Cell Therapy Manufacturing

30 March -1 April 2020 | Business Design Centre London

 

 

2000+
Attendees
700+
1-2-1 Meetings
300+
Speakers
100+
Exhibitors
12
Streams

 

 

Cell Therapy Manufacturing

CELL THERAPY MANUFACTURE, Tuesday 31 March 2020

CONFERENCE DAY 1 - TUESDAY 31st March 2020

Opening Keynotes Day 1 – CAR-T & Immunotherapy focus

Prasad Adusumilli
09:00

Keynote presentaton: Autologous Mesothelin-targeting CAR-T to tackle solid tumours in the clinic

  • The presentation will highlight results to date of mesothelin-targeted CAR T-cell clinical trial results
  • Advances in preclinical research of CAR T-cell therapy for solid tumors will be presented
  • Novel strategies for overcoming hurdles to solid tumor CAR T-cell therapy will be discussed
Panel discussion
09:20

Realizing the promise of ATMPs for patients around the world

  • Working with regulators to navigate scale up challenges in manufacturing
  • Strategies in supply chain and patient delivery
  • Tackling post manufacturing commercialization challenges such as pricing and finding highly skilled experts
  • Durability
10:20

Morning Coffee Break

Mark Sawicki
11:40

Effective Integration Strategies Through a Compliance Unified Ecosystem (CUE)

  • Systems Integration continues to be a major issue in the production and distribution of Advanced Therapies
  • Well-defined strategies for the integration of independent informatics platforms will be critical for future standardization and workflow optimization
  • Cryoport’s Compliance Unified Ecosystem (CUE) is driving standard practices for systems integration in the industry
round tables
12:00

Technology and Strategy Roundtables will run from 12:00-12:45 with 15 minutes for a quick summary from each table at the front of the room. These will take place in the conference rooms: look for you

Technology and Strategy Roundtables will run from 12:00-12:45 with 15 minutes for a quick summary from each table at the front of the room. These will take place in the conference rooms: look for your table number to participate.
1. Raw material supply for the commercial manufacturing of cell and gene therapies
Frank Hecht

Frank Hecht, Vice President Marketing And Sales, CellGenix GmbH

11. Cord blood as a source of new cells
12. Tissue engineering for organ regeneration
Vaidehi Joshi

Vaidehi Joshi, Scientist II, Therapeutics, Organovo

13. TBC
14. Making allogeneic cell therapy a reality
Devyn Smith

Devyn Smith, Chief Operating Officer And Head Of Strategy, Sigilon

15. Industry-no profit alliances: how to optimize synergies
Elena Beltrami

Elena Beltrami, Business Development Manager, Fondazione Telethon

17. How companies can interact with the regulator and various pitfalls to be aware of
John Johnston

John Johnston, Clinical Assessor, Medicines & Healthcare Products Regulatory Agency

18. Ensuring ATMP access to patients
Delphine Roulland

Delphine Roulland, Director Government Affairs And Public Policy, European Confederation of Pharmaceutical Entrepreneurs (Belgium)

19. Roundtable available
2. Physiological conditions and analytical and monitoring tools for 3D cell cultivations
Cornelia Kasper

Cornelia Kasper, Professor, Biopharmaceutical Production And Technology, B.O.K.U.

21. Neurological applications for ATMPs
22. Development of regenerative medicines for cardiovascular indications
David Mazzo

David Mazzo, Chief Executive Officer, Caladrius Biosciences

23. Renal applications for ATMPs
24. Tackling diabetes with ATMPs
3. TBC (Reserved for Schott)
Sebastian Kress

Sebastian Kress, Post Doc, BOKU

5. Considerations for manufacture scale-up from academia to commercial manufacturing
Johannes Van Der Loo

Johannes Van Der Loo, Clinical Vector Core Director, The Children's Hospital of Philadelphia

9. Exploring the crossover between human and veterinary applications for stem cells
Joanna Miller

Joanna Miller, Chief Scientific Officer, Cell Therapy Sciences

13:00

Lunch

Patrick J Hanley
CELL THERAPY MANUFACTURE
14:20

Optimizing Antigen-Specific T Cell Manufacturing

Amandine Breton
CELL THERAPY MANUFACTURE
15:00

Potency assay development: lifecycle approach for cell and gene therapy products

Marco Fadda
CELL THERAPY MANUFACTURE
15:20

Fully closed vs isolator approach in C&GT: how can they collaborate and complement for a successful and sustainable future

  • Are the closed systems really fully closed?
  • In complex processes, how do we manage upstream and downstream?
  • Is there a way to make isolators and closed system collaborating, instead of conflicting?
Ilya Shestopalov
CELL THERAPY MANUFACTURE
15:40

Lessons learned from potency assays for beta-thalassemia and sickle cell disease autologous gene therapy drug products

  • Quantitative potency assays were developed to demonstrate correction of b-thalassemia and sickle cell disease properties in an in-vitro cell culture system.
  • Potency was found to be specific to the beta-globin lentiviral vector and dependent on transduction efficiency of the autologous gene therapy drug product, demonstrating ability to reject sub-functional drug products.
  • Considerations for assay development, qualification results, and redundancy to transduction efficiency methods will be discussed
Steve Oh
CELL THERAPY MANUFACTURE
16:00

Manufacturing allogeneic and autologous cell therapies at GMP level

16:20

Afternoon Break

Dawn Maier
CELL THERAPY MANUFACTURE
17:00

The importance of robust process development and characterization early in clinical development of autologous cell therapies

  • Challenges associated with autologous manufacturing and patient variability
  • Defining and establishing critical quality attributes in the context of patient variability
  • Challenges associated with comparability if you go into Phase one with little to know characterization
Panel discussion
CELL THERAPY MANUFACTURE
17:20

Panel discussion (potency + assays): Predictive clinical functionality - guaranteeing the success of your cell therapy product

a.TowardsQuantitative-biology mechanistic CQAs to prevent failure of late stage developmentb. From ‘potency assays’ to ‘design spaces’ through ‘CQAs’c.When do we have enough quality and predictive data to assess product potency and effectiveness?d. From ‘black box’ to ‘how much is enough’?e. Realtime evaluation of release criteria?
18:00

Close of Conference for the day - Please join us for an evening drinks reception at the iconic Emirates Stadium

last published: 28/Jan/20 14:05

CELL THERAPY MANUFACTURE, Wednesday 1 April 2020

08:55

Opening Remarks

Federico Mingozzi
09:00

Gene therapy 2.0: New clinical data, therapeutic applications and next generation technologies

  • Latest updates on LUXTURNA studies to treat blindness, haemophilia and rare disease
  • Tackling the challenges of viral gene therapies i.e. immunogenicity
  • Developing the next generation of gene therapies, what does the future hold?
Steve Kanner
09:20

Next-generation gene editing technology for allogeneic immune cell therapeutics

  • Next-generation CRISPR-Cas9 technology
  • Significantly enhanced editing specificity
  • Editing in immune cells for generation of functionally tuned therapeutics
Adrian Woolfson
09:40

Repairing the human genome with designed zinc finger editing reagents

  • Overview of Sangamo’s zinc finger protein gene editing technology, including new innovations that facilitate specificity, precision, and gene editing efficiency
  • Will address specific examples of defined therapeutic applications including the generation of reagents suitable for use in tauopathies, Huntington’s disease, and lysosomal storage diseases
Frederic Chereau
10:00

In vivo gene editing paediatric patients with rare diseases

10:20

Networking Refreshments

Christoph Herwig
CELL THERAPY MANUFACTURE
11:20

Adjusting control strategies using Digital Twins

  • Which Quality Attributes of the raw materials do we need to monitor to demonstrate no mix up during parallel processing?
  • Adaptive Digital Twin strategies for varying raw materials as inherent in personalized medicine
  • Integrated Digital Twins for full process chain analysis
Katja Kleinsteuber
CELL THERAPY MANUFACTURE
12:00

Cytof/Mass Cytometry Analytics for CAR T Drug Products – Opportunities and Challenges

Margarida Serra
CELL THERAPY MANUFACTURE
12:20

Bioinspired Manufacturing of hPSC-based Therapy Products

  • Development of novel cell culturing strategies that recreate environmental conditions to excel hPSC proliferation and differentiation/maturation into functional cardiomyocytes and hepatocytes;
  • Advancing manufacture of cell therapy products through metabolic and process understanding
  • Multi-parametric techniques including advanced “-omics” technologies (proteomics, transcriptomics, metabolomics and fluxomics) as complementary analytical tools to support bioprocess understanding and optimization as well as to unveil the mechanism of action of cell therapy products
13:00

Neworking Lunch

Troels Jordansen
CELL THERAPY MANUFACTURE
14:20

Building your own closed manufacturing system

  • Are CMOs really needed?
  • What happens to IP when working with CMOs?
  • Is in-house GMP production really an option?
Sakis Mantalaris
CELL THERAPY MANUFACTURE
14:40

The role of metabolism in cellular therapeutics biomanufacturing: can metabolomics be used for quality assurance & control?

  • The application of metabolomics at all manufacturing stages (input, bioprocess, output) for the monitoring quality control and optimization of cellular therapies for clinical application.
  • Metabolomics can accurately and sensitively capture alterations in the cellular physiological state such as the loss of pluripotency of embryonic (ESCs) and induced pluripotent stem cells (iPSCs) prior to the detection by other techniques
  • The application of metabolomics for the selection of optimal differentiation protocols and for the design of bioactive materials that can enhance osteogenic differentiation of mesenchymal stem cells (MSCs)
  • We have shown that metabolomics can reveal differences in the immunosuppressive properties of MSCs
Panel discussion
CELL THERAPY MANUFACTURE
15:20

Panel discussion: moving towards ‘smart’ and ‘flexible’ integrated process pipelines

a. What are the common bioprocess units suitable for all ATMP manufacture – technology and scale perspectives? b..…and what are the specialisations when it comes to different therapy types? i.Technologiesii.Tools iii. Data c. Inherently variable field eliminating sources of systemic uncertainty towards process streamliningd. Whole-process intensification in cell therapy manufacturing: room to improve
16:20

Networking refreshments

Jelena Ochs
CELL THERAPY MANUFACTURE
17:00

Fully automated cell production for the therapies of the future

CELL THERAPY MANUFACTURE
17:40

Industrial automation of cell therapy manufacturing

Panel discussion
CELL THERAPY MANUFACTURE
18:00

Panel discussion: Building your own manufacturing facility Vs. outsourcing the process to partners

last published: 28/Jan/20 14:05