The UC Davis Cell and Gene Therapy Training Program includes an infrastructure of experienced mentors; facilities essential for basic, translational, and clinical training in stem cell/regenerative medicine and gene therapy; and established graduate programs. The current reporting period provided selected scholars with a carefully planned experience with with core courses including the Ethical, Legal, and Social Implications of Stem Cell Research; Basics of Stem and Progenitor Cells; Literature and Hot Topics in Stem Cell Biology; Cell Culture Training; and addresses topics such as diversity, equity, and inclusion in science, and ensures the competitiveness of trainees for future careers in regenerative medicine and gene therapy in academic institutions and industry.
Reporting Period:
Year 2
Through the initial Alpha Clinic award, we developed the UC Davis/CIRM Cellular Therapy Training Program. This is a two-year program designed to provide a solid foundation in conducting clinical cellular therapy research for MD fellows in the field of cell and gene therapy. This fellowship program is closely linked to the UC Davis Mentored Clinical Research Training Program (MCRTP) through the CTSC. Candidates accepted to this program (2 per year) simultaneously applied to the UC Davis Clinical Research Graduate Group to pursue a Master of Advanced Study (M.A.S.) in Clinical Research degree while participating in the training program. Former trainee Dr. Naseem Esteghamat is now a key faculty member in our BMT and CAR-T programs, leading clinical trials at UC Davis. Former trainee Dr. Ben Waldau is a leading neurosurgeon preforming cell and gene therapy trials at UC Davis. These two are outstanding examples of the success of the program.
In the EDUC4 UC Davis/CIRM Cellular Therapy Training Program program we now additionally include Postdoctoral fellows and Graduate students. To recruit each cohort, an announcement is circulated through our partnering UC Davis CTSC (Clinical Translational Science Center), then graduate students and MD & postdoctoral fellows apply. Successful applicants are selected by an expert committee. Students have didactic coursework and a journal club in cell and gene therapy. Each student is mentored by a team of three experts while participating in the training program, with courses and projects tailored to the field of stem cells and gene therapy.
Our current MD fellows learn how to implement stem cell therapy clinical trials, perform medical monitoring, understand the roles of various members of the clinical staff required to complete the clinical trial, learn the necessity for the Data Safety Monitoring Board (DSMB) and how the members assist in reaching the goal of completing the clinical study. Fellows have ended their training with exposure to and understanding of other critical components unique to stem cell and gene therapy clinical trials. Fellows have worked closely with Dr. Nolta, Dr. Abedi and other mentors who are actively performing Cell and/or Gene Therapy clinical trials and they do have well-rounded education in the logistics of initiating and conducting trials, through immersion in CIRM Alpha Clinic functions. Graduate students and postdoctoral fellows complete basic and translational research with their mentoring team.
This year we have enrolled a total of eight outstanding and diverse scholars in the field of cell and gene therapy. They are contributing greatly to the basic, translational and clinical research at UC Davis, while taking coursework and completing GMP manufacturing certificates as planned. They each have a group of three mentors. We are very fortunate to have them training with our teams at UC Davis.
Reporting Period:
Year 3
We developed the UC Davis/CIRM Cellular Therapy Training Program through the initial Alpha Clinic award. This is a two-year program designed to provide a solid foundation in conducting clinical cellular therapy research for MD fellows in the field of cell and gene therapy. This fellowship program is closely linked to the UC Davis Mentored Clinical Research Training Program (MCRTP) through the CTSC. Candidates accepted to this program (2 per year) simultaneously applied to the UC Davis Clinical Research Graduate Group to pursue a Master of Advanced Study (M.A.S.) in Clinical Research degree while participating in the training program. Former trainee Dr. Naseem Esteghamat is now a key faculty member in our BMT and CAR-T programs, leading clinical trials at UC Davis. Former trainee Dr. Ben Waldau is a leading neurosurgeon performing cell and gene therapy trials at UC Davis. These two are outstanding examples of the success of the program.
We next applied for and were awarded the EDUC4 grant, with PI Dr. Jan Nolta, who is Director of the Stem Cell program and the Gene Therapy Center at UC Davis Health in Sacramento. In the EDUC4 UC Davis/CIRM Cellular Therapy Training Program program we now additionally include Postdoctoral fellows and Graduate students.
To recruit each cohort, an announcement is circulated through our partnering UC Davis CTSC (Clinical Translational Science Center), then graduate students and MD & postdoctoral fellows apply. Successful applicants are selected by an expert committee. Students have didactic coursework and a journal club in cell and gene therapy. Each student is mentored by a team of three experts while participating in the training program, with courses and projects tailored to the field of stem cells and gene therapy. Graduate students and postdoctoral fellows complete basic and translational research with their mentoring team, and through our Monday Morning Program meeting and Speaker Seminar Series, they learn about different ongoing translational projects and clinical studies in our field, happening at UC Davis and beyond.
The program has had a total of four clinical fellows, all enrolled in year 2 (2023) and completing the fellowship this past year (year 3, 2024). We obtained approval from CIRM to carry forward the year 1 funds for fellows to year 2 since we did not get any fellows in year 1.
MD fellows learned how to implement stem cell therapy clinical trials and perform medical monitoring. They were taught the roles of various members of the clinical staff required to complete the clinical trial, the necessity for the Data Safety Monitoring Board (DSMB), and how the members assist in reaching the goal of completing the clinical study. Fellows have ended their training with exposure to and understanding of other critical components unique to stem cell and gene therapy clinical trials by working closely with Dr. Nolta, Dr. Abedi and other mentors who are actively performing Cell and/or Gene Therapy clinical trials. The fellows also have well-rounded education in the logistics of initiating and conducting trials through immersion in CIRM Alpha Clinic functions.
This year (11/01/2023 - 10/31/2024) we have enrolled outstanding and diverse scholars in the field of cell and gene therapy. They are contributing greatly to the basic, translational and clinical research at UC Davis, while taking coursework and completing GMP manufacturing certificates as planned. They each have a group of three mentors. We are very fortunate to have them training with our teams at UC Davis.
Reporting Period:
Year 4
Through the initial Alpha Clinic award to UC Davis we developed the UC Davis/CIRM Cellular Therapy Training Program . This was a two-year program designed to provide a solid foundation in conducting clinical cellular therapy research for MD fellows in the field of cell and gene therapy. This fellowship program was closely linked to the UC Davis Mentored Clinical Research Training Program (MCRTP) through the Clinical Translational Science Center (CTSC). Candidates accepted to this program (2 per year) simultaneously applied to the UC Davis Clinical Research Graduate Group to pursue a Master of Advanced Study (M.A.S.) in Clinical Research degree while participating in the training program.
Former trainee Dr. Naseem Esteghamat is now a key faculty member in our BMT and CAR-T programs, leading clinical trials at UC Davis. Former trainee Dr. Ben Waldau is a leading neurosurgeon performing cell and gene therapy trials at UC Davis. These two are outstanding examples of the success of the program.
We next applied for and were awarded the EDUC4 grant, with PI Dr. Jan Nolta, who is Director of the Stem Cell program and the Gene Therapy Center at UC Davis Health in Sacramento. In the EDUC4 UC Davis/CIRM Cellular Therapy Training Program program we additionally included Postdoctoral fellows and Graduate students.
To recruit each cohort, an announcement is circulated through our partnering UC Davis CTSC, then graduate students and MD & postdoctoral fellows apply.
Successful applicants are selected by an expert committee.
Students have didactic coursework and a journal club in cell and gene therapy. Each student is mentored by a team of three experts while participating in the training program, with courses and projects tailored to the field of stem cells and gene therapy. Graduate students and postdoctoral fellows complete basic and translational research with their mentoring team, and through our Monday Morning Program meeting and Speaker Seminar Series, they learn about different ongoing translational projects and clinical studies in the field of cell and gene therapy.
Our current MD fellows learn how to implement stem cell therapy clinical trials, perform medical monitoring, understand the roles of various members of the clinical staff required to complete the clinical trial, learn the necessity for the Data Safety Monitoring Board (DSMB) and how the members assist in reaching the goal of completing the clinical study. Fellows have ended their training with exposure to and understanding of other critical components unique to stem cell and gene therapy clinical trials. Fellows have worked closely with Dr. Nolta, Dr. Abedi and other mentors who are actively performing Cell and/or Gene Therapy clinical trials and they do have well-rounded education in the logistics of initiating and conducting trials, through immersion in CIRM Alpha Clinic functions.
This year we have enrolled outstanding and diverse scholars in the field of cell and gene therapy. They are contributing greatly to the basic, translational and clinical research at UC Davis, while taking coursework as planned. They each have a group of three mentors. We are very fortunate to have them training with our teams at UC Davis.
Grant Application Details
Application Title:
CIRM Cell and Gene Therapy Training Program 2.0
Public Abstract:
The proposed CIRM Scholars training program is centered within an infrastructure that includes: (1) experienced well-funded mentors; (2) techniques, methodologies, and facilities essential for basic, translational, and clinical training in stem cell/regenerative medicine and gene therapy research; (3) established graduate training programs that provide the spectrum of experiences in predoctoral and postdoctoral training, MD and PhD postgraduate career development, entrepreneurship, responsible conduct of research, rigor and reproducibility, and bioethics; (4) a clinical enterprise that includes a medical school, teaching hospital, community clinics, workforce development programs, training opportunities with core competencies, and a Mentoring Academy; (5) exceptional regenerative medicine infrastructure initiated through prior CIRM funding; (6) core facilities that provide essential expertise in cell and molecular biology, preclinical models, genomics, and informatics/data science, to name a few; (7) a strong, collaborative framework in which to mentor and cultivate scholars with a multidisciplinary team approach, with special emphasis on the recruitment and retention of diverse (underrepresented, disadvantaged) trainees; and (8) community outreach, healthcare engagement, and public education. A strong supportive culture of training and career development is in place which enables expanding the pool and strengthening the pathways of the next generation of diverse scholars who embrace high impact research, team science, and effective community engagement. Core courses for all scholars are coupled with elective didactic courses provided from the extensive course offerings that are tailored to individual scholars needs based on the area of study and as advised by the mentoring team and training program leadership. The program is committed to training investigators in community-engaged research principles and strategies, including communicating science to lay audiences and embracing the role of communities in developing and implementing research programs. The overarching goal is to effectively connect basic and translational investigations with clinical trials and facilitate the identification of new regenerative and gene therapies for patients in need across all age groups.
Statement of Benefit to California:
The CIRM Scholar Research Training Program will provide significant benefit to the State of California and its citizens in the following ways:
• Train diverse scholars to be the next generation of regenerative medicine leaders, advancing basic, translational, and clinical research and serving as mentors for future generations of scholars.
• Develop diverse team-oriented investigators who will facilitate research and engage community partners implementing new cell and gene therapies for a range of human diseases and across all age groups.
• Work with community partners to address health disparities.
• Effectively communicate the science behind new therapies as well as the ethical, legal, and social implications of regenerative medicine and gene therapy research.
Well-trained personnel are needed to eliminate critical bottlenecks in bringing cell and gene therapies to the clinic and to ensure these new therapies will be made available to all patients in need. Training scientists and clinicians committed to the field that remain in the state of California will relieve the statewide shortage. The program will also benefit trainees by providing new workforce opportunities. Over the 10 years of prior funding, our CIRM Training Program included ~60 graduate students, postdoctoral fellows, and clinical fellows that participated in a broad range of stem cell/regenerative medicine research projects. These projects resulted in ~200 publications in peer-reviewed journals. Current positions of former trainees indicate that the majority are in academic or industry positions primarily in California, with others working in healthcare settings, supporting the long-term benefits to California and its citizens. With our recruitment efforts centered on trainees from historically underrepresented groups, and the addition of equity-centered inclusive training practices, the program aims to further increase the diversity of California’s cell and gene therapy expertise thus providing future leaders. The new cohorts of scholars proposed will also be focused on reducing healthcare disparities in California thus providing benefit to a wide range of patients and communities.
