Rahul Singhvi

Chief Operating Officer, Takeda Pharmaceutical Company Limited
When
2019年5月20-21日
Where
アイルランド、ダブリン
Hotel Riu Plaza The Gresham Dublin
2nd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress -第2回世界バイオプロセス、生物学的分析、先端医療医薬品製造学会- 開催日:2019年5月20-21日
開催地:アイルランド、ダブリン、Hotel Riu Plaza The Gresham Dublin
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生物製剤の生産は近年未曽有の成長を見せており、もはや製薬業界の中核となっていますが、製造プロセスには未だ数多くの克服すべき障害があります。将来の医療に対し大きな潜在力が期待できる、複合的な生物製剤や先進的な医薬品の効率的な製造には新たな技術や戦略が必要となります。また、高い基準の品質を維持しながら市場への投入を行わなければなりません。
当会議では、生物製剤やバイオシミラーにまつわる製造プロセスや薬事規制上の課題だけでなく、細胞治療薬や遺伝子治療薬の製造に特化した分科会も開催される予定となっています。細胞株開発、単回使用技術、連続プロセシング、自動化システム、リアルタイムモニタリング、CMC/GMP、QbD戦略、精製の最適化、スケールダウンモデルやスケールアップの効果的な戦略といったバイオプロセシングやプロセス解析に関するあらゆる分野の専門家が集まり、生物製剤の生産における最新の技術的、理論的な開発についての検証を行います。
+ 関連企業や研究機関の幹部による40以上の講演が行われます。
+ 各種の交流イベントが延べ7時間以上予定されています。
+ 専門家が中心となった小グループでの討論や、双方向のパネルディスカッションが予定されています。
Table 1: CMO management - challenges & insights for outsourcing complex biologics
Led by: JENS LOHRMANN, Disease Area, Head Oncology, Technical R&D, Novartis
Table 2: Sharing Practices/Preferences with Sterile Filter Integrity Testing of Drug Product
Led by: KIRSTEN STRAHLENDORF, Senior Scientist, BioProcess R&D Formulation and Stability, Sanofi Pasteur
DSP Expert, Ipsen
Principal Scientist, Novartis
Director Site Projects, Takeda
Marketing and Market Development Manager, SCIEX, CE EMEAI
Scientist, Ipsen
Senior Data Scientist, Boehringer Ingelheim
Chairman Board of Directors, salamanderU
Engineering Lead, GSK
Field Application Engineer Life Sciences EMEA, Entegris
Application and Service Director EMEA and Asia Pacific, Gyros Protein Technologies AB
VP of Technology, Avitide Inc.
Pharmaceutical (Quality) Assessor - Biologics, Health Products Regulatory Authority (HPRA)
Starting Investigator, NIBRT, Ireland
Senior Scientist - Analytical, Centre for Process Innovation
Scientific Leader, GSK
PhD Researcher at KU Leuven and Co-Founder, MyCellHub, Belgium
Manager QC, Janssen Vaccines
Analytical Methods Development Manager, MolMed
Professor, Biotechnology, Austrian Center of Industrial Biotechnology, University of natural resources and science
Director Biologics & Vaccine Analysis, MSD
Senior Scientist, Bioprocess Research and Development, Sanofi
Chief Manufacturing Officer, Orchard Therapeutics
CEO, National Institute for Bioprocessing Research and Training (NIBRT)
Professor and Head, Research Division of Biochemical Engineering, TU Wien, Austria
Chief Operating Officer, Takeda Pharmaceutical Company Limited
Project Manager, Global Technical Support, GSK Vaccines
Head of Process Development - Early Stage, Biopharma, GMS Development and Launch, Biotech Process Sciences, Merck Serono
Senior Director, Process Development and Breakthrough Technologies, CSL Behring
Scientific Director Analytical Development, Janssen
Associate Professor in Cell and Gene Therapy Bioprocess Engineering, UCL, UK
Global Regulatory Affairs CMC Manager - Biotech Products, Merck
Site Control Strategy Lead (Biologics & Small Molecules), Sanofi
Director, Assay Development, BlueRock Therapeutics
Technical Development New Biologic Entities, Analytical Dev., Novartis
DSP Expert, Ipsen
Principal Scientist, Novartis
Director Site Projects, Takeda
Marketing and Market Development Manager, SCIEX, CE EMEAI
Scientist, Ipsen
Senior Data Scientist, Boehringer Ingelheim
Chairman Board of Directors, salamanderU
Engineering Lead, GSK
Field Application Engineer Life Sciences EMEA, Entegris
Application and Service Director EMEA and Asia Pacific, Gyros Protein Technologies AB
VP of Technology, Avitide Inc.
Pharmaceutical (Quality) Assessor - Biologics, Health Products Regulatory Authority (HPRA)
Starting Investigator, NIBRT, Ireland
Senior Scientist - Analytical, Centre for Process Innovation
Scientific Leader, GSK
PhD Researcher at KU Leuven and Co-Founder, MyCellHub, Belgium
Manager QC, Janssen Vaccines
Analytical Methods Development Manager, MolMed
Professor, Biotechnology, Austrian Center of Industrial Biotechnology, University of natural resources and science
Director Biologics & Vaccine Analysis, MSD
Senior Scientist, Bioprocess Research and Development, Sanofi
Chief Manufacturing Officer, Orchard Therapeutics
CEO, National Institute for Bioprocessing Research and Training (NIBRT)
Professor and Head, Research Division of Biochemical Engineering, TU Wien, Austria
Chief Operating Officer, Takeda Pharmaceutical Company Limited
Project Manager, Global Technical Support, GSK Vaccines
Head of Process Development - Early Stage, Biopharma, GMS Development and Launch, Biotech Process Sciences, Merck Serono
Senior Director, Process Development and Breakthrough Technologies, CSL Behring
Scientific Director Analytical Development, Janssen
Associate Professor in Cell and Gene Therapy Bioprocess Engineering, UCL, UK
Global Regulatory Affairs CMC Manager - Biotech Products, Merck
Site Control Strategy Lead (Biologics & Small Molecules), Sanofi
Director, Assay Development, BlueRock Therapeutics
Technical Development New Biologic Entities, Analytical Dev., Novartis
幅広いトピックを網羅しながら2日間にわたって行われるこの学会では、4つの分科会でおよそ30の講演が予定されています。この学会は、各分野の専門家が現在進行中の重要な動きについて検討することができる貴重な機会となっており、ワクチン製剤の自動化、精製技術、T細胞製造技術、糖鎖解析技術などのトピックが取り上げられます。
アジェンダのダウンロード (PDF)Hotel Riu Plaza The Gresham Dublin
23 O’Connell Street Upper, North City, Dublin, D01 C3W7, Ireland
The new Hotel Riu Plaza The Gresham Dublin is located in the heart of Dublin, in a historic building on the famous O’Connell Street, and become one of the city’s emblematic sites. This Irish hotel offers you the best facilities for you to enjoy an unforgettable holiday with RIU Hotels & Resorts.
All of the rooms in this urban Dublin hotel are equipped with the most excellent amenities to cover all your needs during your stay with us, including a television, safe and WiFi connection. We also have a penthouse suite from which you can enjoy spectacular views over the city and the incredible surroundings of the Hotel Riu Plaza The Gresham Dublin
This new hotel in Ireland offers various unique function rooms for you to hold any kind of event. These rooms are perfectly equipped for your meetings to be a resounding success. The Hotel Riu Plaza The Gresham Dublin is also located very close to the Convention Centre Dublin making it the ideal place for business travellers.
Entegris Lifesciences provides product purity, faster time-to-market, while protecting process quality, efficacy and efficiency. From R&D, labs, utilities, CIP, upstream, downstream, buffer media prep to drug substance storage and final filling, Entegris delivers high performing, inert and low E&L solutions for single-use and full-scale processes.
https://www.entegris.com/lifesciences
×At 3M we work with our industry partners to develop better, more efficient manufacturing of safer products that transform lives. For over thirty years, our dedicated technical services and laboratory personnel has been solving the most complex biopharmaceutical manufacturing problems, while cutting-edge 3M technology addresses all your filtration needs. At 3M, we offer a portfolio of biopharmaceutical manufacturing products ranging from membranes, to chromatography filters, to depth filtration systems and process hardware that improve process efficiencies.
×At CPI we work with our partners to develop products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries. In doing so, we support the development of next-generation manufacturing organisations which require highly-skilled jobs, and will result in sustained economic growth for the UK.
×Tackling ATMP operations difficulties requires a tailor-made approach. Our aim is to help our customers overcome their difficulties by offering the most innovative solutions possible, while closely adapting them to their individual needs.
Products
Custom-made cell culture and filling isolators. The use of acrylic resin makes sure the isolator maintains its integrity and withstands H2O2 cleaning over the years.
Custom-made electronic batch record (EBR) system (“SmartReg”) with voice recognition and a voice synthesizer. “SmartReg” allows operators to simply tell what they are doing instead of writing it all down. “SmartReg” also guides the operator through the production steps and generates automatically optimized batch records.
Custom-made ATMP production units (“IP-cProtect”) including isolators, voice-controlled EBR systems and all other needed equipment. IP-cProtect enables to remotely control operation processes in real time.
Custom-made trucks containing a cGMP-classified operation room, changing room and technical area.
This allows formulating drug products next to any hospital.
×Avitide discovers, manufactures and supplies affinity purification solutions to the biopharmaceutical industry. Avitide’s 3-month affinity resin discovery-to-delivery service and proprietary ligand technology platform offers unparalleled speed, project success rate, and purification performance for any class of biopharmaceutical. Avitide is partnered with the majority of top-15 biopharma and top venture-backed biotechnology companies. Partnerships consist of facilitating rapid process development and analytics for speed to clinic, late-stage clinical and commercial life-cycle management projects, fully-continuous downstream processes, and purifying drug substances from closely related product contaminants. Avitide provides flexible arrangements for technology access, securing exclusive intellectual property, and resin supply to its biopharmaceutical partners.
×UGA Biopharma offers contract high speed Cell Line Development for new Biological Drug Candidates, contract Biosimilar Development and a high performance First CHOice® cell culture medium and feed. A large number of development projects were successfully completed for example: Bevacizumab (AVASTIN®), Eculizumab (SOLIRIS®), Darbepoetin alfa (ARANESP®), Nivolumab (OPDIVO®)…
×Emergent BioSolutions provides contract manufacturing services for both bulk drug substances and sterile injectable drug products. Our state-of-the-art, single-use BDS facility enables turnkey upstream and downstream support for microbial, mammalian, and viral cell lines. Our Fill/Finish services include vials and syringes for both liquid and lyophilized products. We also offer lyo cycle development and optimization. Our US & EU based manufacturing facilities currently produce 30+ commercial products, and support a host of clinical stage programs.
×BPS Crowthorne offers a synergetic ‘one-stop shop’ solution specifically for our Irish customers including pharmaceutical and biotech labs, universities, environmental service organisations etc. This is a unique solution in Ireland that offers the combined delivery of services ranging from independent R&D/ lab consultancy services to analytical instruments, validation of your containment and cleanroom facilities to a comprehensive range of freeze drying and process equipment from the market leaders in freeze drying and solvent removal technologies.
×CellGenix is a leading global supplier of high-quality reagents and tools for cell and gene therapy and regenerative medicine applications. As the first company to obtain a GMP manufacturing authorization for cell processing in Europe, we have 25 years of expertise in GMP manufacturing and development of cell therapy products. We offer a comprehensive product portfolio in combination with expert regulatory and technical support to ensure a seamless transition from research to commercialization. Our products combine a maximum of quality and safety due to the state-of-the-art production, stringent in-house quality control and comprehensive documentation.
×Gyros Protein Technologies, enables peptide synthesis and bioanalytical solutions that help scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab® xPand, Gyrolab® xP workstation and Gyrolab xPlore™, are used by scientists in leading pharmaceutical, biotech, CRO, and CMO companies for bioanalytical applications such as pharmacokinetics/pharmacodynamics, immunogenicity, and quantitating bioprocess-related impurities. Our peptide synthesis and bioanalytical solutions accelerate your discovery, development, and manufacturing of safer biotherapeutics.
https://www.gyrosproteintechnologies.com/gyrolab-immunoassay-solutions
×We are a creative events marketing firm that will assist you in ensuring that your endeavors are successful. With a combination of utilizing our robust experience in the industry, professional methods, immense enthusiasm and technology, we are assisting in delivering the best service possible to our esteemed clients.
×Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal.Out of these, 40 journals have already registered goodIMPACT FACTORSas per Journal Citation Reports® 2017. These titles have extensive readership mostly inEurope and North America. For a detailed profile please visit our website athttp://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/. Bentham is offering attendees of this conference discounts on its publication. For more information click here
×Biocompare is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.
×Global Information, Inc. is an information service company holding offices in 6 countries and have sales agency contracts with over 300 research companies around the world. We sell 30,000 market research reports published by these publishers and accept custom-made researches.
×Pharma Journalist is a paramount B2b online magazine platform exhibiting targeted and succinct information concerning the world of Pharmaceutical Industry therefore keeping a tab on the updated and latest updates and trends concerning the field.
×PharmaVOICE magazine provides readers with insightful and thought-provoking commentary about the challenges and trends impacting the life-sciences industry in a multiple-perspective format through articles covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 BPA-qualified subscribers are also kept abreast of the latest trends and information through additional media resources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.
×SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.
For more details regarding SciDoc Publishers:www.scidoc.org
×スポンサーと出展者は、メインカンファレンスの分科会セッション中に設定されている20分ずつの個別会談枠を事前に予約して、希望する相手に会うことができます。会期中は、Global Engageのチームが会場に常駐し、時間通りに会談を行うことができるようお手伝いいたします。
メインカンファレンスの前後に、特定のテーマに関心を持つ方々を対象とした半日あるいは全日のワークショップを開催することができます。Global Engageは、ワークショップについての広報活動を展開し、十分な出席者を確保することができるよう支援します。
Global Engageのデータベースを利用してマーケティングを展開することが可能です。また、ポスターを掲示したり、休憩や昼食会、レセプション、ポスターセッションのスポンサーになったりすることでブランド認知度を高めることができるほか、出席者に配布するランヤードや学会資料のバッグにロゴを印刷するといったブランディングのための追加オプションも用意されています。
会期中、会場内に設けられる専用の展示会エリアですべての出席者に技術や製品を披露することができます。展示会エリアは、休憩や昼食、1日目夕方に行われるレセプションの会場にもなります。
講演の形態
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