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Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit

  • 18th – 19th November 2021
  • Hybrid flag Hybrid Munich, Germany

Gene Therapies, CAR-T Cell Therapies, and other Advanced Therapy Medicinal Products are advancing rapidly, demonstrating tremendous progress while developers continue struggling with CMC, analytical, process development, and manufacturing challenges.

At the Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit on November 18-19, 2021, topics that experts from the industry will discuss include:

  • Important aspects of establishing an efficient and consistent CMC strategy
  • Controlling a product’s CQAs by controlling the process’ CPPs
  • Key factors in easing the complexity of vector development and production
  • Critical elements of controlling a manufacturing process for CGTP
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About the Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit

Gene Therapies, CAR-T Cell Therapies, and other Advanced Therapy Medicinal Products (ATMPs) are advancing rapidly, demonstrating tremendous progress while developers continue struggling with CMC, analytical, process development, and manufacturing challenges.

At the Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit on November 18-19, 2021, topics that experts from the industry will discuss include:

  • Important aspects of establishing an efficient and consistent CMC (Chemistry Manufacturing Controls) strategy
  • Controlling a product’s CQAs (Critical Quality Attributes) by controlling the process’ CPPs (Critical Process Parameters)
  • Key factors in easing the complexity of vector development and production
  • Critical elements of controlling a manufacturing process for CGTP (Cell and Gene Therapy Products) in order to ensure that:
  • Manufacturing process met technical and regulatory requirements for producing safe and efficient products
  • High product quality is achieved
  • Commercially viable CGTP are delivered

The leading practitioners and consultants in the field of gene and cell therapies will guide with their insights, technical, regulatory requirements, and expectations on successful achieving and scaling-up robust, cost and quality efficient product, process development and manufacturing, and also exploring recent developments, emerging technologies and tools.

Join the #VLGeneCell to explore the industry challenges, standards, and advancements on November 18-19, 2021.

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

  • Adenovirus
  • Adeno-Associated Virus (AAA)
  • Advanced Therapy Medicinal Product (ATMP)
  • Analytics
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • Chimeric Antigen Receptor T Cells (CAR-T)
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Commercialisation
  • 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
  • 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

Register now and get 500€ discount

The Early Bird Offer expires in 24 days!

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

  • Important aspects of establishing an efficient and consistent CMC strategy
  • Controlling a product’s CQAs by controlling the process’ CPPs
  • Key factors in easing the complexity of vector development and production
  • Critical elements of controlling a manufacturing process for CGTP

Register now and get 500€ discount

The Early Bird Offer expires in 24 days!

Sarah Thomas, US

Vice President of Quality

REGENXBIO

Sarah Thomas is the VP of quality at REGENXBIO, responsible for the quality as­surance and analytical development/quality control organisations. She has over 30 years’ experience in pharmaceutical and biotech quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led quality teams through the transition from clinical to commer­cial operations, and multiple product approvals. Sarah received an MBA from George Washington University and a BSc in chemistry from Butler University.

Dr. Simon Briggs, UK

Head of Gene Therapy Technical Product Development

Biogen

Dr. Simon Briggs is currently Head of Gene Therapy Technical Product Development at Biogen in the UK. Until recently he was Bioprocess and Manufacturing Senior Manager supporting process development activities in preparation for commercialization of AAV vector-based therapeutics. Until recently, he was a senior technical product steward for Kymriah at Novartis, supporting the successful launch of Kymriah for pALL and DLBCL patients in Europe and Asia. Simon entered the world of cell and gene therapy 20 years ago through a PhD and postdoctoral research at the University of Oxford. He moved from academic research to industry to develop the skills in order to realize the commercial potential of cell and gene therapies and make these life-changing medicines available to patients. Simon has been responsible for bringing OPV data and analytics platforms online in a number of roles supporting a global network of manufacturing partners.

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.

Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.

Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.

In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).

Dr. Vladimir Slepushkin, US

Executive Director, Vector

Technology

Dr. Vladimir Slepushkin until recently was leading process development for manufacturing of lentivirus vectors in suspension cell culture, guiding assay development to support process de­velopment for lentiviral vectors, managing CMO for GMP vector production and T-cell processing, directing research vector core, and providing lentiviral, retroviral and AAV vectors for Kite Pharma. Vladimir proved successful in developing novel high quality products by managing diverse technical groups and cross-functional teams, developing first-in-class clinical product from scratch, including facilities, equipment, manufacturing process, quality systems, regulatory CMC submissions and clinical trials design.

He has proven expertise in technically understanding and leading the development and improvement of cell culture and purification processes, and operations and analytical methods, adhering to customer, regulatory, safety and environmental requirements and guidelines. Vladi­mir is experienced in identifying and resolving regulatory and manufacturing technical problems, as well as intellectual property assessment and licensing. He has authored 59 scientific papers in peer-reviewed journals and he’s an author on 10 patents and patent applications.

Dr. Matthew Fuller, US

Director, Vector Platform Research

Ultragenyx Pharmaceutical Inc. 

Matthew Fuller is the Director of Vector Platform Research at Ultragenyx Pharmaceutical within the Ultragenyx Gene Therapy Research team. He is leading the HeLa Producer Cell Line (HPCL) and Vector Engineering (VE) teams, both of which perform program and platform research to continually optimize and invest in Ultragenyx’s gene therapy platforms and programs. Specifically, the HPCL team focuses on generation, characterization, and improvement of the HeLa-based producer cell line to maximize the quality and quantity of rAAV generated. The VE team focuses on optimization of vector construct regulatory elements to modulate and maximize tissue-specific expression and efficacy. Matthew received a PhD in molecular microbiology/virology from the University of Missouri and a MSPH from Tulane University.

Dr. Gabrielle Humphrey, FR

CMC Consultant

Vectaplus

Gabrielle Humphrey is a CMC consultant specializing in the delivery of viral vector for ATMP. She has in-depth experience in lentiviral vector for CART19 and TCR cell therapy products. Gabby has led manufacturing sciences and technology teams at biotech organizations such as Emergent Biosolutions, Oxford BioMedica, and Adaptimmune. She has a PhD in human nutrition from Robert Gordon University, Aberdeen (UK). She founded her CMC consultancy Vectaplus in France to support the emergence of cell and gene therapy clinical trials in the European Union.

Dr. Luca Biasco, US

Director & Honorary Senior Research Associate (UCL)

AVROBIO

Luca Biasco, PhD, is the Founder and Director of the gene therapy and biology department at AVROBIO and an honorary senior research associate at University College of London (UCL) under the gene therapy program of the Institute of Child Health (ICH) of the Great Ormond Street Hospital (GOSH).

Dr. Biasco graduated in medical biotechnology in 2003 at Alma Mater Studiorum University of Bologna, Italy, and moved to Milan to join the San Raffaele Telethon Institute of Gene Therapy (SR-TIGET), where he obtained his PhD in 2010 and later became a group leader specializing in the study of retroviral/lentiviral vector-host interactions. In this period, he generated the safety data for the marketing authorization of Strimvelis™, the first commercially-approved ex vivo stem cell gene therapy in the world, distributed by GlaxoSmithKline (GSK), and was a consultant of GSK for the safety of lentiviral gene therapy for Wiskott Aldrich Syndrome.

In 2016 he moved to Boston, US, to be an assistant professor at Harvard Medical School where he directed the vector safety team for the gene therapy program at Boston Children's Hospital/Dana Farber Cancer Institute. His research laboratory at Harvard Medical School worked on understanding the properties of stem cell gene therapy products and their in vivo dynamics upon infusion in humans. Over the same period, he was appointed senior research associate in London at UCL, where he conducted translational research on immunodeficiencies and CAR-T cells. In 2019 he became director of R&D at AVROBIO, where he is currently applying state-of-the-art single cell molecular analyses to track the fate and activity of genetically engineered cells in humans. Luca is the author of 29 peer-reviewed manuscripts that comprise publications in high-impact scientific journals such as science, nature medicine and stem cell. He has been the recipient of five international awards in the area of gene therapy and hematology, and he is recognized worldwide as a pioneer in the field of clonal tracking of genetically engineered cells in humans.

Dr. Klaus Richter, DE

Expert Scientist & Group Leader AUC

Coriolis Pharma

Dr. Klaus Richter is the leader of the AUC group at Coriolis Pharma, which is dedicated to the biophysical characterization of drug products and drug substances ranging from small molecules and peptides to viral particles and liposomes. He is a biochemist by training and received a Ph.D. from the Technical University of Munich in the field of protein characterization and worked for several years in the area of structure-function and structure-activity relationships of pharmaceutically relevant proteins before joining Coriolis Pharma. Klaus obtained his Habilitation in 2012 and is the (co-) author of more than 70 publications in the field of protein characterization with diverse biophysical methods, in many cases applying analytical ultracentrifugation (AUC) as a tool to investigate protein structure, protein interaction, and stability.

Dr. Wenliang Dong, NL

Chief Operational Officer

ORCA Therapeutics

Wen has been working in the field of oncology and virus research and development for over 15 years. He has a PhD from the University of Leiden in the Netherlands and an Executive MBA degree from Erasmus University. He has worked at the German Cancer Research Center in Heidelberg, Germany, and at the International Agency for Research on Cancer in Lyon, France.  Wen has worked at Sanquin Plasma Products BV as project leader at the CMO division and as member of the management team of pharmaceutical services. Currently, he is the Chief Operational Officer at ORCA Therapeutics BV, where he has been managing operational activities related to the development of ORCA’s technology from R&D to the clinic.

Dr. Rahul Kaushik, DE

Senior Scientist

ViGeneron 

Dr. Rahul Kaushik is an experienced biochemist, molecular biologist, and cell biologist with 12+ years of preclinical research experience in neuroscience. He has a long-standing interest and experience in using viral vectors and their use in gene manipulation, editing, and potential therapies. As molecular biology unit and project leader at German Center for Neurodegenerative Diseases (DZNE), he designed several novel and innovative AAV and LV vectors and established a small-scale AAV production. Currently, he is working as a senior scientist at ViGeneron, with an aim to develop innovative gene therapy solutions for retinal disorders.

Dr. Susan Faust, US

Founder and CEO

NxGEN Vector Solutions, LLC

Dr. Susan Faust is the Founder and CEO of NxGEN Vector Solutions, LLC. She has experience in scientific research, academic technology transfer, patent prosecution, and business development.

Dr. Faust received a B.S. in Microbiology from the Pennsylvania State University with Minors in Biochemistry and Molecular Biology, a Ph.D. in Cellular and Molecular Biology and a concurrent Master’s Degree in Human Genetics from the University of Michigan. She held a postdoctoral position at the University of Pennsylvania studying the immune response to viral vectors used in gene therapy.

Dr. Faust is an inventor on multiple patent applications, including the recently issued U.S. Patent, No. 11,015,210, which further strengthens the Company’s intellectual property position and coverage for the Company’s CpG-depletion AAV Vector Technology. Dr. Faust has also received numerous awards for her work, including a Young Investigator Award from the American Transplant Congress and the Sanjeev Kumar Excellence in Science Award from the University of Pennsylvania.

Dr. Matthias Bozza, DE

Postdoctoral Researcher - Technology Manager

German Cancer Research Center (DKFZ)

Matthias serves as senior member of the staff and has worked for the last 7 years on the development of an autonomously replicating non-integrating DNA Vector platform in Richard Harbottle’s division at the German Cancer Research Centre in Heidelberg. The aim of this research is to genetically modify cells whilst avoiding the risk of insertional mutagenesis or vector-mediated toxicity. For this work, he has received multiple awards from the American Society for Gene and Cell Therapy, and was awarded in 2020 with the the Scholar-In-Training Award from the American Association for Cancer Research. The DNA Vector Lab at the DKFZ are now implementing their vector platform into clinical pipelines.

Dr. Carmen Brenner, BE

Director MSAT

Novadip

Before taking a position in Novadip, Dr. Carmen Brenner, who received her PhD in biomedical science, has joined Bone Thera­peutics as an R&D project manager. Later Carmen became head of the QC department, first as manager and after as associate director.

Dr. Paul Byrne, UK

Principal Scientist, Cell and Gene Therapy / Biopharmaceutical CMC Solutions

Labcorp

Paul Byrne has over 20 years’ experience in the CRO business and has worked at various levels including study director and head of molecular biology. Paul currently focuses on the analytical support required for cell and gene therapy molecules within the pre-clinical, CMC, and clinical testing areas.

Sarah Thomas, US

Vice President of Quality

REGENXBIO

Dr. Simon Briggs, UK

Head of Gene Therapy Technical Product Development

Biogen

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

Dr. Vladimir Slepushkin, US

Executive Director, Vector

Technology

Dr. Matthew Fuller, US

Director, Vector Platform Research

Ultragenyx Pharmaceutical Inc. 

Dr. Gabrielle Humphrey, FR

CMC Consultant

Vectaplus

Dr. Luca Biasco, US

Director & Honorary Senior Research Associate (UCL)

AVROBIO

Dr. Klaus Richter, DE

Expert Scientist & Group Leader AUC

Coriolis Pharma

Dr. Wenliang Dong, NL

Chief Operational Officer

ORCA Therapeutics

Dr. Rahul Kaushik, DE

Senior Scientist

ViGeneron 

Dr. Susan Faust, US

Founder and CEO

NxGEN Vector Solutions, LLC

Dr. Matthias Bozza, DE

Postdoctoral Researcher - Technology Manager

German Cancer Research Center (DKFZ)

Dr. Carmen Brenner, BE

Director MSAT

Novadip

Dr. Paul Byrne, UK

Principal Scientist, Cell and Gene Therapy / Biopharmaceutical CMC Solutions

Labcorp

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It is a must attend conference for gene and cell developers and manufacturers.

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The excellent speakers faculty, well-presented subjects, and networking opportunities have made this a summit of high value. I will be honored to attend it again.

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