Susan L. Solomon

Banking on iPSC- Is it Doable and is it Worthwhile

The discovery of induced pluripotent stem cells (iPSCs) and concurrent development of protocols for their cell-type specific differentiation have revolutionized studies of diseases and raised the possibility that personalized medicine may be achievable. Realizing the full potential of iPSC will require addressing the challenges inherent in obtaining appropriate cells for millions of individuals while meeting the regulatory requirements of delivering therapy and keeping costs affordable. Critical to making PSC based cell therapy widely accessible is determining which mode of cell collection, storage and distribution, will work. In this manuscript we suggest that moderate sized bank where a diverse set of lines carrying different combinations of commonly present HLA alleles are banked and differentiated cells are made available to matched recipients as need dictates may be a solution. We discuss the issues related to developing such a bank and how it could be constructed and propose a bank of selected HLA phenotypes from carefully screened healthy individuals as a solution to delivering personalized medicine.

Seven Actionable Strategies for Advancing Women in Science, Engineering, and Medicine

Achieving gender equality in science will require devising and implementing strategies to overcome the political, administrative, financial, and cultural challenges that exist in the current environment. In this forum, we propose an initial shortlist of recommendations to promote gender equality in science and stimulate future efforts to level the field.

Cell therapy worldwide: an incipient revolution.

The regenerative medicine field is large, diverse and active worldwide. A variety of different organizational and product models have been successful, and pioneering entrepreneurs have shown both what can work and, critically, what does not. Evolving regulations, novel funding mechanisms combined with new technological breakthroughs are keeping the field in a state of flux. The field struggles to cope with the lack of infrastructure and investment, it nevertheless has evolved from its roots in human stem cell therapy and tissue and organ transplants to a field composed of a variety of products from multiple cell sources with approval for use in numerous countries. Currently, tens of thousands of patients have been treated with some kind of cell therapy.

Breaking ground on translational stem cell research.

Sponsored by the New York Stem Cell Foundation (NYSCF), the “Fourth Annual Translational Stem Cell Research Conference: Breaking Ground” convened October 13–14, 2009 at The Rockefeller University in New York City to discuss translational stem cell research. Attracting over 400 scientists, patient advocates, and stem cell research supporters from fifteen countries, the two‐day conference featured an afternoon of panel discussions, intended for a broad audience, followed by a second day of scientific talks and poster presentations. This report summarizes both days of this exciting conference.

Twenty years of the International Society for Cellular Therapies: the past, present and future of cellular therapy clinical development

Historical perspective Some 20 years ago, as the International Society for Cellular Therapies (ISCT) was being founded (1992), it was impossible to imagine all of the scientifi ca nd clinical advances about to occur in the subsequent two decades. As evidenced by the annual publication rate and manuscript focus, the field of stem cell biology and therapeutics has mushroomed and diversified over the last two decades: 1992 saw 3280 “stem cell” papers published (NCBI database). Given the pioneering work of E. Donall Thomas four decades earlier that led to Thomas and Joseph Murray receiving the Nobel Prize for Medicine in 1990, it is not surprising that the majority (51%) of these papers focused on hematopoietic cells (HSC) and HSC transplantation; 19% of the papers were directed to embryonic stem cell (ESC) biology, with only w1% each on mesenchymal biology or induced pluripotency biology. By 2012 (the last full year of record),

The New York Stem Cell Foundation: Fifth Annual Translational Stem Cell Research Conference

The New York Stem Cell Foundations “Fifth Annual Translational Stem Cell Research Conference” convened on October 12–13, 2010 at the Rockefeller University in New York City. The conference attracted over 400 scientists, patient advocates, and stem cell research supporters from 16 countries. In addition to poster and platform presentations, the conference featured panels entitled “Road to the Clinic” and “Regulatory Roadblocks.”

iPSC-Derived Products: Current Regulations

Developing clinical grade PSC-based cells for use in patients requires not only careful attention to cGMPs (current good manufacturing practices) but also careful consideration of a variety of issues that include accessing tissue in an ethically appropriate fashion and adhering to the current rules and regulations for specific local, national, and international jurisdictions, which, if not harmonized, will likely hinder progress. Countries have developed different ways to accelerate translation, and in this article, we discuss the issues specific to iPSC-based manufacture and how these issues are being resolved.

The Sixth Annual Translational Stem Cell Research Conference of the New York Stem Cell Foundation

ABSTRACTu2002 The New York Stem Cell Foundations “Sixth Annual Translational Stem Cell Research Conference” convened on October 11–12, 2011 at the Rockefeller University in New York City. Over 450 scientists, patient advocates, and stem cell research supporters from 14 countries registered for the conference. In addition to poster and platform presentations, the conference featured panels entitled “Road to the Clinic” and “The Future of Regenerative Medicine.”