Panel discussion: bioanalysis for the development and regulatory approval of cell and gene therapies
As of July 2023, 32 cell and gene therapies have been approved and many more are awaiting approval. The wide variety of cell and gene therapies in the bioanalytical space urges a discussion into their regulation and support. Our expert panel dissect current modalities and their unique analytical challenges, the platforms currently being utilized to facilitate cell and gene therapy development and the primary regulatory challenges standing in the way of the approval of such therapies. Find out more information about approved cell and gene therapy products here: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
What will you learn?
- Learn about the cell and gene therapies currently available, as well as their benefits and drawbacks
- Better understand the platforms currently being utilized to support cell and gene therapies
- Review what needs to be considered to facilitate cell and gene therapy approval
- Consider the role of the bioanalytical scientist in the future of cell and gene therapy development
Who may this interest?
- Laboratory managers
- Contract research organizations
- Bioanalytical scientists
- Individuals in the cell and gene therapy space
Speakers
Kimberley Buytaert-Hoefen
Executive Director and Global Head of Regulatory Services
QPS Holdings, LLC (DE, USA)
Kimberley Buytaert-Hoefen is a seasoned professional with 25 years of preclinical and clinical experience in research and development, gene and cellular therapy, the commercial pharmaceutical and medical device industries. As a former FDA Investigator, she performed surveillance inspections for cause, pre-approval establishment, and post-marketing adverse drug experience reporting. Kimberley is a Subject Matter Expert for pharmaceutical, gene and cellular therapy and medical device manufacturing regulatory strategies, with an emphasis on sterile processing and, as a result, is highly skilled in authoring regulatory documents, interacting with regulatory agencies and consulting on GLP, GCP and GMP regulatory compliance.
Xiaobin Xhang
Principal Scientist
Takeda Pharmaceuticals (Tokyo, Japan)
Xiaobin Zhang is a Principal Scientist in the bioanalytical science and immunogenicity group at Takeda Pharmaceuticals. In this role, Xiaobin leads a team to support the immunogenicity assessment of large therapeutics such as peptides, antibodies, antibody-drug conjugates, multidomain proteins, AAVs and oligonucleotide-based therapeutics for oncology, neuroscience, gastrointestinal and rare diseases. Prior to his role at Takeda, Xiaobin was a Staff Scientist and Lead Scientist at Covance (now Labcorp, NC, USA) and mainly worked on the method development and validation for PK, ADA and NAb assays. Xiaobin also served as a Senior Scientist for cell-based bioassay method development and validation in the GMP lab at PPD (NC, USA). He received his PhD from Peking University Health Science Center (Beijing, China) and postdoctoral training in University of Nebraska Medical Center (NE, USA) and University of Wisconsin-Madison (WI, USA).
Eric Feeley
Senior Field Applications Scientist
Gyros Protein Technologies (Uppsala, Sweden)
Eric is currently a Senior Field Applications Scientist at Gyros Protein Technologies, where he instructs Gyrolab users on optimizing their assay performance and instrument use. He has recently developed extended expertise in AAV and lentiviral titer and impurity Gyrolab assays from assisting customers on these applications. Eric completed his PhD at Duke University (NC, USA) in Jorn Coers’ lab studying host-pathogen interactions, primarily the innate immune response to bacterial pathogens. He spent 3 years at the Ragon Institut (MA, USA) studying infectious disease, specifically HIV and Influenza. Eric has a B.S in Biology from Providence College (RI, USA).
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