Navigating scalability and consistency in the allogeneic supply chain

Sponsor

In this webinar we will focus on the scalability of donor starting material to support the growth and commercialization of allogeneic therapies. Throughout this discussion we will answer the questions: What are the major gaps currently in the industry? How can we gain a better understanding of what makes an ideal starting material? How do we ensure donor centricity as we further develop allogeneic starting material supply chain processes?

Attend this webinar to learn how to navigate the predicted bottlenecks in the allogeneic supply chain. Familiarize yourself with the speed bumps in the industry to ensure efficiency within your supply chain as you move your therapies into later clinical phases and commercialization.

This webinar will focus on looking ahead at the following challenges:

Future scalability of allo as a starting material
Troubleshooting the quality of a good donor
Varying difficulties found based on the cell therapy type
Differing challenges based on the type of material – ( Ex: CBU, mobilized, vs non-mobilized)

Anne Dircks

Principal Solution Owner, Be the Match BioTherapies

A mission-orientated leader with over 10 years of experience working in clinical trials, and owning solutions in the hematopoietic stem cell transplantation, and off-the-shelf allogeneic cell & gene therapy (viral, gene-edited NK/ CAR-T/iPSC) space.

Broad background in product and process development, donor cell/tissue procurement, human leukocyte antigens (HLA) consulting, supply chain and logistics management, apheresis onboarding and training, cell processing, cryopreservation, cGMP and foreign regulatory compliance, infectious disease marker (IDM) testing, and instrumental in donor starting material specifications development in addition to over

Able to guide clinical development teams by designing and executing optimal supply chain solutions and lead the path forward for biopharma companies to reach FDA approval and commercialization for their life-saving therapies.

Currently a Principal Solution Owner at Be the Match BioTherapies.

Dean Lee, PhD

Physician in the Division of Hematology and Oncology, Director of the Cellular Therapy and Cancer Immunology Program

Dean Anthony Lee, MD, PhD, is a physician in the Division of Hematology and Oncology at Nationwide Children’s Hospital and director of the Cellular Therapy and Cancer Immunology Program at Nationwide Children's Hospital and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. He is a professor of pediatrics at The Ohio State University College of Medicine and the DiMarco Family Endowed Chair in Cell Based Therapy. Dr. Lee earned his bachelor’s degree in natural sciences from Fresno Pacific College, completed his medical, doctoral, and pediatric residency training at Loma Linda University then completed a fellowship in pediatric hematology/oncology at Texas Children’s Hospital, Baylor College of Medicine. Dr. Lee is chair of the Cellular Therapy Strategy Group for the Pediatric Blood and Marrow Transplant Consortium, member of the NIH Recombinant DNA Advisory Committee, and member of the Cell Therapy Steering Committee for the Children’s Oncology Group.

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SPEAKERS

Anne Dircks

Principal Solution Owner at Be The Match BioTherapies

Dean Lee

Physician in the Division of Hematology and Oncology at and director of the Cellular Therapy and Cancer Immunology Program, Nationwide Children's Hospital