Advancing Manufacture of Cell and Gene Therapies VI

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 Greg Russotti selected for the 2019 Advancing Manufacture of Cell and Gene Therapies Award

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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 (Sartorius Stedim) 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 (Aston 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 (Vium)

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:

Prof. Corinne Hoesli, McGill University
Prof. Joaquim Cabral, IST Lisbon, Portugal

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 Pharma, A Gilead Company
Justin Cooper-White, University of Queensland
Suzy Farid, UCL
Peter Fuhrken, Cellular Dynamics International
Richard Grant, FloDesign Sonics
Jon Gunther, Juno Therapeutics, A Celgene Company
Thomas Heathman, Hitachi Chemical Advanced Therapeutics Solutions
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, Sartorius Stedim
Mark Powers, Thermo Fisher Scientific
Qasim Rafiq, UCL
Krish Roy, Georgia Tech
Emily Titus, CCRM

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:           Closed                
Poster abstract submission deadline:      Closed

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.

Greg Russotti

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and Engineering Conferences International are pleased to announce that Greg Russotti of Celgene is the recipient of the 2019 Award for Advancing Manufacture of Cell and Gene Therapy.  The award will be presented at the Advancing Manufacture of Cell and Gene Therapy VI conference, January 27-31, 2019 in Coronado, California.

Greg Russotti has established himself as a world leader in the field of cell therapy technical development and manufacturing. He joined Celgene over 12 years ago, just as Celgene began major efforts in the cell therapy field.  He was initially responsible for process and analytical development of all cell-based processes at Celgene and was soon appointed CMC lead for Celgene’s placental cell therapy product, PDA-001, with accountability for all technical operations activities, including process and analytical development, clinical production, quality control, quality assurance, and supply chain. Greg later took on functional responsibility for the aforementioned areas for all cell and tissue-based products.

Greg led Celgene’s technical development efforts to drive five different cell therapy products to IND and clinical stage, including two different placental cell therapy products, cord blood-derived Natural Killer cells, autologous cytotoxic T lymphocytes, and autologous CAR T cells. Greg was awarded Celgene’s most prestigious internal award, the John W. Jackson Leadership Award, in 2011 for driving Celgene’s decision to build in-house cell therapy manufacturing capabilities and leading Celgene in the cell therapy space. This award is given to only one employee in the company each year.

Greg is known globally as a leader in the field, having given over 25 invited presentations and keynote lectures, including two presentations at the FDA, and one at the EMA. He has participated in various panel discussions and has given webinars at the largest cell therapy conferences in the US, Canada, and Europe. Greg was the meeting co-chair for first four Annual ECI Scale-up and Manufacturing of Cell- Based Therapies conferences, from 2012 to 2015, helping shape and build the conference. He remains actively involved as a Steering Committee member.

Greg is actively involved in various national consortia. His roles include:

  • Celgene’s technical cell therapy lead on NIIMBL
  • Executive Committee member of the NSF-funded Center for the Manufacturing of Advanced Therapeutics, being led by the Georgia Tech
  • Industrial Executive Board Chairman of the Marcus Center for the Commercialization of Cell Therapies ($27MM facility) at Georgia Tech
  • Executive Committee member of NIST-funded American Technology Cell Therapy Manufacturing Consortium, led by the Georgia Research Alliance
  • Advisory Board Member of the Cell Therapy Facility at the NJ Institute of Innovation (at NJIT)

Greg has maintained a strong relationship with the academic community by serving in the following roles:

  • Industrial Advisory Board Member in Rutgers University’s Biomedical Engineering and Biochemical/Chemical Engineering Departments
  • Guest lecturer in various classes at Rutgers and in past years at Princeton, Columbia, Georgia Tech, NC State, NJIT, and Michigan State
  • Lecturer at the International Advanced Course on Regenerative Medicine Manufacturing, hosted by Technical University of Lisbon, Loughborough University, and Georgia Tech University, in 2013 in Portugal and in 2016 in Hilton Head, NC

Greg also designed, organized and taught a graduate level topics-based course, “Bioprocess Engineering: Fundamental and Real World Perspectives” in Rutgers University’s Biomedical Engineering and Chemical/Biochemical Engineering Departments from 2000 until 2010, after which he passed the torch to others who have since led this course, which continues to enjoy success. For his active involvement in the Rutgers community and his leadership in the cell therapy field, Greg was awarded the Rutgers Engineering School Distinguished Alumnus Medal of Excellence in Education and Research in 2013. This award is given by Rutgers School of Engineering to one recipient per year.

Prior to joining Celgene in 2006, Greg spent 15 years at Merck Research Laboratories developing products that included live virus vaccines, monoclonal antibodies, recombinant vaccines, and microbially-produced natural products. He worked on development, scale-up, and tech transfer of cell culture, microbial fermentation, and downstream isolation processes to clinical and commercial manufacturing facilities. Greg received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and his Ph.D. in Chemical and Biochemical Engineering from Rutgers University.

Currently, Greg has functional responsibility for all cell therapy development areas at Celgene, including cell culture, isolation and formulation process development, analytical development, product attributes sciences, development operations, which includes high throughput testing and data automation, clinical manufacturing QC, and manufacturing sciences, which supports clinical and commercial manufacturing.

Major Sponsors

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Conference Venue

The conference will take place at Loews Coronado Bay HotelImage 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.

Address:  4000 Coronado Bay Road, Coronado, California  92118.  Tel:  619-600-5966

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.

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.

Car Rental at the airport.

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 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 14, 2018 Register after December 14, 2018
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 $1,060.00 US $1,060.00
Workshop and Saturday Night Accommodations
Saturday Night Hotel Accommodation (for those attending Sunday’s Workshop) you must be registered for the conference in order to book a Saturday night arrival. US $232.48
We have a limited number of rooms for Saturday, January 26, 2019, you must contact
Kathy Chan to book a
Saturday night arrival.
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.

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

Pre-and Post-Conference Reservations

If you are planning to arrive early (before January 27) or to stay after the conference (after January 31), 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 kathy@engconfintl.org.

Special Notes for Payment

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 and late registrants may be housed in a nearby hotel.

All participants are encouraged to register before December 14, 2018.  There 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.  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.  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).

Register Now!

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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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