April 3, 2023

Welcome to hubXchange’s Advanced Therapies Xchange 2023, East Coast, 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 Cell Tx Development, Gene Tx Development, C&G Tx Bioprocessing and C&G Tx Manufacturing.

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

Venue Details: Hilton Boston Woburn Hotel, 2 Forbes Road, Woburn MA 01801


  • Enhancing CAR-T cell efficacy
  • Alternatives to autologous- allogenic and in vivo cell therapies
  • The promise and challenges of PSC-CAR-NK cell therapy
  • Current landscape of non-viral vector technologies
  • Selecting the optimal route of administration and AVV serotype for neurological applications
  • Strategy, technology, and challenges to meeting speed and quality requirements during early phase development
  • Improving the upstream GT bioprocessing
  • Future of autologous cell therapy
  • Tackling the challenges of AAV vector manufacturing

Full Xchange Agenda

Click on each track for detailed agenda

Cell Tx Development

Titles and Bullets
08:00 – 08:30
08:30 – 09:00

Opening Address & Keynote Presentation
Applying principles of the 4th Industrial Revolution to accelerate novel therapeutic development

  • Digitalize data and meta dat
  • Digitalization of “Work” “Flow”
  • Integrate & streamline operations from research to development to manufacturing; and real-world data collection

President & Chief Executive Officer, L7 Informatics

Vasu Rangadass, Ph.D., President and CEO at L7 Informatics, Inc., is a leader in enterprise-scale digital transformation and automation of scientific processes. Previously, Dr. Rangadass was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide an enterprise-wide platform to simplify and optimize care delivery processes in health systems. Prior to Net.Orange, Vasu was the first employee of i2 Technologies (currently Blue Yonder), which later became a global company that revolutionized the supply chain market through innovative approaches based on Six-Sigma principles, operations research, and process optimization.

09:05 – 10:05

Enhancing CAR-T cell efficacy

  • Next generation approaches for cell therapy manufacturing focused on improving response
  • Better CAR: Current approaches to CAR design, construction and T cell engineering
  • Multidimensional analyses that create insights CAR T cell attributes associated with improved response
  • Approaches to data analyses: can product understanding help identify opportunities to identify manufacturing improvements?

Executive Director of Analytical Development, Kite Pharma (Giliead)

Max Tejada is a scientist with 20+ years of experience at Genentech, Gilead, AstraZeneca and Kite where he has led teams focused on the development, validation, and transfer of bioassay or immunoassays for therapeutic proteins, monoclonal antibodies, antibody drug conjugates and cell-based cancer immunotherapies. He has led analytical and Chemistry Manufacturing and Controls (CMC) teams for investigational oncology and immunotherapy programs and has been a contributing author on numerous regulatory filings in both early and late clinical phases. Max obtained his Ph.D. in Biochemistry from Queen’s University in Kingston, Ontario, Canada. He was a post-doctoral fellow in the laboratory of Dr. Napoleone Ferrara at Genentech.

Max Tejada
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 across the world?

  • How to improve the viability of cell therapies post-cryopreservation
  • Important considerations for extending cell viability at room temperature – during transport, and importantly, in the clinic
  • How may the quality of excipients affect the performance of the final cell therapy product?

Head of US Business Development, Albumedix

Brian is a passionate business development expert, with significant experience in identifying and facilitating collaborations in the life science space. Supported by a near four-decade portfolio of experience in recombinant albumin at Albumedix, Brian works with customers developing advanced therapies to support solution finding that gets their advanced therapies from the lab, into production, and deployment.

Brian MacDonald
12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation
Financial and other considerations for early phase cell and gene therapy manufacturing: Build, Buy or Blend?

This talk aims to compare the various options for early phase clinical manufacturing for cell and gene therapies. The traditional option of Build (internalizing manufacturing) and the factors to consider for facility build out, cGMP readiness and routine operations will be discussed, specific to cell and gene therapy operations. The factors and risks to consider with the traditional option of Buy (outsourcing to CDMO) will be discussed. The Blend approach via Azzur Cleanrooms on DemandTM and the acceleration advantages will be discussed. A financial comparison with a model mRNA therapy process/facility for all three options will be included in this presentation.

Chief Innovation Officer, Azzur Group

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was the President and COO of Azzur Cleanrooms on Demand™ and previously served as General Manager of the Boston-area consulting practice. Prior to Azzur, Ravi has been part of the technical operations and quality/validation departments at Baxter, Amgen, and Shire.

Ravi is an expert in phase-appropriate cGMP implementation, process validation, supplier management, and technology transfer. Azzur Cleanrooms on Demand™ offers flexible early-phase cGMP manufacturing options designed to mitigate risk and increase speed to clinic. In addition to his work with Azzur, Ravi is an active member of industry and peer groups, and he is a frequent speaker at industry events.

Ravi Samavedam
13:55 – 14:25
1-2-1 Meetings / Networking Break
14:25 – 14:55
1-2-1 Meetings / Networking Break
15:35 – 16:35

Alternatives to autologous-allogenic and in vivo cell therapies

  • Key challenges of autologous CAR-T cell therapy (in vitro activation and production, target selection, solid tumors, etc)?
  • Challenges and opportunity for allogeneic CAR-T cell therapy
  • Targeting tumor heterogeneity by modular CAR-T technology
  • T cell sources (PBMC, UCB, iPSC)
  • Could other types of cell therapies, CAR-NK, CAR-Macrophage, be a good alternative solution for CAR-T (better safety profile, less GvHD, no MHC, TCR)?

Chief Executive Officer, Biocytogen Boston

Qingcong Lin is SVP of Biocytogen and CEO of Biocytogen Boston Corporation, focusing on Biocytogen global business development on antibody discovery, RenMab/RenLite licensing and therapeutic antibody co-development, in addition to providing services on gene-targeting and humanized mouse models, using cutting-edge ESC and CRISPR-Cas9 technology and preclinical pharmacology, especially antibody in vivo efficacy and toxicity assessment using immune-check point target, cytokine, cytokine receptor, and TAA-humanized mice. Prior to joining Biocytogen, Dr. Lin was SVP of Shenogen Pharma Group. Dr. Lin has extensive expertise in multiple therapeutic areas, including cancer, CVMD, neurology, immunology & inflammation and various technologies, including genetically engineered mouse models, therapeutic antibody engineering, affinity maturation and optimization. Prior to joining Sheongen, Dr. Lin worked at Pfizer as a principal research scientist II and group leader of the antibody engineering group. Before joining Pfizer, he worked at Wyeth and Harvard Medical School as Director of Gene Modification Lab of Harvard-Partners Center for Genetics and Genomics. Dr. Lin received Ph.D. from Albert-Einstein College of Medicine and completed his postdoctoral training at Harvard Medical School.

Qingcong Lin
16:35 – 16:45
Afternoon Refreshments

16:45 – 17:45

The promise and challenges of PSC-CAR-NK cell therapy

  • Promise: CAR-NK cells from pluripotent stem cells (PSC) will potentially provide an inexhaustible cell source of allogenic/off-the-shelf therapeutics for all patients worldwide.
  • Challenges: Tumorigenic potential from undifferentiated PSCs, CMC and manufacture; and limited sustainability in vivo.
  • Discussion points: Differentiation process and QA/QC; scalable manufacture; and gene editing strategy

President and CEO, HebeCell

John Lu, PhD, MPH, is the President and CEO of HebeCell Corporation, focusing on the development and pluripotent stem cell (PSC)-CAR-NK cells for the treatment of human diseases. Before establishing HebeCell, he was the Senior Director of Research at Advanced Cell Technology/Ocata Therapeutics for 11 years. John has more than 20 years of experience in stem cell biology and regenerative medicine as well as >10 year experiences in cancer research. John is the inventor of more than 20 patents in stem cell field: in an analysis of global stem cell patent landscape by Nature Biotechnology in 2014, John’s patent application and citation ranked No. 7 and No. 5, respectively.

John Lu
17:45 – 18:45
Evening Drinks Reception


Advanced Therapies Xchange | East Coast 2023