Speaker's Information
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Sachiko EZOE
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JSRM: Open Innovation Platform to Foster Regenerative Medicine as Universal Treatment
The Japanese Society for Regenerative Medicine (JSRM) is an academic conference for regenerative medicine(RM). JSRM has been involved in various activities for the development of RM such as basic and clinical science, regulatory science, law, medical economy, and education, including the peripheral areas of RM. Through these activities JSRM has been extracting issues involving industry and government to establish RM as universal and standard treatment.
- JSRM has launched some policy proposals to government to ensure the safety and to develop industrialization of RM, which actually resulted in the enforcement of two major acts for RM in Japan, that is, “Act on the Safety of Regenerative Medicine” and “Pharmaceutical and Medical Devices Act”.
- From 2016, JSRM acquires government’s competitive funds as a community to be a nation-wide hub of knowledge called “Regenerative Medicine National Consortium”. Within this project, JSRM set major six missions:
1) Support for clinical researches,
2) Development of human resources,
3) Development of database for RM,
4) Coordination of Academic-Industry Translations,
5) Interactive Communication with Patients/Citizens,
6) International collaboration.
In this presentation, I will introduce these activities.
Bio
Mar 1996 Graduated from Osaka University
Jun 1996~May 1997 Resident at Osaka University Hospital
Jun 1997~Mar 1999 Ashiya Municipal Hospital
Apr 1999~Mar 2003 Osaka University Graduate School of Medicine
Mar 2003 Graduated as a PhD
Apr 2003~Dec 2006 Medical staff at Osaka University Hospital
Jan 2007~Mar 2008 Specially Appointed Assistant Professor at Osaka University Hospital
Apr 2008~Dec 2013 Specially Appointed Associate Professor at Osaka University Hospital
Jan 2014~ May 2017 Associate Professor at Osaka University Hospital
Jun 2017~Now Special Appointed Professor at Graduate School of Medicine/Faculty of medicine Osaka University
and working as an organizer at JSRM
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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.