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.

Based on Past Participant Survey Results (Clinical Cell Therapy Leadership, 2025)

98%

Said the course content was relevant

98%

Felt the course was well organized with adequate time

97%

Rated the in-process and release testing content highly

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

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.

Price (USD)

Category	ISCT Members	Non-Members
Academia	$500	$1230
Industry	$930	$1230
Tier 1 and Tier 2 Reduced Rate	$350	N/A
15% Group Registration Discount available for 5+ Members / Non-Members from the same institution

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.

Group Registration Discount:

Receive 15% off when registering 5+ ISCT Members / Non-Members from the same company or institution.
Contact ISCT at workforcedevelopment@isctglobal.org to obtain the discounted Group Registration Rate.

Pre-clinical development and translational strategy (T cells, iPSCs, gene editing, safety/efficacy data)
IND development, eCTD format, and CMC requirements for regulatory submission
Clinical trial design and analysis (endpoints, release criteria, stopping rules, safety, biomarkers)
GMP cell manufacturing principles, tech transfer, raw materials, and patient-specific production
Viral vector manufacturing challenges and release testing for clinical use
In-process and release testing, potency assays, and qualifying release tests to GMP standards
Quality systems and QA development for early-phase studies and compliance readiness
Correlative studies and immune monitoring (gene transfer, immunogenicity, toxicity, durability)
Team science and building cross-functional programs for product delivery
Commercialization, licensing, IP protection, and academic–industry partnerships
Cost models, reimbursement realities, and patient access challenges in CGT

ELIGIBILITY REQUIREMENTS

None

AS PART OF THIS COURSE, YOU WILL RECEIVE:

10 CMLE Credits
CMLE Certificate upon successful completion

ACCREDITED BY:

24 CMLE Hours

What Past Participants Are Saying

“All the lectures in the course were very interesting, and the speakers demonstrated great expertise in the subject. One of the most engaging sessions was ‘Cell Manufacturing for CGT Applications,’ which addressed the operational requirements and challenges of translating therapies from research to commercialization. The close interaction between coordinators and students made us feel welcome and helped deepen our knowledge.”

Julia T.

“All of it was amazing and taught me so much. I can’t pick a highlight — the entire experience was unforgettable. I learned extensively about CAR T-cell work beyond the experimental phase, including IND writing, clinical trial design, manufacturing, quality control, and future in vivo approaches.”

Dr. Krishna V.

“I absolutely loved every moment of the course. Each topic was enlightening, and I gained valuable knowledge throughout. My favorite part was interacting with mentors and receiving feedback on our projects, along with the session on bioprocess development and quality by design for cell and gene therapies.”

Gaby L.

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

NEW - Clinical Cell Therapy Leadership Micro Course

Clinical Cell Therapy Leadership Micro Course

CELL THERAPY LEADERSHIP MICRO COURSE PLANNING FACULTY

Questions?