Scale-up and Manufacturing of Cell-based Therapies V

An ECI Conference Series

January 15-19, 2017
Hyatt Regency Mission Bay Hotel
San Diego, California

Preliminary Program

Cell-Based Therapies Award Winner – Peter Zandstra

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          Pre-Conference Workshop     Call for Abstracts!

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About This Conference

There is tremendous clinical promise for emerging therapies based on administrating cells to patients to treat a diverse assortment of diseases.  However, the complexity of cells that affords great therapeutic promise also increases the complexity of their manufacture and testing.  Furthermore, there are distinct challenges for the many forms of cell products (e.g., autologous vs. allogeneic, fresh vs. frozen).  The ability to manufacture and perform assays that confirm the quality of cell products will be critical factors in the anticipated success of cell-based therapies.  In particular, it is necessary to develop manufacturing processes that are scalable, cost-effective, and reliable, along with measurements of cell characteristics that are pertinent to product quality.  This conference focuses on the engineering and pragmatic approaches required to develop, refine, characterize, scale-up, automate, validate, and commercialize processes and assays to manufacture, test, store, and distribute cell-based therapies.

A Pre-Conference Workshop will discuss the challenges in defining the product characteristics that are critical for predicting effectiveness and manufacturing bottlenecks throughout the stages of the development cycle.

Plenary Speakers

Stewart Abbot (Fate Therapeutics}
Moving off-the-shelf into patients; development of pluripotent cell-based immunotherapeutics

Kristi Anseth (University of Colorado)
Design of novel materials to regulate stem and progenitor cell expansion and differentiation

Valentin Jossen (Eibl Lab, Zurich Univ. of Applied Science)
How to use Computational Fluid Dynamics in the development of cell therapeutics

Greg Russotti (Celgene Cellular Therapeutics)
CAR-T Manufacturing: Delivering on the Promise of a Transformational Therapy

Invited Speakers

Eytan Abraham (Lonza)
Bespoke Cell Therapy Manufacturing Platforms – A Contradiction in Terms?

Paul Barone (MIT)
Implications of The CAACB Virus Contamination in Biomanufacturing Project for Cell Therapy Manufacturers

Robert Deans (Rubius Tx)
Engineering Red Blood Cells for Therapeutic Function

Terry Fry (US NIH)
Optimizing CAR T cell therapy for Hematologic Malignancies

Sadik Kassim (Novartis)
A Systems Approach for CAR T Cell Therapy Product Characterization

Bernadette Keane (Keane Consulting)
Industry challenges and questions for regulatory authorities

Ben Kleinstiver (Joung Lab, Harvard)
Altering, improving, and defining the specificities of CRISPR-Cas nucleases

Robert Kutner (rocket pharma)
TBD

Dawn Maier (bluebird bio)
 Important considerations for developing autologous cellular therapies such as CAR T cells

Sakis Mantalaris (Imperial College)
Metabolomics and the role of Metabolism in Stem Cell Bioprocessing

Fulvio Mavilio (Genethon)
Gene therapy for inherited blood diseases, from viral vectors to gene editing

Robert Perry (Atara)
TBD

Jamie Piret (University of British Columbia)
Acoustic cell washing and Raman spectroscopy to address cell therapy bioprocess challenges

Donald Powers (Johnson & Johnson)
Cell Therapy Manufacturing:  It’s about “TIME”

Matthias Renner (Paul Ehrlich Institut)
Regulatory aspects of manufacturing and control of genetically modified cells

Marianna Sabatino (Kite Pharma)
TBD

Anandita Seth (Lonza)
Challenges and solutions to quality GMP supply of AAV vectors

Rachel Smith (Capricor)
Process scale-up and characterization for a cardiac-derived cell therapy

David Stroncek (US NIH)
Removal of myeloid cells from autologous leukocytes used for chimeric antigen receptor (CAR) T cell manufacturing improves final product consistency and yields

Nick Timmins (CCRM)
A Penny Today or a Dollar Tomorrow – Early Stage Development for Future Success

Peter Zandstra (University of Toronto)
Award Lecture: Engineering stem cell fate for drug development and therapy

Technical Sessions

Novel technologies for cell therapy manufacturing
Session co-chairs:  Jamie Piret (University of British Columbia) and Jon Rowley (RoosterBio)
Description:  We are in a crucial period for the development of innovative cell therapy manufacturing technologies.  With the first major wave of potential products progressing through clinical trials, many organizations are confronting the challenges of economically ensuring the manufacture of safe and efficacious products.  Manufacturing technologies adopted today will be difficult to displace in the future due to regulatory and other constraints.  Thus, there is a unique window of opportunity for innovations to address the specialized needs of therapeutic cell manufacturing that are not already provided by other fields.  This session will address novel approaches to manufacture living cells ranging from technologies for small scale closed systems, scale-up bioreactor expansion and cell-friendly downstream processing, to improved methods for demonstrating the quality and safety of complex populations of cells.  These challenges must be aggressively addressed since cellular therapies should literally benefit millions of people in need.

Collaborating with regulatory agencies to define the landscape for emerging cell-based therapies – challenges and lessons learned
Session Co-chairs:  Bernadette Keane (Keane Consulting) and Mohammad Heidaran (FDA)
Description:  The complexity and novelty of cell-based therapies compared to traditional biotherapeutics demand carefully crafted regulatory approaches to deliver effective treatments to patients without jeopardizing their safety.  Such approaches must be based on solid scientific data and rationale that is being developed in the industrial, academic, and government sectors.  As the field of cell therapies matures towards ubiquitous commercial realities, regulators across the world have been collaborating with scientific leaders, as well as sponsors of candidate cell therapies, to allow progress while addressing patient needs.  This session will focus on manufacturing-related regulatory challenges and approaches such as the demonstration of product comparability throughout manufacturing changes from early stage clinical development beyond proof-of-concept through to late stage pivotal trials intended to support commercialization.  Additional examples of challenges include sourcing of raw materials, control of cell processing at clinical sites, and development of suitable analytical methods.

Product characterization and potency
Session co-chairs:  Anne Plant (NIST) and Chris Wiwi (Celgene)
Description:  The commercialization of cell-based products presents unique challenges.  An evolving regulatory landscape, rapid advances in manufacturing technologies, complex mechanisms of action (MOA), and inherent variability in cellular material are just a few examples of these challenges. When considering process changes, cellular therapy manufacturers seek to apply sound engineering principles, develop good process understanding and use meaningful analytical methods for product characterization.  The diversity and complex nature of cell therapy products requires an increasingly broad set of analytical tools to assist in this endeavor.  Scientists engaged in assay development are challenged to select the most appropriate methods and adapt these assays to a quality environment.  Cell line and patient variability, poorly defined MOA, lack of reference materials and complex analytical methods/instruments underlie some of the technical difficulties facing the analytical team.  This session will discuss the testing strategies used by cell therapy manufacturers throughout the product development lifecycle, as well as solutions to commercial challenges such as potency assay development, comparability testing, measurement assurance and the automation of analytical methods.

Manufacturing CAR T cells and other cancer immunotherapies: Challenges and progress
Session co-chairs: David Stroncek (NIH) and Marianna Sabatino (Kite Pharma)
Description:  Adoptive T cell therapies have been used for many years to treat cancer, but complex manufacturing requirements and modest clinical benefits have limited the use of these therapies to early phase clinical trials.  T cells genetically engineered to express Chimeric Antigen Receptors (CAR), particularly CD19-CAR T cells, have shown great clinical promise. Since procedures to manufacture CD19-CAR T cells are relatively simple and low cell doses are required, efforts are underway to commercialize these products.  There are, however, some problems associated with manufacturing and analysis of CAR T cells.  Most CAR T cell manufacturing processes were adopted from those used in facilities at academic health centers, which are inefficient, expensive and make little use of automation.  The use of autologous T cells as starting material for CAR T cell manufacturing also presents some challenges with scale-out.  This session will discuss current methods used to manufacture CAR T cells and other T cell cancer immunotherapies and their limitations.  Methods to improve the production and analysis of these cells using automation, closed systems, and other innovations, as well as reducing the cost of manufacturing, will be discussed.

Gene editing, vector production, synthetic biology, and genetic modification of cells
Session Co-chairs:  Paula Alves (IBET) and Robert Kutner (rocket pharma)
Description:  The rapidly evolving fields of cell-based and in vivo gene therapy enable delivery of therapeutic genes or edits to defective genes.  There is a rich variety of delivery vehicles supporting a wide range of specific needs for genetic modification.  As a result, there is a wide variety of possible manufacturing processes and development challenges.  This session will address the major trends impacting bioprocess development including implementation of characterization methodologies to better understand and improve existing and novel expression technologies, the implementation of disposable and affordable manufacturing processes and technologies, and scale-up.  This session will also cover evolving process and expression technologies – and the applications of synthetic biology, data mining, and process modeling strategies – to provide the audience with an updated, contemporary understanding of the trends and challenges in gene and cell therapy.

Upstream and downstream process characterization, scale-up, comparability, and in-line process monitoring
Session co-chairs:  Joaquim Cabral (University of Lisbon) and Fran Meacle (Johnson & Johnson)
Description:  As an increasing number of cell therapies start to demonstrate proof-of-concept in early phase clinical trials, the focus is now becoming how to transition these early phase manufacturing processes to a scale and quality suitable for late stage/commercial production.  This transition brings with it the question of how much the process has changed during scale-up and its impact on product comparability.  This session focuses on process scale-up and characterization including the use of novel types of (disposable) bioreactors, in-line process monitoring, and downstream strategies for cell purification and characterization.

Bioprocess modeling – the road to informed decision-making for successful commercialization
Session Co-chairs: Dolores Baksh (GE Healthcare) and Suzanne S. Farid (University College London)
Description:  Successful development and sustainable commercialization models are top of mind for cell and gene therapy companies.  There is an emerging reliance on model-based approaches to provide enhanced process understanding and predictive insight that helps cell manufacturers more efficiently improve processes and optimize the properties of manufactured cells.  Bioprocess modeling challenges include consideration of needle-to-needle logistics, as well as accounting for all factors that could impact the properties and performance of cell products, including the inherent stochastic variability of manufacturing processes, cell functionality and cell therapy patients.  This session will discuss the role of bioprocess modeling, simulation, optimization and information management tools.  Contributions that present industrially-relevant case studies are especially encouraged.  This can include bioprocess economics models for achieving optimal cost of goods (COGs) at the commercial scale, simulation models to enhance facility design and capacity management across global sites, unit operation models to more accurately predict ideal operating conditions, chemometric models for root cause and data analysis, as well as assessment of the financial impact of process choices on the product development lifecycle.

From method to manufacturing, ramping-up for commercial production
Session Co-chairs:  Nick Timmins (CCRM) and Greg Russotti (Celgene)
Description:  In the lifecycle of cell therapy commercialization, step-changes in thinking and approach occur throughout development as a product progresses from pre-clinical to clinical, and through the clinical trial pipeline.  But perhaps the biggest step of all is that from investigational product to on-market.  Compliance, logistics, scale, focus on cost of goods (COGs), and supply chain considerations, among others, increase substantially in magnitude.  Failure or underperformance in any one of these areas is potentially a fatal blow to success.  In this session, regulators and industry leaders who have walked-the-walk and can talk-the-talk of taking a product from development to commercial operations will share their strategies and vision for a successful commercial process.  As success is best built upon a solid foundation, this session will also explore how the approach used for the preceding development can smooth the transition to commercial manufacturing.

Poster Session:  Covers all conference topics

Session co-chairs:  Corinne Hoesli (McGill University) and Eytan Abraham (Lonza)

Special Journal Issue

The Biochemical Engineering Journal (BEJ) is partnering with ECI Scale-Up and Manufacturing of Cell-Based Therapies V to publish a peer-reviewed special issue devoted to papers from oral and poster presentations at the conference. The conference chairs will prepare a guest editorial with a review of conference highlights to lead off the special issue and stimulate interest in the papers. As part of this partnership, the BEJ will provide open access for 3 months to papers in the assembled special issue. While the special issue is being assembled, papers will be published online 2-3 weeks after acceptance.

The special issue will be co-edited by conference chairs Bill Miller (BEJ Editor) and Tom Brieva. We encourage you to submit your best work to the special issue as an original paper, review, perspective, or short communication, depending on the nature of the presentation (see guide for authors at www.elsevier.com/locate/bej for more details). Details on manuscript submission will be made available closer to the conference.

Please see the special issue from ECI Scale-Up and Manufacturing of Cell-Based Therapies IV http://www.sciencedirect.com/science/journal/1369703X/108.

Conference Organization

Chairs:
Tom Brieva, Celgene Cellular Therapeutics
William Miller, Northwestern University
Chris Mason, University College London

Organizing Committee:
Eytan Abraham, Lonza
Paula Alves, IBET
Dolores Baksh, GE Healthcare
Ravi Bhatia, Janssen
Kim Bure, Sartorius
Joaquim Cabral, University of Lisbon
Jeff Chalmers, Ohio State University
Allen Chen, Bioprocessing Technology Institute
Ron Fedechko, Pfizer
Peter Fuhrken, Cellular Dynamics International
Brian Hampson, Progenitor Cell Therapy
Ohad Karnieli, Kernieli Ltd.
Todd McDevitt, Gladstone Institute
Alvin Nienow, University of Loughborough
So Ra Park, Inha University College of Medicine
Madhusudan Peshwa, Maxcyte
Jamie Piret, University of British Columbia
Anne Plant, NIST
Mark Powers, Thermo Fisher Scientific
Chris Ramsborg, Juno Therapeutics
Nick Timmins, CCRM
Ivan Wall, University College London
Jean Xu, Janssen

Steering Committee:
Barry Buckland, BiologicB
Manuel Carrondo, IBET
Peter Gray, The University of Queensland
Bob Nerem, Georgia Institute of Technology
Lars Nielsen, University of Queensland
Greg Russotti, Celgene Cellular Therapeutics
Peter Zandstra, University of Toronto

Sponsorship Opportunities

To view the Sponsorship Opportunities for this conference, click HERE.

ECI has revamped the sponsor packages to increase exposure.  New opportunities include an industrial promotion session and a brewery tour.

Conference Sponsors

Please click on the logo to visit the site.

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Abstract Submission

Deadline for abstracts for oral presentations:      Closed
Deadline for abstracts for poster presentations:       December 5, 2016

One-page abstracts should be submitted as soon as possible and no later than the deadlines noted above.  Abstracts will be accepted on a rolling basis.  The abstract should include both the significance of the research as well as results that will be discussed in order to allow a scientific assessment of the work by the organizers.

You will be asked to indicate:

  • If your abstract is for an oral and/or poster presentation
  • The session(s) for which it is being submitted
  • If you are a graduate student
  • Your possible interest in submitting a paper for the special issue of the BEJ devoted to this conference

All abstracts should be submitted electronically and submissions must follow the template provided at this link.

Conference Fees and Registration

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, Tuesday and Wednesday nights), all meals (with the exception of dinner on Tuesday and lunch on Wednesday), excursion, taxes, and gratuities from the reception and dinner on Sunday through breakfast on Thursday. Incidental fees (telephone calls, faxes, spa, laundry, etc.) are billed to your personal account by the hotel.

ALL PARTICIPANTS (INCLUDING MEMBERS OF THE ORGANIZING COMMITTEE AND INVITED SPEAKERS) ARE REQUIRED TO REGISTER.

The conference fees are:

Register on or before December 5, 2016 Register after 
December 5, 2016
Participant (single occupancy or sharing room with a guest; guest fee additional) US $2,710.00 US $2,910.00
Participant (sharing a room with another participant) US $2,295.00 US $2,495.00
Bona fide Graduate Student (sharing a room with another student) (Those in this category must send proof of current status – copy of current Student ID can be faxed to 1-212-514-6030 or emailed to Kathy@engconfintl.org) US $1,880.00 US $2,080.00
**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (Includes all conference included meals as well as the conference excursion) US $945.00 US $945.00
Workshop and Saturday Night Accommodations
Saturday Night Hotel Accommodation (for those attending Sunday’s Workshop) you must be registered as a Participant (single occupancy) above in order to select this option online.  

US $201.96

Pre-Conference Workshop for Participant US $350.00
Pre-Conference Workshop for Student US $250.00

If you plan to bring children to the conference, please contact ECI (info@engconfintl.org) for pricing.

Conference Registration

You will need a login name and password to register for ECI conferences through our online system. If you have been a recent participant at an ECI conference or have submitted an online application or request for information about an ECI Conference, you may already have an account with us. If you know your login information, please use it.

If you are not sure whether you already have a login and password, please click on automated password retrieval and enter your e-mail address before creating a new account. If we don’t have a valid email address on file for you, a pop up window will appear stating that no records were found. Click “OK” and then follow the instructions to create a new account.

Pre- and Post-Conference Reservations:  If you are planning to arrive early (before January 15) or to stay after the conference (after January 19) you MUST make hotel reservations directly with the hotel.  Use the appropriate form on THIS PAGE to make your reservations.

If you have any questions or experience any difficulties, please email tressa@engconfintl.org.

Special Notes for Payment

Special Notes and Payment Instructions

We suggest that you register as soon as possible to be certain that you will have a hotel room at the conference rate.  Late registrations will be accepted on a space available basis.

All participants are encouraged to register before December 5, 2016.  There is a discounted price for registering before this date and hotel space cannot be guaranteed for registrations received after this date.  Your registration is not officially confirmed until we receive payment of the amount due.  ECI reserves the right to cancel your room registration if payment is not received. Your invoice/receipt will automatically be e-mailed upon of receipt of your registration.

Because of contractual guarantees made with the hotel for room and meal functions, no shows, late arrivals, missed meals and early departures cannot receive fee adjustments.  If you have a disability and may require accommodation in order to participate fully in this conference, please indicate this when you register. An ECI representative will contact you to discuss your specific needs. If you have special dietary requirements (e.g., vegetarian or a food allergy), please make a note on your registration.  The chef needs to know this information in advance if we are to accommodate you. ECI will attempt to accommodate special requests such as Kosher or Halal meals, but such meals may not be available at all conference sites. Any additional costs for special meal requests must be paid by the participant to ECI.

Payment must be made by credit card (Visa, MasterCard, Amex), check or money order drawn on a U.S. bank in U.S. dollars, payable to ENGINEERING CONFERENCES INTERNATIONAL. Checks or money orders in any other currencies are NOT ACCEPTABLE.  Payment is made on the web site except for those who are sending payment by wire transfer or have a purchase order from their company/institution.

WIRE TRANSFER PAYMENT: If you are planning to make payment by wire transfer, please contact ECI for the bank information. You must add $30 to cover ECI bank charges. Please reference your full name and the conference title.  Either fax a copy of your bank transfer papers to ECI (Fax: +1-212-514-6030) or email a scanned copy to kathy@engconfintl.org.  This is very important – otherwise it is extremely difficult to trace your payment and you may not receive a receipt prior to the conference.

Cancellation Policy: Cancellation must be received by ECI in writing at least 28 days prior to the start of the conference in order for a full refund (less a processing fee) to be considered. The ECI auditors require that refunds for all conference cancellations be processed after the conference so that the necessary back-up information (e.g., hotel list of those in-house) can be attached to the refund request and ECI can verify that the hotel has not charged a cancellation fee.

Cancellation fees:

  • Cancellations received more than 28 days prior to the conference start date are subject to a processing fee of 4% of the total fee, plus any direct expenses incurred by ECI.
  • Cancellations received 15 – 28 days prior to the conference start date are subject to a $250 cancellation fee plus any direct expenses incurred by ECI.
  • Cancellations received 8 – 14 days prior to the conference start date are subject to a $500 cancellation fee plus any direct expenses incurred by ECI.
  • No refunds will be issued for cancellations received less than 7 days prior to the conference start date.
  • No refunds will be issued due to inclement weather or travel disruptions/cancellations.

Registrations can be transferred without incurring any penalty or cancellation fee.

Denied or delayed visa

If a participant is forced to cancel due to a denied or delayed entry visa, ECI will issue a full refund provided that ECI has been notified of a potential visa issue at least four weeks prior to the conference start date.

Change of payment method

If an attendee who has already paid the conference fee with a credit card requests that the fee be refunded to that card so that it can be paid in a different manner (e.g., charged to an alternate credit card, or paid via check or bank transfer), a processing fee of 4% of the total fee amount will apply.

Disclaimer

It may be necessary for reasons beyond the control of ECI to alter the content and timing of the program or the identity of the speakers. In the unfortunate circumstance that an event is cancelled, ECI is not liable for any costs incurred by participants in connection with their attendance.

Smoking is prohibited at ECI conferences and conference functions.

Should you have specific questions regarding your registration, please contact Kathy Chan (Kathy@engconfintl.org).

Transportation

Transportation from the airport – Details are available here: Supershuttle

Entry visas for USA
If you require a visa to enter the USA, please visit the website of The National Academies for the most current, detailed information regarding traveling to the United States.
http://www.nationalacademies.org/visas/Traveling_to_US.html

If you require a special letter of invitation from ECI, please send an e-mail to info@engconfintl.org and we will send you an information form to complete.

Preliminary Program

Click HERE to view the preliminary program.

Register Now!

Please click on THIS LINK to register for this conference.

Conference Venue

San Diego, California’s second largest city, is known worldwide for its spectacular climate, 70 miles of pristine beaches, and attractions such as the San Diego Zoo, Sea World, San Diego Wild Animal Park, and Legoland.  Other highlights include sightseeing in the historic Gaslamp Quarter, Coronado, Little Italy or Balboa Park, the largest urban cultural park in the United States.  In the historic Gaslamp Quarter, consisting of 16½-blocks around Fourth and Fifth Avenues, grand Victorian-era buildings are home to more than 100 of the city’s finest restaurants, 35 pubs and nightclubs and 100 retails shops, as well as theaters, art galleries, offices and residential/work lofts. When the sun sets, this downtown neighborhood attracts thousands of diners, shoppers, theatergoers, and nightclub patrons.

The Hyatt Regency Mission Bay Hotel is located on beautiful Mission Bay.  The property, renovated in 2010, consists of three separate buildings that flank three outdoor pools.  Each of the 429 guestrooms offers the Hyatt “Grand Bed” with clock radios that feature an iPod docking system, a large work desk, flat screen TV and balconies with views of the Pacific Ocean, Mission Bay, or the hotel gardens.  The resort features a large swimming pool with poolside bar, a fine-dining restaurant, a spa, a marina with sport fishing and boat rentals, and has a new waterfront 24-hour Stayfit Gym. It is a quarter mile from SeaWorld and Mission Beach, and three miles from Old Town San Diego. The hotel offers bicycle rentals and features jogging and cycling paths.  There is a complimentary shuttle to Mission Beach.  Either self or valet parking is available with a surcharge.

The hotel is located at 1441 Quivira Avenue in San Diego.

For more information on the area, please visit these web sites:

San Diego Convention and Visitors Bureau: www.sandiego.org
Gaslamp Quarter: www.gaslamp.org
Hyatt Regency Mission Bay Hotel: http://missionbay.hyatt.com/hyatt/hotels-missionbay/index.jsp

General Information

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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T: 1-212-514-6760 F: 1-212-514-6030 E: info@engconfintl.org

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