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Live Event

Biologics Regulatory CMC, Quality and Manufacturing

  • 30th June 2020
  • Zoom flag Zoom
  • ONLINE

Join the Biologics LIVE Webinar, the leading experts will provide an opportunity to participate in the interactive discussion on the innovative strategies, perspectives and best practices in the field.

Discover more about successful process development, manufacturing, quality, CMC technical, and regulatory requirements for biopharmaceuticals. Ask for the brochure.

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About

Preserving growing risks related to biologics, while bringing biopharmaceutical innovations, emerging challenges to be met in the process development, quality / CMC (Chemistry Manufacturing and Controls) technical and regulatory approaches. Best practices to be assessed, novel paths to be defined, and critical issues to be eliminated.

Biologics LIVE webinar on 30 June 2020, leading by experts with many years of experience in the area, will deliver an interactive approach to:

  • learn from subject-specific case studies                                 
  • exchange professional knowledge and expectations, featuring therapeutic proteins and vaccines                                                 
  • get guidance and competent advice, addressing crucial aspects and uncertainty in development, manufacturing, and control of biologics  
  • clarify regulatory guidelines

Join virtually an interactive discussion and practical presentations, exploring industry standards and advancements to:

  • accelerate biological drug product development  
  • design and validate equipment and facilities for biologics production 
  • get more biologic products successfully approved
  • have a controlled, sophisticated manufacturing process
  • deliver safe and commercially viable biologic products

After the event, you will receive a digital certificate of attendance.

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:

  • Antibody

  • Antibody-drug conjugates (ADCs)

  • Biologics

  • Bioproduction

  • Biopharmaceuticals

  • Chemistry, Manufacturing, and Controls (CMC)

  • Contract Manufacturing

  • Deoxyribonucleic acid (DNA)

  • Engineering

  • Facility Management

  • Good Manufacturing Practice (GMP)

  • Investigational New Drug (IND)

  • Investment

  • Manufacturing

  • Monoclonal antibodies (mAb /moAb)

  • Novel Modality

  • Plant / Site Management

  • Process science

  • Process engineers

  • Procurement

  • Production

  • Regulatory

  • Ribonucleic acid (RNA)

  • Supply Chain

  • Therapeutic proteins

  • Quality assurance (QA)

  • Quality control (QC)

  • Quality by Design (QbD)

  • Vaccine

Key Practical Learning Points

  • Optimised biologics process development and manufacturing
  • Critical regulatory CMC strategies to empower successful biologics submissions
  • Emerging science and technologies to facilitate the development and manufacturing of high-quality and new modalities biologic drugs

Dr. Zoltán Kis, UK

Future Vaccines Manufacturing Hub, Research Associate Centre for Process Systems Engineering, Department of Chemical Engineering

Imperial College London

Dr. Zoltán Kis is a Research Associate in the Future Vaccines Manufacturing Hub at the Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London. Zoltán is coordinating the modelling of transformative vaccine production processes for Quality by Design and for supporting the techno-economically feasible implementation of these emerging vaccine platform technologies. 

Zoltán obtained his Ph.D. in Bioengineering from Imperial College London, UK, holds an M.Sc. in Applied Biotechnology, and a B.Eng. in Chemical with Biochemical Engineering. Zoltán has co-authored over 20 scientific and technical publications and presented at over 20 international conferences.

Kai Touw, NL

Technical Lead

Batavia Biosciences

Kai Touw is Technical Lead at Batavia Biosciences, with a focus on translating complex scientific and technical challenges into workable processes. He is a driven and enthusiastic bridge builder between innovation and bioprocessing. Kai has an extensive background in process development for various biopharmaceuticals. Before joining Batavia, Kai held different process development roles within the industry at Janssen Vaccines (NL) and Sartorius (DE), working in the fields of viral vectors, process intensification and advanced data analytics. Kai holds an engineering degree from the technical university of Delft (NL).

Dr. Keith Chidwick, UK

Vice President (Technical)

PAREXEL  Consulting

Dr. Chidwick was a project scientist at Bioproducts Laboratories, developing manufacturing methods for plasma products.  Later on he went on and worked for a consulting/venture capital fund advising on the technical issues of investment in small biotechnology companies.  This involved performing technical and commercial due diligence of potential investments.  At the MHRA he served as a Senior Pharmaceutical Assessor and was later appointed Deputy Manager of the Biologicals Unit. Reviewed, as the Rapporteur / Co-Rapporteur, for the Quality Assessment 18 MAAs.  For 8 years he fulfilled the role of UK expert at EDQM P4 BIO and has been a member of EMA Guideline Drafting groups. In addition to also being a member of the Control Board at NIBSC.

Dr. Chidwick has a BSc and PhD in biochemistry from the University of London as well as an MBA.  He has had five years’ experience as a research fellow at the London Hospital Medical School working in the area of inflammation. Additionally, he was a Senior Lecturer in biochemistry at the University of Westminster.

Dr. Shawn Shouye Wang, US

Director of CMC Management

WuXi Biologics

Shawn Shouye Wang, PhD, is currently Director of CMC Management at WuXi Biologics. He joined WuXi Biologics in 2016 and has led 10+ biologics CMC projects, including 6 integrated IND antibody projects. Meanwhile, he also provides support in WuXi Biologics’ expansion in the US (King of Prussia, PA, and Cranbury, NJ).

Before joining WuXi Biologics, Shawn worked for Bristol-Meyer Squibb and Emergent Biosolutions, mainly in analytical development. Shawn received his PhD in protein chemistry from the University of Science and Technology in China and finished his postdoc training in Sweden and Michigan State University in the US.

Dr. Dengfeng Liu, US

Director of Analytical Development, Quality Control and CMC

Ultragenyx Pharmaceutical Inc.

Dr. Dengfeng Liu is a Director of Analytical Development, Quality Control, and CMC at Ultragenyx Pharmaceutical. Before joining Ultragenyx in 2019, Dr. Liu had worked for Amgen, Novartis, Gilead Science, Medimmune/AstraZeneca for more than 15 years. He has comprehensive CMC development experience encompassing from early-stage pre-IND studies to late-stage PPQ studies, BLA filing.

Dr. Liu accumulates extensive experience with various biologics formats: mAb, ADC, bispecific antibody, gene therapy (AAV), mRNA/LNP, oncolytic virus, fusion protein, peptibodies, peptides, and vaccine. Dr. Liu received his Ph.D. degree from the University of California, Santa Barbara, focusing on mass spectrometry and ion mobility spectroscopy. 

Álvaro Carpintero, ES

Partner

McKinsey & Company

Álvaro is a Partner at McKinsey’s Madrid office. He is the co-leader of the European Pharmaceuticals & Medical Products Practice, a part of the Operations Practice, and leader of the Quality Service Line. He has extensive experience with operations projects in a broad range of sectors, including Pharma, with a strong focus on Pharma Transformation and Biologics Operations Strategy.

Prior to joining McKinsey, He worked for several years in a lean application in the automotive industry. He holds degrees in Mechanical Engineering and Philosophy from Seville University and has an MBA from IESE. He is also an accredited Six Sigma green belt. 

Dr. Zoltán Kis, UK

Future Vaccines Manufacturing Hub, Research Associate Centre for Process Systems Engineering, Department of Chemical Engineering

Imperial College London

Kai Touw, NL

Technical Lead

Batavia Biosciences

Dr. Keith Chidwick, UK

Vice President (Technical)

PAREXEL  Consulting

Dr. Shawn Shouye Wang, US

Director of CMC Management

WuXi Biologics

Dr. Dengfeng Liu, US

Director of Analytical Development, Quality Control and CMC

Ultragenyx Pharmaceutical Inc.

Álvaro Carpintero, ES

Partner

McKinsey & Company

What our
participants
are saying

 “I like the format and the idea of speed networking.I especially like the mix of compliance/ regulatory/ CMC/ academia/ company presentations.

I think there is a need in Europe for such a meeting which will focus on GT from a perspective of developers/ manufacturers to exchange views and opinions."

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Jacek Lubelski

uniQure

“Meeting was really great - content but also networking opportunities especially your initiation to bring people together was really fantastic.

The organisation was really super top!! And the onsite team so perfect!!!”

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Carmen Brenner

BONE THERAPEUTICS S.A.

 “I think the event was a great success to connect on the on goings in this young field, and I would love to join again next year. “

 

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Daniela Woide

ProJect Pharmaceutics GmbH