American medicine is in the midst of an evolutionary change in the way we care for patients. While we have historically relied exclusively on drugs, we are now increasingly turning to complex cellular therapies especially for genetic disorders, infections, and recalcitrant cancers that have eluded developmental therapeutics. Recognizing the potential power of cellular therapies, Children’s Healthcare of Atlanta has establish the Marcus Center for Cellular Therapy to drive our institution to the forefront of novel cell-based therapeutics in an effort to develop new paradigms for the treatment of pediatric diseases. The Center will foster multidisciplinary scientific collaboration towards development of novel cellular therapies and will facilitate the rapid translation of new discoveries into clinical trials through provision of targeted infrastructure and expertise to meet these objectives. Our unwavering goal, is to facilitate successful translation of promising preclinical “home-grown” research into early phase clinical trials in the most expeditious fashion.
To accomplish this lofty goal, the Center will provide two-level grant opportunities designed to fund IND enabling studies. In addition, all center investigators will have access to federal regulatory support without any charge to the investigators. This may include Pre-IND/IND submissions and FDA reporting throughout the study. The Center will maintain an ever-present vision of developing home-grown science into broadly applicable therapies to cure childhood diseases.
Learn more about our mission and plans by viewing the recording of the May 3, 2019 Launch Event Seminar. Click here.
The Marcus Center for Cellular Therapy offers resources for moving translational research into the clinical phase.
- FDA regulatory affairs support
- Consultations on proposed cell and gene therapy studies
- Symposia to discuss latest research and network for new collaboration
- Seminar series
MCCT provides complimentary regulatory support, guidance, and education services to cellular therapy investigators navigating the US Food and Drug Administration (FDA). Examples of services include:
- Education and consultations
- Pre-IND submissions
- IND/IDE initial application submission and continued maintenance
- FDA Annual Reports
- FDA Amendments
*At this time, our regulatory support is tailored specifically towards interactions with the FDA. All investigators will need to work with their division to identify a research team/coordinator for study oversite, protocol preparation, and IRB approval/maintenance.
Contact:
Kristen Herzegh, MPH, RAC
Senior Regulatory Specialist
