About PIVOT
The Pediatric Preclinical In Vivo Testing consortium (PIVOT) provides rigorous preclinical testing of novel molecularly targeted agents using in vivo models of pediatric cancer. PIVOT is an extension and expansion of two previous, highly successful NCI programs: Pediatric Preclinical Testing Program (PPTP; 2004-2014) and Pedatric Preclinical Testing Consortium (PPTC; 2015-2021). PIVOT consortium members have decades of experience in developing and using in vivo models to advance treatment options for the most common childhood cancers.
Background: The Research to Accelerate Cures and Equity (RACE) for Children Act of 2017 requires companies developing targeted cancer drugs for adults to evaluate those drugs for applicability to pediatric cancer. The RACE for Children Act was signed into law in August 2017 as Title V of the FDA Reauthorization Act to amend the Pediatric Research Equity Act (PREA) (21 U.S. Code 355c)
Under the RACE Act, all New Drug Applications (NDA) or Biologics License Applications (BLA) for new active ingredients “intended for the treatment of an adult cancer” and “directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer” must include an investigation to provide “data regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling”. The FDA’s list of over 200 potentially relevant molecular potential pediatric targets can be found here.
PIVOT Consortium Members
| Specialization | Institution | Principal Investigator(s) |
|---|---|---|
| Program Oversight and Regulatory Assistance | National Cancer Institute | Malcolm A Smith, MD, PhD Beverly Teicher, PhD |
| Coordinating Center | The Jackson Laboratory and Seven Bridges | Carol J Bult, PhD Jeffrey H Chuang, PhD Emily Jocoy, PhD Dennis Dean, PhD |
| Brain Tumors | Ann & Robert H. Lurie Children's Hospital of Chicago | Xiao-Nan Li, MD, PhD |
| Childhood Leukemia | Children's Cancer Institute | Richard Lock, PhD |
| Neuroblastoma | The Children's Hospital of Philadelphia | Yael Mosse, MD John M Maris, MD |
| Sarcomas and Other Solid Tumors | Memorial Sloan Kettering Cancer Center | Andrew Kung, MD, PhD Filemon Dela Cruz, MD |
| Ewing sarcoma, Rhabdomyosarcoma, Kidney, and Liver cancers | Greehey Children's Cancer Research Institute | Peter Houghton, PhD Raushan Kurmasheva, PhD |
| Ostesarcoma | The University of Texas MD Anderson Children's Cancer Hospital | Richard G Gorlick, MD |
| Soft Tissue Sarcomas | St. Jude Children's Research Hospital | Michael A Dyer, PhD Elizabeth Stewart, MD |