Cell Therapy Manufacturing

This course discusses the manufacturing of Chimeric Antigen Receptor (CAR) - T cells within an academic GMP facility, along with addressing the challenges associated with integrating this cell therapy into clinical practice.

Learner Objectives:

a.     Understand the steps required to manufacture a CAR-T cell

b.     Describe the limitations of obtaining health insurance coverage for cell therapy

c.      Identify the challenges of adopting cell therapies as standard of care treatment options

d.     Examine solutions for optimizing cell therapy manufacturing

e.     Discuss the goals of the University of Southern California (USC)/Children’s Hospital Los Angeles (CHLA) GMP facility and the California Institute for Regenerative Medicine (CIRM) Alpha Clinic

Course Topics:

1.     Principles of CAR-T cells

2.     Value of CAR-T cell therapy

3.     Roadblocks to CAR-T cell therapy adoption

4.     CAR-T vs. standard care: cost-effectiveness

5.     Cell Therapy Manufacturing

a.     Overcoming challenges

b.     What is cGMP?

c.      Closing the process

d.     Autologous to allogeneic

e.     Viral to non-viral

6.     USC/CHLA CIRM Alpha Clinic

Course Speaker:

Dr. Mohamed Abou-el-Enein, MD, PhD, MSPH is an Associate Professor of Clinical Medicine (Oncology), Pediatrics, and Stem Cell Biology & Regenerative Medicine at USC Keck School of Medicine and serves as the Executive Director of the Joint USC/CHLA Cell Therapy Program. He is also a member of the Norris Comprehensive Cancer Center. 

He is also the Director of the cGMP Core facility at CHLA and the new unit at USC. Dr. Abou-el-Enein is a nationally and internationally recognized expert in planning and executing clinical development programs, designing and operating academic GMP facilities, and in translating cell and gene therapy products from preclinical stage to clinical applications. He has over 11 years of experience in clinical research and regulatory affairs and has successfully brought several cell-based therapies to early phase clinical trials. 

Dr. Abou-el-Enein obtained his Bachelor of Medicine and Surgery (MBBCh) degree from Mansoura University in Egypt in 2005. In 2014, he completed a Masters of Pharmaceutical Sciences and Technologies from the University of Strasbourg in France, a Clinical Research Diploma from Harvard Medical School, and a PhD in the Economics of Manufacturing Clinical-Grade Advanced Therapy Medicinal Products from Charité Medical University in Berlin. He obtained an MPH from the London School of Hygiene and Tropical Medicine and a master’s in manufacturing of advanced Therapy Medicinal Products from the University of Granada in Spain in 2020. 

Abou-el-Enein served as Head of the Clinical Development Platform and Head of Translational Research Unit at the BIH Center for Regenerative Therapies and Berlin Center for Advanced Therapies, respectively, both at the Charité Medical University in Berlin. Abou-el- Enein is one of the inaugural Lawrence Goldstein Policy Fellows of the ISSCR, associate Editor-in- Chief of Molecular Therapy – Methods and Clinical Development, served as regional secretary of the International Society of cell and gene therapy as well as on several other organizations and committees. 

He has been recognized with multiple honors and awards, including the Max-Rubner Prize for Innovation and the Global Eisenhower Fellowship. His publications reflect global leadership in translational development of cell and gene therapy products in top-tier journals such as Cell Stem Cell, BMJ, Lancet Oncology, Molecular Therapy, Nature Biotechnology, Nature Reviews Clinical Oncology. Dr. Abou-el-Enein is a strong advocate for equitable access to safe and effective medical innovations. He is committed to addressing the risk associated with the global rise of clinics marketing unproven stem cell interventions. 

Learner Level: Intermediate / Advanced

Audience:

This course is designed for Clinical Research Coordinators, Clinical Research Nurses, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
• Review the entire activity
• Pass the quiz with 100% of questions answered correctly
• Complete the evaluation at the end
• Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
• Start Date: 05/01/2024
• Expiration Date: 05/01/2027

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information:

This is the third course in a five (5) course program, Innovations in Regenerative Medicine Products.