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7:00am - 8:00am

Registration and Morning Coffee

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Showing of Streams
9:30am - 10:10am

Morning Coffee and Networking

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Showing of Streams
Showing of Streams
2:25pm - 2:45pm

Coffee and Networking

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Showing of Streams
7:00am - 8:00am 60 mins
Registration and Morning Coffee
8:00am - 8:05am 5 mins
Cell and Gene Therapy Bioprocessing
Chairperson's Opening Remarks
  • Miguel Forte - CEO, Zelluna Immunotherapy, Norway
8:00am - 8:05am 5 mins
Cell and Gene Therapy Commercialization
Chairperson's Opening Remarks
  • Miguel Forte - CEO, Zelluna Immunotherapy, Norway
8:00am - 8:05am 5 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Chairperson's Opening Remarks
  • Miguel Forte - CEO, Zelluna Immunotherapy, Norway
8:05am - 8:35am 30 mins
Cell and Gene Therapy Bioprocessing
ARM State of the Industry Update
  • Janet Lynch Lambert - CEO, Alliance for Regenerative Medicine
8:05am - 8:35am 30 mins
Cell and Gene Therapy Commercialization
ARM State of the Industry Update
  • Janet Lynch Lambert - CEO, Alliance for Regenerative Medicine
8:05am - 8:35am 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
ARM State of the Industry Update
  • Janet Lynch Lambert - CEO, Alliance for Regenerative Medicine
8:35am - 9:05am 30 mins
Info
Cell and Gene Therapy Bioprocessing
Adaptimmune case study – SPEAR T-cells
  • John Lunger - SVP Manufacturing and Supply Chain, Adaptimmune, UK
  • Adaptimmune – an introduction
  • TCR technology 

    • Brief overview of the pipeline from discovery through to clinic 
  • Discussion of mfg and supply challenges with TCR


8:35am - 9:05am 30 mins
Info
Cell and Gene Therapy Commercialization
Adaptimmune case study – SPEAR T-cells
  • John Lunger - SVP Manufacturing and Supply Chain, Adaptimmune, UK
  • Adaptimmune – an introduction
  • TCR technology 

    • Brief overview of the pipeline from discovery through to clinic 
  • Discussion of mfg and supply challenges with TCR


8:35am - 9:05am 30 mins
Info
Pre-clinical and Clinical Development for Cell and Gene Therapies
Adaptimmune case study – SPEAR T-cells
  • John Lunger - SVP Manufacturing and Supply Chain, Adaptimmune, UK
  • Adaptimmune – an introduction
  • TCR technology 

    • Brief overview of the pipeline from discovery through to clinic 
  • Discussion of mfg and supply challenges with TCR


9:05am - 9:30am 25 mins
Info
Cell and Gene Therapy Bioprocessing
Panel: Key Considerations in Gene Therapy Manufacturing for Commercialization
  • Moderator Brandy Sargent - Editor, Cell Culture Dish, USA
  • Panelist Nina Forsberg - Marketing Director, Vironova, Sweden
  • Panelist Clive Glover - Senior Global Marketing Manager, Pall, United Kingdom
  • Panelist John Madsen - Head, Process Development Operations, Fujifilm Diosynth Biotechnologies, USA
  • Panelist Tracy TreDenick - Head of Regulatory and Quality Assurance, Founding Partner, BioTechLogic, USA
  • Panelist Ross Verheul - Senior Application Scientist, Beckman Coulter Life Sciences, USA
  • Panelist Joe Hughes - Chief Scientist, VP, Process and Analytical Development, Analytical Development, WuXi AppTec, USA
  • Pratik Jaluria - Executive Director, Process Development and Manufacturing, Adverum, USA

Please join us for an important discussion about gene therapy manufacturing, including the latest in manufacturing methods, analytical analysis and key regulatory considerations. Topics to be discussed include:

  • Planning for scale up, technology transfer and regulatory considerations on the way to commercialization.
  • In-house vs. Outsourcing manufacturing.
  • Ensuring scalability and efficient timelines in manufacturing while still maintaining reasonable cost.
  • Incorporating the right analytics in gene therapy manufacturing
  • Where are we at as an industry and where is there room for improvement.
9:05am - 9:30am 25 mins
Info
Cell and Gene Therapy Commercialization
Panel: Key Considerations in Gene Therapy Manufacturing for Commercialization
  • Moderator Brandy Sargent - Editor, Cell Culture Dish, USA
  • Panelist Nina Forsberg - Marketing Director, Vironova, Sweden
  • Panelist Clive Glover - Senior Global Marketing Manager, Pall, United Kingdom
  • Panelist John Madsen - Head, Process Development Operations, Fujifilm Diosynth Biotechnologies, USA
  • Panelist Tracy TreDenick - Head of Regulatory and Quality Assurance, Founding Partner, BioTechLogic, USA
  • Panelist Ross Verheul - Senior Application Scientist, Beckman Coulter Life Sciences, USA
  • Panelist Joe Hughes - Chief Scientist, VP, Process and Analytical Development, Analytical Development, WuXi AppTec, USA
  • Pratik Jaluria - Executive Director, Process Development and Manufacturing, Adverum, USA

Please join us for an important discussion about gene therapy manufacturing, including the latest in manufacturing methods, analytical analysis and key regulatory considerations. Topics to be discussed include:

  • Planning for scale up, technology transfer and regulatory considerations on the way to commercialization.
  • In-house vs. Outsourcing manufacturing.
  • Ensuring scalability and efficient timelines in manufacturing while still maintaining reasonable cost.
  • Incorporating the right analytics in gene therapy manufacturing
  • Where are we at as an industry and where is there room for improvement.
9:05am - 9:30am 25 mins
Info
Pre-clinical and Clinical Development for Cell and Gene Therapies
Panel: Key Considerations in Gene Therapy Manufacturing for Commercialization
  • Moderator Brandy Sargent - Editor, Cell Culture Dish, USA
  • Panelist Nina Forsberg - Marketing Director, Vironova, Sweden
  • Panelist Clive Glover - Senior Global Marketing Manager, Pall, United Kingdom
  • Panelist John Madsen - Head, Process Development Operations, Fujifilm Diosynth Biotechnologies, USA
  • Panelist Tracy TreDenick - Head of Regulatory and Quality Assurance, Founding Partner, BioTechLogic, USA
  • Panelist Ross Verheul - Senior Application Scientist, Beckman Coulter Life Sciences, USA
  • Panelist Joe Hughes - Chief Scientist, VP, Process and Analytical Development, Analytical Development, WuXi AppTec, USA
  • Pratik Jaluria - Executive Director, Process Development and Manufacturing, Adverum, USA

Please join us for an important discussion about gene therapy manufacturing, including the latest in manufacturing methods, analytical analysis and key regulatory considerations. Topics to be discussed include:

  • Planning for scale up, technology transfer and regulatory considerations on the way to commercialization.
  • In-house vs. Outsourcing manufacturing.
  • Ensuring scalability and efficient timelines in manufacturing while still maintaining reasonable cost.
  • Incorporating the right analytics in gene therapy manufacturing
  • Where are we at as an industry and where is there room for improvement.
9:30am - 10:10am 40 mins
Morning Coffee and Networking
10:10am - 10:15am 5 mins
Cell and Gene Therapy Bioprocessing
Chairperson's Opening Remarks
  • Lior Raviv - Vice President of Development, Pluristem Therapeutics Inc.
10:10am - 10:15am 5 mins
Cell and Gene Therapy Commercialization
Chairperson's Opening Remarks
  • Ohad Karnieli, Ph.D., MBA - CEO, Atvio Biotech
10:10am - 10:15am 5 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Chairperson's Opening Remarks
  • Ken LeClair - VP Technical Development and Manufacturing, Editas Medicine, USA
10:15am - 10:35am 20 mins
Info
Cell and Gene Therapy Bioprocessing
The evolution of analytics in CAR-T cell therapy
  • Tariq Warsi, Ph.D. - Senior Scientist, Process Development, Amgen

CAR-T cell therapy is quickly emerging as an approach that has the potential to be a curative treatment for myriad oncology indications. As this immunotherapy advances in the industry, the analytical tools that exist to determine and track critical quality attributes (CQA) must evolve alongside the treatment. Recent advances in the manufacturing processes have led to improved analytical methods that can measure and track CQA with higher accuracy and reliability. Amgen is positioning itself to be a leader in cell and gene therapy, and as part of this effort we will discuss the next generation of analytical approaches that need to evolve to supplement a better understanding of products.

10:15am - 10:35am 20 mins
Info
Cell and Gene Therapy Commercialization
The evolution of analytics in CAR-T cell therapy
  • Tariq Warsi, Ph.D. - Senior Scientist, Process Development, Amgen

CAR-T cell therapy is quickly emerging as an approach that has the potential to be a curative treatment for myriad oncology indications. As this immunotherapy advances in the industry, the analytical tools that exist to determine and track critical quality attributes (CQA) must evolve alongside the treatment. Recent advances in the manufacturing processes have led to improved analytical methods that can measure and track CQA with higher accuracy and reliability. Amgen is positioning itself to be a leader in cell and gene therapy, and as part of this effort we will discuss the next generation of analytical approaches that need to evolve to supplement a better understanding of products.

10:15am - 10:45am 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Nohla Therapeutics Case Study
  • Colleen Delaney - Founder and Chief Medical Officer, Nohla Therapeutics, USA
10:35am - 10:55am 20 mins
Info
Cell and Gene Therapy Bioprocessing
Analytical method establishment and qualification
  • Ruti Goldberg - Quality Control Validation Project Manager, Pluristem, Israel
  • What type of qualification activities are appropriate
  • What will this look like when the method is validated further along in the process?
  • Specific case studies
10:35am - 10:55am 20 mins
Info
Cell and Gene Therapy Commercialization
Analytical method establishment and qualification
  • Ruti Goldberg - Quality Control Validation Project Manager, Pluristem, Israel
  • What type of qualification activities are appropriate
  • What will this look like when the method is validated further along in the process?
  • Specific case studies
10:45am - 11:15am 30 mins
Info
Pre-clinical and Clinical Development for Cell and Gene Therapies
T Lymphocyte targeting strategies: CAR-T and TCR-T success challenges and path forward
  • Miguel Forte - CEO, Zelluna Immunotherapy, Norway
  • Status to the current field of T lymphocyte adoptive cell therapy
  • Current opportunities and challenges
  • Comparison of CAR-T vs TCR-T
  • Future perspectives
10:55am - 11:15am 20 mins
Info
Cell and Gene Therapy Bioprocessing
New analytical technologies for facilitating QbD in process analytics
  • Junxia Wang - Director, Analytical Development, Mustang Bio Inc., USA
  • Product profiling
  • A look a product potency and functionality
10:55am - 11:45am 50 mins
Info
Cell and Gene Therapy Commercialization
Panel discussion: What can cell therapy manufacturers learn from MAbs to save time and money on the path to commercial scale manufacturing
  • Tariq Warsi, Ph.D. - Senior Scientist, Process Development, Amgen
  • Felipe Bedoya - Leader, CMC for Cell Therapies, Takeda, USA
  • Kim Bure - Sr Director, Global Sales, Akron Biotech, USA
  • Dan Stanton - Editor, BioProcess Insider
  • Where current gaps lie in cell therapy manufacturing – do MAb manufacturers have advice on how to fill these
  • What technologies and process improvements can the cell therapy industry take away from their counterparts
  • Feedback and discussion on how to improve current processes
11:15am - 11:35am 20 mins
Info
Cell and Gene Therapy Bioprocessing
Improving Confidence in Cell Therapy Analytical Methods: When Cell Counts Count
  • Sumona Sarkar - Biomedical Engineer, NIST, USA

Analytical methods are essential for establishing quality attributes of cell-based products and for monitoring key steps in the manufacturing process.  Measurement assurance strategies and standards for cell therapy product characterization have been increasingly recognized for their critical roles in streamlining efforts in R&D, translation, manufacturing and regulatory submissions.  Discussions are underway within various standards development organizations to develop standards to ensure quality, consistency and measurement confidence for cell-based products.  Cell count is a fundamental measurement for cell therapy products, underpinning quality attributes (e.g. identity, purity, potency) used in characterization.  Although performed routinely in laboratories for over a century, this measurement now requires greater confidence and specification to support the development of cell-based products.  NIST, in collaboration with other government agencies and industry stakeholders is developing approaches to provide fit-for-purpose measurement assurance strategies, in the form of documentary standards, experimental designs, and control materials to improve cell counting measurements.  These strategies can be further extended to other aspects of cell characterization that face similar measurement challenges.  

11:15am - 11:45am 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Pre-clinical and Clinical Development of a Next Generation Stromal Cell Therapy
  • Larry Couture - CEO, Orbsen Therapeutics, USA
11:45am - 12:15pm 30 mins
Info
Cell and Gene Therapy Bioprocessing
Importance of using serum-free media in Cell Therapy and Regenerative Medicine applications
  • Vanda Lopez, PhD, MSc - Senior Scientist II, FISI

Cell therapy and regenerative medicine are growing areas that focuses on the application of cells as the therapeutic product. It is critical for the success of these areas that enough cell numbers of with consistent clinical quality are generated. While in other fields cell culture is a part of an overall process to generate a therapeutic product, in cell therapy it is the actual manufacturing process. Cell culture is a process that involves a large number of variables tightly linked, as cell quality and culture media. The removal of undefined components becomes critical when one moves towards creating a consistent manufacturing method and cell product. In here we will address the importance of using serum-free media in cell therapy, and how media performance is impacted by the overall cell culture process. We will also introduce some our currently available products, that target several cell types (HSC, T Cell, NK cells) and can help in addressing some of the challenges in translational cell applications.

11:45am - 12:15pm 30 mins
Info
Cell and Gene Therapy Commercialization
A Platform Production Process for Manufacturing Viral Vector and Vaccine Therapeutics using Vero Cells
  • John Madsen - Head, Process Development Operations, Fujifilm Diosynth Biotechnologies, USA

Biologics/vaccine production processes must be scaled up to be productive enough to supply sufficient medicine for all the patients that require it. Scale-up can be accomplished by maximizing both specific and volumetric productivity of a system. Vero cells are susceptible to infection by a large number of viruses, and multiple approved vaccines use Vero cells in their production process. In this presentation, an overview of a new platform for viral vectors production is presented that has the potential to provide significantly increased productivity for a variety of viral vector types, as a serum-free, suspension-adapted or adherent cell line. This system will be optimized for cell growth and viral vector productivity, in a high cell density, high specific productivity format, using cutting edge single-use technology. This is being developed at FUJIFILM Diosynth Biotechnologies, in College Station, Texas.

11:45am - 12:15pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Please more to another track
1:05pm - 1:25pm 20 mins
Info
Cell and Gene Therapy Bioprocessing
Increasing Flexibility and Process Control to Meet Cell Therapy Manufacturing Needs
  • Pei-Yi Lin - R&D Lead of Cell Culture Media Development, Thermo Fisher Scientific, USA
  • Provide an overview of current trends and objectives of industrial media development for cell therapy
  • Eliminating the need of serum for optimal growth and expansion of T cells
  • Cell culture media and real-time process control are keys to achieve process robustness and scalability
1:05pm - 1:25pm 20 mins
Info
Cell and Gene Therapy Commercialization
Maximizing Yield for Attachment Dependent Cells with the CellCube Perfusion Platform
  • Chris Suarez - Field Application Scientist, Corning Life Sciences, USA

The Corning CellCube system provides a perfusion platform for the mass culture of attachment-dependent cells. The perfusion environment more closely simulates in vivo conditions by distributing nutrients and oxygen across all cells. The integration of a controller system and disposable bioreactor to regulate gas distribution, pH and dO aided optimization for Vero cell expansion in the CellCube.

1:05pm - 1:25pm 20 mins
Info
Pre-clinical and Clinical Development for Cell and Gene Therapies
An Analytical Method for Determining Bioequivalence of Extracellular Vesicles from Cardiosphere-Derived Cells
  • Kristin Luther - Scientist II, Product Development, Capricor Therapeutics, Inc., USA

Translating Extracellular Vesicles (EVs) to the clinic requires the development of potency assays to evaluate the equivalence of the products obtained. EVs obtained from Cardiosphere-derived cells (CDCs) have protective, regenerative, and immunomodulatory effects in animal models. We evaluated the immunomodulatory role of EVs from CDCs and mesenchymal stem cell (MSC) and demonstrated that CDC-EVs polarize macrophage toward an anti-inflammatory phenotype and reduce macrophage recruitment after an acute insult. We also identified a RNA cargo set that differentiates them from MSC-EVs. Using this unique RNA profile, we propose an in vitro analytical method for determining the immunomodulatory potential of different CDC donors.

1:25pm - 1:55pm 30 mins
Info
Cell and Gene Therapy Bioprocessing
Combination of analytical methods for characterization of viral vectors
  • Gillian Payne - Director, Vector Analytics, bluebird bio, USA
  • New combinations of analytical methods used in development and production of Lentiviral vectors for gene therapy
  • Performance of Lentiviral quantification with molecular methods  
1:25pm - 1:55pm 30 mins
Info
Cell and Gene Therapy Commercialization
Combination of analytical methods for characterization of viral vectors
  • Gillian Payne - Director, Vector Analytics, bluebird bio, USA
  • New combinations of analytical methods used in development and production of Lentiviral vectors for gene therapy
  • Performance of Lentiviral quantification with molecular methods  
1:25pm - 1:55pm 30 mins
Info
Pre-clinical and Clinical Development for Cell and Gene Therapies
Marrow Infiltrating Lymphocytes (MILs): Adoptive T cell therapy from a road less travelled by
  • Eric R. Lutz - Sr. Principal Scientist, WindMIL Therapeutics, USA

Adoptive T cell therapy has begun to truly make its mark amongst the burgeoning immunotherapy field. Within the past year we have seen the first FDA approvals of two CAR therapies and virtually dozens of companies now exist that are working to optimize some form of T cell therapy. CARs, TCRs, TILs and now marrow infiltrating lymphocytes (MILs) are all different takes on a familiar theme of personalized medicine.

Bone marrow is generally thought of first and foremost as being the hematopoetic organ of the body. However, a growing body of evidence shows that the bone marrow is a niche of both life- long memory T cells and of cells that exist in a different activation state than peripheral blood T cells. These characteristics may make them superior cells for adoptive immunotherapy approaches.

 With this knowledge in hand we have developed a method to isolate, activate and expand bone marrow T cells, the product of which we call MILs. While having some similarities to other types of adoptive T cell therapy we believe our product is unique relative to other products currently being developed by virtue of the fact that MILs are the only adoptive T cell therapy where the cells are both inherently tumor-specific and of a central memory phenotype. Herein we will describe the distinctive properties of MILs, how we have used them in multiple myeloma and other hematologic malignancies, how we plan to use them for solid cancer indications and finally how they may serve as a platform cell for genetic modification.

1:55pm - 2:25pm 30 mins
Info
Cell and Gene Therapy Bioprocessing
Interference by host cell chromatin depresses efficiency of AAV purification
  • Peter Gagnon - Chief Scientific Officer, BIA Separations, Slovenia

This presentation will demonstrate the major pathways by which residual chromatin from host cells interferes with purification of all biologics produced by cell culture, and particularly with AAV. Examples will be shared how to manage chromatin contamination to achieve more effective and more economical processes.

1:55pm - 2:25pm 30 mins
Cell and Gene Therapy Commercialization
Please move to another track
1:55pm - 2:25pm 30 mins
Info
Pre-clinical and Clinical Development for Cell and Gene Therapies
GPS for Cell Therapy: Optimizing Treatment Efficacy and Safety via Enforced Cell Navigation
  • Robert Sackstein - Professor, Departments of Medicine and Dermatology, Harvard Medical School, Director, Harvard Program of Excellence in Glycoscience, and Co-Director, Harvard Glycoscience Center, USA

Culture-expanded cells can offer cure for immune diseases, degenerative conditions, malignancies, infectious diseases, and congenital/genetic conditions. Immense attention has been given to optimizing pertinent cell collection and propagation, and, where appropriate, genetic manipulation, yet little interest has been directed at the most fundamental of all hurdles in cell-based therapeutics: assuring that the administered cells colonize the sites where they are needed. This presentation will inform on a platform technology known as “GPS” that enforces cell trafficking to target sites, consequently diminishing the dosing levels of needed cells, markedly improving efficacy and patient safety, and reducing both production and patient-care costs.

2:25pm - 2:45pm 20 mins
Coffee and Networking
2:45pm - 3:30pm 45 mins
Cell and Gene Therapy Bioprocessing
High-Impact Ideas and Use-Inspired Research….a chat with MIT’s Bob Langer on How to Create Innovations That Matter
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
2:45pm - 3:30pm 45 mins
Cell and Gene Therapy Commercialization
High-Impact Ideas and Use-Inspired Research….a chat with MIT’s Bob Langer on How to Create Innovations That Matter
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
2:45pm - 3:30pm 45 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
High-Impact Ideas and Use-Inspired Research….a chat with MIT’s Bob Langer on How to Create Innovations That Matter
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
3:30pm - 4:15pm 45 mins
Cell and Gene Therapy Bioprocessing
Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
3:30pm - 4:15pm 45 mins
Cell and Gene Therapy Commercialization
Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
3:30pm - 4:15pm 45 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
4:15pm - 5:00pm 45 mins
Cell and Gene Therapy Bioprocessing
The Complex World of Biosimilar Process Development
  • Elsie DeBella, PhD - Vice President, Biologics Process and CMC Development, Momenta Pharmaceuticals
4:15pm - 5:00pm 45 mins
Cell and Gene Therapy Commercialization
The Complex World of Biosimilar Process Development
  • Elsie DeBella, PhD - Vice President, Biologics Process and CMC Development, Momenta Pharmaceuticals
4:15pm - 5:00pm 45 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
The Complex World of Biosimilar Process Development
  • Elsie DeBella, PhD - Vice President, Biologics Process and CMC Development, Momenta Pharmaceuticals
5:00pm - 6:45pm 105 mins
Cell and Gene Therapy Bioprocessing
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
5:00pm - 6:45pm 105 mins
Cell and Gene Therapy Commercialization
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
5:00pm - 6:45pm 105 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
6:45pm - 6:50pm 5 mins
Cell and Gene Therapy Bioprocessing
End of Conference Day One
6:45pm - 6:50pm 5 mins
Cell and Gene Therapy Commercialization
End of Conference Day One
6:45pm - 6:50pm 5 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
End of Conference Day One