2017 ASBMT - ISCT Cell Therapy Training Course
Applications are Now Being Accepted for the 2017 ISCT-ASBMT Cell Therapy Training Course!
Scholarship Applications are now open! For more information and to apply, please click here.
ISCT-ASBMT Cell Therapy Training Course
Application period: December, 15, 2016 - March 1, 2017
Tuition, travel, housing, and meal expenses will be paid by ISCT, ASBMT, and corporate sponsors for up to 12 scholars to attend the course. Participants will be competitively selected. Preference will be given to fellows and faculty with no more than two years of BMT and Cellular Therapy experience following training or a faculty appointment.
Objectives and Curriculum
The ISCT/ASBMT Boards of Directors created the course because of concerns that there is an unfulfilled need for cell therapy training covering the process of translational research to cell manufacturing and clinical trials in cellular therapy including regulatory components. The course has four elements: (1) a proposal for a cell product by the scholar presented at the beginning of the course and refined in small group discussion with faculty before presentation of a final version at the end of the course; (2) visits to GMP facilities manufacturing cell products; (3) didactic lectures; (4) round tables and informal discussions with faculty.
The course aims to cover:
- Development of Investigational New Drug [IND] – Applications and the chemistry, manufacturing and control documentation required to support them. This will include collation of pre-clinical data, preparation of SOPs & worksheets, development of release criteria, establishment of quality indicators, validation of procedures, training of staff, and pre-clinical Pharm/Tox studies.
- Translating Project to GMP Facility – Translational research design and execution. Full scale engineering runs and final process qualification, developing QA and QC programs.
- Development of Manufacturing and Testing Procedures to Provide Clinical Products and the Accompanying Documentation for the Trial Including – PGMP infrastructure, inventory management, environmental monitoring, cleaning & changeover, production monitoring, coordination of product testing, competency & proficiency testing, SOP creation, review & revision, performing audits, review quality indicators, developing stability testing.
- Product Release & Follow-up – Assembling batch/manufacturing records, collate test results, Issuing certificate of analysis, perform audits, controlled GMP storage, release for administration, product follow-up and recall.
- Protocol Development – Inclusion of correlative studies.
- Infusion Cell Therapy Products – Pre-infusion conditioning, monitoring infusion reactions, patient follow-up.
- Clinical Trial Design – Including research subject eligibility and recruitment, biostatistics, clinical trial conduct, regulatory approvals, monitoring adverse effects, long-term follow-up (correlative studies), research ethics.
- Team Science – Approaches to forming and sustaining a multi-disciplinary translational research team. Collaboration between laboratory and clinic, communication, strategies for pursuing and developing a successful career in cell therapy.
The 2017 Course Directors are John Barrett, MD, Senior Investigator at the National Heart, Lung, and Blood Institute and Dave DiGiusto, PhD, Executive Director, Stem Cell and Cellular Therapeutic Operations, Stanford Hospital and Clinics.
The faculty for the course will be established investigators, participating for multiple days to work with and mentor the trainees.
The faculty members will share their career stories and anecdotes. They will tell how they got where they are and the lessons learned along with way. Free time for rest, recreation, and creative thinking will be built into the schedule.
Eligibility and Application
This program is open to all geographic regions. Geographical scholar representation will be six from North America (US/Canada/Mexico) and six international scholars outside of North America.
An applicant must be a Fellow-in-Training or have a Junior Faculty position and must be an ISCT and/or ASBMT member and sponsored by an ISCT and/or ASBMT member. For purposes of this program, "junior faculty” is defined as two years or less teaching in the BMT and Cellular Therapy field. Other applicants may be considered based on perceived need and it is judged that they would benefit from the course.
- A 2-5 page letter of application is required, providing the applicant’s background, training, interest in cellular therapy and clinical research, career goals, and an outline of a translational research project in cell therapy to be further refined during the course.
- Details of the proposed translational research project should be a major portion of the application letter. The applicant must have a mentor from his/her institution whom to work in implementation of the project after the course.
- Applicants must also submit a letter of recommendation from their mentor to be considered.
Applicant selection will be based on curriculum vitae, proposed translational cellular therapy project, the quality of mentor supervision available and, all other things being equal, regional representation.
Particular attention and weighting will be placed on the applicant’s reasons for attending the course. This should be explained in the letter of application.
Please send applications and attachments to Maureen Knight, ASBMT Project Manager at email@example.com.