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Focus Sessions provide in-depth coverage of specific topics of interest, chosen and presented by select academic and industry groups. Held concurrently from 9:00-12:00 on Wednesday 26 June, these educational opportunities in science, society, and education are open to all meeting attendees and included with your registration. 

 

Clinical Development and Commercialization of iPSC-Based Therapies

Presented by Allele Biotech

With a number of iPSC-based cell therapy programs around the globe heading into clinical phase, this will be a timely discussion from the thought leaders on their experiences of planning and executing clinical trials using iPSC-derived products. The attendees will have an opportunity to listen to experts speak from first-hand experience about designing and conducting a first-in-human clinical trial using iPSC-derived cells, cGMP manufacturing challenges, regulatory landscape for product approval across jurisdictions, and challenges and path to commercialization of an iPSC-based product. The speaker presentations will be followed by a panel discussion.

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Stem Cell Engineering for Therapeutic Applications

Presented by the Beckman Research Institute, City of Hope

Stem cell-derived therapeutics are at the forefront of regenerative medicine and, with technological advances, provide new approaches to unmet medical needs. City of Hope is a leader in this area, and this Focus Session features a review of the latest stem cell engineering technologies and selected disease-specific therapeutics. Experts will first cover 3 key areas: hematopoietic graft engineering to optimize transplantation outcome, novel nuclease-based genome editing of adult stem cells, and epigenomic editing of embryonic stem cells using targeted methylation. Then, applications of stem cell technology to three important disease areas will be reviewed: an IPSC-derived approach to leukodystrophies, a diabetes model of organoid function for pancreatic stem cell differentiation, and use of neural stem cells for delivery of cancer therapy to brain. This focus on stem cell technologies will expose the attendees to the latest laboratory and clinical strategies for application of stem cells to therapeutics.

Speakers & Agenda

Tools For Basic and Applied Research

Presented by the COREdinate Group (Sponsored by Thermo Fisher and Stem Cell Technologies)

Stem Cell COREdinates (www.COREdinates.org) is a consortium of human pluripotent stem cell-focused core facilities that have joined forces to share experiences, expertise with protocols and reagents, and to establish “best practices.” In the first part of our Focus session we will have selected presentations from Stem Cell COREdinate members. These presentations will cover different aspects of our activities including reprogramming, banking, gene editing, disease modeling. The second part of the session focuses on Parkinson disease. We invited speakers from the MJ Fox Foundation, from the California Parkinson Registry and from the GForce (A Global Effort to Bring Cell Based Therapies to PD Patients).

Speakers & Agenda

From Fundamental to Therapeutic Applications of Pluripotent Stem Cells

Presented by the French and Belgian Societies for Stem Cell Research

The French and Belgian societies for stem cell research are pleased to invite you to their joint focused session highlighting stem cell research in France and in Belgium. Both societies have been recently created to foster the exchange with the international community, to encourage the general field of research and to promote professionals in stem cell research. In this context, the objective of this focused session is to present the diversity of the different themes of research around stem cells developed among both societies. This overview will be the occasion to give young scientists the opportunity to present recent results. Short selected talks will also be presented by PhD students and post-doctoral fellows including by those interested in seeking a position. This session will also include discussions around research opportunities in France and Belgium and modalities to integrate existing academic structures. The last slot will thus be dedicated testimonies from different young scientists who have gone through the process.

Speakers & Agenda

Cutting Edge Regenerative Medicine Using Stem Cells

Presented by the Japan Agency for Medical Research and Development (AMED)

After Professor Shinya Yamanaka in Japan was awarded the Nobel Prize for the induction of iPS cells support has been given to make the clinical application of regeneration in Japan a reality by the All Japan. As a result, the world’s first clinical application of iPS was carried out. Clinical study and trial on retinal diseases (age-related macular degeneration) and Parkinson’s diseases have been started, in addition plans for research on spinal cord injuries and heart failure etc are scheduled. Studies using somatic stem cells are also being driven. In this session we will introduce Japan's support system and announce the progress on regenerative medicine research in the clinical application stage, safety, and ethics, etc. There will also be talks about trends and efforts in regenerative medicine research in the UK and the US. At the end a discussion with the audience will be held regarding the future direction of research.

Speakers & Agenda

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New Insights into Early Human Development: Scientific, Policy and Ethical Considerations

Presented by the ISSCR Ethics Committee

In this focus session, panelists will discuss scientific, ethical and policy issues raised by the use of human pluripotent stem cells or extended embryo culture to model various stages of early human development. The session will include presentations describing how researchers are using stem cells to better understand implantation, gastrulation and organogenesis, and discussions of technical and other challenges in such research. The session will also feature a review of current policies pertaining to research involving early human embryos and analyze whether they are fit-for-purpose and adequately address ethical issues raised by such research. How to inform and engage the broader community and the public at large on these advances, specifically around the need to develop an appropriate and consistent nomenclature, will also be discussed.

Speakers & Agenda

From Innovation to Product: Developing an Investigational New Drug (IND) Application

Presented by the ISSCR Industry Committee

With stem cell science rapidly moving from the laboratory towards the patient, there is a growing interest in the translational pathway and the processes involved. This is especially true for academics who are increasingly looking to capitalize on discoveries. Drawing on experts from industry and academics, this program focuses on the critical aspects of the Investigational New Drug application including the preclinical data, manufacturing information and the clinical protocols necessary for a cell-based clinical trial. This material is relevant to similar documents required for clinical trials in other regulatory regions.

Speakers & Agenda