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

SpecializationInstitutionPrincipal Investigator(s)
Program Oversight and Regulatory AssistanceNational Cancer InstituteMalcolm A Smith, MD, PhD
Beverly Teicher, PhD
Coordinating CenterThe Jackson Laboratory and
Seven Bridges
Carol J Bult, PhD
Jeffrey H Chuang, PhD
Emily Jocoy, PhD
Dennis Dean, PhD
Brain TumorsAnn & Robert H. Lurie Children's Hospital of ChicagoXiao-Nan Li, MD, PhD
Childhood LeukemiaChildren's Cancer InstituteRichard Lock, PhD
NeuroblastomaThe Children's Hospital of PhiladelphiaYael Mosse, MD
John M Maris, MD
Sarcomas and Other Solid TumorsMemorial Sloan Kettering Cancer CenterAndrew Kung, MD, PhD
Filemon Dela Cruz, MD
Ewing sarcoma, Rhabdomyosarcoma, Kidney, and Liver cancersGreehey Children's Cancer Research InstitutePeter Houghton, PhD
Raushan Kurmasheva, PhD
OstesarcomaThe University of Texas MD Anderson Children's Cancer HospitalRichard G Gorlick, MD
Soft Tissue SarcomasSt. Jude Children's Research Hospital Michael A Dyer, PhD
Elizabeth Stewart, MD