cost comparison amoung using CMO, leasing a facility and building/operating a new facility

Jason Li, Vice President, Genor Biopharma, China

IND提出に向けた抗体薬物複合体の開発と製造

  • Conjugation and purification process development from small-scale to pilot scale
  • Challenges in preclinical studies for IND application in China
  • Regulatory considerations in China

Jun Xiang, Vice President of Biotechnology Institute of Shanghai CP Guojian, Shanghai CP Guojian Pharmaceutical Co., Ltd, China

12:20

ケーススタディ:施設間での技術移転の重要な側面

  • Ensuring facility fit of the receiving site
  • How process and facility engineering work together
  • Timing
  • Risk assessment
  • Development of technologies and application

Suyamburam Sathasivam, General Manager R&D Biotechnology, Sun Pharma, India

プロセスと品質

ケーススタディ:生物学的製剤の同等性/同質性研究の実施

  • How does it change during scale-up process?
  • What kind of method/model to use to prevent change of protein quality

Andrea Ji, Senior Scientist, Late Stage Pharmaceutical Development, Genentech Inc, A member of Roche, United States

13:00

生物製剤関連企業の幹部を交えた昼食会
VIP 1: Zhe Ru Zhang, CEO, Shanghai JMT-Bio Inc, China
VIP 2: Xueming Qian, Chairman and CEO, MabSpace Biosciences, China
VIP 3: Deepak Hedge, Product Development Director, Platform Technology Science China, GSK Shanghai R&D, GlaxoSmithKline, China
Exchange business cards and have an informal chat with the above guests during the networking lunch!

14:30

革新的な技術

ケーススタディ:分析的類似性の計画に基づく生物学的類似性の確証

  • How to establish acceptance criteria? Variability amongst the different sourced RMPs (reference medicinal product)?
  • How to establish process related impurities and its comparison with innovator product?
  • Statistical considerations
  • In-vitro/Lab comparison vs. Clinical comparison
  • Effect of age/shelf life of RMP (reference medicinal product)

Claudia Lin, Vice President of Quality and Compliance, Innovent Biologics, China

破壊的/革新的なバイオマニュファクチャリング技術

  • Revolution of Biomanufacturing technologies
  • Key areas of Biomanufacturing technology innovation
  • Economically disruptive technologies of the future

Steven Lee, CEO, DRL Biologics Singapore Operations Pte Ltd, Singapore

15:10

ケーススタディ:単回使用システム殺菌時の課題および製品/プロセスの品質と効率を確保するためのベストプラクティス

James Sayer, Director, Global Product Quality, Amgen, United States

品質保証にまつわる障害のトレンド

  • What are the key factors that led to plant closings in the last 18 months?
  • What steps can we take to ensure our operations to not go down the path that leads to plant closure?
  • What are current hot buttons for EMA and FDA inspections?

Scott Wheelwright,CEO, Complya Asia, China

15:50

午後の休憩

16:20

性能検証、適合性試験、検証

下流工程における洗浄と殺菌

  • Implementation of suitable cleaning protocols
  • Cleaning solutions
  • Developing cleaning procedures

ケーススタディ:QbDの手法を応用するための体系的なアプローチとプロセス検証時のリスク緩和

  • Developing QbD
    • Designing & optimizing the process
    • Small scale vs. large scale
  • Process validation: specification
  • Quality attribute analytical
  • Post approval process monitoring
  • Life-cycle & raw material control
  • In-process control vs. DP control
  • Extractable & Leachable Quantification

Kim Wong, Director, Facilities & cGMP Support, BioProcess Research & Development, Sanofi Pasteur Ltd, Canada

17:00

ケーススタディ:バイオマニュファクチャリング施設に対応する重要な供給系の設計と適合性試験

  • The economic and compliant system design for critical utility systems.
  • Its impact to Biomanufacturing facility and operation
  • Project strategy
  • Commissioning plan

Michael Lee, Plant Director, JHL Biotech, China

汚染防止対策の確実な実施

  • Low endotoxin recovery
  • Bioburden control
  • Use of Isolators vs. Laminar Air Flow system

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)

ワークショップ A
8:00 - 12:00

Boehringer Ingelheimの施設で行われる参加者限定のワークショップ

Senior Representative, Boehringer Ingelheim Biopharmaceuticals


ワークショップ B
14:00 - 17:00

バイオテクノロジー製品に対応する危機管理戦略と品質管理戦略

The goal of this workshop is to train QA, QC and operations managers in the following areas.  After attending this course you will understand

  • The concept of risk as used by regulatory authorities
  • How to evaluate risk in process development, analytical methods, and facility validation
  • How to manage risk to improve product safety and reduce production failures

Key Topics to be Discussed include: 

  • Risk
    • What do we mean by risk
    • How do we evaluate risk
    • How do we measure risk
    • How do we control risk
  • ICH Q10 and regulatory concepts of risk
  • Risk management for process development and analytical methods
  • Risk management for audits and inspections
  • Risk management for qualification and validation

Workshop Leader:

Scott Wheelwright
CEO
Complya Asia, China

Scott is the founder of Complya Asia, a consultancy in China focused on helping clients meet international requirements for cGMP and Quality Assurance.  Dr. Wheelwright is one of the founders of Innovent Biologics, a biopharmaceutical firm in China. Dr. Wheelwright has thirty years experience in bringing novel products to market with work experience that encompasses both large and small pharmaceutical, biotech and other life science companies.  Dr. Wheelwright received his PhD in chemical engineering from the University of California at Berkeley and performed post-doctoral studies at the Max Planck Institute for Biophysics in Frankfurt, Germany.  He is the author of a book on protein purification and has published numerous articles on manufacturing, process development, and bringing products to market.  Dr. Wheelwright currently resides in Suzhou China.

 

ポストカンファレンス
ワークショップ

2016年5月19日 (木)

ワークショップ C
8:00 - 12:00

生物製剤の充填/製剤化入門:開発の経緯、課題、可能性
Since the first batch of biologics, the field of drug fill/finish has grown substantially. When switching from API to biologics manufacturing, changes have been made to accommodate these valuable and vulnerable molecules.  This workshop focuses on discussing the details and specifics of modern biologics fill/finish manufacturing.

Key Topics to be Discussed include: 

  • Formulation development
  • Drug product design and design space
  • Sophisticated machineries/equipment
  • Control methods
  • Monitoring and control of particulates during manufacturing
  • PAT for fill-finish operation
  • Trends in material and area qualifications

Workshop Leader:


Feng He
Senior Director and Quality Head
Genor BioPharma

Dr. He joined Genor Biopharma in 2014, prior to which he had worked for Amgen Seattle for six years as Scientist and Senior Scientist, Drug Product Development. His working experience includes contract settings to deliver commercial formulation recommendations to clients, biophysical characterization, pre-formulation, and formulation of vaccine candidates including proteins, viruses and virus-like particles; formulation and lyophilization of bacteria-based pharmaceutical products; stability studies of macromolecular systems; characterization of protein-ligand interaction and refolding of recombinant biopharmaceuticals. He has a PhD in Biochemistry and Biophysics and M.A. in Mathematics at University of Kansas, B.S. Biosciences and Biotechnology in Shanghai JiaoTong University. Dr. He is now serving as adjunct professor in the department of pharmaceutical chemistry at the university of Kansas


視察ツアー
14:00 - 18:00

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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