Our Organization

Administrator: Luca G. Capicchioni

Executive Assistant: Debbie Saucedo

Purpose: Oversee finances and support coordinate ensure the effective operations of the Center

Roles Responsibilities:

• • Oversee and facilitate communication among Center members and programs
  • Organize and coordinate Center meetings
  • Maintain, oversee and administer the Center budget
  • Organize Annual Jonas Center Cell Therapy Symposium and the Rowley lecture
  • Oversee Membership
  • Promote and coordinate philanthropic efforts with Development Office
  • Develop and maintain Center website

Associate Director: Mylove Mortel

Purpose: Facilitate the proper conduct of cellular therapy clinical trials

Roles Responsibilities:

• • Coordinate and oversee research nurses and clinical research associates to support the conduct of cellular therapy clinical trials
  • Ensure that clinical trials are conducted in compliance with all applicable federal regulations, ICH/GCP guidelines, and institutional policies
  • Ensure accurate, complete, and timely data collection and reconciliation of data discrepancies
  • Ensure compliance with FACT guidelines and accreditation
  • Ensure accurate and timely data entry for CIBMTR reporting
  • Maintain database for the cell therapy biorepository
  • Facilitate FDA IND submissions for cell therapy

Associate Director: Peter Riedell, MD

Clinical Director: Satya Kosuri, MD

Purpose: Oversee and coordinate cellular therapy clinical research at the University of Chicago

Roles Responsibilities:

• • Facilitate and ensure the proper conduct of cellular therapy clinical trials
  • Provide critical review and prioritization for all clinical cellular therapy protocols
  • Ensure the safety and rights of human subjects participating in clinical trials
  • Facilitate continuity of medical care during study participation
  • Support research and development of investigator-initiated clinical trials
  • Conduct and oversee DSM for all cell therapy clinical review

Director: Amittha Wickrema, PhD

Purpose: Support translational and clinical research involving cellular therapeutics

Roles Responsibilities:

• • Manufacturing cell and gene biotherapeutics
  • Assist investigators in planning and conducting cell therapy clinical trials
  • Assist in the preparation of grant applications to fund trials involving the core and for Investigational New Drug (IND) applications to the FDA
  • Assist in the preclinical development, scale-up, and validation of cellular products and vaccines

Facility Description

The Advanced Cellular Therapeutics Facility (ACTF) is located within the Medical Center and is part of the Jonas Center for Cellular Therapy. The new state-of-the-art facility was commissioned and activated in December of 2018 and occupies approximately 8,000 square feet in the Duchossois Center for Advanced Medicine (DCAM). The ACTF is FDA-registered (FIN 3004775432) to manufacture Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps).  The facility is also FACT accredited.

Our team is highly trained and skilled, with over 70 years of combined experience in cellular processing and manufacturing for clinical applications. The ACTF is capable of processing and manufacturing cells under 361 and 351 regulations as described in 21 CFR. Cell processing suites include both ISO7 (cGMP) and ISO8 (GTP) spaces along with multiple support spaces for cellular therapy product development. Recently, the facility has initiated the manufacture of CAR-T cells using closed platforms.

Associate Director: Justin Kline, MD

Purpose: Lead and coordinate a team science approach to address key scientific questions to develop personalized cell therapies to treat cancer and other diseases

Roles Responsibilities:

• • Coordinate and foster selected key research efforts on cellular therapeutic within CCC and throughout UCM
  • Support early, high-risk yet promising laboratory research related to cellular therapy through engagement with laboratory and clinical investigators and start-up funding
  • Link laboratory and clinical investigators to share and discuss scientific advances and clinical issues related to cellular therapy and specific diseases
  • Advance basic and pre-clinical discoveries into the clinical phase of development for initial evaluation