Pharma
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.
Read morePreserving 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:
Join virtually an interactive discussion and practical presentations, exploring industry standards and advancements to:
After the event, you will receive a digital certificate of attendance.
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)
About Speaker
About Speaker
About Speaker
About Speaker
Ultragenyx Pharmaceutical Inc.
About Speaker
McKinsey & Company
About Speaker
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 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. 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.
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.
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.
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.
Ultragenyx Pharmaceutical Inc.
McKinsey & Company
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