I end my term as I began, with a greeting that is at the heart of the culture of ISCT- that our colleagues and fellow members are our friends. We can depend on one another, educate one another, and collaborate with one another with our shared goals to drive the development, translation, and adoption of novel cellular therapies for the benefit of patients worldwide.
Approximately 20 years after I first became aware of ISCT (then ISHAGE), I wrote an application for nomination to stand for election as President-Elect (2018-2020). At that time, I wrote that the “establishment of the Early Stage Professionals group is an important recent milestone. We must build and extend our mentoring, education and training programs at all stages of professional development.” Each of these elements has been expanded and enhanced since that time, even during the headwinds of the pandemic, at a rate that is exceptional. At the beginning of the Early Stage Professionals (ESP) mentoring program in the 2018-2019 cohort there were 26 ESP mentees and 10 mentors. In the 2021-2022 ESP mentoring program, there are 93 ESP mentees and 50 mentors. We have also implemented the ESP Leadership Development Program where ESPs apply to for a chance to join an ISCT Committee in a formal ESP position for a 2-year term. The ESP leadership and mentoring team can be very proud! I have served as a mentor in the ESP program since the pilot program several years ago and have found it extraordinarily rewarding. It gave me the idea at the 2021 Virtual Annual Meeting to invite an ESP to co-chair the Presidential Plenary with me. I was pleased to co-chair last year with Shabnum Patel, and this year will welcome Nisha Durand.
Credit goes to the ISCT Head Office and ISCT leaders for two significant improvements to main platforms for our education and communication. Firstly, the ISCT website was revised and upgraded following engagement and input from a wide selection of members. The richness of our ISCT resources and activities was always there. Now it is more much accessible, organized, and expanded. Just take a look at the Resources Library. Secondly, in the early days of the Society, the Telegraft originated as a paper snail mailed newsletter, evolved into an email with links, and is now fully integrated into the ISCT website as the Telegraft HUB enabling our members to connect, read top news and key articles covering cell and gene therapy translation, and to connect with peers though various ISCT Communities.
In a previous Telegraft column, I made the analogy between the three pillars of the ISCT- Scientific, Regulatory and Quality Operations, and Commercialization, as akin to the Rosetta Stone. In the same way that the Rosetta Stone serves to align and translate three languages, the three pillars of ISCT serve to align and integrate diverse disciplines. Only in this way can the translation of advanced cell and gene therapies accelerate. Enhancing knowledge integration among diverse fields through cross-fertilization and educational initiatives was another one of the core themes of my 2018 election nomination statement. ISCT has educational initiatives of all flavors. Of recent note is the Andalusian Network for the Design & Translation of Advanced Therapies (ANd&tAT), an online education program for ISCT members based on core topics from the Master in Manufacturing of ATMPs at the University of Granada/ANd&tAT in which 3 full tuition scholarships were awarded for ISCT EU members. Another educational program recently announced is the Workforce Development in Biomanufacturing, a global partnership with ISCT and the U.S. National Science Foundation funded center Cell Manufacturing Technologies (CMaT). We are now welcoming the first cohort of trainees; registration will close May 11th. ISCT has engaged and been engaged with many organizations with complementary expertise, many of which are seeking our expertise. The World Health Organization not only selected the Society journal Cytotherapy to publish on the harmonization of International Nonproprietary Names definitions for cell and cell-based gene therapy substances, but also recently requested the input of ISCT key subject matter experts in considerations on Regulatory Convergence of Cell and Gene Therapy Products. We are excited about continuing our collaboration with the WHO on these and other important issues. The ISCT impact is local to global.
What percentage of your friends and family can accurately recount to you the technology, policy and ethical issues surrounding CAR T cells, germline gene editing, in vivo gene editing, RNA vaccines, regulatory agency review and approval? What about the general public? In 2018 I wrote, “The science and technology behind these discoveries is less accessible to the general public than ever, and opportunists market unproven therapies to the vulnerable.” Because of this, in addition to our internal facing educational initiatives for the benefit of members, we must also continue and augment our outreach to the public, to patients, to regulators and governments. What began as the Presidential Task Force on Unproven and Unethical Cell and Gene Therapies is a central element of the ISCT outward facing educational and communication goals. It became evident that this task force had evolved into a standing committee given its importance and level of activity. It was also evident that we needed to reframe the scope to include more than unethical opportunists. With input from a group of ISCT leaders, we considered a name change to reflect our goals of promoting the role of rigorous ethical research and appropriate investigation and application of cell-based therapies. To that end, the task force became the Committee on the Ethics of Cell and Gene Therapy (ECGT) and recruited new members with complementary legal and regulatory expertise and geographic diversity.
In 2020, with the onset of the pandemic and social unrest, I thought we should communicate our ISCT outward facing persona by implementing a Values Statement to complement our Mission and Vision Statement. If the Mission Statement is to answer “Why do we exist?” and the Vision Statement is “What is our goal?”, the Values are “How will we accomplish it?” Our ISCT Values Statement is five core tenets that we hold to be true. That we:
- Promote innovation in translational research
- Strive for excellence in everything we do
- Respect and support diversity and inclusivity
- Uphold the highest ethical standards
- Serve our members and advocate for our society
These values get to our ISCT identity. With the field innovating and expanding rapidly, we want to ensure our character and the ISCT family feel is maintained and reinforced as our membership continues to grow and grow. At 2018 year end, ISCT membership totaled 1,425, at 2021 year end membership totaled 2,284. For 2022, with five more months still to go for membership interest, we are trending approx. 50% higher than 2021.
As our ISCT community has grown in so many ways, I want to emphasize these initiatives are a direct result of our membership’s energy and enthusiasm for our mission. Together we are stronger than any one sector, than any one region. As President Elect and for the past two years as your President, I have had unique insight to the Society and to the efforts of a select group of people some may not know or may only know by name. Great amounts of unmitigated praise must be heaped on ISCT CEO Queenie Jang, and her team in Head Office: Audrey Le, Kim Shand, Meagan Pasternak, Felix Grignon, Simone Stickland, Rosalie Ho, Shelby Calvert, Oliver Tang, Elizabeth Lam, and Abe Granat. It is no exaggeration to say they keep the ISCT train running, and consistently going above and beyond to support our mission. I owe great thanks to the ISCT Officers serving on the Executive Management Committee and the ISCT Board of Directors, as well as all of our Regional Leadership, Committee Chairs, Co-Chairs, Committee Members, and the ISCT membership at large. I would like to personally thank ISCT Immediate Past President John Rasko for his mentorship and service to the Society. Jacques Galipeau, my friend, the gavel which I received virtually from John in virtual Paris will soon be hand delivered to you. I trust that you will lead the Society with insight, intelligence, and camaraderie.
In the opening scene of the movie Forrest Gump, Forrest is on a bench befriending a stranger offering her chocolate and says, “My momma always said ‘life is like a box of chocolates, you never know what you are going to get.’” At the beginning of 2020, we did not know we were going to get a global pandemic of epic proportions. I am proud of and grateful for the efforts of all in the progress that ISCT has made over the past two years despite these significant headwinds. And we persist, we will meet in person for our Annual Meeting in San Francisco, and we will thrive on the energy of our membership. Remember, don’t be afraid to try new things, talk to strangers, everyone can be insightful, stay optimistic, and do what you love.