Speaker's Information
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Kyosuké MANO
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JSRM: Open Innovation Platform to Foster Regenerative Medicine as Universal Treatment
There have been many challenges to share knowledge and experience of Regenerative Medicine Clinical Application for its novelty and interdisciplinarity. In this talk, JSRM’s unique approach to establish the Open Innovation Platform will be revealed.
Bio
TBA
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Kasey KIME
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Enabling successes in Cell and Gene Manufacturing through Regulatory Partnerships
Kasey Kime will speak about Thermo Fisher Scientific’s successes in partnerships with global cell and gene therapy manufacturers to help them to move towards commercialization. She will discuss case studies where Thermo has navigated challenging situations with both researchers in pre-clinical research and manufacturers and provided the appropriate solutions such as Cell Therapy Systems (CTS™) or customization to meet regulatory expectations globally. She will also speak about the work of the regulatory affairs team across major markets and how they actively contribute to standards development and regulatory initiatives for raw/ancillary materials and cell therapy automation. Kasey will also touch on the importance of regulatory documentation in the selection of GMP ancillary reagents and other key considerations.
Bio
Kasey Kime has ten years of global quality and regulatory affairs experience in Life Sciences. She is part of Thermo Fisher Scientific’s regulatory affairs division and is overseeing regulatory compliance of technologies developed for cell and gene therapy applications. Her areas of expertise include raw material risk assessment for biopharmaceutical development and quality assessment of instruments developed for automating cell and gene therapy manufacturing. Kasey also contributes to standards development through participating in working groups with the US and Europe Pharmacopeias (USP/ EP), International Standards Organization (ISO), Standards Coordinating Body (SCB) and Alliance for Regenerative Medicine (ARM). Prior to her work at Thermo Fisher Scientific, Kasey held positions as Quality Assurance Manager at a diagnostic pathology laboratory and a Cord Blood Bank in New Zealand. Kasey holds a Bachelor's Degree in Medical Laboratory Science and holds post graduate degrees in Microbiology and Quality Systems Management from Massey University, New Zealand.
Kasey Kime will speak about Thermo Fisher Scientific’s successes in partnerships with global cell and gene therapy manufacturers to help them to move towards commercialization. She will discuss case studies where Thermo has navigated challenging situations with both researchers in pre-clinical research and manufacturers and provided the appropriate solutions such as Cell Therapy Systems (CTS™) or customization to meet regulatory expectations globally. She will also speak about the work of the regulatory affairs team across major markets and how they actively contribute to standards development and regulatory initiatives for raw/ancillary materials and cell therapy automation. Kasey will also touch on the importance of regulatory documentation in the selection of GMP ancillary reagents and other key considerations.
Bio
Kasey Kime has ten years of global quality and regulatory affairs experience in Life Sciences. She is part of Thermo Fisher Scientific’s regulatory affairs division and is overseeing regulatory compliance of technologies developed for cell and gene therapy applications. Her areas of expertise include raw material risk assessment for biopharmaceutical development and quality assessment of instruments developed for automating cell and gene therapy manufacturing. Kasey also contributes to standards development through participating in working groups with the US and Europe Pharmacopeias (USP/ EP), International Standards Organization (ISO), Standards Coordinating Body (SCB) and Alliance for Regenerative Medicine (ARM). Prior to her work at Thermo Fisher Scientific, Kasey held positions as Quality Assurance Manager at a diagnostic pathology laboratory and a Cord Blood Bank in New Zealand. Kasey holds a Bachelor's Degree in Medical Laboratory Science and holds post graduate degrees in Microbiology and Quality Systems Management from Massey University, New Zealand.