Abstract: Safety Considerations in the Generation of Clinical Grade Autologous IPS Cell Lines
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Abstract: Safety Considerations in the Generation of Clinical Grade Autologous IPS Cell Lines
Motivated to be a part of the solution and support the continued and sustainable growth of the cell and gene therapy sector, ISCT is spearheading efforts in workforce development, training, and education. In 2022 ISCT was a key player in driving the development and deployment of programs and initiatives available not only to ISCT members but also to the wider CGT community.
In 2022, ISCT successfully launched two new training programs to address critical skills gaps in manufacturing, partnering with the Andalusian Network for the Design and Translation of Advanced Therapies (ANd&tAT) to offer three full-tuition scholarships to ISCT members in Europe. While in parallel, partnering with CMaT, the NSF Engineering Research Center for Cell Manufacturing Technologies, to the first edition of the online program for biomanufacturing.
Recognizing that a third of ISCT members are early-stage professionals, ISCT invested significant resources in expanding the global ESP mentoring and leadership development programs. For the wider global ISCT community, the society also made significant efforts to expand its digital resources for not only facilitating topical and encouraging cross-collaboration with regional committees.
Bruce Levine, PhD
ISCT Past President (2020 – 2022)
United States
“My passion for ISCT stems from the fact that in my career, no other society has played as integral a role in my professional development.“
Patrick Hanley
ISCT Representative to NASEM
Childrens National Hospital
United States
Meagan Pasternak, BA
ISCT Head Office
Canada
Elena Cooper, MSc
ISCT ESP Committee
United States
Maryam Pasdar, BSc
ISCT ESP Committee
United States
Being recognized as a leader in driving efforts in workforce development, ISCT was invited to take part in the workshop on Training the Regenerative Medicine Workforce for the Future hosted by the Forum on Regenerative Medicine at the National Academies of Sciences, Engineering and Medicine (NASEM).
The virtual workshop, Co-Chaired by ISCT North America Regional VP, Patrick Hanley, Featured Sessions from ISCT Head Office Senior Manager Meagan Pasternak and ISCT ESP Members Elana Cooper and Maryam Pasdar, which addressed issues related to lack of workforce diversity and opportunities to support workforce development in the future.
Identifying the limited number of skilled workers in manufacturing and product development as a major barrier to growth in the CGT sector, ISCT partnered with The National Science Foundation (NSF) Engineering Research Center for Cell Manufacturing Technologies (CMaT) to develop and deliver the first Workforce Development in Biomanufacturing course.
Developed by field experts from academic, regulatory, clinical, and commercial domains, the online program introduces key topics in cell and gene therapy manufacturing not only to up skill the existing biomanufacturing workforce but also provide those transitioning from other related fields with the fundamental knowledge and skillset unique to the space.
Following the successful global launch of the pilot program in June 2022, ISCT announced its plans to continue to offer the course on an annual basis and introduce three additional program dates throughout the year.
To further build on the learning of the online program, ISCT’s partnership with CMaT will see the introduction of the first innovative hands-on, on-site course, which will launch mid-2023.
Feedback from Inaugural Course
Queenie Jang,
BSc (Pharmacy), MBA
CEO, ISCT
Canada
“This biomanufacturing course, delivered in collaboration with CMaT, is a first step to address the broader needs of CGT training for both industry and academia. The overwhelmingly positive feedback we have received from the participants who took part in the course shows us that we are on the right track.”
“CMaT is tremendously excited to collaborate with ISCT and offer this critically needed course for the Cell Therapy Industry. We were humbled to see the community’s strong support and enthusiasm for this first offering”
Krishnendu Roy, PhD
Robert A. Milton Chair, CMaT
United States
“Working in the GMP facilities alongside experienced teachers and other international students enabled viable discussions, effective sharing of experiences and allowed us to put theory into practice.”
Katja Sirviö
MSc (Pharm)
Kuopio Center for
Gene and Cell Therapy
Finland
Alejandro Barquero
MPharm, MSc
Advent Bioservices Ltd
United Kingdom
“If you want to broaden your network and have fruitful exchanges with other field professionals from different ATMP backgrounds and countries, this is definitely the program for you.”
In partnership with ANd&AT and Universidad de Granda, supported by an educational grant from Miltenyi, ISCT was delighted to launch the first ISCT Master Scholarship Program in 2021/2022.
Available to ISCT members in Europe, the program offers three full-tuition scholarships to enroll in the Master Degree or Specialization Degree in Manufacturing of Advanced Therapy Medicinal Products, offered by the University of Granada/ Andalusian Network for the design and translation of Advanced Therapies (ANd&tAT).
The first of its kind, these programs are uniquely designed for technologies presently working in Good Manufacturing Practice (GMP)-compliant facilities within Europe producing cell therapy, gene therapy or tissue-engineered products for human use.
Following the demand for the 2021/2022 course, ISCT will continue to offer these scholarships on a Biennial basis.
Congratulations to the awardees of the inaugural ISCT Europe Master Programme Scholarship on their completion of the 2021/2022 Master in Manufacturing of ATMPs at the University of Granada/ Andalusian Network for the design and translation of Advanced Therapies.
2021/2022 Scholars:
In 2022, ISCT was delighted to continue The ESP Mentoring Program. Designed to help guide the career and professional development of early-stage CGT professionals, the program connects ESPs with ISCT’s global network of CGT experts.
Since its launch in 2018, the mentoring program has seen significant growth with benefits for both mentee and mentor applications alike. 2022 was a stand out year for the program with 93 participating mentees and 50 participating mentors from across the globe.
Lindsay Davies, PhD
CellTherEx Consulting
Sweeden
“I have been a mentor for the last 2 years and really enjoyed speaking with ESPs, learning where they feel they need support and help for further development and tailoring sessions and topics to their individual requirements. I believe I have learnt as much from them as they have been able to learn from me.”
“If I were to describe in one word my early experience with my mentor, this word would be EMPOWERING! It’s exactly what I was hoping for. Early on they helped me identify my professional strengths and deficits, and helped me expand my research ideas.”
Diana Cirstea, MD
Massachusetts
General Hospital
United States
“I have had the opportunity to work with big names in the field, learn from them and apply the knowledge in my developing research. Since committee members are from around the world, I have gained exposure to global perspectives and updates on the latest methods and study directions“
Reza Yarani, PhD
Stanford University
United States
The ISCT ESP leadership development program offers Early Stage Professionals (ESPs) a chance to join an ISCT Committee in a formal ESP position for a 2-year term providing a practical and immersive learning experience.
In 2022, ISCT was delighted to receive 46 applications from ESP members interested in the program. These applications were from over 18 countries globally, and positions were awarded on participating scientific, industry, regulatory, regional and communications committees.
Through the program, ESPs receive guidance from key global opinion leaders while collaborating on real-world projects in their area of interest that will advance the field of cell and gene therapy.
With a focus on expanding access to educational resources on a global level, ISCT leaders were motivated to develop and deliver a strong portfolio of webinars featuring both member-exclusive and open-access content. Many of the webinars were delivered as curated series leveraging ISCT expert committees to engage with international experts to share perspectives and knowledge with the wider community.
To foster global engagement and learning, ISCT encouraged cross-collaboration between regional committees to host joint webinar series, bringing together the ISCT North America and the ISCT South & Central America regional executive committees to deliver a series on Cancer Vaccines for Oncological Therapy and Implementing a new clinical CAR T program: Manufacturing your own.
2022 marked an unprecedented level of engagement for the ISCT webinar series, with members accessing content live and on demand.
ISCT has a specialized career site focused on CGT talent and opportunities. In 2022, the site saw record-breaking engagement. with the increasing demand for talent, ISCT is proud to provide a resource tool that presents quality opportunities to talent, ensuring that career seekers are able to use it as a reliable and selective point of access for first-choice job options in cell and gene therapy.
The career centre also provides job posters access to a select group of global CGT professionals with the expertise and skills needed to thrive in a fast-growing field to help streamline the recruitment process.
Queenie Jang, BSc (Pharmacy), MBA
Chief Executive Officer
Canada
Over the last year, ISCT has focused its investments on building a home for workforce development within the DNA of ISCT. Working with our expansive network of global key opinion leaders and subject matter experts, we have made significant investments to expand our educational offerings. From online resources to practical in-person programs, ISCT members now have access to a wide array of supports.
In recent years, the Cell and Gene Therapy (CGT) field has seen exponential growth, which has outpaced the rate at which new professionals enter. As result, we have witnessed major skill and labor shortages affecting the entirety of the field. Identifying this as a critical issue to the advancement of the sector, ISCT is motivated to be at the forefront of addressing this issue. We see it as our duty to Support the driven and diverse group of regulatory, commercial, and academic professionals and remove barriers and open doors for newcomers entering the field.
Through forming strategic partnerships with outside organizations such as CMaT ANd&AT and Universidad de Granda, ISCT has successfully developed and globally deployed a number of workforce programs spanning translational research to good manufacturing practices and regulatory understanding. 2022 marked not only the launch of the online workforce development in biomanufacturing course in partnership with CMAT but also the decision to make this a recurring program offered four times annually due to the critical need and demand for skilled personnel. Through our partnership with ANd&AT and Universidad de Granda, ISCT, was proud to awarded three European ISCT members full-tuition scholarships to enrol in the Master in Manufacturing of Advanced Therapy Medicinal Products (ATMPs).
Taking a step further to demonstrate ISCT’s unwavering commitment to helping bridge the labour gap in the market, alongside our dedicated head office liaisons, ISCT has formed a specialist workforce development committee. This committee, in collaboration with our global network of subject matter experts, will design training programs created by ISCT members for ISCT members that are tailored to the specific needs of professionals based on their region, area of focus and skill level.
Understanding the criticality of Early Stage Professionals (ESP) for the continued growth of the CGT sector, ISCT has made a deliberate decision to expand and invest in our ESP resources, programs and committees. ESPs currently make up a third of our overall global membership, and we are delighted to see these members becoming more active and engaged in the society. Our ESP Mentoring Program and our ESP Leadership Development Program reached record numbers of participants in 2022, allowing us to connect ESPs with our global CGT network and provide them with practical experience and connections that will last a lifetime. If the cell and gene sector is to continue to grow at the current rapid pace, we must continue to support ESPs and provide them with the tools they need to succeed and excel in their careers.
With workforce development being the greatest challenge that lies ahead for cell and gene therapies, ISCT is proud to champion and spearhead these initiatives. ISCT members, no matter what stage of their professional development, now have more access than ever to the key knowledge and networks that they need to become an effective part of the workforce. We will continue to work collaboratively with our all our stakeholders to develop paths and open doors for both interested professionals and newcomers alike.
As a truly global organization, ISCT leverages a regional model to deploy solutions to global issues on a regional level. Spearheaded by passionate volunteer leadership, who understand the needs and concerns unique to each region, ISCT addresses the emergent needs of CGT professionals across the globe. With partnerships including regional partner organizations, regulatory bodies, and stakeholder communities, each of the ISCT regional committees drives the advancement of translational science at a high global standard.
Our committees work autonomously to deliver key scientific meetings, stimulate membership growth, and develop regional professional networks. Through 2022, our committees worked hard to develop the groundwork for new committees with a special focus on early-stage professionals and facilitated several major events that have continued to build consensus across the sector.
In 2022, to further the society’s commitment to workforce development, ISCT formed three new regional early-stage professionals subcommittees in Asia, Australia and New Zealand and South-Central America. Supported by the respective regional executive committee, these subcommittees were created to promote regional and global engagement and networking for early-stage professionals providing them with resources and career guidance to ensure their success.
Championed by regional volunteers, the Asia, Australia and New Zealand and South-Central America subcommittees are in full swing developing key initiatives to drive ESP membership and engagement in each region. ISCT is currently working on establishing ESP subcommittees in both North America and Europe for 2023.
ISCT regional committees deliver high-quality programmes globally, with autonomous planning supported by the society’s global network and resources. . As restrictions eased post-pandemic, regional executive committees were excited to return to in-person meetings and reconnect face-to-face with the wider ISCT community.
With a reignited vigour to connect cell and gene therapy professionals globally, 2022 was a particularly active year for regional events. ISCT regional committees partnered and collaborated with several external groups and organizations as well connecting with other ISCT committees.
In August, the Australia & New Zealand Regional Executive Committee hosted its first in-person regional meeting post-pandemic. The highly anticipated event welcomed 137 delegates to Brisbane, Australia, and featured workshops and panel discussions with particular attention to quality, regulatory affairs, education, training, commercialization and clinical practice.
Meanwhile, in North America, the leadership team hosted a virtual interactive member-focused regional town hall meeting in October to connect and engage with members in the region. The meeting facilitated open discussions focused on workforce development and retention challenges, including both commercial and academic perspectives.
To facilitate cross-regional collaboration, The North America and South & Central America Regional Executive Committees partnered to present a two-part webinar series. The first installment discussed the clinical manufacturing of CAR T Cells, and the second explored the mechanism, safety and efficacy of mRNA-based cancer vaccines for oncological therapy. The collaborative series brought together subject matter experts and key opinion leaders from across both regions and received over 550 registrants from across the globe.
In Australia & New Zealand, ISCT leaders held a joint virtual scientific meeting with the Biotherapeutics Association of Australasia (BAA) to address developments in cell and gene therapies. The two-day event, held in February 2022, hosted scientific presentations featuring both international and regional speakers to discuss the latest developments in the clinical and commercial delivery of cell and gene therapies and the latest regulatory updates relevant to the region.
Leaders in Asia were delighted to continue its partnership with the Korean Society of Blood and Marrow Transplantation (KSBMT) with a joint session on gene editing and gene therapy at the International Congress of Blood and Marrow Transplantation (ICBMT), the 27th Annual congress of KSBMT in September. The long-standing partnership between ISCT and KSBMT is a key partnership for the region. It fosters international cooperation in education and research in the field of hematopoietic stem cell transplantation and cell & gene therapy.
In May the Asia executive committee partnered with the Japanese Society for Transplantation and Cellular Therapy (JSTCT) to participate in a joint session at The 44th JSTCT Annual Meeting in Yokohama, Japan. ISCT held a joint session chaired by Satoshi Takahashi, MD, PhD, Past ISCT Asia Regional Vice-President, JSTCT 2022 President, on ‘Strategies to Improve Classical CBT by Introducing New Cellular Therapies’. The session also included a remote presentation from William YK Hwang, MBBS, MMed, FRCP, FAMS, ISCT Asia Regional Vice-President Elect.
In October, the South and Central America Committee again partnered with the Brazilian association of cell and gene therapy (CGT) for the XII Congress of ABTCel – Gen in Rio de Janeiro. ISCT invited speakers participated both in-person and virtually, leading discussions on topics such as manuscript writing, cell therapy and therapies for cancer through sessions and interactive workshops. Alongside event participation, The South and Central America regional leaders were proud to sponsor the top-scoring abstract awards and provide a special abstract supplement showcasing all accepted abstracts from the meeting publication in Cytotherapy, the official journal of ISCT.
Janet Macpherson, PhD
Australia
C. Russell Y. Cruz, MD, PhD
USA
Available to ISCT members, Telegraft is the go-to resource to keep up to date with the latest Society activities and important developments in cell and gene therapy.
2022 brought exciting updates for Telegraft, with the launch of the ‘Telegraft Hub,’ the new online home for ISCT news and community. Alongside monthly e-newsletters, ISCT members now have access to the online interactive hub, allowing them to connect with peers and access key updates and curated content.
The Telegraft Editorial Board works to engage and connect the whole ISCT community across academia, science, regulation and commercial by sharing insightful discussions and up-to-date information on critical issues affecting the field of cellular therapy.
Michele Sugrue, MT
USA
Wouter Van’t Hof, PhD
USA
Joaquim Vives, PhD
Portugal
Rounak Dubey, MBBS, MD
India
Shyam Bhakta, MD, MBA
India
Ashley Krull, BSc, PhD
USA
Cytotherapy®, the official journal for the International Society for Cell and Gene Therapy (ISCT), publishes novel and innovative results from high quality scientific and clinical studies in the fields of cell and gene therapy. In 2021, Cytotherapy has continued to successfully advance and expand the field of cell and gene therapy for clinical researchers, oncologists, hematologists, physicians, and regulatory experts alike. The Journal had a 6.196 impact factor for 2022, a new record from which the editorial board hopes to grow further.
You can read issues of Cytotherapy® here.
Follow Cytotherapy® on Twitter to stay up to date on all the latest news and publications.
In January 2022, Dr. Rachel Burga was appointed as the new assistant editor for Cytotherapy. With a background in biomedical engineering and immunology, Rachel is the Principal Scientist of Cell Therapy at Obsidian Therapeutics. She has been an active member of ISCT since 2016 and currently sits on the Early-Stage Professionals Committee as Co-Chair.
As Assistant Editor, Rachel will work closely with Senior Editor Dr. Donald G. Phinney and Commissioning Editor, Dr. Patrick Hanley, to raise awareness of the Cytotherapy brand. In her first term, Rached helped recruit outstanding content for the journal and work closely with the ISCT membership to ensure that the journal continues to support the Society’s mission.
Rachel Burga, PhD
Assistant Editor, Cytotherapy
United States
Each year, ISCT hosts the Insta-Your-Cells Photo Challenge, calling on community members to submit interesting images from under the microscope. These images are selected to feature on the front cover of Cytotherapy®, the Official Journal of ISCT, showcasing the fascinating world of cells to peers around the globe.
The winning image of the 3rd annual Insta Your Cells Photo Challenge was submitted by Philippe Cohen, MD, PhD, France. ISCT Head Office prepared a framed keepsake to celebrate this iconic first-place image.
Emily Hopewell, PhD
Indiana University School Of Medicine
United States
Patrick Hanley, PhD
Children’s National Hospital
United States
Recognizing the current skills gaps in CGT translation as a critical issue for the cell sector, in November 2022, ISCT Formed the ISCT Workforce Development Committee.
Led by Co-chairs Emily Hopewell, PhD and Patrick Hanley, PhD the committee will provide strategic guidance to identify, develop and deliver ISCT training and development programs.
Programs will focus on the specific needs of professions based on their region, industry, and skill level to support the sustainable growth of the cell and gene therapy sector.
Throughout 2023, the committee will focus on Identifying and prioritizing urgent needs for training and educational programs for professionals working across the full spectrum of translational science, starting from pre-clinical development through to patient access, to develop and deliver comprehensive programs to upskill and train the existing CGT workforce.
Laertis Ikonomou, PhD
The State University of New York at Buffalo
United States
In October 2021, the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies formally became the ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT). This change is intended to reflect the committees revised mission to identify key ethical issues associated with the development, regulatory authorization, and distribution of cell and gene therapies.
In 2022, the Committee re-affirmed its position on, and concerns with, speculative immune cell banking. Following the 2022 US federal court ruling in favor of California Stem Cell Treatment Center, Inc., and Cell Surgical Network Corporation, the Committee contributed to publishing an ISCT position and press release, highlighting the dangers of unproven cell therapies to patient safety.
Undertaking its broader remit, the ECGT Committee developed and published informed positions providing guidance and clarity on complicated ethical matters within the CGT space. The Committee has undertaken the task of developing resources to address ethical topics, and potential issues, arising from the EU Hospital Exemption and the US expanded access pathway. The Committee organized a roundtable session at the ISCT 2022 San Francisco Annual Meeting addressing both pathways, and published a position paper on Hospital Exemption within the framework of safety and ethical interests of patients. On January 19, 2022, the Committee launched the ISCT Expanded Access Working Group.
Over the course of 2022, the Committee has worked to develop a guide for the general public, which analyses the regenerative medicine industry, focusing on distinctive features of unproven cell and cell-based products, suggesting practical strategies to address marketing of such products, and providing an overview of reporting mechanisms available to patients across different jurisdictions globally. This comprehensive guide will be published in 2023 and provides an important resource to protect patients globally.
Patricia J. Zettler, JD
The Ohio State University
United States
The ISCT Expanded Access Working Group was launched with the mandate to identify and address practical, ethical, and regulatory issues that arise from the use, and potential misuse, of the expanded access pathway by various CGT stakeholders.
Since its launch, the Working Group has been developing informed perspectives on expanded access to generate educational resources that promote innovation in translational research while upholding the highest ethical standards. The Working Group submitted a short report reviewing the history and current state of the US expanded access pathway, and highlighting three emerging areas of concern. The report will be published in Cytotherapy in early 2023.
The overarching objective of the Working Group is to further refine its position on ethical issues arising from the use, and potential misuse, of the expanded access pathway, culminating in the development of a code of ethics. In developing this code of ethics, ISCT will seek out input and endorsement from other organizations in the field.
Kevin Bosse, PhD RAC
Nationwide
Children’s Hospital
United States
Rachel Burga, PhD
Obsidian Therapeutics
United States
The ISCT Early Stage Professionals Committee (ESP) strives to engage and connect ESP with the wider CGT sector on a regional and global level. Co-Chaired by Kevin Bosse, PhD RAC and Rachel Burga, PhD, the committee provides networking opportunities and career development resources for professionals to excel in their careers.
The committee hosts a variety of tailored events and workshops, such as the ISCT ESP Mentoring Program and the ISCT ESP Leadership Development program helping connect professionals with key opinion leaders and subject matter experts.
In 2022, ISCT formed three regional ESP subcommittees in Asia, Australia and New Zealand and South Central America to drive ESP membership and increase interactions between ESPs and regional leadership.
Cytotherapy®, the official journal for the International Society for Cell and Gene Therapy (ISCT), publishes novel and innovative results from high quality scientific and clinical studies in the fields of cell and gene therapy.In 2021, Cytotherapy has continued to successfully advance and expand the field of cell and gene therapy for clinical researchers, oncologists, hematologists, physicians, and regulatory experts alike. The Journal had a 6.196 impact factor for 2022, a new record from which the editorial board hopes to grow further.
You can read issues of Cytotherapy® here.
This year, Cytotherapy® also launched a Twitter account to share fresh updates and resources.
In February 2022, Rachel Burga was appointed as the new assistant editor for Cytotherapy. With a background in biomedical engineering and immunology, Rachel is the Principal Scientist of Cell Therapy at Obsidian Therapeutics. She has been an active member of ISCT since 2016 and currently sits on the Early-Stage Professional Committee as Co-Chair.
As Assistant Editor, Rachel will work closely with Senior Editor Donald G. Phinney and our Commissioning Editor, Dr. Patrick Hanley, to raise awareness of the Cytotherapy brand. She will also help recruit outstanding content for the journal and work closely with the ISCT membership to ensure that the journal continues to support the society’s mission.
Rachel Burga, PhD
Assistant Editor, Cytotherapy
United States
Each year, ISCT hosts the Insta-Your-Cells Photo Challenge, calling on community members to submit interesting images from under the microscope. These images are selected to feature on the front cover of Cytotherapy®, the Official Journal of ISCT, showcasing the fascinating world of cells to peers around the globe.
The winning image of the 3rd annual Insta Your Cells Photo Challenge was submitted by Philippe Cohen, MD, PhD, France. ISCT Head Office prepared a framed keepsake to celebrate this iconic first-place image.
Take a look at the stunning submissions selected to be featured on the front cover of Cytotherapy® this year.
Janet Macpherson, PhD
Australia
C. Russell Y. Cruz, MD, PhD
USA
Available to ISCT members, Telegraft is the go-to resource to keep up to date with the latest Society activities and important developments in cell and gene therapy.
2022 brought exciting updates for Telegraft, with the launch of the ‘Telegraft Hub,’ the new online home for ISCT news and community. Alongside monthly e-newsletters, ISCT members now have access to the online interactive hub, allowing them to connect with peers and access key updates and curated content.
The Telegraft Editorial Board works to engage and connect the whole ISCT community across academia, science, regulation and commercial by sharing insightful discussions and up-to-date information on critical issues affecting the field of cellular therapy.
Nancy H. Collins, PhD
USA
Satyam Arora, MD
USA
Rounak Dubey, MBBS, MD
India
Shyam Bhakta, MD, MBA
India
Ashley Krull, BSc, PhD
USA
Michele Sugrue, MT
USA
Wouter Van’t Hof, PhD
USA
Joaquim Vives, PhD
Portugal
ISCT acknowledges the service of its members, volunteering expertise, time, and energy to the vast task of advancing the field of cell and gene therapies.
From mentoring the next generation to publishing key standards and fostering relationships across the sector, ISCT members set the gold standard.
We acknowledge these Society leaders who have completed terms of service in a formal position in 2021.
Your hard work and dedication have continually pushed the society to new heights, and we cannot wait to connect again soon:
John Rasko, AO, MBBS, PhD, FRCPA, FRACP, FAHMS
Chair, Strategic Advisory Council (Immediate Past President)
June 2020 – June 2022
Royal Prince Alfred Hospital
Sydney, Australia
Lizette Caballero, BS, MT(ASCP)
Global Secretary
June 2019 – June 2022
UCSF Blood and Marrow Transplant Lab
San Francisco, CA, United States
Rajiv Khanna, PhD AO
Australia & New Zealand, Regional Vice-President
June 2020 – June 2022
QIMR Berghofer Medical Research Institute
Brisbane, Australia
Mitchell Cairo, MD
North America, Regional Vice-President
June 2020 – June 2022
New York Medical College
New York, NY, United States
Karen Nichols, Esq.
Chief Regulatory Officer
March 2016 – June 2022
Vertex Pharmaceuticals
Cambridge, MA, United States
Vicki Antonenas, BSc, MSc
Elected Member Technologist
June 2020 – June 2022
Sydney Cellular Therapies Laboratory,
Westmead Hospital
Australia
Patrick Hanley, PhD
Co-Chair Immuno-Gene
Therapy Committee
Children’s National Hospital
United States
Giuseppe Orlando, MD, PhD
Co-Chair Gastrointestinal Committee
Wake Forest University
United States
Rachele Ciccocioppo, MD
Co-Chair Gastrointestinal Committee
University of Verona
Italy
George Muschler, MD
Co-Chair Orthopedic & Musculoskeletal Therapies
Cleveland Clinic
United States
Christian Jorgensen, MD, PhD
Co-Chair Orthopedic & Musculoskeletal Therapies
University Hospital Lapeyronie
France
Sarah Chan, Ma PhD
ECGT Committee
University of Edinburgh
United Kingdom
Andrew Hoffman, DVM, DVSc
Exosomes Committee
University of Pennsylvania
United States
John Fink, MBA
Co-Chair Process Development and Manufacturing Committee
PerkinElmer, Inc.
United States
Emily Hopewell, PhD
Indiana University School of Medicine
United States
Aaron Tze Kai Tan
Stanford University
United States
Lizbeth Diaz Polo, MD
University of San Martin de Porres
Spain
Jordan Greenberg, PhD
Shoreline Biosciences
United States
Shabnum Patel, PhD
CARGO Therapeutics
United States
Nancy H. Collins, PhD
University of Toledo
Toledo, OH, United States
Satyam Arora, MD
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute
India
Lab Practices Committee
Vicki Antonenas, BSc, MSc
Westmead Hospital
Australia
Europe Legal & Regulatory Affairs Committee
Paula Salmikangas, PhD
NDA Group
Finland
As a truly global organization, ISCT leverages a regional model to deploy solutions to global issues on a regional level. Spearheaded by passionate volunteer leadership, who understand the needs and concerns unique to each region, ISCT addresses the emergent needs of CGT professionals across the globe. With partnerships including regional partner organizations, regulatory bodies, and stakeholder communities, each of the ISCT regional committees drives the advancement of translational science at a high global standard.
Our committees work autonomously to deliver key scientific meetings, stimulate membership growth, and develop regional professional networks. Through 2022, our committees worked hard to develop the groundwork for new committees with a special focus on early-stage professionals and facilitated several major events that have continued to build consensus across the sector.
In 2022, to further the society’s commitment to workforce development, ISCT formed three new regional early-stage professionals subcommittees in Asia, Australia and New Zealand and South-Central America. Supported by the respective regional executive committee, these subcommittees were created to promote regional and global engagement and networking for early-stage professionals providing them with resources and career guidance to ensure their success.
Championed by regional volunteers, the Asia, Australia and New Zealand and South-Central America subcommittees are in full swing developing key initiatives to drive ESP membership and engagement in each region. ISCT is currently working on establishing ESP subcommittees in both North America and Europe for 2023.
ISCT regional committees deliver high-quality programmes globally, with autonomous planning supported by the society’s global network and resources. . As restrictions eased post-pandemic, regional executive committees were excited to return to in-person meetings and reconnect face-to-face with the wider ISCT community.
With a reignited vigour to connect cell and gene therapy professionals globally, 2022 was a particularly active year for regional events. ISCT regional committees partnered and collaborated with several external groups and organizations as well connecting with other ISCT committees.
In August, the Australia & New Zealand Regional Executive Committee hosted its first in-person regional meeting post-pandemic. The highly anticipated event welcomed 137 delegates to Brisbane, Australia, and featured workshops and panel discussions with particular attention to quality, regulatory affairs, education, training, commercialization and clinical practice.
Meanwhile, in North America, the leadership team hosted a virtual interactive member-focused regional town hall meeting in October to connect and engage with members in the region. The meeting facilitated open discussions focused on workforce development and retention challenges, including both commercial and academic perspectives.
To facilitate cross-regional collaboration, The North America and South & Central America Regional Executive Committees partnered to present a two-part webinar series. The first installment discussed the clinical manufacturing of CAR T Cells, and the second explored the mechanism, safety and efficacy of mRNA-based cancer vaccines for oncological therapy. The collaborative series brought together subject matter experts and key opinion leaders from across both regions and received over 550 registrants from across the globe.
In Australia & New Zealand, ISCT leaders held a joint virtual scientific meeting with the Biotherapeutics Association of Australasia (BAA) to address developments in cell and gene therapies. The two-day event, held in February 2022, hosted scientific presentations featuring both international and regional speakers to discuss the latest developments in the clinical and commercial delivery of cell and gene therapies and the latest regulatory updates relevant to the region.
Leaders in Asia were delighted to continue its partnership with the Korean Society of Blood and Marrow Transplantation (KSBMT) with a joint session on gene editing and gene therapy at the International Congress of Blood and Marrow Transplantation (ICBMT), the 27th Annual congress of KSBMT in September. The long-standing partnership between ISCT and KSBMT is a key partnership for the region. It fosters international cooperation in education and research in the field of hematopoietic stem cell transplantation and cell & gene therapy.
In May, the ISCT Asia Regional Executive Committee partnered with the Japanese Society for Transplantation and Cellular Therapy (JSTCT 2022) to host a joint session on ‘Strategies to Improve Classical CBT by Introducing New Cellular Therapies’. The session was chaired by Satoshi Takahashi, MD, PhD, Past ISCT Asia Regional Vice-President, JSTCT 2022 President and included a remote presentation from William YK Hwang, MBBS, MMed, FRCP, FAMS, ISCT Asia Regional Vice-President Elect.
In October, the South and Central America Executive Committee again partnered with the Brazilian association of cell and gene therapy (CGT) for the XII Congress of ABTCel – Gen in Rio de Janeiro. ISCT invited speakers participated both in-person and virtually, leading discussions on topics such as manuscript writing, cell therapy and therapies for cancer through sessions and interactive workshops. Alongside event participation, The South and Central America regional leaders were proud to sponsor the top-scoring abstract awards and provide a special abstract supplement showcasing all accepted abstracts from the meeting publication in Cytotherapy, the official journal of ISCT.
