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Informa
7:00am - 8:00am

Registration and Morning Coffee

Showing of Streams
9:45am - 10:15am

Morning Coffee and Networking

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

Coffee and Networking

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
more
8:00am - 8:05am 5 mins
Cell and Gene Therapy Commercialization
Chairperson's Opening Remarks
  • Miguel Forte - CEO, Zelluna Immunotherapy, Norway
more
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
more
8:05am - 8:25am 20 mins
Cell and Gene Therapy Bioprocessing
Novartis Case Study – Beyond CD19
more
  • Feedback on pipelines and candidates beyond first generation CAR-T’s
  • What has been learnt from 2017 success and what is next
8:05am - 8:25am 20 mins
Cell and Gene Therapy Commercialization
Novartis Case Study – Beyond CD19
more
  • Feedback on pipelines and candidates beyond first generation CAR-T’s
  • What has been learnt from 2017 success and what is next
8:05am - 8:25am 20 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Novartis Case Study – Beyond CD19
more
  • Feedback on pipelines and candidates beyond first generation CAR-T’s
  • What has been learnt from 2017 success and what is next
8:25am - 8:45am 20 mins
Cell and Gene Therapy Bioprocessing
Adaptimmune case study – SPEAR T-cells
  • Dan Williams - VP Research and Technology Operations, Adaptimmune, UK
more
  • Case study on TCR candidates
8:25am - 8:45am 20 mins
Cell and Gene Therapy Commercialization
Adaptimmune case study – SPEAR T-cells
  • Dan Williams - VP Research and Technology Operations, Adaptimmune, UK
more
  • Case study on TCR candidates
8:25am - 8:45am 20 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Adaptimmune case study – SPEAR T-cells
  • Dan Williams - VP Research and Technology Operations, Adaptimmune, UK
more
  • Case study on TCR candidates
8:45am - 9:05am 20 mins
Cell and Gene Therapy Bioprocessing
Tmunity case study
8:45am - 9:05am 20 mins
Cell and Gene Therapy Commercialization
Tmunity case study
8:45am - 9:05am 20 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Tmunity case study
9:05am - 9:25am 20 mins
Cell and Gene Therapy Bioprocessing
Panel: What can be learnt from those already manufacturing at commercial scale
more
  • What is the next big thing beyond CD19?
  • How do manufacturing strategies differ for solid tumours, NK cells, TCR’s as opposed to CAR-T
  • Is investment in the market too focussed on CAR-T? Is it neglecting other therapies?
9:05am - 9:25am 20 mins
Cell and Gene Therapy Commercialization
Panel: What can be learnt from those already manufacturing at commercial scale
more
  • What is the next big thing beyond CD19?
  • How do manufacturing strategies differ for solid tumours, NK cells, TCR’s as opposed to CAR-T
  • Is investment in the market too focussed on CAR-T? Is it neglecting other therapies?
9:05am - 9:25am 20 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Panel: What can be learnt from those already manufacturing at commercial scale
more
  • What is the next big thing beyond CD19?
  • How do manufacturing strategies differ for solid tumours, NK cells, TCR’s as opposed to CAR-T
  • Is investment in the market too focussed on CAR-T? Is it neglecting other therapies?
9:25am - 9:45am 20 mins
Cell and Gene Therapy Bioprocessing
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

9:25am - 9:45am 20 mins
Cell and Gene Therapy Commercialization
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

9:25am - 9:45am 20 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

9:45am - 10:15am 30 mins
Morning Coffee and Networking
10:15am - 10:20am 5 mins
Cell and Gene Therapy Bioprocessing
Chairperson's Opening Remarks
10:15am - 10:20am 5 mins
Cell and Gene Therapy Commercialization
Chairperson's Opening Remarks
10:15am - 10:20am 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
more
10:20am - 10:40am 20 mins
Cell and Gene Therapy Bioprocessing
The evolution of analytics in CAR-T cell therapy
  • Tariq Warsi, Ph.D. - Senior Scientist, Process Development, Amgen
more

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.

10:20am - 10:50am 30 mins
Cell and Gene Therapy Commercialization
forward look at the future of cell therapy manufacturing
  • Donna Rill - Vice President of Manufacturing, Cell Medica Inc.,USA
more
  • What does the future of manufacturing look like?
  • Review of different technologies out there
  • Where do the gaps lie?
10:20am - 10:50am 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
more
10:40am - 11:00am 20 mins
Cell and Gene Therapy Bioprocessing
Analytical method establishment and qualification
  • Ruti Goldberg - Quality Control Validation Project Manager, Pluristem, Israel
more
  • 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
10:50am - 11:20am 30 mins
Cell and Gene Therapy Commercialization
Implementation of an affordable and scalable manufacturing strategy
  • Jon Gunther, PhD - Associate Director, Juno Therapeutics
more
  • Case study 
10:50am - 11:20am 30 mins
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
more
  • Status to the current field of T lymphocyte adoptive cell therapy
  • Current opportunities and challenges
  • Comparison of CAR-T vs TCR-T
  • Future perspectives
11:00am - 11:20am 20 mins
Cell and Gene Therapy Bioprocessing
New analytical technologies for facilitating QbD in process analytics
  • Junxia Wang - Director, Analytical Development, Mustang Bio Inc., USA
more
  • Product profiling
  • A look a product potency and functionality
11:20am - 11:40am 20 mins
Cell and Gene Therapy Bioprocessing
Improving Confidence in Cell Therapy Analytical Methods: When Cell Counts Count
  • Sumona Sarkar - Biomedical Engineer, NIST, USA
more

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.  

11:20am - 11:50am 30 mins
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
  • Trent Munro - Principal Scientist, Amgen
  • Lan Cao - Senior Director, Cell Therapy Head of Product Development and Clinical Manufacturing, Takeda Pharmaceuticals International Co., USA
more
  • 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
11:20am - 11:50am 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
more
11:50am - 12:20pm 30 mins
Cell and Gene Therapy Bioprocessing
Technology Workshop
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

11:50am - 12:20pm 30 mins
Cell and Gene Therapy Commercialization
Technology Workshop
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  1. Use an exhibition stand to meet new clients in the main networking area
  2. Raise your corporate profile and shape your corporate image with logo placement
  3. Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

11:50am - 12:20pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Technology Workshop
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

1:25pm - 1:55pm 30 mins
Cell and Gene Therapy Bioprocessing
Combination of analytical methods for characterization of viral vectors
  • Gillian Payne - Director, Vector Analytics, bluebird bio, USA
more
  • 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
Cell and Gene Therapy Commercialization
Combination of analytical methods for characterization of viral vectors
  • Gillian Payne - Director, Vector Analytics, bluebird bio, USA
more
  • 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
Pre-clinical and Clinical Development for Cell and Gene Therapies
Marrow Infiltrating Lymphocytes (MILs): Adoptive T cell therapy from a road less travelled by
  • Kimberly Noonan - Co-Founder and CSO, WindMIL Therapeutics, USA
more

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
Cell and Gene Therapy Bioprocessing
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

1:55pm - 2:25pm 30 mins
Cell and Gene Therapy Commercialization
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

1:55pm - 2:25pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

2:25pm - 2:45pm 20 mins
Coffee and Networking
2:45pm - 3:30pm 45 mins
Cell and Gene Therapy Bioprocessing
Biotech Week Boston (BWB) Keynote
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
more
2:45pm - 3:30pm 45 mins
Cell and Gene Therapy Commercialization
Biotech Week Boston (BWB) Keynote
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
more
2:45pm - 3:30pm 45 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Biotech Week Boston (BWB) Keynote
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
more
3:30pm - 4:15pm 45 mins
Cell and Gene Therapy Bioprocessing
Bioprocessing 4.0 – Digital Technologies are Transforming Biologics Manufacturing
  • Thomas Seewoester, Ph.D. - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
more
3:30pm - 4:15pm 45 mins
Cell and Gene Therapy Commercialization
Bioprocessing 4.0 – Digital Technologies are Transforming Biologics Manufacturing
  • Thomas Seewoester, Ph.D. - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
more
3:30pm - 4:15pm 45 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Bioprocessing 4.0 – Digital Technologies are Transforming Biologics Manufacturing
  • Thomas Seewoester, Ph.D. - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
more
4:15pm - 4:45pm 30 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
more
4:15pm - 4:45pm 30 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
more
4:15pm - 4:45pm 30 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
more
4:45pm - 6:30pm 105 mins
Cell and Gene Therapy Bioprocessing
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
4:45pm - 6:30pm 105 mins
Cell and Gene Therapy Commercialization
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
4:45pm - 6:30pm 105 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
6:30pm - 6:35pm 5 mins
Cell and Gene Therapy Bioprocessing
End of Conference Day One
6:30pm - 6:35pm 5 mins
Cell and Gene Therapy Commercialization
End of Conference Day One
6:30pm - 6:35pm 5 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
End of Conference Day One