Advancing Manufacture of Cell and Gene Therapies VIII

February 4 – 8, 2024
Loews Coronado Bay Hotel
Coronado, CA

Register Now

Preliminary Program (Dec 7, 2023)

Conference Organization

Conference Chairs

About This Conference

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

In February 2024, ECI will deliver yet another unique meeting with a specific focus on the latest advancements, trends and disruptions from the past two years impacting both cell and gene therapies. Our attendees and speakers include scientists and engineers in various sectors from all over the world working to improve manufacturing of advanced therapeutics. The sessions will cover advances and emerging concepts and technologies related to gene editing, digitalization and automation, manufacturing strategies, and much more. We welcome, celebrate, and take pride in achieving such a diverse environment that we feel helps deliver a very unique meeting. The conference delivers an appreciation of the field’s achievement, an acknowledgement of the hurdles, and a sense of direction for the future. Check back often as details on session titles, keynote speakers, and the overall program are updated regularly. We hope to see you there!

Session Descriptions

Session 1: Viral vector and gene editing platforms – Progress and challenges in process development, manufacturing, product characterization and technology landscape.   

Session Chairs

Invited Speakers

Since the first commercially viral vector (Vv)-based gene therapy approval in 2015, a number of Vv therapies have made their way into the late stages of clinical development and commercialization. These therapies target a multitude of indications from ophthalmology to musculoskeletal indications using different vector serotypes and resulting in a wide range of annual demand. However, substantial improvements in Vv manufacturing are essential in order to provide the right capacity, while reducing costs and increasing process robustness and quality. Moreover, the differences in needs between different programs (vector, serotype, dose size etc.) makes it challenging to establish platform processes for Vvs.

Additionally, other non-viral vector gene editing technologies including peptide-based and lipid-based systems as well as CRISPR–Cas9 technology and electroporation have increasingly been explored as alternatives to viral-based gene editing. This session aims to address Vv manufacturing challenges, as well as advances in emerging non-vector gene-editing technologies and their deployment in human clinical trials. 

• Viral vector upstream process: Technologies, titres, cell densities, scalability, reagent selection (transfection reagents, media with or without serum)
• Viral vector downstream process: yields, full to empty capsids separation, new protocols 
• Continuous process in viral vector processing: Perfusion, continuous chromatography, product stability, automation 
• Product quality and process control: product quality, full to empty capsid separation, in-line, off-line and at line process monitoring and control  
• Advances in novel gene editing modalities 
• Analytical methods for process and product characterization of Vvs and other gene editing methods 
• Analytical methods Add a component of analytics specific to vectors and gene editing 

Session 2: Advances in Cell Therapy Manufacturing Technology to Enable Autologous and Allogeneic Applications 

Session Chairs

Invited Speakers

The cell therapy field is now comprised of commercially approved, autologous CART therapies, as well as emerging next-generation products that employ autologous and allogeneic approaches. Given the different manufacturing challenges associated with each type of cellular product (e.g., scale, centralized v. decentralized supply chains), novel technologies and flexible solutions are required from the bioprocessing community to continue to drive down therapy costs. In this session, we will explore the latest cell therapy manufacturing technologies that can resolve these challenges with a focus on: 

• Novel manufacturing platforms for next-generation cell therapies e.g., iPSC, γδ T-cells, gene-modified CD34+, MSC, exosomes 
• New upstream/cell culture reagents and technologies e.g., bioreactors, xeno-/serum-free media, cytokines and growth factors, process scaling strategies (up/out) 
• Advanced downstream processing technology including cell separation, drug product fill/finish, cryo-preservation/formulation 
• Advances in assessing and qualifying raw materials for autologous and/or next-generation exosomes, etc. 
• Add the possibility of Quality Control approaches/advances 

Session 3: Digitization, Process Control, and Closed-system Automation in Cell and Gene Therapies

Session Chairs

Invited Speakers

Digitization and process automation will be critical for scalable and quality-driven manufacturing of cell and gene therapies. It can help with product consistency, reducing the cost of goods and labor, and ultimately improving access to these therapies. Digitization involves reducing paper-based data and integrating diverse types of data, including reagent and raw material data, cell and product specific data, analytical data, process measurement data, and data from the supply chain, as well as clinical and patient data. Focus on digitization is expected to allow for better decision-making, identification of key process and product attributes, reduction of cost-of-labor, reduction of mistakes or failures and overall improvement of manufacturing. Similarly, automation is key to scalable production and quality control of cell and gene therapies. Current efforts are focused on end-to-end fixed process automation, integration of analytical tools, and, ultimately, process control with automation. 

Topics of interest for this session include:  

• End-to-end automation of processes and assays in cell and gene therapies 
• The current state of digitization and related software and data management tools 
• Development of in/at line process sensors and analytical tools/algorithms and integration of them into automated processes.  
• Use of digitization and process/supply-chain models to reduce cost and labor or to improve decision making 
• Digitization strategies for centralized v decentralization manufacturing models

Session 4: In-Process and Analytical Control Strategies for Cell and Gene Therapies 

Session Chairs

Invited Speakers

The diversity and complexity of cell and gene therapies has increased in a very short amount of time due mostly to rapid development of different vector hosts, understanding of gene editing mechanisms and evading the human immune response.  The process, ancillary reagents and associated in-process analytics, as well as the Potential Critical Quality Attributes required to ensure a safe and efficacious product are filled with challenges and many lessons learnt.  In-Process methods are required to provide quick, precious results to drive process development, while Release/Stability methods need to be robust, validated and many must be stability indicating, while Characterization Methods must be informative and may need to meet the requirements of release methods.  We aim to discuss the unique challenges of these different methods and analytes, such that we can understand what methods are universal and which may be adopted to the different analytes today and tomorrow.  

We invite abstracts that address some of the latest approaches to the analytical control of these varied analytes.  Topics of particular interest are: 

• Rapid analytical testing 
• pCQA assessment of cell and gene therapies 
• Adoption of analytical methods from other therapeutic modalities 
• Phase appropriate analytic control of ancillary reagents 
• Potency methods relationship to Mechanism of Action. 
• Quality by Design 
• Bioprocess control and monitoring 
• Establishing Stability Protocols  

Session 5: Critical Early Decisions in Regulatory Strategies and Standards to Facilitate Product Development

Session Chairs

Invited Speakers

This session will explore the question how do we ensure products meet evolving guidances and remain consistent across sites, throughout process changes, and over time. The cell and gene landscape is quickly evolving with the pace of new product development accelerating and an ever increasing number of products advancing through clinical trial stages to commercialization. It is critical that regulatory strategies not only accommodate the faster timelines but also include earlier consideration of issues related to more mature products. These strategies need to balance the investment in early process development efforts with the requirements for comparability studies at later stage clinical trials or commercial production.

Topics of interest for this session include:

• Implications of regulatory guidance updates 
• Lifecycle management of processes and product definition
• Approaches to ensure consistent quality across multiple manufacturing sites
• Design and strategies related to comparability studies

We invite abstract submissions focusing on: 

• Latest regulatory guidance updates 
• Management of multicenter and global clinical trials 
• Lifecycle management of manufacturing strategies; Approaches to COGS reduction 
• Addressing royalty stacks 
• Centralized and decentralized manufacturing models 

Fireside Chat

Moderator

Speakers / Panelists

A recap of the last 2 years and outlook into the future of cell and gene therapies

Cell and gene therapies industry continues to thrive. There is no doubt that interest on these life changing therapies is high. Yet the last few years have been challenging for everyone and our industry has inevitably felt the crunch. Investments have changed. The same amount of dollars now need to stretch further, the overall pot is lower than it was during the pandemic and opportunistic investors have directed their focus elsewhere. 

The sector has also changed. We are considerably more mature as an industry and therefore the expectations are now different. Good science is a given, a must, but is enough? For more “established” autologous therapies or viral vectors as well as for more novel therapeutics that promise to address solid tumors and other unvalidated pathways, the expectation is that manufacturing of commercial products will become robust, efficient and more cost effective to yield long lasting, profitable businesses. 

We will discuss with a panel of experts how, if at all, investment has changed. Is the focus on enabling technologies for CGTs rather than largely on therapeutic assets? And if so, does that mean it is an opportunity to push for tools and technologies that will enable Industry 4.0 that we have been talking about for the past few years?

Call for Abstracts

Session titles are available above.  Please use these titles to pre-select up to two 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 18, 2023                
Poster abstract submission deadline: September 18, 2023             

Poster size:  Your poster should be no larger than 1.5 meter high and 1.0 meter wide (Portrait Style)

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.

Pre-Conference Workshop

Cell and Gene therapy value chain inherently is different from current biopharma products because it is closed loop and has a highly complex supply chain. In essence, successful execution requires collaboration and coordination of a complex network consisting of raw material suppliers, technology suppliers, specialty product distributors, manufacturing facilities, etc. This workshop will discuss the strategic design principles for operating models.

This workshop will include four sessions:

1. Manufacturing strategy – centralized vs. de-centralized, in-house vs. CDMO
2. Supply chain strategies for critical reagents at various stages of clinical development
3. Cost of goods modeling
4. Critical Capabilities/skill sets required (open forum)

Workshop Agenda

Pre-Conference Workshop Fee and Registration

Pre-Conference Workshop registration includes workshop registration and lunch on Sunday. Accommodation for Saturday, Feb 3 is not included and needs to be reserved separately. Workshop registration can be add-on during the conference registration process. Please see the conference fee and registration section for details.

Workshop Fees:
Participants: US $395
Students: US $275

Building a flexible manufacturing strategy to navigate turbulent global markets 

Chairs

Moderators

Speakers

Conference Fees and Registration

Conference Fees

The conference fee includes the following: conference registration, accommodations (nights of Sunday (February 4), Monday (February 5), Tuesday (February 6), and Wednesday (February 7); check-out on Thursday (February 8)), four breakfasts, three lunches, three dinners, and coffee breaks plus snacks.  Dinner on Monday (February 5) is on your own. Incidental fees (laundry, minibar 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 January 8, 2024	Register after  January 8, 2024
Participant (single occupancy or sharing room with a guest**; guest fee additional)	US $3,400	US $3,800
Participant (sharing a room with another participant/student)	US $2,800	US $3,200
Bona fide Graduate Student (sharing a room with another participant/student) (Those in this category must upload proof of current status during registration – copy of current Student ID or a letter from your University confirming your student status)	US $2,385	US $2,685
Bona fide Graduate Student (single occupancy or sharing room with a guest**; guest fee additional) (Those in this category must upload proof of current status during registration – copy of current Student ID or a letter from your University confirming your student status)	US $2,985	US $3,285
**Fees for Guest/accompanying person sharing bedroom with a participant. (Includes all conference included meals and activities) Guests/accompanying persons may not attend technical sessions.	US $1,140	US $1,140
**Fees for Guest/accompanying person sharing bedroom with a participant. (Room ONLY, NO meals and activities) Guests/accompanying persons may not attend technical sessions.	US $-	US $-

If you plan to bring children to the conference, please contact Kathy Chan for pricing.

Conference Registration

Register Now

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 Kathy Chan.

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 January 8, 2024.  There is a discounted price for registering before this date.  Hotel space cannot be guaranteed for registrations received after January 8, 2024.  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 or a certificate of attendance (sent after the conclusion of the conference), please contact Kathy Chan.

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 that ECI pays a surcharge for.

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 Kathy Chan for the bank information. You must add $30 to cover ECI bank charges. Please reference your full name and the conference title.  Please email a scanned copy to Kathy Chan.  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. The Engineering Conferences International conferences calendar and other information can be found on the ECI web site: www.engconfintl.org

Pre and Post Conference Reservation Form

Coming soon!

Call for Nominations and Cell and Gene Therapies Award

Advancing Manufacture of Cell and Gene Therapies Award

NOMINATION DEADLINE:  September 14, 2023

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, Peter Zandstra and Greg Rusotti. 

The award nominations will be judged according to criteria as set forth in this document. 

Award

For each conference, an award of cash and a commemorative plaque will be presented to the recipient at the conference.  The 2024 award is sponsored by Engineering Conferences International (ECI).

Eligibility

This Award is open to all industrial and academic researchers and practitioners in the field of cell-based therapies. It is expected that the award recipient will register and attend the conference. 

Evaluation

Nomination packages will be evaluated by a committee of leaders in the field established by the conference chairs

Criteria

The nominations will be judged on the originality, impact, and overall quality of work; significance to the development and commercialization of cell-based therapies; and other supporting information in the nomination package. 

Nomination Package

(all documents should have 1 inch margins all around and use font no smaller than Arial 11 or Times 12 point). 

Self-nominations are welcome.  The nomination package must consist of the following items:

1) A nomination cover sheet;

2) A nomination letter of no more than 3 pages including a description of the nominee’s contributions to the development and commercialization of Cell-Based Therapies; and

3) A resume including publications, patents, and other contributions by the nominee.

Optional items:

A maximum of two supporting letters from individuals in the field may be provided. 

The items in the nomination package should include the following information:

1) Name of nominee

2) Present position (exact title)

3) Mailing address (including email)

4) Education, including (a) Institution; (b) Degree received; (c) Year; (d) Major or field 

5)  Positions held
a) Companies or institutions
b) Positions or titles
c) Time periods

6)  Academic and/or professional honors and awards

7)  Technical and professional society memberships and offices held

8)  Supporting letters

9)  Nominator’s name, address (including email), signature and date

THE COMPLETE NOMINATION PACKAGE should be submitted in electronic form as a SINGLE PDF FILE WITH THE NAME OF THE NOMINEE, and should include the scanned, signed letters of support (if any). 

Nomination packages are due by midnight EST September 14, 2023 to:

Barbara Hickernell, ECI Executive Director, at barbara@engconfintl.org

Call for Nominations for Chris Hewitt Award

Engineering Conferences International is pleased to announce that nominations for the Christopher Hewitt Outstanding Young Investigator Award are now open.  The award recipient will be a promising young scientist whose work shows exceptional promise in the field of process development of cell based and gene based therapies.  The award includes the opportunity to present their research at the conference as well as the waiver of the conference registration fee. 

Chris was a leading biological engineer, distinguished for his research using flow cytometry and cell sorting to understand the interaction of the cell with the bioreactor environment within such diverse areas as microbial fermentation, bio-remediation, bio-transformation, brewing and cell culture. He was also the co-founder of the Centre for Biological Engineering at Loughborough University, where he developed a world-leading team in regenerative medicine bioprocessing. In particular, his team made a significant contribution to the literature on the culture and recovery of fully functional human mesenchymal stem cells in stirred bioreactors based on sound biochemical engineering and fluid dynamic considerations essential to scale-up for commercialization.  In recognition of his achievements, he was elected Fellow of the Royal Academy of Engineering in 2018. 

Chris Hewett was an active contributor to the ECI conference series “Advancing Manufacturing for Cell based and Gene Based Therapies”.  

Eligibility:  Any graduate student or post-doc is eligible as is any researcher with fewer than 5 years of industrial or academic experience.  Individuals who meet these criteria are invited to submit an abstract to be considered for presentation at the 2024 Advancing Manufacture of Cell and Gene Therapies Conference, curriculum vitae; and two supporting letters of recommendation.  

Submission of Nominations: Nominations will be accepted from January 1, 2023 through September 15, 2023..  The abstract should be submitted through the normal ECI procedure but a copy of it should accompany the curriculum vita and letters of recommendation.  Please email to barbara@engconfintl.org – subject line should read: Christopher Hewitt Award Nomination for (name of nominee)

Sponsors

Sponsor Packages

Package A – Basic sponsorship: $3,300 

• Name of Company on Sponsor List in program 

Package A+ – Basic social event sponsorship (limit 3 – first come first served): $5,000

• Name of Company on Sponsor List in program 
• Branding (banner) at evening social event (banner to be provided by sponsoring company) 

Package B – Sponsor a break: $6,500  

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

Package C – Exhibit and attend: $13,500 

• Name of Company on Sponsor List in program 
• Full page advertisement in digital 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): $23,500 

• Name of Company on Sponsor List in program 
• Full page advertisement in digital 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 VIII 
369 Lexington Ave., Suite 389 
New York, NY 10017 

Payment can also be made via wire transfer or credit card. Please note that a 3.5% transaction fee will be  applied to contributions made by credit card. You must reference your company name and the conference title “Advancing Manufacture of Cell & Gene  Therapies VIII” or code (24-AT) so the contribution can be identified. Thank you in advance.

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.

Check-in begins at 4:00 PM and Check-out time is by 12:00 PM.

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.

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.