As cell & gene therapies continue to progress at a rapid pace, apheresis and collection centers face the challenges of keeping up with demand, while maintaining high-quality levels. Watch this on demand webinar for insights into current challenges and how the implementation of standardized processes can help ease the strain on the existing infrastructure, mitigate risk and ensure patients receive high-quality therapies.
Watch this on demand webinar to hear about:
- The importance of standardized processes and dedicated support to ensure consistent, compliant, high-quality cell collections
- Strategies for standardizing collection protocols to ensure high-quality starting material is provided to manufacturers
- Opportunities to integrate standardization to relieve resource constraints in collection centers, caused by the increased demand for cell and gene therapies
Following the presentation, you will have the opportunity to pose your questions to our panelists:
- Amy Hines, BSN, RN, Director of Collection Network Management, Be The Match BioTherapies
- Greg Whitehead, Vice President of Quality, bluebird bio
- Heather Steinmetz QA Manager for Bone Marrow Transplant at UCLA Health
The webinar is free of charge, but space is limited, so register today to guarantee your spot. A link of the recorded webinar will be available to all registrants after the live broadcast.
Amy Hines, BSN, RN, Director of Collection Network Management, Be The Match BioTherapies
In her role, Amy oversees the performance of apheresis and marrow collection centers and cell therapy labs in the network, and ensures their on-going compliance with FDA and International standards and criteria, industry best practices, and appropriate regulatory and accrediting entities. She joined NMDP/Be The Match in 2013 and managed the NMDP/Be The Match apheresis and marrow collection center network of more than 90 apheresis centers and 80 marrow collection centers. Amy has nearly 20 years of experience in the cellular therapy field. Her career in this field began as a stem cell transplant registered nurse at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., in 1999. Over the course of 12 years in Grand Rapids, Amy held a wide range of positions including Staff Nurse on a 15-bed pediatric unit, Transplant Coordinator, Program Manager, Clinical Research Coordinator of the Children’s Oncology Group (COG), and finally Program Administrator for the pediatric and adult stem cell transplantation programs.
Greg Whitehead, Vice President of Quality, bluebird bio
Greg Whitehead is the Vice President of Quality for bluebird bio, a gene therapy company committed to transforming lives and making hope a reality for patients with severe genetic and rare diseases and with cancer. Greg’s career in biotech spans more than 25 years with the last 14 years dedicated to the development and commercialization of cell and gene therapies. Before joining bluebird bio, Greg spent a decade in Quality at Dendreon where he was involved with the approval and launch of Provenge®, the first FDA-approved immunotherapy made from a patient’s own immune cells. He is committed to ensuring that quality is embedded in the very fiber of the drug product supply chain for the sake of patients, this includes the collection of HPC-A. Greg’s work to bridge FDA and EMA expectations of HPC-A as a starting material to GMP drug product manufacturing with hospital, nurse and doctor expectations of appropriate medical care has included extensive work across the US and EU in hundreds of facilities.
Heather Steinmetz QA Manager for Bone Marrow Transplant at UCLA Health
In the role of Quality Assurance Manager, Heather works with the Hemapheresis Unit, Stem Cell Lab and Adult & Pediatric clinical transplant program. Since 2015, she has worked in collaboration with all areas to ensure regulatory compliance in incorporated into all aspects of the program. Most recently, she has served as operational lead implementing all FDA approved CAR-T therapies within the Hematologic Malignancy/Stem Cell Transplant (HM/SCT) Program. Throughout her career, Heather has worked within the bone marrow transplant field. She began as a donor coordinator for 4 years at BeTheMatch guiding unrelated donors through donation. In 2010, she joined UCLA as a CIBMTR Coordinator. While reviewing and reporting patient status to the CIBMTR registry, she learned key elements fundamental to the success of the HM/SCT program. Heather transitioned her donor and patient experience into the QA Manager role providing a cohesive understanding of the entire program.