ADVANCED THERAPIES XCHANGE
San Diego, USA
February 29, 2024

Welcome to hubXchange’s Advanced Therapies Xchange Europe 2024, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in cell and gene therapeutics.

Discussion topics will cover Viral Vector Production, Autologous C&G, Allogeneic Cell Therapies, and iPSCs Technology.

Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.

Venue: Handlery Hotel San Diego, 950 Hotel Circle North, San Diego CA 92108

SNAPSHOTS OF DISCUSSION TOPICS

Track 1: Viral Vector Production

Transitioning from adherent cultures to suspension cultures when scaling AAV vector production.
Enhancing yield and purity of vectors through optimized chromatography purification techniques.

Track 2: Autologous C&G

Block-chain enabled digital platforms to break down siloes in autologous cell therapy manufacturing.
Improving efficiency and reducing inter-batch variation with automated Cell Expansion Systems.

Track 3: Allogeneic Cell Therapies

Enabling long-term storage and transportation using Cryopreservation Techniques.
Implementing microfluidic chip-based assays to provide real-time information on critical quality attributes.

Track 4: iPSCs Technology

Assessing genetic stability with arrayComparative Genomic Hybridization (aCGH).
Addressing heterogeneity challenges using single-cell clonal expansion.

Full Xchange Agenda

Click on each track for detailed agenda

Viral Vector Production

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05

Transitioning from adherent cultures to suspension cultures when scaling AAV vector production.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Defining gene-editing nucleases and plasmid DNA manufacturing strategies (TBC)

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Poster Session

15:35 – 16:35

Enhancing yield and purity of vectors through optimized chromatography purification techniques.

16:35 – 17:35

Evening Drinks Reception

Autologous C&G

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05

Digital platforms to break down siloes in autologous cell therapy manufacturing. (TBC)

Alice Lin, Head of Analytical Development & QC, Neogene Therapeutics

Experienced biotech professional with 5+ years leadership roles focusing on assay development and quality control. Participated in 10+ filing including IND, IMPD, and BLA of cell therapy products. Well-versed in AD/QC, regulatory requirements, cross-functional CMC project management and global tech transfers.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Beyond development and into the clinic: How do we mitigate the impacts of the narrow cell viability window to make cell therapies viable at scale, as treatments in hospitals worldwide? (TBC)

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Poster Session
Manufacturing of Autologous Novel T Cell Therapies Using the Cocoon® Platform Automated System (TBC)

15:35 – 16:35

Improving efficiency and reducing inter-batch variation with automated Cell Expansion Systems.

How can we ensure consistent product quality in autologous cell therapy when starting with patient-specific cell sources, given inherent biological variations?
What measures can be taken to standardize critical process parameters, such as culture conditions, to reduce inter-batch variability and improve reproducibility?
How can we integrate real-time monitoring and data analytics into our cell expansion systems to gain better control over the manufacturing process and enable quicker corrective actions?
In the context of automated cell expansion, how can we proactively address the risk of cross-contamination, particularly when handling patient-derived cells, and what best practices should be implemented?
-What regulatory and compliance challenges need to be addressed to ensure the adoption of automated cell expansion systems for autologous cell therapy while maintaining product quality and patient safety?

Yang Qiu, Director (MSAT), ImmPACT Bio

Yang is currently the Director of MSAT at ImmPact Bio. He has held various leadership positions in process development and clinical manufacturing of various CAR-T or iPSC-derived cell therapy products (including VX-880 and VX-264 by Vertex Pharmaceutics, Ebvallo and ATA-188 by Atara Biotherapeutics, FT596, FT522 and FT819 by Fate Therapeutics).

16:35 – 17:35

Evening Drinks Reception

Allogeneic Cell Therapies

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation ALBUMEDIX (Elm)

09:05 – 10:05

Cryopreservation, Long Term Storage, logistcs

Large scale fill finish and cryopreservation
Storage and stability
Shipping logistics and storage at clinical sites

Amanda Medcalf Conerty, Exec. Director Analytical and Process Development and Manufacturing, Artiva Biotherapeutics

Amanda is the Executive Director of Process, Analytical Development and Manufacturing at Artiva Biotherapeutics, Inc., a biotechnology company dedicated to developing off-the-shelf, allogeneic, NK cell therapies. Amanda is an ASCP-certified clinical laboratory scientist with more than 20 years of in cell therapy development and manufacturing. Currently, she leads PD, AD, manufacturing, and supply chain operations for cell products across all development programs. Prior to Artiva, Amanda spent more than 8 years at Fate Therapeutics, where she held positions of increasing responsibilities in the CMC group, culminating in her position as Senior Director of Manufacturing and Quality Control. Amanda holds a BS in Clinical Laboratory Science and a Graduate Certificate in Reproductive Laboratory Science from the University of Kentucky.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Poster Session

15:35 – 16:35

Using closed system automation to improve consistency and repeatability in allogeneic T cell manufacturing processes

How can we successfully implement automation and closed system manufacturing for allogeneic T cell therapies?
What commercially available technology(s) are most compatable with the unique requirements and workflows for allogeneic t cell processes (i.e. cell engineering, purification, high capacity expansion, etc.)?
What approaches are developers taking to automate some or all of the manufacturing workflow for allogeneic t cell therapies?
What CMC / regulatory strategies are most effective to move from legacy to more advanced systems, and what is the sentiment from the FDA on how this can be properly and safely accomplished? What is needed to show true comparability and how does this criteria change depending on the stage of development your program is in?

Matthew Beton, Director (Process Development), Tr1X

Matt is the current Director of Process Development at Tr1X – a company developing a novel class of off-the-shelf reguatory T-cell based products to cure autoimmune and inflammatory diseases. Matt has over a decade of experience in C&GT process development and manufacturing, with a successful track record of helping small to midsize Biotechs advance their cell therapy programs starting from early pre clinical development to Phase I/II clinical trials, and on to BLA filing. Prior to Tr1X, Matt served as the Associate Director of MSAT for Poseida Therapeutics, where he oversaw late stage process development and MSAT for the company’s leading allogeneic cell therapy assets, P-BCMA-ALLO1 and P-MUC1C-ALLO1.

16:35 – 17:35

Evening Drinks Reception

iPSCs Technology

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation ALBUMEDIX (Elm)

09:05 – 10:05

Implementing in-process assays to monitor and steer successful manufacturing outcomes

What are suitable rapid in-process-control testing approaches for iPSC and their derivatives?
How to select the best quality iPSC clones early and with greater confidence?
Can image analysis combined with machine learning enable an autonomous process decision control strategy?

Thorsten Gorba, Vice President of Process and Analytical Development, Aspen Neuroscience

Thorsten Gorba, VP of Process & Analytical Development at Aspen Neuroscience, is a developmental neuroscientist and stem cell biologist, who has been a consultant to the advanced therapies field. He has 25 years of academia, biotechnology, and pharmaceutical industry experience. He recently served as the founding Translating Center Director of the Cell and Gene Therapy Center at IQVIA, where he was responsible for its initial build and sustainable operation. Before IQVIA, Thorsten worked at StemCells, Inc. where he was tasked with leading assay design, qualification and process implementation for neural stem cell product release used in several neurological clinical trials.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 15:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Poster Session

15:35 – 16:35

Addressing heterogeneity challenges using single-cell clonal expansion.

16:35 – 17:35

Evening Drinks Reception

ADVANCED THERAPIES XCHANGE San Diego, USAFebruary 29, 2024

SNAPSHOTS OF DISCUSSION TOPICS

Full Xchange Agenda

Viral Vector Production

Partners

ADVANCED THERAPIES XCHANGE
San Diego, USA
February 29, 2024