Advancing Manufacture of Cell and Gene Therapies VI

Call For Abstracts!

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Call for Nominations:  Advancing Manufacture of Cell and Gene Therapies Award

About This Conference

Building on the strong momentum established at our previous meetings (Scale-Up and Manufacture of Cell-Based Therapies), we are pleased to announce that the Advancing Manufacturing Cell & Gene Therapy VI conference is scheduled for January 27-31, 2019, at the Loews Coronado Bay Hotel, California, USA. This conference is unique in the cell/gene therapy field, as it is focused on the technological challenges and engineering solutions for the robust and cost-effective manufacturing of cell and gene therapies. Moreover, owing to the restricted number of participants (~400), welcoming location and overall format, this conference is a valuable opportunity to showcase new and existing approaches with key academic and industrial leaders.

In addition to a comprehensive series of oral sessions speakers from academic and industrial groups, we have designed the conference to foster networking and facilitate informal discussion around key engineering advances and issues. This will be enabled via several poster sessions, informal drinks and a focused workshop on viral manufacturing challenges & next generation technologies.

Keynote talks and technical sessions will be organized into the following streams:

Session 1 – Advances in cell processing: New Techniques for new therapies

Session Chairs: Jeff Chalmers (Ohio State University) and Tom Heathman (Hitachi Chemical Advanced Therapeutics Solutions)

The cell therapy industry has advanced rapidly from demonstrating promising clinical data to achieving commercially approved products. Due to the unprecedented speed of this development, several challenges remain in the manufacture of these cell therapy products that must be resolved through development of new technologies and solutions from across our entire community. In this session, we will explore potential cell therapy technologies that can resolve these challenges.

We invite abstract submissions focusing on:

  • Novel product platforms for next generation cell therapies (e.g. iPSCs, T-cells, gene-modified CD34+, MSCs and exosomes);
  • 2) New upstream processing technology (e.g. bioreactors, xeno-/serum-free culture media, cell selection, and scale-up/scale-out of patient-specific/off-the-shelf products);
  • 3) New downstream processing technology (e.g. cell separation, formulation and fill, cryopreservation and point-of-care thawing); and
  • 4) New technology to automate, integrate and execute closed cell therapy processing.

Session 2 – Engineering challenges of in vivo gene therapy

Session Chairs: Fernanda Masri (Sartorius Stedim) and Michael Greene (Novartis)

Gene therapy has rapidly advanced over the last few years thanks to the creation and application of sophisticated gene-editing technologies. These technologies have brought significant advantages such as targeted gene insertion and improved safety profiles. As a consequence, and strengthened by shorter regulatory approval times, commercial development and time to clinic have seen rapid acceleration. This session aims to address recent advances in viral vector production, emerging gene-editing tools and their deployment in human clinical trials.

In this session, we invite abstracts that address topics such as:

  • The manufacturing and scale up of established viral vector technologies (e.g., lentivirus), as well as next generation gene-editing tools (e.g., CRISPR/Cas9);
  • The clinical application and associated safety and efficacy profiles;
  • Limitations and technology gaps in the current state of the art, along with potential emerging solutions.

Session 3 – Gene-modification of cells for therapy

Session Chairs: Sean Palecek (University of Wisconsin-Madison) and Phil Bassett (Adaptimmune Ltd.)

Genetic modification of cells offers the potential of designing cells for immunotherapy and regenerative medicine applications.  In recent years, advances in gene editing precision have revealed the true potential of cell therapies. To realize the full potential of cell therapies, more efficient and precise methods are needed to introduce exogenous or modify endogenous genes in the human genome.

In this session, we welcome abstracts that:

  • Describe recent advances in gene modification of cells for therapy. Specific areas that could be explored include viral vector production; nonviral gene editing; and synthetic biology approaches to engineering therapeutic cells to improve their safety and potency.
  • Describe novel strategies for manufacturing and subsequent applications of gene-edited therapeutic cells.

Session 4: Product Characterization and Analytics 

Session Chairs: Damian Marshall (Cell and Gene Therapy Catapult) and

Eric Rutjens (Novartis)

As the cell therapy industry moves towards closed, automated processing and more product enter clinical development there is an increased requirement for tools and technologies to allow better control over the manufacturing process. This opens-up exciting opportunities to look at the how frameworks such as process analytical technologies (PAT) can be applied to improve product manufacture, how in-process analytics can be applied to support real time product release and how new analytical strategies can be developed to support adaptive manufacturing.

In this session, we invite abstracts that address some of the latest approaches to product characterization and associated analytical techniques. Topics of particular interest include:

  • New biosensors or technologies for in-process monitoring;
  • Application of advanced techniques for high level product characterization;
  • Technologies to allow feedback control during manufacturing;
  • Advancements towards real-time testing for cell therapy products; and
  • Development of better potency assays to allow fast, safe release of products.

Session 5:  Big data, analytics and control strategies 

Session chairs: David Pollard (Kite Pharma) and Krish Roy (Georgia Institute of Technology)

The continued efforts to drive down costs and improve efficiency of cell therapy process development and manufacturing require multiple, integrated IT strategies. This session will discuss big data strategies such as digital lab solutions for process development as well as electronic batch record/automated data capture for clinical and commercial manufacturing.  Examples could include automation and real time process monitoring to speed problem solving and improve process robustness, while utilizing the latest process analytical technology.   In addition, data mining capability and AI approaches across the cell manufacturing process can enhance identification of CQAs and CPPs and could be key to enhancing quality assurance. Data mining and AI can enable improved process understanding of complex interactions, such as the relationship of the patient incoming apheresis to the manufacturing performance and clinical outcome. The integration of data from genomic and metanomic approaches will also be discussed for the further progression of truly personalized approaches.

Session 6: Bioprocess modeling for successful commercialization of advanced therapies 

Session Chairs: Jon Gunther (Juno Therapeutics) and Suzanne Farid (University College London)

Key to the success of the advanced therapies sector are cost-effective manufacturing and sustainable commercialization models. Bioprocess modeling efforts have a critical role to play in enhancing predictive insight as well as providing line-of-sight to feasible business models.

This session invites papers that:

  • Discuss insights from bioprocess modeling, simulation and optimization tools such as chemometric and agent-based modeling;
  • Present applications of such modelling approaches with industrially-relevant case studies addressing manufacturing and supply chain decisions for cell and gene therapies are particularly encouraged. This can include techno-economic feasibility for achieving optimal cost of goods (COG) at the commercial scale, simulation models to enhance facility design and capacity management across global sites for scale-up and scale-out scenarios, asset strategies optimization, business models for point-of-care versus centralized distribution for global deployment, the financial impact of process choices on the product development lifecycle, and chemometrics for enhanced process understanding and root cause analysis.

Session 7: Revolutionizing/Delivering the pipelines

The cell and gene therapy industry has advanced at an incredible speed over the last decade and now embraces a wider spectrum of advanced methodologies targeting several hematological malignancies and rare diseases, with powerful efficacy. Patients are benefiting from these new therapies thanks to advances in fundamental underpinning science, new translational tools and technologies, adaptation of flexible regulatory frameworks and introduction of accelerated access pathways. This represents tremendous success for the industry but what are the current limitations in delivering these medicines to mainstream healthcare?

In this final session, we invite abstracts that:

  • Focus on the vision for delivering the pipelines of emerging cell and gene products over the next decade.
  • Focus on addressing how these new medicines will be delivered in the context of mainstream healthcare. Themes that might be explored include transformation of supply chain logistics; clinical infrastructure for delivery to patients; synergizing parallel services for end-to-end manufacture.

We invite you to sign up for the next mailing in order to get updated program information and pass along to colleagues information about this conference.

Sincerely,

Conference Chairs:

Dolores Baksh (GE Healthcare),
Rod Rietze (Novartis) and
Ivan Wall (Ashton University)

Plenary Speakers

Plenary 1:  Fireside chat – Delivering commercial cell products: Engineering problems that remain

Timothy Moore (Kite – A Gilead Company)
Phil Vanek (GE Healthcare)
Greg Russotti (Celgene)

Plenary 2:  Gene Therapy  (Speaker TBA)

Plenary 3:  Big data processing and analytics

Jeff Caron (GE Healthcare and Life Sciences Digital)

Plenary 4:  Revolutionizing/delivering the pipelines

Chris Mason (Avro Biotech)

Conference Organization

Conference Chairs:

Dolores Baksh, GE Healthcare
Rod Rietze, Novartis
Ivan Wall, Aston University

Poster Chair:

Corinne Hoesli, McGill University

Student Liaison:  

Elizabeth Cheeseman, Loughborough University

Organising Committee:

Stewart Abbott, Fate Therapeutics
Eytan Abraham, Lonza
Paula Alves, IBET
Steven Bauer, FDA
Joaquim Cabral, University Lisbon
Jessica Carmen, Maxcyte
Jeff Chalmers, Ohio State University
Vijay Chiruvolu, Kite Pharm
Justin Cooper-White, University of Queensland
Suzy Farid, UCL
Peter Fuhrken, Cellular Dynamics International
Richard Grant, Invetec
Jon Gunther, Juno Therapeutics
Thomas Heathman, PCT
Corinne Hoesli, McGill University
Brian Lee, PBS
Kaye Lee, GSRAC
Sheng Lin-Gibson, NIST
Damian Marshall, CGT Catapult
Fernanda Masri, Sartorius Stedim
Todd McDevitt, Gladstone Institute
Brian Murphy, Celgene
Alvin Nienow, University of Birmingham
So Ra Park, Inha University College of Medicine
David Peritt, Sigilon
Jamie, Piret, University of British Columbia
David Pollard, Kite Pharma
Mark Powers, Thermo Fisher Scientific
Qasim Rafiq, UCL
Krish Roy, Georgia Tech
Emily Titus, University of Toronto

Steering Committee:

Tom Brieva, Celgene
Barry Buckland, BiologicB
Manuel Carrondo, IBET
Peter Gray, University of Queensland
Chris Mason, UCL
Bill Miller, Northwestern University
Bob Nerem, Georgia Tech
Lars Nielsen, University of Queensland
Greg Russotti, Celgene
Peter Zandstra, University of Toronto

Abstract Submission

Session titles are available above.  Please use these titles to pre-select up to three sessions where you believe your work fits best.

Abstracts (one page maximum) that include specific results and conclusions to allow a scientific assessment of the proposed oral presentation are invited.  Please prepare your abstract according to this template: docx or doc.

Abstracts must be submitted electronically using the template provided at: THIS LINK.

Oral abstract submission deadline:           September 4, 2018                
Poster abstract submission deadline:      September 10, 2018               

Poster size:  4 ft. x 4 ft. (1.2 m x 1.2 m)

Abstracts of all presentations will be made available to conference participants prior to the start of the conference.

Note:  Only a limited number of oral presentation slots are available and thus all submissions for oral sessions will be considered for both oral and poster presentation.

Cell and Gene Therapies Award

PURPOSE:  The Advancing Manufacture of Cell and Gene Therapies Award recognizes outstanding contributors to the development and commercialization of Cell-Based Therapies. Past recipients include Bob Nerem, Kim Warren, and Peter Zandstra. The award nominations will be judged according to criteria as set forth in this document.

Call for Nominations: 

Conference Venue

The conference will take place at Loews Coronado Bay Hotel (4000 Coronado Bay Road, Coronado, California).  Image result for loews coronado bay resortSet on Coronado Bay directly across the street from Silver Strand State Beach, the hotel is just over two miles to San Diego National Wildlife Refuge Complex. The hotel is set on a 15-acre peninsula with beach access via a pedestrian underpass.  The multi-building, three-floor resort offers 439 rooms and suite that are light and airy.  Image result for loews coronado bay resortRoom views include bay, marina, pool or gardens.  There is free Wi-Fi and the rooms have Keurig coffeemakers and ample outlets.  The hotel has tennis courts, bicycle rentals, a fitness center, spa and three swimming pools.  Both self and valet parking are available for an additional fee.

San Diego attractions such as the San Diego Zoo, Balboa Park and the Gaslamp Quarter are each approximately a 25 minute trip from the hotel.

Transportation

Please plan to fly into San Diego International Airport (SAN) as it is the closest to the conference venue. The Loews Coronado Bay is located approximately 20 minutes from San Diego International Airport.  The Loews Coronado Bay Resort does NOT offer a complimentary shuttle to and from the airport.    Instagram iFrame Pop Up

Shuttle Transportation: Super Shuttle offers a variety of rides from shared shuttles to private limos with baggage claim meeting.  ECI will offer a discounted rate for shuttle transportation.

Conference Fees and Registration

Fees for this conference are estimated at:
Participants:
Single Occupancy – $3,000
Shared Occupancy – $2,500

Graduate Students:
Shared Occupancy – $2,100

Please note that the conference fee is inclusive and includes registration, accommodations (Sunday (January 27), Monday (January 28), Tuesday (January 29), and Wednesday night (January 30), all meals (except one dinner on your own) from dinner on Sunday through breakfast on Thursday.

Registration is scheduled to open in early September, 2018.

General Information about ECI

Engineering Conferences International (ECI) is a global engineering conferences program, originally established in 1962, that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

The format of the weeklong research conference provides morning and late afternoon or evening sessions in which major presentations are made. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. This format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe that the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

All participants are expected both to attend the entire conference and to contribute actively to the discussions. The recording/photographing of lectures and presentations is forbidden. As ECI conferences take place in an informal atmosphere, casual clothing is the usual attire.

Engineering Conferences International
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