ADVANCING MANUFACTURE OF CELL AND GENE THERAPIES VII

An ECI Conference Series

Feb 6-10, 2022
Loews Coronado Bay Hotel
Coronado, CA

Attendance at this conference is restricted to those fully* vaccinated against Covid-19.

Your registration will not be considered complete until your proof of vaccination is uploaded via the registration portal and verified by ECI staff. Acceptable proof includes copies of a U.S. CDC vaccination card or a certificate/document issued by the relevant health agency in your country of residence along with a government issued photo ID, such as a driver’s license or passport. If you have questions about these requirements, please email Kathy@engconfintl.org

* Two doses of an FDA or WHO authorized two dose Covid-19 vaccine, received at least 14 days prior to the conference OR one does of an FDA or WHO authorized single dose Covid-19 vaccine, received at least 14 days prior to the conference.

Approved vaccines: Pfizer/BioNTech (2 dose); Moderna (2 dose); Janssen/Johnson & Johnson; Oxford/AstraZeneca; Serum Institute of India-Covishield; Sinopharm (Beijing); Sinovac.

We are all in this together. Thank you for being part of our community and following these policies. We look forward to see you in person very soon.

About This Conference

The ECI Advancing Manufacture of Cell and Gene Therapies conference is a biennial meeting that brings together leading figures from academia and industry to showcase and debate the latest breakthroughs in advancing engineering and manufacturing of next generation therapies. 

This 2021 event will provide interactive opportunities for a diverse set of attendees, ranging from trainees to experienced practitioners, to examine the latest advances in product manufacture, analytics, non-viral gene delivery, cell engineering and the future of product release (detailed information on each session provided below).

Conference Chairs

Sean Palecek, University of Wisconsin, USA
Damian Marshall, Achilles Therapeutics, UK
Fernanda Masri, Cell & Gene Therapy Catapult, UK

Steering Committee 

Dolores Baksh (Akron Bio, USA)
Mike Betenbaugh (Johns Hopkins University, USA)
Tom Brieva (Tmunity Therapeutics, USA)
Barry Buckland, Chair (BiologicB,LLC, USA)
Manuel Carrondo (IBET – Instituto de Biologia Experimental e Tecnológica, Portugal)
Peter Gray (AIBN – University of Queensland, Australia)
Chris Mason (Avro Bio, United Kingdom)
Bill Miller (Northwestern University, USA)
Lars Nielsen (The University of Queensland, Australia)
Rod Rietze (iVexSol, Inc., USA)
Greg Russotti (Century Therapeutics, USA)
Ivan Wall (Aston University, United Kingdom)
Peter Zandstra (University of British Columbia, Canada)

Organizing Committee

Paula Alves, IBET & ITQB, Portugal
Sven Ansorge, ExCellThera, Canada
Stefano Baila, Anemocyte, Italy
Ricardo Baptista, Procella Therapeutics, Sweden
Nina Bauer, MilliporeSigma, USA
Lorraine Borland, Sartorius, UK
Amit Chandra, YPOSKESI, France
Elizabeth Cheeseman, Independent Consultant, UK
Tania Pereira Chilima, Univercells Technologies, Belgium
Gisele Deblandre, MaSTherCell, Belgium
Jo Mountford, SNBTS Advanced Therapeutics, Scotland
Clive Glover, Pall, UK
Azadeh Golipour, AVROBIO, USA
Mike Kallos, University of Calgary, Canada
Masahiro Kino-oka, Osaka University, Japan
Todd McDevitt, Gladstone Institutes, USA
Chris Moore, Exact Sciences, USA
Nicholas Ostrout, Lonza, US
Qasim Rafiq, University College London, UK
David Schaffer, University of California-Berkeley, USA

Conference Program

Conference Sessions

Session 1: Gene editing and emerging technologies

Session Chairs: 

Ricardo Baptista, Procella Therapeutics, Sweden
Krishanu Saha, University of Wisconsin, USA

Session Scope:

This session focuses on state-of-the-art technologies, technical advancements, and challenges to implementing gene delivery and editing methods that support the manufacture of gene-edited products, including gene therapies and cell-based products for autologous and allogeneic therapies. 

Confirmed Speakers:

Keynote – Michele Sadelain, Memorial Sloan Kettering – USA
Samir El Andaloussi, Karolinska Institute – Sweden
Tom Brieva – Tmunity Therapeutics – USA

Invited Speakers:

Boon Hwa Neo, Lonza – USA
Alois Jungbauer, University of Vienna – Austria
Lili Belcastro, Bristol Myers Squibb – USA
Lauren Sarko, University of Wisconsin-Madison – USA

Session 2: Advances in viral vector manufacturing

Session Chairs: 

Sven Ansorge, ExCellThera, Canada
Paula Alves, IBET, Portugal

Session Scope:

Viral vector manufacturing presents a significant bottleneck to further advance cell and gene therapies. This session will provide an overview of current state-of-the art industrial viral vector manufacturing while also highlighting strategies that are currently explored in R&D settings to reduce viral vector capacity constraints currently faced by the field. 

Confirmed Speakers:

Keynote: David Schaffer, University of California – Berkeley, USA
Ying Jing, Bluebird Bio, USA
Manny Otero, Turnstone Biologics, USA
Konstantin Konstantinov, Codiak Bioscience – USA

Invited Speakers:

Gwendal Gränicher, Max Planck Institute – Germany
Annabel Lyle, University College London – UK
Kory Blocker, University of Pennsylvania – USA
Nripen Singh, Passage Bioscience – USA
Carme Ripoll Fiol, University College London – UK
Tania Pereira Chilima, Univercells – Belgium

Session 3: Advances in cell therapy manufacturing

Session Chairs: 

Jo Mountford, SNBTS, Scotland
Masahiro Kino-oka, Osaka University, Japan

Session Scope:

Many of the emerging technologies in cell production have led to more stable manufacturing processes; however, these have tended to be cell type, or product, specific. It is essential to capture and apply common lessons from these developments to a wider range of products, in particular those that require multi-phase processing with widely differing requirements (e.g. iPSC-derived cell products).  Further, increasingly complex products (combining genetic modification, cell differentiation, etc.) necessitate the development of new manufacturing, monitoring, and analytics technologies that improve process stability, efficiency, and robustness. 

Confirmed Speakers:

Keynote: Jen Moody, Pall Corporation – Canada 
Allan Dietz, Mayo Clinic – USA
Rupa Pike, Thermo Fisher Scientific – USA
Ricardo Baptista, Procella Therapeutics – Sweden

Invited Speakers:

Rui Li, University of Minnesota – USA
Jeff Zurawski, DiscGenics – USA
Ioannnis Papantoniou, Katholieke Universiteit Leuven – Belgium
Sho Sato, Fujifilm Cellular Dynamics – USA
Lavanya Peddada, Century Therapeutics – USA
Bryan Wang, Georgia Tech – USA

Session 4: Analytics and big data

Session Chairs: 

Behnam Ahmadian Baghbaderani, Lonza, USA 
Boyan Yordanov, Scientific Technologies, UK

Session Scope:

As the cell and gene therapy fields continue to advance, we are using larger and more complex data sets to generate a deeper understanding of product quality and to derive control strategies to improve product manufacture.  However, deriving process understanding from big data remains difficult.  

Confirmed Speakers:

Keynote – Dayue Chen, Genentech – USA
Nicholas Clarkson, Oxford Biomedica – UK
Susanne Rafelski, Allen Institute for Cell Science – USA
Marc-Olivier Baradez, Cell and Gene Therapy Catapult – UK

Invited Speakers:

James Colter, University of Calgary – Canada
Shreyas Rangan, University of British Columbia – Canada
Roland Ashton, Bristol Myers Squibb – USA

Session 5: The future of product release

Session Chairs: 

Lorraine Borland, Sartorius Stedim Biotech, UK 
Azadeh Golipour, AVROBIO, USA

Session Scope:

Whilst bioproduction methods and in-process analytics become ever more complex for cell and gene therapy products, regulatory lot release remains highly dependent on traditional testing approaches. In order to meet our industry needs for the rapid release of these products whilst meeting regulatory standards we must look to new quality control strategies and innovative methodologies. In this session we will explore the regulatory challenges, our current limitations and technology gaps and how we can address these points. 

Confirmed Speakers:

Keynote – Yan Zhang, Mission Bioscience – USA
Luca Biasco, AvroBio – USA
Stuart Wright, Sartorius Stedim Biotech, UK 
Amy Glekas, Merck Millipore – USA

Invited Speakers:

Ian Anderson, Pharmaron – UK
Lily Li, Cell and Gene Therapy Cataput – UK
Purna Venkataraman, Bluebird Bio – USA

Pre-Conference Workshop

Workshop chairs:

Thomas Heathman, Ori Biotech North America, USA

Nina Bauer, MilliporeSigma, USA

Carolyn Yeago, Georgia Tech, USA

Workshop Contact Email:  cgt2022preconfws@engconfintl.org

ECI Pre-Conference Workshop

How Can Analytics Enable Manufacturing Automation, Process Robustness, and Deliver Patient Access to Life-Saving Cell-Based Therapies?

Background

Cell-based therapy manufacturing is a complex, often manual, time- and labor-intensive process. As a consequence, price tags remain high, and treatments are only available to a select few. While the focus is typically on manual labor and lack of automation, product understanding is another component that contributes to the complexity. For true process automation to enable scalability in the cell-based therapy industry, analytical methods must be developed and implemented that have a path to becoming fully integrated into cell-based therapy manufacturing processes. 

Overview

In this workshop, you will learn from and work with preeminent industry and academic experts to assess the role testing and analytics will play in enabling next-generation cell-based therapymanufacturing.

This will be approached in four consecutive sessions:

1. Lessons from Past Experience: Learning from the previous biopharmaceutical industries (e.g. monoclonal antibody industry) to identify core gaps in establishing efficient testing and characterization paradigms for cell-based therapy products.

2. Solutions and Technologies: Identifying existing and emerging technologies to address these gaps in the mid-term and explore application to product characterization and drug discovery.

3. Impact Assessment: Assessing the integration of routine testing and manufacturing automation and discussing next steps in process and analytical optimization and standardization.

4. Building a Roadmap: Defining a development plan and identifying appropriate industry and academic sectors for enablement of the generated solutions. 

Audience and Outcomes

The workshop is aimed at members of the cell-based therapy industry at all levels of technical expertise that want to understand and discuss the role of analytical methods in enabling manufacturing automation. Bringing together a broad range of backgrounds and experiences will help the attendees to develop a deeper understanding of cell-based therapy product testing. Through case study-led workshops, the participants will assess the current state of the cell-based therapy industry and work jointly on a roadmap for implementing analytical methods that will enable manufacturing automation based on profound product understanding.

Confirmed Speakers

  • Damian Marshall, Achilles Therapeutics, UK
  • Taby Ahsan, MD Anderson Cancer Center, USA
  • Scott Jackson, NIST, USA
  • Joseph Valdez, Berkeley Lights, Inc., USA
  • John Churchwell, Cell & Gene Therapy Catapult, UK

Call for Abstracts

All submissions should be submitted electronically HERE.

Submission deadline is September 13, 2021 for both oral poster presentation.

Please prepare your abstract according to this template: docx or doc.

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.

Christopher Hewitt Outstanding Young Investigator Award

ECI is pleased to announce that Andy Tay Kah Ping (Imperial College London/National University of Singapore) is the winner of the first Christopher Hewitt Outstanding Young Investigator Award.

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, Tuesday and Wednesday nights), all meals, 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 31, 2021Register after December 31, 2021
Participant (single occupancy or sharing room with a guest; guest fee additional)US $2,990.00 US $3,190.00 
Participant (sharing a room with another participant)US $2,510.00 US $2,710.00 
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 $2,095.00 US $2,295.00 
**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (Includes all conference included meals as well as the conference excursion)US $1,265.00 US $1,265.00 

Workshop 
Pre-Conference Workshop for ParticipantUS $350.00
Pre-Conference Workshop for StudentUS $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. 

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

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.  

All participants are encouraged to register before December 31, 2021There is a discounted price for registering before this date.  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 and COVID-19 vaccination proof is verified by ECI staff.  ECI reserves the right to cancel your room registration if payment is not received or your vaccination proof is invalid. Your invoice/receipt will automatically be e-mailed upon of receipt of your registration.  Should you need a signed receipt, please contact Kathy Chan (kathy@engconfintl.org).

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. The participant must pay any additional costs for special meal requests to ECI.

Payment must be made by credit card (Visa, MasterCard, and 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 must be 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 may 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 if 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). 

Venue Information

The conference will take place at Loews Coronado Bay Hotel (4000 Coronado Bay Road, Coronado, California).  Set 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. Room 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.

Sponsor Logos

Gates Foundation

Sponsor Packages

Package A – Basic sponsorship: $3,000 

• Name of Company on Sponsor List in program 

Package A+ – Basic social event sponsorship (limit 3 – first come first served): $4,500 • Name of Company on Sponsor List in program 

• Branding (banner) at evening social event 

Package B – Sponsor a break: $6,000  

• Name of Company on Sponsor List in program 
• Named sponsor at an event (e.g., coffee break, poster session) 
• Full page advertisement in program 
• Company logo and link on conference website 
• Company logo displayed on screen between sessions 

Package B+ – Advanced social event sponsorship (limit 1 – first come first served): $7,500

• Name of Company on Sponsor List in program 
• Branding (banner) at evening social event (banner to be provided by sponsoring company) • Brief (< 3 min) welcome address at social event 
• Name of Company on Sponsor List in program 
• Named sponsor at an event (e.g., coffee break, poster session) 
• Full page advertisement in program 
• Company logo and link on conference website 
• Company logo displayed on screen between sessions 

Package C – Exhibit and attend: $12,500 

• Name of Company on Sponsor List in program 
• Full page advertisement in program 
• Company logo and link on conference website 
• Company logo displayed on screen between sessions 
• Table display 
• 1 complimentary all-inclusive registration 

Package D – Sponsor a session (first come first served): $22,000 

• Name of Company on Sponsor List in program 
• Full page advertisement in program 
• Company logo and link on conference website 
• Company logo displayed on screen between sessions 
• Table display (premium location – sponsor’s choice) 
• Sponsor a session: includes introduction to the session chairs and 1 slide (2 min) to introduce the  company 
• 1 complimentary all-inclusive registration 
• Digital advertisement pre-conference announcement / program 
• Company information packet available in attendees’ registration materials 

Kevin Korpics (kevin@engconfintl.org) (+1-212-514-6760) may be contacted for invoicing and other  questions. Please make checks payable to:  

Engineering Conferences International 
Attn: Advancing Manufacturing of Cell & Gene Therapies VI  
32 Broadway, Suite 314  
New York, NY 10004  

Payment can also be made via wire transfer or credit card.  

You must reference your company name and the conference title “Advancing Manufacture of Cell & Gene  Therapies VII” or code (21-AT) so the contribution can be identified. Thank you in advance.

General Information about ECI

Engineering Conferences International (ECI) is a not-for-profit, 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 conference provides morning and late afternoon or evening sessions in which major presentations are made. Poster sessions will be scheduled for evening discussion as well. 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 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.

Smoking is prohibited at ECI conferences and conference functions.