INTERNATIONAL TRAINING COURSE - CAR-T and Gene Therapy Specialist - ICMED
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
INTERNATIONAL COURSE
CAR-T and Gene Therapy Specialist
1 INTERNATIONAL EDITION – JUNE 2021
17 – 18 – 19 June 2021
From 3.00 pm to 8.00 (GMT+1)
INTERNATIONAL TRAINING COURSE
CAR-T and Gene Therapy Specialist
ICMED s.r.l - Via Fratelli Casiraghi 34 - 20099 Sesto San Giovanni (MI)
Email: info@icmed.net
INTERNATIONAL COURSE
CAR-T and Gene Therapy Specialist
1 INTERNATIONAL EDITION – JUNE 2021
Background
In recent years the development of new “living drugs” capable of "engaging" the patient’s immune system led
to unprecedented clinical results, especially for cancer therapy. Cellular therapies represent one of the principal
approaches for personalized medicine for diseases that have limited therapeutic options. High-quality
standards are needed for the management of cell therapy drug products (for both commercial and non-
commercial use) and qualified personnel is required for the clinical organization and project and quality
management.
,
Objective
This training course aims at providing the technical and practical knowledge for the management of CAR-T and
Gene Therapy projects (commercial and non-commercial). In this context, the role of CAR-T and Gene Therapy
Specialist will be defined and personnel with this role will be trained.
The course qualifies operators with a both the perspective of the clinical unit and of the pharmaceutical
company/sponsor. In particular, the following topics will be analyzed and discussed:
• the cycle of preparation of CAR-T/Gene Therapy products.
• The subjects involved in the process and their different roles.
• The international standards of quality for CAR-T Cells and Gene Therapy products.
• The organization of a CAR-T Center and Gene Therapy Unit.
• The quality system of a CAR-T Center and Gene Therapy Unit.
Target Audience
Healthcare personnel involved in the Stem Cell transplant Center and CAR-T Centers Gene Therapy units and
personnel employed at pharmaceutical companies, such as:
• Hematologists
• Oncologists
• Medical transfusionists
• Biologists
• Pharmacists
• Nurse staff
• Researchers
• Quality and data managers
• Pharma medical directors
• Pharma field specialists
• Study monitors
• Study coordinators
ICMED s.r.l - Via Fratelli Casiraghi 34 - 20099 Sesto San Giovanni (MI)
Email: info@icmed.net
INTERNATIONAL COURSE
CAR-T and Gene Therapy Specialist
1 INTERNATIONAL EDITION – JUNE 2021
Program
The training course is organized in 3 days and at the end there will be a final examination.
Once passed the final exam, the participant will be awarded a certificate of "Car-T Specialist and Gene Therapy
Expert" and will be inserted in the official international list of CAR-T and Gene Therapy Expert.
DAY 1: Regulatory and documentary requirements for the start-up of a Car-T Center/Gene-Therapy
Unit
The first module is aimed at analyzing the compliance of the CAR-T/Gene Therapy Center/Unit with the international
legislation of tissues. The role of the "Car-T and Gene Therapy Specialist " will be described both in the context of health
care institution/hospital and pharmaceutical company) according to the following:
• General introduction to Cell and Gene Therapy
• The management process of CAR-T and Gene Therapy products
• Clinical Trials and Cell/Gene therapy process
• The quality organization of a CAR-T Center and Gene Therapy Unit
• The international quality standards (JACIE e JACIE-FACT)
DAY 2: The organizational system in a Car-T and Gene Therapy Unit and the qualification process
The second module is aimed at examining the development of the organizational system for CAR-T and Gene Therapy
Unit and the evaluation process carried out by a pharmaceutical company, in order to qualify the center.
• The role of the CAR-T /Gene Therapy Specialist in the vision of the sponsors of the study.
• The role of the CAR-T Gene Therapy Specialist in the context of the clinical Center/Unit.
• How to define and structure the organizational system of a Car-T Center/Gene Therapy Unit.
• The qualification process of the pharmaceutical company
• Experience from some Car-T Centers**
DAY 3: The Leukapheresis process and the role of the Pharmacist
The third module is aimed at evaluating the facility, equipment, procedural and organizational requirements for procedure
of leukapheresis/apheresis. Moreover, the role of the pharmacist in the CAR-T and Gene Therapy process will be
defined.
• The process of leukapheresis/apheresis.
• Performance indicators.
• The validation of the processes.
• The role of the pharmacist.
• The acceptance and management of the drug product.
FINA ASSESSMENT: the final exam will allow the attendee to obtain the certificate of
"INTERNATIONAL CAR-T and GENE THERAPY SPECIALIST"
ICMED s.r.l - Via Fratelli Casiraghi 34 - 20099 Sesto San Giovanni (MI)
Email: info@icmed.netINTERNATIONAL COURSE
CAR-T and Gene Therapy Specialist
1 INTERNATIONAL EDITION – JUNE 2021
Speakers
Dr. Vincenzo Iaconianni
Vincenzo Iaconianni is the CEO of ICMED s.r.l., an Italian company specialized in consulting and
education in Healthcare. ICMED s.r.l. He is consultant of stem cell transplant centers, biobanks, GMP
facilities and support their path until the accreditations and certifications according to the international
standards. Moreover, ICMED s.r.l. designs and organizes specialized training course in the field of
CAR-T, GCP, GMP and quality concepts.
Dr. Cristina Maccalli.
Dr. Maccalli is a Principal Investigator at the Laboratory of Immune and Biological
Research Department, Sidra Medicine. Her expertise is in the field of immunology, tumor immunology
and immunotherapy. Her interest is aimed at the development of precision medicine approaches
based on immunology and immunotherapy for cancer patients. Main focus is on the manufacturing,
molecular and functional characterization of T-lymphocytes engineered with Chimeric Antigen Receptor (CAR) for
targeting of hematological and solid tumors.
Dr. Maria Giuseppina Cefalo*
Dr. Cefalo is a Phase 1 Unit Coordinator in Bambino Gesù Children’s Hospital, Hemato-Oncology
and Cell/Gene Therapy Department from March 2019. After the Medical degree “cum laude” at
Catholic University of Sacred Heart, Rome (Italy), dr. Cefalo post-graduated in Pediatrics at Catholic
University of Sacred Heart, Rome (Italy). Now, Dr. Cefalo is the Phase 1 Unit Coordinator in Bambino
Gesù Children Hospital.
Dr. Fredrick L. Locke
Frederick L. Locke, MD is a medical oncologist and translational investigator dedicated to discovering
and implementing ways to use the immune system against lymphoid malignancies. He is the Co-
Leader of the Immuno-Oncology Program at Moffitt Cancer Center, where he also serves as Vice-
Chair and an Associate member in the Department of Blood and Marrow Transplant and Cellular
Immunotherapy. Dr. Locke oversaw the creation, and leads, Moffitt’s Immune Cell Therapy (ICE-T)
program. This cross departmental effort provides specialized care of high-risk immunotherapy and cellular therapy
patients, regardless of tumor type. Dr. Locke is a first or senior author on numerous high impact publications, including
articles in the New England Journal of Medicine, Lancet Oncology, Journal of Clinical Oncology, JAMA Oncology, and
Blood.
Date Online Training
Thursday, 17 June 2021, 3.00 pm to 8.00 pm (GMT +1)
Friday, 18 June 2021, 3.00 pm to 8.00 pm (GMT +1)
Saturday, 19 June 2021, 3.00 pm to 8.00 pm (GMT +1)
Fees (plus VAT)
Euro 1.500 + VAT 22%
Registration fee: Euro 250 + IVA 22%
Registration
You register online at www.icmed.net
Presentations
The presentations will be made available on your website personnel area before the online meeting.
ICMED s.r.l - Via Fratelli Casiraghi 34 - 20099 Sesto San Giovanni (MI)
Email: info@icmed.netINTERNATIONAL COURSE
CAR-T and Gene Therapy Specialist
1 INTERNATIONAL EDITION – JUNE 2021
Technical Requirements
For our webinars, we use ZOOM, one of the leading suppliers of online meetings. At http://www. https://zoom.us/test you
can check if your system meets the necessary requirements for the participation at a ZOOM meeting and at the same time
install the necessary plug-in. Please just enter your name and email ad - dress for the test. If the installation is not possible
because of your rights for the computer system, please contact your IT department. ZOOM is a standard nowadays and
the necessary installation is fast and easy.
ICMED s.r.l - Via Fratelli Casiraghi 34 - 20099 Sesto San Giovanni (MI)
Email: info@icmed.netYou can also read
