Clinical Cell Therapy Leadership Micro Course

Clinical Cell Therapy Leadership Micro Course

Developed by world-renowned leaders in Cell and Gene Therapy (CGT) directing the biennial ISCT Cell Therapy Leadership Training Program, the Cell Therapy Leadership training micro-course is an 10-hour on-demand course designed for Principal Investigators, Clinical Development Scientists, and Industry professionals involved in translational research, product development, and clinical trial sponsorship.

You will learn how to effectively navigate the complexities of bringing CGT products from bench to bedside, with comprehensive insights into critical areas such as IND submissions, clinical trial design, GMP standards, Quality Assurance, Technology Licensing, and patient access. 

Self-paced
10-hour training
WHAT YOU WILL LEARN
  • Key considerations for translating research to clinical manufacturing
  • Key insights for effective IND submissions
  • Analytical approaches to study design, product safety and release criteria to support clinical decision-making and regulatory approval
  • Correlative studies in assessing gene transfer, immunogenicity, and toxicity 
  • Strategic implementation of GMP standards in cell and gene therapy manufacturing
  • Insights into optimizing viral vector production and release testing
  • Leading effective cell therapy teams
  • Regulatory insights for establishing robust quality systems in early product development for meeting regulatory requirements
  • CAR-T and gene therapies cost structure
  • Academia-to-industry partnerships, IP production, and commercialization pathways

PRICE (USD)
IISCT Members INon-Members
Academia $500 $1230
Industry $930

Did you know you can become an ISCT member for as little as $55/year? Learn more about ISCT membership benefits here.

For full details on our course policies, including cancellations, complaints and appeals processes and our privacy policy, click here.

DESIGNED FOR:

Clinical development scientists, principal investigators, industry professionals sponsoring clinical trials, fellow-in-training, junior faculty members, and clinicians focusing on CGT product development and commercialization.

ACCREDITED BY:

10 CMLE Hours

UPON COMPLETION, YOU WILL RECEIVE:
  • 10 CMLE Credits
  • Certificate of Course Completion from ISCT

Note: Completing all training modules and passing the quizzes is mandatory to receive a course completion certificate. 

CELL THERAPY LEADERSHIP MICRO COURSE PLANNING FACULTY 

Bruce Levine, PhD
Barbara and Edward Netter Professor
University of Pennsylvania

Philadelphia, PA, United States



Emily Hopewell, PhD
Assistant Professor
Director Cell and Gene Therapy Manufacturing
Indiana University
Indianapolis, IN, USA


Andrew Fesnak, MD
Assistant Professor of Clinical Pathology and Laboratory Medicine
Perelman School of Medicine
Director, Cell Manufacturing and Development, CVPF
University of Pennsylvania
Philadelphia, PA, USA



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Cell Therapy Leadership Training Program

Format: In-person training and mentoring
Length:
5-day training

A premier ISCT scholarship initiative that integrates advanced training and mentorship from world-renowned CGT experts to develop future CGT leaders.