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3rd Gene and Cell Therapy: Quality Developments to Commercialization Online Summit

  • 6th – 7th October 2021
  • Hopin flag Hopin
  • ONLINE

Addressing manufacturing controls, cell and gene therapies experts and advisers will exchange practical insights and expectations on

  • critical elements of establishing a robust CMC (Chemistry Manufacturing Controls) strategy,
  • CQAs (Critical Quality Attributes),
  • CPPs (Critical Process Parameters),
  • key factors in easing the complexity of vector production,
  • critical considerations on the sophistication of production processes and performance

for CGTP (cell and gene therapy products) in order to assure that production processes meet technical, regulatory, and cost-efficiency excellence for manufacturing safe products. 

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About Gene and Cell Therapies Event

While the global gene and cell therapies markets are evolving and the number of clinical trials investigating gene and cell therapies is increases, companies continue facing hurdles with CMC, analytical, process development, and production challenges.

At the 3rd Gene and Cell Therapy: Quality Developments to Commercialization Online Summit on 6-7 October 2021, while addressing manufacturing controls, cell and gene therapies experts and advisers will exchange practical insights and expectations on

  • critical elements of establishing a robust CMC (Chemistry Manufacturing Controls) strategy,
  • CQAs (Critical Quality Attributes),
  • CPPs (Critical Process Parameters),
  • key factors in easing the complexity of vector production,
  • critical considerations on the sophistication of production processes and performance

for CGTP (cell and gene therapy products) in order to assure:

  • production processes meet technical, regulatory, and cost-efficiency excellence for manufacturing safe products,
  • commercially viable CGTPs are delivered.

Cell and gene therapy approvals and fast-track product designations have high support from regulatory bodies, encouraging manufacturers to produce and commercialize these products rapidly.

The leading experts and consultants will share their practical experience and perspectives towards achieving and scaling-up robust cost and quality efficient manufacturing and vector process development, exploring emerging technologies in the field.

Join #VLGeneCell to explore gene and cell therapy development standards and advancements on October 6-7, 2021.

Who should attend

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

  • Adenovirus
  • Adeno-associated Virus (AAV)
  • Advanced Therapy Medicinal Product (ATMP)
  • Analytics
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • Cancer Immunotherapy
  • Chimeric antigen receptor T cells (CAR-T)
  • Chimeric antigen receptor macrophages (CAR-M)
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Comparability
  • Compliance
  • Gene Therapy
  • GMP (Good Manufacturing Practices)
  • Gene Therapy Medicinal Products (GTMPs)
  • Cell-Based Medicinal Products (CBMPs)
  • Immuno-Oncology
  • Immunology
  • Immunology Chemistry
  • Immunotherapy
  • Lentivirus (LV)
  • Manufacturing
  • Market Access
  • Medical Affairs
  • Non-Viral Vectors
  • Oncology
  • Ocular Gene Therapy
  • Product Characterisation
  • Process Development
  • Production Engineering
  • Quality Assurance
  • Quality Control
  • Research and Development (R&D)
  • Regenerative Medicine
  • Regulatory
  • Safety
  • Scale Up
  • Stem Cell
  • Supply Chain
  • Viral Vector

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Enhancing cell and gene therapies process development, manufacturing, cost, and quality efficiency
  • Powering by emerging science and technologies, cell and gene therapies maturing
  • Accelerating CMC & quality progress of gene and cell therapies (GCT) products
  • Meeting consistent CGTP safety, efficiency, and GMP manufacturing standards
  • Optimizing and scaling vector production processes and performance
  • Coupling new technologies and processes with sophisticated CQAs
  • Advancing analytical approaches while overcoming complexity challenges
  • Designing a robust supply chain for gene, cell, and precision medicine therapies
  • Strengthening the link between manufacturing and commercialization of GCTP

Dr. Stefano Baila, IT

Director of Operation and BD

Anemocyte

Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia.  Since that time he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT.  Stefano also worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T. Now he serves as Director of Operation and BD for Anemocyte 

 

John Taylor, US

Process Development Scientist

MilliporeSigma

John Taylor is a field-based Process Development Scientist at MilliporeSigma based in Philadelphia, Pennsylvania, USA. John is focused on robust process design, optimization, and scale-up of MilliporeSigma bioprocessing technologies used in biotherapeutics purification. John's current role has allowed him to support cell and gene therapy companies as they navigate through the challenges associated with process development and implementation. Prior to joining MilliporeSigma, he was an Assistant Scientist at Janssen R&D, where he focused on the process development of quick-to-market monoclonal antibodies. John received his M.S. in Biochemical Engineering from Villanova University in 2020 and his B.S. in Biological Engineering from NC State University in 2015. 

Dr. Stefano Baila, IT

Director of Operation and BD

Anemocyte

John Taylor, US

Process Development Scientist

MilliporeSigma

BROCHURE 

Request the 3rd Gene and Cell Therapy: Quality Developments to Commercialization Online Summit brochure and find out the latest topics and ideas that will be shared.

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What our
participants
are saying

I thoroughly enjoyed the conference. It was very well-organized! Kudos to you and the rest of the organizing team. My presentation was well received, and I found the questions and following discussions quite insightful. Thank you again for inviting me. I will be glad to participate in future conferences organized by the Vonlanthen group.

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Thank you very much for involving me in this conference, I enjoyed the opportunity. 

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Attendee

The Q&A after presentations was very useful, and the presentations were complex and comprehensive. I have enjoyed this experience. Thank you.

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