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ISCT GRP Workshop

ISCT Global Regulatory Perspectives Co-Chairs: Karen Nichols (US) and Dominic Wall (AU) Key Topics in Combination Products Interviewers: Karen Nichols (US) David DiGiusto (US) Panelists: Melanie Eacho (US) Colin White (US) Patrick Bedford (CA) Sterility Controls, Past...


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Safety Matters, Long-Term Follow-Up, Accreditation and Clinical Registries for Regenerative medicine Product

The field of regenerative medicine has shown tremendous growth in just a few short years, with advancements at all stages of translation for cell-based therapeutics. This session will highlight important considerations and recent steps taken to improve the safety and efficacy of regenerative...


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Qualification, Regulation of Gene Editing Tools in Cell & Gene Therapy

Recent advances in genome editing technologies have substantially improved our ability to make changes in the genomes of eukaryotic cells. Viral vectors and programmable nucleases are already revolutionizing our ability to interrogate the function of the genome. This session provides an overview...


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FDA Cell Therapy Liasion Meeting 2018 Report

2018 Topics: Comparability of IPSC Lines for a Master Cell Bank Challenges in Capturing Long Term Follow Up of Recipients of Genetically Modified Cells RMAT Designation Update Licensing of Cord Blood Units for Indications Other than Currently Approved Human Platelet Lysate...


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FDA Cell Therapy Liasion Meeting 2019 Report

2019 Topics: Exclusion of Maternal Donors with Positive Screening but Negative Confirmatory Infectious Disease Testing Results, Impact on Public Cord Blood Banking Regenerative Medicine Advanced Therapy (RMAT) Update Impact of Unproven Cellular Products in the Field Participating...


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FDA Cell Therapy Liasion Meeting 2020 Report

2020 Topics: Request for an update of the RMAT program Donor Adverse Events Cellular Therapies Infectious Disease Lookbacks Related to Blood Product Transfusions May Not Identify All Those At Risk Alternative BLA Pathway to Approved Genetically Modified Autologous HCTP products ...


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Qualifications of Ancillary/Raw Materials for Clinical Use

This session will walk through the step by step approach to qualify Ancillary/Raw Materials for Clinical Use. The presentation will focus on the following: Step by step qualification pathway Region specific regulations and guidance Common industry issues Case studies #Regulatory ...

ISCT Webinar 11.8.2017 Recording.mp4

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Challenges and Potential Solutions for Taking Your Cell and Gene Therapy Clinical Program to Japan

Regulatory changes within PMDA supporting Conditional Approval of promising cell and gene therapy (CGT) products in Japan, have led to greater interest in taking CGT clinical programs to Japan for development, partnering and earlier commercialization. In response to these changes, the October 10...


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Case Registration in Cell Therapy

The case registration system can contribute to gaining precise activity information. In the hematopoietic stem cell transplantation (HSCT) field, there are at least 3 major systems internationally; CIBMTR (North America), EBMT (Europe) and JDCHCT (Japan) and each registry continues to be a...

Recording (2).mp4

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Partnering in Japan: The Athersys • Healios Story

Favorable regulatory changes came into effect at PMDA in November 2014 which introduced potential for conditional market approval of CGT / RM therapeutic candidates after Phase II clinical development and led to increased interest for partnering in Japan. As a result, ISCT and FIRM formed a...

Recording (3).mp4